Doctors Medical Center

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 42321 Based on interview and record review, the hospital failed to comply with the regulatory requirements for EMTALA for one of 20 patients (Pt 1) when: Pt 1 arrived by ambulance on 9/27/25 at 12:53 p.m. and Hospital 1 failed to provide the necessary stabilizing treatment for an Emergency Medical Condition (EMC) within the capabilities of Hospital 1’s emergency department (ED). Pt 1, a 13-year-old boy came to the ED after having a witnessed fall in his electric wheelchair at a park. Pt 1 had a medical history of muscular dystrophy (a group of genetic disorders causing progressive muscle weakness and wasting, stemming from gene mutations affecting proteins crucial for muscle health, leading to loss of mobility, difficulty with daily tasks, and sometimes impacting the heart and breathing muscles) and is wheelchair bound. Hospital 1 failed to stabilize Pt 1’s injuries, provide for adequate pain control caused by the injuries and did not follow the instructions of the Orthopedic surgeon from Hospital 2 (receiving hospital) prior to transport. The hospital was aware of the nature of the injury, the age of the patient (13 years old) and the physical disabilities of Pt 1 requiring the use of the wheelchair (WC) and upon arrival to the ED Pt 1’s heart rate was in the 120’s (normal is below 100). Pt 1’s x-rays (images of the body’s internal structures) showed a total of 5 fractures (breaks in bone), and he was only provided 1 mg (unit of measurement- milligram) of morphine (pain medication) during his 8.5-hour ED stay. Pt 1’s heart rate started to trend up to the 150’s and his saturations started to drop; he was placed on oxygen but was transferred without any further treatment to Hospital 2 which was 1.5 hours away. Hospital 2’s orthopedic surgeon on call recommended Pt 1’s bilateral (both) femur (long bone in upper leg) fractures be splinted prior to transfer and this was not done. Pt 1 left Hospital 1 at 9:45 p.m. to Hospital 2 by ambulance with a heart rate in the 150’s that was not addressed. Pt 1’s transfer paperwork was not filled in completely and did not include that the risks of transfer were reviewed with the patient or his mother, last set of vital signs at Hospital 1 not documented and which medical records for Pt 1 were sent. These failures resulted in Pt 1 not being stabilized prior to transferring to Hospital 2. Pt 1 did not receive pain medication until 5.5 hours after arrival and only received 1 mg or Morphine one time, did not have his bilateral legs splinted per Ortho recommendation prior to Transfer to Hospital 2 and was transferred with a heart rate in the 150’s that was not being addressed, and had the potential for Pt 1 and his mother to not be informed of the risks [death, worsening condition, low risk, or other] of being transferred and had the potential to prevent the receiving hospital from knowing the patients’ medical condition, causing delays in emergency care. (Refer to A 2407 and A 2409) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner.”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 42321 Based on interview and record review, the hospital failed to provide the necessary stabilizing treatment for an Emergency Medical Condition (EMC) within the capabilities of Hospital 1’s emergency department for one of 20 patients (Patient (Pt) 1), when on 9/27/25 at 12:53 p.m. Pt 1 was transported to the Emergency Department (ED) by ambulance following a trauma incident involving a fall from his wheelchair and did not stabilize Pt 1’s injuries, provide for adequate pain control caused by the injuries and did not follow the instructions of the Orthopedic surgeon from Hospital 2 (receiving hospital) prior to transport. The hospital was aware of the nature of the injury, the age of the patient (13 years old) and the physical disabilities of Pt 1 requiring the use of the wheelchair (WC) and upon arrival to the ED Pt 1’s heart rate was in the 120’s (normal is below 100). Pt 1’s x-rays (images of the body’s internal structures) showed a total of 5 fractures (breaks in bone) and he was only provided 1 mg (unit of measurement- milligram) of morphine (pain medication) during his 8.5 hour ED stay. Pt 1’s heart rate started to trend up to the 150’s and his saturations started to drop; he was placed on oxygen but was transferred without any further treatment to Hospital 2 which was 1.5 hours away. Hospital 2’s orthopedic surgeon on call recommended Pt 1’s bilateral (both) femur (long bone in upper leg) fractures be splinted prior to transfer and this was not done. These failures resulted in Pt 1 being transferred in pain and not splinted to help decrease movement of fractures causing more pain and his heart rate not being addressed prior to transfer. Upon arrival to Hospital 2, Pt 1 received pain medication, his bilateral lower extremities were splinted and he needed to be placed on 10 L (liters- unit of measurement) nonrebreather (an emergency medical device designed to deliver high concentrations of oxygen-typically 60% to 95%-to patients breathing on their own) for hypoxia (insufficient oxygen levels in bodily tissues, which can be life-threatening and requires immediate medical attention) and was gradually transitioned to nasal canula (NC- a lightweight, flexible, medical-grade tube used to deliver supplemental oxygen). Findings: During a review of Pt 1’s face sheet dated 9/27/25, the face sheet indicated Pt 1 was a 13-year-old (yo) male that was admitted to Hospital 1’s Emergency Department (ED) on 9/27/25 at 12:56 p.m. with a chief complaint (cc) of fall. During a review of Pt 1’s document titled, “EMS (Emergency Services) Patient Care Report (ambulance documentation)” dated 9/27/25, indicated “Nature of Call: Falls ... Dispatch Priority: Emergent ... Response Mode to Scene: Emergent Downgraded to Non-Emergent ... Destination Name: [name of Hospital 1] ... Arrived at Patient: 09/27/2025 12:21 ... Patient Arrived at Destination: 09/27/2025 12:53:55 [12:53 p.m.] ... Primary Impression: Traumatic Injury Initial Patient Acuity: Lower Acuity (Green) ... Medical/Surgical History: Muscular dystrophy (a group of genetic disorders causing progressive muscle weakness and wasting, stemming from gene mutations affecting proteins crucial for muscle health, leading to loss of mobility, difficulty with daily tasks, and sometimes impacting the heart and breathing muscles) ... Detailed Findings ... Face Abrasion to L cheek and forehead ... Knee-Left: Abrasion Knee-Right: Abrasion ... Forearm-Left: Abrasion ... Narrative: Arrived on scene at local park to find 13yo M (male) supine (lying flat on his back) on ground beside power wheelchair. Pt states that while traversing (traveling) a steep incline the power chair was unable to obtain proper traction and began slipping backwards. Mom applied resistance, trying to assist pushing chair uphill but reports that she and wheelchair with son slid down embankment. Mother states that at bottom of embankment chair tipped and son went with chair. Pt was restrained and mother released seatbelts. Mother denies LOC (loss of consciousness) and reports that pt is at baseline mentation and presentation. Pt has injuries as noted in physical assessment portion. Pt groans and grunts but when asked if he is hurting denies any pain or discomfort ...” EMS Report indicated initial vital signs at 12:36 p.m. blood pressure (BP) 116/87, heart rate (HR) 127 (normal is 60-90), respiratory rate (RR) 20, oxygen (O) 94 percent on room air, no pain; at 12:59 p.m. HR136. EMS Report indicated, “ ... Printed Name of Authorized Representative [name of Registered Nurse (RN) 1] ...” During a review of Pt 1’s document titled, “ED Note” dated 9/27/25, at 2:19 p.m., indicated, “Time seen: 09/27/2025 13:28:17 (1:28 p.m.) Chief Complaint: BIBA (brought in by ambulance) from park, cc fall, neg (negative) head strike, neg LOC, GCS (Glasgow Coma Scale, a neurological tool to assess consciousness in patients. 3 (deep coma) to 15 (fully alert)) 15, h/o (history of) muscular dystrophy, WCB (wheelchair bound) History Of Present Illness: 13-year-old male BIBA, accompanied by mother, is presented to the ED ... complaints of fall. Per mother, patient was in his motorized wheelchair, at the park. The wheelchair died and patient began sliding down the trail. His wheelchair tipped over and fell on top of him. Denies loss of consciousness. Patient endorses abrasions to this chest, face, and back. He complains of b/l (bilateral-both) knee pain, left clavicular pain, left foot pain and left wrist pain ... Vital Signs: Last Charted: Heart Rate 129 bpm (beats per minute) (H (high)) (09/27 13:07) Respiratory Rate 20 breaths/min (H) ... blood pressure 116/60 ... Pulse Oximetry 96%... Alert and oriented x 3 (a patient is fully aware of their person, place, and time). No acute distress ... Some facial abrasions ... Extremities: Tenderness to b/l (bilateral- both) knees, excoriations to left knee, tenderness to left foot, tenderness to left clavicle (collarbone), tenderness right medial (middle) clavicle next to manubrium (top of chest bone) ... Initially x-rays were obtained and shows bilateral lower extremity fractures (breaks) of the distal femur (lower part of thigh bone). Discussed with our on-call orthopedic surgeon [MD 2- surgeon who deals with bones] here who recommends consultation and possible transfer to [name of Hospital 2] and pediatric orthopedic surgery. Initial conversation with pediatric orthopedic surgery recommended splint and outpatient follow-up. However, the patients [medical status] likely changed after phone call. Patient became acutely (suddenly) confused and altered along with increased heart rate of 120-130 and desaturation (lowering of oxygen levels in the blood) of 80% (Normal 94-100). He was placed on 2 L (liters- unit of measurement) nasal cannula (plastic tubing used to transport oxygen into the patient’s nose). The patient’s case discussed with [Hospital 2], [Medical Doctor (MD) 3] accepted the transfer. At this time, further imaging was obtained including full body CT (computed tomography scan, is a medical imaging technique used to obtain detailed internal images of the body) imaging and CTA (Computed Tomography Angiography, a non-invasive imaging test that uses X-rays, a computer, and a contrast dye to create detailed 3D pictures of blood vessels and blood flow). Further imaging shows more fractures including the left humerus (long bone in upper arm) ...” The ED Note was completed by MD 1. During an interview on 1/9/26, at 11:35 a.m., with RN 1, RN 1 stated she worked for Hospital 1 from March 2025 to mid-October 2025. RN 1 stated when she came to work for Hospital 1, she did not have any prior ED experience. RN 1 stated she worked on 9/27/25 and was assigned Pt 1 who had presented to the ED for a ground level fall from his wheelchair and had a history of muscular dystrophy. RN 1 stated the area she was assigned to B Pod was for lower acuity patients like a medical surgical area (stable patients). RN 1 stated she was told Pt 1 had a power wheelchair (WC) and while he was at the park the battery died while they were going up a hill and it rolled back, and the child tipped over on the WC. RN 1 stated when she received Pt 1, he said he was not in any pain, he had no IV access, she checked his vital signs, assigned him an ESI of 3 (Urgent: Stable vital signs but requires multiple resources (e.g., labs, X-rays) for diagnosis/treatment (e.g., abdominal pain, persistent fever).) and MD 1 came to see the patient and ordered x-rays. RN 1 stated no medications were ordered at that time. RN 1 stated Pt 1 and his mother left for x-ray, and they were gone for a long time, approximately an hour, and when they got back Pt 1 did not complain of any pain. RN 1 stated, “When we lowered his bed, he looked uncomfortable but once again when asked about pain he said no pain.” RN 1 stated Pt 1’s mom informed her of Pt 1’s fractures. RN 1 stated when she left for lunch Pt 1 was stable and when she came back the Trauma RN was putting in an IV and Pt 1 was being taken to CT and moved over to the trauma area. RN 1 stated she did not recall Pt 1’s heart rate being elevated before she left for lunch and he had been on continuous monitoring since he arrived at her pod. RN 1 stated she was not part of the trauma review done afterwards for Pt 1. RN 1 remembers her manager asked her about Pt 1’s pain level. RN 1 stated Pt 1 looked stable the whole time she had him and does not recall his oxygen saturations dropping. During a concurrent interview and record review on 1/7/26 at 3:30 p.m., with the Interim Director of ED (EDD) and Interim Clinical Operations Coordinator (COC) of ED, Pt 1’s electronic medical records (EMR) for his ER visit on 9/27/25 was reviewed. During the review of the EMR for Pt 1 the EDD and COC stated they recalled doing a trauma review on Pt 1’s ED visit. Pt 1’s EMR for 9/27/25 indicated Pt 1 arrived at the ED on 9/27/25 BIBA at 12:56 p.m. with chief complaint of fall from his electric WC. Pt 1’s EMR contained the following orders and medication administration times: Triage Part 1, Ordered by System. Date/Time 12:58 p.m. Completed by RN 1 at 1:11 p.m. Triage Part 2, Ordered by System. Date/Time 12:58 p.m. Completed by RN 1 at 1:12 p.m. Primary Assessment, Ordered by System. Date/Time 12:58 p.m. Completed by RN 1 at 1:12 p.m. XR (x-ray) Chest 1 View, XR Pelvis 1 View, XR Foot 2 Views Left, XR Knee 1 or 2 Views Right and Left, XR Wrist complete Minimum 3 Views Left, XR Clavicle Left, Stat (now), fall with pain. Order date/time: 9/27/25 1:46 p.m. Ordered by MD 1 XR Femur Minimum 2 Views Right and Left, Stat, Fracture. Order date/time: 9/27/25 4:24 p.m. Ordered by MD 1 XR Shoulder Complete Min 2 Views Left, Stat, Shoulder pain. Ordered date/time: 9/27/25 4:48 p.m. Ordered by MD 1 CT Abdomen and Pelvis with contrast, CT Chest with Contrast, CT Head or Brain without (w/o) contrast, CT Spine Cervical, Lumbar, and Thoracic w/o contrast, Urinalysis with culture if indicated, US Misc Diagnostic Procedure (FAST exam- Focused Assessment with sonography for Trauma- bedside ultrasound used to quickly find internal bleeding, checking abdomen, heart and lungs- often takes minutes and helps MD immediately decide if a patient needs surgery, especially if they are unstable), Trauma Alert Level 2, Stat, Trauma, order date/time: 9/27/25 5:20 p.m. Ordered by MD 1 Complete Blood Count with Auto Differential (CBC- blood test checks your overall health) and Comprehensive Metabolic Panel (CMP- blood test that checks electrolytes, kidney and liver function), blood, Stat, Nurse collect, ordered date/time: 9/27/25 5:23 p.m. Ordered by MD 1 CTA Lower Extremity with contrast Right, Stat, Traumatic Dislocation (bone forced out of normal position). Order date/time: 9/27/25 5:24 p.m. Ordered by NP ED Transfer Patient to Another Facility, Routine, Once, [name of Hospital 2], NPO (nothing by mouth), Bedrest, ordered 9/27/25 5:31 p.m. Ordered by MD 1 XR Elbow Complete Minimum 3 Views Left, Stat, Trauma, order date/time: 9/27/25 5:33 p.m. Ordered by MD 1 XR Elbow 2 Views Left, Stat, Trauma, order date/time: 9/27/25 5:33 p.m. Ordered by MD 1 Iopamidol (contrast dye used for scans) 80 mL, IV, Once, Stat. Order date/time: 9/27/25 6:25 p.m. Ordered by MD 1. Administered at 6:25 p.m. NS (normal saline- sterile solution of salt in water) 0.9 % (percent) 1,000 mL (unit of measurement milliliters), IV infuse over 20 hours, rate 50 mL/hr, order date/time: 9/27/25 6:36 p.m. Ordered by NP. Started at 6:30 p.m. by RN 2. Morphine (pain medication) 1 milligram (mg- unit of measurement) IV Push, Once, Stat, order date/time 9/27/25 6:37 p.m. Ordered by MD 1. Administered at 6:58 p.m. by RN 2 for pain level 7 out of 10. XR (x-ray) Forearm 2 Views Left, Stat, Trauma, order date/time: 9/27/25 6:38 p.m. Ordered by NP Zofran (nausea medication) 4 milligrams (mg) IV Push, Once, Stat, order date/time: 9/27/25 6:59 p.m. Ordered by MD 1. Administered at 7 p.m. by RN 2. Review of Pt 1’s Vital Sign Flow sheet dated 9/27/25, the flow sheet indicated: At 1:07 p.m. Temperature (T) 36.6 Celsius (unit of measurement C. Normal 36-38), Heart Rate (HR) 129 (H-High) beats per minute (bpm- Normal 60-100), Respiratory Rate (RR) 20 breaths per minute (breaths/min- Normal 12-18), Systolic Blood Pressure (BP) 116 mmHG (unit of measurement - millimeters of mercury. Normal 90-138), Diastolic BP 60 mmHG (Normal 45-84), SpO2/Pulse Oximetry (O) 96 Percent (%- of oxygen in one’s blood. Normal 95-100) on room air. No actual or suspected pain. Documented by RN 1 At 4 p.m. Oxygen (O) 93 %. Documented by RN 4. At 4:30 p.m. O 89 % (L-Low) on room air. Documented by RN 4. At 5:25 p.m. HR 132 (H), RR 36 (H), O 98 % on 3 L (liters) nasal cannula (NC), BP 100/64. Documented by RN 4. At 5:30 p.m. HR 137 (H), RR 20, O 99% on 3 L NC, BP 87/75 (L). Documented by RN 2. At 5:40 p.m. HR 139 (H), RR 26 (H). Documented by RN 2. At 6:27 p.m. HR 127 (H), RR 28 (H), O 100 %, BP 117/73. Documented by RN 2. At 6:30 p.m. placed on continuous monitor and vital signs now checked every 10 minutes. HR 132 (H), RR 24 (H), O 100%, BP 115/61. Documented by RN 2. At 6:40 p.m. HR 133 (H), RR 28 (H), O 100 %. Documented by RN 2. At 6:50 p.m. HR 135 (H), RR 24 (H), O 100 %. Documented by RN 2. At 7 p.m. HR 124 (H), RR 28 (H), O 100 %. Documented by RN 2. At 6:58 p.m. Numeric Rating Pain Score 7. Documented by RN 2. At 7:05 p.m. HR137 (H), RR 21, BP 109/63, O 100%. Documented by RN 2. At 7:20 p.m. HR 133 (H), RR 26 (H), O 100 %. Documented by RN 2. At 7:30 p.m. HR 139 (H), RR 26 (H), O 100 %, BP 100/61. Documented by RN 2. At 7:40 p.m. HR 142 (H), RR 25 (H), O 100 %. Documented by RN 2. At 8 p.m. HR 145 (H), RR 27 (H), O 99%. Documented by RN 2. At 8:10 p.m. HR 144 (H), RR 28 (H), O 99 %. Documented by RN 2. At 8:20 p.m. HR 149 (H), RR 20 (H), O 99 %. Documented by RN 2. At 8:30 p.m. HR 150 (H), RR 26 (H), O 99 %. Documented by RN 2. At 8:40 p.m. HR 152 (H), RR 22 (H), O 98 %. Documented by RN 2. At 8:50 p.m. HR 154 (H), RR 21 (H), O 98 %. Documented by RN 2. At 9 p.m. HR 153 (H), RR 18, O 98 %. Documented by RN 2. At 9:12 p.m. HR 158 (H), RR 25, BP 105/82. Documented by RN 2. At 9:45 p.m. Numeric Rating Pain Score 5. Documented by RN 2. During an interview on 1/8/26, at 11 a.m. with MD 1, Pt 1’s ED visit on 9/27/25 was reviewed. MD 1 stated on 9/27/25 Pt 1 was roomed and bedded before he signed up to take care of him. MD 1 stated that he triaged Pt 1 as he had a fall out of his WC. MD 1 stated he had spoken to Pt 1 and his mother at bedside and it was difficult to figure out where his pain was, but that mom stated it was in his legs and his wrists. MD 1 stated he tried to get a bunch of imaging to figure out where his injuries were. MD 1 stated Pt 1 was able to speak to him and was able to tell him he was in pain. MD 1 stated he spoke with the mother of Pt 1 but at the time of the discussion she did not tell him the type of WC, how big it was, and to MD 1’s understanding at the time, Pt 1 had fallen out of the WC. MD 1 stated once he recognized the femur fracture, he reached out to their on-call orthopedic doctor [MD 2] and got a consult and discussed that there were actually two femur fractures, plan to transfer to Hospital 2 and deferred to the Hospital 2’s Orthopedic doctor for splinting recommendations. MD 1 stated Hospital 2’s Orthopedic doctor recommended splinting both of Pt 1’s legs prior to transfer. MD 1 stated the Trauma Nurse helped him contact the Trauma team and they got involved in Pt 1’s care when Pt 1 became unstable and there was a concern for possible embolism (blood clot that can block a vessel). MD 1 stated he remembers more imaging being ordered and he ordered Morphine and Zofran for Pt 1, as Pt 1 had thrown up two times. MD 1 stated he became concerned when Pt 1 became altered and his oxygen level went down. MD 1 stated he spoke with Hospital 2 to update on Pt 1 new findings and new plan to transfer to Hospital 2. MD 1 stated Pt 1 was also found to have a humerus fracture. During an interview on 1/9/26, at 10 a.m. with Trauma RN (RN 2), RN 2 stated on 9/27/25 she started her shift as the Charge Nurse at 3 a.m. and at 6:30 a.m. she took over the Trauma RN role until midnight. RN 2 stated Hospital 1 ED was short staffed on 9/27/25. RN 2 stated as a charge nurse you scan the tracking board and just because she was now the Trauma nurse her CN brain does not shut off, this is when she noticed bilateral femur fractures on the board and it, “Stopped me in my tracks.” RN 2 stated she recalls looking into Pt 1’s chart and seeing his name, age 13 and had already been here for 3-4 hours. RN 2 believe Pt 1 was a level 1 Trauma and was worried she had missed something since she was not assigned this patient. RN 2 stated she went to Pt 1’s Pod, did not see the nurse and noticed Pt 1 was Tachycardic (Tachy-heart rate faster than 100) and Tachypneic (respiratory rate faster than 20 breaths/minute), she spoke with mom at bedside, mom explained his motorized WC battery died and it rolled and fell on top of Pt 1. RN 2 stated she clarified with the mom the WC was a 400 lbs. motorized scooter. RN 2 stated she asked mom about Pt 1 history and mom informed her that Pt 1 has muscular dystrophy and that mom was concerned because Pt 1 was predisposed to embolism. RN 2 stated when she went to speak with MD 1 to see what the plan was, “He told me he had spoken to Ortho and plan was to splint and discharge home.” RN 2 stated she spoke up and did not feel discharging Pt 1 was appropriate in this circumstance. RN 2 stated she walked away and contacted the Trauma Care Manager to clarify when she could call a Trauma overhead since Pt 1 had already been there for 3-4 hours. RN 2 stated she went to tell MD 1 to contact Trauma immediately. RN 2 stated she went back to B Pod for Pt 1. RN 2 went to leave Pt 1 and then the Trauma Nurse Practitioner (NP) showed up to assess Pt 1 and within three minutes all trauma orders were placed. RN 2 stated Pt 1 initially was not on oxygen she believes the NP asked us to put it on him, Pt 1 was on continuous vital signs monitoring and he was having moments of hypoxia (low oxygen saturations). RN 2 stated during the physical assessment of Pt 1 he was crying and saying his legs hurt and as we were trying to put an IV in and when we touched his arm, he was crying again saying his arm was hurting. RN 2 stated we needed a stat x ray to his arm. The x ray showed a humerus fracture. RN 2 stated she was concerned because Pt 1 was tachy, hypotensive (low blood pressure) and had no IV access but the NP was able to get an IV in. RN 2 stated she got Pt 1 stat to CT for trauma, multiple staff went with him, his legs looked like they were naturally crossed, because his legs were not splinted, they had a difficult time doing a full body CTA. RN 2 said he would not fit in the scanner, and she did not feel safe manipulating his legs without a provider present because of the fractures. RN 2 stated they could not get the on-call Ortho to come in to splint Pt 1. RN 2 stated after the CTA she took Pt 1 back to her Trauma area and resumed 100 percent care of the patient. RN 2 stated she made Pt 1 and his mother comfortable, but she was not sure why it took so long to get Pt 1 pain medication. RN 2 stated then, as the Trauma nurse, she received two Level 1 Traumas patients and a Level 2 Trauma patient was coming, so she had to grab one of the intake nurses [RN 3] from the front to finish giving report of Pt 1 to transport. RN 2 stated she gave report to the Medic that had come to transfer Pt 1 to Hospital 2 but the Medic was upset because Pt 1 was not splinted. RN 2 stated she called MD 2 (the ortho MD) and he stated that he declined to splint Pt 1’s legs and wanted us to put a sling on his arm. RN 2 stated she asked MD 2 if he was going to come in and see the patient and he said he would, “review the x-ray and get back to me”, he wanted Hospital 2 to splint Pt 1. RN 2 stated she helped RN 3 to put Pt 1’s arm in a sling prior to leaving. RN 2 stated RN 3 did ask RN 2 about her concerns with Pt 1’s heart rate being in the 150’s but RN 2 stated she was dealing with the other traumas and did not get a chance to address Pt 1’s heart rate before the transfer occurred. During a review of Pt 1’s document titled, “Physician Progress Note” dated 9/27/25, at 8 p.m., the progress note indicated, “ ... Patient is still pending transfer to higher level of care [Hospital 2]. Per emergency room physician orthopedics [MD 2] was aware of the patient as well as Ortho resident and are also aware of new finding of humerus fx. patient continues to await immobilization (splint to decrease movement, to help with pain and healing) of fractures by orthopedics service ... [NP].” During an interview on 1/8/26, at 10 a.m., with Trauma Nurse Practitioner (NP), NP stated she has been a trauma nurse since 2011. NP stated when she was called to consult on Pt 1 on 9/27/25, the decision to transfer the patient to Hospital 2 was already made and there was already an Orthopedic consult done. NP stated she saw Pt 1 in ED B Pod where he was tachycardic, complaining of pain in his legs, had not had any pain medication yet and did not have an IV. NP stated she spoke with Pt 1’s mother at bedside, she informed her that the WC was 300 pounds and that Pt 1 was trapped under the WC. NP stated she knew Pt 1 would need more scans she ordered a pan scan (comprehensive whole-body CT to include Thoracic (upper and mid-back) and lumbar (lower back) spine) and T and L spine and was able to get an IV and pain medication. NP stated she wanted to make sure Pt 1 did not have any further injuries and make sure he was 100 percent stable. NP stated there were no other acute injuries except for a humerus fracture and they let Ortho know about this finding. NP stated she thinks Pt 1 was initially seen by ED MD and plain films for bilateral lower extremities (bil LE), he was tachycardic and hypoxic and she wanted to make sure there were no pelvic injuries. NP stated, “We were able to rule out an emergency medical condition (for Pt 1.)” NP stated she saw Pt 1 about 5 p.m. and Pt 1’s transfer was not held up due to waiting on results, but he was not transferred until after 8 p.m. NP stated Pt 1 was able to tell her his name and that he had pain and where he was but, he was a little dazed. NP 1 stated Pt 1 should have been a trauma activation maybe not initially but after seeing the bilateral lower extremity fractures. NP 1 stated she was able to pull more information out of the mother of Pt 1. Pt 1’s mother told her the WC had died while going up a hill, it fell back and it toppled over while Pt 1 was still inside it. NP stated she does feel like there was a delay in care for Pt 1. NP stated she feels that if they had gotten a better story of the fall for Pt 1 then there may not have been a delay. NP stated she ordered pain medication and the ED MD was also still caring for Pt 1 as well. NP stated she would have medicated Pt 1 before he was transferred since his HR was in the 150’s and he was having pain. During an interview on 1/8/26, at 4 p.m., with CN 2, CN 2 stated she was the night charge nurse for Hospital 1 ED on 9/27/25 starting her shift at 5 p.m. to 5 a.m. the next day. CN 2 stated when she came on shift, she was told by RN 2 that there was a patient in B Pod that had bilateral femur fractures, and she wasn’t sure what to do because the patient had already been here for 3-4 hours. CN 2 stated she spoke with CN 1 and then told RN 2 to activate the trauma team for Pt 1 right away. At this time MD 1 had only ordered plain films (x-rays). CN 2 stated there was a delay in care for Pt 1 because there was a delay in activating the trauma protocol. CN 2 was informed Pt 1 was a hard stick (difficult to find a vein to place an IV) but an IV was eventually placed. CN 2 stated Pt 1 was taken for a pan scan (CTA) head to toe and then taken back to a trauma room. CN 2 stated when she first saw Pt 1, he was hypoxic and tachy and she believed he had low blood pressure. CN 2 stated “He did not appear to be having any signs of distress, but his vital signs showed otherwise”. CN 2 stated at the time Pt 1 was being transferred out to Hospital 2 she was not sure why Pt 1 did not have splints put on his bilateral legs, but that Hospital 2 had requested them be put on. CN 2 stated Ortho did not do a formal consult. CN 2 stated when she got ahold of the ortho on call (MD 2) he did not want to splint and by that time another trauma had come in. CN 2 stated she did ask MD 1 about the splinting (not being done) and he said he didn’t know about the splinting or he would have done it himself. CN 2 stated she did not feel it was appropriate to transfer Pt 1 with his heart rate in the 150’s, no pain medication for last score of five out of 10 on the pain scale and no splints on his legs prior to transfer. CN 2 stated because Pt 1’s care was not appropriate she escalated the issue to the chief of surgery and her upper management. CN 2 stated, “A lot of balls dropped in this case, several different ways.” CN 2 stated she was upset that this happened. CN 2 stated if Pt 1 was activated as a trauma patient upon arrival he would have had all of his scans and IV in place right away and would have been assigned a one to one trauma nurse and trauma provider. CN 2 stated vital signs for trauma patients start out initially every five minutes for the first 20 minutes then every 30 minutes and can be adjusted (more frequently or less frequently) based on the status of the patient. During an interview on 1/8/26, at 10:30 a.m., with Orthopedic Doctor (MD 2), MD 2 stated he was on call for orthopedics on 9/27/25 and he received a page at 5:30 p.m. so he called and spoke with MD 1. MD 2 stated MD 1 called about Pt 1 and asked if we take kids and I told him, “It depends on the situation.” MD 2 stated he was told Pt 1 was a 13-year-old with femur fracture. MD 2 stated he pulled up Pt 1’s x-rays at home and noticed Pt 1 had bilateral femur fractures. MD 2 stated he recommended Pt 1 would need to follow up with Hospital 2 and MD 1 should call over to Hospital 2 ortho on call and get their recommendations. MD 2 stated he did not come into the hospital to see the patient and that it is not always expected for ortho to come in. MD 2 stated Pt 1 had contractures and splinting to stretch his legs out might be difficult, so he asked MD 1 to get a recommendation from Hospital 2. MD 2 stated he received another page around 8:30 p.m. for Pt 1. MD 2 stated MD 1 or the nursing staff at Hospital 1 informed him Pt 1 might be transferred to Hospital 2 and their pediatric ortho recommends splinting Pt 1’s legs. MD 2 stated he received another page around midnight to let him know that Pt 1 was transferred and did not get his splinting done prior to transfer. MD 2 stated he reviewed Pt 1’s chart and noticed NP’s note indicated ED told her Ortho would splint, he stated, “I never got a request to put the splint on”. MD 2 stated he believed the ED would splint Pt 1 themselves. MD 2 stated, “They never asked me to do it”. MD 2 stated this was an oversight and he was not sure what the miscommunication was. MD 2 stated he was not aware that Pt 1 was a trauma patient, and he only knew that Pt 1 had bilateral femur fractures and a humerus fracture. MD 2 stated he was asked by the ED Nurse Manager to put a note in Pt 1’s chart after the fact. During a review of Pt 1’s document titled, “Consult Note EMR” dated 9/27/25 at 5:45 p.m., the note indicated, “Brief ortho consult: Orthopedic recommendations based on review of imaging, clinical photos, and information provided: 13 yo with hx of muscular dystrophy s/p motorized mobility scooter accident with bilateral closed distal femur fractures. Further imaging review demonstrates L proximal humerous minimally to nondisplaced fracture. Fixed flexed position of lower extremities ... Recommend discussion with [name of Hospital 2] vs (versus) [name of Hospital 3] for recommendations on splinting, and further care either by transfer or outpatient follow up. Patient cannot be managed here in house. Likely bilateral long leg splints and transfer to [Hospital 2]. ED expressed understanding of this plan. [MD 2] Orthopedic Surgery PGY3 ...” During an interview on 1/9/26, at 4 p.m., with RN 3, RN 3 stated she was asked by RN 2 to assist in taking over Pt 1 and calling report to Hospital 2 and making sure Pt 1 left with EMS crew. RN 2 informed her that RN 2 had already given report to the CCT (critical care transport nurse- who helps move injured patients while moving between facilities) nurse. RN 3 stated she remembers calling report to Hospital 2 and the nurse asking about why Pt 1 was not splinted. RN 3 stated she was not sure but she would find out why Pt 1 was not splinted. RN 3 stated she remembers telling the CCT nurse not to leave and by the time she went to look for MD 1 to get clarification and came back, EMS had left with Pt 1. RN 3 stated she could not locate MD 1 for clarification and she had to explain to the nurse on the phone for Hospital 2 that the EMS had left with the patient and they did not wait as “I had asked them to”. RN 3 stated she does not recall handling the transfer paperwork for Pt 1. RN 3 says she remembered Pt 1’s heart rate was a little elevated and he had just vomited before she had come over to help transfer him but that he did not look like he was in any distress. Hospital 1 is 1.5 hours away from Hospital 2 and Pt 1 was transferred by ambulance. During a review of Pt 1’s Face Sheet from Hospital 2, dated 9/27/25 indicated arrival time of 11:24 p.m. and inpatient admit time of 1:18 a.m. with diagnosis of Fractures. During a review of Pt 1’s document from Hospital 2 titled, “ED Provider Notes” date of service 9/27/25 at 11:21 p.m., the note indicated, “...13 year 9 month male ... chief complaint Trauma Level 2, Leg injury and Arm injury ... history was provided by referring physician and transport team ... history of Duchenne muscular dystrophy (DMD) who was riding his motorized scooter earlier when the battery powered off and he fell forward in the scooter landed on top of him ... injuries elsewhere in his body so it is little unclear exactly the mechanism. He was taken to an outside hospital where he had multiple x-rays done which showed bilateral distal femur fractures as well as a left proximal humerus fracture. No CT scans were done. It was reported that he became altered although his baseline is not well-documented. He also was reported to be hypoxic and was placed on oxygen. He was observed there for 4 to 5 hours without any additional testing or imaging done and then transferred here for further evaluation. It was recommended by our orthopedic surgeon for him to be placed in lower extremity splints however he was not placed in them prior to transport. He is in a sling in his left upper extremity ... Past Medical History: Asthma, Autism ... Developmental delay, Duchenne muscular dystrophy ... Obesity, Obstructive sleep apnea syndrome (sleep disorder where throat muscles relax too much during sleep, causing repeated blockage (obstruction) of the airway, leading to pauses in breathing (apneas)) ... Vitals BP 104/54 ... Pulse 151 ... Temp 36.5 C ... Resp 24 ... Wt. (weight) 82.8 kg (kilograms- unit of measurement) SpO2 98%... GCS 15 ... Problems Addressed: Blunt trauma to chest ... acute illness or injury Details: Troponin elevated, may be 2/2 underlying DMD but will likely need to be trended ... Closed fracture both femurs ... Long leg splints placed IV morphine/fentanyl prn (as needed) Closed fracture of proximal end of left humerus ... Left arm sling maintained ... Hypoxia: undiagnosed new problem with uncertain prognosis Details: Unclear etiology - pulmonary contusion vs cardiac contusion vs baseline ...” During a review of Pt 1’s document from Hospital 2 titled, “Trauma H&P (history and physical)” dated 9/28/25 at 12:52 a.m., the H&P indicated, “ ... Seen 1200 hrs am ... 13 year 9 month male with significant PMH of Asthma (on albuterol and Flovent), Autism, and Duchenne Muscular Dystrophy (on chronic steroids) who presented to OSH (Other Separate Hospital - Hospital 1) ED after a fall out of his electric wheelchair ... patient fell out of WC, and then the WC fell on top of him ... reported that he became altered although his baseline was not well documented ... He was placed on oxygen d/t hypoxia, 3 L. He was placed in LUE sling ... It was recommended by our Orthopedics team that bilateral long leg splints be placed, this was done upon arrival to our ED, not done at OSH [Hospital 1]. Upon arrival here patient needing to be on 10L nonrebreather for hypoxia gradually transitioned to NC. He received fentanyl (IV strong pain medication) 25 mcg (micrograms- unit of measurement) once back from CT d/t (due to) pain. Admitted to floor under Trauma services ...” During a review of Hospital 1’s policy titled, “PC.PR.1.58 Trauma Team Triage Policy, Protocol & Criteria” dated 10/23/25, indicated, “POLICY The trauma service and trauma team members will be notified of incoming trauma patients to ensure timely and appropriate assessment, management and treatment of the trauma patient. The appropriate team (tiered response) will report to the Emergency Department immediately after the trauma alert is called and prior to the arrival of the trauma patient. PROTOCOL Based on trauma activation criteria the interventions, radiological studies, and laboratory studies will be obtained for trauma patients as per Attachment A: Trauma Protocol. PURPOSE To notify and mobilize the trauma team based on defined physiologic, anatomic or mechanism of injury as reported by the pre-hospital personnel, emergency department personnel, or trauma service. To expedite care of the trauma patient, the members of the trauma team will be contacted prior to the arrival of the patient (for EMS patients) or immediately upon arrival of walk-in patients. ASSESSMENT A. Level I Criteria (Critical Trauma Activation): Any patient meeting the following criteria will be classified as Critical Trauma Activation. A Level I activation will be called ... Respiratory rate under 10 or over 29 per minute. Any sign of respiratory insufficiency ... Age 10-64 years: SBP less than 90 mmHg or heart rate (HR) greater than SBP ... Two or more proximal long bone fractures (humerus or femur) ... Deterioration of previously stable patient now meeting Level 1 Activation Criteria ... ED physician/Trauma Team discretion ... B. Level II Criteria (Trauma Alert) Any patient meeting the following criteria will be classified as trauma alert. A Level II Alert will be called ... Falls All ages from height greater than 10 feet ... Struck by large or heavy falling object ... Falls or collisions ... Patients with a mechanism attributed to trauma ... C. Level III Criteria (Trauma Alert) Any patient meeting the following criteria will be classified as trauma alert. A Level III Alert will be called ... Falls ... All ages: Falls with suspected significant injury ... E. For Level II activation, the emergency department physician will be activated at the time of field notification or immediately upon arrival of walk in patients. When injuries are confirmed by initial evaluation or radiographic findings outlined in the level II section, trauma team notification will take place expeditiously. The trauma surgeon, or appropriately credentialed allied health professional (AHP), will be available within 30 minutes upon notification ... F. For Level III activation, the emergency department physician will be activated at the time of field notification or immediately upon arrival of walk in patients. When injuries are confirmed by initial evaluation or radiographic findings outlined in the level III section, trauma team notification will take place expeditiously for a trauma consult ... Patients meeting any level of response can be upgraded at any time at the discretion of the emergency physician ...” During a review of Hospital 1’s policy titled, “MOD COMP-RCC 5.16 EMTALA POLICY” dated 4/24/24, policy indicated, “ ...II. Purpose: To ensure individuals presenting to Doctor’s Medical Center’s emergency department receive an appropriate Medical Screening Examination (MSE) and stabilizing treatment or appropriate transfer in accordance with Emergency Medical Treatment and Labor Act of 1986 (EMTALA) and that incoming transfer requests are accepted or declined in accordance with EMTALA ... Emergency Medical Condition: A condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in placing the individual’s health [or the health of an unborn child] in serious jeopardy, serious impairment to bodily functions, or serious dysfunction of bodily organs. Refer to Obstetrical Patient Presenting to the Emergency Department/OBED policy ... V. Procedure: A. [Name of Hospital 1] will provide an appropriate MSE within the capability of [Name of Hospital 1] to any individual coming to the Dedicated Emergency Department, including ancillary services routinely available, to determine whether or not an Emergency Medical Condition exists ... [Name of Hospital 1] will provide an individual who is determined to have an Emergency Medical Condition further medical examination and treatment as is required to stabilize the Emergency Medical Condition, including admission for inpatient care, or arrange an appropriate transfer of the individual to another medical facility with the Capability to provide the stabilizing care. C. [Name of Hospital 1] will not transfer an unstable patient with an Emergency Medical Condition unless: 1. A physician certifies the medical benefits expected from the transfer outweigh the risks ... F. Doctor’s Medical Center will maintain a list of physicians who are on-call for duty after the initial MSE to provide further evaluation and/or treatment necessary to stabilize an individual with an Emergency Medical Condition. The list must include the names of individual physicians on call; names of groups or practices are not sufficient ...””

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 42321 Based on interview and record review, the hospital failed to appropriately transfer one of 20 sampled patients (Pt 1) to the receiving hospital (Hospital 2) when Pt 1 was brought in by ambulance for trauma related injuries and was determined to need transport to Hospital 2 for higher level of care and Pt 1 was not appropriately stabilized prior to transfer. Pt 1 suffered several trauma related fractures and experienced pain that affected his heart rate and vital signs and ED staff did not follow the instructions of Hospital 2’s orthopedic surgeon to splint the fractures and treat the pain prior to transfer. The appropriate transfer forms were not complete, documented evidence of risks of transfer were not reviewed with the mother of Pt 1 (who was 13 years old) and the transfer documents did not include the last set of vitals signs. These failures had the potential for Pt 1 and his mother to not be informed of the risks of being transferred and had the potential to prevent the receiving hospital from knowing the patients’ medical condition, causing delays in emergency care. Findings: During a review of Pt 1’s face sheet dated 9/27/25, the face sheet indicated Pt 1 was a 13-year-old (yo) male that was admitted to Hospital 1’s Emergency Department (ED) on 9/27/25 at 12:56 p.m. with a chief complaint (cc) of fall. During a review of Pt 1’s document titled, “ED Note” dated 9/27/25, at 2:19 p.m., indicated, “Time seen: 09/27/2025 13:28:17 (1:28 p.m.) Chief Complaint: BIBA (brought in by ambulance) from park, cc fall, neg (negative) head strike, neg LOC, GCS (Glasgow Coma Scale, a neurological tool to assess consciousness in patients. 3 (deep coma) to 15 (fully alert)) 15, h/o (history of) muscular dystrophy, WCB (wheelchair bound) History Of Present Illness: 13-year-old male BIBA, accompanied by mother, is presented to the ED ... complaints of fall. Per mother, patient was in his motorized wheelchair, at the park. The wheelchair died and patient began sliding down the trail. His wheelchair tipped over and fell on top of him. Denies loss of consciousness. Patient endorses abrasions to this chest, face, and back. He complains of b/l (bilateral-both) knee pain, left clavicular pain, left foot pain and left wrist pain ... Vital Signs: Last Charted: Heart Rate 129 bpm (beats per minute) (H (high)) (09/27 13:07) Respiratory Rate 20 breaths/min (H) ... blood pressure 116/60 ... Pulse Oximetry 96%... Alert and oriented x 3 (a patient is fully aware of their person, place, and time). No acute distress ... Some facial abrasions ... Extremities: Tenderness to b/l (bilateral- both) knees, excoriations to left knee, tenderness to left foot, tenderness to left clavicle (collarbone), tenderness right medial (middle) clavicle next to manubrium (top of chest bone) ... Initially x-rays were obtained and show bilateral lower extremity fractures (breaks) of the distal femur (lower part of thigh bone). Discussed with our on-call orthopedic surgeon [MD 2- surgeon who deals with bones] here who recommends consultation and possible transfer to [name of Hospital 2] and pediatric orthopedic surgery. Initial conversation with pediatric orthopedic surgery recommended splint and outpatient follow-up. However, the patients [medical status] likely changed after phone call. Patient became acutely (suddenly) confused and altered along with increased heart rate of 120-130 and desaturation (lowering of oxygen levels in the blood) of 80% (Normal 94-100). He was placed on 2 L (liters- unit of measurement) nasal cannula (plastic tubing used to transport oxygen into the patient’s nose). The patient’s case discussed with [Hospital 2], [Medical Doctor (MD) 3] accepted the transfer. At this time, further imaging was obtained including full body CT (computed tomography scan, is a medical imaging technique used to obtain detailed internal images of the body) imaging and CTA (Computed Tomography Angiography, a non-invasive imaging test that uses X-rays, a computer, and a contrast dye to create detailed 3D pictures of blood vessels and blood flow). Further imaging shows more fractures including the left humerus (long bone in upper arm) ...” The ED Note was completed by MD 1. During a concurrent interview and record review on 1/7/26 at 3:30 p.m., with the Interim Director of ED (EDD) and Interim Clinical Operations Coordinator (COC) of ED, Pt 1’s electronic medical records (EMR) for his ER visit on 9/27/25 was reviewed. Pt 1’s EMR for 9/27/25 indicated Pt 1 arrived at the ED on 9/27/25 BIBA at 12:56 p.m. with chief complaint of fall from his electric WC. Pt 1’s EMR indicated that Pt 1 was transferred to Hospital 2 at approximately 9:45 p.m. EDD and COC stated they were not able to locate the Transfer paperwork for Pt 1 but ED Discharge note for Pt 1 indicated at 9:45 p.m. Registered Nurse (RN) 2, documented ED Disposition as Transfer; ED Condition as Good, Stable, Unchanged; ED Accompanied by Self, Parent, EMT/paramedics. During a review of Pt 1’s document titled, “Interfacility Transfer Summary” (ITS) dated 9/27/25, it indicated that Pt 1 was accepted for transfer to Hospital 2, receiving physicians name and date of transfer seen, transferring physician name and reason for transfer “Bilateral Femur Fractures/AMS (altered mental status)”; reason for transfer “Comprehensive or specialty services needed ... The patient is stable and transfer poses no significant medical risks ...”. The ITS MD 1’s transferring physician signature is present. The ITS for Pt 1 was not completely filled in, the following documentation was missing: Pt 1’s last set of vital signs, missing discharge time and the discharging nurse’s signature, and missing what documents had been sent to the receiving hospital. During a review of Pt 1’s document titled, “EMERGENCY DEPARTMENT PATIENT TRANSFER REQUEST/ACKNOWLEDGEMENT FORM” (EDPTR) dated 9/27/25, indicated Pt 1 Receiving Facility: Hospital 2 Reason for Transfer: Specialty Services Needed. The EDPTR indicated, “PATIENT TRANSFER ACKNOWLEDGEMENT: I Understand that I have a right to receive medical screening, examination and evaluation by a physician or other appropriate personnel without regard to my ability to pay prior to any transfer or discharge from this hospital and that I have a right to be informed of the reasons for any transfer or discharge. I acknowledge that I have received medical screening, examination, and evaluation by a physician or other appropriate personnel and that I have been informed of the reasons for my transfer. I hereby authorize [Name of Hospital 1] to release medical information regarding my recent care and treatment to the receiving facility. DATE: 9/27/25 Time: 5:39 p.m. PATIENT’S REPRESENTATIVE: [Pt 1’s Mother’s name] RELATIONSHIP: Mother ...” During a review of Pt 1’s document titled, “EMERGENCY DEPARTMENT PATIENT TRANSFER PHYSICIAN CERTIFICATION FORM” dated 9/27/25, indicated, “[Pt 1’s name] Receiving Facility: [Hospital 2’s name] PHYSICIAN CERTIFICATION OF STABILITY: I declare that I have examined and evaluated this patient. Based on this evaluation and the information available to me at this time, I have concluded within reasonable medical probability that: (1) This patient is pregnant... OR (2) This patient is medically stable and transferred to the indicated receiving facility and at this time cannot reasonably be expected to result in a material deterioration in or jeopardy to the patient’s medical condition or expected chances of recovery. PHYSICIAN CERTIFICATION-NECESSITY FOR TRANSFER: I declare that I have examined and evaluated this patient and based on this evaluation and the information available to me at this time and the reasonable risks and benefits to the patient, I have concluded for the reasons which follow, that the medical benefits reasonably expected from the provision of emergency treatment at the indicated receiving facility outweigh the increased risks to the patient and if pregnant, to the unborn child from effecting the transfer. (please explain) [nothing written in this area] Physician signature: [MD 1’s signature] date: 9/27 time: 1737 [5:37 p.m.] Physician’s name (please print): [MD 1’s name].” During a review of Pt 1’s documents titled, “Interfacility Transfer Summary, EMERGENCY DEPARTMENT PATIENT TRANSFER REQUEST/ACKNOWLEDGEMENT FORM, and the EMERGENCY DEPARTMENT PATIENT TRANSFER PHYSICIAN CERTIFICATION FORM” there was no indication that the risks [death, worsening condition, low risk, or other] of transfer were reviewed with the patient or his mother. These documents were provided on the last day of the survey and per Hospital 1 they had to request the documents from Hospital 2 because they were not able to locate them in their records. During a review of a professional medical reference titled, “CMS.gov ... Emergency Room Rights” updated last on 6/12/25, retrieved from https://www.cms.gov/priorities/your-patient-rights/emergency-room-rights indicated, “You have rights in an emergency room under EMTALA. You have these protections: An appropriate medical screening exam to check for an emergency medical condition, and if you have one, Treatment until your emergency medical condition is stabilized, or An appropriate transfer to another hospital if you need it. The law that gives everyone in the U.S. these protections is the Emergency Medical Treatment and Labor Act, also known as “EMTALA.” This law helps prevent any hospital emergency department that receives Medicare funds (which includes most U.S. hospitals) from refusing to treat patients. This means that a hospital emergency department must ... 3. Transfer you if necessary. If your emergency medical condition can’t be stabilized by the staff and facilities available, the hospital must offer to provide an appropriate transfer to a hospital that has the staff and facilities available to stabilize your emergency medical condition. Before transferring you, the hospital must explain the benefits and risks ...””

“COMPLIANCE WITH LAWS CFR(s): 482.11 Compliance with Federal, State and Local Laws This Condition is not met as evidenced by: 49419 Based on observation, interview and record review, the facility failed to be in compliance with Federal, State and Local laws when: 1. The hospital failed to adhere to required Cardiovascular Surgery Service Staff as set forth in the California Code of Regulations Title 22 section 70435 (b)(2) when three of the three sampled patients, (Patient (Pt) 1, Pt 2 and Pt 3), did not have a minimum of three surgeons constitute a surgical team for the performance of cardiovascular operative procedures which require extracorporeal [outside the body] bypass [a procedure that temporarily takes over the functions of the heart and lungs during open-heart surgery]. The hospital also failed to meet the conditions set forth in the program flex (allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass) approved by California Department of Public Health (CDPH) with a condition requiring first assistant to be an independent and fully qualified surgeon and a Physician Assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures. (Refer to A021) 2. The hospital failed to ensure the contracted vendor for Food and Nutrition Services met the organizational standards as required by State laws and regulations as specified in the State Health and Safety Code (HSC)1265.4 statue when the Executive Chef Manager, the position responsible for the day-to-day supervision of dietetic services at BHC Campus 2 was not qualified. (Refer to A023 finding 1) 3. The hospital failed to ensure the contracted vendor for Food and Nutrition Services met the organizational standards as required by State laws and regulations as specified in the Title 22, Section 70275(a), when the hospital did not have a Registered Dietitian (RD) provide guidance and oversight to the food service operations manager and staff of the dietetic service at a sufficient duration and frequency at two of two campuses (Main Hospital Campus 1 and BHC Campus 2). (Refer to A023 finding 2) 4. The hospital failed to ensure the contracted vendor for Food and Nutrition Services met the organizational standards as required by State laws and regulations as specified in the Title 22, Section 70275(a), when the hospital did not have a RD reporting to hospital administration. (Refer to A023 finding 3) The cumulative effect of this systemic failure resulted in the facility’s substantial noncompliance with federal, state and local laws.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 42321 Based on observation, interview, and record review, the hospital failed to have an effective governing body (GB) that is legally responsible for the conduct of the hospital when: 1. The GB did not provide sufficient oversight and resources to ensure the hospital’s contracted service for Food and Nutrition Services employed full-time equivalent (FTEs) Registered Dietitians (RD) to provide clinical nutrition care. Four of five full-time equivalent (FTEs) Registered Dietitians (RDs - Lead RD, RD 2, RD 3, RD 4, RD 5) did not work on the premises or conduct face-to-face patient nutritional physical assessments which resulted in the provision of medical nutrition therapy that was not in accordance with the hospital’s position description for the Registered Dietitian or the current standards of practice. (refer to A083) 1a. The medical staff office did not have a system in place to ensure adequate and qualified personnel performed open heart surgery with bypass and complied with the written agreement for the 3-surgeon rule in accordance with medical staff bylaws and California Code of Regulations, Title 22 Division 5 article 6 section 70435(b) (2). The hospital failed to evaluate on an annual basis personnel who performed open heart surgeries with bypass. The hospital failed to have an on-going quality assurance program that included a methodology for periodic review of the effectiveness of the 3-surgeon rule. The hospital failed to maintain a record of emergent cases where the 3-surgeon rule was not applied. (Refer to A347, findings 1, 2 and 3) 2. The GB did not provide oversight and resources to ensure the hospital provided surgical services in a well-organized manner in accordance with hospital policy and professional standards of practice when: 2a. The hospital did not have program requirements for residents (RS - physicians who have completed medical school and are undergoing postgraduate training in a specific specialty) listed, did not have a process to validate before procedures if two of the two sampled residents RS 1 and RS 2 and one of the one registered nurse first assistants (RNFA) 1 performing the surgery were competent and meets the credentialing and residency program requirements. The hospital did not have active standardized procedure as required by board of registered nurses to support RNFA performing Endoscopic Vein Harvesting (EVH -is a minimally invasive technique used during open heart surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries). (Refer to A-0945) 2b. The hospital failed to ensure that operative reports included description of the significant surgical tasks that were conducted by practitioners other than the primary surgeon when two of two sampled patients, Patient (Pt) 1 and Pt 2 underwent open heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure and Endoscopic Vein Harvesting ( EVH -is a minimally invasive technique used during CABG surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries) part of the procedure was completed by the assistant and their operative report did not describe the EVH portion of the procedure was completed by a practitioner other than the surgeon. (Refer to A-0959) 3. The GB did not provide sufficient oversight and resources to ensure the hospital had a well-organized and effective nursing service when: 3a. Nursing staff did not administer medications in accordance with physician’s order for Patient 5 and Patient 6 (refer to A405, Findings 1 and 2). 3b. Nursing staff at the Behavioral Healthcare Campus 2 did not review the clinical nutritional care of patients and did not complete meal intake documentation in the medical records in accordance with hospital policies. (Refer to A-0398 Finding 1) 3c. One of two patients (Pt 31) did not have vital signs completed every two hours when Pt 31 was given an Emergency Severity Index (ESI-a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious) of 2 according to the hospital’s P&P titled, “MOD ED.1.04 Standard of Care Policy.” (Refer to A-0398 Finding 4) 3d. One of one patients (Pt 10) did not have urine output measured and recorded in the medical record for a 24 hour period, a physical assessment performed by a student nurse was not validated by a registered nurse, and the events preceding a stroke alert activation and a rapid response team call were not documented by Pt 10’s nurse, in accordance with the hospital’s P&P titled, “PC.AD.1.08 Documentation Policy.” (Refer to A-0398 Finding 5) 4. The GB did not provide sufficient oversight and resources to ensure the hospital protected and promoted each patient’s rights when: 4a. Hospital staff did not provide Patient 10 care in a safe setting and did not treat Patient 10 and Patient 10’s family members with respect and dignity. Hospital staff did not acknowledge and act promptly on a written grievance submitted by the family on behalf of Patient 10. (Refer to A144 and A119) 4b. Two of two sampled patients (Pt 28 and 29) were not given the right to make informed decisions when consents and discharge instructions were not interpreted by a qualified interpreter to ensure the patient could fully understand the information provided according to the hospital’s policy and procedure (P&P) titled, “MOD.EAC.01.04.PR.01 Language Assistance Services (Including Interpreters) Procedure.” (Refer to A131) 5. The GB did not provide sufficient oversight and resources to ensure the hospital met the regulatory requirements for the Condition of Participation for Infection Prevention and Control Programs as evidenced by multiple situations where staff did not follow infection control policies and procedures or standards of practice to keep a sanitary environment and reduce the risk of cross-contamination and infections in patient, staff and visitors. (refer to A750, Findings 1 through 7) 6. The GB did not provide sufficient oversight and resources to ensure the hospital’s pharmaceutical services met the needs of patients when: 6a. Drugs in the pharmacy medication freezer were not stored in accordance with manufacturer instructions and room temperatures were not monitored in four of four medication storage rooms containing non-refrigerated medications. These failures had the potential to expose patients to unstable and/or unsterile medications potentially leading to therapeutic failure in patients. (Refer to A-0491) 6b. The hospital failed to have an effective system in place to identify loss or theft of all controlled drugs (drugs that are regulated by the federal government due to potential of abuse/addiction) dispensed from 25 of 25 operating room (OR) Anesthesia Workstations (AWS, a type of automated dispensing cabinet [ADC]). In addition, the hospital was unable to facilitate the Drug Diversion Prevention Committee’s ability to accurately review controlled drug usage trends and patterns according to hospital policy for anesthesia providers (highly trained healthcare professionals who administer drugs during surgery). These failures had the potential for unsafe controlled drug use, lack of accountability, risk of controlled drug theft or unauthorized use and patient harm. (Refer to A-0494) 6c. The hospital failed to ensure documentation of a completed AIMS assessment (AIMS, a formalized rating scale used to assess unusual movements) for Patient 9 who was administered multiple antipsychotics (drugs used to treat symptoms of psychosis in conditions like schizophrenia). This failure had the potential to increase Patient 9’s risk of side effects including involuntary/jerky movements, muscle stiffness, and tremors that could interfere with daily activities, cause distress and/or overall reduced quality of life. (Refer to A-0500) 6d. The hospital failed to ensure that the IV (intravenous, through the vein) sterile (germ free) compounding (mixing) room had walls that were cleanable, and compounding pharmacy staff had completed required competencies consistent with standards of practice. This failure had the potential to expose patients to contaminated IV drugs. (Refer to A-0501) 6e. The hospital failed to ensure that outdated or unusable medications were not available for use. This had the potential for exposing patients to contaminated or ineffective medications. (Refer to A-0505) 7. The GB did not provide sufficient oversight and resources to ensure the hospital had an organized food and nutrition services when: 7. a. The position for the Registered Dietitian (Lead RD) did not have a role in providing oversight to the food service operations or guidance to the Director of Food and Nutrition Services (DFNS) at two of two campuses (Main Hospital Campus 1 and BHC Campus 2); (Refer to A- 0619 Finding 1) 7b. Professional standards of practice were not followed when the Clinical Nutrition Manager (CNM) position and Lead RD position were supervised by the DNFS. The DNFS was not a Registered Dietitian, had no healthcare credentials and would not be qualified to evaluate the professional skills of a RD. It is the responsibility of the Registered Dietitian to provide guidance and oversight to the DNFS. (Refer to A- 0619, Finding 2) 7c. The clinical nutrition screening, prioritization and assessment policy did not address the specialized nutritional needs for patients at the BHC Campus 2 when the nutrition risk screening policy was based on patients admitted to the general acute care hospital and did not reflect the nutrition risk factors specific to a behavioral health inpatient. As a result, the RDs would only assess the nutritional needs of behavioral health when they received a consult. (Refer to A- 0619, Finding 3) 7d. A system was not in place to recruit and hire Registered Dietitian’s in accordance with the published job description and the professional standard to support face-to-face nutritional physical assessments of patients. Four of five full-time equivalent positions for RDs were hired with the knowledge the RDs were unable to be on the hospital premises, would perform their jobs remotely and not be able to conduct nutrition-focused physical exams (NFPE) on patients. (Refer to A-0619, Finding 4) 7e. Two food service workers (FSW 1 and FSW 2) were not competent in their job duties when incorrect portion sizes were used during a lunch meal observation on May 20, 2025, at the Main Hospital Campus 1 and May 22, 2025, at the BHC Campus 2. (Refer to A-0622) 8. The GB did not provide sufficient oversight and resources to ensure the hospital had a hospital-wide Quality Assessment and Performance Improvement Program (QAPI- is a systematic approach to improving the quality of care and services delivered to patients) when: 8a.The Director of Quality (DQ) could not provide the data that was being used to monitor the effectiveness of the approved Program Flex (a request to change or modify or deviate from the standard regulations) from 2022 that allowed the Cardiovascular (CV) Surgical Department to use an Advanced Practice Practitioner (APP-healthcare professional with advanced education such as a nurse practitioner or physician assistant) as the 2nd assistant during cardiac surgeries that require bypass. (Refer to A-283 & A-308) 8b. Health Information Management (HIM) Department (manages patients’ data, ensuring its quality, integrity, and security) was not reporting their quality data to the quality department and thus it was not being monitored and tracked by Quality. (Refer to A-283 & A-308) 9. The GB did not provide sufficient oversight and resources to ensure the hospital had medical record services under qualified supervision, safeguarding protected sensitive health information and adequately supporting prompt completion of medical records, with a patient census of 332 at Campus 1 and 38 at campus 2 as evidenced by: 9a. The facility failed to employ a qualified individual to supervise the medical record services, as the assigned Director of Health Information Management (HIM) lacked the required credential. (Refer to tag A-0432). 9b. The facility failed to identify and implement safeguards for special categories of sensitive health information, specifically genetic testing results and reproductive health information, as required under state and federal law. (Refer to tag A-0441). 9c. The facility failed to ensure that medical records were completed promptly following patient encounters in three clinics operating under the hospital’s license. In three of three sampled outpatient specialty clinic records, physician documentation was incomplete or lacking for days following the date of service visit. (Refer to tag A-0450). The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care in a safe and responsible manner for all patients.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 37529 Based on observation interview and record review the facility failed to protect and promote each patient’s rights when; 1. Patient 10 experienced a change in level of consciousness, and a respiratory arrest and the circumstances leading up to the events were not clearly explained in either instance to Pt 10’s daughter or documented in the medical record; Pt 10 was left soiled in her bed for over two hours despite Pt 10’s daughter asking the staff to change Pt 10; The nursing staff in the ICU were laughing and talking during the time Pt 10’s family was there to say goodbye to Pt 10; Pt 10 bit her tongue at the time her breathing tube was removed (extubation) resulting in pain and bleeding, the nursing staff did not administer an adequate amount of the medications ordered for comfort care after Pt 10 experienced extreme distress following extubation; and Pt 10’s body was removed from the hospital approximately five hours after her death and transported to a mortuary in a nearby city without the hospital first notifying Pt 10’s daughter and obtaining consent. Pt 10’s daughter was informed by the hospital Pt 10 was transported due to patient being too big for the hospital’s morgue. (Refer to A144) 2. Two of two sampled patients (Pt 28 and 29) were not given the right to make informed decisions when consents and discharge instructions were not interpreted by a qualified interpreter to ensure the patient could fully understand the information provided according to the hospital’s policy and procedure (P&P) titled, “MOD.EAC.01.04.PR.01 Language Assistance Services (Including Interpreters) Procedure.” (Refer to A131) 3. The facility grievance process was not implemented for prompt resolution when Patient (Pt) 10’s family member sent a grievance through certified mail, and it was not acknowledged for sixteen days after it was received by the hospital. (Refer to A119) The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all times.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 42321 Based on interview and record review the hospital failed to create a hospital-wide Quality Assessment and Performance Improvement Program (QAPI- is a systematic approach to improving the quality of care and services delivered to patients) when: 1.The Director of Quality (DQ) could not provide the data that was being used to monitor the effectiveness of the approved Program Flex (a request to change or modify or deviate from the standard regulations) from 2022 that allowed the Cardiovascular (CV) Surgical Department to use an Advanced Practice Practitioner (APP-healthcare professional with advanced education such as a nurse practitioner or physician assistant) as the 2nd assistant during cardiac surgeries that require bypass. (Refer to A-283 & A-308) 2.Health Information Management (HIM) Department (manages patients’ data, ensuring its quality, integrity, and security) was not reporting their quality data to the quality department and thus it was not being monitored and tracked by Quality. (Refer to A-283 & A-308) The cumulative effect of these systemic problems resulted in the facility’s inability to comply with statutory requirements for Quality Assessment and Performance Improvement and placed all patients at risk of not receiving care in a safe setting.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 49419 Based on observations, interview and record review, the hospital failed to have an organized medical staff responsible for the quality of medical care provided to patients when: 1. Three of three cardiovascular (heart and blood vessels) surgery cases requiring the use of an extracorporeal (outside the human body) coronary (heart) bypass machine (a machine that temporarily takes over the function of the heart and lungs, putting oxygen in the blood and pumping that blood throughout the body) did not have the required three members of the Cardiovascular (CV) surgical team in the Operating Room (OR) during a CV surgery requiring a coronary bypass machine. (Refer to A-0347 Finding 1.) 2. The medical staff failed to ensure that an annual review of all qualified non-surgeons who participated in CV surgery requiring a coronary bypass machine was performed and that the annual review included letters of competency from the supervising physician(s). (Refer to A-0347 Finding 2.) 3. The medical staff failed to ensure that the hospital’s on-going quality assurance program included a methodology for periodic review of the effectiveness of the required three members of the CV surgical team in the OR during a CV surgery requiring a coronary bypass machine. (Refer to A-0347 Finding 3.) 4. The medical staff failed to ensure the hospital created and maintained a record of any emergency situations in which the required three members of the CV surgical team in the OR during a CV surgery requiring a coronary bypass machine were not present. (Refer to A-0347 Finding 4.) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality care in a safe environment and placed patients undergoing CV surgery at risk for many types of adverse events, including; but not limited to, strokes, heart attacks, and death.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 42321 Based on observations, interviews and record reviews the hospital failed to have a well-organized and effective nursing service when: 1. Three of three patients (Patient 45, 46, and 47) were reviewed for clinical nutrition care at BHC Campus 2 and had incomplete meal intake documentation in the medical record. (Refer to A-0398 Finding 1) 2. One of five sampled Glucometers (a device for measuring the concentration of glucose in the blood) had controls performed (a way to check the blood glucose meter and test strips are working together properly to deliver accurate results) with expired control solutions (solution use to test the functionality of meter and strips) not in accordance with the hospital’s P&P titled “ PC.AD.1.38 Blood Glucose Monitoring,”(Refer to A-0398 Finding 2) 3. One of one patient (Pt 27) did not have a temperature and respiration rate assessed and documented every one hour while receiving intravenous (IV-in a vein) magnesium sulfate (a high-risk medication to help prevent seizures [sudden uncontrolled bursts of electrical activity in the brain]) according to the hospital’s P&P titled, “MOD L&D.1.18 Magnesium Sulfate Management In Obstetrics.”(Refer to A-0398 Finding 3) 4. One of two patients (Pt 31) did not have vital signs completed every two hours when Pt 31 was given an Emergency Severity Index (ESI-a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious) of 2 according to the hospital’s P&P titled, “MOD ED.1.04 Standard of Care Policy.”(Refer to A-0398 Finding 4) 5. One of one patients (Pt 10) did not have urine output measured and recorded in the medical record for a 24 hour period, a physical assessment performed by a student nurse was not validated by a registered nurse, and the events preceding a stroke alert activation and a rapid response team call were not documented by Pt 10’s nurse, in accordance with the hospital’s P&P titled, “PC.AD.1.08 Documentation Policy.”(Refer to A-0398 Finding 5) 6. One of six sampled patients (Patient (Pt) 5’s Nozin (a nasal sanitizer swab used to kill germs in the nose) nasal swab was not administered with the correct number of swabs in each nostril as ordered by the physician and as instructed by the manufacturer. (Refer to A-0405 Finding 1) 7. One of six sampled patients (Pt 6) propofol (a potent drug used for sedation with a high potential for abuse/misuse) was administered without an independent double check (second nurse witness/co-sign) in accordance with the hospital’s policy and the propofol dose was adjusted without documentation of the Richmond Agitation-Sedation Scale score (RASS, a medical scale used to measure the agitation or sedation level) as ordered by the physician. (Refer to A-0405 Finding 2) The cumulative effect of these system problems resulted in the hospital’s inability to provide quality nursing care in a safe setting.”

“MEDICAL RECORD SERVICES CFR(s): 482.24 The hospital must have a medical record service that has administrative responsibility for medical records. A medical record must be maintained for every individual evaluated or treated in the hospital. This Condition is not met as evidenced by: 39051 Based on observation, interview and record review the hospital failed to provide medical record services under qualified supervision, safeguarding protected sensitive health information and adequately supporting prompt completion of medical records, with a patient census of 332 at DMC-Campus 1 and 38 at DBHC-campus 2 as evidenced by: 1. The facility failed to employ a qualified individual to supervise the medical record services, as the assigned Director of Health Information Management (HIM) lacked the required credential. This failure resulted in the facility’s inability to ensure professional oversight of medical records/health information management, placing patients at risk for documentation errors, legal noncompliance, and privacy violations (Refer to tag A-0432). 2. The facility failed to identify and implement safeguards for special categories of sensitive health information, specifically genetic testing results and reproductive health information, as required under state and federal law. This failure resulted in the potential unauthorized access, use, or disclosure of legally protected information, violating patient rights and increasing the risk of discrimination and legal liability (Refer to tag A-0441). 3. The facility failed to ensure that medical records were completed promptly following patient encounters in three clinics operating under the hospital’s license. In three of three sampled outpatient specialty clinic records, physician documentation was incomplete or lacking for days following the date of service visit. This failure resulted in delayed entry or validation of clinical information, which jeopardized continuity of care, delayed billing, and increased the risk of omitted details or errors in documentation accuracy (Refer to tag A-0450). The cumulative effect of these systemic failures resulted in improper oversight of the facility’s documentation practices, inadequate protection of sensitive health information, and delays in medical record completion-ultimately compromising patient care, privacy, and organizational compliance. Credentialed HIM leadership is essential to ensuring regulatory compliance, safeguarding protected health information, and maintaining a timely and accurate medical record system. The facility’s failure to assign qualified personnel in this key role contributed to broad noncompliance under this Condition of Participation.”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 46393 Based on observation, interview and record review, the hospital failed to have pharmaceutical services meet the needs of patients when: 1. Drugs in the pharmacy medication freezer were not stored in accordance with manufacturer instructions and room temperatures were not monitored in four of four medication storage rooms containing non-refrigerated medications. These failures had the potential to expose patients to unstable and/or unsterile medications potentially leading to therapeutic failure in patients. (Refer to A-0491) 2. The hospital failed to have an effective system in place to identify loss or theft of all controlled drugs (drugs that are regulated by the federal government due to potential of abuse/addiction) dispensed from 25 of 25 operating room (OR) Anesthesia Workstations (AWS, a type of automated dispensing cabinet [ADC]). In addition, the hospital was unable to facilitate the Drug Diversion Prevention Committee’s ability to accurately review controlled drug usage trends and patterns according to hospital policy for anesthesia providers (highly trained healthcare professionals who administer drugs during surgery). These failures had the potential for unsafe controlled drug use, lack of accountability, risk of controlled drug theft or unauthorized use and patient harm. (Refer to A-0494) 3. The hospital failed to ensure documentation of a completed AIMS assessment (AIMS, a formalized rating scale used to assess unusual movements) for Patient 9 who was administered multiple antipsychotics (drugs used to treat symptoms of psychosis in conditions like schizophrenia). This failure had the potential to increase Patient 9’s risk of side effects including involuntary/jerky movements, muscle stiffness, and tremors that could interfere with daily activities, cause distress and/or overall reduced quality of life. (Refer to A-0500) 4. The hospital failed to ensure that the IV (intravenous, through the vein) sterile (germ free) compounding (mixing) room had walls that were cleanable, and compounding pharmacy staff had completed required competencies consistent with standards of practice. This failure had the potential to expose patients to contaminated IV drugs. (Refer to A-0501) 5. The hospital failed to ensure that outdated or unusable medications were not available for use. This had the potential for exposing patients to contaminated or ineffective medications. (Refer to A-0505) The cumulative effects of these systemic failures resulted in the hospital’s inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the Conditions of Participation: Pharmaceutical Services.”

“FOOD AND DIETETIC SERVICES CFR(s): 482.28 The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company may be found to meet this Condition of Participation if the company has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company maintains at least the minimum standards specified in this section and provides for constant liaison with the hospital medical staff for recommendations on dietetic policies affecting patient treatment. This Condition is not met as evidenced by: 28773 Based on observation, interview and record review, the hospital failed to ensure an organized food and nutrition services when: 1. a. The position for the Registered Dietitian (Lead RD) did not have a role in providing oversight to the food service operations or guidance to the Director of Food and Nutrition Services (DFNS) at two of two campuses (Main Hospital Campus 1 and BHC Campus 2); (Refer to A- 0619 Finding 1) b. Professional standards of practice were not followed when the Clinical Nutrition Manager (CNM) position and Lead RD position were supervised by the DNFS. The DNFS was not a Registered Dietitian, had no healthcare credentials and would not be qualified to evaluate the professional skills of a RD. It is the responsibility of the Registered Dietitian to provide guidance and oversight to the DNFS.(Refer to A- 0619, Finding 2) c. The clinical nutrition screening, prioritization and assessment policy did not address the specialized nutritional needs for patients at the BHC Campus 2 when the nutrition risk screening policy was based on patients admitted to the general acute care hospital and did not reflect the nutrition risk factors specific to a behavioral health inpatient. As a result, the RDs would only assess the nutritional needs of behavioral health when they received a consult. (Refer to A- 0619, Finding 3) d. A system was not in place to recruit and hire Registered Dietitian’s in accordance with the published job description and the professional standard to support face-to-face nutritional physical assessments of patients. Four of five full-time equivalent positions for RDs were hired with the knowledge the RDs were unable to be on the hospital premises, would perform their jobs remotely and not be able to conduct nutrition-focused physical exams (NFPE) on patients. (Refer to A-0619, Finding 4) 2. Two food service workers (FSW 1 and FSW 2) were not competent in their job duties when incorrect portion sizes were used during a lunch meal observation on May 20, 2025, at the Main Hospital Campus 1 and May 22, 2025, at the BHC Campus 2. (Refer to A-0622) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of dietetic services for the health and safety needs of patients in compliance with the Condition of Participation for Food and Dietetic Services.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 42321 Based on observations, interview and record review, the hospital failed to meet the regulatory requirements for the Condition of Participation for Infection Prevention and Control Programs as evidenced by: 1. Two of four ice machines were not maintained according to the hospital’s policy titled, “Ice Machines Cleaning”. (Refer to A-0750 Finding 1) 2. Ice was found in two open plastic cups in the patient nutrition freezer in the Labor and Delivery patient nutrition room and not according to the hospital’s P&P titled, “Ice Handling.” (Refer to A-0750 Finding 2) 3. There was no monitoring of potentially hazardous foods prepared from ingredients stored at ambient (temperature of the surrounding environment) room temperature at the Behavioral Healthcare (BHC) Campus 2. (Refer to A-750 Finding 3) 4. Food Service Worker (FSW) 2 did not restrain facial hair when serving food for the lunch meal service on May 22, 2025, at the BHC Campus 2. (Refer to A-750 Finding 4) 5. Raw meat was stored above ready to eat food in a reach-in refrigerator at the Main Hospital Campus 1 retail area. (Refer to A-750 Finding 5) 6. The hospital failed to ensure that Gastroenterologist (DR 4 - medical doctor specializing in the digestive system and related organs) had eye protection during the entire colonoscopy procedure for Patient (Pt) 11. (Refer to A-750 Finding 6) 7. Pt 1’s open-heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) was performed in Operating Room (OR) 15 that had flooring with cracks. (Refer to A-750 Finding 7) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality care in a safe and sanitary environment and place patients and staff at risk of cross contamination and post operative infection.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 49230 Based on observation, interview and record review, the hospital failed to provide surgical services in a well-organized manner in accordance with hospital policy and professional standards of practice when: 1. The hospital did not have program requirements for residents (RS - physicians who have completed medical school and are undergoing postgraduate training in a specific specialty) listed, did not have a process to validate before procedures for two of two sampled residents RS 1 and RS 2 performing the surgery were competent and meets the credentialing and residency program requirements. The hospital did not have active standardized procedure as required by board of registered nurses for one of one registered nurse first assistants (RNFA) 1 to support RNFA performing Endoscopic Vein Harvesting (EVH -is a minimally invasive technique used during open heart surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries). (Refer to A-0945) 2. The hospital failed to ensure that operative reports included description of the significant surgical tasks that were conducted by practitioners other than the primary surgeon when two of two sampled patients, Patient (Pt) 1 and Pt 2 underwent open heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure and Endoscopic Vein Harvesting ( EVH -is a minimally invasive technique used during CABG surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries) part of the procedure was completed by the assistant and their operative report did not describe the EVH portion of the procedure was completed by a practitioner other than the primary surgeon. (Refer to A-0959) The cumulative effect of these systemic problems resulted in the failure to assure surgical services achieved high standards of care jeopardizing the health and safety of surgical patients.”

“COMPLIANCE WITH LAWS CFR(s): 482.11(a) The hospital must be in compliance with applicable Federal laws related to the health and safety of patients. This Standard is not met as evidenced by: 49230 Based on observation, interviews and record review, the hospital failed to adhere to required Cardiovascular Surgery Service Staff as set forth in the California Code of Regulations Title 22 section 70435 (b)(2) when: Three of the three sampled patients, Patient (Pt 1, Pt 2 and Pt 3), did not have a minimum of three surgeons constitute a surgical team for the performance of cardiovascular operative procedures which require extracorporeal [outside the body] bypass [a procedure that temporarily takes over the functions of the heart and lungs during open-heart surgery]. The hospital also failed to meet the conditions set forth in the program flex (allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass) approved by California Department of Public Health (CDPH) with a condition requiring first assistant to be an independent and fully qualified surgeon and a Physician Assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures. These failures resulted in potential risk to patients’ life, health, and well-being during open-heart surgical procedures. Findings: During a concurrent observation and interview on 5/22/25 at 8:55 a.m. with the Registered Nurse Quality (QRN) 3 and Assistant Director of Nursing Surgical Services (ADON) in operating room (OR) 15, Patient (Pt) 1’s surgical procedure was observed. Pt 1 underwent an open-heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure with three separate bypass were created during the surgery. The ADON validated and verified the staffing in the room for the entire procedure included a primary cardio thoracic surgeon (SUR -a specialized surgeon who performs surgery on the heart, lungs, and other organs within the chest cavity) 1, resident surgeon (RS -a physician who has completed medical school and is undergoing supervised training in a specific surgical specialty to become a board-certified surgeon ) 1, Anesthesiologist (ANS - a medical doctor specializing in administering anesthesia and managing pain during medical procedures and surgeries) 1, Perfusionist (PER - healthcare professional who operates the heart-lung machine during certain surgeries, like open heart surgery, to maintain the patient’s blood flow and oxygenation while the heart is stopped) 1, Registered Nurse First Assist (RNFA -is a Registered Nurse (RN) who works in an expanded role as a surgical first assistant and is responsible for working with the surgical team, in surgery, at the direction of the surgeon) 1, two RNs working as scrub nurses (work within the sterile field, directly assisting the surgeon with instruments and supplies during the procedure) and a circulating nurse (nurse who works outside the sterile field, managing patient care, coordinating with the surgical team, and ensuring a safe environment). The ADON stated that was the normal staffing for cardiovascular surgical cases at their hospital. The ADON stated that resident surgeon was the first assisting surgeon, and they typically have RNFA or Physician Assistant (PA -licensed medical professionals who work under the supervision of a licensed physician) as second assistant surgeon in the room. The ADON stated the hospital does not normally require scheduling two surgeons for the CABG procedures as the hospital has resident surgeons working with the primary surgeons. The ADON stated as far as he was aware, the resident surgeon was okay to be in the room as first assisting surgeon under the supervision of primary board-certified cardiothoracic surgeon. The ADON was unable to comment on what a resident surgeon can and cannot do at the hospital or during the surgical procedure. The ADON also was not able to comment on what year or specialty (specific area of training) residents were and stated the OR team does not have access or any way to validate, or to see or check program requirements (define the specific types and scope of surgical procedures they are authorized to perform at a hospital). The ADON stated he would have to defer to Director of Surgical Services (DSS) regarding residents and person in charge of residency program, however, his understanding was the surgeon was responsible for overseeing the residents. During an interview on 5/22/25 at 10:55 a.m. with the DSS, the DSS stated he was aware of the state regulation and staffing requirement for cardiac vascular operative surgery cases. The DSS stated CABG cases must have a second physician in OR and do not require the second physician to be board certified cardiac surgeon. The DSS stated the hospital has cardiovascular surgery fifth year residents as second physician in the OR. The DSS stated the facility also has California Department of Public Health approved flex [program flexibility, which allows a hospital to temporarily deviate from specific regulatory requirements while still meeting the intent and purpose of those regulations] that allows them to staff mid-level providers [Physician assistant or RNFA] as third surgeon in cardiovascular cases requiring bypass. The DSS stated the resident surgeon’s credentialing, privileges and program requirements were with “Hospital B” and not currently listed in their system. The DSS stated medical staff, and human resources would be able to speak about the process. During a concurrent interview and record review on 5/22/25 at 11:00 a.m. with the ADON and DSS, Pt 2’s electronic medical record (EMR) was reviewed for the “OR Intraoperative record”. A review of Pt 2 ‘s “OR intraoperative record” indicated Pt 2 had CABG surgery on 3/31/25. Pt 2 went in to the OR at 7:15 a.m., surgery start time was 8:13 a.m. and end time was 11:37 a.m. SUR 2 was the primary surgeon and was in the OR from 7:15 a.m. to 11:37 a.m. RS 2 was in the room from 7:45 a.m. to 8:15 a.m. [RS 2 left 2 minutes after the case started]. The ADON stated that record does not reflect any other surgeon was in the operating room besides SUR 1 during the entire surgical procedure and RS 2 was in the room for only two minutes at the start of surgery. The ADON stated the “OR Intraoperative report” indicated RNFA 1 and PA 1 were assisting SUR 1 with the case as well. The ADON stated PA 1 was in Pt 2’s surgery from 7:15 a.m. to 11:37 a.m., same as SUR 1. The ADON stated RNFA 1 was in Pt 2’s surgery from 7:15 a.m. to 9:51 a.m. The ADON stated he was unable to comment if the hospital had another surgeon available or on call for the duration of Pt 2’s surgery, however, [he believed] the approved program flex allows them to have a PA or RNFA as third surgeon. During a concurrent interview and record review on 5/22/25 at 11:05 a.m. with the ADON and DSS, Pt 3’s EMR was reviewed for the “OR Intraoperative record”. The review of Pt 3’s “OR Intraoperative record” indicated Pt 3 had MITRAL VALVE (located between the left heart chamber) repair [removes and repairs part of the damaged mitral valve to allow the valve to fully close and stop leaking] and TRICUSPID VALVE (located on the right side of the heart between the right atrium and right ventricle) repair surgery on 3/31/25. Pt 3 went in to the OR on 3/31/25 at 7:42 a.m., surgery started at 8:47 a.m. and ended at 2:00 p.m. SUR 3 was the primary surgeon and was in the OR from 7:42 a.m. until 2:10 p.m. RS 2 was also listed as being present in the room from 7:42 a.m. until 2:10 p.m. The ADON stated he was not able to find any other surgeon listed as being present in the room during the procedure. The ADON stated he was unable to comment how RS 2 was present for both Pt 2 and Pt 3 as first assistant [second surgeon] at the same time. The ADON stated he could only go by the record, and it appears to him that RS 2 just went to check in Pt 2’s room and stayed with Pt 3’s procedure. The ADON stated the entry times do not appear correct as they are overlapping. The ADON validated even with overlapping of time RS 2 was only in the room for Pt 2 for two minutes after the surgery was started and no other independent and qualified surgeon except RNFA or PA was in the room during the procedure for both Pt 2 and Pt 3. During an interview on 5/22/25 at 2:15 p.m. with SUR1, SUR 1 stated surgery for Pt 1 was uneventful and had no concerns with RS 1’s performance. SUR 1 stated he was board certified in cardiac surgery and his understanding for number of surgeons in OR for CABG was, “As soon as you anticipate or as soon as patient goes on bypass [medical device that temporarily takes over the functions of the heart and lungs during surgery, especially open-heart surgery], expectation is to have two surgeons in the room and PA or RNFA could be the third”. SUR 1 stated he was informed that residents could be assisting surgeon. SUR 1 stated he performs surgeries at a different facility in the town as well and they are, “Required to have two independent surgeons not residents” in operating room at all times for CABG procedures. SUR 1 stated he always has challenges getting the second surgeon at this hospital and has to call his colleagues from another hospital to assist him. SUR 1 stated the facility started using resident surgeons and it allowed some consistency in assuring first assistant as resident surgeon. SUR 1 stated he has not experienced any adverse outcomes with residents assisting. SUR 1 stated RS 1 currently requires supervision and would be practicing independently next year. During a concurrent interview and record review on 5/22/25 at 4:37 p.m. with the DSS and Manager Accreditation and regulatory (MA) 1, Title 22 of the California Code of Regulations (CCR -is a comprehensive set of rules and regulations that govern various aspects of programs in California) section 70435 Cardiovascular Surgery Service Staff was reviewed, and the program flex document was reviewed. Title 22 CCR section 70435 indicated “ ... (b) Cardiovascular operative service. (1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Thoracic Surgery or the American Board of Surgery with training and experience in cardiovascular surgery. He shall be responsible for: (A) Implementing established policies and procedures. (B) Training and supervising the nurses and technicians in special techniques. (C) Training and supervising the clinical perfusionists. (2) A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph (b) (1) above ...”. The review of “APPROVAL OF PROGRAM FLEXIBILITY” by CDPH dated October 18, 2022, indicated, “ ... This letter is in response to the request submitted by [Hospital name] for program flexibility for California Code of Regulations T22 DIV5 CH1 ART6-70435(b)(2). The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass ... The use of the PA as a second assistant is at the discretion of the primary surgeon ... The facility is required to have a 3-team cardiovascular surgical team in the OR ... The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures ...” The DSS stated he was aware of the requirements set forth in CCR and conditions in the program flex. The DSS stated he was not able to comment if the RS 1 was an independent and qualified surgeon as required per CCR and flex approval conditions for first assistant to primary surgeon for CABG procedure. The DSS stated he was in charge of the surgery scheduling team [individuals responsible for coordinating all aspects of scheduling surgical procedures] and it was not standard practice at the hospital to identify first assistant in cardiac surgery cases during scheduling process. The DSS stated he was not able to comment on what criteria was used to determine that RS 1 or surgery residents were able to be scheduled as first assistant or second surgeon in the CABG. The DSS stated he would have to defer to Medical staff office for all the surgery resident requirements and would have to look into this practice. The MA 1 stated she was aware of the program flex and CCR staffing requirements and the MA 1 stated approved flex was addressed to her name. The MA 1 stated that she posted it in the lobby upon receiving the approval of program flex and shared with leadership team. The MA 1 stated she cannot comment if the hospital was in compliance with the condition set fourth in the approved flex. The MA 1 stated she does not know if it was appropriate to schedule RS 1 as first assistant to the primary surgeon and as a second surgeon in the CABG case. Both MA 1 and DSS stated they both understood and were aware that program flex authorization was to use mid-level provider as second assistant or third surgeon, they were still required to have second qualified surgeon in the room as first assist. During an interview on 5/22/25 at 5:35 p.m. with the Chief Nursing Officer (CNO), the CNO stated she has reviewed the approved program flex and it was her understanding that surgery residents were not independently qualified surgeons to be the first assistant [second surgeon] in a cardiac surgery. The CNO stated surgery residents need supervision but she was not aware who was responsible at the facility for the oversight of the residency program. The CNO agreed that surgical staff should know what residents can and cannot do while the residents are at their facility assisting with surgeries in the OR. The CNO stated she would need to follow up with her leadership team and do additional research prior to commenting on compliance with state regulations for number of surgeons and conditions listed in the program flex to use mid-level provider [PA or FNP] as a third surgeon [second assistant to primary surgeon]. During an interview on 5/23/25 at 8:05 a.m. with the Chief Executive Officer (CEO) and the CNO, the CEO stated the hospital leadership team did their research, and had also reached out to “Hospital B” for guidance on surgical resident requirements. The CEO stated that they have reached out to their hospital’s legal counsel and realized that the hospital leadership misunderstood the approved flex. The CEO stated the cardiovascular surgery team at this time was not meeting the CCR and program flex conditions. The CEO stated effective immediately, the OR team had made changes and now the hospital requires the second independent and qualified surgeon (first assistant) to be identified ahead of the scheduled surgery and present for the entire surgical procedure. The CEO stated that hospital will not be using surgical residents as first assistant moving forward. During a concurrent interview and record review on 5/23/25 at 10:39 a.m. with the SUR 1 and Director of Quality (DQ), the SUR 1 stated he was the division chief for Cardiac Surgery. SUR 1 stated he had been the division chief for two years. SUR 1 stated he was just made aware of the approved program flex and he was not previously aware of the conditions in the flex. SUR 1 stated this was his first time looking at the conditions set forth in the approved program flex. SUR 1 stated he now understands that the program flex is for the use of PA or RNFA for the third surgeon requirement. SUR 1 stated, the hospital, moving forward, will set up a schedule for the surgeons and will have a qualified person as second surgeon or first assistant and their name will also be listed on the surgery schedule moving forward. SUR 1 stated it was his practice to always have a second surgeon in the room and it was his understanding that a second surgeon was required when patients go on bypass. SUR 1 stated he started working with the residents as second surgeon (first assistant) approximately eight months ago. SUR 1 stated he was informed it was okay to have residents as first assistant as these were fifth year cardiac surgery resident. SUR 1 stated these residents were one year away from being independent surgeons. SUR 1 stated although residents were safe and very good in assisting, these residents were not independent and fully qualified surgeons as required in conditions of program flex approval. During an interview on 5/27/25 at 1:53 p.m. with the perfusionist (PER) 2, PER 2 stated that he has been working at the facility since 2013. PER 2 stated he also works at another facility across town. PER 2 stated that at this hospital it was common not to have a second surgeon or first assist that was a surgeon in the room during cardiac surgical procedures. PER 2 stated, “Many times, perhaps half of the time,” a second surgeon is not available or present in the OR during the CABG procedure. PER 2 also stated when he worked across town in a different hospital, that facility always has second surgeon in the operating room during the entire duration while the patient is on a heart lung machine. During a concurrent interview and record review on 5/28/25 at 2:01 p.m. with the SUR 3, Pt 3’s EMR was reviewed for the “OR Intraoperative record” dated 3/31/25. SUR 3 stated he had been operating at the hospital since 2017. SUR 3 stated he was a board-certified cardiothoracic surgeon. SUR 3 stated he was not aware of the conditions or requirements of the program flex. SUR 3 stated it was his understanding that he was required to have another physician as a second surgeon during his procedures and cardio thoracic surgery residents meet that requirement. SUR 3 stated he had spoken with other teaching institutions, and it was a standard practice to have cardiac surgery residents as first assistant surgeon. SUR 3 stated he requires his residents to stay with him during the entire surgical procedure. SUR 3 validated RS 2 was with him for the entire surgical procedure for Pt 3. During a concurrent interview and record review on 5/29/25 at 3:30 p.m. with RN 5, Pt 2’s EMR was reviewed. RN 5 stated she was in the OR for Pt 2’s surgery and was responsible for documentation of times when everyone was entering and leaving OR during the surgery. RN 5 stated she does not recall Pt 2 specifics, but she always documented exact times. RN 5 reviewed the EMR and Pt 2’s “OR Intraoperative record” and stated that Pt 2’s record reflects that RS 2 was in the room from 7:45 a.m. to 8:15 a.m., surgery start time was 8:13 a.m. RN 5 validated that EMR reflects she was the one that documented times for RS 2. RN 5 stated that she was unable to comment on cardiovascular surgery staffing requirements, however, she was not aware that second surgeon [first assistant] have to be in the operating room at all times. RN 5 stated that as long as someone was available she thought it was okay to proceed with the surgical procedure. During a concurrent interview and record review on 5/30/25 at 12:47 p.m. with SUR 2, Pt 2’s EMR was reviewed for the “OR Intraoperative record” dated 3/31/25. SUR 2 stated he was unable to comment on RS 2 times in the OR. SUR 2 stated the times listed may or may not be accurate. SUR 2 stated he does not recall who was in the room during the surgery. SUR 2 stated he was not aware of any program flex that hospital had in place, however, he was aware of the surgery staffing requirements for cardiac surgeries. SUR 2 stated he expected to have second surgeon in the OR during surgery. SUR 2 stated as far as he was aware, residents can function as first assistant [second surgeon] in the room and RNFA or PA can function as third surgeon. SUR 2 stated if the record reflects RS 2 left two minutes after procedure start, then it could not be accurate. During a concurrent interview and record review on 5/30/25 at 2:25 p.m. with the DSS and MA 1, OR case logs [systematic record of individual patient cases] for month of March 2025, April 2025 and May 2025 were reviewed for the cardiovascular surgeries. The review of OR case logs for the whole month of March 2025 indicated total of 22 open heart surgeries were done, and out of 22 cases 15 cases had resident surgeon as first assistant (second surgeon), two cases did not have any second surgeon that was a physician or resident. Out of 22 cases in March 2025, five cases did have second surgeon that was independent and qualified surgeon, however, three of those cases second surgeon was only in the room for less than 10 minutes. A review of April 2025 case log for cardiac surgeries indicated a total of 28 open heart surgeries were done at the hospital. Out of the 28 cases, 17 cases had a resident as first assistant (second surgeon), and two cases did not have any second surgeon that was a physician or resident. Out of 28 cases, nine cases did have second independent and qualified surgeon, however, six out of eight cases, that surgeon was in the room for ten or less minutes. The DSS and MA 1 both stated that this reported data was accurate and DQ validated it by manually counting it. The DSS stated the hospital team did not have a good understanding of the approved program flex and were not compliant with the conditions of approved program flex and requirement for cardiac surgery staffing under CCR. The DSS stated he now understands the CCR requirement and approved program flex. The DSS stated effective 5/23/25 changes have been put in place to ensure second independent and qualified surgeon would be present during all open-heart surgeries. The DSS stated going forward the second surgeon would be scheduled, and the OR team would be able to validate and confirm presence of independent and qualified second surgeon [first assistant] prior to patient’s surgery.”

“LICENSURE OF PERSONNEL CFR(s): 482.11(c) The hospital must assure that personnel are licensed or meet other applicable standards that are required by State or local laws. This Standard is not met as evidenced by: 28773 Based on observation, interviews, and review of hospital documents, the hospital failed to ensure the contracted vendor for Food and Nutrition Services met the organizational standards as required by State laws and regulations as specified in: 1. The State Health and Safety Code (HSC)1265.4 statue when the Executive Chef Manager, the position responsible for the day-to-day supervision of dietetic services at BHC Campus 2 was not qualified; 2. Title 22, Section 70275(a), when the hospital did not have a Registered Dietitian (RD) provide guidance and oversight to the food service operations manager and staff of the dietetic service at a sufficient duration and frequency at two of two campuses (Main Hospital Campus 1 and BHC Campus 2); and 3. Title 22, Section 70275(a), when the hospital did not have a RD reporting to hospital administration. This failure put patients at risk of compromised nutritional outcomes for a combined hospital census of 370 on May 20,2025. Findings: During the survey from 5/20/25 to 5/27/25, observations, interviews and document reviews indicated multiple concerns related to food safety and sanitation operations including: incorrect portions were served during lunch meal service at both campuses; there was no monitoring for cooling of ambient foods and facial hair was not restrained during meal service at BHC Campus 2, lack of competencies on food service staff (Cross refer A-0622 and A-0750). California regulations, Title 22 Section 70271 defines Dietetic service as the provision of safe, satisfying and nutritious foods with appropriate staff. Additionally, California regulation, Title 22 Section 70275(b) requires that, if a dietitian is not employed full-time, managing the day-to-day operations of dietetic services, a full-time person who has completed a supervisor’s training program shall be employed to be responsible for the operation of the food service. 1. During a review of the hospital organizational structure for the Food and Nutrition Services department, the Director of Food and Nutrition Services had the following positions reporting to the position: Operations Manager, Patient Services Manager, Retail Manager, Executive Chef Manager from BHC Campus 2, Executive Chef and Lead RD. During a review of the personnel file for the Executive Chef Manager (ECM) at BHC Campus 2, showed that ECM was not qualified for the position in accordance with the Health and Safety Code 1265.4 (b). During a concurrent interview on 5/22/25 at 2:49 p.m. the Interim Director of Food and Nutrition Services (IDFNS) confirmed the ECM was not qualified in accordance with State requirements to manage the day-to-day operations of dietetic services. California Health and Safety Code 1265.4 describes seven qualification pathways of the full-time position responsible for the day-to-day operation of dietetic services. (1) A baccalaureate degree with major studies in food and nutrition, dietetics, or food management and has one year of experience in the dietetic service of a licensed health facility. (2) A graduate of a dietetic technician training program approved by the American Dietetic Association, accredited by the Commission on Accreditation for Dietetics Education, or currently registered by the Commission on Dietetic Registration. (3) A graduate of a dietetic assistant training program approved by the Dietetic Association. (4) Is a graduate of a dietetic services training program approved by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility. (5) Is a graduate of a college degree program with major studies in food and nutrition, dietetics, food management, culinary arts, or hotel and restaurant management and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility. (6) A graduate of a state approved program that provides 90 or more hours of classroom instruction in dietetic service supervision, or 90 hours or more of combined classroom instruction and instructor led interactive web-based instruction in dietetic service supervision. (7) Received training experience in food service supervision and management in the military equivalent in content to paragraph (2), (3), or (6). During a review of the ECM job description, it showed under “Summary”, oversees kitchen operation while maintaining a safe and sanitary work environment for the staff and that they prepare or direct preparation of meals in accordance with corporate programs and guidelines. It showed ECM reports to the Director of Food and Nutrition and that complies with regulatory agencies, including federal, state, and Joint Commission. This job description was for an executive Chef in general and qualifications for this type of position at the campus. 2. California Code of Regulations, Title 22, Section 70275 states (a) A registered dietitian shall be employed on a full-time, part-time or consulting basis. Part-time or consultant services shall be provided on the premises at appropriate times on a regularly scheduled basis and of sufficient duration and frequency to provide continuing liaison with medical and nursing staffs, advice to the administrator, patient counseling, guidance to the supervisor and staff of the dietetic service, approval of all menus and participation in development or revision of dietetic policies and procedures and in planning and conducting in-service education programs. During a review of the Clinical Nutrition Manager (NCM) position description, dated August 2017, showed the CNM reported to the Director of Food and Nutrition Services (DFNS), however supervisory and oversight responsibilities of the CNM was limited to the clinical nutrition staff. The CNM position duties which required a Registered Dietitian did not include any oversight responsibilities for dietetic services such as guidance to the supervisor (DNFS) and the staff of the dietetic service. It was also noted the CNM position is currently vacant. During a review of the position description for the DNFS, dated March 2006, showed the DNFS position reported to the contracted vendors Regional Director of Operations. The position description did not reflect any direct reporting structure to hospital leadership. The position description did not indicate the DNFS received guidance from a Registered Dietitian (RD). 3. In contrast, during a review of the hospital organization chart, the reporting structure indicated the DFNS was under the hospital’s Chief Operating Officer (COO) however, it did not show how the vacant CNM position would report to hospital leadership indicate how the CNM or Lead RD would give advice to the administrator. During an interview with the Lead RD on 5/21/25 at 2:19 p.m., Lead RD stated she has been in the position for two months and her job responsibilities were limited to functions in clinical nutrition. The Lead RD also stated she was based out of state and traveled to the hospital for approximately one week each month. While onsite she stated she introduced herself to others, attended ICU rounds, met with pharmacy, food service staff and the patient service manager as well as attended a director meeting with the IDNFS. The Lead RD stated she had not closely looked at or inspected food services, observations of meal service or patient meal tray audits yet as she had other priority items to do while onsite.”

“CONTRACTED SERVICES CFR(s): 482.12(e) The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. This Standard is not met as evidenced by: 28773 Based on staff interviews and review of hospital documents, the hospital failed to ensure the contracted service for Food and Nutrition Services was met when the contract employed four of five full-time equivalent (FTEs) Registered Dietitians (RDs - Lead RD, RD 2, RD 3, RD 4, RD 5), to provide clinical nutrition care, that did not work on the premises or conduct face-to-face patient nutritional physical assessments which resulted in the provision of medical nutrition therapy that was not in accordance with the hospital’s position description for the Registered Dietitian or the current standards of practice. These failures resulted in not following standards of practice for clinical nutrition services for a hospital census of 370 patients; and could result in patients receiving suboptimal nutrition services and decreased nutrition and could lead to increased hospital readmission rates. Findings: During the course of the full validation survey from 5/20/25 to 5/28/25, eight patient records (Patient 40, 41, 42, 43, 44, 45, 46, 47) were reviewed for clinical nutrition care at both campuses. During an interview and concurrent review of patient records on 5/21/25 starting at 10:24 a.m., the RD (RD 1) stated she started working at the hospital one month ago and she also wanted to include the Lead RD for the interview since she was newer. RD 1 stated the Lead RD lived out of state and was in Michigan. The Lead RD stated she has worked in a remote capacity at the hospital for two years and about two months ago became the interim clinical nutrition manager. The Lead RD stated since RDs are not at the hospital in person they are not able to do nutrition focused physical exams (NFPE) on the patients when conducting the nutrition assessments. RD 1 stated she does conduct NFPE when she does nutrition assessments on the patients. During an interview with the Lead RD at 5/21/25 at 2:19 p.m., she stated she was onsite in for 4 to 5 days in each month of March and April. The activities she conducted during that time were introducing herself to staff, attending the rounds in the Intensive Care Unit (ICU) and meeting with the Pharmacy director. During an interview with RD 2 on 5/21/25 at 2:51 p.m., RD 2 stated she is physically located in Kentucky and works part time at the hospital reviewing the medical records of patients on the units including the neonatal intensive care unit (NICU) and behavioral health hospital. During a review of the RD schedule dated May 2025, showed there were two RDs that were located in Eastern Standard Time (EST), two that were in Central Standard Time (CST), three that were in Pacific Standard Time (PST), one of which was RD 1 who was onsite. During a review of the RD roster for the Main Hospital Campus 1, it indicated there were 5 RD FTEs, one of which was onsite. During a review of a document from the Interim Director of Food and Nutrition Services, it indicated 80% of the medical nutrition therapy was provided by offsite Registered Dietitians accomplished through a paper review of the electronic medical record. During a review of the RD position description dated 2017, indicated essential functions and responsibilities included “Assesses the nutritional status of neonates/ infants, pediatric, adolescent, adult and/or geriatric patient ...Uses parameters such as ...nutrition-focused physical assessment.” During a review of the Commission on Dietetic Registration, the credentialing agency for the Academy of Nutrition and Dietetics document, titled, “Revised 2024 Scope and Standards of Practice for the Registered Dietitian Nutritionist” indicated under Standard 7, Providing Person-Population-Centered Nutrition Care, the RD conducts nutrition assessment and obtains and assesses findings from nutrition-focused physical exam (NFPE). During an interview on 5/27/25 at 3:34 p.m. with the Chief Operating Officer (COO) regarding Food and Nutrition Services (FANS) Contract. The COO stated FANS reports up to him. The COO stated he was aware that the Clinical RDs are not physically located onsite except for the one new hire. He stated there has been challenges regarding recruiting for onsite positions. The COO stated he did not think there were any other allied health professionals that worked at the hospital that were not seeing patients in person. COO stated he thought the contract had policies and procedures regarding protocols when the RDs worked remotely. COO acknowledged the hospital had similar concerns with the RDs being remote and they were trying to offer more to attract more in person RDs. COO stated he was not aware of any other patient facing disciplines that function remotely since they all require a physical component. COO stated the physicians would state that patients cannot do surgery on themselves therefore they need to see patients in person. During a review of the hospital contract for Food and Nutrition Services, dated effective 10/1/19, indicated the 4.45 FTEs for inpatient dietitians (RDs) were employees of the contractor/vendor. The contract did not include the responsibility of the contractor to provide and meet professional standards.”

“PATIENT RIGHTS: REVIEW OF GRIEVANCES CFR(s): 482.13(a)(2) [The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance.] The hospital’s governing body must approve and be responsible for the effective operation of the grievance process, and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee. This Standard is not met as evidenced by: 37529 Based on interview and record review, the facility failed to implement a grievance process for prompt resolution of patient grievances when Patient (Pt) 10’s family member sent a grievance through certified mail and it was not acknowledged for sixteen days after it was received by the hospital. This resulted in a delay in the investigation and response to Pt 10’s family member’s grievance. Findings: During an interview on 5/29/25 at 11:10 a.m. with Pt 10’s family member, Pt 10’s family member stated she sent a grievance letter to the hospital through certified mail on 5/9/25. Pt 10’s family member stated she received the return receipt indicating the hospital signed for the certified mail on 5/14/25 and she has not heard from the hospital regarding the grievance. During a concurrent interview and record review on 5/30/25 at 11:32 a.m. with the Director of Quality (DQ) and Data Coordinator (DC) 1, the hospital’s “2025 Grievance Log,” was reviewed. DC 1 stated Pt 10’s family member’s grievance was received on 5/21/25. DC 1 stated part of job duties included logging patient grievances. DC 1 stated she was the main person who checked the department’s mailbox in the hospital but other staff who went to the mail room could check for mail. DC 1 stated mail could get placed into the wrong department’s mailbox which delayed the mail getting to the department. DC 1 stated the mailbox was checked daily, except on weekends. DC 1 stated a grievance did not get logged until the letter was physically opened and read. During a concurrent interview and record review on 5/30/25 at 11:40 a.m. with the DQ and DC 1, Pt 10’s family member’s certified mail was reviewed. The envelope indicated the certified mail was mailed on 5/10/25 and addressed to “Patient Relations/Risk Management/Quality D. [Name of hospital].” DC 1 stated the envelope was addressed to the department and would have been placed into the department’s mailbox. DC 1 stated she was unaware of how certified mail was received at the hospital. The DQ stated she did not know certified mail was received in the mail room. During a concurrent interview and record review on 5/30/25 at 11:45 a.m. with the DQ and DC 1, Pt 10’s “Seven Day Letter (SDL),” dated 5/28/25 was reviewed. The “SDL” indicated, “ ... Thank you for contacting us on May 21, 2025, concerning your mother’s visit to [name of hospital]. We have received your grievance and are in the process of investigating your concern. You will be notified of our findings and actions upon completion of our investigation. Should you have any questions, please feel free to contact us at [telephone number] ...” The DQ stated a grievance should be completed within seven days after it has been received. The DQ stated if a grievance could not be completed within seven days, a seven-day letter was sent to the patient or family member to acknowledge receipt of their grievance, and an investigation was being conducted. The DQ stated the “SDL” was a template and did not address how long it would take to complete the investigation. The DQ stated the hospital staff knew it had 30 days to complete the investigation and send a resolution letter to the patient or family member. The DQ stated, “We normally don’t let them know how long.” During an interview on 5/30/25 at 12:10 p.m. with the Health Information Management Operations Manager (HIMOM), the HIMOM stated her department was in charge of receiving mail sent to the hospital. The HIMOM stated the hospital received mail like “regular mail.” The HIMOM stated mail was placed in a basket and then sorted out to the departments in their mailbox. The HIMOM stated if an envelope was addressed to the quality department, it would be placed into their mailbox. The HIMOM stated she did not know who signed for certified mail. During an interview on 5/30/25 at 12:24 p.m. with the Manager of Accreditation (MA) 1, MA 1 stated a courier picked up the hospital’s mail daily and signed for certified mail. MA 1 stated the courier then dropped the certified mail into the basket to be sorted out by the mail room staff. MA 1 stated she did not know if the courier kept a log of certified mail. MA 1 stated she did not know why it would take six days for the department to receive mail. During a review of the hospital’s P&P titled, “CLN.11.01.MOD Patient Complaints & Grievances,” dated 4/24/25, the P&P indicated, “ ... “Grievance” is a formal written or verbal complaint that is made to the hospital by a patient, or the patient’s representative (these include any request that their complaint be handled as a formal grievance with a response) ... POLICY: ... The hospital’s process for managing complaints and grievances must incorporate the following objectives: ... Provide a planned, systematic mechanism for receiving and promptly acting upon issues expressed by patients and/or patient representatives ... If the resolution of the grievance is determined to take longer than seven days, the Grievance Committee or designee will send a response to the patient informing him/her that the hospital is still working to resolve the grievance and that the hospital will follow-up with a written response within a stated number of days (a “Deferral Letter”) ...””

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 49538 Based on interview and record review, the hospital failed to ensure patient’s had the right to make informed decisions about care for two of two sampled patients (Pt 28 and 29) when: 1. Consents and discharge instructions were not interpreted by a qualified interpreter to ensure the patient could fully understand the information provided according to the hospital’s policy and procedure (P&P) titled, “MOD.EAC.01.04.PR.01 Language Assistance Services (Including Interpreters) Procedure.” This failure denied Pt 28 and 29 of their right to make informed decisions about, participate in their care and potentially could affect all non-English speaking patient treated at the hospital. Findings: 1. During a concurrent interview and record review on 5/27/25 at 11:30 a.m. with Quality Review Nurse (QRN) 1, Pt 28’s “History and Physical (H&P-a comprehensive assessment of a patient, combining a medical history with a physical examination),” dated 3/27/25 was reviewed. The “H&P” indicated, “ ... Date/Time of Admission/Birth: 3/27/2025 at [12:15 p.m.] ... ADMISSION DIAGNOSES: Preterm ELBW [extremely low birth weight-babies born weighing less than 1000 grams] AGA [appropriate for gestational age-an infant whose size is considered appropriate for their AGA] female infant [status post] cesarean delivery [a surgical procedure where a baby is delivered through an incision in the mother’s abdomen and uterus] at 28 3/7 weeks gestation [the period of time between conception and birth; average length is 40 weeks], birthweight 940 g [grams-unit of measure]; Respiratory distress [a condition where a person struggles to breathe due to inadequate oxygen exchange in the lungs]; Hypoglycemia [low blood sugar]; Sepsis [a serious condition in which the body responds improperly to an infection] evaluation ... MATERNAL HISTORY: ... Language preference: Spanish. Interpreter required: YES ... PSYCHOSOCIAL: ... Parents updated in PACU [Post-Anesthesia Care Unit-the recovery room where patients are taken after surgery or procedures that involve anesthesia (medicine that is used to put you in a state like deep sleep during surgery)] and at bedside using Spanish speaking RN. Consent obtained for central lines and donor breast milk ...” QRN 1 stated Pt 28’s mother’s preferred language was Spanish, and a Spanish speaking nurse interpreted for the physician to obtain the consents. During a concurrent interview and record review on 5/27/25 at 11:35 a.m. with QRN 1, Pt 28’s “Consent to Surgery/Special Procedures (Informed Consent),” dated 3/27/25 and “Consent for the Use of Donor Human Milk in the Neonatal Intensive Care Unit (Donor Milk Consent),” dated 3/27/25 were reviewed. The “Informed Consent” indicated Pt 28’s mother signed the form. QRN 1 stated the “Informed Consent” was written in Spanish, but no interpreter signature was on the form. The “Donor Milk Consent” indicated Pt 28’s mother signed the form. QRN 1 stated the “Donor Milk Consent” was written in Spanish but no interpreter signature was on the form. During a concurrent interview and record review on 5/27/25 at 11:40 a.m. with QRN 1, Pt 28’s “Interpreter Flowsheet (IF),” dated 3/27/25 and “Form Browser (FB),” dated 3/27/25 were reviewed. QRN 1 stated the “IF” and “FB” indicated no interpreter was used to explain the “Informed Consent” and “Donor Milk Consent.” QRN 1 stated the hospital’s policy indicated a qualified interpreter should have been used. QRN 1 stated hospital staff were not qualified interpreters, and the hospital used qualified interpreters through a video call. QRN 1 stated a qualified interpreter went through a program to ensure he or she could translate accurately. QRN 1 stated a qualified interpreter should be used for any consent and invasive (breaking the skin or inserting an instrument into the body) procedure. During a concurrent interview and record review on 5/27/25 at 2:10 p.m. with Registered Nurse Educator (RNE) 1, Pt 29’s “Face Sheet,” undated, and “Consent for Anesthesia Services (CAS),” dated 3/15/25 were reviewed. The “Face Sheet” indicated Pt 29’s preferred language was Spanish. The “CAS” indicated no interpreter was used to translate the form. RNE 1 stated the “CAS” was written in Spanish, but no interpreter signature was present on the form. During a concurrent interview and record review on 5/27/25 at 2:15 p.m. with RNE 1, Pt 29’s “Electronic Medical Record (EMR-a digital version of a patient’s paper medical chart),” dated 3/15/25 was reviewed. RNE 1 stated there was no interpreter documentation in the “EMR” that an interpreter was used for Pt 29’s “CAS.” RNE 1 stated an interpreter should be used to ensure the patient understood what was to be done. During a concurrent interview and record review on 5/27/25 at 2:20 p.m. with RNE 1, Pt 29’s “Discharge Instructions (DI),” dated 3/17/25 and “EMR,” dated 3/17/25 were reviewed. RNE 1 stated the “DI” was written in Spanish and was signed by Pt 29. RNE 1 stated there was no interpreter documented on the “DI.” RNE 1 stated the “EMR” indicated RN 6 interpreted the discharge instructions to Pt 29 since RN 6 spoke Spanish. RNE 1 stated discharge instructions did not need to be interpreted by a certified interpreter. RNE 1 stated hospital staff were able to interpret discharge instructions if they spoke the same language as the patient. During an interview on 5/29/25 at 2:32 p.m. with the Director of Obstetrics (DB), the DB stated she expected nurses to use an interpreter when obtaining an epidural consent and document the interpreter on the consent form. The DB stated she expected nurses to use a qualified interpreter when providing discharge instructions. During an interview on 5/29/25 at 2:35 p.m. with the Director of NICU and Pediatrics (DP), the DP stated she expected nurses to use the hospital’s translation device only and to document the interpreter in the medical record. During a review of the hospital’s P&P titled, “MOD.EAC.01.04.PR.01 Language Assistance Services (Including Interpreters) Procedure,” dated 7/24/24, the P&P indicated, “ ... Interpreting Services ... Prompt Call for Interpreters ... The health care professional in charge of coordinating the care for an LEP [Limited English Proficient-Individuals who do not speak English as their primary language and who may have a limited ability to read, write, speak, or understand English] Patient shall continue to assess in consultation with the Patient (and, where appropriate, the Patient’s family members or close friends) the need for Qualified Interpreters ...throughout the Patient’s receipt of Facility services ... provision of Patient rights, informed consent or permission for treatment ... explanation of procedures, tests, treatment, treatment options or surgery ... discharge instructions ...” During a review of the hospital’s P&P titled, “MOD.EAC.01.04 Language Assistance Services (Including Interpreters) (Model Policy),” dated 7/24/24, the P&P indicated, “ ... PURPOSE: To establish guidelines to accommodate Limited English Proficient Individuals in the delivery of healthcare services. Limited English Proficient Individuals will be provided with language assistance services at no cost to allow them an equal opportunity to participate in and benefit from healthcare services ... DEFINITIONS: Limited English Proficient (LEP) Individuals: Individuals who do not speak English as their primary language and who may have a limited ability to read, write, speak, or understand English ... Qualified Interpreter: Is an interpreter who, via a Video Remote Interpreting (VRI) Service or an on-site appearance, can interpret effectively, accurately, and impartially, both receptively and expressively, using any necessary specialized vocabulary. Qualified Interpreters include, for example, oral transliterators, and cued-language transliterators ...””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to ensure care was provided in a safe setting for 1 of 1 sampled patients, Patient (Pt) 10 and failed to ensure the patient’s and the patient’s surrogate’s right to emotional health and safety (the components of an emotionally safe environment: respect, dignity, and comfort) when: Patient 10 experienced a change in level of consciousness, and a respiratory arrest and the circumstances leading up to the events were not clearly explained in either instance to Pt 10’s daughter or documented in the medical record; Pt 10 was left soiled in her bed for over two hours despite Pt 10’s daughter asking the staff to change Pt 10; The nursing staff in the ICU were laughing and talking during the time Pt 10’s family was there to say goodbye to Pt 10; Pt 10 bit her tongue at the time her breathing tube was removed (extubation) resulting in pain and bleeding, the nursing staff did not administer an adequate amount of the medications ordered for comfort care after Pt 10 experienced extreme distress following extubation; and Pt 10’s body was removed from the hospital approximately five hours after her death and transported to a mortuary in a nearby city without the hospital first notifying Pt 10’s daughter and obtaining consent. Pt 10’s daughter was informed by the hospital Pt 10 was transported due to patient being too big for the hospital’s morgue. These failures resulted in Pt 10 experiencing fear and physical distress, and her family experiencing emotional distress. Findings: During an interview on 5/29/25 at 11:06 a.m. with Pt 10’s daughter (FM 3), FM 3’s concerns about Pt 10’s care were discussed. FM 3 stated Pt 10 was brought to the hospital on 11/20/24 after she was noted to be confused and showed signs of a possible stroke. The work up did not show an acute stroke just signs of the old one. FM 3 stated the doctor told her that her mother could go home or be admitted to the hospital to observe her and even though her mom did not want to stay FM 3 agreed to Pt 10 being admitted. FM 3 stated her mom had a previous stroke and was left with left sided weakness and some difficulty with speech, and other residual effects and came to live with FM 3 in 2021. FM 3 stated she is her mom’s durable power of attorney (DPOA- has decision-making authority). FM 3 stated throughout Pt 10’s hospitalization there were “multiple failures in care, communication and basic human dignity. The most distressing part of this experience was witnessing my mother visibly suffer during what should have been her final moments of peace. The inadequate and uncoordinated execution of comfort care left lasting emotional trauma on our family.” FM 3 stated on 11/22/24 in the afternoon her mom was doing better and was working with the speech therapist, so FM 3 left the hospital to drop off her son. FM 3 stated she received a call while she was gone and was told her mom had a seizure. FM 3 stated she returned to the hospital and found that Pt 10 was unresponsive, and staff told her Pt 10 might wake up. FM 3 stated she still did not understand what happened but stated her mom was never ok after that. FM 3 stated she was told Pt 10 had new small strokes. She said that evening FM 3 thought her mom needed to be changed because it smelled and asked the staff to change her, but the nurse told her it was just gas. FM 3 stated her mom was left so long sitting in her bowel movement (BM) it was dried onto her skin. FM 3 stated the sheets were not even on the mattress under her mom. FM 3 stated the Certified Nursing Assistant (CNA) on the night shift changed and bathed her mom. The next morning on 11/23/24, she called really early to check on her mom and was told she was doing fine, so she stopped to get a coffee on the way into the hospital. When she arrived around 6:15 a.m. they were calling a code (Code blue- a life threatening medical emergency where the patient’s heart has stopped beating or patient has stopped breathing) on her mom. FM 3 stated she overheard the nurses debating about whether her mom was a DNR (Do Not Resuscitate- a legally recognized order that means a patient does not want to be revived if they stop breathing or their heart stops beating.) or full code (a medical term that indicates patient’s preference for full resuscitation and all life saving measures if they stop breathing or their heart stops). FM 3 stated her mom was a full code and she had just discussed this with the staff the previous night, but Pt 10 had a DNR wrist band on. FM 3 stated she was told Pt 10 coded because when she had a seizure the previous day she bit her tongue, and it was swollen and obstructed her airway, so she had a respiratory arrest (stopped breathing). FM 3 stated she still does not fully understand what happened. FM 3 stated her mom’s tongue was bloody and swollen and over the next few days ended up looking infected and smelled really bad. FM 3 stated Pt 10 was in Intensive Care Unit (ICU) after that and then one thing after another happened, and her kidneys were failing. FM 3 stated the doctor talked to her about the code status and questioned Pt 10’s quality of life. FM 3 stated she told the doctor her mom “survived a previous stroke and had a life, her mom got around in her scooter, took her dog on a leash to the park, and went to Walmart independently. FM 3 stated her mom was artistic and painted. FM 3 stated she felt the staff was disrespectful when she wanted to give her mom a chance to see if she could recover. FM 3 stated one staff member made comments that if he couldn’t use the bathroom independently he wouldn’t want to live like that. FM 3 stated the ICU had curtains in between the patient rooms so you can hear everything, and the nursing staff could be heard laughing and talking during the ICU stay, and FM 3 stated a family member said something to the staff about that but did not feel the staff cared. FM 3 stated when her mom had another stroke and there was no chance she would recover she made the decision for comfort care (specialized medical care aimed at easing suffering and improving quality of life with people with serious medical conditions). FM 3 stated it was such a hard decision, but she did not want her mom to suffer. FM 3 stated the nurse practitioner that talked to her about the process, explained Pt 10 would receive continuous medication and Intravenous (IV-directly in the vein) push medication so she would not suffer when the breathing tube was removed. FM 3 stated her husband and Pt 10’s sister were with her at Pt 10’s bedside. FM 3 stated when the breathing tube was removed her mom bit her swollen tongue again and they did not have a bite block, they had to get it from another floor, so there was a delay in getting in in her mouth to prevent her from biting down. FM 3 stated her mom’s eyes were bulging out, she looked scared, was gasping for air and squeezing her hand and her husband’s hand. FM 3 stated it was so awful, Pt 10’s sister screamed and left the room. FM 3 stated she asked the staff to please give her mom more medication because she was suffering, but Pt 10’s nurse told her this was normal. FM 3 stated she kept asking them for more medication for her mom, but it was an hour before the nurse brought more medication for her mom. She stated soon after the nurse gave her the medications, her mom passed away. FM 3 stated someone came in to check her mother to verify she had passed but that was almost 10 minutes after it happened. FM 3 stated she made the difficult decision to go to comfort care because she did not want her mom to suffer and wanted her to be able to die with dignity, and then had the opposite happen. FM 3 stated watching her mom suffer and struggle for air like she did, has left her and her family traumatized. FM 3 stated some time after her mom died she left the hospital and went home. Since no one asked her about what mortuary she wanted before she left the hospital she assumed they would call her the next day. When she did not get a call she called the hospital. FM 3 stated she was told “your mother is no longer here.” FM 3 stated she was told “due to her mother’s size she was taken to an overflow mortuary in Salida.” FM 3 stated she was very surprised her mother was transported to a mortuary she (FM 3) did not choose without someone informing her beforehand. FM 3 stated telling someone who has just lost a loved one that their family member was moved because they were too big was disrespectful. During a concurrent interview and record review on 5/29/25 at 12:30 p.m. with the Stroke Coordinator (SC), Pt 10’s medical record was reviewed. The record indicated Pt 10 was a 59 year old female who was admitted on 11/20/24 with symptoms of a stroke (a loss of blood flow to part of the brain, which damages brain tissue). Pt 10 had a history of a previous stroke with residual left sided weakness, hypertension (elevated blood pressure), atrial fibrillation (AFib- an arrhythmia that occurs when the upper chambers of the heart [atria] beat irregularly and fast), diabetes, and chronic kidney disease. The stroke protocol was initiated, the imaging studies did not reveal an acute (new, recent) stroke initially, and Pt 10 was admitted to the 1 Med Telemetry unit. The SC stated 1 Med Telemetry is also one of the designated units where patients who have had a stroke are admitted. The medical record indicated on 11/22/24 at 3:40 p.m., RN 20 sent an electronic message to MD 15, “Patient was screaming, unable to tell us what was wrong. Then she had some flatulence and an emesis (vomit) episode. There were some bright streaks of blood in the emesis. Lung sounds a bit coarse; she might have aspirated (vomited in her lungs). I will give her some Zofran [medication for nausea and vomiting].” The record does not indicate whether there was a response from MD 15, and the medication administration record indicated Pt 10 did not receive Zofran. The record indicated on 11/22/24 at 3:51 p.m. an “Internal [Inpatient] Stroke Alert” was initiated. The SC stated when a hospitalized patient shows signs of a potential stroke, an “Internal” stroke alert is activated as opposed to when a person with a possible stroke comes to the ED then a “Stroke Alert” is activated. When an internal stroke alert is initiated, a specially trained nurse, a neurocritical response nurse (NCRN), responds and assesses the patient following the stroke alert protocol. A review of the “Rapid Response Team (RRT) record” dated 11/22/24, indicated at 3:51 p.m. the NCRN assessed Pt 10 and noted Pt 10 was “Comatose. Decrease level of consciousness, sudden loss of movement/weakness in face, arm, leg” with a National Institute of Health Stroke Scale (NIHSS- a tool used by healthcare providers to objectively quantify the impairment caused by a stroke) score of 38 (Severe stroke). Pt 10’s Glasgow Coma Scale (GCS- a neurological assessment tool used to measure a patient’s level of consciousness) score was 5 (on a scale from 3 to 15, with 3 being the lowest [comatose state] and 15 being the highest [normal, alert state]) with Pt 10 exhibiting decorticate posturing (a reflex body position which is usually a sign of a severe injury or disruption to the brain). The SC stated neither the RRT record, or the nurses notes indicate who activated the Internal Stroke Alert, or what occurred after the 3:40 p.m. message sent by RN 20 to MD 15 to prompt the stroke alert call. Review of the order report for 11/22/24, indicated at 3:49 p.m. RN 20 obtained telephone orders for a Computed tomography (CT- a medical imaging technique used to obtain detailed internal images of the body) scan of the brain for “altered level of consciousness,” and at 3:53 p.m. orders were obtained for a chest x-ray for “respiratory distress,” and a CT scan of the chest for “shortness of breath.” At 15:55 Pt 10’s respiratory rate was 26 breaths (respirations) per minute (rpm- normal 14-20 per minute), oxygen saturation 98%, and Pt 10 noted to be snoring, with labored respirations. At 3:58 p.m. the stroke alert protocol orders including lab tests and imaging were initiated. At 4 p.m. RN 20 obtained telephone orders for Lorazepam (a medication given for anxiety, seizures, agitation) 1 mg IV push and Keppra 500 mg IV (a medication for the treatment of seizures) and both medications were given. There was no documentation in the record indicating what if any seizure activity was observed. During a record review on 5/29/25 beginning at 1:15 p.m. with the Stroke Coordinator (SC), Pt 10’s medical record was reviewed. Review of the nursing assistant’s note dated 11/22/24 at 8:25 p.m., indicated, “Pt was left soiled, and family was very unhappy. Pt bed was not properly placed, bedding was very dirty. Nurse and I did a full bed change and bathe pt with family member. Pt family was happy how well we clean, and bathe pt. Addressed to charge Nurse. They waited for dayshift 2 hours to clean pt family requested. During report CNA did not address this situation with me in report.” The medical record indicated on 11/23/24 at 6:06 a.m., a RRT call was initiated. The RRT record indicated, “RRT Comment: RRT called for agonal breathing/biting on tongue/recent stroke alert. Physician Assistant [PA] at bedside. RRT Interventions: Appropriate protocol initiated. RRT Physician contacted at 6:10 a.m. Intensivist consulted for intubation/transfer to Cardiovascular Intensive Care Unit (CVICU). RRT Intubation Time: 6:20 a.m. RRT Outcome: Transfer to ICU/CCU. See PA prog. notes/orders, see nursing documentation ...” The SC stated although the RRT note indicated to refer to the nursing notes and the PA notes, she is unable to find any documentation regarding if Pt 10 was observed during this time (4 a.m. to 6:06 a.m.), if vital signs were obtained, or who initiated the RRT call. During a concurrent interview and record review on 5/29/25 at 1:45 p.m. with the Stroke Coordinator (SC), Pt 10’s medical record was reviewed. Review of the nurse practitioner’s note dated 11/29/24 at 7:32 p.m., indicated, “Called to bedside by nursing staff, patient’s family request to make patient Do Not Resuscitate, discussed with patient’s daughter and her aunt at bedside. Patient daughter states that she does not want her mom to suffer and wants to take her off of life support, discussed comfort care. Will proceed with comfort care once medications are ready, will start morphine drip and as needed pushes and then will extubate patient and patient’s daughter is aware that patient will die however she does not want her mother to suffer, discussed with nursing staff. Patient is DNR and comfort care.” During a concurrent interview and record review on 5/29/25 at 2 p.m. with the stroke coordinator, Pt 10’s orders dated 11/29/24, indicated “Comfort Care Orders” were placed at 7:48 p.m. and included orders for Morphine 2 mg IV push every hour as needed for pain and a continuous IV infusion of Morphine 100mg/100ml 0.9% saline for Pain/Respiratory discomfort, start at 2 mg per hour, Titrate (adjust dose) every 30 minutes by 1 mg to patient comfort. Maximum rate 15 mg per hour. The comfort care orders also included an order for Lorazepam 1 mg IV every two hours as needed for nausea and vomiting. In addition to the comfort care orders, at 7:50 p.m. a separate order for Morphine 2 milligrams [mg] intravenous (IV) was ordered to be given Stat (immediately, without delay). Review of the Medication Administration Record (MAR) dated 11/29/24, indicated the Stat dose of Morphine 2 mg IV push was given at 8:30 p.m., and at 9:22 p.m. the morphine infusion was started at 2 mg per hour. Review of the respiratory care notes dated 11/29/24 at 10:28 p.m., indicated at 9:49 p.m. Pt 10 was extubated (breathing tube removed), and a bite block was placed. The MAR indicated morphine 2 mg IV push was not given again when the orders allowed at 9:30 p.m., and was not given again after the initial dose at 8:30 p.m. The MAR indicated the morphine infusion was not titrated up 1 mg when the orders allowed at 9:52 p.m., and was not increased to 3 mg per hour until 10:32 p.m. Review of Communication/Notification notes dated 11/29/24, indicated at 10:30 p.m., “Physician Communication Notified Of: Patient condition, Patient/proxy request. Physician Communication Comments: Patient is tachypneic and requires increased rate on morphine drip. Okay to max drip.” The MAR indicated at 10:32 p.m. Lorazepam 1 mg was given IV push, and at 10:40 p.m. the morphine infusion was increased to the maximum dose of 15 mg per hour, and at 10:45 the infusion was discontinued. Pt 10 was pronounced dead at 10:46 p.m. Review of the nurses notes indicated there was no documentation in the record from the time Pt 10 was extubated at 9:49 p.m. until the time Pt 10 was pronounced dead. There was nothing in the record regarding what occurred when Pt 10 was extubated, how Pt 10 looked and responded to the extubation and subsequent dying process, or what measures were implemented to provide comfort including medications given to address any patient distress. During a concurrent interview and record review on 5/29/25 at 3 p.m. with the Patient Safety Officer (PSO), a document from Pt 10’s medical record titled, “Mortuary-Autopsy Consent” was reviewed. The top section of the document consisted of the notification of death and indicated Pt 10’s daughter, a physician assistant, and the supervisor received notification of Pt 10’s death from Pt 10’s nurse on 11/29/24 at 10:46 p.m. The next section of the document “Authorization and Release” was supposed to indicate consent to deliver the remains of the deceased to the mortuary chosen by the family, and was to include the name, address and phone number of the chosen mortuary, and the name, relationship, and signature of the responsible person who authorized the release of the deceased to the mortuary, the date, time, and method of the authorization (phone, signed permit, other), and the name of two witnesses, however this section was left blank. There was a space indicating “Family: Contact Name, Telephone number” which listed Pt 10’s daughter and her telephone number. Toward the bottom of the page was space to document the date and time that “The above authorized mortuary was notified and instructions given for pick up within 72 hours,” and the signature of person who notified them, however this section was left blank. Finally, the last section of the form was “Coroner/Mortuary’s Receipt” to indicate the printed name of the mortuary representative or coroner’s badge number who received the body, which was also left blank, and the received date and time which indicated 11/30/24 at 3:37 a.m. There was an unreadable signature in the space for “Signature Mortuary Representative/Coroner,” the “ID Band Check,” box was left blank, and there was an unreadable signature in the space for “Security Signature.” There was no information on the document that identified what mortuary Pt 10 was transported to and no evidence Pt 10’s daughter was contacted about mortuary choice, or that authorization or consent for transport to a mortuary was obtained. The PSO stated she was able to find out that the person who signed as the Mortuary Representative/Coroner was an employee of [Name of Mortuary], and the person who signed as Security was [Name of Security Officer], who worked for the hospital. The PSO provided an untitled document with Pt 10’s hospital identification at the top, the date and time of death (11/29/24 at 10:46 p.m.), DOB [Pt 10’s date of birth], weight [Pt 10’s weight], the unit (CVICU), the date and time picked up (11/30/24 at 1:15 a.m.) and time placed in holding location (1:25 a.m.). The document had a place to indicate the name and phone number of the mortuary, and the date and time the mortuary was contacted, however this was left blank. The document indicated “Name of Next of Kin Authorizing Release: [Name of Pt 10’s daughter], Phone number and relationship: [Pt 10’s daughter’s phone number]. The document indicated, “Releasing to [Prepopulated Name of Mortuary] (Family verification): 1st call attempt Next of Kin, 2nd call attempt Next of Kin,” and both the first call attempt and the second call attempt were blank. The document indicated the “Date and Time Released to Mortuary or Coroner,” was 11/30/24 at 3:37 a.m., and the “Picking up Officer” and the “Releasing Officer,” were both identified as [last name of Security Officer], who worked for the hospital. There were handwritten comments at the bottom of the document which indicated, “No mortuary selected. Called [Name of Mortuary] due to overweight.” There was no documentation that Pt 10’s daughter gave consent or authorization for her mother (Pt 10) to be taken to [Name of Mortuary], or that an attempt to notify Pt 10’s daughter before or after Pt 10 was transported to [Name of Mortuary] was made. The PSO was asked what the comment about “overweight” meant. The PSO stated the spaces in the hospital’s morgue are not large so “bariatric” (extremely overweight) patients can’t fit there so the hospital uses [Name of Mortuary] as overflow. The PSO stated she is not positive of the exact name of the mortuary because it may have changed. The PSO stated she is not sure what the weight limit is, but thinks it is less than 300 lbs. The contract with [Name of Mortuary] was requested, however the hospital was unable to find one. During an interview on 5/30/25 at 4 p.m. with the Security Supervisor (SS 2), SS 2 stated patients that weigh over 250 pounds are taken to [Name of Mortuary] in Salida. SS 2 stated the hospital morgue had spaces that cannot support weight that exceeds that amount so once the security officer is told the weight they know if they will need to transfer the body to [Name of Mortuary]. SS 2 stated the security officer is supposed to contact the next of kin, explain the situation and get their consent before the patient is transported. During an interview on 6/2/25 at 1:40 p.m. with a nurse from the stroke team (NCRN 2), the NCRN stated when she is taking care of someone who is going to be extubated and receive comfort care during the dying process, she ensures the orders for medications are written and she has the IV medication infusing prior to the patient being extubated. NCRN 2 stated she also makes sure she has the medication for IV push readily available as well as the medication prescribed for anxiety so that if her patient needs medication she will be prepared. NCRN 2 stated every patient’s response is different and she observes her patients response and vital signs to be alerted to patient distress. She will also help the family understand what they are seeing and answer questions if needed. If the patient was in distress she would document that. NCRN stated she is not sure why medication would not have been given if the patient was in distress and medication was ordered. Review of the hospital’s P&P titled. “MOD SS.1.05 Patient Rights,” dated 9/24/24, indicated, “ ... [Name of Hospital] and its staff protect and promote each patient’s rights. These rights apply to all patients, or when applicable, their representatives ... All patients’ rights apply to the person who has legal responsibility to make decisions regarding medical care on your behalf ...You have the right to: Considerate and respectful care, and to be made comfortable. You have the right to respect for your cultural psychosocial, spiritual, and personal values, beliefs and preferences ... Receive information about your health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care (including unanticipated outcomes) in terms you can understand. You have the right to effective communication and to participate in the development and implementation of your plan of care ... Reasonable responses to any reasonable requests made for service ...Receive care in a safe setting, free from mental, physical, sexual or verbal abuse and neglect, exploitation or harassment ...” Review of the P&P titled “Comfort Measures Only [CMO] Policy And Protocol, dated 8/28/19, indicated, “ ...Each patient’s case and situation is unique and decisions about each patient’s care should reflect this. Care will be individualized to suit the circumstances of each patient and, all care should be planned with the patient’s comfort as the primary focus. This care should be provided in the least stressful setting and, therefore, these patients generally should not require an ICU environment ... Medications: The guiding principle in providing medication to a patient who is to receive CMO is that the aim of the medication is to provide palliation of symptoms for the patient. High on this list would be analgesics, antipyretics, sedatives, anxiolytics and seizure medications. Other relief of symptoms medications may be given for the goal of patient comfort ...” Review of the hospital’s P&P titled, “Documentation Policy” dated 9/28/22, indicated, “ ...The patient medical record reflects the complete picture of the patient’s health status, treatment and progress from admission to discharge from which other health professionals can take over responsibility for the patient concerned ...It should include a comprehensive assessment; identified problems; expected outcomes; the plan of care and care delivered (or not delivered); teaching given; advice sought in decision making; and the patient’s response to treatment ...All Clinical Staff Members are responsible for documentation of clinical care given and ensuring that the standard of that documentation meets all legal and professional requirements. Documentation shall be completed timely ...Assessments will be completed and signed by licensed personnel. Assessments may be completed by a student extern, and then confirmed and signed by licensed personnel...All assessment data collected from a licensed vocational nurse [LVN] or student nurse will be reviewed, checked for accuracy, and co-signed by licensed personnel ...Patients are reassessed a minimum of every shift and as needed by an RN. LVNs and non-licensed personnel may collect and record data ...Changes in patient condition are documented within the appropriate electronic health record [EHR] system review, along with physician notifications ... Chart “annotation” may be used for narrative charting ...” Review of the American College of Chest Physicians article titled, “Compassionate Extubation In Adult ICUs,” dated 10/20, indicated, “ ...Interdisciplinary protocols should be developed to standardize practices surrounding compassionate extubation, to improve symptom control and reduce the presence of agonal breathing ...Using standardized compassionate extubation process could alleviate patient suffering at the end of life and cause less emotional discomfort to the clinicians ...” Review of the article in Mayo Clinic Proceedings titled, “Ethical Decision Making With End-of-Life Care: Palliative Sedation and Withholding or Withdrawing Life-Sustaining Treatments,” dated 10/2010, indicated, “ ...Palliative sedation [PS]has an important place on the continuum of appropriate palliative care at the end of life. It is appropriate therapy for refractory and unacceptably severe suffering. At the end of life, patient goals often shift to comfort, and removal of burdens and relief of suffering become paramount. The sedation level should be balanced according to the patient or surrogate’s value placed on the effectiveness of symptom relief, and perceived benefits of such relief ...Because intensive care units are specially equipped and attended by highly specialized staff with the goal of preserving life, these rooms are in high demand and should be reserved for the critically ill whose primary goal is survival. Furthermore, the intensive care setting can be hectic and uncomfortable for families. For those who prioritize comfort at the time of inevitable death, intensive care units are generally a suboptimal setting for palliative sedation. If, however, goals of care shift from life prolongation to comfort and a short interval to death precludes transfer from the intensive setting, PS can be effectively implemented in this setting ...””

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 42321 Based on interview and record review, the hospital failed to collect data on the Cardiovascular Program Flex that was approved in 2022 to May 2025. This failure resulted in the quality department’s inability to identify if there were opportunities for improvement in this high-risk area that affects patients’ safety. Findings: During an interview on 5/30/25, at 3:48 p.m., with the Director of Quality Improvement (DQ), the DQ stated there was not an official project in place to monitor the use of the Program Flex (a request to change or modify or deviate from the standard regulations) for Cardiothoracic surgery first and second assists (first assist must be an independent qualified surgeon and second assist can be physician assistant or a registered nurse first assistant). The DQ stated the hospital was not following the Program Flex approved for Cardiothoracic use of first and second assistants. During a review of the Hospital’s program flex approval letter for California Code of Regulations T22 (Title 22) DIV5 (Division 5) CH1 (Chapter 1) ART (Article) 6-70435(b)(2), dated 10/18/22, indicated, “The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass. Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: ... 4. The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non- surgeon cannot be the first assist for cardiovascular operative procedures ... 14. As part of the hospital’s on-going quality assurance program, a methodology for periodic evaluation of the effectiveness of this alternate method shall be developed. There shall be provisions for recommendations to be made to the administration and medical staff and any follow-up action ...” During a review of the hospital’s “Performance Improvement Annual Appraisal & Quality Assessment and Performance Improvement Plan 2024-2026,” the plan indicated, “The QAPI plan guides the organization’s performance improvement efforts. The QAPI regulation requires a written plan. This plan is a framework for an effective, comprehensive, data driven program that focuses on the indicators that reflect outcomes of care, quality and patient safety. The purpose of the Performance Improvement Program at [name of this hospital] is to ensure patients are provided high quality care in an environment of minimal risk. This is accomplished through the collaborative efforts of staff in different areas, disciplines and professional backgrounds consistent with the hospital’s mission, vision and goals ...””

“QAPI GOVERNING BODY, STANDARD TAG CFR(s): 482.21 ... The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement) ... The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Standard is not met as evidenced by: 42321 Based on interview and record review the hospital’s Governing Body failed to ensure that the Quality Assessment and Performance Program (QAPI- is a systematic approach to improving the quality of care and services delivered to patients) involved all hospital departments and services when: 1. The Program Flex (a request to change or modify or deviate from the standard regulations) for the Cardiovascular Department approved in 2022, was not followed and the hospital allowed a fifth year resident in cardiothoracic surgery as the surgical first assist ,and 2.The Health Information Management (HIM) Departments (manages patients’ data, ensuring its quality, integrity, and security) were not being monitored by the quality department’s program. These failures resulted in the Governing Body’s inability to ensure that the QAPI program reflected the complexity of the hospitals organization and services. Findings: During a review of hospital’s Governing Body minutes and Quality minutes from October 2024 to April of 2025, there was no mention of the Program Flex for the Cardiovascular Department approved in 2022 and no mention of the Health Information Management (HIM) Department’s quality data. 1. A review of Title 22 of the California Code of Regulations (CCR -is a comprehensive set of rules and regulations that govern various aspects of programs in California) section 70435 Cardiovascular Surgery Service Staff was conducted, and the program flex document was reviewed. Title 22 CCR section 70435 indicated “ ... (b) Cardiovascular operative service. (1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Thoracic Surgery or the American Board of Surgery with training and experience in cardiovascular surgery. He shall be responsible for: (A) Implementing established policies and procedures. (B) Training and supervising the nurses and technicians in special techniques. (C) Training and supervising the clinical perfusionists. (2) A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph (b) (1) above ...”. The review of “APPROVAL OF PROGRAM FLEXIBILITY” by CDPH dated October 18, 2022, indicated, “ ... This letter is in response to the request submitted by [Hospital name] for program flexibility for California Code of Regulations T22 DIV5 CH1 ART6-70435(b)(2). The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass ... The use of the PA as a second assistant is at the discretion of the primary surgeon ... The facility is required to have a 3-team cardiovascular surgical team in the OR ... The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures ...” During an interview on 5/27/25 at 4:30 p.m., with the Hospital’s Governing Body (GB) representatives, the GB representatives stated that they were informed about the use of a fifth year resident in cardiothoracic surgery as the first assist on this last Thursday 5/22/25. A fifth year resident would not be considered an independent and fully functioning surgeon as stated in the Program Flex. The GB representatives stated the Program Flex was reviewed with them and it was explained to them that the hospital had not been following the flex. The GB representatives stated they did not know the hospital was not following this Program Flex until that day. The GB representatives stated the GB expect the hospital to follow the flex, and the hospital has already started making changes. The GB stated the GB is responsible for the quality of care provided at this hospital. 2. During an interview on 5/30/25, at 3:48 p.m., with the Director of Quality Improvement (DQ), the DQ stated there was not an official project in place to monitor the use of the Program Flex for Cardiothoracic surgery first and second assists. The DQ stated the hospital was not following the Flex approved for Cardiothoracic use of first and second assistants. The DQ stated although HIM was monitoring its own projects HIM was not reporting to the Quality Department at all. The DQ stated she has all departments color coded and each color meets quarterly and HIM was missed (HIM was never assigned a color code). The DQ stated she uses data from the HIM department all the time and now she plans to include them during her quarterly meetings for Quality. During a review of the Hospital’s Quality Program Binder, created and updated by the DQ, the binder had no quality data mentioning the conditions approved by the Cardiothoracic Program Flex and had no quality data from the HIM Department. During a review of the hospital’s “Performance Improvement Annual Appraisal & Quality Assessment and Performance Improvement Plan 2024-2026,” the plan indicated, “The QAPI plan guides the organization’s performance improvement efforts. The QAPI regulation requires a written plan. This plan is a framework for an effective, comprehensive, data driven program that focuses on the indicators that reflect outcomes of care, quality and patient safety. The purpose of the Performance Improvement Program at [name of this hospital] is to ensure patients are provided high quality care in an environment of minimal risk. This is accomplished through the collaborative efforts of staff in different areas, disciplines and professional backgrounds consistent with the hospital’s mission, vision and goals ...””

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 49419 Based on interview and record review, the hospital failed to ensure the Medical Staff was accountable to the Governing Body when: 1. The Medical Staff office did not have a system in place to ensure adequate and appropriate staff in the Operating Room (OR) for cardiovascular (heart and blood vessels) surgical procedures that require the use of an extracorporeal (outside the living body) coronary (heart) bypass machine (a machine that temporarily takes over the function of the heart and lungs, putting oxygen in the blood and pumping that blood throughout the body) in accordance with a signed agreement to comply with California Code of Regulations, Title 22 Division 5 article 6 section 70435(b) (2). 2. The medical staff failed to ensure that an annual review of all qualified non-surgeons who participated in CV surgery requiring a coronary bypass machine was performed and that the annual review included letters of competency from the supervising physician(s). The hospital did not comply with the provision of ensuring CV open heart surgery with bypass consisted of a 3-surgeon team, one of which is board certified or board eligible by the American Board of Thoracic Surgery, one member could be an independent and qualified surgeon and the third member could be a physician assistant (PA), registered nurse first assistant (RNFA) or other qualified non-surgeon. However, a PA or RNFA could not be the first assistant for CV procedures. The hospital did not have a system in place to evaluate the qualifications of the RNFA and PAs on an annual basis. The hospital did not ensure each CV open heart surgery with bypass had a first assistant that was an independent qualified surgeon. 3. The medical staff failed to ensure that the hospital’s on-going quality assurance program included a methodology for periodic review of the effectiveness of the required three members of the CV surgical team in the OR during a CV surgery requiring a coronary bypass machine. 4. The medical staff failed to ensure the hospital created and maintained a record of any emergency situations in which the required three members of the CV surgical team in the OR during a CV surgery requiring a coronary bypass machine were not present. These failures had the potential to result in harm to patients undergoing CV surgery, including the possibility of many types of adverse events, including but not limited to strokes, heart attacks, and death. Findings: 1. During a concurrent observation and interview on 5/22/25 at 8:55 a.m. with the Registered Nurse Quality (QRN) 3 & Assistant Director of Nursing Surgical Services (ADON) in operating room (OR) 15, Patient (Pt) 1’s surgical procedure was observed. Pt 1 underwent an open-heart Coronary Artery Bypass Graft (CABG - is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) surgical procedure that included three separate bypass grafts. The ADON validated and verified the staffing in the room for the entire procedure included a primary cardio thoracic surgeon (SUR - a specialized surgeon who performs surgery on the heart, lungs, and other organs within the chest cavity) 1, resident surgeon (RS - a physician who has completed medical school and is undergoing supervised training in a specific surgical specialty to become a board-certified surgeon ) 1, Anesthesiologist (ANS - a medical doctor specializing in administering anesthesia and managing pain during medical procedures and surgeries) 1, Perfusionist (PER - healthcare professional who operates the heart-lung machine during certain surgeries, like open heart surgery, to maintain the patient’s blood flow and oxygenation while the heart is stopped) 1, Registered Nurse First Assist (RNFA - is a Registered Nurse (RN) who works in an expanded role as a surgical first assistant and is responsible for working with the surgical team during surgery, at the direction of the primary surgeon) 1, two RNs working as scrub nurses (work within the sterile field, directly assisting the surgeon(s) with instruments and supplies during the procedure) and a circulating nurse (nurse who works outside the sterile field, managing patient care, coordinating with the surgical team, and ensuring a safe environment). The ADON stated that was the normal staffing for cardiovascular surgical cases at their hospital. The ADON stated that resident surgeon was the first assisting surgeon, and they typically have RNFA or Physician Assistant (PA - a licensed medical professional who works under the supervision of a licensed physician) as second assistant surgeon in the room. The ADON stated the hospital does not normally require scheduling two independent, fully qualified surgeons for the CABG procedures as the hospital has resident surgeons working with the primary surgeons. The ADON stated as far as he was aware, the resident surgeon was okay to be in the room as first assisting surgeon under the direct supervision of a primary board-certified cardiothoracic surgeon. The ADON was unable to comment on what a resident surgeon can and cannot do at the hospital or during the surgical procedure. The ADON also was not able to comment on what year or specialty (specific area of training) residents were and stated the OR team does not have access or any way to validate, or to see or check privileges (define the specific types and scope of surgical procedures they are authorized to perform at a hospital). The ADON stated he would have to defer to Director of Surgical Services (DSS) regarding residents and person in charge of residency program, however, his understanding was the surgeon was responsible for overseeing the residents. During an interview on 5/22/25 at 10:55 a.m. with the DSS, the DSS stated he was aware of the state regulation and staffing requirement for cardiac vascular operative surgery cases. The DSS stated CABG cases must have a second physician in OR and do not require the second physician to be a board certified cardiac surgeon. The DSS stated the hospital has cardiovascular surgery fifth year residents as the second physician in the OR. The DSS stated the facility also has a California Department of Public Health approved Program Flex that allows them to staff mid-level providers [Physician assistant or RNFA] to replace a third surgeon in cardiovascular cases requiring bypass. The DSS stated the resident surgeon’s credentialing and privileges were with “Hospital B” and not currently listed in their system. The DSS stated medical staff and human resources would be able to speak about the process. During a concurrent interview and record review on 5/22/25 at 11:00 a.m. with the ADON & DSS, Pt 2’s electronic medical record (EMR) was reviewed for the “OR Intraoperative record”. A review of Pt 2 ‘s “OR intraoperative record” indicated Pt 2 had CABG surgery on 3/31/25. Pt 2 went in to the OR at 7:15 a.m., surgery start time was 8:13 a.m. and end time was 11:37 a.m. SUR 2 was the primary surgeon and was in the OR from 7:15 a.m. to 11:37 a.m. RS 2 was in the room from 7:45 a.m. to 8:15 a.m. [RS 2 left 2 minutes after the case started]. The ADON stated that record does not reflect any other surgeon was in the operating room besides SUR 1 during the entire surgical procedure and RS 2 was in the room for only two minutes at the start of surgery. The ADON stated the “OR Intraoperative report” indicated RNFA 1 and PA 1 were assisting SUR 1 with the case as well. The ADON stated PA 1 was in Pt 2’s surgery from 7:15 a.m. to 11:37 a.m., same as SUR 1. The ADON stated RNFA 1 was in Pt 2’s surgery from 7:15 a.m. to 9:51 a.m. The ADON stated he was unable to comment if the hospital had another surgeon available or on call for the duration of Pt 2’s surgery, however, [he believed] the approved program flex allows them to have a PA or RNFA as third surgeon. During a concurrent interview and record review on 5/22/25 at 11:05 a.m. with the ADON & DSS, Pt 3’s EMR was reviewed for the “OR Intraoperative record”. The review of Pt 3’s “OR Intraoperative record” indicated Pt 3 had MITRAL VALVE (located between the left atrium and left ventricle) repair [removes and repairs part of the damaged mitral valve to allow the valve to fully close and stop leaking] and TRICUSPID VALVE (located on the right side of the heart between the right atrium and right ventricle) repair surgery on 3/31/25. Pt 3 went in to the OR on 3/31/25 at 7:42 a.m., surgery started at 8:47 a.m. and ended at 2:00 p.m. SUR 3 was the primary surgeon and was in the OR from 7:42 a.m. until 2:10 p.m. RS 2 was also listed as being present in the room from 7:42 a.m. until 2:10 p.m. The ADON stated he was not able to find any other surgeon listed as being present in the room during the procedure. The ADON stated he was unable to comment how RS 2 was present for both Pt 2 and Pt 3 as first assistant [second surgeon] at the same time. The ADON stated he could only go by the record, and it appears to him that RS 2 just went to check in Pt 2’s room and stayed with Pt 3’s procedure. The ADON stated the entry times do not appear correct as they are overlapping. The ADON validated even with overlapping of time RS 2 was only in the room for Pt 2 for two minutes after the surgery was started and no other independent and qualified surgeon except RNFA or PA was in the room during the procedure for both Pt 2 and Pt 3. During an interview on 5/22/25 at 2:15 p.m. with SUR1, SUR 1 stated surgery for Pt 1 was uneventful and had no concerns with RS 1’s performance. SUR 1 stated he was board certified in cardiac surgery and his understanding for number of surgeons in OR for CABG was, “As soon as you anticipate or as soon as patient goes on bypass [medical device that temporarily takes over the functions of the heart and lungs during surgery, especially open-heart surgery], expectation is to have two surgeons in the room and PA or RNFA could be the third”. SUR 1 stated he was informed that residents could be assisting surgeon. SUR 1 stated he performs surgeries at a different facility in the town as well and they are, “Required to have two independent surgeons not residents” in operating room at all times for CABG procedures. SUR 1 stated he always has challenges getting the second surgeon at this hospital and has to call his colleagues from another hospital to assist him. SUR 1 stated the facility started using resident surgeons and it allowed some consistency in assuring first assistant as resident surgeon. SUR 1 stated he has not experienced any adverse outcomes with residents assisting. SUR 1 stated RS 1 currently requires supervision and would be practicing independently next year. During a concurrent interview and record review on 5/22/25 at 4:37 p.m. with the DSS & the Manager Accreditation and regulatory (MA) 1, Title 22 of the California Code of Regulations (CCR - is a comprehensive set of rules and regulations that govern various aspects of programs in California) section 70435 Cardiovascular Surgery Service Staff was reviewed, and the program flex document was reviewed. Title 22 CCR section 70435 indicated “ ... (b) Cardiovascular operative service. (1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Thoracic Surgery or the American Board of Surgery with training and experience in cardiovascular surgery. He shall be responsible for: (A) Implementing established policies and procedures. (B) Training and supervising the nurses and technicians in special techniques. (C) Training and supervising the clinical perfusionists. (2) A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph (b) (1) above ...”. The review of “APPROVAL OF PROGRAM FLEXIBILITY” by CDPH dated October 18, 2022, indicated, “ ... This letter is in response to the request submitted by [Hospital name] for program flexibility for California Code of Regulations T22 DIV5 CH1 ART6-70435(b)(2). The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass ... The use of the PA as a second assistant is at the discretion of the primary surgeon ... The facility is required to have a 3-team cardiovascular surgical team in the OR ... The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures ...” The DSS stated he was aware of the requirements set forth in CCR and conditions in the program flex. The DSS stated he was not able to comment if the RS 1 was an independent and qualified surgeon as required per CCR and flex approval conditions for first assistant to primary surgeon for CABG procedure. The DSS stated he was in charge of the surgery scheduling team [individuals responsible for coordinating all aspects of scheduling surgical procedures] and it was not standard practice at the hospital to identify first assistant in cardiac surgery cases during scheduling process. The DSS stated he was not able to comment on what criteria was used to determine that RS 1 or surgery residents were able to be scheduled as first assistant or second surgeon in the CABG. The DSS stated he would have to defer to Medical staff office for all the surgery resident requirements and would have to look into this practice. The MA 1 stated she was aware of the program flex and CCR staffing requirements and the MA 1 stated approved flex was addressed to her name. The MA 1 stated that she posted it in the lobby upon receiving the approval of program flex and shared with leadership team. The MA 1 stated she cannot comment if the hospital was in compliance with the condition set forth in the approved Program Flex. The MA 1 stated she does not know if it was appropriate to schedule RS 1 as first assistant to the primary surgeon and as a second surgeon in the CABG case. Both MA 1 & DSS stated they both understood and were aware the program flex authorization was to use mid-level provider as second assistant or third surgeon; and, that they were still required to have second independent and fully qualified surgeon in the room as first assist. During an interview on 5/22/25 at 5:35 p.m. with the Chief Nursing Officer (CNO), the CNO stated she has reviewed the approved program flex and it was her understanding that surgery residents were not independent and fully qualified surgeons and therefore were not qualified to be the first assistant [second surgeon] in a cardiac surgery case requiring bypass. The CNO stated surgery residents need supervision but she was not aware who was responsible at the facility for the oversight of the residency program. The CNO agreed that surgical staff should know what residents can and cannot do while the residents are at their facility assisting with surgeries in the OR. The CNO stated she would need to follow up with her leadership team and do additional research prior to commenting on compliance with state regulations for number of surgeons and conditions listed in the program flex to use mid-level provider [PA or FNP] as a third surgeon [second assistant to primary surgeon]. During an interview on 5/23/25 at 8:05 a.m. with the Chief Executive Officer (CEO) and the CNO, the CEO stated the hospital leadership team did their research, including reaching out to “Hospital B” for guidance on surgical resident requirements. The CEO stated that they have reached out to their hospital’s legal counsel and realized that the hospital leadership misunderstood the approved flex. The CEO stated the cardiovascular surgery team at this time was not meeting the CCR and Program Flex conditions. The CEO stated effective immediately- and now the hospital requires the second independent and fully qualified surgeon (first assistant) to be identified ahead of the scheduled surgery and present for the entire surgical procedure. The CEO stated the hospital will not be using surgical residents as first assistants in cardiovascular surgeries moving forward. During a concurrent interview and review on 5/23/25 at 9:45 a.m. with the CCS, the CNO and the Director of Quality (DQ), the facility’s Approval of Program Flexibility for California Code of Regulations T22 DIV5 CH1 ART 6-70435(b)(2) dated 3/10/2023 (Program Flex document) was reviewed. The CCS stated he was not familiar with the Approval of a Program Flex and then read the document. After reading the document, the CCS stated, “I was told this morning that there will be a surgeon as first assistant for every case of surgery requiring bypass.” The CCS was asked to read the 4th condition of approval, “The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for the CV operative procedure.” When asked whether a resident was an independent, fully qualified surgeon, the CSS stated, “No, a resident is not an independent and fully qualified surgeon.” The CCS stated “No” when asked whether a 5th year resident (a Doctor of Medicine or Doctor of Osteopathy who is a student in a Graduate Medical Education Program), a fellow (a Doctor of Medicine or Doctor of Osteopathy who is a student in a Graduate Medical Education Program) or an interventional cardiologist met the criteria to be a first assistant. The CCS stated an independent and fully qualified surgeon would be a licensed surgeon with full privileges to be a first assistant based on experience operating in body cavities. When asked what an independent and fully qualified surgeon was, the CNO stated someone who, “is fully qualified as a surgeon with a license to practice independently.” The CNO stated a 5th year resident is not an independent and fully qualified surgeon, is not credentialed by the hospital and is not privileged by the hospital. During a concurrent interview and record review on 5/23/25 at 10:39 a.m. with the SUR 1 and Director of Quality (DQ), the SUR 1 stated he was the division chief for Cardiac Surgery. SUR 1 stated he had been the division chief for two years. SUR 1 stated he was just made aware of the approved program flex and he was not previously aware of the conditions in the flex. SUR 1 stated this was his first time looking at the conditions set forth in the approved program flex. SUR 1 stated he now understands that the program flex is for the use of PA or RNFA for the third surgeon requirement. SUR 1 stated, the hospital, moving forward, will set up a schedule for the surgeons and will have a qualified person as second surgeon or first assistant and their name will also be listed on the surgery schedule moving forward. SUR 1 stated it was his practice to always have a second surgeon in the room and it was his understanding that a second surgeon was required when patients go on bypass. SUR 1 stated he started working with the residents as second surgeon (first assistant) approximately eight months ago. SUR 1 stated he was informed it was okay to have residents as first assistant as these were fifth year cardiac surgery resident. SUR 1 stated these residents were one year away from being independent surgeons. SUR 1 stated although residents were safe and very good in assisting, these residents were not independent and fully qualified surgeons as required in conditions of program flex approval. During an interview on 5/27/25 at 1:53 p.m. with the perfusionist (PER) 2, PER 2 stated that he has been working at the facility since 2013. PER 2 stated he also works at another facility across town. PER 2 stated that at this hospital it was common not to have a second surgeon or first assist that was a surgeon in the room during cardiac surgical procedures. PER 2 stated, “Many times, perhaps half of the time,” a second surgeon is not available or present in the OR during the CABG procedure. PER 2 also stated when he worked across town in a different hospital, that facility always has second surgeon in the operating room during the entire duration while the patient is on a heart lung machine. During an interview on 5/27/2025 at 4:30 p.m. with three representatives of the Board of Trustees, when asked about their knowledge of the Program Flex approval, the Chair stated she had only learned about it, “the night before.” The GB representatives stated that they were informed about the use of a 5th year resident in cardiothoracic surgery as the first assist on this last Thursday 5/22/25. The GB representatives stated the Flex was reviewed with them and it was explained to them that the hospital had not been following the flex. The GB representatives stated they did not know the hospital was not following this Flex until that day. The GB representatives stated the GB expect the hospital to follow the flex, and the hospital has already started making changes. The GB stated the GB is responsible for the quality of care provided at this hospital. During a review of hospital’s Governing Body minutes and Quality minutes from October 2024 to April of 2025, there was no mention of the Program Flex for the Cardiovascular Department approved in 2022 and no mention of the Health Information Management (HIM) Department’s quality data. During a concurrent interview and record review on 5/28/25 at 2:01 p.m. with the SUR 3, Pt 3’s EMR was reviewed for the “OR Intraoperative record” dated 3/31/25. SUR 3 stated he had been operating at the hospital since 2017. SUR 3 stated he was a board-certified cardiothoracic surgeon. SUR 3 stated he was not aware of the conditions or requirements of the program flex. SUR 3 stated it was his understanding that he was required to have another physician as a second surgeon during his procedures and cardio thoracic surgery residents meet that requirement. SUR 3 stated he had spoken with other teaching institutions, and it was a standard practice to have cardiac surgery residents as first assistant surgeon. SUR 3 stated he requires his residents to stay with him during the entire surgical procedure. SUR 3 validated RS 2 was with him for the entire surgical procedure for Pt 3. During a concurrent interview and record review on 5/29/25 at 3:30 p.m. with RN 5, Pt 2’s EMR was reviewed. RN 5 stated she was in the OR for Pt 2’s surgery and was responsible for documentation of times when everyone was entering and leaving OR during the surgery. RN 5 stated she does not recall Pt 2 specifics, but she always documented exact times. RN 5 reviewed the EMR and Pt 2’s “OR Intraoperative record” and stated that Pt 2’s record reflects that RS 2 was in the room from 7:45 a.m. to 8:15 a.m., surgery start time was 8:13 a.m. RN 5 validated that EMR reflects she was the one that documented times for RS 2. RN 5 stated that she was unable to comment on cardiovascular surgery staffing requirements, however, she was not aware that second surgeon [first assistant] have to be in the operating room at all times. RN 5 stated that as long as someone was available she thought it was okay to proceed with the surgical procedure. During a concurrent interview and record review on 5/30/25 at 12:47 p.m. with SUR 2, Pt 2’s EMR was reviewed for the “OR Intraoperative record” dated 3/31/25. SUR 2 stated he was unable to comment on RS 2 times in the OR. SUR 2 stated the times listed may or may not be accurate. SUR 2 stated he does not recall who was in the room during the surgery. SUR 2 stated he was not aware of any program flex that hospital had in place, however, he was aware of the surgery staffing requirements for cardiac surgeries. SUR 2 stated he expects to have second surgeon in the OR during surgery. SUR 2 stated as far as he was aware, residents can function as first assistant [second surgeon] in the room and RNFA or PA can function as third surgeon. SUR 2 stated if the record reflects RS 2 left two minutes after procedure start, then it could not be accurate. During a concurrent interview and record review on 5/30/25 at 2:25 p.m. with the DSS & MA 1, OR case logs [systematic record of individual patient cases] for month of March 2025, April 2025 and May 2025 were reviewed for the cardiovascular surgeries. The review of OR case logs for the whole month of March 2025 indicated total of 22 open heart surgeries were done, and out of 22 cases 15 cases had a resident as the first assistant (second surgeon), two cases did not have any second surgeon that was a physician or resident. Out of 22 cases in March 2025, five cases did have second surgeon that was independent and qualified surgeon, however, in three of those cases the second surgeon was only in the room for less than 10 minutes. A review of April 2025 case log for cardiac surgeries indicated a total of 28 open heart surgeries were done at the hospital. Out of the 28 cases, 17 cases had a resident as first assistant (second surgeon), and two cases did not have any second surgeon that was a physician or resident. Out of 28 cases, nine cases did have a second independent and qualified surgeon; however, in six of eight cases, that surgeon was in the room for ten or fewer minutes. The DSS and MA 1 both stated that this reported data was accurate and DQ validated it by manually counting it. The DSS stated the hospital team did not have a good understanding of the approved Program Flex and were not compliant with the conditions of approved program flex and requirement for cardiac surgery staffing under CCR. The DSS stated he now understands the CCR requirement and approved program flex. The DSS stated effective 5/23/25 changes have been put in place to ensure a second independent and qualified surgeon would be present during all open-heart surgeries. The DSS stated going forward the second surgeon would be scheduled, and the OR team would be able to validate and confirm presence of an independent and qualified second surgeon [first assistant] prior to patient’s surgery. During review of the OR case log for cases requiring extracorporeal bypass provided by the hospital for dates March 1, 2025 through 5/21/25, a random sample of 10 of the 63 cases found 10 of the 10 cases sampled did not have an independent, fully qualified surgeon other than the Primary Surgeon in the operating room. Each of the 10 cases also listed the first assistant as either a PA or an RNFA. 2. During continued concurrent interview and review on 5/23/25 at 9:45 a.m. with the CCS, CNO and DQ, the facility’s Program Flex document was reviewed. The CCS read Condition #9, “Annual review of all qualified non-surgeon (sic) used in this capacity will include letters of competency from the supervising physician and routine chart review will be conducted.” When asked whether he, as supervising physician, had written letters of competency annually, CCS stated, “No, I have not” written such letters. Nor was the CCS aware that any other Primary Surgeon had written such letters. When asked about annual chart reviews, the CCS stated neither a PA nor an RNFA documents anything in the chart, so there was never any chart review that he performed. The Medical Staff Manager (MSM) was then contacted and by phone stated that for PAs, “Not performing annually, only at recredentialing, so every 2 years.” During an interview on 5/20/2025 at 2:05 p.m. Credentialing Coordinator 1 in the Medical Staff Office, stated RNFAs are not privileged through the Medical Staff Office but rather through Human Resources; and, the timeline for review was every two years. 3. During continued concurrent interview and review on 5/23/25 at 9:45 a.m. with the CCS, CNO and DQ, the facility’s Program Flex document was reviewed. CCS read Condition 14, “As part of the hospital’s on-going quality assurance program, a methodology for periodic evaluation of the effectiveness of this alternate method shall be developed. There shall be provisions for recommendations to be made to the administration and medical staff and follow-up.” The CCS stated he was neither familiar with a methodology nor any evaluation performed. The DQ stated, “QAPI had not been monitoring.” During an interview on 5/30/25, at 3:48 p.m., with the Director of Quality Improvement (DQ), the DQ stated there was not an official project in place to monitor the use of the Program Flex (a request to change or modify or deviate from the standard regulations) for Cardiothoracic surgery first and second assists (first assist must be an independent qualified surgeon and second assist can be physician assistant or a registered nurse first assistant). The DQ stated the hospital was not following the Program Flex approved for Cardiothoracic use of first and second assistants. During a review of the Hospital’s program flex approval letter for California Code of Regulations T22 (Title 22) DIV5 (Division 5) CH1 (Chapter 1) ART (Article) 6-70435(b)(2), dated 10/18/22, indicated, “The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass. Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: ... 4. The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non- surgeon cannot be the first assist for cardiovascular operative procedures ... 14. As part of the hospital’s on-going quality assurance program, a methodology for periodic evaluation of the effectiveness of this alternate method shall be developed. There shall be provisions for recommendations to be made to the administration and medical staff and any follow-up action ...” During a review of the hospital’s “Performance Improvement Annual Appraisal & Quality Assessment and Performance Improvement Plan 2024-2026,” the plan indicated, “The QAPI plan guides the organization’s performance improvement efforts. The QAPI regulation requires a written plan. This plan is a framework for an effective, comprehensive, data driven program that focuses on the indicators that reflect outcomes of care, quality and patient safety. The purpose of the Performance Improvement Program at [name of this hospital] is to ensure patients are provided high quality care in an environment of minimal risk. This is accomplished through the collaborative efforts of staff in different areas, disciplines and professional backgrounds consistent with the hospital’s mission, vision and goals ...” During a review of the Hospital’s Quality Program Binder, created and updated by the DQ, the binder had no quality data mentioning the conditions approved by the Cardiothoracic Program Flex. 4. During continued concurrent interview and review on 5/23/25 at 9:45 a.m. with the CCS, CNO and DQ, the facility’s Program Flex document was reviewed. The CCS read Condition 17, “The facility shall maintain a record of any emergency situation in which the first assistant is not a physician. This record shall be available to CDPH upon request.” The CCS stated he was not familiar with such a record and could not provide that to me upon my request. The CCS stated he did not know whether there was no list because there was no list or because there had been no emergency situations in which the first assistant was not a physician. The DQ stated, “QAPI has not been monitoring.””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 28773 Based on observation, interview and record review, the facility failed to ensure all licensed nurses adhered to the hospital’s policies and procedures (P&P), when: 1. Three of three patients (Patient 45, 46, and 47) were reviewed for clinical nutrition care at BHC Campus 2 and had incomplete meal intake documentation in the medical record. This failure had the potential to result in patient safety risks including poor intake to go unnoticed, causing delayed intervention by dietitians or physicians leading to malnutrition, dehydration, or other complications. Changes in appetite or intake can be early signs of medical issues and lack of documentation may delay recognition and treatment. 2. One of five sampled Glucometers (a device for measuring the concentration of glucose in the blood) had controls performed (a way to check the blood glucose meter and test strips are working together properly to deliver accurate results) with expired control solutions (solution use to test the functionality of meter and strips) not in accordance with the hospital’s P&P titled “ PC.AD.1.38 Blood Glucose Monitoring,” This failure placed patients at risk for inadequate blood glucose monitoring and management and could negatively affect physical and emotional wellbeing of patients that are already vulnerable. 3. One of one patient (Pt 27) did not have a temperature and respiration rate assessed and documented every one hour while receiving intravenous (IV-in a vein) magnesium sulfate (a high-risk medication to help prevent seizures [sudden uncontrolled bursts of electrical activity in the brain]) according to the hospital’s P&P titled, “MOD L&D.1.18 Magnesium Sulfate Management In Obstetrics.” This failure placed Pt 27 at risk for respiratory depression (when you breathe too slowly or too shallowly), hypothermia (a condition in which the body’s core temperature drops below 95 degrees Fahrenheit), and magnesium toxicity (a condition where there is too much magnesium in the blood). 4. One of two patients (Pt 31) did not have vital signs completed every two hours when Pt 31 was given an Emergency Severity Index (ESI-a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious) of 2 according to the hospital’s P&P titled, “MOD ED.1.04 Standard of Care Policy.”This failure placed Pt 31 at risk for delay detection of changes in condition and delayed care. 5. One of one patients (Pt 10) did not have urine output measured and recorded in the medical record for a 24 hour period, a physical assessment performed by a student nurse was not validated by a registered nurse, and the events preceding a stroke alert activation and a rapid response team call were not documented by Pt 10’s nurse, in accordance with the hospital’s P&P titled, “PC.AD.1.08 Documentation Policy.” These failures resulted in the potential for delayed detection of acute kidney injury, dehydration or fluid overload, delayed detection of a change of condition, incomplete and/or inaccurate nursing assessment, and an incomplete medical record. Findings: 1. During a clinical record review of Patient 45 in the presence of Shift Manager (SMDBH) DBH Campus 2, Patient 45 was admitted to the campus on 5/16/25 with a past medical history of Diabetes Mellitus (a chronic metabolic disorder characterized by persistent high blood sugar levels). During a review of physician diet orders dated 5/16/25, a consistent carbohydrate diet (CCD) was ordered. Review of meal intakes dated 5/16 to 5/22/25, indicated no intake documented for breakfast. During a concurrent interview on 5/22/25 at 10:45 a.m. with SMDBH, he stated nursing would document if there were refusals of the meals and would let psych or medical know as well. During a clinical record review of Patient 46, in the presence of SMDBH, Patient 46 was admitted on 4/23/25 and discharged on 5/22/25. Physician’s orders dated 4/23/25, indicated Patient 46 was ordered a CCD. Review of meal intakes for Patient 46, showed incomplete documentation, and nursing would document meal consumption in two different areas in the chart. A concurrent interview with SMDBH on 5/22/25 at 11:10 a.m., SMDBH stated staff is supposed to document in the meal percentages for each meal in the electronic medical record. SMDBH acknowledged the staff was documenting in two separate areas but stated the staff are supposed to document under meal intake section. During a clinical record review of Patient 47, in the presence of SMDBH, Patient 47 was admitted on 5/15/25 with a modified sodium diet. Review of meal intakes for Patient 47, showed very few intakes were documented. During a concurrent interview with SMDBH on 5/22/25 at 12:23 p.m., SMDBH acknowledged very little meal intakes were documented, and the nursing policy was that staff were to document meal intakes for each meal. During an interview with the Director of Patient Care Services (DPCDBH) at DBH Campus 2 on 5/23/25 at 9:12 a.m., DPCDBH stated the meal intake section should be entered in the patient chart by the clinical technician and she became aware this was a concern. During a review of the hospital policy and procedures titled “PC.AC.108 Documentation Policy”, dated approved 9/28/22, indicated the purpose is to outline responsibilities related to documentation of patient care from admission through discharge. It indicated documentation shall be completed timely. It indicated under assessment and interventions, “Activities of daily living are documented as applicable (e.g. ... diet and amount taken...) Nursing Assistants (NA) will assist in documenting such findings. 49538 2. During a concurrent observation and interview on 5/20/25 at 11:30 a.m. with Director of NICU and Pediatrics (DP) and Registered Nurse Educator (RNE) 1, in the Obstetrics Triage department, a glucometer kit was observed to have two vials of expired glucose control solution. The DP validated the observation and stated the labeled expiration date on the glucose control solution vials were 5/17/25. RNE 1 stated the glucose control solution should be changed every three months according to the standard recommendation from the manufacturer. The DP stated it was important to not use expired glucose control solutions because it can give inaccurate results. During a review of the facility’s P&P titled, “PC.AD.1.38 Blood Glucose Monitoring,” dated 7/24/24, the P&P indicated, “ ... Quality control testing is to be performed sequentially with low and high control solutions. Quality control must be performed: a. Daily or when requested by the [brand name Glucometer]. b. When a new vial of test strips is opened. c. If a test result’s validity is in question. d. Whenever a vial of test strips is left uncapped. e. To recertify an operator (Recertification once a year. QUALITY CONTROL TESTING. 1. To ensure the [brand name Glucometer] meter is functioning properly, QC [quality control] will be required every 24 hours. Both a level 1 and level 2 will need to be done prior to continuing to use the meter. The meter will lock out until QC has been completed. 2. Controls are good for 3 months. Each vial should be dated with the open date and expiration date ... 4. Discard outdated strips and controls ... “ During a review of facility’s Glucometer “Operators Manual (OM),” dated 3/2013, the “OM” indicated, “... Accurately testing known levels of glucose ensures that the system and your technique used in testing give accurate results on patient tests. Glucose control solutions have defined (known) values. The results for solutions must first fall within a certain acceptable range in order to allow valid patient testing ... Intervals between running glucose control tests are determined by your facility. These intervals are entered when the system is configured ... Glucose control tests should be run in the following circumstances: Before using the meter for patient testing the first time ...At the glucose control intervals established by your facility, if established ...When using a new test strip vial for the first time... When using a new test strip lot for the first time (and as a result a new test strip code) ...If a test strip vial was left open ... If questionable test results are displayed repeatedly ...If you wish to test the performance of the system ...” 3. During a review of Pt 27’s “History and Physical (H&P-a comprehensive assessment of a patient, combining a medical history with a physical examination),” dated 5/20/25 was reviewed. The “H&P” indicated, “ ... 40-year-old G [gravida-the total number of confirmed pregnancies that a female has had] 3 P [para-the number of births that a female has had] 0 ... at 32 weeks and 1 day ... history of chronic hypertension [HTN- high blood pressure] and left-sided CVA [cerebrovascular accident-stroke, loss of blood flow to a part of the brain] in 2021 ... presents as a transfer ... for superimposed severe preeclampsia [a disorder that can occur during pregnancy or after childbirth in which there is high blood pressure and other signs of organ injury] on chronic hypertension ...” During a concurrent interview and record review on 5/23/25 at 10:40 a.m. with Registered Nurse Educator (RNE) 1 and Quality Review Nurse (QRN) 1, Pt 27’s “Medication Administration Record (MAR-a record of drugs administered to a patient),” dated 5/20/25 to 5/21/25 and “Vital Signs Flowsheet (VSF),” dated 5/20/25 to 5/21/25 were reviewed. The “MAR” indicated Pt 27 was started on IV magnesium sulfate on 5/20/25 at 4 p.m. and stopped on 5/21/25 at 2:45 p.m. The “VSF” indicated Pt 27 had a temperature assessed on 5/20/25 at 3:52 p.m., 7:30 p.m., 8:10 p.m., 11:29 p.m., 5/21/25 at 3:30 a.m., 7:29 a.m., 11:30 a.m., 1:30 p.m. The “MAR” indicated Pt 27 had a respiratory rate assessed on 5/20/25 at 9 p.m., 11:29 p.m., 5/21/25 at 3:30 a.m., 7:29 a.m. RNE 1 stated Pt 27’s temperature and respiratory rate should have been assessed and documented every hour while on IV magnesium sulfate. RNE 1 stated it was important to assess the respiratory rate since magnesium sulfate was a muscle relaxer and depressed the central nervous system. RNE 1 stated nurses should assess and document a respiratory rate and temperature hourly per the hospital’s policy. During an interview on 5/29/25 at 2:32 p.m. with the Director of Obstetrics (DB), the DB stated she expected nurses to follow the hospital’s policy to check respiratory rate and temperature hourly when a patient is on IV magnesium sulfate. During a review of the hospital’s P&P titled, “MOD L&D.1.18 Magnesium Sulfate Management In Obstetrics,” dated 2/28/24, the P&P indicated, “ ... PURPOSE: The purpose of this policy is to provide guidelines for the safe and effective administration of Magnesium Sulfate for obstetrical patients. Magnesium sulfate is used for prevention and treatment of seizures in women with severe preeclampsia, eclampsia, to provide fetal neuro-protection when preterm birth is anticipated or likely in 24 hours (after 24 weeks’ gestation but before 32 weeks’ gestation) ... PROCEDURE: ... Assessment, Monitoring and Documentation: ... Antepartum/Intrapartum - Assess and document maternal and fetal status parameters ... Maternal status parameters: Vital Signs (HR [heart rate], BP [blood pressure], RR [respiration rate], Temp [temperature]) ... every hour ...” 4. During a review of Pt 31’s “Emergency Department Note-Physician (EDNP),” dated 3/30/25, the “EDNP” indicated, “ ... 27 [year old female] presenting to the [emergency department] for 10 day history of chest tightness, dry cough, and shortness of breath.” During a concurrent interview and record review on 5/29/25 at 11 a.m. with Shift Manager (SM) 1, Pt 31’s “Emergency Department Triage Form (EDTF),” dated 3/29/25 and “Vital Signs Flowsheet (VSF),” dated 3/29/25 to 3/30/25 were reviewed. The “EDTF” indicated, “Chief Complaint: Chest tightness, dry cough, SOB [shortness of breath], for a week ... ESI level: 2 ...” The “VSF” indicated Pt 31 had vital signs completed on 3/29/25 at 7:10 p.m. and was blood pressure (BP) was 131/86 millimeters of mercury (mmHg-unit of measure; normal 120/80 mmHg), respiratory rate (RR) 18 breaths per minute (normal 12-18 breaths per minute), heart rate (HR) 94 beats per minute (bpm; normal 60-100 bpm), temperature 36.5 degrees Fahrenheit (normal 97-99 degrees Fahrenheit), oxygen saturation 100% (normal 95-100%). The “EDTF” indicated Pt 31’s next set of vital signs were completed on 3/30/25 at 12:49 a.m. SM 1 stated an ESI of 2, vital signs should be completed every two hours if the patient’s “condition warrants” according to the hospital’s “Standard of Care” policy. SM 1 stated Pt 31’s chief complaint, “vital signs on arrival was fine and EKG looks good,” it did not warrant more vital signs monitoring. During an interview on 5/30/25 at 3:22 p.m. with the Director of Emergency Department (DED), the DED stated a patient with an ESI of 2 should have vital signs completed at a minimum of every two hours per the hospital’s policy. The DED stated he expected nurses to follow the policy. During a review of the hospital’s P&P titled, “MOD ED.1.04 Standard of Care Policy,” dated 1/23/25, the P&P indicated, “ ... PURPOSE/EXPECTED OUTCOME: A. To provide a standard of care for persons presenting to the emergency department for care ... POLICY: ... Triage: Initial Patient Assessment ... The Emergency Severity Index (ESI) is utilized to assign patient triage priority/urgency ... Based upon patients presenting problem, needed resources for care, and physical assessment, the patient is assigned one of five levels of priority/urgency: ... Level 2 - Patient is unstable and requires timely response by physician and nurses ... Patient Reassessment: ... Reassessment may include, but is not limited to: ... Patient’s current condition/status ... Vital signs ... Reassessment times are as follows unless warranted more frequently: .. Level 2 - minimally every 2 hours ...” 37529 5. During a concurrent interview and record review on 5/29/24 at 12:30 p.m. with the Stroke Coordinator (SC), Pt 10’s medical record was reviewed. The record indicated Pt 10 was a 59 year old female who was admitted on 11/20/24 with symptoms of a stroke (a loss of blood flow to part of the brain, which damages brain tissue). Pt 10 had a history of a previous stroke with residual left sided weakness, hypertension (elevated blood pressure), atrial fibrillation (AFib- an arrhythmia that occurs when the upper chambers of the heart [atria] beat irregularly and fast), diabetes, and chronic kidney disease. The stroke protocol was initiated, the imaging studies did not reveal an acute (new, recent) stroke initially, and Pt 10 was admitted to the 1 Med Telemetry unit. The SC stated 1 Med Telemetry is also one of the designated units where patients who have had a stroke are admitted. On 11/22/24 at 9:10 a.m. Pt 10 had a Magnetic Resonance Imaging scan [MRI-a medical imaging technique] which indicated the presence of small acute strokes, and this critical result was communicated by the radiologist to Pt 10’s nurse (RN 20) at 10:54 a.m. Review of the “Communication and Notification” documentation indicated on 11/22/24 at 10:55 a.m. RN 20 sent an electronic message to Pt 10’s physician (Medical Doctor [MD] 15), “Magnetic Resonance Imaging [MRI-a medical imaging technique] showed acute infarct [blockage in a blood vessel in the brain, an ischemic stroke] to L middle cerebral artery [MCA one of the main arteries supplying blood to the brain], as well as small infarcts to left parietal [lobe of the brain],” and the record did not indicate whether there was a response from the physician. Review of the “Neurology Tele-Medicine Consultation,” dated 11/22/24 at 1:24 p.m. indicated a neurologist consult was done via an audio and video telehealth system with assistance from the nurse. The neurologist’s consult note indicated, “Date/Time Patient Seen: 11/22/24 from 13:10 to 13:24 [1:10 p.m. to 1:24 p.m.] REASON FOR CONSULTATION: Acute MCA stroke ...General: No acute distress ...Respirations are non-labored ... Neurologic Examination: Level of alertness: Alert and awake Affect: Appropriate Phonation: Normal audible speech. No dysarthria noted. Orientation: Oriented to her name and city but not month or age. Language: Dysfluent but follows simple commands. Attention and Concentration: Normal ... National Institute of Health Stroke Scale score 16. [NIHSS-a standardized tool used to assess the severity of a stroke. Scores range from 0- 42, with 16-20 indicating moderate to severe stroke, 21-42 indicating severe stroke].” Continued record review with the SC indicated on 11/22/24 at 1:35 p.m., RN 20 sent an electronic message to MD 15 informing him Pt 10 had a headache, and that [brand name] (acetaminophen) was not ordered for pain. The nurses notes do not indicate whether there was a response from MD 15, but a review of the orders report indicated at 1:35 p.m. MD 15 ordered [brand name] for mild pain and [brand name] (hydrocodone 5mg/acetaminophen 325 mg) every four hours as needed for moderate pain, however the medication administration record (MAR) dated 11/22/24 indicated Pt 10 did not receive [brand name] or [brand name]. Review of the nursing assessments indicated on 11/22/24 at 1:45 p.m., a nursing student completed a head to toe assessment, however the content of the assessment had not been validated and signed by a registered nurse, so it remained as a pending note. The record indicated at 3:40 p.m., RN 20 sent an electronic message to MD 15, “Patient was screaming, unable to tell us what was wrong. Then she had some flatulence and an emesis episode. There were some bright streaks of blood in the emesis. Lung sounds a bit coarse; she might have aspirated. I will give her some [brand name, medication for nausea and vomiting].” The record does not indicate whether there was a response from MD 15, and the medication administration record indicated Pt 10 did not receive [Brand name]. The record indicated on 11/22/24 at 3:51 p.m. an “Internal [Inpatient] Stroke Alert” was initiated. The SC stated when a hospitalized patient shows signs of a potential stroke, an “Internal” stroke alert is activated as opposed to when a person with a possible stroke comes to the ED then a “Stroke Alert” is activated. When an internal stroke alert is initiated, a specially trained nurse, a neurocritical response nurse (NCRN), responds and assesses the patient following the stroke alert protocol. Review of the “Rapid Response Team (RRT) record” dated 11/22/24, indicated at 3:51 p.m. the NCRN assessed Pt 10 and noted Pt 10 was “Comatose. Decrease level of consciousness, sudden loss of movement/weakness in face, arm, leg” with a NIHSS score of 38 (Severe stroke). Pt 10’s Glasgow Coma Scale (GCS a neurological assessment tool used to measure a patient’s level of consciousness) score was 5 (on a scale from 3 to 15, with 3 being the lowest [comatose state] and 15 being the highest [normal, alert state]) with Pt 10 exhibiting decorticate posturing (a reflex body position which is usually a sign of a severe injury or disruption to the brain). The SC stated neither the RRT record, or the nurses notes indicate who activated the Internal Stroke Alert, or what occurred after the 3:40 p.m. message sent by RN 20 to MD 15 to prompt the stroke alert call. Review of the order report for 11/22/24, indicated at 3:49 p.m. RN 20 obtained telephone orders for a CT scan of the brain for “altered level of consciousness,” and at 3:53 p.m. orders were obtained for a chest x-ray for “respiratory distress,” and a CT scan of the chest for “shortness of breath.” At 15:55 Pt 10’s respiratory rate was 26 breaths (respirations) per minute (rpm- normal 14-20 per minute), oxygen saturation 98%, and Pt 10 noted to be snoring, with labored respirations. At 3:58 p.m. the stroke alert protocol orders including lab tests and imaging were initiated. At 4 p.m. RN 20 obtained telephone orders for [brand name] (a medication given for anxiety, seizures, agitation) 1 mg IV push and [brand name] 500 mg IV (a medication for the treatment of seizures) and both medications were given. There was no documentation in the record indicating what if any seizure activity was observed. The record indicated the NCRN spoke with the stroke team physician, imaging was completed, and by 4:36 p.m. the stroke team physician had determined there was no large vessel occlusion (LVO-a major blood vessel in the brain is blocked causing a sudden interruption of blood flow to the brain) he could safely access (for clot removal). Pt 10 remained on the telemetry unit. Continued record review with the SC indicated on 11/22/24 at 8 p.m. Pt 10’s respiratory rate was 25 rpm, GCS was 6, and NIHSS was 36, and a large amount of oral secretions were suctioned. At 10:30 p.m. and midnight the vital signs were obtained however there was no respiratory rate documented either time. On 11/23/24 at 4 a.m. the respiratory rate was 24 rpm, and the neurological assessment remained abnormal. At 6:06 a.m., a RRT call was initiated. The RRT record indicated, “RRT Comment: RRT called for agonal breathing/biting on tongue/recent stroke alert. Physician Assistant [PA] at bedside. RRT Interventions: Appropriate protocol initiated. RRT Physician Contacted at 6:10 a.m. Intensivist consulted for intubation/transfer to CVICU. RRT Intubation Time: 6:20 a.m. RRT Outcome: Transfer to ICU/CCU. See PA prog. notes/orders, see nursing documentation ...” The RRT record does not include a place for documentation of vital signs or patient assessment. The RRT record was completed by the RRT nurse and signed by the RRT nurse and the RRT Respiratory Therapist at 6:44 a.m. The record was reviewed for narrative nurses notes, vital signs, patient assessments, physician communication notes for the period of time from 11/23/24 at 4 a.m. to 6:06 a.m. when the RRT activation occurred, and the SC was unable to find any documentation by Pt 10’s nurse (RN 21) or any other nursing staff. The SC stated although the RRT note indicated to refer to the nursing notes and the PA notes, she is unable to find any documentation regarding if Pt 10 was observed during this time (4 a.m. to 6:06 a.m.), if vital signs were obtained, or who initiated the RRT call. Review of the Intake and Output (I&O) record (documentation of the time and amount of Intake-all fluids [oral, intravenous, tube feeding] and Output- urine, emesis [vomit], liquid stool) dated 11/22/24 from 7 a.m. through 11/23/24 at 6:59 a.m. indicated there was no urine output for that twenty-four hour period. The physician’s orders dated 11/20/24 at 6:37 p.m., indicated, “Intake and Output.” Review of the nephrologist’s (a physician who specializes in kidney care) consultation note dated 11/23/2024 at 2:42 p.m. indicated, “ ...Made her [Pt 10’s daughter] aware that the patient has advanced renal insufficiency and will need close monitoring. Monitor strict urine output ...Did make the daughter aware the patient could end up needing dialysis in the near future...Will follow closely.” Review of the lab test results dated 11/21/24-11/25/24 indicated on 11/21/24 Pt 10’s creatinine (a waste product normally removed from the blood by the kidneys) level was 4.2 milligrams per deciliter (mg/dL, normal range 0.6 - 1.1), and 4.8 mg/dL on 11/23/24, and 6.4 mg/dL on 11/25/24. On 11/27/24, Pt 10 was started on hemodialysis (a procedure that filters waste and excess fluid from the blood when the kidneys are unable to). During a concurrent interview and record review on 5/29/25 at 3:25 p.m. with the director of the 1 Med Telemetry unit (DTU), Pt 10’s record was reviewed. Regarding the lack of output documented for 11/22/24 from 7 a.m. through 11/23/24 at 6:59 a.m., the DTU stated having no urine output recorded for 24 hours is definitely concerning, and stated the urine output should have been recorded and totaled each shift. The student nurse’s unvalidated assessment on 11/22/24 at 1:45 p.m. was reviewed and the DTU stated the nurse was supposed to review and validate the accuracy of the assessment and indicate that in the designated place in the electronic record. If that was not done, the assessment remains incomplete. The Stroke Alert call documentation on 11/22/24 and the RRT call on 11/23/24 were reviewed with the DTU and the lack of nursing documentation preceding the events was discussed. The DTU stated “we chart by exception,” but was unable to explain what that means specific to the two events in question. Review of the policy and procedure P&P titled, “PC.AD.1.08 Documentation Policy,” dated 9/28/22, indicated, “Totals for intake and output (I&O) are documented each shift or more frequently depending on the patient’s condition.” Review of the P&P titled, “PC.AD.1.08 Documentation Policy,” dated 9/28/22, indicated,” ...The patient medical record reflects the complete picture of the patient’s health status, treatment and progress from admission to discharge from which other health professionals can take over responsibility for the patient concerned ...It should include a comprehensive assessment; identified problems; expected outcomes; the plan of care and care delivered (or not delivered); teaching given; advice sought in decision making; and the patient’s response to treatment ...All Clinical Staff Members are responsible for documentation of clinical care given and ensuring that the standard of that documentation meets all legal and professional requirements. Documentation shall be completed timely ...Assessments will be completed and signed by licensed personnel. Assessments may be completed by a student extern, and then confirmed and signed by licensed personnel...All assessment data collected from a licensed vocational nurse [LVN] or student nurse will be reviewed, checked for accuracy, and co-signed by licensed personnel ...Patients are reassessed a minimum of every shift and as needed by an RN. LVNs and non-licensed personnel may collect and record data ...Changes in patient condition are documented within the appropriate electronic health record [EHR] system review, along with physician notifications ... Chart “annotation” may be used for narrative charting ...””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 46393 Based on observation, interview, and record review, the hospital failed to ensure medications were administered in accordance with the physician orders, hospital policies and accepted standards of practice for two of six patients sampled (Patient 5 and 6) when: 1. Patient (Pt) 5’s Nozin (a nasal sanitizer swab used to kill germs in the nose) nasal swab was not administered with the correct number of swabs in each nostril as ordered by the physician and as instructed by the manufacturer. This failure had the potential to result in Pt 5 receiving less effective nasal treatment, in addition increasing Pt 5’s risk of developing a preventable nasal infection. 2. Pt 6’s propofol (a potent drug used for sedation with a high potential for abuse/misuse) was administered without an independent double check (second nurse witness/co-sign) in accordance with the hospital’s policy and the propofol dose was adjusted without documentation of the Richmond Agitation-Sedation Scale score (RASS, a medical scale used to measure the agitation or sedation level) as ordered by the physician. These failures had the potential to increase risk of misuse or abuse of propofol, in addition increasing Pt 6’s risk for excessive agitation or sedation potentially causing Pt 6 pain and/or discomfort. Findings: 1. During a medication pass observation on 5/21/25 at 9:30 a.m., with Registered Nurse (RN) 3, in the presence of the Shift Manager at Campus 1 (SMDMC), RN 3 was observed administering a Nozin nasal swab medication to Pt 5 by applying five (5) swabs in one circular motion in each nostril. During a record review of Pt 5’s physician order for “ethanol topical (Nozin),” dated 5/5/25, indicated, “one application swab each nostril q (every) 12 h (hours)...Instructions...insert swab tip into the right nostril and with moderate pressure, swab 8 times clockwise and then 8 times counter-clockwise ensuring to swab the inside front pocket of the right nare. Resaturate swab, repeat process in left nare swabbing 8 times clockwise and then 8 times counter-clockwise...” During an interview on 5/21/25 at 2:20 p.m., RN 3 acknowledged she should have swabbed Pt 5 nostrils with the Nozin nasal swab 8 times clockwise and counter-clockwise as prescribed and stated she only swabbed each nostril 5 times. RN 3 stated, “I thought it was [ordered] for 4 to 5 seconds.” During an interview on 5/22/25 at 3:23 p.m. with Director of Pharmacy (DOP), she stated nursing staff should have administered the Nozin nasal swab as prescribed and according to the manufacturer’s instructions to prevent infection or growth of bacteria. The DOP stated, the medication only worked if used as prescribed and as instructed by the manufacturer. During a review of the hospital’s policy and procedure (P&P) titled, “PC.AD.1.21 Medication Administration Policy,” dated 3/27/25 indicated, “Basic Safe Medication Administration Practices...Staff shall confirm the following prior to administering each medication...The correct dose: To ensure that the dosage matches the ordered dose...All parts of the medication order shall be reviewed, including additional instructions and parameters for use...” During a review of Nozin drug information, dated 5/2025, provided by the hospital, indicated, “Application steps...1. Insert swab tip into RIGHT nostril. Do not go deeper than tip of swab...2. With moderate pressure, swab around nostril eight (8) times clockwise. Cover all surfaces including inside tip of nostril...3. squeeze to resaturate swab tip...4. insert ampule into RIGHT nostril again and swab eight (8) times counterclockwise...5. repeat steps 1, 2, 3, 4 in LEFT nostril...” 2a. During a review of Pt 6’s “ED (Emergency Department) Note,” dated 4/21/25, the “ED Note” indicated, Pt 6 was admitted to the hospital on 4/21/25. During a review of Pt 6’s physician’s order for propofol titratable (adjustable) IV (intravenous, into the vein) infusion (directly into the bloodstream), dated 4/21/25 at 11:44 a.m., indicated, “Propofol IV additive 1,000 mg (milligrams, unit of measure)...5 mcg (micrograms, unit of measure)/ kg (kilograms, unit of measure)/min (minute)]...” During a group concurrent interview and clinical record review on 5/21/25 at 3:52 p.m. with the ICU Director (ICUD) and the Quality Review Nurse (QRN) 2, Pt 6’s “Medication Administration Record (MAR) Summary,” dated 4/21/25 at 12:45 p.m. was reviewed. The MAR Summary indicated, the first bag of propofol was administered on 4/21/25 at 12:45 p.m. at 5 mcg/kg/min, by one nurse, without documentation of a second nurse witness/co-sign on the MAR. The group acknowledged there was no documentation that a second nurse witnessed/co-signed the first propofol administration on 4/21/25 at 12:45 p.m. The ICUD stated a second licensed nurse should have witnessed/co-signed on the MAR when the first bag of propofol was administered according to the hospital’s policy. During a review of the hospital’s P&P titled, “PC.AD.1.21 Medication Administration Policy,” dated 3/27/25 indicated, “...High Alert medications are identified on the High Alert Medication Administration Independent Double Check, & Related Safety Precautions Policy and require a second licensed nurse independent double check prior to the administration of the medication...” During a review of the hospital’s P&P titled, “MOD CO.2034.PR.01 MOD High Alert Medication Administration Independent Double Check, & Related Safety Precautions,” dated 4/24/24 indicated, “Independent Double Check...Certain High-alert Medications require an Independent Double Check...A Practitioner and a second Practitioner shall separately and independently check the physician order and/or the medication administration record (MAR) with the medication dose prepared for the patient to determine it is correct before the administration of these medications and when any key therapeutic changes are performed...Procedure applies when...Initiating a High-alert, Independent Double Check Medication...Both Practitioners shall document the verification process on the MAR or other designated documentation location...Table 1: Additional Considerations & Specific Requirements...High alert medication...Anesthetic Agents [used for sedation or to prevent pain during surgery or procedures]...General, inhaled, and IV (e.g. [example] propofol ...)...Nursing independent double check...Two nurses shall perform an independent double check with every new bag...” 2b. During a review of Pt 6’s physician’s order for propofol titratable IV infusion, dated 4/21/25 at 11:44 a.m., indicated, “Propofol IV additive 1,000 mg...5 mcg/kg/min...start at 5 mcg/mg/min, titrate [Adjust] by 5 mcg/kg/min every 5 min...For goal RASS score of -1 [Richmond Agitation-Sedation Scale- a medical scale used to measure the agitation or sedation level on a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with “awakens to voice” and ending with “unarousable.” Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation is apprehension and anxiety, and highest level of agitation is combative and violent. RASS level 0 is “alert and calm.” RASS -1 is “drowsy not fully alert, but has sustained awakening.”] During a group concurrent interview and clinical record review on 5/21/25 at 3:52 p.m. with the ICUD and the QRN 2, Pt 6’s “MAR Summary,” dated 4/21/25 at 12:45 p.m. was reviewed. The MAR Summary indicated, propofol was increased from 5 mcg/kg/min to 10 mcg/kg/min on 4/21/25 at 16:40 (or 4:40 p.m.) but the RASS score was not documented. The group acknowledged the RASS was not documented. The ICUD stated that the RASS should have been documented on 4/21/25 at 16:40 (or 4:40 p.m.) when the propofol administration was increased. During an interview on 5/22/25 at 3:26 p.m. with the Director of Pharmacy (DOP), she stated the RASS score should have been documented for Pt 6’s propofol IV infusion and stated for any titratable drip the goal on the physician’s order is what should haven monitored and documented by hospital staff. During a review of the hospital’s P&P titled, “MOD.CC.1.08 Pain Management, IV Sedation and Delirium Prevention & Treatment Procedure (PAD),” dated 9/24/24, indicated, “Pain, Sedation, and Delirium Monitoring and Management...A RN (Registered Nurse) will perform level of sedation assessments and record the results at a minimum of every 4 hours. Sedation assessments will be done utilizing the Richmond Agitation and Sedation Scale (RASS), with a target sedation score of 0 to -2...A sedation score will be documented upon administration of any sedative.” A review of the Prescribing Information for propofol dated 9/2022, retrieved from DailyMed (a public website maintained by the U.S. Food and Drug Administration), indicated, “Failure to reduce the infusion rate in patients receiving [propofol] for extended periods may result in excessively high blood concentrations (levels) of the drug. Thus, titration to clinical response and daily evaluation of sedation levels are important during use of propofol...””

“ORGANIZATION AND STAFFING CFR(s): 482.24(a) The organization of the medical record service must be appropriate to the scope and complexity of the services performed. The hospital must employ adequate personnel to ensure prompt completion, filing, and retrieval of records. This Standard is not met as evidenced by: 39051 Based on interview and record review, the facility failed to employ a qualified individual to supervise the medical record services, as the assigned Director of Health Information Management (HIM) lacked the required credential. This failure resulted in the facility’s inability to ensure professional oversight of medical records/health information management, placing patients at risk for documentation errors, legal noncompliance, and privacy violations. Findings: 1. During an interview on 5/20//25 at 11:08 a.m.with the DHIM (Director Health Information Management), she stated she has worked 34 years for the health system. The DHIM at the facility has responsibility for not only Medical Records/Health Information Management but also Centralized Scheduling, Communications/Switchboard and the Mail Room. The DHIM stated she reports to the Chief Financial Officer (CFO). The “Initial Documents Request” for HIM/Medical Records provided to the facility during the entrance conference was reviewed with the DHIM and included item E. “AHIMA(American Health Information Management Association)/AAPC (formerly American Academy of Professional Coders, now known as just AAPC) Continuing Education Validation of Credentials for Directors, Managers, Supervisors, Coders, CDI Specialists, etc. if Job Description requires credential.” The DHIM verbalized that she understood this requested item. Acceptable options for providing credentials validation were explained to the DHIM. The DHIM did not offer which credential she possessed nor was a credential listed on her business card. 2. During a review of a document titled “[Name of Facility] Job Title - Director of HIM” the job description’s “Position Qualifications” were found to include under “License/Certificates/Credentials” the requirement for an “Accredited Record Technician or Registered Record administrator - American Health Information Association or equivalent (requirement can be satisfied if noted level of certification is maintained by individual in the line of authority for appropriate oversight).” 3. During a review on the AHIMA website https://www.ahima.org it was noted that the correct name for this credential-granting entity should be “American Health Information Management Association,” that the Accredited Record Technician and Registered Record Administrator credentials were revised in the year 2000 and became Registered Health Information Technician and Registered Health Information Administrator, respectively, and that there is no existing acceptable equivalent for these credentials. 4. During a review of a document titled “DMC HIM Org Chart 2025” it showed that the facility’s HIM Director has a solid line accountability to the facility’s Chief Financial Officer, and a dotted line of communication to the Director, HIM Hospital OPS (Operations) over Arizona/California corporate health system hospitals. 5. During a review of credentials produced by the facility for HIM staff, the validated RHIT credential belonged to the corporate level HIM Director. A valid credential was not supplied by the facility for their Director HIM employee directly responsible for daily HIM operations. 6. During a review of federal and state laws pertaining to requirements for the individual supervising HIM/Medical Records, under 42 CFR (Code of Federal Regulations) Section 482.24(a) “The hospital must employ adequate personnel” for the medical record service. More stringent (strict) state law, CCR (California Code of Regulations), Title 22, Division 5, Chapter 1, Article 7, Section 70747 Medical Records Service, Paragraph (b) requires “The medical records service shall be under the supervision of a registered health information administrator or registered health information technician.””

“PROTECTING PATIENT RECORDS CFR(s): 482.24(b)(3) The hospital must have a procedure for ensuring the confidentiality of patient records. Information from or copies of records may be released only to authorized individuals, and the hospital must ensure that unauthorized individuals cannot gain access to or alter patient records. Original medical records must be released by the hospital only in accordance with Federal or State laws, court orders, or subpoenas. This Standard is not met as evidenced by: 39051 Based on observation, interview and record review, the facility failed to identify and implement safeguards for special categories of sensitive health information, specifically genetic testing results and reproductive health information, as required under state and federal law. This failure resulted in the potential unauthorized access, use, or disclosure of legally protected information, violating patient rights and increasing the risk of discrimination and legal liability. Findings: 1. During a concurrent interview and record review on 5/20/25 at 1:30 pm with the the facility’s patient authorization form titled, “Release of Information - ROI (1) EDEMF2236 - REV 10/2022” was noted to have a checklist of highly confidential information listed for which the patient must specifically authorize the use and/or disclosure. The checklist does not include genetic testing results or reproductive health information. When asked regarding these omissions, the Director, Health Information Management (DHIM) stated she was unaware of specific legal requirements for special handling of these two additional classes of protected sensitive health information. 2. During a concurrent observation and interview on 5/21/25 at 9:45 am with the Clerk, Health Information Management (CHIM) in the Health Information Management (HIM) department at her Release of Information Desk, the CHIM demonstrated the process used for preparing a release of medical records. The CHIM stated she has worked 14 years handling Release of Information functions. When asked to identify the categories of highly confidential information, the CHIM acknowledged the existence of the checklist on the facility’s patient authorization form but was unaware of specific legal requirements for special handling of records containing genetic testing or reproductive health sensitive information. When asked how she stays current with legal updates regarding protected health information, the CHIM responded that she does computer modules training and consults her immediate supervisor Manager, Health Information Management (MHIM) or if not available, the DHIM. During a review of the United States Department of Health and Human Services (DHHS) website covering Genetic Information, found at https://www.hhs.gov/hipaa/for-professionals/special-topics/genetic-information/index.html, the Genetic Information Nondiscrimination Act (GINA) was noted as signed into law in May of 2008, with two Titles (sections) enacted during 2009. The Final Rule implementing GINA became effective January 10, 2011. In 29 CFR (Code of Federal Regulations) Part 1635, Section 1635.3(c) Genetic Information is defined to include results of genetic tests, family medical history, and participation in genetic services or research. The website’s home page further advises that on January 25, 2013, DHHS published a final rule entitled “Modifications to the HIPAA [Health Information Portability and Accountability Act] Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act, and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules” (2013 Omnibus Rule) modifying HIPAA to classify genetic information as Protected Health Information (PHI). During a review of the California Legislative Information website addressing Genetic Information legislation, found at https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201120120SB559, the California Genetic Information Nondiscrimination Act (CalGINA) was signed into law in September 2011 and took effect on January 1, 2012. CalGINA amends anti-discrimination laws already in effect to prohibit genetic discrimination in areas such as housing; mortgage lending; employment; education; and public accommodations. CalGINA provides broader protections from genetic discrimination than does the federal Genetic Information Nondiscrimination Act (GINA) of 2008, which is limited to employment and health insurance coverage. Unlike GINA, CalGINA has no cap on damages which may be sought for genetic discrimination. During a review of the DHHS website covering Reproductive Health Care, found at https://www.hhs.gov/hipaa/for-professionals/special-topics/reproductive-health/index.html, the Office for Civil Rights (OCR) was noted to have issued a Final Rule in April 2024, entitled “HIPAA Privacy Rule to Support Reproductive Health Care Privacy.” The Final Rule strengthens the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule by prohibiting the disclosure of protected health information related to lawful reproductive health care in certain circumstances. The effective date was June 25, 2024. The compliance date, the date persons subject to this regulation must comply with the applicable requirements of this Final Rule, was December 23, 2024, except for the Notice of Privacy Practices. The compliance date for the Notice of Privacy Practices is February 16, 2026. Regulated entities are required to obtain an attestation when they receive a request for PHI (protected health information) potentially related to reproductive health care from the requestor that the use or disclosure is not for a prohibited purpose. Such attestation is required when the request for PHI is for health oversight activities, judicial and administrative proceedings, law enforcement purposes or disclosures to coroners and medical examiners. During a review of the California Department of Public Health’s (CDPH’s) website listing their All Facilities Letters (AFLs) it was noted that on January 16, 2024 CDPH issued AFL 24-03, to inform all licensed health care facilities about the provisions of AB (Assembly Bill) 352 and the associated requirements. AB 352 was signed into law in 2023, amending California’s Confidentiality of Medical Information Act (CMIA) to enhance privacy protections for sensitive services, including abortion and abortion-related care. Specifically, it prohibits health care providers from knowingly disclosing, transmitting, transferring, sharing or granting access to medical information related to lawful abortion services to any individual or entity from another state, unless a valid authorization is obtained under CMIA. During a review of a website post by the California Hospital Association placed on May 16, 2024, it was noted that hospitals were advised that DHHS’s Office for Civil Rights finalized a Privacy Rule to Protect Reproductive Health Information, effective June 25, 2024 with compliance required by December 23, 2024. Hospitals were also advised that covered entities were required to obtain a signed attestation that certain requests for PHI related to reproductive health care are not for any of the prohibited purposes. Reference was made to OCR’s Model Attestation form which can be given to persons requesting such PHI.”

“MEDICAL RECORD SERVICES CFR(s): 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. This Standard is not met as evidenced by: 39051 Based on interview and record review, the facility failed to ensure that medical records were completed promptly following patient encounters in three clinics operating under the hospital’s license. In three of three sampled outpatient specialty clinic records, physician documentation was incomplete or lacking for days following the date of service visit. This failure resulted in delayed entry or validation of clinical information, which jeopardized continuity of care, delayed billing, and increased the risk of omitted details or errors in documentation accuracy. Findings: During concurrent interview and record review on 5/21/25 at 2:15 pm AND on 5/22/25 at 10:16 am with the Director, Health Information Management (DHIM), selecting one random record from each of three specialty clinics on the hospital’s license, the following were the findings: Patient 37 was seen in the CV (Cardiovascular) Clinic on 5/16/25 with the chief complaint of palpitations (irregular heart beat), chest pain and dyspnea (difficulty breathing). Testing was ordered in addition to an echocardiogram obtained the month prior and the patient was scheduled to return in two weeks. The Clinic utilizes the NextGen EHR (electronic health record) and the DHIM advised that the cardiologist does a separate dictation. At the time of record review, five days following the patient’s visit, no documentation by the cardiologist was found. Patient 38 was seen in the Darroch Brain and Spine Institute (DBSI-spine/pain management) Clinic on 5/16/25 with the chief complaint of pain due to lumbar stenosis. This was a new patient with a seven month history of back pain and x-rays were obtained on 5/21/25. The Clinic utilizes the Athena EHR, a system which does not show a referral for new patients not already in the database, requiring identification by patient matching. The physician initiated a History and Physical Exam report which was not finalized and authenticated at the time of record review, six days following the patient’s visit. Patient 39 was seen in the Maternal-Fetal Medicine Clinic on 5/20/25 with the chief complaint of gestational diabetes mellitus uncontrolled at 31 weeks gestation (the process of baby’s development occurring in the uterus before birth) and a history of C-section (Caesarean section, a surgical procedure where a baby is delivered through an incision in the mother’s abdomen). Ultrasounds were obtained and reported back. The Clinic was opened one month ago for high risk mothers and babies and utilizes the Cerner/ Horizon Patient Folder (HPF) EHR, which is integrated with the hospital’s EHR. At the time of record review, two days following the patient’s visit, no documentation by the physician was found. When asked how long the clinic physicians have to document patient encounters, the DHIM responded “fourteen days.” During a review of a document titled “Medical Staff Rules and Regulations, Doctors Medical Center,” 2021 final version, under Section B. Medical Records, paragraph 1, it states that “The attending physician is responsible for the electronic preparation of a complete, accurate and legible medical record for each patient. This applies to all practitioners credentialed by the medical staff. Such record shall be adequate for purposes of use for the continuity of care for the patient.” Under paragraph 2, it states “A complete medical history and physical examination must be completed ...24-hours after admission for each patient.” Under paragraph 5, it states “Pertinent progress notes shall be recorded timely in the health record and shall provide information required for continuity of care and transferability.” “If transcribed progress notes are used in lieu of electronic progress notes, the turnaround time shall be 2 hours. If the mandated turnaround time cannot be met, the physician must augment the electronic medical record to ensure continuity of care. Any critical treatment information shall be part of the note even if the transcribed note is expected shortly.” Under paragraph 21, it states “All of the patient’s medical records shall be completed, dated/timed and authenticated, insofar as possible, at the time of discharge, including progress notes ....” Under Section E. Consultations, paragraph 2, it states “Consultations are expected to be provided within 24 hours.” During a review of Doctors Medical Center Patient Care - Administrative Manual Policy titled “PC.AD.1.08 Documentation Policy,” under Section III. POLICY: paragraph 3, item 1, All Medical Record entries should be made as soon as possible after the care is provided, or an event or observation is made.” During a review of federal and state requirements for medical record completion, it was noted that under federal law, 42 CFR (Code of Federal Regulations) Section 482.24(c)(1) “All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures.” Under State law, Title 22, Division 5, Chapter 1. General Acute Care Hospitals, Article 7. Administration, Section 70751 Medical Record Availability, paragraph (g) “Medical records shall be completed promptly and authenticated or signed by a licensed healthcare practitioner acting within the scope of his or her professional licensure within two weeks following the patient’s discharge.” Such a time frame applies to inpatient discharges rather than ambulatory clinic visits for specialty care with documentation relied upon for care continuity by the patients’ primary care practitioners.”

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 46393 Based on observation, interview and record review, the hospital failed to maintain drug storage areas in accordance with acceptable standards of practice and hospital policies when: 1. At Campus 1, one box of Gliadel Wafers (a wafer-like chemotherapy implant used for brain cancer), containing three wafers, was identified stored inside the pharmacy medication freezer at a higher temperature than instructed by the manufacturer. 2. At Campus 2, the hospital failed to ensure controlled room temperature was monitored and documented in four of four medication storage rooms containing non-refrigerated medications. These failures had the potential to expose patients to unstable and/or unsterile medications potentially leading to therapeutic failure in patients. Findings: 1. During an observation on 5/20/25 at 11:45 a.m. in the hospital pharmacy at Campus 1 there was one opened box of Gliadel Wafers (eight wafers per box), containing three Gliadel Wafers, identified stored inside the pharmacy medication freezer. During a concurrent interview and record review on 5/22/25 at 3:18 p.m., with the Director of Pharmacy (DOP), the Gliadel Wafer manufacturer storage instructions and the pharmacy freezer temperature logs for April and May 2025 were reviewed. The DOP acknowledged the Gliadel Wafers should have been stored at or below -4 degree Fahrenheit (F, a temperature measurement) according to the manufacturer instructions. The DOP confirmed the pharmacy medication freezer temperature was higher than the manufacturer’s instructions on the following dates and times: - On 4/6/25 at 20:07 (8:07 p.m.), -2.6 degree F; - On 4/7/25 at 17:28 (5:28 p.m.), 0 degree F; - On 4/11/25 17:34 (5:34 p.m.), -3.8 degree F; - On 4/15/25 11:24 a.m., -1.3 degree F; - On 4/22/25 17:41 (5:41 p.m.), -1.7 degree F; - On 4/30/25 17:28 (5:28 p.m.), -3.6 degree F; - On 5/4/25 16:48 (4:48 p.m.), -0.3 degree F; and - On 5/15/25 18:08 (6:08 p.m.), -0.1 degree F. During the same concurrent interview and record review on 5/22/25 at 3:18 p.m., the DOP stated it was important to store medications at the manufacturer specified temperature to ensure the medication maintained its potency and stability. During a review of the hospital’s policy and procedure (P&P) titled, “PHARM.1.21 Medication Storage Access and Security Policy,” dated 2/27/25, indicated, “Medications are stored under conditions suitable for product stability...Any medication which is not maintained according to special storage requirements are not to be administered and should be disposed of in the appropriate pharmaceutical waste container.” A review of Gliadel Wafers manufacturer’s instructions provided by the hospital, dated May 2022, indicated, “Store Gliadel Wafer at or below -20 degree Celsius [C, a temperature measurement] (-4 degree F).” 2. During a visit to Campus 2 on 5/23/25 at 9:30 a.m., controlled room temperature was not observed to have been monitored or documented in four of four medication rooms containing non-refrigerated medications as follows: 2a. During an observation on 5/23/25 at 9:46 a.m. in the C1 building medication room, there was no room temperature thermostat, and no room temperature monitoring log observed that indicated daily room temperature was monitored and documented. During an interview on 5/23/25 at 9:54 a.m. with Registered Nurse (RN) 4, when asked to describe how the controlled room temperature monitoring for the C1 building medication room was done, RN 4 stated, “I haven’t done that before on day shift.” During an interview on 5/23/25 at 9:56 a.m. with the DOP, the DOP stated the hospital had not monitored or documented daily room temperature in the C1 Building medication room. 2b. During an observation on 5/23/25 at 10:00 a.m. in the C2 Building medication room, there was no room temperature thermostat, and no room temperature monitoring log observed that indicated daily room temperature was monitored and documented. During an interview on 5/23/25 at 10:06 a.m. with the DOP, the DOP stated the hospital had not monitored or documented daily room temperature in the C2 Building medication room. 2c. During an observation on 5/23/25 at 10:08 a.m. in the D Building medication room, there was no room temperature thermostat, and no room temperature monitoring log observed that indicated daily room temperature was monitored and documented. During an interview on 5/23/25 at 10:15 a.m. with the DOP, the DOP stated the hospital had not monitored or documented daily room temperature in the D Building medication room. 2d. During a concurrent observation and interview on 5/23/25 at 10:25 a.m. with the DOP and the Shift Manager at Campus 2 (SMDBH), in the Intake Building medication room, there was no room temperature thermostat, and no room temperature monitoring log observed that indicated daily room temperature was monitored and documented. The DOP stated the hospital had not monitored or documented daily room temperature in the Intake Building medication room. During a follow-up interview on 5/23/25 at 12:20 p.m. with the DOP, she stated it was important to have monitored and documented controlled room temperature in medication storage rooms because medications needed to be stored at the required temperatures according to manufacturer’s instructions for optimal stability and sterility. Further review of the hospital’s P&P titled, “PHARM.1.21 Medication Storage Access and Security Policy,” dated 2/27/25, indicated, “Controlled Room Temperature Range: 20 C (68 F) to 25 C (77 F)...””

“PHARMACY DRUG RECORDS CFR(s): 482.25(a)(3) Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. This Standard is not met as evidenced by: 46393 Based on interview and record review, the hospital failed to ensure there was an effective system in place to identify loss or theft of all controlled drugs (drugs that are regulated by the federal government due to potential of abuse/addiction) dispensed from 25 of 25 operating room (OR) Anesthesia Workstations (AWS, a type of automated dispensing cabinet [ADC]) when: 1a. For one of four patients reviewed for controlled drug discrepancies, Patient (Pt) 7, the hospital was unable to account for one midazolam (a controlled drug used as a sedative) vial dispensed from OR 9 AWS; and 1b. The hospital was unable to facilitate the Drug Diversion Prevention Committee’s ability to accurately review controlled drugs usage trends and patterns in the hospital, according to hospital policy, for anesthesia providers (highly trained healthcare professionals who administer drugs in the OR). These failures had the potential for unsafe controlled drug use, lack of accountability, risk of controlled drug theft or unauthorized use and patient harm. Findings: 1a. During an interview on 5/22/25 at 10:42 a.m., with the Director of Pharmacy (DOP), when asked about the process for reconciliation of controlled drugs dispensed in the hospital, the DOP stated there were four (4) specific pharmacy technicians (RXT) assigned the responsibility of reconciling controlled drug discrepancies (records of drugs taken out of an automated dispensing cabinet [ADC, machine containing controlled drugs] by nurses or providers but are not accounted for by administration or waste records) in the hospital. The DOP stated the assigned RXTs performed daily reviews of the following four controlled drug discrepancy reports generated electronically from the ADC: (i) Controlled drug dispensed from ADC but not documented as administered to a patient in the electronic medical record (EHR); (ii) Dose reconciliations from ADC if the dose ordered did not match the dose administered and/or wasted; (iii) Pending unresolved ADC discrepancies by nursing staff that were not closed by the end of their shift; and (iv) Controlled Substance Manager (CSM, the machine in the pharmacy securely stores and tracks all controlled drugs in the hospital) Exceptions Report which included any controlled drug that was dispensed from the CSM in the pharmacy to be delivered to the nursing units. During the same interview on 5/22/25 at 10:42 a.m., the DOP stated the RXTs reported any unresolved controlled drug discrepancies to her for follow-up with the Nursing Director responsible for overseeing the staff involved with the unresolved discrepancy. During a concurrent interview and record review on 5/22/25 at 11:35 a.m., Pt 7’s medical record and the ADC report titled, “Transactions by Item/Procedure,” dated 1/9/25, were reviewed with the DOP. The ADC report indicated one midazolam 2 mg (milligram, unit of measurement) / 2 ml (milliliter, unit of measurement) injection vial was dispensed on 1/3/25 at 9:19 a.m. from the OR 9 AWS for Pt 7 by an anesthesiologist. The DOP was unable to locate an anesthesia record in Pt 7’s medical record with documentation that indicated a midazolam injection was administered to the patient. The DOP stated the unresolved controlled drug discrepancy for midazolam 2mg/2ml injection vial was entered into the hospital’s risk management system by RXT 2. The DOP stated she emailed the Chief of Anesthesiology about the unresolved controlled drug discrepancy on 1/13/25. The DOP stated the last email communication related to the unresolved controlled drug discrepancy was on 1/23/25. The DOP acknowledged the discrepancy had remained unresolved without additional follow-up since 1/23/25 and the midazolam 2mg/2ml injection vial was still unaccounted for. The DOP stated pharmacy staff were responsible for following up with unresolved controlled drug discrepancies. A review of the hospital’s policy and procedure (P&P) titled, “MOD CLN.10.04 MOD Controlled Substance Diversion Prevention and Detection (AD 1.27),” dated 2/28/24, indicated, “Controlled Substance Surveillance and Audits...The Pharmacy Department shall conduct operating room post case reconciliation of Controlled Substances. Anesthesia patient records shall be reviewed and reconciled to confirm Controlled Substance ordering, administration, and waste, if applicable, are properly documented. If a Controlled Substance documentation issue cannot be resolved, it shall be documented in the hospital’s risk management system for review and action and a Compliance Matter opened if diversion is suspected...” 1b. During an interview on 5/22/25 at 10:42 a.m., the DOP stated the hospital used a computer software system that tracked controlled medication use to monitor staff behavior based on controlled drug usage, including dispense and wastage trends. The DOP stated the software was interfaced (connected) to the ADC’s controlled drug dispense history and the controlled drug administration history from the patients’ electronic health record (EHR) to allow monitoring of staff behaviors related to controlled drug usage. The software reconciled the dispense and the administration for every controlled drug transaction. The DOP stated the software generated an Individual Risk Identification Score (IRIS) to proactively identify behavior abnormalities such as: wasting with the same person, dispensing more of one drug, taking too long to dispense, and administering/wasting the full package of medications. The DOP stated, any staff (doctors and nurses) identified with a high IRIS (score above 5) generated by the system was considered an individual with a high usage of controlled drugs. The DOP stated individuals with high usage were discussed with the Nursing Director. During an interview on 5/22/25 at 11:29 a.m., the DOP stated the process for reconciliation of controlled drugs dispensed from the 25 OR AWS in the hospital was not the same as for all other nursing units in the hospital because the administration of controlled drugs in the OR was manually documented on paper “Anesthesia Records” by the anesthesia providers (including Anesthesiologists and Certified Registered Nurse Anesthetists [CRNAs]). Due to the manual paper documentation of controlled drug administration in the OR, the pharmacy was unable to obtain the same electronic discrepancy reports from the ADC for controlled drugs dispensed from the 25 OR AWS in the hospital. The DOP stated the process for reconciliation of controlled drugs dispensed from the 25 OR AWS was done manually by RXT 2 during weekly audits. The DOP stated not every controlled drug dispensed from the OR AWS were audited by RXT 2. The DOP stated RXT 2 completed random audits by generating a report from the ADS of the controlled drugs dispensed from the 25 OR AWS and randomly picked approximately 300 to 400 of the controlled drugs dispensed every month to be audited. The DOP stated RXT 2 documented the total number of controlled drug transactions he audited on a document titled, “Anesthesia Audit Sheet 2025.” During an interview on 5/22/25 at 3:32 p.m. with the DOP, the DOP stated, the controlled drug monitoring system was ineffective to accurately track and trend all the controlled drugs dispensed from the 25 OR AWS in the hospital. When asked if the pharmacy could have identified every time an anesthesia provider dispensed a controlled drug from the OR AWS but had not administered or wasted it, the DOP stated, “No.” The DOP stated the current controlled drug monitoring system for the 25 OR AWS relied on a manual random audit which was unable to identify and report every controlled drug discrepancy from the 25 OR AWS in the hospital. The DOP acknowledged it was the pharmacy’s responsibility to ensure there was an effective system in place for reconciliation and accountability of all controlled drugs in the hospital. During a concurrent interview and record review on 5/22/25 at 3:40 p.m., RXT 2’s “Anesthesia Audit Sheet 2025 (audit sheet),” and the ADS controlled drug dispense reports for the 25 OR AWS dated January, February, March, and April 2025 were reviewed with the DOP. The DOP confirmed the following: - In January 2025, the dispense report indicated there were 1,987 controlled drugs dispensed from the 25 OR AWS and the audit sheet indicated 574 (or 29% [percent, unit of measurement]) of the controlled drugs dispensed were audited by RXT 2; - In February 2025, the dispense report indicated there were 1,866 controlled drugs dispensed from the 25 OR AWS and the audit sheet indicated 227 (or 12%) of the controlled substances dispensed were audited by RXT 2; - In March 2025, the dispense report indicated there were 1,846 controlled substances dispensed from the 25 OR AWS the audit sheet indicated 561 (or 30%) of the controlled drugs dispensed were audited by RXT 2; and - In April 2025, the dispense report indicated there were 1,789 controlled drugs dispensed from the 25 OR AWS and the audit sheet indicated 441 (or 25%) of the controlled drugs dispensed were audited by RXT 2. During the same interview and record review on 5/22/25 at 3:40 p.m., the DOP stated it was important to accurately reconcile all controlled drugs dispensed from the ADS (including the OR AWS) because controlled drugs could have been given to the wrong person for which it was not prescribed, making it an illegal medication. Additionally, the DOP stated, if controlled drugs were not accounted, the patient could have received medication that had been tampered with that could have led to a patient safety issue. During a follow-up interview and record review on 5/23/25 at 11:55 a.m., a further review of the “Anesthesia Audit Sheet 2025 (audit sheet),” dated January, February, March, and April of 2025 was conducted with the DOP. The audit sheet indicated, the number of anesthesia providers (out of 77 total) audited each month by RXT 2 were as follows: - In January 2025, 40 anesthesia providers (52%); - In February 2025, 26 anesthesia providers (34%); - In March 2025, 54 anesthesia providers (70%); and - In April 2025, 51 anesthesia providers (66%). During the same interview and record review on 5/23/25 at 11:55 a.m., the DOP confirmed the number of anesthesia providers audited in January through April 2025 by RXT 2 as listed above. During an interview on 5/23/25 at 12 p.m. with the DOP, the DOP stated she did not review all the related anesthesia records that were audited every month by RXT 2. The DOP stated she only reviewed the numbers documented on the “Anesthesia Audit Sheet 2025.” The DOP was unable to locate the anesthesia records that were audited by RXT 2. The DOP stated it was important to have an effective system to monitor and prevent controlled drug diversion to prevent controlled drugs from getting into the community and causing harm. When asked how an ineffective system for controlled drug monitoring affected the Drug Diversion Prevention Committee’s ability to accurately review controlled drug trends and usage patterns for anesthesia providers, the DOP stated when the committee was provided incomplete data, the committee was unable to make an effective assessment of how the diversion prevention program is going. Further review of the hospital’s P&P titled, “MOD CLN.10.04 MOD Controlled Substance Diversion Prevention and Detection (AD 1.27),” dated 2/28/24, indicated, “The Drug Diversion Prevention Committee and/or Authorized Personnel assigned by the Tenet Entity’s chief executive shall review Controlled Substance trend and usage pattern reports at least quarterly.””

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 46393 Based on interview and record review, the hospital failed to ensure an Abnormal Involuntary Movement Scale (AIMS, a formalized rating scale used to assess unusual movements) assessment was completed in accordance with the hospital’s policy, for one of one patient (Pt) reviewed for antipsychotic use at Campus 2, Pt 9. Pt 9 was administered multiple antipsychotics (medications used to treat symptoms of psychosis in conditions like schizophrenia) for over one year without documentation of a completed AIMS assessment. This failure had the potential to increase Pt 9’s risk of experiencing serious and sometimes irreversible side effects commonly associated with antipsychotics such as involuntary/jerky movements, muscle stiffness, and tremors, that could interfere with daily activities and cause distress and/or overall reduced quality of life. Finding: During a group concurrent interview and record review on 5/23/25 at 9:25 a.m., with the Shift Manager at Campus 2 (SMDBH) and the Director of Patient Care Services at Campus 2 (DPCDBH), Pt 9’s medical record was reviewed. They stated Pt 9 was admitted over one year ago, on 3/9/24, to Campus 2. They acknowledged Pt 9 had been administered multiple antipsychotics, including quetiapine (brand name Seroquel, an antipsychotic medication for bipolar disorder, depression, and schizophrenia) and haloperidol (brand name Haldol, an antipsychotic medication for mental illness such as schizophrenia). When asked if an AIMS assessment was completed when Pt 9 was admitted to Campus 2, they were unable to locate documentation of a completed AIMS assessment in the patient’s electronic medical record. They both stated an AIMS assessment should have been completed and stated they needed to check the patient’s hard chart (the physical, paper-based version of a health record). During a review of Pt 9’s “Admission Record,” dated 5/1/25, indicated Pt 9 was initially admitted to the hospital at Campus 2 on 3/9/24. Her medical record indicated she had diagnoses including schizoaffective disorder (a mental health condition that combines symptoms of schizophrenia [hallucinations and delusions] with symptoms of a mood disorder [depression or mania]). During a review of Pt 9’s “Medication Reconciliation,” dated 3/10/25, indicated a provider order for: haloperidol 20 mg (milligram, unit of measurement) one tablet by mouth three times a day, start date 1/18/25. Her medical record indicated she had been administered haloperidol in various doses, since 3/9/24 (over one year), and had current provider’s orders for haloperidol as follows: - Haloperidol decanoate 100 mg intramuscular (directly into the muscle) injection every 4 weeks, start date 12/2/24; and - Haloperidol 10 mg by mouth three times a day, start date 5/21/25. During a review of Pt 9’s “Medication Reconciliation,” dated 3/10/25, indicated a provider order for: quetiapine 100 mg by mouth at bedtime, start date 2/3/25. Her medical record indicated she had been administered quetiapine since 4/19/24 (over one year) and had a current provider order for quetiapine 100 mg by mouth at bedtime, start date 2/13/25. During a review of Pt 9’s “Medication Reconciliation,” dated 12/2/24, indicated she had been administered other antipsychotic medications, including olanzapine (used for schizophrenia) and clozapine (used for schizophrenia). Her medical record indicated she was administered various doses of olanzapine between March to December 2024 and various doses of clozapine between March to November 2024. Pt 9’s medical record did not indicate current provider’s orders for olanzapine or clozapine. During a review of Pt 9’s “Medication Administration,” dated 5/1/25 to 5/27/25, indicated, she had been administered the following antipsychotic medications between 5/1/25 to 5/27/25: - Haloperidol 10 mg by mouth three times a day; - Quetiapine 100 mg by mouth at bedtime; and - Haloperidol decanoate 100 mg by IM injection (monthly IM injection administered on 5/19/25). During a follow-up interview on 5/23/25 at 9:38 a.m., the DPCDBH stated she was unable to locate documentation of a completed AIMS assessment in Pt 9’s hard chart and stated she needed to check if the document was scanned into the hospital’s medical record database. She stated an AIMS assessment would have been completed by the nurse and the physician would have verified it. During a follow-up interview on 5/23/25 at 10:16 a.m., the DPCDBH stated she was unable to locate documentation of a completed AIMS assessment in Pt 9’s medical record (electronic, hard chart, or scanned database). During a follow-up interview on 5/23/35 at 10:22 a.m., the DPCDBH stated an AIMS assessment was important for monitoring for EPS side effects from antipsychotics. She stated an AIMS assessment should have been completed for Pt 9 when she was admitted to Campus 2. During a concurrent interview and record review on 5/23/25 at 12:15 p.m., the drug information for quetiapine was reviewed with the Director of Pharmacy (DOP) from Lexicomp (a comprehensive drug information resource), dated 5/20/25, provided by the hospital, indicated “...Monitoring parameters...extrapyramidal symptoms (EPS, drug-induced movement disorders such as tardive dyskinesia [TD, involuntary/jerky movements] when taking antipsychotics)...Use a formalized rating scale at least annually (once a year)...” The DOP acknowledged Pt 9 should have been monitored for EPS movement side effects when administered antipsychotics, including quetiapine. During a review of the hospital’s P&P titled, “MOD.DBHC.1.46 Abnormal Involuntary Movement Scale (AIMS) Assessment for Tardive Dyskinesia,” dated 8/23/23, indicated, “On admission, all patients admitted to [Campus 2] will be assessed by their RN [Registered Nurse] utilizing the Abnormal Involuntary Movement Scale (AIMS- attachment A). If the patient develops Tardive Dyskinesia [TD, a movement disorder] and/or other abnormal involuntary movements during their hospitalization, a second AIMS assessment will be completed. Assessments will be documented on the AIMS form.” During a review of Lexicomp’s haloperidol drug information, dated 5/27/25, provided by the hospital, indicated, “Haloperidol causes extrapyramidal symptoms (EPS), also known as drug-induced movement disorders, in all ages...Haloperidol has a high propensity [tendency] to cause EPS...Monitoring parameters...extrapyramidal symptoms...Use a formalized rating scale at least annually...” A review of the Prescribing Information (PI, detailed description of a drug’s uses, doses, warnings, side effects, and drug-drug interactions) for olanzapine tablets, dated 9/2022, retrieved from DailyMed (a public website maintained by the U.S. Food and Drug Administration), indicated, “Tardive dyskinesia...A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs.” A review of the PI for clozapine tablets, dated 1/2024, retrieved from DailyMed, indicated, “Tardive dyskinesia (TD) has occurred in patients treated with antipsychotic drugs, including clozapine. The syndrome consists of potentially irreversible, involuntary, dyskinetic movements.””

“PHARMACIST SUPERVISION OF SERVICES CFR(s): 482.25(b)(1) §482.25(b)(1) - All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. This Standard is not met as evidenced by: 46393 Based on observation, interview and record review, the hospital failed to ensure sterile (germ-free) compounding (mixing) of IV (intravenous, into the vein) drugs met the standards required by USP 797 (United States Pharmacopeia Convention chapter describing conditions and practices for compounding sterile drugs) when: 1. The pharmacy’s Cleanroom Suite (where sterile IV drugs are made) non-hazardous buffer room (room to mix IV drugs) had damaged wall areas that were uncleanable, 2. The initial garbing competency (the ability to properly put on and take off protective clothing) evaluation was not successfully completed three times in a row by one staff pharmacist. These failures had the potential of exposing patients to contaminated IV drugs leading to hospital acquired infections. Findings: 1. During a concurrent observation and interview on 5/20/25 at 2:26 p.m., with Pharmacy Technician (RXT) 1 and the Director of Pharmacy (DOP), the hospital pharmacy’s IV Cleanroom Suite was visually inspected. In the non-hazardous buffer room, a wall was identified containing three areas of damaged drywall. RXT 1 and the DOP acknowledged and confirmed the above observations. The RXT 1 and DOP both stated the damaged drywall areas were not smooth and therefore, were uncleanable. RXT 1 and the DOP stated they were unable to determine how long the wall had been damaged. The DOP stated she was not informed by pharmacy staff regarding the damage on the wall. During a review of photos from the non-hazardous buffer room provided by the hospital on 5/20/25, the photos indicated the three damaged drywall areas on the wall measured between two (2) centimeters (cm, unit of measurement) and four (4) cm long and/or wide. During a follow-up interview on 5/22/25 at 3:19 p.m. with the DOP, the DOP stated the DOP stated the USP 797 standards required walls to be smooth to allow efficient and appropriate cleaning to prevent microbial growth. The DOP stated microbial growth could have caused a negative impact on patients if they received unsterile compounded medications. According to the most recently updated USP 797, which became effective on November 1, 2023: “...The surfaces of ceilings, walls, floors, doors, door frames, fixtures, shelving, work surfaces, counters, and cabinets in the classified area must be smooth, impervious, free from cracks and crevices, and nonshedding so they can be cleaned and disinfected and to minimize spaces in which microorganisms and other contaminants can accumulate. Surfaces should be resistant to damage (e.g. [example], rust) by cleaning agents, sporicidal and other types of disinfectants, and tools used to clean. Junctures between the ceiling and the walls and between the walls and the floor must be sealed to eliminate cracks and crevices where dirt can accumulate...Walls must be constructed of, or may be covered with, durable material...and the integrity of the surface must be maintained...” 2. During a concurrent interview and record review on 5/20/25 at 3:28 p.m. with the DOP, the Pharmacist’s (RPH) initial garbing competency evaluation titled, “Competency Assessment: Hand Hygiene and Garbing for Nonhazardous Sterile Compounding,” dated 3/21/25, indicated, the RPH failed one out of three gloved fingertip and thumb sampling (GFT) on 3/21/25 and repeated one successful GFT on 3/31/25. The DOP acknowledged the RPH had not successfully completed three initial garbing competency evaluations in a row, including GFT, on 3/31/25 and stated the RPH should have. During a follow-up interview on 5/22/25 at 3:21 p.m. with the DOP, the DOP stated the USP 797 standards required compounding staff to successfully complete initial garbing competency evaluations in a row, including GFT, and stated it was important to follow the requirements to ensure compounding staff had efficient hand hygiene and garbing practices. According to the most recently updated USP 797, which became effective on November 1, 2023: “Demonstrating Competency in Garbing and Hand Hygiene...Before beginning to compound...or have direct oversight of compounding personnel, personnel must successfully complete an evaluation no fewer than 3 separate times. The 3 successful completions must be in succession-failure of any of the 3 initial garbing competency evaluations requires repeat testing until personnel successfully complete 3 evaluations in a row. The garbing competency evaluation consists of a visual observation and gloved fingertip and thumb sampling (GFT) of both hands...Each of the 3 initial competency evaluations must occur after performing a separate and complete hand hygiene and full garbing procedure. All garbing competencies must be completed with gloved fingertip and thumb sampling after garbing...and a documented visual audit while performing hand hygiene and garbing procedures...””

“SECURE STORAGE CFR(s): 482.25(b)(2)(i) §482.25(b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. This Standard is not met as evidenced by: 49230 Based on observation, interview, and record review the hospital failed to ensure that medications were kept locked and secured to prevent unauthorized access when two of the four Cardiac Catheterization Laboratory (Cath Lab - specialized area in a hospital equipped with imaging technology used for diagnosing and treating heart and blood vessel conditions) room, Cath Lab “Red” and Cath Lab “Purple”, were not in use and had anesthesia carts (carts arranged or customized with supplies, medication and equipment to administer anesthesia) that were left open and had unlocked medication drawers. This failure had the potential for unmonitored and unauthorized access to medications in anesthesia carts by unauthorized individuals, placing the hospital at risk for diversion of medications. Findings: During a concurrent observation and interview on 5/21/25 at 4:15 p.m. in Cardiac Catheterization Laboratory with the Director of Cath Lab (DCL) and Registered Nurse (RN) 16 all Cath Lab rooms were toured. RN 16 stated the hospital has a total of five Cath Lab rooms, however the hospital only has four operational rooms that were used for patient care. During the observation Cath Lab room “Red” and Cath Lab room “ Purple” were empty with no one inside and had open and unlocked Anesthesia Carts (carts arranged or customized with supplies, medication and equipment to administer anesthesia). Both anesthesia carts had medication drawers left open, slightly pulled out and open with access to all medications. RN 16 validated the Cath Lab schedule and stated that Cath lab room “Red” had last case at 3:15 p.m. and had been cleaned by Environmental Service (EVS - responsible for maintaining a clean and sanitary environment) and ready to use for next patient. RN 16 stated the cart had been sitting open for more than an hour and a half. RN 15 stated that Cath Lab room “Purple” had been sitting open for more than 10 minutes and last case was completed around 4:30 p.m. RN 16 stated EVS team and all Cath Lab employees had access to any of the Cath Lab rooms. RN 16 stated EVS team did go in and clean the “Red” room and had it set up for the tomorrow’s cases. RN 16 stated the medications should be kept locked and secured. RN 16 stated Anesthesia team was responsible for securing the carts. During an interview on 5/22/25 at 10:45 a.m. with the Chief of Anesthesia (DR 2), DR 2 stated it was not acceptable to have the anesthesia carts unlocked and unattended after the cases. DR 4 stated that he was made aware of the findings from yesterday in Cath Labs where two carts were left opened and unattended. DR 4 stated that he expects all anesthesia providers to ensure carts were locked prior to leaving the Cath Lab rooms. During an interview on 5/22/25 at 3:45 p.m. with the DCL, the DCL stated he expected Anesthesia carts to be kept locked when anesthesia staff was not present and expected it to be locked by anesthesia providers prior to leaving Cath lab rooms after each case. The DCL stated Cath Lab rooms were not staffed in the evenings, nights or weekends and it was not acceptable to leave open and unlocked anesthesia carts with access to medications. During a concurrent interview and record review on 5/23/25 at 8:30 a.m. with the Manager of Accreditation and Regulatory (MA) 1, anesthesia cart medication drawer content list was reviewed. That list indicated the carts in Cath Lab “Red” and Cath Lab “Purple” were stocked with medication that included succinylcholine (helps relax muscles during surgery or while a patient is on a breathing machine), rocuronium (Paralyzing agent- Used during surgery or Anesthesia ) and other medications. MA 1 stated EVS and other staff should not be able to access these medications. MA 1 stated succinylcholine and rocuronium had the potential to cause serious harm and she expected these medications to be kept locked up. During a review of Statement on “Security of Medications in the Operating Room” with the last amended date 10/18/23 by American Society of Anesthesiologist, retrieved from “https://www.asahq.org/standards-and-practice-parameters/statement-on-security-of-medications-in-the-operating-room” , statement indicated, “ ... A secure environment of care is necessary for medication safety ... Recommended Policies ... Anesthesia carts and anesthesia machines may remain unlocked, and non-controlled* medications may be left in or on top of unlocked anesthesia carts or anesthesia machines immediately prior to, during, and immediately following surgical cases in a secure anesthetizing location, so long as there are authorized personnel present ... “”

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 46393 Based on observation, interview, and record review, the hospital failed to ensure outdated or unusable medications were not available for use in two of four medication rooms at Campus 2, when: 1. One expired medication was stored along with unexpired medications against the hospital’s policy in one of four medication rooms; and 2. One used medication vial intended for single use was not discarded according to the manufacturer’s specifications in one of four medication rooms. These failures had the potential for exposing patients to contaminated or ineffective medications. Findings: During a visit to Campus 2 on 5/23/25 at 9:30 a.m., outdated or unusable medications were identified stored in two of four medication rooms as follows: 1. In the C2 Building medication room, during an observation on 5/23/25 at 10:04 a.m. with the Director of Pharmacy (DOP) and the Shift Manager at Campus 2 (SMDBH), Patient (Pt) 8’s opened and expired medication inhaler (device that delivers medication directly into the lungs) albuterol (medication for lung disease) was identified. An orange sticker was observed labeled on the albuterol inhaler that indicated it had expired on 5/14/25. During an interview on 5/23/25 at 10:05 a.m. with the SMDBH, he acknowledged the albuterol inhaler was expired on 5/14/25 and stated it should have been discarded. 2. In the Intake Building medication room, during a concurrent observation and interview on 5/23/25 at 10:25 a.m. with the DOP and the SMDBH, one opened and used preservative free Sterile Water for Injection (water that is free from germs used to dissolve medications) 10 ml (milliliter, unit of measurement) vial, intended for single use, was identified. The vial was observed to have a handwritten date that indicated an expiration date, “5/22 (2025).” The SMDBH acknowledged the vial was intended for single use and stated it should have been discarded. During an interview on 5/23/25 at 12:11p.m. with the DOP, the DOP stated used medication vials intended for single use should not have been dated or kept and stated it should have been discarded after use. Additionally, regarding the expired albuterol inhaler, the DOP stated medications should have been reviewed for expiration date before administration and the expectation was for staff to have discarded the medication when it expired. During a review of the hospital’s policy and procedure (P&P) titled, “PHARM.1.21 Medication Storage Access and Security Policy,” dated 2/27/25, indicated, “All expired, damaged, and/or contaminated medications are segregated until they are removed from the hospital.”

“EMERGENCY LABORATORY SERVICES CFR(s): 482.27(a)(1) Emergency laboratory services must be available 24 hours a day. This Standard is not met as evidenced by: 42321 Based on interview and record review the hospital failed to obtain and provide STAT (immediately) troponin (rapid blood test used to measure the protein (troponin) released by the heart muscle when it is damaged) results per policy of one hour when on 1/2/25, nine of 74 sampled patients (Patient (Pt) 17, Pt 18, Pt 48, Pt 49, Pt 50, Pt 51, Pt 52, Pt 53, and Pt 54) had STAT troponins ordered and not drawn for two hours after order was placed. These failures resulted in the nine patients not having their STAT troponin checked in a timely manner and had the potential to cause delay in their treatment. Findings: During a review of a hospital document titled, “Lab Report for 1/2/25, Troponin,” dated 1/2/25, the Lab report indicated on 1/2/25, 74 patients had a troponin level checked; of the 74 patients nine had a troponin level ordered STAT and were not drawn for greater than two hours after they were ordered. During an interview and document review on 5/21/25, at 11:05 a.m., with Assistant Director of Laboratory (ADL), the “Laboratory TAT (Turnaround Time) STAT” details form was reviewed. The ADL stated based on this TAT STAT form on 1/2/25, the lab had not met its goal of having labs drawn and results obtained in an appropriate time frame. The ADL stated he would have expected a stat troponin lab to be drawn within 30 minutes of the order placement. The ADL stated on 1/2/25, only 31.7 percent of troponin lab draws were drawn on time. The TAT STAT form indicated the goal was to draw a troponin in less than ten minutes after ordered, receive the specimen in the lab in less than 10 minutes after lab draw and receive the result in less than 35 minutes. The TAT goal is less than 55 minutes and the hospital goal is greater than 75 percent. The ADL stated on 1/2/25 the TAT goal for Troponin was not met but that there are many contributing factors that could have affected the collection time of the troponin. The ADL stated the contributing factors included staffing levels, difficult draws, staff not escalating difficult patients, and delays due to patients being off the floor for procedures. The ADL stated waiting over two hours to have a STAT troponin lab draw was not acceptable, “but all labs face these issues”. During a review of the hospital’s policy titled, “Laboratory Turnaround Times” dated 8/11/24, the policy indicated, “ ... STAT: Stat orders are drawn and resulted within one (1) hour if the test methodology allows ...” During a review of professional reference titled, “Troponin,” dated 4/23/23, retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK507805/#:~:text=Diagnosing%20cardiac%20emergencies,troponins.%5B3%5D, indicated, “ ... Diagnosing cardiac emergencies is one of the most crucial tasks delegated to the emergency provider. The broad differential diagnosis of chest pain must be narrowed down quickly and accurately to perform the life-saving treatments patients require.[1] Along with the history and physical examination, several important diagnostic tools are used to differentiate the different causes of chest pain.[2] One tool that has become an essential component of cardiac workups and diagnosis is the measurement of troponins.[3] ...””

“ORGANIZATION CFR(s): 482.28(a) Organization This Standard is not met as evidenced by: 28773 Based on observation, staff interview and review of hospital documents, the hospital failed to ensure Food and Nutrition Services (FANS) was organized and managed effectively when: 1. A Registered Dietitian (RD) did not have a role in providing oversight to the food service operations or guidance to the Director of Food and Nutrition Services (DFNS) at two of two campuses (Main Hospital Campus 1 and BHC Campus 2) in accordance with professional standards of practice. 2. Professional standards of practice were not followed when the Clinical Nutrition Manager (CNM) position and Lead RD position were supervised by the DNFS who had no clinical expertise and was not qualified to evaluate the professional skills of an RD. The hospital failed to ensure the Registered Dietitian provided guidance and oversight to the DNFS. 3. The clinical nutrition screening, prioritization and assessment policy did not address the specialized nutritional needs for patients admitted with behavioral health/mental health disorders located at the BHC Campus 2 when the nutrition risk screening policy was based on patients admitted to the general acute care hospital and did not reflect the nutrition risk factors specific to a behavioral health inpatient. As a result, RDs limited assessment of the nutritional needs of behavioral health patients only following a consult from the physician or nursing staff. 4. A system was not in place to recruit and hire Registered Dietitian’s in accordance with the published job description and the professional standard of practice to support face-to-face nutritional physical assessments of patients. Four of five full-time equivalent (FTE) positions for RDs were hired with the knowledge the RDs were unable to be on the hospital premises, would perform their jobs remotely and not be able to conduct nutrition-focused physical exams (NFPE) on patients. These failures had the potential to result in inadequate oversight of the Food and Nutrition Services food safety and sanitation practices, inadequate or ineffective food service staff training and competency. Additionally, the lack of a nutrition screening specific to the needs of the behavioral health population may result in gaps in the adequacy of nutrition care provided to patients. (Cross Reference A-0023, A-0083, A-0622, A-0750) Findings: 1. During the survey from 5/20/25 to 5/27/25, observations, interviews and document reviews indicated multiple concerns related to food production, safety and sanitation operations including: incorrect portions were served during lunch meal service at both campuses, there was no monitoring for cooling of ambient foods and facial hair was not restrained during meal service at BHC Campus 2, lack of competencies on food service staff (Cross refer A-0622, A-0750). During an interview with the Lead RD on 5/21/25 at 2:19 p.m., Lead RD stated she has been in the position for 2 months and her job responsibilities were limited to functions in clinical nutrition. The Lead RD also stated she was based out of state and traveled to the hospital for approximately one week each month. While onsite she stated she introduced herself to others, attended ICU rounds, met with pharmacy, food service staff and the patient service manager as well as attended a director meeting with the Interim Director of Food and Nutrition Services (IDFNS). The Lead RD stated she had not closely looked at or inspected food services, observations of meal service or patient meal tray audits yet as she had other priority items to do while onsite. During an interview with the IDFNS on 5/22/25 at 2:49 p.m., IDFNS stated they currently have a vacant Clinical Nutrition Manager (CNM) position and right now the RD oversight is done remotely by the Lead RD. The IDFNS acknowledged there was no oversight by a RD at the BHC Campus 2 at this time either. During a review of the Clinical Dietitian position description for the Lead RD, dated 2017, indicated the clinical dietitian reported to multiple positions within the contracted vendors leadership team. It indicated no supervisory responsibilities of dietetic services and did not show any functions in food services. During a review of the Clinical Nutrition Manager (CNM) position description, dated August 2017, indicated the supervisory responsibilities for this position were limited to clinical nutrition staff. It did not include the responsibility of providing guidance and oversight to the DFNS and dietetic services staff. 2. Dietary Services is defined as the provision of food and drink to patients in accordance with a physician’s order (LawInsider, 2023). A Registered Dietitian/Nutritionist (RDN) is a health care professional educated in nutrition and foods, who is able to translate scientific information into practical solutions. An RDN has completed a bachelor’s degree program, an accredited supervised practice program and has successfully completed a national exam (Academy of Nutrition and Dietetics). The RDN has a scope of practice in California law. In contrast the DFNS’s qualifications were listed as a Certified Dietary Manager (CDM) whose expertise is managing foodservice operations and ensuring food safety, usually in a healthcare facility. They are responsible for implementation of menus, foodservice purchasing, and food preparation. The CDM does not have a scope of practice in California Law. During a review of the FANS organization chart, indicated the Lead RD was supervised by the DFNS, which would not reflect a relationship that allowed for the Lead RD to provide guidance and oversight to the DFNS as a peer. In contrast, the position description of the Clinical Dietitian (RD), Lead RD, dated 2017, indicted this position could report to a variety of listed positions: CNM, Nutrition System Director, Assistant Director Clinical & Patient Services, Lead/Lead Specialists, or DFNS. The position description for the reporting of the RD included positions that were not shown on the departments organization structure and did not seem to be specific to the hospital. Similarly, Lead RD was supervised by the DFNS, a position with no formal training on the clinical nutrition needs of patients, and therefore unable to evaluate the skill set of a Registered Dietitian. During a review of the currently vacant Clinical Nutrition Manager (CNM) position description, dated August 2017, showed the CNM also reported to the DFNS. During an interview with the Chief Operating Officer (COO) on 5/27/25 at 3:34 p.m., the COO stated the IDFNS report directly to him. 3a. Patients with psychiatric illness encounter unique challenges in maintaining a healthy diet. The relationship between mental illness and nutritional status is bidirectional, shaped by both structural and illness-related barriers. Structural barriers-such as limited access to healthy foods, insufficient social support, low socioeconomic status, taste preferences, and daily habits-affect individuals with psychiatric illness and the general population alike. However, individuals with severe mental illness are at greater risk for food insecurity due to financial instability or tenuous housing. In addition to these structural barriers, patients with psychiatric illness often experience illness-related obstacles. Certain psychotropic medications can increase appetite, while cognitive impairment or reduced motivation can hinder ability to shop for and prepare healthy meals (Teasdale, et al., 2017). Growing evidence indicates that nutritional interventions should play a central role in psychiatric care. This emerging body of research highlights the importance of improving diet quality, adopting specific dietary patterns, and incorporating supplements when appropriate to support mental health outcomes. By incorporating nutrition management into routine care using existing resources, psychiatrists can empower patients to take charge of both their mental and physical health. Looking into the future, ongoing research efforts aim to further validate and standardize these interventions in psychiatric practice (Psychiatric News, Volume 60, Number 1). During the course of the full validation survey from 5/20/25 to 5/28/25, three patients (Patient 45, 46, 47) were reviewed for clinical nutrition care at the BHC Campus 2. None of the patients were seen by a RD for a nutrition assessment. During a review of recommendations in Frontiers in Psychiatry, titled “Nutrition Needs in Mental Healthcare: Study of a Prospective Analytic Observational Study Assessing Nutritional Status, Eating Behavior and Barriers to Healthy Eating in Psychiatric Inpatients and Outpatients Compared to Healthy Adults”, dated 6/14/22, indicated “The planning and implementation of effective nutritional interventions in mental healthcare require a valid assessment of patients’ nutritional status, challenges and needs. However, to date, no validated nutritional risk screening methods that also consider overnutrition exist for people with mental disorders (9). Similar to the somatic hospital setting (10), regular nutritional risk screening should be established in mental healthcare. However, nutritional risk screening should not only focus on the identification of undernourished or malnourished patients.” (Front Psychiatry. 2022 Jun 14;13: 906234. doi: 10.3389/fpsyt.2022.906234) a1. During a review of the clinical record for Patient 47, Patient was admitted on 5/15/25 for major depressive disorder with a physician’s diet order, dated 5/15/25, of a modified sodium diet. During an interview with the Lead RD on 5/22/25 at 3:59 p.m. regarding the clinical nutrition policy, Lead RD stated they use the same screening tool as the main hospital for the DBH Campus 2 and that will capture any weight loss or decreased appetite. Lead RD stated they do not use any other specific standard of practice for the specialized nutrition needs of that patient population. The Lead RD stated she reached out to the regional RD and the policy and procedure is based on the Academy of Nutrition and Dietetics and to meet the hospital’s length of stay. She stated the RDs only see patients at DBH Campus 2 for consult or a screen score of 2 or greater. The Lead RD confirmed they see patients at the Main Hospital Campus 1 for length of stay but not at the DBH Campus 2 and was unsure why it was different. During an interview with the Director of Patient Care Services (DPCDBH) at DBH Campus 2 on 5/23/25 at 9:12 a.m., DPCDBH stated the RDs automatically receive a list of the patient diets and look at patients that have consistent carbohydrate diets or any modified diets and will see those patients. She stated nursing does an assessment on patients and if any concerns they would notify the RD or physician. DPCDBH stated there is not any type of standard of practice resource that they use to ensure the nutritional needs of patients at the DBH campus 2 are being met. During a review from the Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), listed the nutritional indicators for Schizophrenia. It indicated “A dietary assessment indicating a probable inadequate intake of nutrients (related to inadequate intake, altered absorption, altered metabolism, or increased needs)-followed by a physical examination and observation of lesions potentially related to nutrients-are indicators of nutritional risk. These findings, followed by laboratory assessment, can validate the cause of lesions, guide treatment, and document effectiveness of treatment.” It showed a “Behavioral Health Nutrition Risk Assessment Form”. It indicated, “Patients with any high nutritional risk factors are highest priority for nutrition assessment and a nutrition care plan. Patients with moderate nutritional risk require in-depth nutrition assessment and a nutrition care plan. Screening programs recommend referral for weight management if a weight gain of 5% above baseline weight is observed.” Further review of the current standard of practice from AND NCM indicated nutritional indicators for Mood Disorders, Alcoholism and Drug Addiction. The Mood Disorders indicated nutritional indicators included some of the following: Depressed mood with significant change in appetite and intake, Persistent somatic complaints, taking one or more psychiatric medication and food Insecurity. These also indicated when a nutrition consultation was recommended. The hospital policy and procedure did not include any of the unique nutrition risk factors associated with caring for behavioral health inpatients. a2. During a review of clinical records for Patient 46, Patient 46 was admitted to BHC Campus 2 on 4/23/25 with a diagnosis of chronic paranoid schizophrenia and discharged on 5/22/25. Review of the physician’s orders dated 4/23/25 indicated Patient 46 was on a consistent carbohydrate diet (CCD-a diet used in the treatment of diabetes). Review of the meal intakes, dated 4/23/25 until 5/8/25, indicated there was sporadic documentation of how the patient was eating. Additionally, the location of nursing documentation of meal intake in the medical record was inconsistent. In some instances, it was listed under the “calorie count” section and in other instances it was listed in the “meal intake” section. During a concurrent interview with Shift Manager (SMDBH) DBH Campus 2 on 5/22/25 at 11:10 a.m., SMDBH stated the staff are supposed to document the intake of each meal in the “meal percentages” section of the medical record. During an interview with the Director of Patient Care Services (DPCDBH) at DBH Campus 2 on 5/23/25 at 9:12 a.m., DPCDBH stated the RDs automatically receive a list of the patient diets and look at patients that have consistent carbohydrate diets. The hospital was unable to demonstrate Resident 46 received the benefit of a nutritional assessment. a3. During a review of clinical record for Patient 45, Patient 45 was admitted on 5/16/25 for unspecified dependency alcohol use. History and physical dated 5/16/25, indicated history of diabetes. The patient was confined to a wheelchair. Patient 45’s physician ordered diet dated 5/16/25 was a CCD- of five carbohydrates per meal and Gatorade two times a day to hydrate . There was no documentation of a nutrition assessment despite the physician’s order of a carbohydrate consistent diet. 3b. During the course of the full validation survey from 5/20/25 to 5/28/25, one of five patient records (Patient 40) reviewed for clinical nutrition care at the Main Hospital Campus 1 had a delayed nutrition assessment. The hospital policy and procedures for nutrition assessment did not follow the current standard of practice. During a review of an article from the Academy of Nutrition and Dietetics (AND) titled “Nutrition for People with Lung Cancer” published 9/18/23, indicated “About 45% to 69% of people with lung cancer experience malnutrition, which is associated with reduced quality of life, increased symptom severity and shorter survival rates.” It also indicated “Weight loss is very common for these patients, and it can occur or be exacerbated by factors such as the location of the tumor, metastasis or treatments including surgery, radiation and chemotherapy and immunotherapy medications. RDNs work with these patients and their caretakers or families to mitigate the effect of malnutrition on their bodies, which can help them withstand long-term treatment and improve medical outcomes and quality of life.” (https://www.eatrightpro.org/news-center/practice-trends/nutrition-for-people-with-lung-cancer) Review of the face sheet (front page of the chart that contains a summary of basic information about the patient) for Patient 40, indicated Patient 40 was admitted on 5/14/25 to the hospital with a diagnosis of acute renal failure (sudden and rapid loss of kidney function, a decline in the kidneys’ ability to filter waste and maintain fluid balance). Review of the history and physical dated 5/14/25, indicated Patient 40 had a chief complaint of not feeling well, had a poor appetite and was undergoing chemotherapy treatment for advanced metastatic lung cancer. The Nutrition Screen dated 5/14/25 had a malnutrition screening tool (MST) score of 1. A score of two or greater creates an automatic trigger for a dietitian consult. Review of the Nutrition Assessment dated 5/21/25, indicated Patient 40 was currently NPO (nothing by mouth). The Registered Dietitian (RD) documented Patient 40 had a nutrition diagnosis of increased nutrient needs (protein and energy) related to increased energy expenditure as evidenced by a catabolic disease state. RD documented the patient’s estimated nutrition needs were as 2100 to 2520 calories per day and 101 to 126 grams of protein per day. RD documented a nutrition recommendation to resume diet when medically feasible and add strawberry nutrition supplement three times a day. Review of the meal intakes dated 5/15/25 to 5/21/25, indicated variable oral intakes from 25 to 100 percent (%), mostly 40-50%. Review of nutritional supplement intake from 5/14 to 5/21/25 revealed Patient 40 consumed 25% of the supplement once. The remaining documented offerings indicated 0% consumption. Review of the diet orders dated 5/14/25, indicated nutrition supplement three times a day and a regular diet. There were multiple NPO orders on 5/14, 5/15 and 5/21 after midnight. Based on the documented meal intake Patient 40’s meal intake met less than 50% of his estimated nutritional needs. During a concurrent interview with the Lead RD on 5/21/25 at 11:52 a.m., Lead RD stated they rely on nursing to trigger them to see the patient or the physician according to their policy. Lead RD stated the policy and procedure for nutrition assessment is based on a patient’s length of stay of greater than after seven days, the presence of wounds, a BMI (body mass index-a measure to determine whether a person has a healthy body weight for their height) of less than 18 or NPO/clear liquid greater than five days. Lead RD stated the policy and procedure references the eNCPT of 2017 (Academy of Nutrition and Dietetics electronic Nutrition Care Process Terminology). The Lead RD stated they do not see patients that have nutrition supplement orders since there are many patients that just will request them, and it is more of a preference and is not necessarily indicative of patients not eating well or needing them due to their nutritional status. The Lead RD stated she would ask her contract company for their other references for the policy and was not sure why they do not include diagnoses or therapeutic diet orders to bring the RD in earlier. During a review of the hospital policy and procedures titled “F&N.1.79 Nutrition Screening, Prioritization and Assessment (D003A), dated approved 5/27/20 and next review date in review, indicated an initial screening assessment and prioritization process is implemented to identify patients who may require medical nutrition therapy. It indicated the RD acts on consults using the prioritization table and if a consult is received for a criterion not in the prioritization table, the RD can complete the task without completing a nutrition assessment. The policy indicated the RD evaluates information from the following sources: consults from physicians, nurses and other healthcare professionals, multidisciplinary rounds, orders for enteral or parental nutrition or nothing by mouth or clear liquids greater than five days. It indicated that within two days, the RD will assess patients from a nursing referral for MST score of two or greater, nurse request for nutrition consult, nurse/other healthcare professional referral, OB patients with certain diagnoses, education referral, pressure injury stage II or greater, calorie count, or BMI of less than 18. It also indicated that by day seven to see patients with LOS of seven or greater. The policy did not indicate any differences that pertain to the DBH Campus 2. During a review of the Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), dated 2025, the NCM indicated to have Screening for nutrition problems other than malnutrition that included anticoagulant therapy, obesity, patients with history of heart failure, presence of edema on admission, and need for sodium-restricted diet. It also indicated, “In adults undergoing dialysis, assessments are best obtained after treatment when body fluid compartment levels are more likely to be balanced.” The NCM referenced “KDOQI Clinical Practice Guideline for Nutrition in CKD (CPG)”, dated 2020, the CPG indicated, “. . .percent change in usual body weight (dry weight in maintenance dialysis patients) may be a more reliable measure.” The hospital policy and procedure did not reflect the current standard of practice. 4. During the course of the full validation survey from 5/20/25 to 5/28/25, eight patient records (Patient 40, 41, 42, 43, 44, 45, 46, 47) were reviewed for clinical nutrition care at both campuses. During an interview and concurrent review of patient records on 5/21/25 starting at 10:24 a.m., the RD (RD 1) stated she started working at the hospital one month ago and she also wanted to include the Lead RD for the interview since she was newer. RD 1 stated the Lead RD lived out of state and was in Michigan. The Lead RD stated she has worked in a remote capacity at the hospital for two years and about two months ago became the interim clinical nutrition manager. The Lead RD stated since RDs are not at the hospital in person they are not able to do nutrition focused physical exams (NFPE) on the patients when conducting the nutrition assessments. RD 1 stated she does conduct NFPE when she does nutrition assessments on the patients. During a review of the RD schedule dated May 2025, showed there were two RDs that were located in Eastern Standard Time (EST), two that were in Central Standard Time (CST), three that were in Pacific Standard Time (PST), one of which was RD 1 who was onsite. During a review of the RD roster for the Main Hospital Campus 1, it indicated there were five RD FTEs, one of which was onsite. During a review of a document from the Interim Director of Food and Nutrition Services, it indicated 80% of the medical nutrition therapy was provided by offsite Registered Dietitians accomplished through a paper review of the electronic medical record. During a review of the RD position description dated 2017, indicated essential functions and responsibilities included “Assesses the nutritional status of neonates/ infants, pediatric, adolescent, adult and/or geriatric patient ...Uses parameters such as ...nutrition-focused physical assessment.” During a review of the Commission on Dietetic Registration, the credentialing agency for the Academy of Nutrition and Dietetics document, titled, “Revised 2024 Scope and Standards of Practice for the Registered Dietitian Nutritionist” indicated under Standard 7, Providing Person-Population-Centered Nutrition Care, the RD conducts nutrition assessment and obtains and assesses findings from nutrition-focused physical exam (NFPE). During an interview with the IDFNS on 5/22/25 at 2:49 p.m. IDFNS acknowledged they had mostly offsite RDs and they were trying to recruit and bring on more that were onsite. IDFNS stated they were bringing on another onsite RD soon.”

“COMPETENT DIETARY STAFF CFR(s): 482.28(a)(3) There must be administrative and technical personnel competent in their respective duties. This Standard is not met as evidenced by: 28773 Based on observation, staff interview, and review of hospital documents, the hospital failed to ensure two food service workers (FSW 1 and FSW 2) were competent in their job duties when incorrect portion sizes were used during a lunch meal observation on May 20, 2025, at the Main Hospital Campus 1 and May 22, 2025, at the BHC Campus 2. The combined census of both campuses was 370 on May 20,2025. This failure had the potential to result in patients being served inadequate amounts of food and the menu not being followed that can result in and affect patients’ nutritional and medical status. Findings: 1. During an observation of the lunch meal service on 5/20/25 starting at 11:45 a.m. at the Main Hospital Campus 1, FSW 1 was serving the hot menu items on the lunch meal line. There was a #16 scoop (1/4 cup, 2 ounces) in the chopped meatloaf and chopped broccoli. There was no scoop in the ground meat loaf. There was #8 scoop (1/2 cup) in the mashed potatoes. Another staff would call out what diet was needed, FSW 1 used the #16 scoop for the ground and chopped diets throughout meal service. During an observation and concurrent interview with FSW 1 on 5/20/25 at 12:27 p.m., FSW 1 stated one container was ground meatloaf, and the other was chopped meatloaf. FSW 1 confirmed she used the #16 scoop for the meatloaf on both the chopped and ground diets as well as for the chopped broccoli. During an interview with the Interim Director of Food and Nutrition Services (IDFNS) on 5/20/25 at 12:30 p.m., IDFNS stated the portions should have been a #10 scoop (3/8 cup) for both the ground and chopped meat and a #8 scoop (1/2 cup) for the chopped vegetables. During a review of the lunch menu for 5/20/25, indicated the portion size for the mechanical soft diets should have been 3 ounces of meatloaf, one (1) cup soft broccoli, and ½ cup mashed potatoes. For the ground diet, it showed 3 ounces chopped meatloaf, and ½ cup yellow squash. During a review of FSW 1 personnel file, FSW 1’s position description, indicated essential duties and responsibilities included serving and preparing using correct portioning. The hospital failed to provide any in-services or competencies related to the position duties for FSW 1. 2. During an observation of the lunch meal service at BHC Campus 2 on 5/22/25 starting at 11:29 a.m., FSW 2 was serving the hot lunch meal option to the patients. On the steam table, there were baby carrots with a slotted spoon, roasted potatoes with a slotted spoon, and Salisbury steak with tongs for serving. There was no measurement on the slotted spoons to indicate the serving size. During an interview with FSW 2 on 5/22/25 at 11:50 a.m., FSW 2 stated that he would just fill up the slotted spoons and said it is the same as the four-ounce spoodle (a kitchen utensil that combines the features of a spoon and a ladle, often used for portion control) but he just uses these spoons instead. During a review of the lunch menu for 5/22/25, indicated Salisbury steak with demi glaze, six -ounce (spatula), roasted potatoes with fresh herbs four-ounce portion, and roasted carrots ½ cup. During a review of personnel files. No personnel file or competencies could be located for FSW 2. During a review of the hospital policy and procedures, subject titled “Associate Competency Program Overview #E001”, dated revised 1/25, indicated staff are competent to perform their responsibilities. The policy indicated that periodic assessment for evaluation of Associate Competency and ongoing training and development with in-service education. During an interview with the IDFNS on 5/27/25 at 3:03 p.m., IDFNS stated they do monthly “CHAT” in-services at both campuses. IDFNS stated they do not necessarily have job competencies on the staff. During the survey the hospital was unable to demonstrate evaluation of staff competencies or in-service training in relationship to staffs’ position duties.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 28773 Based on observation, interview and record review, the facility failed to maintain a clean and sanitary environment in accordance with hospital’s policy and procedures (P&P), and the Centers for Disease Control and Prevention (CDC) standards of practice for infection control when: 1. One of two ice machines in the Postpartum patient nutrition room had yellow and brown colored liquid build-up behind the ice chute and one of two ice machines located in the kitchen at the Behavioral Health Campus (BHC) 2 had a black substance in the water trough and on the ice machine grate and was not maintained according to the hospital’s P&P titled, “Ice Machines Cleaning.” 2. Ice was found in two open plastic cups in the patient nutrition freezer in the Labor and Delivery patient nutrition room and not according to the hospital’s P&P titled, “Ice Handling.” 3. There was no monitoring of potentially hazardous foods prepared from ingredients stored at ambient (temperature of the surrounding environment) room temperature at the BHC Campus 2. 4. Food Service Worker (FSW) 2 did not restrain facial hair when serving food for the lunch meal service on May 22, 2025, at the BHC Campus 2. 5. Raw meat was stored above ready to eat food in a reach-in refrigerator at the Main Hospital Campus 1 retail area. These failures had the potential to place patients at risk for cross contamination (process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and the spread of infection. 6. The hospital failed to ensure that Gastroenterologist (DR 4 - medical doctor specializing in the digestive system and related organs) had eye protection during the entire colonoscopy procedure for Patient (Pt) 11. This failure had the potential to expose DR 4 to chemical and bodily fluids and the potential for cross contamination. 7. Pt 1’s open-heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) was performed in Operating Room (OR) 15 that had flooring with cracks. This failure had the potential to allow bacteria to harbor in the cracked and chipped surfaces leading to an increased risk of post operative infection for Pt 1. Findings: 1. During a concurrent observation and interview on 5/20/25 at 2:44 p.m. in the Postpartum patient nutrition room with the Director of the Neonatal Intensive Care Unit (NICU) and Pediatrics (DP), there was yellow and brown colored liquid build-up behind the ice chute. The DP took a dry paper towel and was able to wipe the liquid off. The liquid was sticky. The DP stated she was not sure what the liquid was. The DP stated it should not be there and could cause contamination if the ice touched it when dispensed and was given to patients. During a concurrent interview and record review on 5/28/25 at 2:13 p.m. with Environmental Services (EVS-housekeeper) 1, a picture of the ice machine in the Postpartum patient nutrition room that was taken on 5/20/25 during the initial tour of this department was reviewed. EVS 1 stated her assigned area was in Postpartum. EVS 1 stated the ice machine was dirty with the yellow and brown colored liquid. EVS 1 stated patients could get sick from a dirty ice machine. EVS 1 stated she was responsible to clean the outside of the ice machine as part of her daily duties. EVS 1 stated she did not complete a daily log for cleaning the ice machine. During an observation of the ice machine located in the kitchen at the BHC Campus 2, in the presence of the Plant Operations Technician (POT) on 5/22/25 at 10:01 a.m., there was a black substance on the side of the ice machine grate (where ice is formed) and in the water trough (where water collected and then used to make ice). The POT acknowledged the substance and stated this is cleaned by outside company and they would provide documents to show when cleaned last. No documentation was provided. During an interview on 5/30/25, at 10 a.m., with the Director of Infection Control (ICD), the ICD stated environmental services should be cleaning the ice machines daily, build up can happen on the ice machines and wet areas can accumulate microorganisms and transmit bacteria to anyone using ice from these ice machines. The ICD stated the last time he did infection control rounds at the Behavioral Health Campus 2 was in August of 2024. The ICD stated he expects the staff at both campuses to report any infection control issues to management and submit any infection control problems through their reporting system. The ICD stated this is how he gets reports and addresses the issues. The ICD stated he is the only full-time infection preventionist on site and he has one part time infection preventionist who works remotely. The ICD stated he does not feel that he has enough staff for the size of the campuses he covers but that this hospital follows the corporate model so there currently is no infection prevention position open or posted. During a review of the hospital’s P&P titled, “Ice Machines Cleaning,” dated 11/25/20, the P&P indicated, “ ... Purpose: To remove all dust, dirt & waste ice from the surfaces of the ice machine, leaving it clean and free from odors, soil, marks or smears ... Follow regulatory and manufacturer’s recommendations related to tools, logs, cleaning products & process ...” During a review of the manufacturer’s “Brand Name” instructional manual, dated 5/2001, indicated, “ ... Dispense Area Sanitation ... The dispense area; spouts, sink, grill and splash panel will need periodic cleaning and maintenance. 1. The ice chute may be pulled down to remove it from the ice dispenser. Wash and sanitize it ... Cleaning and Sanitizing ... It is the USER’S RESPONSIBILITY to see that the unit is properly maintained. It is always preferable, and less costly in the long run, to avoid possible down time by keeping it clean; adjusting it as needed ... The following is a list of recommended maintenance that will help keep the machine running with a minimum of problems. Maintenance and Cleaning should be scheduled at a minimum of twice per year. Sanitizing of the ice storage bin should be scheduled for a minimum of 4 times a year ...” 2. During a concurrent observation and interview on 5/20/25 at 11:45 a.m. in the Labor and Delivery patient nutrition room with the DP and Registered Nurse Educator (RNE) 1, two uncovered plastic cups were filled with ice in the freezer and the ice pieces were fused together. The DP stated the plastic cups filled with ice in the freezer should not be there and could cause contamination if used for patients. The DP stated she did not know what they were doing in the freezer. During an interview on 5/30/25, at 10 a.m., with the Director of Infection Control (ICD), the ICD stated ice should not be stored in open containers in the freezer. The ICD stated it puts patients at risk of cross contamination. During a review of the hospital’s P&P titled, “Ice Handling,” dated 9/22/21, the P&P indicated, “ ... POLICIES: ... Ice must be protected from splash, drip, and hand contamination during storage and service. In the event of a mechanical malfunction, ice will be transported in a clean, covered food-grade container from another machine in the facility/community or bought from an approved source ...” During a professional reference tiled, “Why the ice cubes in my ice container stick together? (WIC)”, dated 3/22/18, the “WIC” indicated, “ ... If ice cubes have not been used for a long period of time, the cubes melt into each other during the defrost cycles and stick together ...” During a professional reference titled, “Preventing Ice contamination with Safe Practices (PIC)”, dated 4/15/20, the “PIC” indicated, “ ... The FDA [Food and Drug Administration] defines ice as food ... Since ice contamination starts with the user, you need to make sure your employees are handling the ice properly ... never throw unused ice back into the ice bin. If a server accidently fills an extra glass with ice, they should toss that ice into a sink...” 3. Potentially hazardous foods (PHF) are those capable of supporting bacterial growth associated with foodborne illness. Protein based foods such as canned meat are considered to be a PHF and require time and temperature control for food safety. Similarly, PHF foods that are prepared with room temperature ingredients must also be monitored for time and temperature control (USDA Food Code, 2022). During an observation of the initial kitchen tour at BHC Campus 2 on 5/22/25 starting at 8:59 a.m., there was a container of tuna salad dated 5/22 and the temperature was 37.4 degrees Fahrenheit (F). During an interview with Food Service Worker (FSW) 2 on 5/22/25 at 11:27 a.m., FSW 2 stated that he made the tuna salad. FSW 2 stated he gets the tuna from the dry storage room and mayo either from refrigerator or dry storage room. FSW 2 stated he will make the tuna salad according to the recipe then put it in a container with a label and date. FSW 2 stated he does not check the temperature of the tuna before putting it in the refrigerator or monitor it for cooling. During an interview with Executive Chef Manager (ECM) at BHC Campus 2 on 5/22/25 at 11:56 a.m., ECM confirmed they store tuna in dry storage area and the mayo could be stored in either refrigerator or dry storage area. ECM stated they do not have a log or monitor the cooling of ambient foods. ECM further indicated that was not a policy in place at the campus. During a concurrent review of the cooling log with ECM, it indicated that there was a separate place on the log to monitor the cooldown of ambient temperature foods. The log indicated food must be cooled to 41 degrees F (Fahrenheit) or below within 4 hours. ECM acknowledged there was a spot on the log for the monitoring of ambient temperature foods. During a review of the hospital policy and procedure subject titled, “Food Handling Guidelines (HACCP)” #B007, indicated “Cooling of potentially hazardous foods prepared from room temperature ingredients: Food shall be cooled within 4 hours to 41°F if prepared from ingredients at room temperature. Use the Cooling Log form at the end of this policy to document the temperature of the food at the following times: at the end of food preparation and at 4 hours after the end of food preparation.” 4. During an observation of the lunch meal service at BHC Campus 2 on 5/22/25 starting at 11:29 a.m., FSW 2 was serving the hot lunch meal option to the patients. FSW 2 had facial hair above lip that was not restrained in the beard restraint. During an interview with the Executive Chef Manager (ECM) at BHC Campus 2 on 5/22/25 at 11:56 a.m., ECM stated the expectation is to have all facial hair covered. During an interview on 5/30/25, at 10 a.m., with the Director of Infection Control (ICD), the ICD stated he does monitor staff to make sure they are wearing appropriate personal protective equipment (PPE) properly to include covering of their facial hair. The ICD stated it is the expectation that staff wear PPE properly and it is everyone’s responsibility to check this is being done. According to the 2022 Federal Food and Drug Administration (FDA) Food Code indicates, food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food; clean equipment, utensils, and Linens; and unwrapped single-service and single-use articles. 5. During an observation of the initial kitchen tour at Main Hospital Campus 1 on 5/20/25 starting at 11:10 a.m., in the retail area, in a reach-in refrigerator there was a container of raw beef on a shelf above produce. During a concurrent interview with the Interim Director of Food and Nutrition Services (IDFNS), he confirmed raw meat should be on the bottom rack and not above produce. According to the 2022 Federal Food and Drug Administration (FDA) Food Code, indicates raw beef, poultry, and meats must be stored separately or below cooked or ready to eat foods to avoid cross contamination and potential for foodborne illness. 6. During a review of Patient (Pt) 11’s “History and Physical (H&P),” dated 5/21/25, the “H&P” indicated, Pt 11 had history of colon (large intestine) polyps (abnormal tissue growths) and was planned for Coloscopy (a procedure where a flexible, lighted tube with camera called a colonoscope is inserted into the rectum to examine the entire colon). During an observation on 5/21/25 at 10:11 a.m. in the procedure room four with the Quality Nurse (QRN) 4, Pt 11’s coloscopy procedure was observed. During the entire procedure observed Gastroenterologist (DR 4 - medical doctor specializing in the digestive system and related organs) performing the procedure did not have eye protection on. QRN 4 validated the observation and stated that she also observed that DR 4 did not have eye protection. The remainder of the entire team in the procedure room had eye protection on during the procedure. During an interview on 5/21/25 at 11:20 a.m. with the Director of surgical services (DSS) and Nursing Manager for endo (MEN) department, the DSS stated he expects everyone in the procedure assisting to have eye protection during coloscopy. The DSS stated it was normal practice to have a face shield or eye protection during coloscopy to avoid splashing into eyes.nThe DSS stated it was important to avoid risk of potential splashes or sprays of bodily fluids during the procedure. The DSS stated he was unable to comment why DR 4 did not have it during this procedure as it was a standard for her and in colonoscopy procedure. During an interview on 5/30/25, at 10 a.m., with the Director of Infection Control (ICD), the ICD stated if there is risk of bodily fluids and splashing, staff should wear splash guards to include eye protection and or face shield during these high-risk splash procedures. During a review of an article by American Society for Gastrointestinal Endoscopy (ASGE) titled “Personal protective equipment in GI endoscopy”, dated 2023, published in “iGIE Volume 2, No. 2”, retrieved from https://www.igiejournal.org/action/showPdf?pii=S2949-7086%2823%2900054-7 , the article indicated “ ... GI endoscopic procedures place operators and personnel at risk for exposure to infectious pathogens, hazardous chemicals ... research has demonstrated that bacterial exposure can occur in individuals standing as far as 6 feet beyond the endoscope insertion site ... Eye protection ... Ocular contamination by body fluids during endoscopy presents a significant risk, because of both direct splashing of aerosolized fluids and hand to eye contamination by the endoscopist ... eye protection is a critical aspect of effective PPE. Protective eyewear consists of goggles and face shields of various designs and materials. They are also regulated by OSHA standards and must be appropriate to the specific expected hazard ...” During review of Occupational Safety and Health Administration (OSHA - U.S. government agency within the Department of Labor with a primary mission to ensure that workers have safe and healthy working conditions by setting and enforcing standards, providing training and assistance, and conducting workplace inspections) regulations, retrieved from https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.133, the OSHA regulation standards indicated, “ ... 1910.133(a)(1) The employer shall ensure that each affected employee uses appropriate eye or face protection when exposed to eye or face hazards from flying particles, molten metal, liquid chemicals, acids or caustic liquids, chemical gases or vapors, or potentially injurious light radiation ...” 7. During a concurrent observation and interview on 5/22/25, at 8:55 a.m. with the Assistant Director of Nursing (ADON), in the operating room (OR 15) during Pt 1’s surgical procedure, observed the operating room flooring had multiple seams running the length of the floor. The seams were split in multiple places and there were cracks in the flooring next to the seam. The ADON stated hospital was working on a plan to replace the flooring in the OR. The ADON stated it was not acceptable and agreed it could be a potential source for infection in surgical patients. The ADON stated he was aware that OR floor should not have cracks or opening where it would be hard to clean and disinfect. During a concurrent observation and interview on 5/22/25 at 2:15 p.m. with the cardio thoracic surgeon (SUR - a specialized surgeon who performs surgery on the heart, lungs, and other organs within the chest cavity)1 that performed procedure on Pt 1, the SUR 1 was shown the cracks in the seams in Pt 1’s room. SUR 1 stated flooring was not acceptable in cardiac [heart] surgery operating room and could be source of infection in patients that are already vulnerable going through open heart surgery. SUR 1 stated Pt 1 underwent open-heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) in OR 15 and cracked flooring potentially could be a source of infection for any patients undergoing surgical procedures. During an observation on 5/22/25 at 10:37 with the ADON, OR 3 flooring was also observed to have a crack in the flooring next to seams. The ADON stated he would place the work order to get in repaired as soon as possible. The ADON stated the cracked flooring was not acceptable in the OR environment and would be fixed as soon as possible. During an interview on 5/30/25 at 8:08 a.m. with the Director of Environmental Services (DEVS), the DEVS stated his team was responsible for cleaning OR floors. The DEVS stated cracked flooring or cracked seams in the OR flooring are not acceptable and a potential source for infection. The DEVS stated there is a risk that blood and body fluids could collect in the cracks, and it would not be possible to clean and disinfect the cracked floor effectively. The DEVS stated her team had made the OR leadership team aware of the flooring condition and hospital is in the process of repairing and or replacing the flooring. During an interview on 5/30/25, at 10 a.m., with the Director of Infection Control (ICD), the ICD stated floors in the OR should be continuous with no cracks or seams so they can be cleaned and disinfected easily. The ICD stated if there are cracks and open seams, staff cannot guarantee everything is removed and cleaned properly thus leaves the risk of cross contamination and can lead to infection. During a review of the AORN publication Outpatient Surgery article, “How to Maintain a Clean OR Environment,” dated 10/10/2007, the article indicated,”...To ensure a clean environment, evaluate the environment weekly or monthly for overall cleanliness as well as general condition...Are there cracks, nicks, or grooves on the floor? If so, repair them immediately to prevent bacteria from festering in the spaces...” During a review of the Health Facilities Management article titled, “The role of maintenance in infection prevention,” dated 8/16/19, the article indicated, “...Health care-associated infections (HAI) concerns to look for include: Damaged flooring in clinical areas. Damaged flooring does not provide a smooth, cleanable surface and can result in an infection prevention concern; Peeling paint or damaged wall surface. A wall surface that is not smooth is not cleanable...””

“SURGICAL PRIVILEGES CFR(s): 482.51(a)(4) Surgical privileges must be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privileges of each practitioner. This Standard is not met as evidenced by: 49230 Based on observation, interview and record review, the hospital failed to delineate surgical privileges for all practitioners performing surgery in accordance with competencies of each practitioner outlined in the medical staff bylaws and failed to maintain a roster of practitioners specifying the surgical privileges of each practitioner when: The hospital did not have surgical program prerequisites and requirements for residents (RS - physicians who have completed medical school and are undergoing postgraduate training in a specific specialty) listed, did not have a process to validate before procedures for two of two sampled residents RS 1 and RS 2 performing surgery were competent and met the credentialing and residency program requirements. The hospital did not have active standardized procedure as required by board of registered nurses to support one of one registered nurse first assistant (RNFA) 1 performing Endoscopic Vein Harvesting (EVH -is a minimally invasive technique used during open heart surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries). These failures had the potential for increased risk of adverse events in patients requring open heart surgery as part of their physician ordered treatment plan. Findings: During a concurrent observation and interview on 5/22/25 at 8:55 a.m. with the Registered Nurse Quality (QRN) 3 and Assistant Director of Nursing Surgical Services (ADON) in operating room (OR) 15, Patient (Pt) 1’s surgical procedure was observed. Pt 1 underwent an open-heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure with three separate bypass were created during the surgery. The ADON validated and verified the staffing in the room for the entire procedure included a primary cardio thoracic surgeon (SUR -a specialized surgeon who performs surgery on the heart, lungs, and other organs within the chest cavity) 1, resident surgeon 1, Anesthesiologist (ANS - a medical doctor specializing in administering anesthesia and managing pain during medical procedures and surgeries) 1, Perfusionist (PER - healthcare professional who operates the heart-lung machine during certain surgeries, like open heart surgery, to maintain the patient’s blood flow and oxygenation while the heart is stopped) 1, Registered Nurse First Assist (RNFA -is a Registered Nurse (RN) who works in an expanded role as a surgical first assistant and is responsible for working with the surgical team, in surgery, at the direction of the surgeon) 1, two RNs working as scrub nurses (work within the sterile field, directly assisting the surgeon with instruments and supplies during the procedure) and a circulating nurse (nurse who works outside the sterile field, managing patient care, coordinating with the surgical team, and ensuring a safe environment). The ADON stated that was the normal staffing for cardiovascular surgical cases at their hospital. The ADON stated that resident surgeon was the first assisting surgeon, and they typically have RNFA or Physician Assistant (PA -licensed medical professionals who work under the supervision of a licensed physician) as second assistant surgeon in the room. The ADON stated the hospital does not normally require scheduling two surgeons for the CABG procedures as the hospital has resident surgeons working with the primary surgeons. The ADON stated as far as he was aware, the resident surgeon was okay to be in the room as first assisting surgeon under the supervision of primary board-certified cardiothoracic surgeon. The ADON was unable to comment on what a resident surgeon can and cannot do at the hospital or during the surgical procedure. The ADON also was not able to comment on what year or specialty (specific area of training) residents were and stated the OR team does not have access or any way to validate, or to check program requirements for residents (define the specific types and scope of surgical procedures they are authorized to perform at a hospital and supervision requirement). The ADON stated he would have to defer to Director of Surgical Services (DSS) regarding residents and person in charge of residency program, however, his understanding was the surgeon was responsible for overseeing the residents. RNFA 1 was observed to perform the EVH part of the procedure. The ADON stated it was normal for RNFA 1 to do EVH during CABG surgeries. The ADON stated RNFA 1 has been doing EVH part of CABG surgeries for many years at the hospital and the hospital has a standardized procedure to ensure compliance as required for RNFA to perform EVH during CABG procedures. The ADON stated the RNFAs do not document the EVH procedure as being completed by them and it was documented by the surgeons in their notes. During an interview on 5/22/25 at 10:55 a.m. with the DSS, the DSS stated he was aware of the state regulation and staffing requirement for cardiac vascular operative surgery cases. The DSS stated CABG cases must have a second physician in OR and do not require the second physician to be board certified cardiac surgeon. The DSS stated the hospital has cardiovascular surgery fifth year residents as second physician in the OR. The DSS stated the facility also has California Department of Public Health approved flex [program flexibility, which allows a hospital to temporarily deviate from specific regulatory requirements while still meeting the intent and purpose of those regulations] that allows them to staff mid-level providers [Physician assistant or RNFA] as third surgeon in cardiovascular cases requiring bypass. The DSS stated the resident surgeon’s program specific requirements were with “Hospital B” and not currently listed in their system. The DSS stated medical staff, and human resources would be able to speak about the process. The DSS stated that RNFA reports to him and the hospital have policy and standardized procedures for RNFA’s to work in the surgery. During a concurrent interview and record review on 5/22/25 at 4:37 p.m. with the DSS & Manager Accreditation and regulatory (MA) 1, Title 22 of the California Code of Regulations (CCR -is a comprehensive set of rules and regulations that govern various aspects of programs in California) section 70435 Cardiovascular Surgery Service Staff was reviewed, and the program flex document was reviewed. Title 22 CCR section 70435 indicated “ ... (b) Cardiovascular operative service. (1) A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Thoracic Surgery or the American Board of Surgery with training and experience in cardiovascular surgery. He shall be responsible for: (A) Implementing established policies and procedures. (B) Training and supervising the nurses and technicians in special techniques. (C) Training and supervising the clinical perfusionists. (2) A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass. At least one surgeon must meet the requirements outlined in subparagraph (b) (1) above ...”. The review of “APPROVAL OF PROGRAM FLEXIBILITY” by CDPH dated October 18, 2022, indicated, “ ... This letter is in response to the request submitted by [Hospital name] for program flexibility for California Code of Regulations T22 DIV5 CH1 ART6-70435(b)(2). The alternative means of compliance with T22 DIV5 CH1 ART6-70435(b)(2) include Your request for program flexibility of T22 DIV5 CH1 ART6-70435(b)(2) is approved under the following conditions: allowing appropriately credentialed and privileged physician assistants (PAs) to act as second assistants during all cardiovascular operative procedures that require extracorporeal bypass ... The use of the PA as a second assistant is at the discretion of the primary surgeon ... The facility is required to have a 3-team cardiovascular surgical team in the OR ... The primary surgeon and first assist must be independent and fully qualified surgeons. A physician assistant (PA), registered nurse first assistant (RNFA) and other qualified non-surgeon, cannot be the first assist for cardiovascular operative procedures ...” The DSS stated he was aware of the requirements set forth in CCR and conditions in the program flex. The DSS stated he was not able to comment if the RS 1 was an independent and qualified surgeon as required per CCR and flex approval conditions for first assistant to primary surgeon for CABG procedure. The DSS stated he was in charge of the surgery scheduling team [individuals responsible for coordinating all aspects of scheduling surgical procedures] and it was not standard practice at the hospital to identify first assistant in cardiac surgery cases during scheduling process. The DSS stated he was not able to comment on what criteria was used to determine that RS 1 or surgery residents were able to be scheduled as first assistant or second surgeon in the CABG. The DSS stated he would have to defer to Medical staff office for all the surgery resident requirements and would have to look into this practice. The MA 1 stated she was aware of the program flex and CCR staffing requirements and the MA 1 stated approved flex was addressed to her name. The MA 1 stated that she posted it in the lobby upon receiving the approval of program flex and shared with leadership team. The MA 1 stated she cannot comment if the hospital was in compliance with the condition set forth in the approved flex. The MA 1 stated she does not know if it was appropriate to schedule RS 1 as first assistant to the primary surgeon and as a second surgeon in the CABG case. Both MA 1 and DSS stated they both understood and were aware of the program flex authorization was to use mid-level provider as second assistant or third surgeon but they were still required to have second qualified surgeon in the room as first assist. MA 1 stated she will provide information on the person in charge of residency program or someone that can speak to residents role. During an interview on 5/22/25 at 5:35 p.m. with the Chief Nursing Officer (CNO), The CNO stated surgery residents need supervision but she was not aware who was responsible at the facility for the oversight of the residency program. The CNO agreed that surgical staff should know what residents can and cannot do while the residents are at their facility assisting with surgeries in the OR. The CNO stated she would need to follow up with her leadership team and do additional research prior to commenting on compliance with state regulations. The CNO stated she would need to find out from the medical staff office. During a concurrent interview and record review with the ADON on 5/28/25 at 9:04 a.m., the hospital policy and procedures (P&P) titled “Registered Nurse First Assistant (RNFA) Standardized Procedure” with an approval date 4/24/19 was reviewed. The P&P indicated “ ... To outline the nursing responsibilities for Registered Nurse First Assistants (RNFA) ... The RNFA must adhere to the policies and procedures of the surgical facility and must remain within the scope of practice as stated by the Nurse Practice Act of the State of California ... Saphenous Vein Harvesting: Open Heart ... Dissection ... Clamps tributaries ...Leaves pedicle or “neck” ... Ties without causing adventitial constriction of vein lumen ... Clip tributaries on leg side close to leg to avoid impinging on vein .... Cannulation with dilation ... Endoscopic ... Utilizes optical vessel dissector ... Utilizes bipolar cautery to dissect braches ... Utilizes retractor ... Ligates vein .... [Hospital Name] RN’s currently approved to function as RNFA’s under standardized procedure will be maintained by the Operating Room and on [hospital application name], the hospital intranet, which will be maintained by the Medical Staff Office. See attached list for competent operating room RNFA’s ... The initial evaluation of their competency to perform the outlined functions will be performed by the sponsoring physician at the time of their training ... The standardized procedure will be reviewed annually ....” The ADON stated this is the only standardized procedure and policy they have currently that allows RNFA to do EVH, however, policy had not been reviewed for over four years since 4/24/21. The ADON validated this policy from 2019 is what OR staff and other hospital staff would see active to verify and validate RNFA performing EVH in CABG cases. The ADON stated RNFA standardized procedure policy supposed to be reviewed annually as listed in the P&P and should have been current. The ADON stated more than half of the staff members that are listed as competent are no longer working at the hospital as RNFA. The ADON stated he had been functioning as RNFA himself in surgeries before 2019 and his name was not even on that policy. The ADON stated the policy had been in review for two years and he was unable to comment why it was not completed. During an interview on 5/28/25 at 10:38 a.m. with the RN 7, RN 7 stated she was the charge RN for heart surgeries in operating room. RN 7 stated residents works directly with the surgeon and surgeons were in charge of the resident. RN 7 stated staff in the surgery does not have access to check or review of the program requirements for residents (specific surgical procedures and conditions authorized to manage and perform at the hospital and supervision requirements). RN 7 stated as far as she was aware staff in operating room have nothing to do with residents and rely on the surgeon to supervise. RN 7 stated that surgeon was responsible to supervise and ensure that residents were doing what they were permitted to do at the hospital. RN 7 stated that RNFA privileges were not listed anywhere as well. RN 7 stated that RNFA’s go to training and management tell them if they were ok to be in surgery and able to perform EVH or other procedures. RN 7 stated the hospital only had couple of RNFA’s that assist with Cardiac surgeries and they have been assisting for more than five years. RN 7 staff know them well and if they encounter someone new then they would inquire with the management team to ensure that they were okay to be in the room. During a concurrent interview and record review with the ADON on 5/28/25 at 3:20 p.m. with the Manager of Medical Staff office (MMS), the hospital policy and procedures (P&P) titled “Registered Nurse First Assistant (RNFA) Standardized Procedure” with an approval date 4/24/19 was reviewed. The P&P indicated “ ... .... [Hospital Name] RN’s currently approved to function as RNFA’s under standardized procedure will be maintained by the Operating Room and on [hospital application name], the hospital intranet, which will be maintained by the Medical Staff Office. See attached list for competent operating room RNFA’s ...”. MMS stated she was not aware of this policy and Medical Staff office have nothing to do with RNFA. MMS stated currently medical staff office does not list RNFA’s in their software as outline in the policy, have no oversite of the RNFA and were not involved in the process of ensuring competency, compliance or evaluation processes for RNFA. MMS stated the hospital leadership was working on identifying the person in charge of residency program and the new residents go through human resources. MMS validated that currently program requirements for residents were not listed their software for operating room staff to check and validate. During an interview on 5/29/25 at 8:45 a.m. with MA 1, MA 1 stated she was still unable to find the person in charge of residency program at the hospital. A request was made again to provide information on the person in-charge of the residency program, requested MA 1 to provide information on last time someone from sponsoring institution attended the hospital Medical Staff meeting or if the hospital had any meeting minutes that reflects attendance as required by Medial Staff Bylaws. Training protocols approved by DMC Med staff or any record of trainee evaluations for cardiac surgery residents as required by the hospital Medial Staff Bylaws was also requested and not provided. During a concurrent interview and record review on 5/29/25 at 3:30 p.m. with RN 5 and ADON, Pt 2’s EMR was reviewed. RN 5 stated she was in the OR for Pt 2’s surgery and was responsible for documenting the times staff were entering and exiting the OR during the surgery. RN 5 stated she does not recall Pt 2 specifics, but she always documented exact times. RN 5 reviewed the EMR and Pt 2’s “OR Intraoperative record” and stated that Pt 2’s record reflects that RS 2 was in the room from 7:45 a.m. to 8:15 a.m., surgery start time was 8:13 a.m. RN 5 validated that EMR reflects she was the one that documented times for RS 2. RN 5 stated that she was unable to comment on cardiovascular surgery staffing requirements, however, she was not aware that second surgeon [first assistant] had to be in the operating room at all times. RN 5 stated that as long as someone [another surgeon] was available she thought it was okay to proceed with the surgical procedure. RN 5 stated currently she was not aware of any way for staff to look up and check program requirements for any residents in the OR. RN 5 stated that program requirements for residents are not listed in the hospital system like surgeons. RN 5 stated currently staff were not checking what residents were allowed to do and does not verify any privileges or credentials while they were operating. RN 5 stated RNFA follows Association of Peri-Operative Registered Nurses (AORN) standards and she believes she can look up AORN standards. RN 5 stated the she was not aware if the hospital had any list of RNFAs that were deemed competent and management usually tells them what they are competent to do. RN 5 stated she does not have a way to validate their [RNFA] privileges, competency or what the RNFA were able to perform during CABG. During a concurrent interview and record review on 5/29/25 at 3:53 p.m. with the ADON, document titled “THE RN AS FIRST ASSISTANT TO THE SURGEON” retrieved from California Board of Registered Nursing (BRN) from https://www.rn.ca.gov/pdfs/regulations/npr-b-18.pdf, indicated “ ... The role of RN first assistant to the surgeon requires the performance of a combination of nursing and medical functions ... In order to perform those functions considered to be first assistant to the surgeon, the RN must adhere to standardized procedures ... STANDARDIZED PROCEDURES FOR MEDICAL FUNCTIONS ... The means designated to authorize performance of a medical function by a registered nurse is a standardized procedure developed through collaboration among registered nurses, physicians and administrator in either a licensed health facility or an organized health care system which is a licensed health facility where the standardized procedures are to be used ... GUIDELINES FOR DEVELOPING STANDARDIZED PROCEDURES ... must be developed according to the following guidelines which were jointly promulgated by the Board of Registered Nursing and the Medical Board of California. (Board of Registered Nursing, Title 16, California Code of Regulations (CCR) Section 1474; Medical Board of California, Title 16 CCR Section 1379.) ... Standardized procedures shall include a written description of the method used in developing and approving them and any revision there of ... Each standardized procedure shall ... Be in writing, dated and signed by the organized health care system personnel authorized to approve it ... Specify which standardized procedure functions registered nurses may perform and under what circumstances ... NPR-B-18 THE RN AS FIRST ASSISTANT TO THE SURGEON REV 05/1998, 06/16/2011 2 ... State any specific requirements which are to be followed by registered nurses in performing particular standardized procedure functions ... Specify any experience, training and/or education requirements for performance of standardized procedure functions ... Establish a method for initial and continuing evaluation of the competence of those registered nurses authorized to perform standardized procedure functions ... Provide for a method of maintaining a written record of those persons authorized to perform standardized procedure functions ... Specify the scope of supervision required for performance of standardized procedure functions, for example, telephone contact with the physician ... Set forth any specialized circumstances under which the registered nurse is to immediately communicate with a patient’s physician concerning the patient’s condition ... State the limitations on settings, if any, in which standardized procedure functions may be performed ... Specify patient record-keeping requirements ... Provide for a method of periodic review of the standardized procedures ...” The ADON stated he was aware of the BRN statement on the role of the RNFA and the hospital policy was developed to meet the requirements. The ADON stated he also understood that the hospital needs to have standardized procedures, and staff need to be able to have method of checking and validating RNFA’s ability to perform EVH or other part of surgical procedure. The ADON stated currently the standardized procedure policy needed to be reviewed and updated to meet the BRN requirements. The ADON stated he still was not able to comment on the RS and was waiting to hear from leadership. The ADON stated the human resource department or medical staff was responsible for resident’s requirements. During an interview on 5/30/25 at 4:35 p.m. with the CNO, the CNO stated no one at this time can speak about the residency program. The CNO stated that they have identified the person in-charge of the residency program, however, they are waiting on confirmation from leadership team. The CNO also stated the hospital does not currently have any evaluation for surgery residents to provide and it was being conducted by “Hospital B”, sponsoring hospital for the residents. The CNO stated she was unable to comment on the training protocol or provide any information on designee from the sponsoring institution that communicates or attends Medical Executive Committee [group of physicians and other key medical staff within a hospital or healthcare organization responsible for making decisions related to patient care, clinical policies, and physician performance] meeting. During a concurrent interview and record review on 5/30/25 with the DSS & MA 1, OR case logs [systematic record of individual patient cases] for month of March 2025, April 2025 and May 2025 were reviewed for the cardiovascular surgeries. The review of OR case logs for the whole month of March 2025 indicated total of 22 open heart surgeries were done, and out of 22 cases 15 cases had resident surgeon as first assistant (second surgeon), two cases did not have any second surgeon that was a physician or resident. Out of 22 cases in March 2025 , five cases did have second surgeon that was independent and qualified surgeon, however, three of those cases second surgeon was only in the room for less than 10 minutes. A review of April 2025 case log for cardiac surgeries indicated a total of 28 open heart surgeries were done at the hospital. Out of the 28 cases, 17 cases had a resident as first assistant (second surgeon), and two cases did not have any second surgeon that was a physician or resident. Out of 28 cases, nine cases did have second independent and qualified surgeon, however, six out of eight cases, that surgeon was in the room for ten or less minutes. The DSS and MA 1 both stated that this reported data was accurate and DQ validated it by countin manually. The DSS stated the hospital team did not have a good understanding of the approved program flex and were not compliant with the conditions of approved program flex and requirement for cardiac surgery staffing under CCR. The DSS stated he now understands the CCR requirement and approved program flex. The DSS stated effective 5/23/25 changes have been put in place to ensure second independent and qualified surgeon would be present during all open -heart surgeries. The DSS stated going forward the second surgeon would be scheduled, and the OR team would be able to validate and confirm presence of independent and qualified second surgeon [first assistant] prior to patient’s surgery. The DSS stated he still will be working with the division chief for expectations for residents. The DSS stated he will also be working with medical staff and hospital leadership to figure out the best way to validate what the operating room staff and residents can or cannot do. During the review of hospital’s current “MEDICAL STAFF BY LAWS” indicated, “ ... ARTICLE 12: GRADUATE MEDICAL EDUCATION ... 12.1 As [Hospital name] acts as a training site for undergraduate and graduate medical education, the Medical Executive Committee shall receive input from and provide updates for representatives from the Sponsoring Institutions (SI). The Designated Institutional Official of the SI, as well as the Program Director of each residency program shall be invited to attend the Medical Executive Committee Meeting as non-voting members. 12.2 One or more members of the [Hospital name] medical staff leadership, usually the Chief of Staff or the Chief Medical Officer, shall attend the Sponsoring Institution’s Graduate Medical Education Committee Meeting as the representative of [Hospital name] as training site ...” During a review of hospital’s current “MEDICAL STAFF RULES AND REGULATIONS” , the “MEDICAL STAFF RULES AND REGULATIONS” indicated “ ...PHYSICIAN TRAINEES Physician trainee positions entail the provision of patient care services commensurate with the trainee’s level of advancement and competence, as defined in the training program protocols approved by the Medical Executive Committee and Governing Body. The training programs shall maintain a record of trainee evaluations and shall utilize such evaluations for determining the trainee’s progression within the training program. The physician trainee categories are as follows ....A Resident Physician enrolled in a residency training program approved by the Medical Executive Committee and the Governing Body may be permitted to provide patient care services at the Hospital pursuant to the conditions stated in these Bylaws, Rules and Regulations, the rules and regulations of the Department(s) to which residents are assigned, and any agreements between the Hospital and the residency training program. Resident Physicians can make medical notations in patient charts, conduct examinations, write or give verbal orders for patient care, perform procedures, under the supervision of their clinical instructor ...””

“OPERATIVE REPORT CFR(s): 482.51(b)(6) An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. This Standard is not met as evidenced by: 49230 Based on observation, interview and record review, the hospital failed to ensure that operative reports included description of the significant surgical tasks that were conducted by practitioners other than the primary surgeon when: Two of two sampled patients, Patient (Pt) 1 and Pt 2 underwent open heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure and Endoscopic Vein Harvesting ( EVH -is a minimally invasive technique used during CABG surgery to harvest the greater saphenous vein (GSV - longest vein in the human body, running from the foot to the thigh) for use as a conduit to bypass blocked coronary arteries) part of the procedure was completed by the assistant and their operative report did not describe the EVH portion of the procedure was completed by a practitioner other than the primary surgeon. This failure had the potential for adverse effects in patient well-being and lack of patient’s understanding of risk associated with surgery. Findings: During a concurrent observation and interview on 5/22/25 at 8:55 a.m. with the Registered Nurse Quality (QRN) 3 & Assistant Director of Nursing Surgical Services (ADON) in operating room (OR) 15, Patient (Pt) 1 surgical procedure was observed. Pt 1 underwent open heart surgical procedure Coronary Artery Bypass Graft (CABG -is a surgical procedure to bypass blockages in the coronary arteries, blood vessels that supply the heart muscle with oxygen-rich blood, enabling it to function properly and restoring blood flow to the heart) procedure with three separate bypass were created during the surgery. The ADON validated and verified the staffing in the room for the entire procedure included primary cardio thoracic surgeon (SUR -a specialized surgeon who performs surgery on the heart, lungs, and other organs within the chest cavity) 1, resident surgeon (RS -a physician who has completed medical school and is undergoing supervised training in a specific surgical specialty to become a board-certified surgeon ) 1, Anesthesiologist (ANS - a medical doctor specializing in administering anesthesia and managing pain during medical procedures and surgeries)1, Perfusionist (PER - healthcare professional who operates the heart-lung machine during certain surgeries, like open heart surgery, to maintain the patient’s blood flow and oxygenation while the heart is stopped) 1, Registered Nurse First Assist (RNFA -is a registered nurse (RN) who works in an expanded role as a surgical first assistant and are responsible for working with the surgical team, in surgery, at the direction of the surgeon)1, two RNs working as scrub nurses (works within the sterile field, directly assisting the surgeon with instruments and supplies during the procedure) and circulating nurse (nurse works outside the sterile field, managing patient care, coordinating with the surgical team, and ensuring a safe environment). RNFA 1 was observed to perform EVH part of the procedure. The ADON stated it was normal for RNFA 1 to do EVH during CABG surgeries. The ADON stated RNFA 1 has been doing EVH part of CABG surgeries for many years and the hospital has a standardized procedure to ensure compliance as required for RNFA to perform EVH during CABG procedures. The ADON stated the RNFAs do not document the EVH procedure and it was documented by the surgeons in their notes. During a concurrent interview and record review on 5/30/25 at 10:25 a.m. with the Manager of Accreditation and Regulatory (MA) 2, Pt 1’s “Operative note” for surgery on date 5/22/25 by cardiac thoracic surgeon (SUR) 1 was reviewed. The review of the “Operative note” for surgery on 5/22/25 indicated “ ... NAME OF OPERATION: Coronary artery bypass graft x 3, left internal mammary to left anterior descending artery [A blood vessel from the chest was used to bypass the blocked artery supplying the heart’s front wall], saphenous vein graft ...[ veins from the leg (saphenous veins) were used as bypass grafts] ... Endoscopic venous harvesting [The veins used for the bypass grafts were taken from the legs using a minimally invasive technique with a small camera and tools] ... “ The MA validated the operative report does not state specific significant surgical tasks that were conducted by practitioners other than the primary surgeon. The MA stated that the operative note does mention EVH was done but does not state it was completed by RNFA 1. The MA 2 stated she was unable to comment on the expectations or requirements for operative report and would have to defer to surgery director for any comments. During an interview on 5/29/20 at 3:50 p.m. with the ADON, the ADON stated he had the chance to review Pt 1 and Pt 2’s operative reports and reports of other cardiac surgery patients. The ADON stated none of the patients’ operative notes specifically indicate that EVH was completed by RNFA. The ADON stated all of the operative reports have RNFA listed as assistant to the surgeon. The ADON also stated that the technique of EVH was mentioned in the report, however, it does not specifically state that it was completed by RNFA or any specific part of the surgical procedure was completed by the assistants to the surgeons rather than primary surgeon. The ADON stated he was not aware of any requirements for documentation for the assisting surgeon. During a concurrent interview and record review on 6/2/25 at 10:34 a.m. with the Director of Surgical Services (DSS) state operations manual [outlines the specific requirements hospitals must meet to be eligible for Medicare and Medicaid reimbursement], “Appendix A - Survey Protocol, Regulations and Interpretive guidelines for hospital” with an issue date of 4/19/24 was reviewed. The surgical services condition of participation A-0959 was reviewed. The DSS stated he has reviewed the operative report for Pt 1 and Pt 2 and agreed that their operative report does not indicate significant surgical tasks were completed by practitioners other than primary surgeon. The DSS stated although surgical report lists the details of procedures, it does not specifically state which part was done by the assistant. The DSS stated he will inform the chief of surgery about the requirements for operative reports. The DSS stated as far he was aware currently none of the cardiac surgery operative notes indicate that EVH was done by RNFA and agreed that EVH is a significant part of the CABG surgery.”

“DIRECTOR OF RESPIRATORY SERVICES CFR(s): 482.57(a)(1) There must be a director of respiratory care services who is a doctor of medicine or osteopathy with the knowledge, experience and capabilities to supervise and administer the service properly. The director may serve on either a full-time or part-time basis. This Standard is not met as evidenced by: 49230 Based on interview and record review, the Medical Director of Respiratory care failed to ensure procedures performed by Respiratory Therapists (RT) and the amount of supervision required to carry out the procedures by RTs were designated in writing involving three of three Respiratory Therapists (RT 1, RT 2 and RT 3). RT 1 and RT 2 were permitted to perform Arterial line placement and RT 1 and RT 3 were permitted to perform intubation on patients without written policies and procedures and without written policies specifying how the procedures would be supervised. The Medical Director of Respiratory Services was aware of this practice and did not submit to the Medical Staff proposed policies and procedures for approval specifying the qualifications, training, experience and supervision requirements of RTs to perform A-lines and intubation on patients. These failures had the potential for increased risk of complications in patients with insertion of A-line and intubation performed by RT. Findings: During an interview on 5/29/25 at 10:59 a.m. with the Manager for Respiratory Therapy (MRT), the MRT stated the respiratory therapist (RT) at the hospital insert Arterial lines in the Intensive Care Unit (ICU - specialized hospital unit for patients with life-threatening conditions that need specialized medical care and interventions) routinely. MRT stated they have a module (a structured, self-contained unit of instruction designed to help learners acquire specific competencies or skills) for A-line insertion procedure training for RTs. MRT stated RTs were required to complete the module, perform three supervised A-line insertion procedures initially and then have to insert one A-line yearly to remain competent in performing the procedure. MRT stated staff can sign each other off on performing the A-line insertion procedure. MRT stated the hospital does not have a policy or criteria that has been reviewed and approved by medical staff on the requirements for supervision, training and competency on the procedure of inserting A-line. MRT stated his medical director (DR 5) for respiratory therapy was aware of the requirements, sign offs required for RT’s to insert an A-line and was ok with RT inserting A-lines in ICU. The MRT stated the hospital or the department does not have any formal A-line insertion procedure policy. MRT stated he was not aware of any adverse outcomes or complications in patients when RTs inserted A- lines. MRT stated DR 5 signs off the competency for A-line insertion but does not supervise them performing the procedure and does not evaluate their technique for performing the procedure. MRT stated the hospital use [Brand name] clinical evidence-based references for the procedure and validated that it does not list training, qualification or supervision requirement for the RT performing the procedure. During an interview on 5/29/25 at 1:52 p.m. with the Director of Critical Care (ICUD), the ICUD stated he was in charge of ICU. ICUD stated that A-line insertion procedure was invasive and had the potential for complications. ICUD stated that he was unable to comment on the process of training and competency requirements of RT. ICUD stated that he expected the hospital to have a policy and procedure for A-line insertion and supervision requirements. ICUD stated he was unable to comment if one A-line insertion per year was sufficient to be competent. During a phone interview on 5/30/25 at 9:54 a.m. with DR 5, DR 5 stated she was the medical director for RT team. DR 5 stated she was aware that the A-line insertion procedures were being performed by the RT team in ICU. DR 5 stated she was ok with RT performing these procedures. DR 5 stated hospital did not have any policy outlining the procedures and requirements for supervision and training for RTs performing these procedures. DR 5 stated she was made aware earlier by MRT regarding the need for A-line policy. DR 5 stated that hospital needed to work on the policy and add the requirement for more than one A-line insertion performed annually to remain competent. DR 5 stated A-line insertions had the potential to cause complication and she expected only competent RTs to perform the procedure. DR 5 stated she was not aware of any complications in patients from A- line insertion procedure performed by RTs. During a review of document titled “DIRECTORSHIP AGREEMENT” with an effective date of 10/2/23, the “DIRECTORSHIP AGREEMENT” indicated “ ... Director is a physician duly licensed to practice medicine in the State of California (“State”) and is qualified in the specialty of Respiratory (“Specialty”) ... Director shall perform the Services required hereunder in accordance with: (1) all applicable federal, state, and local laws, rules and regulations; (2) all applicable standards of The Joint Commission and any other relevant accrediting organizations; and (3) all applicable bylaws, rules, regulations, procedures, and policies of Hospital and its medical staff; such bylaws, rules, regulations, procedures, and policies shall include, without limitation, those relating to timely completion of medical records ... DESCRIPTION OF DUTIES AND RESPONSIBILITIES ... At least annually, review and make recommendations as necessary to revise the Unit/Service’s policies and procedures ... Assist the appropriate Medical Staff Committee in reviewing and revising Medical Staff Rules and Regulations which pertain to the Unit/Service ... Respiratory Care Department ... Provide medical oversight to technical department personnel in the inpatient, ambulatory care and home care settings ... Oversee medical compliance with department policies ... Oversee monitoring and evaluation of quality, safety and propriety and follow-up services ... Assist the appropriate Medical Staff Committee in reviewing and revising Medical Staff Rules and Regulations which pertain to the Department ...” During a concurrent interview and record review with the MRT on 6/2/25 at 12:21 p.m. RT 1 and RT 2’s competencies were reviewed. RT 1 and RT 2 both had signed competency for A-line insertion. MRT stated that he had already reached out to DR 5 and would be updating the requirement for supervising the RT for A-line competency, minimum required procedures performed annually. MRT stated the plan is to get the policy formally approved with hospital medical staff as soon as possible. MRT also stated the hospital currently have two RTs (RT 1 and RT 3) performing intubation and the hospital does not have any policy for RTs intubating adult patients. MRT stated they have policy for neonatal intubation and he would be working on intubation policy for adult patients. MRT stated he agreed that a criteria needed to be defined and approved by medical staff for RT performing invasive procedures. MRT stated that although DR 5 was aware and verbally approved the competencies, training and criteria for A-line insertion and intubation, the hospital does not have any formal policy outlining the education, training, criteria, or supervisor requirements for RTs to perform invasive procedures of A-line insertion and intubation. During a review of statement on the Scope of Practice for respiratory therapist by Respiratory board of California, retrieved on 6/10/25 from https://www.rcb.ca.gov/licensees/scope_of_practice.shtml#:~:text=Can%20respiratory%20care%20practitioners%20place,a%20licensed%20respiratory%20care%20practitioner. The RT Scope of Practice indicated , “ ... insertion of arterial lines is within the scope of practice of a licensed respiratory care practitioner. That being said, the onus is on the licensed health facility employing the respiratory care practitioner to develop appropriate training and competencies that would ensure this function is provided in a manner that would be safe when administered to the public ...” During a review of professional reference titled “ Arterial Lines”, dated March 23, 2025, retrieved from “https://www.ncbi.nlm.nih.gov/books/NBK499989/“, the professional reference indicated, “ ... The incidence of complications in arterial catheterization among adult patients typically falls within 10% to 13%, with variations depending on the placement site ... Clinical Significance ... Arterial line placement and monitoring represent widely accepted standards of care for patients who are critically ill .... Despite these advantages, arterial catheterization has risks, including potential complications such as catheter-related infections and a chance of distal blood flow compromise. Moreover, the landscape of hemodynamic monitoring has evolved, introducing alternative techniques that have led to a decreased frequency of arterial catheterization. Consequently, the routine placement of arterial catheters in managing critically ill pediatric patients should be approached with caution and not considered standard practice ...” During a review of professional reference titled “Tracheal intubation in the ICU: Life saving or life threatening?”, dated 2011, retrieved from “https://pmc.ncbi.nlm.nih.gov/articles/PMC3237146/“, the professional reference indicated “ ... Tracheal intubation (TI) is a routine procedure in the intensive care unit (ICU), and is often life saving. However, life-threatening complications occur in a significant proportion of procedures, making TI perhaps one the most common but underappreciated airway emergencies in the ICU ... TI can be an acute airway emergency in itself. Unstable haemodynamics and failing oxygenation during emergency intubations can be life-threatening. Delaying securing airway or awaking the patient is not an option in case of difficulty in the ICU. Intubation failure or predicted difficulty should lead to alternatives such as NIPPV or tracheostomy. TI performed or supervised by experienced doctors is associated with fewer complications. Familiarity with rescue airway techniques is helpful. Developing standardized evidence-based protocols is the need of the hour for airway management in the ICU environment. Hence, implementation of an intubation care bundle along with a pre-planned approach to difficult airway is essential for safe TI in the ICU ...””

“RESPIRATORY CARE PERSONNEL POLICIES CFR(s): 482.57(b)(1) Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures must be designated in writing. This Standard is not met as evidenced by: 49230 Based on interviews and record review, the hospital failed to ensure procedures performed by Respiratory Therapists (RT) and the amount of supervision required to carry out the procedures by RTs were designated in writing involving three of three Respiratory Therapists (RT 1, RT 2 and RT 3). RT 1 and RT 2 were permitted to perform Arterial line placement and RT 1 and RT 3 were permitted to perform intrubaiton on patients without written policies and procedures and without written policies specifiying how the procedures would be supervised. The Medical Director of Respiratory Services was aware of this practice and did not submit to the Medical Staff proposed policies and procedures for approval specifying the qualifications, training, experience and supervision requirements of RTs to perform A-lines and intubation on patients. RTs performing A-lines and intubations on patients. performed by Respiratory Therapists have written policies that specified qualifications, training, experience and supervision requirements for three of three Respiratory Therapists (RT 1, RT 2, and RT 3) when RT1 and RT 2 were allowed to perform Arterial line (A-line- thin, flexible tube (catheter) that is inserted into an artery and used to continuously monitor blood pressure and take blood samples) insertion procedure and RT 1 and RT 3 were allowed to perform intubation (medical procedure where a breathing tube, called an endotracheal tube, is inserted into the windpipe (trachea) to help a person breathe when they are unable to do so on their own or when it’s necessary to deliver oxygen and/or medication ). These failures had the potential for increased risk of complications in patients with insertion of A-line and intubation performed by RT. Findings: During an interview on 5/29/25 at 10:59 a.m. with the Manager for Respiratory Therapy (MRT), the MRT stated the respiratory therapist (RT) at the hospital insert Arterial lines in the Intensive Care Unit (ICU - specialized hospital unit for patients with life-threatening conditions that need specialized medical care and interventions) routinely. MRT stated they have a module (a structured, self-contained unit of instruction designed to help learners acquire specific competencies or skills) for A-line insertion procedure training for RTs. MRT stated RTs were required to complete the module, perform three supervised A-line insertion procedures initially and then have to insert one A-line yearly to remain competent in performing the procedure. MRT stated staff can sign each other off on performing the A-line insertion procedure. MRT stated the hospital does not have a policy or criteria that has been reviewed and approved by medical staff on the requirements for supervision, training and competency on the procedure of inserting A-line. MRT stated his medical director (DR 5) for respiratory therapy was aware of the requirements, sign offs required for RT’s to insert an A-line and was ok with RT inserting A-lines in ICU. The MRT stated the hospital or the department does not have any formal A-line insertion procedure policy. MRT stated he was not aware of any adverse outcomes or complications in patients when RTs inserted A- lines. MRT stated DR 5 signs off the competency for A-line insertion but does not supervise them performing the procedure and does not evaluate their technique for performing the procedure. MRT stated the hospital use [Brand name] clinical evidence based references for the procedure and validated that it does not list training, qualification or supervision requirement for the RT performing the procedure. During an interview on 5/29/25 at 1:52 p.m. with the Director of Critical Care (ICUD), the ICUD stated he was in charge of ICU. ICUD stated that A-line insertion procedure was invasive and had the potential for complications. ICUD stated that he was unable to comment on the process of training and competency requirements of RT. ICUD stated that he expected the hospital to have a policy and procedure for A-line insertion and supervision requirements. ICUD stated he was unable to comment if one A-line insertion per year was sufficient to be competent. During a phone interview on 5/30/25 at 9:54 a.m. with DR 5, DR 5 stated she was the medical director for RT team. DR 5 stated she was aware that the A-line insertion procedures were being performed by the RT team in ICU. DR 5 stated she was ok with RT performing these procedures. DR 5 stated hospital did not have any policy outlining the procedures and requirements for supervision and training for RTs performing these procedures. DR 5 stated she was made aware earlier by MRT regarding the need for A-line policy. DR 5 stated that hospital needed to work on the policy and add the requirement for more than one A-line insertion performed annually to remain competent. DR 5 stated A-line insertions had the potential to cause complication and she expected only competent RTs to perform the procedure. DR 5 stated she was not aware of any complications in patients from A- line insertion procedure performed by RTs. During a concurrent interview and record review with the MRT on 6/2/25 at 12:21 p.m. RT 1 and RT 2’s competencies were reviewed. RT 1 and RT 2 both had signed competency for A-line insertion. MRT stated that he had already reached out to DR 5 and would be updating the requirement for supervising the RT for A-line competency, minimum required procedures performed annually. MRT stated the plan is to get the policy formally approved with hospital medical staff as soon as possible. MRT also stated the hospital currently have two RTs (RT 1 and RT 3) performing intubation and the hospital does not have any policy for RTs intubating adult patients. MRT stated they have policy for neonatal intubation and he would be working on intubation policy for adult patients. MRT stated he agreed that a criteria needed to be defined and approved by medical staff for RT performing invasive procedures. MRT stated that although DR 5 was aware and verbally approved the competencies, training and criteria for A-line insertion and intubation, the hospital does not have any formal policy outlining the education, training, criteria, or supervisor requirements for RTs to perform invasive procedures of A-line insertion and intubation. During a review of statement on the Scope of Practice for respiratory therapist by Respiratory board of California, retrieved on 6/10/25 from https://www.rcb.ca.gov/licensees/scope_of_practice.shtml#:~:text=Can%20respiratory%20care%20practitioners%20place,a%20licensed%20respiratory%20care%20practitioner. The RT Scope of Practice indicated , “ ... insertion of arterial lines is within the scope of practice of a licensed respiratory care practitioner. That being said, the onus is on the licensed health facility employing the respiratory care practitioner to develop appropriate training and competencies that would ensure this function is provided in a manner that would be safe when administered to the public ...” During a review of professional reference titled “ Arterial Lines”, dated March 23, 2025, retrieved from https://www.ncbi.nlm.nih.gov/books/NBK499989/, the professional reference indicated, “ ... The incidence of complications in arterial catheterization among adult patients typically falls within 10% to 13%, with variations depending on the placement site ... Clinical Significance ... Arterial line placement and monitoring represent widely accepted standards of care for patients who are critically ill .... Despite these advantages, arterial catheterization has risks, including potential complications such as catheter-related infections and a chance of distal blood flow compromise. Moreover, the landscape of hemodynamic monitoring has evolved, introducing alternative techniques that have led to a decreased frequency of arterial catheterization. Consequently, the routine placement of arterial catheters in managing critically ill pediatric patients should be approached with caution and not considered standard practice ...””

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 45977 Based on observation, interview, and record review, the hospital failed to comply with the regulatory requirements for EMTALA for one of 21 patients, when: The hospital failed to provide an appropriate medical screening examination (MSE- an assessment performed by Qualified Medical Personnel [QMP] for the purpose of determining whether an emergency medical condition [EMC] exists) within the capability of the hospital’s emergency department (ED) for one of 21 patients (Patient (Pt) 1) when Pt 1 was brought in by caretaker on 12/9/24 at 3:45 p.m. with chief complaint of increasing severity of abdominal pain for four days and not eating except for popcorn. Pt 1 was known to have a genetic intellectual disability and was triaged with an Emergency Severity Index (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 is the most serious, in order to prioritize care) of 3. Physician Assistant (PA) did not begin an evaluation until 7:06 p.m. (over 3 hours from first triaged) and did not conduct a physical examination of the abdomen, the source of the chief complaint. PA ordered a urine test and blood laboratory tests. Two hours later at 9:08 p.m., Medical Doctor (MD) 1 examined Pt 1 and immediately recognized the probable EMC and ordered a CT which indicated sigmoid volvulus (twisted colon). At 10:39 p.m. patient was intubated and put on a mechanical ventilator. On 12/10/22 at 2:20 a.m. (almost 11 hours after first being seen), patient was emergently taken to OR for Left sigmoid colectomy (removal of colon) and on 12/12/22, a right hemicolectomy (removal of colon) was done. These failures resulted in the PA not conducting a physical examination of the abdomen, delay in recognizing the emergent nature of symptoms and could have contributed to delay in surgical intervention and outcome of Pt 1. The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 45977 Based on interview and record review, the hospital failed to provide an appropriate medical screening examination (MSE- an assessment performed by Qualified Medical Personnel [QMP] for the purpose of determining whether an emergency medical condition [EMC] exists) within the capability of the hospital’s emergency department (ED) for one of 21 patients (Patient (Pt) 1) when Pt 1 was brought in by caretaker on 12/9/24 at 3:45 p.m. with chief complaint of increasing severity of abdominal pain for four days and not eating except for popcorn. Pt 1 was known to have a genetic intellectual disability and was triaged with an Emergency Severity Index (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 is the most serious, in order to prioritize care) of 3. Physician Assistant (PA) did not begin an evaluation until 7:06 p.m. (over 3 hours from first triaged) and did not conduct a physical examination of the abdomen, the source of the chief complaint. PA ordered a urine test and blood laboratory tests. Two hours later at 9:08 p.m., Medical Doctor (MD) 1 examined Pt 1 and immediately recognized the probable EMC and ordered a CT which indicated sigmoid volvulus (twisted colon). At 10:39 p.m. patient was intubated and put on a mechanical ventilator. On 12/10/22 at 2:20 a.m. (almost 11 hours after first being seen), patient was emergently taken to OR for Left sigmoid colectomy (removal of colon) and on 12/12/22, a right hemicolectomy (removal of colon) was done. These failures resulted in the PA not conducting a physical examination of the abdomen, delay in recognizing the emergent nature of symptoms and could have contributed to delay in surgical intervention and outcome of Pt 1. Findings During a concurrent interview and record review on 2/11/25, at 10:40 a.m., with the Emergency Department Director (EDD) and RN Shift Manager of ED (SM 1), Pt 1’s “Electronic Medical Record [EMR],” dated 12/9/22 was reviewed. The triage form indicated Pt 1 was triaged at 3:45 p.m. and assigned an ESI Level of 3. EDD stated, the nurse who triaged Pt 1 no longer works at the hospital. Review of the document “ED Note-Physician,” dated 12/9/22, at 7:06 p.m. by PA 1, indicated Pt 1 was seen by PA 1 at 7:06 p.m. The note indicated, “ ...Chief Complaint: Cough and n[nausea]/v[vomiting]/diarrhea x[for] 4 days ... 55-year-old male with some sort of developmental disorder brought in by caregiver today with complaints of nausea, vomiting, diarrhea and some lower abdominal pain that began earlier this afternoon. Caregiver states the symptoms started after eating some popcorn at the movie theater earlier today. He endorses 3 episodes of vomit thus far. Caregiver has attempted to administer some medications, but patient has been unable to take them without wanting to vomit ...” The ED Physician’s Note indicated Pt 1 had a past medical history, “Developmental disorder (Patient Stated)”. The ED Physician’s Note indicated, “Physical Exam: ... General: Alert, no acute distress. Head: normocephalic/atraumatic [normal head with no signs of injury] Eyes: EOMI [Normal eye movement] Respiratory: Respirations are non-labored Psychiatric: Cooperative. ... “ No physical exam of the abdomen was indicated. Review of the document “ED Note-Physician,” dated 12/9/22, at 9:08 p.m. by MD 2, indicated Pt 1 was seen by MD 2 at 7:06 p.m. The note indicated, Pt 1 “ ... with hx [history] developmental disorder, presents with cough, nausea, vomiting, and diarrhea x 4 days.” MD 2 performed a physical exam including the abdomen. The note indicated, “His initial exam demonstrated abdominal discomfort and some distention without rebound or other peritoneal signs. CT [scan] of the abdomen and pelvis with contrast was ordered. Patient deteriorated during ED course, vital signs were checked and he became poorly responsive with labored breathing, as a result he was emergently intubated without complication. CT of abdomen and pelvis with contrast results were later received which demonstrated sigmoid volvulus with significant fecal retention [constipation]. General surgery was contacted, and ... quickly replied to evaluate patient in case. Patient also became hypotensive [low blood pressure], despite IV [intravenous - through the vein] fluid bolus of 2 L [liters] normal saline. Levophed [medication used to increase blood pressure] was added after which time he appeared to maintain ... stability. ... patient will be admitted to intensive care unit.” During an interview on 2/11/25, at 2:56 p.m., with the Emergency Medical Director (EMD), EMD stated he was aware of Pt 1’s hospital visit. EMD stated, there was a delay in the MSE and we should try to see the patient as soon as possible. EMD stated, there has been much improvement since 2022. During a concurrent interview and record review on 2/12/25, at 3:30 p.m., with PA 1, Pt 1’s “Electronic Medical Record [EMR],” dated 12/9/22 was reviewed. PA 1 stated, he barely recalled patient as it had been some time. PA 1 stated, he remembers it was busy because of COVID and not like that now. Review of the document “ED Note-Physician,” dated 12/9/22, at 7:06 p.m. PA 1 stated, it does not appear he did an abdominal exam of the patient. PA 1 stated, he probably should have done a physical exam of the abdomen as it was the primary complaint of the patient. PA 1 stated, when talking with caregiver of patient, it can be hard to determine the patient’s symptoms as the information can be subjective. During a concurrent interview and record review on 2/13/25, at 10:00 a.m., with MD 1, Pt 1’s “Electronic Medical Record [EMR],” dated 12/9/22 was reviewed. MD 1 stated, he had reviewed the record and his notes. MD 1 stated, MSE (being initiated) over three hours is not normal as the goal is (within) 30 mins. MD 1 stated, he reviewed the labs that had been ordered by the PA 1 and stated they were nonspecific and did not prompt a level of concern. MD 1 stated, he did not see the patient at 7:09 p.m. but at 9:08 p.m. as the time auto populated in his note. MD 1 stated Pt 1 was difficult to understand because he is Assyrian and developmentally delayed, and caregiver made it difficult to determine patient’s specific complaints. MD 1 stated, after the exam, he ordered the CT scan at 9:24 p.m. MD 1 stated, he did not see anything that would have notified him earlier of Pt 1’s decompensation at 10:40 p.m. MD 1 stated, abdominal pain was waxing and waning and intermittent. MD 1 stated, overall outcome would have probably been the same. During a concurrent interview and record review on 2/13/25, at 10:36 a.m., with MD 2, Pt 1’s “Electronic Medical Record [EMR],” dated 12/9/22 was reviewed. MD 2 stated, he did not see the patient but worked with supervising PA 1. MD 2 stated, if the PAs have questions or have something that is complicated, he will help or take the patient himself. MD 2 stated, the physical exam not being documented in “ED Note-Physician,” dated 12/9/22, at 7:06 p.m., was problematic. MD 2 stated, for a MSE, he would have done an abdominal exam. During a concurrent interview and record review on 2/13/25, at 11:05 a.m., with EDD, “Disposition Log”, dated 12/9/22, “Multiple Group Schedule”, dated 12/22, and “Emergency Department - Daily Staffing Schedule”, dated 12/9/22 were reviewed. EDD stated, he was not working at the hospital in 2022 as he started October 2024. EDD stated, 288 patients were seen on 12/9/2022, 80 percent were seen in the waiting rooms and not in the treatment rooms as that was the process. EDD stated, ambulance volume was low but 27 walk outs had occurred, resulting in almost 10 percent which is much higher than now. EDD stated, admissions were low. EDD stated, nursing staffing could be better for the mid shift when the peaks occur. EDD stated, 2 open shifts or missing mid shift providers were noted on the schedule and supply is not matching demand. During an interview on 2/13/25, at 11:49 a.m., with the Chief Nursing Officer (CNO), the CNO stated, she expects the MSE to be done quickly and no more than 20 minutes. CNO stated, patients should not have to wait a long time to be seen by the doctor. CNO stated, she expected the PA should have touched Pt 1’s abdomen as part of the focused assessment when the patient complains of abdominal pain. During a review of the hospital’s policy and procedure (P&P) titled, “MOD COMP-RCC 5.16 EMTALA POLICY,” dated 4/24/24, the P&P indicated, “ ... PURPOSE: To ensure individuals presenting to Doctor’s Medical Center’s emergency department receive an appropriate Medical Screening Examination (MSE) and stabilizing treatment or appropriate transfer in accordance with Emergency Medical Treatment and Labor Act of 1986 (EMTALA) ... Doctor’s Medical Center will provide an appropriate MSE within the capability of Doctor’s Medical Center to any individual coming to the Dedicated Emergency Department, including ancillary services routinely available, to determine whether or not an Emergency Medical Condition exists... “ During a review of the hospital’s policy and procedure (P&P) titled, “Standard of Care Policy [ED 1.04],” dated 1/23/25, the P&P indicated, “ ... Any person presenting to the Emergency Department for care will receive a Medical Screening Examination (MSE). ... 2. Patients shall be triaged and ongoing assessment of physical and psychosocial problems of patients within the emergency care system will be performed as evidenced by written or electronic documentation. ... 3. Assessment data is used to determine and prioritize patient care needs and plan of care. ... 4. Data received from the patient, as well as from the patient’s family/significant others are included in the assessment ... 5. Patient evaluation is an interdisciplinary process. Assessment data is documented in a common location and shared among disciplines to enhance the continuity of care and decrease duplication of data collection. ...” During a review of the hospital’s P&P titled, “Medical Screening Examination [ED 1.03],” dated 9/28/22, the P&P indicated, “ ...State and Federal regulations require the provision of a medical screening examination to all patients presenting to the Emergency Department for care. The medical screening exam may include the provision of ancillary diagnostic services routinely available in the hospital if necessary to determine whether the individual has an emergency medical condition ...The determination of the patient’s presenting condition [i.e., emergent, or non-emergent] will be made for each patient. MSE- Each patient may be triaged to determine priority for medical screening. The MSE will be based on the patient’s condition and prior history and may include at least the following: a. Patient’s chief complaint, age, sex, duration of onset of chief complaint, date and time, level of distress, and any other pertinent medical history. b. Vital signs, general observation, and focused examination. c. Initiation and documentation of any necessary testing, treatments and/or procedures. The scope of the examination is tailored to the patient’s presenting symptoms and the medical history of the patient. The MSE is an ongoing monitoring process, which continues until a medical emergency condition is found not to exist or until appropriate steps to stabilize the presenting emergency medical condition begin...””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 40644 Based on observation, interview, and document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when the hospital-wide quality assessment and performance improvement (QAPI) efforts did not correct infection control findings related to sanitary conditions in the hospital kitchen from previous surveys dated 5/31/24 and 9/17/24. These failures resulted in continued infection control risks in the kitchen, which date back to 5/31/24. (refer to A0309 and A0750.) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner for patients, staff and visitors who eat food prepared in the hospital kitchen.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 40644 Based on observation, interview and administrative document review, the hospital failed to maintain an effective, comprehensive, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program when the program did not effectively identify, collect data, track data, develop, or implement performance improvement activities consistent with their own Plans of Correction dated 5/31/24 and 9/17/24 when infection control deficiencies were not corrected or monitored for ongoing compliance (cross reference A-309) The cumulative effect of these systemic problems resulted in the facilities inability to comply with statutory requirements for Quality Assessment and Performance Improvement and placed all patients at risk of not receiving care in a safe setting.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 45929 Based on observation, interview, and record review, the hospital failed to meet the regulatory requirements for the Condition of Participation: §482.42 Infection Prevention and Control and Antibiotic Stewardship Programs and did not have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections- infection one gets while receiving treatment in a healthcare facility) and other infectious diseases, when: 1. The wheels on the bottom of a food preparation table in the kitchen were covered with dried brown and black debris (Refer to A-0750 Finding 1). 2. Labeling stickers, pieces of plastic and paper, corn kernels, crumbs, and various debris were observed on the floors and shelving of the kitchen’s walk-in refrigerators and freezers (Refer to A-0750 Finding 2). 3. Three of six cooling fans’ grilles contained dust inside the kitchen’s walk-in produce refrigerators (Refer to A-0750 Finding 3). 4. Six of six convection ovens in the kitchen had black, brown, and red grime on the racks, walls, and base of the ovens (Refer to A-0750 Finding 4). 5. The barbeque-type grill in the kitchen was covered with dried black and brown grime and yellow stains on the ledges (Refer to A-0750 Finding 5). 6. Registered Nurse (RN) 5 entered Patient (Pt) 23’s contact/enteric isolation (a set of precautions healthcare workers and visitors take to prevent the spread of intestinal germs from a patient to others by wearing an isolation gown and gloves) room in the Emergency Department (ED)without donning (putting on) an isolation gown and gloves to protect the spread of infection (Refer to A-0750 Finding 6). 7. No gowns or gloves were readily available for use to enter an isolation room in the ED (Refer to A-0750 Finding 7). 8. Pt 2 and Pt 34’s Intravenous (IV-method of administering medications and fluids directly into the vein) infusion sets (device connecting bags of medications and fluids into the patient’s IV access); Pt 32 and Pt 35’s tube feeding (administration of nutrition through a tube inserted directly into the gastrointestinal tract) solution sets; and Pt 2’s disposable patient circuit (a device used to deliver medical gas or oxygen to a patient’s lungs) were not labeled with the date and time of initiation (Refer to A-0750 Finding 8). 9. RN 2 did not perform hand hygiene after a wound dressing change for PT 8 and Pt 8’s dressing was not labeled with the date and time of initiation (Refer to A-0750 finding 9). The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality patient care in a safe and sanitary environment.”

“QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: 1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of distinct improvement projects is conducted annually. This Standard is not met as evidenced by: 40644 Based on observation, interview and record review, the hospital’s governing body did not ensure the hospital-wide quality assessment and performance improvement (QAPI) efforts addressed priorities for improved quality of care and patient safety and that all improvement actions are evaluated when issues identified in the previous surveys dated 5/31/24 and 9/17/24 related to Infection Control were not corrected, tracked, and monitored for compliance. These failures placed all patients, visitors, and staff at continued risk for hospital acquired infections and illnesses from contaminated kitchen surfaces. Findings: During an interview on 1/10/25 at 9:15 a.m. with two members of the Governing Body (GB,) Governing Board Member (GBM) 1 stated she was aware that the Centers of Medicare and Medicaid Services sets out specific responsibilities for the GB to oversee Quality Assurance and Performance Improvement (QAPI) program in the hospital. GBM 1 stated the GB has responsibility for ensuring that patients receive care in a safe setting. GBM 1 stated the GB was given a copy of the Plan of Correction dated 5/31/24 and 9/17/24 and they were aware that there have been problems with sanitation in the kitchen. GBM 1 stated she was “not really aware” that the same or similar issues had been ongoing since the California Department of Public Health (CDPH) survey dated 5/31/24. GBM 1 stated, “when there are so many opportunities for improvement in a hospital, sometimes we lose track of the details, and we trust that the Directors of the departments are on top of those details.” GBM 2 stated he will be more involved with observations in the kitchen and will ask more questions about the quality improvement projects in the kitchen in the future. GBM 2 stated, “Now that I know the extent of the problem and how long it has been going on, I will make sure there are changes, so thank you for bring this to our attention.” During an interview on 1/7/25 at 3:50 pm with the Chief Operating Officer (COO) regarding continued issues with infection control concerns in the kitchen, the COO stated the Food and Nutrition staff report to him, and he was responsible for ensuring the kitchen is safe and sanitary. The COO stated he has done tours in the kitchen himself and was aware that it needed to be cleaned more often. During a review of the hospital document titled, “Plan of Correction” submitted by hospital leadership and approved by the California Department of Public Health on 12/9/24 indicated, “ ...On September 10, 2024, FANS (Food and Nutrition Services) staff cleaned all items identified during the survey including: 1. Drawers - ensuring drawers do not contain crumbs and personal items. 2. The floor under fixed equipment - ensuring that food, grease and black grime are removed. 3. The floor drain under refrigerators - ensuring there is no food or other debris in the floor drain. 4. Shelves in reach-in refrigerators -The metal was immediately removed and replaced with plastic trays to prevent chards. 5. The plate warmer - ensuring the warmer does not contain crumbs or other debris. 6. The food warmer and the convection oven - ensuring there is no black and red grime or other findings. The Facilities Services Department assisted the Food and Nutrition (FANS) department with adjusting deep cleaning process from every 60 days to every 30 days. This deep cleaning includes under certain equipment, all drains, and ovens and hood. The contacted company, [vendor name] is scheduled next on October 14, 2024, and October 15, 2024, to deep clean the hoods in the kitchen, and on October 21, 2024, to deep clean under the equipment and drains. [Vendor] will continue to be utilized for deep cleaning every month. A Daily end of shift rounding was implemented on 9/25/2024 to ensure the kitchen cleanliness is maintained. This form is signed by FANS leadership to ensure that FANS standards are maintained. The FANS department attends and reports their QAPI initiatives, action plans, and findings at the QAPI committee meeting ...” During an observation on 1/7/25 at 10:50 a.m. in the hospital kitchen, the wheels on the bottom of a food preparation table were covered with dried brown and black debris. During a concurrent interview and record review on 1/10/25 at 8:48 a.m. with the Infection Control Director (ICD), “Food Preparation Table Image (FPTI, photograph of the wheels taken by the surveyor)”, dated 1/7/25 at 10:50 a.m., was reviewed. The ICD identified the debris as rust on the food preparation table wheels and stated the rust had to have happened over time. During a concurrent observation and interview on 1/7/25 at 10:53 a.m. in the kitchen’s walk-in freezer and with the Food & Nutrition Director (FND), labeling stickers, pieces of plastic and paper, corn kernels, crumbs and various debris were on the floors and shelving. The FND stated the floors are swept every time stock is received. The FND stated stock is received approximately 4 times per week. During a concurrent interview and record review on 1/10/25 at 8:49 a.m. with the ICD, “Freezer and Refrigerator Images (FRI, photographs of the floor and shelving in the freezer and refrigerator taken by the surveyor)”, dated 1/7/25, were reviewed. The ICD stated he would expect the floor to be swept at the end of each day. During a review of a professional reference from the “United States Food & Drug Administration (FDA) Food Code”, dated 2017, the “FDA” indicated, “ ... The presence of food debris or dirt on nonfood contact surfaces may provide a suitable environment for the growth of microorganisms which employees may inadvertently transfer to food. If these areas are not kept clean, they may also provide harborage for insects, rodents, and other pests ...”. During a concurrent observation and interview on 1/7/25 at 10:55 a.m. in the kitchen’s walk-in produce refrigerator 1 with the Food & Nutrition Director (FND), two of three cooling fans had dust on the grilles. The FND stated the fans are cleaned by the maintenance department once a month and as needed. During a concurrent observation and interview on 1/7/25 at 10:56 a.m. in the kitchen’s walk-in produce refrigerator 2 with the Food & Nutrition Director (FND), one of three cooling fans had dust on the grilles. During a concurrent interview and record review on 1/10/25 at 8:50 a.m. with the ICD, “Fan Images (FI, photographs of the fans in the food storage areas taken by the surveyor)”, dated 1/7/25 were reviewed. The ICD stated the fans had dust on them. During a review of a professional reference from the “United States Food & Drug Administration (FDA) Food Code”, dated 2017, the “FDA” indicated, “ ... Walls and Ceilings, Attachments ... attachments to walls and ceilings such as light fixtures, mechanical room ventilation system components, vent covers, wall mounted fans ...shall be easily cleanable ...”. During a concurrent observation and interview in the kitchen on 1/7/25 at 10:57 a.m. with the FND, six of six convection ovens contained black, brown, and red grime on the racks, walls, and base of the ovens. The FND stated the ovens were deep cleaned weekly. During an interview on 1/9/25 at 2:55 p.m. with the FND, the FND stated when she began employment at the hospital in 5/2024, the kitchen equipment was damaged from lack of cleaning. The FND stated some current employees in the kitchen were “... not on board with change ...”. During a concurrent interview and record review on 1/10/25 at 8:52 a.m. with the ICD, “Oven Images (OI, photographs of the convection ovens taken by the surveyor)”, dated 1/7/25, were reviewed. The ICD stated the oven buildup of grime happened over time and can affect “... food condition ...”. The ICD stated he expected the kitchen cleaning at minimum to follow the manufacturer’s Instructions for Use (IFU). During a review of “Gas Convection Oven Owner’s Manual (OOM)”, dated 11/2023, the “OOM” indicated, “ ... Cleaning ... oven interior is finished with porcelain enamel coating. ‘Spillovers’ should be cleaned from the interior bottom surface as soon as possible to prevent carbonizing and burnt-on condition. Grease or any residue should be cleaned from interior surfaces as soon as it accumulates ... Daily Cleaning and Maintenance .... Remove interior rack and rack slide frames ... wash the racks and rack slides in a sink with mild detergent and warm water. Dry them thoroughly with a clean cloth ... wash interior surfaces with mild detergent and warm water ... For stubborn accumulation of grease and carbon build up, use a commercial Non-Caustic oven and Grill Cleaner ...”. During a concurrent observation and interview on 1/7/25 at 11:00 a.m. in the kitchen with the FND, a barbeque-type grill in the kitchen was covered with dried black and brown grime and yellow stains on the ledges. The FND stated the grill was cleaned once a week. During a concurrent interview and record review on 1/7/25 at 3:50 p.m. with the Chief Operating Officer (COO), “Oven & Grill Images (OGI, photographs of the convection ovens and grill taken by the surveyor)”, dated 1/7/25, were reviewed. The COO stated the kitchen equipment might have been overlooked in the cleaning process due to new equipment slated to arrive soon. During a concurrent interview and record review on 1/10/25 at 8:52 a.m. with the ICD, “Grill Image (GI, photographs of the grill taken by the surveyor)”, dated 1/7/25, was reviewed. The ICD stated the buildup of grime had to have happened over days and he would expect cleaning to follow the manufacturer’s Instructions for Use (IFU) or more frequently. The ICD stated if debris was not going away, the cleaning needs to be more frequent. During a review of “Operational Manual Gas Charbroiler (OMGC)” (undated), the “OMGC” indicated, “ ... Cleaning ... Scrape top grates during broiling with a wire brush to keep the grates clean. Do not allow debris to accumulate on the grates ... Top grates may be immersed in strong commercial cleaning compound overnight. In the morning rinse with hot water ... Daily, when cool, remove top grates and radiants to clean where fat, grease, or food can accumulate”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 47205 Based on interview and record review, the hospital failed to ensure Licensed Nurses (LNs) followed policies and procedures (P&Ps) in developing, maintaining current, and patient specific nursing care plans (NCP- a process through which the nurse identifies, documents, and keeps track of a patient’s state or condition, needs, and risks) for two of fourteen (14) sampled patients (Pt 27 and Pt 3) when: 1. Pt 27’s NCP had not been updated or changed to reflect Pt 27’s medically complex problems, needs, and risks after Pt 27 experienced a change of condition requiring a transfer from a medical surgical unit (lower level of care) to a critical care unit (higher level of care). Once in Critical Care Unit, Pt 27 was intubated with ventilator (a procedure that involves inserting a tube into a patient’s airway and connecting it to a ventilator -a machine used to help a patient breathe) support, administered continuous intravenous (IV) vasopressor (an agent that raises blood pressure by constricting (squeezing) blood vessels), and placed on extracorporeal membrane oxygenation (ECMO- a type of artificial life support that can help a person whose lungs and heart aren’t functioning correctly) support, none of which were reflected on care plans. This failure resulted in Pt 27 receiving care in a critical care unit without an assessment and development of a patient specific NCP to guide care and had the potential to result in patient harm if critical care needs were not met. 2. Pt 3 was admitted to the hospital without any wounds (pressure ulcer- a sore or wound in the skin caused by prolonged pressure on an area of the body) and developed pressure ulcers and nurses did not create a new care plan for new wounds. This failure resulted in Pt 3 developing a wound while admitted to the hospital and worsening of that wound while an inpatient in the hospital. Findings: 1. During a review of Pt 27’s “Face Sheet (FS-a document that contains a summary of a patient’s personal information),” dated 1/8/25 and “History and Physical (H&P), dated 1/8/25, the FS indicated Pt 27 was admitted to the hospital on 1/5/25 at 5:23 p.m. The H&P indicated, “ ...78-year-old female with history of hypertension (high blood pressure), transferred to hospital from another hospital for concerns of STEMI (ST-segment- The ST Segment represents the interval between ventricular (relating to, or being a ventricle, which is a fluid-filled cavity in the heart or brain) depolarization (the electrical activity that occurs in the heart’s ventricles when they are stimulated and contract) and repolarization (the process by which the heart’s ventricles regain their ability to depolarize after a contraction) elevation myocardial infarction) a life-threatening type of heart attack that occurs when a coronary artery (major blood vessels, in your body, supplying blood to your heart), is completely blocked. (also known as a massive heart attack or sudden cardiac arrest), chronic (a condition that lasts for a long time and usually cannot be cured, but can be controlled) obstructive pulmonary disease (COPD- a chronic lung disease causing difficulty in breathing), and Coronary artery disease (CAD- a common heart disease that occurs when plaque builds up in the coronary arteries, reducing blood flow to the heart. It’s also known as coronary heart disease or ischemic heart disease.)...” During a concurrent interview and record review on 1/8/25 at 11:36 a.m. with Registered Nurse Quality (RNQ) 1, Pt 27’s “Electronic Medical Record (EMR-an electronic record of health-related information on an individual),” 1/5/25 to 1/8/25, and “Interdisciplinary Care Plans (ICP),” dated 1/5/25 to 1/8/25 were reviewed. RNQ1 stated Pt 27’s NCPs were not representative of the patient’s condition observed during our tour of the Cardiovascular Intensive Care Unit (CVICU) on 1/7/25. RNQ1 stated the NCP identified as active and displayed in the EMR were not patient specific, and did not reflect the change of condition or transfer to a critical care unit for life saving interventions (i.e.: intubated and on a ventilator, multiple vasopressor drips, and on ECMO). RNQ1 stated she would expect new conditions along with nursing interventions to be documented by the primary nurse in Pt 27’s medical record. RNQ1 confirmed the three NCPs listed in Pt 27’s EMR, “...Heart Failure Care Plan (initiated) 01/05/2025 6:41 p.m. ...Pain Care Plan (Initiated) 01/05/2025 at 6:42 p.m... Discharge Planning Care Plan (Initiated) 01/05/2025 1:42 p.m....”were initiated when the patient was alert and able to participate, probably on admission (1/5/25), were not patient specific, and did not accurately represent Pt 27’s current critical medical needs and risks.” 2. A review of Pt 3’s History and physical (H&P) indicated Pt 3 was admitted to the hospital with diagnosis of obstructive uropathy (a condition in which the flow of urine is blocked). A review of “Nursing Note” for Pt 3 dated 11/3/24 indicated “Mepilex dressing noted in the coccyx area, no redness or wound noted”. A review of Pt 3’s “Wound Care Note” by the Wound Care Nurse (WCN), dated 11/15/24, indicated “ ...Coccyx (the last bone at the bottom (base) of your spine) to R&L (Right and Left ) Buttocks (one of two round, fleshy mounds of tissue behind the pelvis) evolving deep tissue injury (unstageable pressure injury)...” A review of Pt 3’s care plan, indicated staff did not create care plan for wounds for Pt 3. During a concurrent interview and record review on 1/10/25 at 11:00 a.m., with the Registered Nurse Shift Manager (RNSM), RNSM reviewed Pt 3’s care plan and stated staff did not create individualized care plan for Pt 3’s wounds, and creating care plan for wound is important because staff is doing care and treatment based on what they see on the care plan. During an interview on 1/10/25 at 11:35 a.m. with the Chief Nursing Officer (CNO) and Quality Director (QD), CNO stated [NCPs] drive the care of the patient. CNO stated the purpose of the CP is to meet the patient needs ensuring all staff are “on the same page” when delivering care to the patient. CNO stated the goal [of the NCP] is to get patients well and in better medical condition “than they came to us in.” During a review of the hospital’s P&P titled, “PC.AD.1.08 Documentation Policy,” dated 9/28/22, the P&P indicated, “... II. PURPOSE: To outline responsibilities related to documentation of patient care from admission through discharge...III. POLICY: Clinical Documentation is taken to mean a process of recording and communicating a written rationale of intervention, and as such becomes part of the patient medical record. The patient medical record reflects the complete picture of the patient’s health status, treatment, and progress from admission to discharge from which other health professionals can take over responsibility for the patient concerned and for the retrieval of data for research and management. It should include a comprehensive assessment; identified problems; expected outcomes; the plan of care and care delivered (or not delivered); teaching given; advice sought in decision making; and the patient’s response to treatment; discharge and plans for ongoing care... 11. Assessment and Interventions: a. The EHR system generated tasks for fall, Braden, reflect Columbia Suicide Risk Assessment, and Interdisciplinary Education will be completed. All applicable sections will be documented and updated throughout the course of the patients’ hospitalization... c. ... Each patient (including short stay observation) will have a Plan of Care [NCP] developed. Identified care problems and care goals shall be developed and documented by the RN and ancillary departments as indicated. Identified patient needs that are not pertinent to hospitalization will not be addressed in the plan of care. i. Care plan will be updated every shift and with changes in patient status/condition. Upon discharge note whether the problem is “ongoing at discharge”, or “met.” The patients’ problem list is initiated within 8 hours of admission. Nursing care is administered with attention to the problems identified. ...” During a review of a professional reference titled, “Nursing Process,” dated 4/10/23, retrieved from https://www.ncbi.nlm.nih.gov/books/NBK499937/, the Nursing Process indicated, “ ...Planning ...The planning stage is where goals and outcomes are formulated that directly impact patient care based on EDP (Evidence-based Practice- recommendations for nursing care that are based on scientific evidence) guidelines. These patient-specific goals and the attainment of such assist in ensuring a positive outcome. Nursing care plans are essential in this phase of goal setting. Care plans provide a course of direction for personalized care tailored to an individual’s unique needs. Overall condition and comorbid conditions play a role in the construction of a care plan. Care plans enhance communication, documentation, reimbursement, and continuity of care across the healthcare continuum. Goals should be: 1. Specific; 2. Measurable or Meaningful; 3. Attainable or Action-Oriented; 4. Realistic or Results-Oriented; 5. Timely or Time-Oriented ...””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 45929 Based on observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment to avoid sources and transmission of infection in accordance with infection control standards and hospital policy and procedure when: 1. The wheels on the bottom of a food preparation table in the kitchen were covered with dried brown and black debris. 2. Labeling stickers, pieces of plastic and paper, corn kernels, crumbs, and various debris were observed on the floors and shelving of the kitchen’s walk-in refrigerators and freezers. 3. Three of six cooling fans’ grilles contained dust inside the kitchen’s walk-in produce refrigerators. 4. Six of six convection ovens in the kitchen had black, brown, and red grime on the racks, walls, and base of the ovens. 5. The barbeque-type grill in the kitchen was covered with dried black and brown grime and yellow stains on the ledges. 6. Registered Nurse (RN) 5 entered Patient (Pt) 23’s contact/enteric isolation (a set of precautions healthcare workers and visitors take to prevent the spread of intestinal germs from a patient to others by wearing an isolation gown and gloves) room in the Emergency Department (ED) without donning (putting on) an isolation gown and gloves, and did not wash hands with soap and water after touching door handle in isolation room. 7. No gowns or gloves were readily available for use to enter an isolation room in the ED. 8. Pt 2 and Pt 34’s Intravenous (IV-method of administering medications and fluids directly into the vein) infusion sets (device connecting bags of medications and fluids into the patient’s IV access); Pt 32 and Pt 35’s tube feeding (administration of nutrition through a tube inserted directly into the gastrointestinal tract) solution sets; and Pt 2’s disposable patient circuit (a device used to deliver medical gas or oxygen to a patient’s lungs) were not labeled with the date and time of initiation. 9. RN 2 did not perform hand hygiene after a wound dressing change for PT 8 and Pt 8’s dressing was not labeled with the date and time of initiation. These failures had the potential to place patients at risk for cross contamination (process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect), organism growth, and the spread of infection. Findings: 1. During an observation on 1/7/25 at 10:50 a.m. in the hospital kitchen, the wheels on the bottom of a food preparation table were covered with dried brown and black debris. During a concurrent interview and record review on 1/10/25 at 8:48 a.m. with the Infection Control Director (ICD), “Food Preparation Table Image (FPTI, photograph of the wheels taken by the surveyor)”, dated 1/7/25 at 10:50 a.m., was reviewed. The ICD identified the debris as rust on the food preparation table wheels and stated the rust had to have happened over time. 2. During a concurrent observation and interview on 1/7/25 at 10:53 a.m. in the kitchen’s walk-in freezer and with the Food & Nutrition Director (FND), labeling stickers, pieces of plastic and paper, corn kernels, crumbs and various debris were on the floors and shelving. The FND stated the floors are swept every time stock is received. The FND stated stock is received approximately 4 times per week. During a concurrent observation and interview on 1/7/25 at 10:54 a.m. in the kitchen’s walk-in produce refrigerator 1 with the Food & Nutrition Director (FND), labeling stickers, pieces of plastic, and black grime were on the floors. The FND stated the floors are swept every time stock is received. The FND stated stock is received approximately 4 times per week. During a concurrent interview and record review on 1/10/25 at 8:49 a.m. with the ICD, “Freezer and Refrigerator Images (FRI, photographs of the floor and shelving in the freezer and refrigerator taken by the surveyor)”, dated 1/7/25, were reviewed. The ICD stated he would expect the floor to be swept at the end of each day. During a review of a professional reference from the “United States Food & Drug Administration (FDA) Food Code”, dated 2017, the “FDA” indicated, “ ... The presence of food debris or dirt on nonfood contact surfaces may provide a suitable environment for the growth of microorganisms which employees may inadvertently transfer to food. If these areas are not kept clean, they may also provide harborage for insects, rodents, and other pests ...”. 3. During a concurrent observation and interview on 1/7/25 at 10:55 a.m. in the kitchen’s walk-in produce refrigerator 1 with the Food & Nutrition Director (FND), two of three cooling fans had dust on the grilles. The FND stated the fans are cleaned by the maintenance department once a month and as needed. During a concurrent observation and interview on 1/7/25 at 10:56 a.m. in the kitchen’s walk-in produce refrigerator 2 with the Food & Nutrition Director (FND), one of three cooling fans had dust on the grilles. During a concurrent interview and record review on 1/10/25 at 8:50 a.m. with the ICD, “Fan Images (FI, photographs of the fans in the food storage areas taken by the surveyor)”, dated 1/7/25 were reviewed. The ICD stated the fans had dust on them. During a review of a professional reference from the “United States Food & Drug Administration (FDA) Food Code”, dated 2017, the “FDA” indicated, “ ... Walls and Ceilings, Attachments ... attachments to walls and ceilings such as light fixtures, mechanical room ventilation system components, vent covers, wall mounted fans ...shall be easily cleanable ...”. 4. During a concurrent observation and interview in the kitchen on 1/7/25 at 10:57 a.m. with the FND, six of six convection ovens contained black, brown, and red grime on the racks, walls, and base of the ovens. The FND stated the ovens were deep cleaned weekly. During an interview on 1/9/25 at 2:55 p.m. with the FND, the FND stated when she began employment at the hospital in 5/2024, the kitchen equipment was damaged from lack of cleaning. The FND stated some current employees in the kitchen were “ ... not on board with change ...”. During a concurrent interview and record review on 1/10/25 at 8:52 a.m. with the ICD, “Oven Images (OI, photographs of the convection ovens taken by the surveyor)”, dated 1/7/25, were reviewed. The ICD stated the oven buildup of grime happened over time and can affect “ ... food condition ...”. The ICD stated he expected the kitchen cleaning at minimum to follow the manufacturer’s Instructions for Use (IFU). During a review of “Gas Convection Oven Owner’s Manual (OOM)”, dated 11/2023, the “OOM” indicated, “ ... Cleaning ... oven interior is finished with porcelain enamel coating. ‘Spillovers’ should be cleaned from the interior bottom surface as soon as possible to prevent carbonizing and burnt-on condition. Grease or any residue should be cleaned from interior surfaces as soon as it accumulates ... Daily Cleaning and Maintenance .... Remove interior rack and rack slide frames ... wash the racks and rack slides in a sink with mild detergent and warm water. Dry them thoroughly with a clean cloth ... wash interior surfaces with mild detergent and warm water ... For stubborn accumulation of grease and carbon build up, use a commercial Non-Caustic oven and Grill Cleaner ...”. 5. During a concurrent observation and interview on 1/7/25 at 11:00 a.m. in the kitchen with the FND, a barbeque-type grill in the kitchen was covered with dried black and brown grime and yellow stains on the ledges. The FND stated the grill was cleaned once a week. During a concurrent interview and record review on 1/7/25 at 3:50 p.m. with the Chief Operating Officer (COO), “Oven & Grill Images (OGI, photographs of the convection ovens and grill taken by the surveyor)”, dated 1/7/25, were reviewed. The COO stated the kitchen equipment might have been overlooked in the cleaning process due to new equipment slated to arrive soon. During a concurrent interview and record review on 1/10/25 at 8:52 a.m. with the ICD, “Grill Image (GI, photographs of the grill taken by the surveyor)”, dated 1/7/25, was reviewed. The ICD stated the buildup of grime had to have happened over days and he would expect cleaning to follow the manufacturer’s Instructions for Use (IFU) or more frequently. The ICD stated if debris was not going away, the cleaning needs to be more frequent. During a review of “Operational Manual Gas Charbroiler (OMGC)” (undated), the “OMGC” indicated, “ ... Cleaning ... Scrape top grates during broiling with a wire brush to keep the grates clean. Do not allow debris to accumulate on the grates ... Top grates may be immersed in strong commercial cleaning compound overnight. In the morning rinse with hot water ... Daily, when cool, remove top grates and radiants to clean where fat, grease, or food can accumulate ...”. 6. During a review of Patient (Pt) 23’s “ED Note (EDN)”, dated 1/7/25, the “EDN” indicated Pt 23 came to the ED on 1/7/25 with abdominal discomfort, was being treated for C-difficile (C-Diff, a potential life-threatening, enteric [affecting the intestines] bacterial infection that causes diarrhea and inflammation of the colon) and was awaiting admission. During a concurrent observation and interview on 1/7/25 at 2:10 p.m. in Pt 23’s room with RN 5, RN 5 donned a gown and gloves while inside the isolation room. RN 5 then provided care to Pt 23. When she was finished with patient care, RN 5 removed her gown and gloves and washed her hands with soap and water in the room. RN 5 grasped the door handle to open the door, exited the room and used hand sanitizer located outside the room. RN 5 stated she now needed to find a sink to wash her hands with soap and water again because Pt 23 had C-Diff, which hand sanitizer does not kill. During an interview on 1/7/25 at 2:20 p.m. with EDM and EDD, the EDM stated Pt 23 was placed in the room without an anteroom because it was the only private room in the section for patients who were waiting to be admitted. The EDD stated the ED “ ... should have a better set up ...” for isolation purposes. During a review of “Transmission Based Precautions (TBP)”, dated 5/22/24, “TBP” indicated, “ ... Policy ... Use of universal (standard) precautions for contact with blood/body fluids, mucous membranes, and non-intact skin ... will prevent the transmission of most microorganisms and most infectious diseases ... However, additional precautions may be needed for patients suspected or confirmed to be infected or colonized with pathogens [organisms that cause disease collect] which are highly transmissible ... Contact/Enteric isolation- For organisms/diseases that are gastrointestinal in origin, transmitted via contact or indirect contact ... all hand hygiene to be done with soap and water. (example: C difficile) ... Contact isolation ... Staff must wear gloves and gowns when entering the room ... the employee must don the appropriate PPE before contact occurs ... Enteric Isolation ... Staff must wear gloves and gowns when entering the room. Change gloves after contact with potentially infective material or objects that could be contaminated. Remove gloves and gown and dispose in trash prior to leaving the room and immediately wash hands with soap and water ... *Hand sanitizer containing Alcohol should not be used as it will not remove some of the enteric germs [germs from the intestine] ...”. 7. During a concurrent observation and interview on 1/7/25 at 2:10 p.m. in the ED with ED Manager (EDM) and ED Director (EDD), Pt 23 was in a private room with a window, on contact isolation. Other patients were immediately outside the room in the hallway. Pt 23’s room did not have an anteroom (an adjacent room to put on and remove gowns and gloves and wash hands). RN 5 was inside Pt 23’s room donning a gown and gloves. No gowns or gloves were visibly available outside the room. The EDM stated there used to be a rack on the wall for Personal Protective Equipment (PPE, infection protection equipment such as gowns, masks, and gloves), but it was taken down to paint the walls. The EDM stated the walls were painted a couple of months ago and the racks were not put back on the wall. The EDM and EDD stated they did not have PPE carts (a cart containing PPE, placed outside of a patient’s room, so that PPE is available to don prior to entering the room) in the ED. 8. During a concurrent observation and interview on 1/7/25, at 11:02 a.m., with nurse manager (NM 1), Pt 34’s IV solution set (tubing) was inspected. The IV solution set included an unlabeled (with the date and time of initiation to indicate how old it was) saline flush (fluid used to ensure all medication was infused into the patient) solution, an empty albumin (medication to restore the body’s fluid balance and increase blood pressure) bag attached through secondary tubing to the flush solution line. After inspection of the IV solution set, NM 1 was unable to determine how long the flush bag was in use because it was unlabeled. NM 1 stated staff were expected to affix a label to the IV solution bags to determine the date, time and who had hung the IV solution. During a record review of Pt 34’s medication administration record (MAR) titled, “MAR January 06, 2025 - January 09, 2025,” dated 1/9/25, the MAR indicated Pt 34 received five administrations of albumin with the first administration starting at 1/6/25, 6:40 p.m. to the last administration on 1/7/25, 5:53 a.m. Patient 34 also received a saline bolus (a rapid administration of a salt based fluid to increase blood pressure) on 1/7/25, at 4:17 a.m. During a concurrent observation and interview on 1/7/25, at 11:15 a.m., with NM 1, an enteral (administration of nutrition through a tube inserted directly into the gastrointestinal tract) feeding solution set infusing a bottle of tube feeding solution into Pt 35 was inspected. After inspection, NM 1 stated the enteral feeding solution set was not labeled appropriately and NM 1 was unable to determine how long the tube feeding set was in use. NM 1 stated staff were expected to change the feed set every 24 hours and label the feed set and bottle with a date and time of setup. During a concurrent observation and interview on 1/7/25, at 2:05 p.m., with nurse supervisor (NS 1), an enteral feeding solution set infusing a bottle of tube feeding solution into Pt 32 was inspected. After inspection, NS 1 stated the enteral feeding bottle was not labeled appropriately. NS 1 stated staff were expected to label the feed set or bottle with a date and time of setup and ensure it was replaced every 24 hours. During an interview on 1/10/25, at 8:50 a.m., with the Infection Control Director (ICD), the ICD stated changing IV and tube feeding solution sets were expected to be done according to hospital policy to prevent growth of pathogenic organisms in the equipment. During an interview on 1/10/25, at 11:30 a.m., with Chief Nursing Officer (CNO), the CNO stated primary nursing staff were responsible to ensure IV and tube feeding solutions and lines were labeled with the date, time and nurse who started the solution. During a review of hospital policy and procedure (P&P) titled “Venous Access Device, Prevention, Insertion and Maintenance Policy, Procedure and Protocol,” dated 5/22/24, the P&P indicated “the policy establishes guidelines ... to reduce the incidence of ... complications related to vascular access [providing access to the patient’s veins] devices ... label all IV infusions with hang date, time, nurse initials, patient name and solution.”. During a review of hospital P&P titled, “Enteral Feedings,” dated 5/22/19, the P&P indicated for “use of manufacturer prepared tube feedings ... these preparations will be labeled with the product name, strength, patient name, room number and date prepared ... tube feeding hang times are appropriate: Ready to Hang bottles/bags - 24 hours hang time ... feeding tube maintenance will be the responsibility of nursing.”. During a record review of Pt 2’s H&P, indicated Pt 2 was admitted to the hospital with the diagnosis of Acute respiratory failure with hypoxia (a condition where the lungs cannot supply enough oxygen to the body). During a concurrent observation and interview on 1/7/25 at 1:40 p.m., in Pt 2’s room with the Registered Nurse (RN) 1, Pt 2 was receiving Intravenous (IV) medication with no label that identified patient’s name and no date the tubing was hung. Pt 2 also had an IV access on the right hand and one on the left hand with no date and time. RN 1 stated all the IVs, including bags and supplies, should be labeled with the date and name of the patient. During a concurrent observation and interview on 1/7/25 at 2:00 p.m., in Pt 2 ‘s room with the Respiratory Therapist (RT) 1, Pt 2 was using Vapotherm machine (a medical device that delivers oxygen through a tube) and the tube connected to the machine did not have a date and time label to indicate when it was initiated. RT 1 stated RTs usually do not label the tube connected to Vapotherm machine. RT 1 stated he did not know how often to change the tube and stated it was changed whenever tube is not clean. During an interview on 1/9/25 at 10:20 a.m., with the Respiratory Therapist Manager (RTM), RTM stated the RTs should change the Vapotherm’s tube every 30 days and label the tube with the date and time of initiation. RTM stated the RTs were not labeling or documenting the changing of the tubes. During a record review of the facility’s policy and procedure “Venous Access Device [VAD]: Prevention, Insertion and Maintenance Policy, Procedure, and Protocol “dated 5/22/24, indicated “ ...d. Label all IV infusions with hang date, time, nurse initials, patient name, and solution. e. Label all IV tubing near the VAD connection with name of medication and label device type when applicable ...”. During a record review of the facility’s policy and procedure “Vapotherm High Velocity Therapy (HVNI) Protocol” dated 9/24/24, indicated “ ...Disposable Patient Circuit [tubing] is Valid for 30-day continuous single patient use [ used for one patient only] ...”. 9. During a record review of Pt 8’s History and Physical (H&P) the record indicated Pt 8 was admitted to the hospital with the diagnosis of abdominal abscess (An enclosed collection of pus in tissues, organs, or confined spaces in the body. An abscess is a sign of infection and is usually swollen and inflamed). During a concurrent observation and interview on 1/7/25 at 2:15 p.m., in Pt 8’s room with RN 2 and RN 3, RN 2 finished the wound dressing change, removed gloves, and without sanitizing hands, touched the wound vac machine (a suction device that helps the wound heal) and programmed the machine. After RN 2 and RN 3 finished the dressing change, they left the room without writing date and time or any other information on the dressing. RN 2 stated, the nurses should write on the dressing, the date, time, type of the dressing and how many pieces of dressing they used for the dressing change. RN 2 stated she should have sanitized hands after removing the gloves and before touching the wound vac machine, but she did not do that. During a record review of the facility’s policy and procedure titled “PC.AD.1.12 Hand Hygiene Policy” dated 10/26/22, indicated “ ...Decontaminate hands after removing gloves. NOTE: Gloves are not a substitute for hand hygiene ...”. During a record review of the facility using 3M guideline for V.A.C (vacuum assisted closure) therapy “A reference source for clinicians” dated 2021, indicated “ ...Always count the total number of pieces of foam used in the wound. Document the foam quantity and dressing change date on the foam quantity label if available, and in the patient chart ...”.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 40644 Based on interview and administrative document review, the hospital failed to maintain an effective, comprehensive, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program when the program did not effectively identify, collect data, track data, develop, or implement performance improvement activities consistent with their own Plan of Correction dated 5/31/24 when: 1. Interpreters were not used to communicate with patients in their preferred languages. (Cross reference A-309, A-117.) 2. Pain assessment and reassessments were not corrected or monitored for ongoing compliance. (Cross reference A-309, A-398 finding 1.) 3. Infection control deficiencies were not corrected or monitored for ongoing compliance (cross reference A-309, A-750) The cumulative effect of these systemic problems resulted in the facilities inability to comply with statutory requirements for Quality Assessment and Performance Improvement and placed all patients at risk of not receiving care in a safe setting.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 47205 The facility failed to meet the regulatory requirements for the Condition of Participation: §482.42 Infection Prevention and Control and Antibiotic Stewardship Programs as evidenced by the following: Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections- infection one gets while receiving treatment in a healthcare facility) and other infectious diseases, when: 1. Multiple drawers in the food preparation areas of the kitchen had a build-up of crumbs, one drawer had a binder with food crusted and personal items. According to the FDA Federal Food Code all non-food contact surfaces of the kitchen should be kept clean. (Refer A-0750 Finding 1). 2. The floor underneath fixed equipment in the kitchen had a buildup of trash, food, grease, and black grime. There was a build-up of food in the floor drain that was under a reach- in refrigerator. According to the FDA Federal Food Code all non-food contact surfaces of the kitchen should be kept clean. (Refer A-0750 Finding 2). 3. Shelves in 3 reach-in refrigerators in the kitchen near the tray line area (where food is plated for the patients) were coated in metal chards and build-up of black dust like substance. The plate warmer had a build-up of food crumbs. A commercial food warmer (used to keep food warm prior to service) had a build-up of black and red grime and convection ovens had a build-up of red and black grime. According to the FDA Federal Food Code all non-food contact surfaces of the kitchen should be kept clean. (Refer A-0750 Finding 3). 4. Five (5) of 27 ice machines (IMs) on the facility main campus were observed to be visibly soiled, and were not maintained according to facility P&P and manufacturer instructions for use (IFU). (Refer A-0750 Finding 4). The ice machine in the main kitchen [IM 1] and another in the 3 West unit nourishment room [IM 2] had a pink or black slime build-up. (Refer A-0750 Finding 4). The ice machine in the 4 North Medical Surgical pantry room [IM 3], had a black residue in the water catch sink area of the machine. (Refer A-0750 Finding 4). The ice machine in the CVICU [IM 4] had visible white-colored and textured splash stains on the stainless-steel surfaces and the water collection trays and black-colored debris was observed on white tissue after wiping the ice dispenser spout. (Refer A-0750 Finding 4). The CCU ice machine [IM 5] had visible, pink-colored stains in the ice shoot and spray guard covering. (Refer A-0750 Finding 4). 5. One (1) of 1 surgical instrument tray was stored on a trash can, and not in accordance with standards published by the American National Standards Institute and the Association for the Advancement of Medical Instrumentation (ANSI/AAMI - a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals). (Refer A-0750 Finding 5). 6. An Intravenous (IV) administration set (connects the bag of solution to the patient’s IV access site) was not labeled with date and time of initiation for two of two patients (Pt 36 and Pt 45) in accordance with hospital policy and procedure. (Refer A-0750 Finding 6). 7. Expired formula and formula sterile water was found in the Emergency Department (ED) supply room according to Food Safety and Inspection Services (FSIS-part of a science-based national system to ensure food safety and food defense) standards. (Refer A-0750 Finding 7). 8. Four (4) of 4 sampled pill crushers (a device that turns pills into powder) were not cleaned per manufacturer recommendation in the CVICU and CCU. The pill crushers were observed to be visibly soiled with white-colored chalk-like residue, and brown and orange-colored stains to metal pieces and throughout the device. (Refer A-0750 Finding 8). 9. Licensed nurses (LNs) in the Emergency Department (ED) failed to discard sharps (medical devices like needles, scalpels, and other tools that cut or go into the skin) in a sharps container ( made from rigid puncture-resistant plastic or metal with leak-resistant sides and bottom, and a tight-fitting, puncture-resistant lid with an opening to accommodate depositing a sharp but not large enough for a hand to enter) when a used IV catheter insertion needle, a small plastic dark red fluid-filled container, and a binder with a red smudge was observed to be on top of a crash cart in an occupied patient room and an empty bag of IV fluids (liquids that are administered directly into a vein to replace water, sugar, and salt) was observed laying on the floor and not discarded in accordance with the expectations of the CNO, per facility P&P and nursing standard of practice. (Refer A-0750 Finding 9). 10. The hospital did not ensure staff in the CVICU followed manufacturer instructions when using specialized pouches for dirty surgical instruments. (Refer A-0750 Finding 10). The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality patient care in a safe and sanitary environment.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 40644 Based on interview and record review, the hospital failed to ensure patient’s rights were considered for two of five sampled patients (Pt 27 and Pt 28) when patients preferred language was other than English and there was minimal to no documentation an interpreter was used for either patient during their hospitalization. These failures had the potential for patients whose preferred language was other than English to not receive and fully understand procedures and/or education provided to them and could result in negative health outcomes when the interpreting system was not utilized to communicate with Pt 27 and Pt 28 according to the hospital’s Policy and Procedure. Findings: 1. During a concurrent interview and record review on 9/12/24 at 10:20 a.m. with Registered Nurse (RN) 1, Pt 27’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 9/2/24 and the “Face Sheet [FS- a document that contains a summary of a patients’ personal information],” dated 9/1/24, were reviewed. “The “H&P” indicated, Pt 27 was admitted to the hospital on 9/1/24 at 10:31 p.m. for hypercalcemia (high calcium level in the blood), and hypoxemic respiratory failure (low oxygen in the blood). RN 1 stated the “FS” indicated Pt 27’s preferred language was Spanish. During a concurrent interview and record review on 9/12/24 at 10:30 a.m. with RN1, Pt 27’s “Interdisciplinary Patient Education SMART Template (Template)” dated 9/3/24 to 9/5/24 were reviewed. The “Template” indicated, six nurses documented, the “Barriers to Learning: -Language Barrier:” but did not document interpreter services were provided by a certified interpreter. RN 1 stated, LNs should use certified interpreters when patients had a language barrier. During a concurrent interview and record review on 9/12/24 at 10:45 with RN 1, Pt 27’s “Electronic Medical Record (EMR)” dated 9/3/24 to 9/5/24 was reviewed. RN 1 stated when an interpreter was used, LNs could document the information in the rounding comments and frequent assessments. The “EMR” indicated no documentation of interpreter use in the round’s comments or frequent assessments. RN 1 stated the “EMR” indicated no interpreter documentation besides “Conditions of Admission (COA-patient’s obligation with respect to hospital services they receive)” form. During an interview on 9/16/24 at 2:20 p.m. with RN 3, RN 3 stated she cared for Pt 27 on 9/3/24, 9/4/24, and 9/5/24 during the a.m. shift. RN 3 stated she did not use the interpreter line to communicate with Pt 27. RN 3 stated Pt 27’s daughter would interpret for her whenever she needed to communicate with Pt 27. RN 3 stated she did not document Pt 27’s daughter interpreting education to the patient. RN 3 stated she knew how to use the interpreter tablets. RN 3 stated she should use the interpreter phone line or tablet when speaking to the patient. During an interview on 9/16/24 at 4:40 p.m. with Director of Patient Care Services (DPCS) 2, DPCS 2 stated all units have tablets that provide language services by video to provide interpreter services to non-English speaking patients. DPCS 2 stated LNs could also call an interpreter line on the telephone for interpreter services. DPCS 2 stated her expectation was for LNs to utilize video or telephone interpreters for patient education, procedures, and any consents the patient needed to sign. DPCS 2 stated patients needed to understand the care they were receiving, in their preferred language. DPCS 2 stated LNs were supposed to document the interpreter identification number in the patient’s medical record when using an interpreter. During a concurrent interview and record review on 9/12/24 at 11:10 a.m. with RN 1, Pt 28’s “H&P,” and “FS” dated 9/7/24 were reviewed. The “H&P” indicated Pt 28 was admitted to the hospital on 9/7/24 at 7:30 p.m. for a pulmonary thromboembolism (blood clot in the lung), dyspnea (difficulty breathing), and a liver mass (abnormal growth of tissue). RN 1 stated the “FS” indicated Pt 28’s preferred language was Spanish. During a concurrent interview and record review on 9/12/24 at 11:15 a.m. with RN 1, Pt 27’s “Template” dated 9/8/24 to 9/12/24 were reviewed. The “Template” indicated, seven nurses documented, the “Barriers to Learning: -Language Barrier:” but did not document interpreter services were provided by a certified interpreter. RN 1 stated, LNs should use certified interpreters when patients had a language barrier. During a concurrent interview and record review on 9/12/24 at 11:20 with RN 1, Pt 28’s “Electronic Medical Record (EMR)” dated 9/8/24 to 9/12/24 was reviewed. RN 1 stated when an interpreter was used, LNs could document the information in the rounding comments and frequent assessments. The “EMR” indicated no documentation of interpreter use in the round’s comments or frequent assessments. RN 1 stated the “EMR” indicated no interpreter documentation besides the COA form. During an interview with RN 1 on 9/12/24 at 11:30 a.m. RN 1 stated she cared for Pt 28 on 9/9/24 during the a.m. shift. RN 1 stated she did not utilize the interpreter tablet when completing her morning assessments on Pt 28. RN 1 stated she utilized a Spanish speaking LN to interpret information when Pt 28 asked her a question about pain medications. RN 1 stated she did not document the Spanish staff member interpreting for her in Pt 28’s EMR. RN 1 stated she should have documented using a Spanish interpreter to communicate with Pt 28. RN 1 stated she should have used the certified interpreter tablet or phone line per hospital policy. During an interview on 9/16/24 at 3:20 p.m. with DPCS 1, DPCS 1 stated all units have little green translator electronic tablets and LNs should use them for interpreter services for non-English speaking patients. DPCS 1 stated LNs should use interpreter services for purpose and side effects of medication, and to determine if medication was effective, bedside education, new treatments, invasive things, and any procedures. DPCS 1 stated LNs were supposed to get interpreter staff identification number and document the number in the patients EMR. DPCS 1 stated utilizing certified interpreters was important to ensure communication was appropriate for the patient, and to not have information translated incorrectly. During an interview on 9/17/24 at 4:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated, her expectation was for LNs to use the interpreter tablets for non-English speaking patients. The CNO stated her expectation was for LNs to utilize interpreters for new medication education, consents, procedures, and any consents patients needed to sign. The CNO stated LNs were expected to document the interpreter identification number in the patient chart. During a review of the hospital’s Policy and Procedure titled, “Language Assistance Services (Including Interpreters) Procedure,” dated 7/24/24, indicated, “ ...Prompt Call for Interpreters ... the need for Qualified Interpreters and other Auxiliary Aids and Services throughout the Patient’s receipt of Facility services ... Determination of a Patient’s medical history or description of ailment or injury; ...provision of Patient rights, informed consent or permission for treatment; ... explanation of procedures, tests, treatment, treatment options or surgery; ... explanation of medications prescribed including dosage as well as how and when the medication is to be taken and any possible side effects; ... explanation regarding follow -up treatment, therapy, test results or recovery; discharge instructions; ...blood and organ donation ... Video Remote Interpreting (VRI) Services ... the [hospital] will ensure that it provides (i) real-time, full-motion video and audio ... Restricted Use of Other Interpreters ... Except in the limited circumstances ... shall not rely on a family member ... to interpret communications between Facility Personnel and that Person ...”. During a review of the hospital’s “Instructions for Use (IFU)” for the [brand name of tablet] Language Services on iOS, undated, the “IFU” indicated, “ ... More than 200 languages are available over audio ... Web based tool ...”. During a review of professional reference titled, “Clinicians’ Obligations to Use Qualified Medical Interpreters When Caring for Patients with Limited English Proficiency,” dated 3/2017, (retrieved from https://journalofethics.ama-assn.org/article/clinicians-obligations-use-qualified-medical-interpreters-when-caring-patients-limited-english/2017-03) indicated, “ ... Access to language services is a required and foundational component of care for patients with limited English proficiency (LEP) ... In the United States, patients with LEP have a legal right to access health care in their preferred language ...”.”

“USE OF RESTRAINT OR SECLUSION CFR(s): 482.13(e) Patient Rights: Restraint or Seclusion. All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. This Standard is not met as evidenced by: 40644 Based on interview and record review, the hospital failed to protect and promote each patient’s rights for one of three patients (Pt 23) when the hospital policy and procedure (P&P) titled, “Restraints and Seclusion” was not followed. LNs did not document monitoring and assessment information according to hospital policy for Pt 23. These failures had the potential for Pt 23 to go unmonitored for an extended period and violated Pt 23’s right to care in a safe setting. (Refer A-0154 Finding 1) Findings: 1. During a concurrent interview and record review on 9/11/24 at 3:32 p.m. with Registered Nurse Quality (RNQ) 1, Pt 23’s “History and Physical (H&P),” dated 9/8/24, was reviewed. The “H&P” indicated, “ ... Patient was brought in from her assisted living with severe shortness of breath, altered level of consciousness [change in state of awareness] and hypotension [blood pressure lower than normal] ... history of dementia [condition that causes loss of memory, thought, and reasoning] ... acute hypoxic respiratory failure [not enough oxygen in body’s tissues]. ...”. Pt 23 was admitted to the hospital on 9/8/24 at 10:15 a.m. with sepsis (serious infection that can lead to lead to tissue damage organ failure or death) and acute hypoxic respiratory failure. During a concurrent interview and record review on 9/11/24 at 3:40 p.m. with Registered Nurse Quality (RNQ)1 Pt 23’s “Physician Order (PO) 1,” dated 9/8/24, was reviewed. The “PO 1” indicated, “ ... Restraint [device that limits movement] Initiation Non-Violent ... Reason for Restraints: Interferes with Medical Device ... Soft limb ... All Extremities ... 4 Point Restraint ... Restraint location: ... All extremities ...”. RNQ 1 stated 4-point restraints were soft material restraints that went around the patient’s wrists and ankles and attached to the bed frame, to prevent movement of arms and legs. During a concurrent interview and record review on 9/11/24 at 3:43 p.m. with RNQ 1 Pt 23’s “Restraint Placement Monitoring (RPM)” dated 9/8/24 to 9/10/24, were reviewed. The RPM indicated Pt 23 was placed in restraints on 9/8/24 at 5:15 p.m. and no documentation was monitored until 8 p.m. RNQ 1 stated patients with non-violent restraints were to have restraint monitoring documented every 2 hours. RNQ 1 stated Pt 23 should have had monitoring documented at 7:15 p.m. RNQ 1 stated LNs monitored and documented reason for restraints, alternatives attempted, points of restrains, learner profile, and a patient assessment every two hours. During an interview on 9/16/24 at 2:37 p.m. with Registered Nurse (RN) 2, RN 2 stated he was Pt 23’s primary nurse on 9/8/24 during the a.m. shift. RN 23 stated his shift was from 7:00 a.m. to 7:30 p.m. RN 2 stated he applied Pt 23’s 4-point restraints. RN 2 stated Pt 23 was pulling at medical equipment and kicking her IV pole. RN 2 stated he called the physician and obtained the order for restraints. RN 2 verified on the “RPM” he applied Pt 23’s restraints at 5:15 p.m. RN 2 stated he should have monitored and documented Pt 23’s restraints at 7:15 p.m. or reported to the ongoing night shift nurse to monitor and document at 7:15 p.m. RN 2 stated monitoring patients every two hours assured patients remained safe, and allowed LNs to determine if restraints were still needed. During an interview on 9/16/24 at 3:45 p.m. with Director of Patient Care Services (DPCS) 2, DPCS 2 stated her expectation was for LNs to monitor patients and document according to hospital policy. During an interview on 9/17/24 at 4:22 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectation was for LNs to assess restrained patients and document according to P&P. The CNO stated LNs needed to address the reason patients were in restraints to determine if they were in the least restrictive restraint, or if restraints were still needed. The CNO stated LNs needed to assess restrained patients to assure their needs were met, such as nutrition, hydration, pain, and bathroom needs. During a review of the hospital’s P&P titled, “Restraints and Seclusion,” dated 4/24/24, indicated, “ ... Non-violent/Medical Behavior: Behavior resulting from a non-psychiatric medical condition and/or does not jeopardize the immediate safety of others but may result in harm to self. ... Staff must discontinue Restraint or Seclusion at the earliest possible time, regardless of the scheduled expiration of the order. ... a patient in restraints is monitored at least every two hours or sooner according to the patient needs ... When restraint or Seclusion is used, there must be documentation in the patient’s medical record of the following: ... The patient’s response to the intervention(s) used including the rational for continued use of the intervention ... Individual patient assessments and reassessments ... All employees whose responsibilities are affected by this policy are expected to be familiar with the basic procedures and responsibilities created by this policy ...”. During a review of professional reference titled, Patient Restraint and Seclusion,” dated 11/14/22, (retrieved from https://www.ncbi.nlm.nih.gov/books/NBK565873/ f (nih.gov)) indicated, “ ... Healthcare workers should know that restraint and seclusion can have significant adverse implications on patients and should be deemed a last resort. Healthcare professionals must follow the 4 basic ethical healthcare principles: autonomy, justice, beneficence, and non-maleficence. Per beneficence - the act of doing good - and non-maleficence - do no harm; healthcare providers must ensure the administration of restraint is implemented as a last resort ... Healthcare workers must also be sure to appropriately monitor the patient following restraint and seclusion to avoid deleterious [causing harm] effects such as pressure ulcers, skin breakdown, abrasions, asphyxia, strangulation, incontinence, depression, social isolation, and drug overdose or interaction ...”.”

“QAPI EXECUTIVE RESPONSIBILITIES CFR(s): 482.21(e)(1), (e)(2), (e)(5) The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: 1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained . (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. (5) That the determination of the number of distinct improvement projects is conducted annually. This Standard is not met as evidenced by: 40644 Based on interview and record review, the hospital’s governing body did not ensure the hospital-wide quality assessment and performance improvement efforts addressed priorities for improved quality of care and patient safety and that all improvement actions are evaluated when issues identified in the previous survey in May 2024 related to Patient Rights, Nursing Services, and Infection Control were not corrected, tracked, and monitored for compliance These failures resulted in avoidable negative outcomes to patients. Patients 27 and 28 did not receive information in a language they could fully understand, patients (Pt) Pt 5, Pt 10, Pt 26, Pt 27, Pt 38, Pt 45, and Pt 50 did not have their pain adequately controlled, and placed all patients, visitors, and staff at continued risk for transmission of and cross contamination and increased the potential for hospital acquired infections and illnesses. Findings: Review of the hospital document titled, “Plan of Correction,” dated 5/31/24 indicated: “ ...CMS 2567 - A117- Patient Rights: Notice of Rights. Finding: Based on interview and record review, the hospital failed to ensure patient’s rights were considered for two of three sampled patients (Pt 11 and Pt 12) when patients preferred language was other than English and there was minimal (for informed consents) to no documentation an interpreter was used for either patient during their hospitalization. These failures had the potential for patients whose preferred language was other than English to not receive and fully understand procedures and/or education provided to them and could result in negative health outcomes when bilingual staff who were not competent interpreters communicated with patients and did not use the interpreting system to communicate with patients in accordance with the hospital’s policies and procedures ...” Record review of the Corrective Actions included: Beginning on 6/17/2024, education regarding the use of interpreter services was provided to the inpatient hospital staff working in direct patient care via huddles, which included a signed attestation of understanding. Monitoring: The DBHC (Doctors Behavioral Health Center) Director or designee conducts audits on all charts for consent compliance at DBHC. Monitoring is conducted for until three consecutive months of 100% compliance is achieved. Once 100% compliance is achieved random weekly audits will be conducted to ensure compliance with the policy. LEP Coordinator/Quality Department audits 5 charts per week to ensure that the language interpreter services are used and documented for translation per hospital policy and regulatory standards on 100% of audits completed. Weekly chart audits occur until 100% compliance is achieved for 3 concurrent months. The Quality Department will audit charts monthly to ensure sustainability. Data is reported to Quality Council, MEC, and BOG quarterly.” During a concurrent interview and record review on 9/12/24 at 10:20 a.m. with Registered Nurse (RN) 1, Pt 27’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 9/2/24 and the “Face Sheet [FS- a document that contains a summary of a patients’ personal information],” dated 9/1/24, were reviewed. “The “H&P” indicated, Pt 27 was admitted to the hospital on 9/1/24 at 10:31 p.m. for hypercalcemia (high calcium level in the blood), and hypoxemic respiratory failure (low oxygen in the blood). RN 1 stated the “FS” indicated Pt 27’s preferred language was Spanish. During a concurrent interview and record review on 9/12/24 at 10:30 a.m. with RN1, Pt 27’s “Interdisciplinary Patient Education SMART Template (Template)” dated 9/3/24 to 9/5/24 were reviewed. The “Template” indicated, six nurses documented, the “Barriers to Learning: -Language Barrier:” but did not document interpreter services were provided by a certified interpreter. RN 1 stated, LNs should use certified interpreters when patients had a language barrier. During a concurrent interview and record review on 9/12/24 at 10:45 with RN 1, Pt 27’s “Electronic Medical Record (EMR)” dated 9/3/24 to 9/5/24 was reviewed. RN 1 stated when an interpreter was used, LNs could document the information in the rounding comments and frequent assessments. The “EMR” indicated no documentation of interpreter use in the round’s comments or frequent assessments. RN 1 stated the “EMR” indicated no interpreter documentation besides “Conditions of Admission (COA-patient’s obligation with respect to hospital services they receive)” form. During an interview on 9/16/24 at 2:20 p.m. with RN 3, RN 3 stated she cared for Pt 27 on 9/3/24, 9/4/24, and 9/5/24 during the a.m. shift. RN 3 stated she did not use the interpreter line to communicate with Pt 27. RN 3 stated Pt 27’s daughter would interpret for her whenever she needed to communicate with Pt 27. RN 3 stated she did not document Pt 27’s daughter interpreting education to the patient. RN 3 stated she knew how to use the interpreter tablets. RN 3 stated she should use the interpreter phone line or tablet when speaking to the patient. During an interview on 9/16/24 at 4:40 p.m. with Director of Patient Care Services (DPCS) 2, DPCS 2 stated all units have tablets that provide language services by video to provide interpreter services to non-English speaking patients. DPCS 2 stated LNs could also call an interpreter line on the telephone for interpreter services. DPCS 2 stated her expectation was for LNs to utilize video or telephone interpreters for patient education, procedures, and any consents the patient needed to sign. DPCS 2 stated patients needed to understand the care they were receiving, in their preferred language. DPCS 2 stated LNs were supposed to document the interpreter identification number in the patient’s medical record when using an interpreter. During a concurrent interview and record review on 9/12/24 at 11:10 a.m. with RN 1, Pt 28’s “H&P,” and “FS” dated 9/7/24 were reviewed. The “H&P” indicated Pt 28 was admitted to the hospital on 9/7/24 at 7:30 p.m. for a pulmonary thromboembolism (blood clot in the lung), dyspnea (difficulty breathing), and a liver mass (abnormal growth of tissue). RN 1 stated the “FS” indicated Pt 28’s preferred language was Spanish. During a concurrent interview and record review on 9/12/24 at 11:15 a.m. with RN 1, Pt 27’s “Template” dated 9/8/24 to 9/12/24 were reviewed. The “Template” indicated, seven nurses documented, the “Barriers to Learning: -Language Barrier:” but did not document interpreter services were provided by a certified interpreter. RN 1 stated, LNs should use certified interpreters when patients had a language barrier. During a concurrent interview and record review on 9/12/24 at 11:20 with RN 1, Pt 28’s “Electronic Medical Record (EMR)” dated 9/8/24 to 9/12/24 was reviewed. RN 1 stated when an interpreter was used, LNs could document the information in the rounding comments and frequent assessments. The “EMR” indicated no documentation of interpreter use in the round’s comments or frequent assessments. RN 1 stated the “EMR” indicated no interpreter documentation besides the COA form. During an interview with RN 1 on 9/12/24 at 11:30 a.m. RN 1 stated she cared for Pt 28 on 9/9/24 during the a.m. shift. RN 1 stated she did not utilize the interpreter tablet when completing her morning assessments on Pt 28. RN 1 stated she utilized a Spanish speaking LN to interpret information when Pt 28 asked her a question about pain medications. RN 1 stated she did not document the Spanish staff member interpreting for her in Pt 28’s EMR. RN 1 stated she should have documented using a Spanish interpreter to communicate with Pt 28. RN 1 stated she should have used the certified interpreter tablet or phone line per hospital policy. During an interview on 9/16/24 at 3:20 p.m. with DPCS 1, DPCS 1 stated all units have little green translator electronic tablets and LNs should use them for interpreter services for non-English speaking patients. DPCS 1 stated LNs should use interpreter services for purpose and side effects of medication, and to determine if medication was effective, bedside education, new treatments, invasive things, and any procedures. DPCS 1 stated LNs were supposed to get interpreter staff identification number and document the number in the patients EMR. DPCS 1 stated utilizing certified interpreters was important to ensure communication was appropriate for the patient, and to not have information translated incorrectly. During an interview on 9/17/24 at 4:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated, her expectation was for LNs to use the interpreter tablets for non-English speaking patients. The CNO stated her expectation was for LNs to utilize interpreters for new medication education, consents, procedures, and any consents patients needed to sign. The CNO stated LNs were expected to document the interpreter identification number in the patient chart. During a review of the hospital’s Policy and Procedure titled, “Language Assistance Services (Including Interpreters) Procedure,” dated 7/24/24, indicated, “ ...Prompt Call for Interpreters ... the need for Qualified Interpreters and other Auxiliary Aids and Services throughout the Patient’s receipt of Facility services ... Determination of a Patient’s medical history or description of ailment or injury; ...provision of Patient rights, informed consent or permission for treatment; ... explanation of procedures, tests, treatment, treatment options or surgery; ... explanation of medications prescribed including dosage as well as how and when the medication is to be taken and any possible side effects; ... explanation regarding follow -up treatment, therapy, test results or recovery; discharge instructions; ...blood and organ donation ... Video Remote Interpreting (VRI) Services ... the [hospital] will ensure that it provides (i) real-time, full-motion video and audio ... Restricted Use of Other Interpreters ... Except in the limited circumstances ... shall not rely on a family member ... to interpret communications between Facility Personnel and that Person ...”. During a review of the hospital’s “Instructions for Use (IFU)” for the [brand name of tablet] Language Services on iOS, undated, the “IFU” indicated, “ ... More than 200 languages are available over audio ... Web based tool ...”. During a review of professional reference titled, “Clinicians’ Obligations to Use Qualified Medical Interpreters When Caring for Patients with Limited English Proficiency,” dated 3/2017, (retrieved from https://journalofethics.ama-assn.org/article/clinicians-obligations-use-qualified-medical-interpreters-when-caring-patients-limited-english/2017-03) indicated, “ ... Access to language services is a required and foundational component of care for patients with limited English proficiency (LEP) ... In the United States, patients with LEP have a legal right to access health care in their preferred language ...”. Review of the hospital document titled, “Plan of Correction”, dated 5/31/24 indicated: “ ...CMS 2567 -A385 - Nursing Services ... Finding 5: One of two sampled patients did not have her pain assessed and documented while she was receiving epidural pain medication according to hospital policy. Policy & Procedures: Finding 4: The hospital Pain Management policy, vital sign guidelines and physician order sets were reviewed. There was a reference added for Elsevier for vital signs assessment frequency. Elsevier is the Tenet Healthcare approved clinical reference platform. Completion date: 06/17/2024 Finding 5: L&D (Labor and Delivery) Epidural Management of the Laboring Patient Guidelines was reviewed without changes. Other Corrective Actions: Finding 4: The Director and Assistant Director and respective leaders developed an education plan for staff responsible for taking and documenting vital signs regarding compliance with vital signs and standardization of measurements and documentation. Elsevier was confirmed to be accessible from all hospital pc desktops for ease of reference. Completion date: 06/17/2024. Finding 5: The Director and respective leaders developed an education plan for staff responsible for assessing, managing, and reassessing pain regarding compliance with pain assessment while receiving epidural pain medication and standardization of measurements and documentation. Assess fetal heart rate, uterine contractions, maternal vital signs, signs of high spinal or ascending block, perception and level of pain relief once regional analgesia or anesthesia is initiated. Then every 3 minutes for the first 15 minutes, then every 5 for the next 15 min, then every 15 minutes thereafter. The frequency of subsequent assessment should be based on maternal-fetal response to medication, maternal-fetal condition, and the stage of labor Completion date: 08/7/2024. Training: Finding 4: Labor and Delivery and Postpartum Staff responsible for taking and documenting vital signs were educated by nursing leadership regarding standardization of vital sign measurements, importance of documentation and references to Elsevier learning and reference platform. Staff verbalized understanding as competency and had no questions or concerns. Competency is validated by audits conducted by nursing leadership (see monitoring). Finding 5: Beginning the Week of August 5th, 2024, Labor and Delivery staff responsible for pain assessment, management and reassessment were educated by nursing leadership regarding standardization of pain assessment and reassessment, as well as the importance of accurate and timely documentation. Staff verbalized understanding as competency and had no questions or concerns. Competency is validated by audits conducted by nursing leadership (see monitoring). Completion date: 08/7/2024 ... Finding 5: 30 records per month will be audited for pain assessment and reassessment until three consecutive months of 100 % compliance is achieved. Results of audits will be reported to the Quality Committee, MEC and Board of Governors quarterly to ensure compliance. Completion date: Estimated 8/7/2024. Responsible Person(s): Finding 4: The Director of Women’s and Children’s Services, The Director of Neonatal and Pediatric Services, and the Chief Nursing Officer. Finding 5: The Director of Women’s and Children’s Services, The Director of Neonatal and Pediatric Services, and the Chief Nursing Officer ... One of two sampled patients (Pt 61) was not offered pain medication prior to the start of a large wound dressing according to the hospital’s pain policy and hand hygiene was not performed per hospital policy. Policy & Procedures: On 5/27/2024, the policy for Pain Management PC.AS.1.24 was reviewed. No revisions were required ...On 5/27/2024, all nursing staff working were provided education in huddles regarding patients receiving adequate pain control prior to a wound care dressing change. All staff on leave of absence, vacation, or otherwise not working and new hires will complete education upon return and prior to return to work. Completion date: 5/27/2024. Monitoring: ...On 5/27/2024 Inpatient Nursing Directors began randomly auditing wound care dressing changes in real time to ensure patients received adequate pain control prior to a wound care dressing change. These audits will continue until 100% compliance is achieved for 3 consecutive months. The data are reported through the Performance Improvement structure to Infection Prevention & Quality Council, MEC, and BOG quarterly. Completion date: 05/27/2024. Responsible Person(s): Inpatient Nursing Directors and Chief Nursing Officer ...” During a review of Pt 26’s “History and Physical [H&P- complete patient assessment by physician]”, dated 9/4/24, the “H&P” indicated, Pt 26 was admitted to the hospital as an inpatient on 9/4/24 at 7:24 p.m. for status post (after surgery) hardware infection. Pt 26 had a recent left tibia (long bone in lower leg) open reduction internal fixation (ORIF- a surgical procedure for repairing fractured bone using either plates, screws, or a rod) with an external (outside the body) frame attached to internal (inside the body) hardware (implant, such as a plate, rod, screw, or nail that is used to hold bones together). During a concurrent observation and interview on 9/10/24 at 3:07 p.m. with Pt 26 in Pt 26’s hospital room, Pt 26 was observed with his left leg elevated on a pillow. The top of Pt 26’s left leg right below his knee had a round metal frame encircling his leg, with metal pins puncturing his skin. Pt 26 stated he was in the hospital due to an infection in his left leg from a recent surgery. Pt 26 stated his leg was very painful at times. Pt 26 stated, nursing staff must be “very busy” because they are slow to answer his call light and bring him his pain medication. Pt 26 stated, he received both oral and intravenous (IV- in the vein) scheduled and as needed pain medication. Pt 26 stated he had scheduled pain medication every four hours. Pt 26 stated when his pain medication was late it was hard to keep his pain controlled. During a review of Pt 26’s “MO 1”, dated 9/5/24 at 10:05 a.m., the “MO 1” indicated, “ ... morphine [narcotic medication used for moderate to severe pain] ... 2 milligrams, [mg- a unit of measurement] ... Injection [administering a liquid] ... IV Push [IVP -pushing into intravenous line] ... Q2hr [every 2 hours] ... PRN [as needed] ... Pain Breakthrough [pain not controlled with scheduled medications] ...”. During a concurrent interview and record review on 9/12/24 at 3:15 p.m. with Registered Nurse Quality (RNQ) 1, Pt 26’s “Pain Assessment Flowsheet (PAF)”, and “Medication Administration Record [MAR- an electronic record of medications that were given]”, dated 9/9/24 were reviewed. The “PAF” indicated, Pt 26’s pain was assessed on 9/9/24 at 10:53 a.m. as a nine (severe). RNQ 1 stated, a pain score of 1-3 was mild pain, 4-6 was moderate pain and 7-10 was severe pain. The “MAR” indicated 2 mg morphine IVP was administered at 10:53 a.m. RNQ 1 stated, Pt 26’s pain was not reassessed until 9/9/24 at 1 p.m. and scored an eight. RNQ 1 stated, Pt 26 should have had a pain reassessment on 9/9/24 at 11:53 a.m. one hour after pain medication was administered. During an interview on 9/16/24 at 2:37 p.m. with Registered Nurse (RN) 2, RN 2 stated nursing staff were supposed to reassess and document pain after administration of medication within one hour. RN 2 stated reassessment was important because some patients do not respond to certain types of medications. RN 2 stated patients also needed to be monitored for sedation after certain types of pain medication administration, respirations, and heart rate needed to be closely monitored for the safety of the patient. During a review of Pt 27’s “H&P, dated 9/2/24, the “H&P” indicated, Pt 27 arrived in the ED with intractable (hard to control) back and pelvic (basin-shaped complex of bones that connects the trunk and the legs) pain. Pt 27 had a past medical history of recurrent hypercalcemia (high blood calcium), severe osteoporosis (bone mass and strength decreases) with multiple thoracolumbar fractures (area of the back between the ribcage and the lower back). T4, T12, (mid back) L1, L3, L4 (lower back), and occlusive deep vein thrombosis (DVT-blood clots form in deep veins). Pt 27 was admitted to the hospital as an inpatient on 9/1/24 at 10:31 p.m. with hypoxemic respiratory failure (not enough oxygen in the blood). During a concurrent interview and record review on 9/12/24 at 9:30 a.m. with RN 1, Pt 27’s “PAF”, and “MAR”, dated 9/7/24 were reviewed. The “PAF” indicated Pt 27’s pain was assessed on 9/7/24 at 5:32 a.m. as nine (severe). The “MAR” indicated, on 9/7/24 at 5:32 a.m. Pt 27 was administered 10 mg oxyCODONE by mouth. RN 1 stated Pt 27’s pain was reassessed on 9/7/24 at 8 a.m. as zero. RN 1 stated, Pt 27 should have had a pain reassessment on 9/7/24 at 6:32 a.m. one hour after pain medication was administered. RN 1 stated pain reassessments were important to evaluate the effectiveness of administered medications. During a review of Pt 27’s “MO 1”, dated 9/2/24 at 12:50 a.m., the “MO 1” indicated, “ ... oxyCODONE [narcotic medication for moderate to severe pain] ... 10 mg ... 2 tab ... Oral ... Q4hr [every 4 hours] ... PRN [as needed] ... Pain Severe ...”. During a concurrent interview and record review on 9/12/24 at 10 a.m. with RN 1, Pt 27’s “PAF”, and “MAR”, dated 9/7/24 were reviewed. The “PAF” indicated Pt 27’s pain was assessed on 9/7/24 at 5:32 a.m. as nine (severe). The “MAR” indicated, on 9/7/24 at 5:32 a.m. Pt 26 was administered 10 mg oxyCODONE by mouth. RN 1 stated Pt 27’s pain was reassessed on 9/7/24 at 8 a.m. as zero. RN 1 stated, Pt 26 should have had a pain reassessment on 9/7/24 at 6:32 a.m. one hour after pain medication was administered. RN 1 stated pain reassessments were important to evaluate the effectiveness of administered medications. During a review of Pt 27’s “MO 1”, dated 9/2/24 at 12:50 a.m., the “MO 1” indicated, “ ... oxyCODONE [narcotic medication for moderate to severe pain] ... 10 mg ... 2 tab ... Oral ... Q4hr [every 4 hours] ... PRN [as needed] ... Pain Severe ...”. During a review of Pt 5’s “H&P, dated 8/26/24, the “H&P” indicated, Pt 5 arrived in the Emergency Department (ED) on 8/25/24 at 6:33 p.m. with abdominal (stomach) pain. Pt 5 was admitted to the hospital as an inpatient on 8/25/24 at 11:58 p.m. with diverticulitis (small pouches in the intestines become inflamed or infected), with micro perforation (a very small hole/puncture), and sepsis (serious infection that can lead to lead to tissue damage organ failure or death). During a review of Pt 5’s “Medication Order (MO 1)”, dated 8/25/24 at 6:54 p.m., the “MO 1” indicated, “ ... Acetaminophen [a pain reliever medication] ... 1,000 milligrams [mg - a unit of measurement] ... 2 tab [tablets] ... Oral ... STAT [immediately] ...”. During a review of Pt 5’s “MO 2”, dated 8/25/24 at 7:42 p.m., the “MO 2” indicated, “ ... oxyCODONE [narcotic medication for moderate to severe pain] ... 10 mg ... 2 tab ... Oral ... STAT ...”. During a concurrent interview and record review on 9/16/24 at 4:31 p.m. with RNQ 1, Pt 5’s “PAF”, and “MAR”, dated 8/25/24 to 8/26/24 were reviewed. RNQ 1 stated Pt 5’s pain was assessed on 8/25/24 at 6:40 p.m. as 10 (severe). RNQ 1 stated, a pain score of 1-3 was mild pain, 4-6 was moderate pain and 7-10 was severe pain. The “MAR” indicated, on 8/25/24 at 6:58 p.m. Pt 5 was administered 1,000 mg acetaminophen. RNQ 1 stated Pt 5’s pain was reassessed on 8/25/24 at 8:13 p.m. as an eight (severe). RNQ 1 stated, Pt 5 should have had a pain reassessment on 8/25/24 at 7:58 p.m. one hour or less after pain medication was administered. During a concurrent interview and record review on 9/16/24 at 4:40 p.m. with RNQ 1, Pt 5’s “PAF”, and “MAR” dated 8/25/24 to 8/26/24 were reviewed. RNQ 1 stated, on 8/25/24 at 8:10 p.m. Pt 5 was administered 10 mg oxyCODONE for a pain score of 8. The “PAF” indicated, pain or sedation level (level of drug-induced sleep) was not assessed again until 8/26/24 at 2:32 a.m. The pain reassessment was documented as “no actual pain present”, no numerical score was associated with the pain reassessment. RNQ 1 stated a pain reassessment should have been completed on 8/25/24 at 9:10 p.m. one hour after administration of the narcotic medication. RNQ 1 stated pain reassessments were important to ensure patients were getting pain control as well as not being overly sedated by pain medications. During a review of Pt 10’s “H&P”, dated 9/9/24, the “H&P” indicated, Pt 10 was admitted to the hospital as an inpatient on 9/9/24 at 7:20 p.m. with acute cholecystitis (redness and swelling of gallbladder [pouch like organ in upper right of stomach]) and presumed gallstone pancreatitis (swelling of pancreas [organ behind stomach that produces digestive juices and hormones]) Pt 10 was admitted for laparoscopic cholecystectomy (small holes in stomach for small instrument to remove gallbladder). During a review of Pt 10’s “MO 1”, dated 9/13/24 at 6:06 p.m., the “MO 1” indicated, “ ... acetaminophen - HYDROcodone [narcotic medication] ... 325 mg [acetaminophen] 5 mg [HYDROcodone] ... 1 tab ... Oral ... Q4hr [every 4 hours] ... PRN [as needed] ... Pain Mild ... [1-3] ...”. During a concurrent interview and record review on 9/17/24 at 9:15 a.m. with RNQ 1, Pt 10’s “PAF”, and “MAR” dated 9/13/24 were reviewed. RNQ 1 stated, on 9/13/24 at 5:48 p.m. Pt 10 was administered 325 mg-5 mg acetaminophen HYDROcodone for a pain score of 3. The “PAF” indicated, on 9/13/24 at 8 p.m. a pain reassessment of three was documented. Pt 10’s “PAF” indicated a pain acceptable intensity score of 3. RNQ 1 stated a pain reassessment should have been completed on 9/13/24 at 6:48 p.m. one hour after administration of the narcotic medication. During a concurrent interview and record review on 9/13/24 at 9 a.m. with the Director of Women and Children Services (DWC) and Registered Nurse (RN) 4, Pt 38’s H&P was reviewed. The H&P indicated, Pt 38 was a 33-year-old, gravida (G- the total number of confirmed pregnancies) 4 para (P- the number of live births) 2 at 35.6 weeks gestation (the period of time when something is conceived and developed; normal gestation is 40 weeks). Pt 38 was admitted for severe preeclampsia (a serious blood pressure condition that develops during pregnancy) for a repeat cesarean section (C/S- the surgical delivery of a baby through a cut made in the birth parent’s abdomen and uterus). During a concurrent interview and record review on 9/13/24 at 9:05 a.m. with the DWC and RN 4, Pt 38’s “Medication Administration Record (MAR),” dated 9/12/24, and “Pain Assessment Flowsheet (PAF),” dated 9/12/24 were reviewed. The MAR indicated, “ ...acetaminophen-hydrocodone ... 325 [milligrams (mg-unit of measure)]-10 mg oral) ... 1 tab ... [every] 4 [hour] [as needed] ...” The MAR indicated Pt 38 was administered acetaminophen-hydrocodone 325 mg-10mg by mouth at 8:41 a.m. RN 4 stated the PAF indicated Pt 38 had a pain assessment at 8 a.m. and 2 p.m. which indicated Pt 38 had no pain. RN 4 stated Pt 38 did not have a pain assessment completed when Pt 38 was administered pain medication at 8:41 a.m. nor did Pt 38 have a pain reassessment within one hour of pain medication administration. The MAR indicated Pt 38 was administered acetaminophen-hydrocodone 325 mg-10mg by mouth at 3:35 p.m. with a pain score of 9 (severe) out of 10 (Mild Pain=score of 1-3, Moderate Pain=score of 4-6, Severe Pain=score of 7-10). RN 4 stated the PAF indicated Pt 38’s pain was not reassessed until 9:44 p.m. (a lapse of 6 hours and 9 minutes). RN 4 stated pain medication administered by mouth should be reassessed within the hour. RN 4 stated a pain assessment before administering pain medication was to make sure the appropriate pain medication is administered for the patient’s pain score. RN 4 stated there were different pain medications for different pain scores. RN 4 stated a pain assessment should have been reassessed within the hour after pain medication administration to make sure it was effective and there were no side effects (undesirable effect of a drug). The DWC stated she expected LNs to complete a pain assessment and/or reassessment when pain medication was administered. During a concurrent interview and record review on 9/13/24 at 2:02 p.m. with Shift Manager (SM) 2, Pt 45’s “Consult Note (CN),” dated 9/12/24 and “Face Sheet (FS-a document that contains a summary of a patients’ personal information), dated 9/13/24, were reviewed. The CN indicated, “ ... 77 [year-old] [female] [past medical history] [gastroesophageal reflex disease (GERD- a common condition in which the stomach contents move up into the esophagus)], [hypertension- when the pressure in your blood vessels is too high] ... epigastric [abdominal] pain 9/10/2024 ...” The FS indicated Pt 45 was admitted to the facility on 9/12/24 at 1:40 p.m. for a small bowel obstruction (a blockage in the small intestine that prevents food, liquid, gas, and stool from passing through normally). During a review of Pt 45’s physician “Medication Order (MO)”, dated 9/11/24 at 11:15 a.m., the MO indicated, “ ... morphine [narcotic medication used for moderate to severe pain] ... 4 mg ... Injection [administering a liquid] ... IV Push [IVP -pushing into intravenous line] ... Q4hr [every 4 hours] ... PRN [as needed] ... PRN reason ...Abdominal Pain ...”. During a concurrent interview and record review on 9/13/24 at 2:10 p.m. with SM 2, Pt 45’s “MAR,” dated 9/10/24 to 9/12/24, and “PAF,” dated 9/10/24 to 9/12/24, were reviewed. The MAR indicated Pt 45 was administered morphine 4 mg IVP on 9/10/24 at 8:50 p.m. and 9/11/24 at 1:37 a.m. The PAF indicated Pt 45’s had a pain assessment on 9/10/24 at 8:02 p.m. with a pain score of 5 (moderate) and the next pain assessment was 9/11/24 at 7:18 a.m. with no pain (a lapse of 11 hours and 16 minutes). SM 2 stated Pt 45 did not have a pain reassessment within 30 minutes to an hour to see if the pain medication was effective. SM 2 stated Pt 45 did not have a pain assessment before administering morphine 4 mg IVP on 9/11/24 at 1:37 a.m. and a pain reassessment was not completed within 30 minutes to an hour. The MAR on 9/11/24 at 11:18 a.m. indicated Pt 45 received morphine 4 mg IVP and a pain score of 9 (severe). SM 2 stated the PAF indicated Pt 45 did not have a pain reassessment within 30 minutes to an hour. The PAF indicated the next pain assessment was on 9/11/24 at 9:14 p.m. with no pain (a lapse of 9 hours and 56 minutes). The MAR on 9/11/24 at 8:14 p.m. indicated Pt 45 received morphine 4 mg IVP. SM 2 stated the PAF indicated Pt 45 did not have a pain assessment when morphine 4 mg IVP was administered on 9/11/24 at 8:14 p.m. The MAR indicated Pt 45 was administered morphine 4 mg IVP on 9/12/24 at 1:50 p.m. SM 2 stated the PAF indicated Pt 45 did not have a pain assessment when morphine 4 mg IVP was administered on 9/12/24 at 1:50 p.m. SM 2 stated the PAF indicated Pt 45 had a pain reassessment on 9/12/24 at 2:48 p.m. (a lapse of 58 minutes) with no pain. During a concurrent interview and record review on 9/13/24 at 2:25 p.m. with SM 2, Pt 45’s “MAR,” dated 9/13/24 and “PAF,” dated 9/13/24 were reviewed. The MAR at 6:16 a.m. indicated Pt 45 was administered hydromorphone (a medication to treat moderate to severe pain) 1 mg IVP with a pain score of 8 (severe). SM 2 stated the PAF indicated Pt 45 had a pain assessment at 9:50 a.m. (a lapse of 3 hours and 34 minutes) with a pain score of 5 (moderate). SM 2 stated Pt 45 did not have a pain assessment completed within 30 minutes to an hour after pain medication administration. The MAR at 10:45 a.m. indicated Pt 45 was administered hydromorphone 1 mg IVP with a pain score of 7 (severe). SM 2 stated the PAF indicated Pt 45 did not have a pain reassessment as of current time (2:33 p.m.). SM 2 stated Pt 45 did not have a pain reassessment completed within 30 minutes to an hour. During a concurrent interview and record review on 9/17/24 at 1:48 p.m. with RN 5, Pt 50’s “Emergency Department Note - Physician (EDNP),” dated 9/10/24 was reviewed. The EDNP indicated, “ ...a 73-year-old female patient with no known past medical history ... was brought in by [ambulance] from [Name of Shelter] with complaints of nausea, vomiting and headache ...” During a concurrent interview and record review on 9/17/24 at 1:48 p.m. with RN 5, Pt 50’s “MAR,” dated 9/10/24 and “PAF,” dated 9/10/24 were reviewed. The MAR at 8:15 a.m. indicated Pt 50 received acetaminophen 1,000 mg by mouth. RN 5 stated the PAF indicated Pt 50 had a pain assessment at 7:29 a.m. with a pain score of 4 (moderate) and 11:21 a.m. with no pain. RN 5 stated Pt 50 should have had a pain reassessment completed within one hour after pain medication administration. During an interview on 9/16/24 at 3:17 p.m. with Director of Patient Care Services (DPCS) 1, DPCS 1 stated, nursing staff were expected to reassess patients after pain medication was administered. DPCS 1 stated nursing staff were expected to complete a full pain assessment daily and with vital signs, every four hours. DPCS 1 stated nursing staff were expected to document pain assessments. During an interview on 9/16/24 at 3:25 p.m. with DPCS 3, DPCS 3 stated, nursing staff were expected to reassess patients within one hour or sooner after administration of pain medications. DPCS 2 stated nursing staff were expected to complete comprehensive, complete pain assessments and to document the pain assessments according to hospital policy. During an interview on 9/16/24 3:40 p.m. with DPCS 2, DPCS 2 stated her expectation was for nursing staff to complete pain assessments every shift and within an hour after pain medications were administered. DPCS 3 stated, her expectation was for nursing staff to follow hospital policy for pain assessments. During an interview on 9/17/24 at 4:20 p.m. with the Chief Nursing Officer (CNO), the CNO stated nursing staff were expected to reassess patients within one hour after administration of pain medications. The CNO stated nursing staff could speak to physicians for additional or different medications when pain was not controlled. The CNO stated nursing staff were expected to document responses to pain medications timely. During a review of the facility’s “P&P” titled, “PC.AD.1.24 Pain Management Policy,” dated 4/27/22, the “P&P” indicated “ ... Conduct an appropriate assessment and/or reassessment of a patient’s pain consistent with the scope of care, treatment, and service ... The 0-10 Numeric Rating scale shall be used to score pain as appropriate using the “Mild, Moderate, and Severe” pain indications referenced ... A focused reassessment for the presence and intensity of pain shall be performed as a component of the shift assessment ... and any intervention intended to lessen the patient’s pain (e.g., administration of pain medications ...) ... ongoing and dynamic process which shall take place within a clinically appropriate time frame ...”. During a professional reference review titled, “Pain management in hospitals: patients’ satisfaction and related barriers,” dated 9/25/18, (found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6207353/) indicated, “ ... Suboptimal pain control has been frequently reported in healthcare settings and documented to negatively impact patients’ health. Patients’ perception regarding pain management may influence their satisfaction regarding treatment ...”. During a concurrent interview and record review on 9/12/24 at 2:22 p.m. with RN 1, Pt 49’s “H&P,” dated 9/4/24, was reviewed. The “H&P” indicated Pt 49 was admitted to the hospital on 9/4/24 at 3:06 a.m. with a one-day history of being “found down [patient found on the ground]” Pt 49 was admitted for severe sepsis (life-threating infection), multiple pressure injuries (areas of damaged skin caused by prolonged pressure on the body), and metabolic encephalopathy (brain dysfunction caused by chemical imbalance, can cause confusion). During a review of the facility P&P “Documentation Policy (PC.AD.1.08) dated 3/23/23, the P&P indicated, “ ...II. Purpose: To outline responsibilities related to documentation of patient care from admission through discharge ...III. Policy: ...it should include ....care delivered (or not delivered); ...advice sought in decision making; and the patient’s response to treatment ...3. Charting by exception is to be utilized as a method of charting designed to minimize clerical activities; a notation (annotation) is made only when there is a deviation from the baseline or expected outcome, or when a procedure or expected activity is to be omitted ... 10 ... g. Changes in patient condition are documented within the appropriate HER system review; along with physician notifications ...” During a review of the hospital document titled Plan of Correction, dated 5/31/24 indicated: “ ...CMS 2567 - INFECTION CONTROL SURVEILLANCE, PREVENTION Tag: A750- 482.42(a)(3) Findings A750 14 A, B, C, D, and E ... Finding 14: In the kitchen responsible for patient food storage, preparation, and service: 14.A A black substance was on surfaces throughout the pot and pan room where food preparation utensils and equipment were cleaned; the facility did not follow the recommendations of the Infection Preventionist and the contracted service, who found the substance to be mold; and the facility did not follow their policy and procedures for monitoring and maintaining a clean kitchen. 14.B. A Black substance was on the surface of the walk-in food storage refrigerator door frame and rubber gasket (a rubber strip around the circumference of the door and/or door frame to help produce an air-tight seal to keep the outside temperatures from entering while simultaneously keeping cool air inside) which was not in accordance with the facility’s Sanitation Program policy and procedure. 14.C. Floors in food preparation areas were dirty and were in poor condition and maintenance of the floor was not in accordance with policy and procedure and standards of practice. 14. D. Walk-in refrigerator food storage shelving was not clean and in poor condition and not in accordance with the facility’s policy and procedure for kitchen sanitation and maintenance. 14. E. Walk-in food storage refrigerator fan guards were not clean and were not maintained in accordance with the facility’s policy and procedure for maintenance and sanitation of the kitchen. Corrective Actions: On 5/16/2024, a deep cleaning of all surfaces and listed equipment was completed, including the fan in the walk-in refrigerator. Additional flooring cleaning specialists professionally cleaned the kitchen floors the evening of 5/21/2024 and 5/22/2024. The kitchen floor tiles in poor condition were replaced during the time of the survey. The walk-in refrigerator food storage shelving was deep cleaned on 05/16/2024. Any shelving that did not meet cleanliness and integrity standards was immediately removed ....Completion date: 5/22/2024 ... Monitoring: Dietary leadership/designee Infection Preventionist/designee rounds and conducts observation of kitchen cleanliness. Rounds are conducted weekly for compliance for three consecutive months at 100% compliance. The auditor documents on the rounding checklist. After 100% compliance is achieved for three consecutive months, rounding will be conducted monthly to ensure sustainability. The data is reported to the Infection Prevention Committee, Quality Department, Quality Council, Medical Executive Committee (MEC), and Board of Governors (BOG) monthly. Completion date: 5/31/2024 and on-going. Responsible Person(s): FANs Director, AA, COO ...” Multiple drawers in the food preparation areas of the kitchen had a build-up of crumbs, one drawer had a binder with food crusted and personal items. According to the FDA Federal Food Code all non-food contact surfaces of the kitchen should be kept clean. The floor underneath fixed equipment in the kitchen had a buildup of trash, food, grease, and black grime. There was a build-up of food in the floor drain that was under a reach- in refrigerator. According to the FDA Federal Food Code all non-food contact surfaces of the kitchen should be kept clean. Shelves in 3 reach-in refrigerators in the kitchen near the tray line area (where food is plated for the patients) were coated in metal chards and build-up of black dust like substance. The plate warmer had a build-up of food crumbs. A commercial food warmer (used to keep food warm prior to service) had a build-up of black and red grime and convection ovens had a build-up of red and black grime. According to the FDA Federal Food Code all non-food contact surfaces of the kitchen should be kept clean. During an interview on 9/17/24 at 4:30 p.m. with the CNO, the CNO stated, “of course I’m disappointed that there are deficiencies that haven’t been corrected. The expectation is that we follow our Plan of Corrections.” During a review of hospital policy titled, “Performance Improvement Program,” the policy indicated, “ ...3. AUTHORITY AND RESPONSIBILITY” The Governing Body authorizes the establishment of this performance improvement program. The governing body is responsible for assuring: that an ongoing program for quality improvement is defined implemented and maintained. That the ongoing program for patient safety including reduction of medical errors is defined implemented end of maintained ...””

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 47205 Based on interview and record review, the hospital failed to assign licensed nurses (LNs) to meet the needs of patients who presented to the Emergency Department (ED) for emergent care. ED patients were triaged (a medical process that involves sorting and prioritizing patients based on their medical needs and the available resources) then returned to the (ED) waiting room (WR), rather than be admitted to the main ED, due to practice of closing patient beds/rooms to free up a Registered Nurse (RN) to cover staff breaks. This failure had the potential to result in delayed patient care and for ED patients to not receive ordered treatments and/or medications to address their emergent needs due to their placement in the WR where the patient’s nurse cannot continually assess the patient’s condition and obtain vital signs as the situation warrants and treatments are limited (e.g.: no IV, or IV medications may be given to the patient) to ensure the patient is not placed at risk for harm or injury while unattended by a RN in the WR. Findings: During a concurrent interview and record review on 9/17/24 at 9:17 a.m. of the 7/4/24 ED schedule with the ED Manager (EDM) and RNQ 3, the EDM stated she is “acting” or “interim” (there is no permanent manager currently) ED Manager, prior to this she was an ED Shift Manager. EDM stated she has taken over the staffing and scheduling for the ED. EDM explained her scheduling process, which includes staff self-schedule submissions, with the goal of an even number of staff assigned throughout the schedule (i.e.: high volume days are staffed with a greater number of staff to meet anticipated higher volume of patients coming to the ED for care). EDM stated her goal is to staff to a minimum of 10 RNs daily. EDM stated unanticipated leave of absences, sick calls and several open RN and ED Tech (ED Technician- main function is to support registered nurses in a hospital emergency department to provide the highest quality patient care.) positions have prompted her to submit four (4) “Traveler Requests” (nurses who are not employees of the hospital, but work for another agency and supply temporary help) to fill behind these open positions, however this process is not an immediate remedy due to the hiring and onboarding process can be approximately 4-6 weeks prior to being able to work in the ED. EDM stated that Central Staffing (department that manages the day-to-day staffing for patients admitted to the hospital) sometimes has staff available to float into the ED, as needed to supplement their nursing staff. EDM stated the nurse-to-patient ratio is 1 LN to 4 patients in the ED and they try to meet that requirement when scheduling LNs. EDM stated another goal is to staff a “break nurse” (a nurse whose primary job is to take over care for nurses so they can go on break). If a dedicated break nurse is not available, the nurses break each other (this means nurse A takes on nurse B’s patient assignment (e.g.: nurse to patient ratio increases to 1:8 from 1:4) or the charge nurse covers breaks, or if trauma nurse (a registered nurse (RN) who specializes in providing life-saving care to patients with critical injuries or medical emergencies.) doesn’t have patients in the trauma and higher acuity patient care areas (C and D pods) they can come over and help with breaks. EDM stated if a trauma patient presents for care, the trauma nurse must return to the trauma area to provide care. EDM stated “mid-shifters also help with covering breaks, as they arrive to work [at 9:00 a.m., 10:00 a.m., 11:00 a.m., 12:00 p.m., 3:00 p.m., and 3:00 a.m.] The EDM stated of the mid-shifters, “their assignments aren’t fixed. There are days when staff do not get breaks, rarely happens.” EDM stated D and C pods along with Express Care [of mental health patients] are always open. ED Tech assignments are based on area open in the ED, one ED Tech may be assigned to cover multiple areas such as in “B” pod- which is a “catch all area and doesn’t always have an ED Tech assigned because aren’t always open.” EDM stated her expectation is that the ED Techs should be rounding, but it “doesn’t always happen.” During a review of the facility P&P “Standard of Care Policy (ED.1.04) dated 10/23/22, the P&P indicated, “ ...I. Purpose: These are the fundamental components of care that are to be applied to any patient presenting for treatment to the ED. This standard of care must be used in conjunction with more specific protocols that are relevant to the patient’s chief complaint ...II. Policy: ...2. All patient conditions will be classified and prioritized utilizing the Emergency Severity Index [ESI] ...The patient’s nurse is responsible for continually assessing the patient’s condition and obtaining vital signs as the situation warrants . Patient acuity will determine the frequency of vital signs. Abnormal vital signs will be checked prior to discharge, and persistent abnormalities will be brought to the physician’s attention ... 9 ....a. Documentation of any changes in patient status and physician notification when significant changes occur ...””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 40644 Based on interviews and record reviews, the facility failed to develop current nursing care plans for one of eight sampled patients (Pt 43) when Pt 43 was placed on non-violent restraints and the care plan for restraints was not initiated at placement. This failure had the potential to result in necessary nursing care not being provided to the Pt 43 and potential for patient harm. Findings: During a review of Pt 43’s “Face Sheet (FS-a document that contains a summary of a patients’ personal information),” dated 9/9/24 and “History and Physical (H&P), dated 9/8/24, the FS indicated Pt 43 was admitted to the facility on 9/8/24 at 7:11 p.m. The H&P indicated, “ ...62 year old female with history of bipolar disorder, work related [TBI] that presented to the [emergency room] with alter mental status ... She is not demonstrating weakness and is not able to follow commands or responding to questions ...” During a concurrent interview and record review on 9/17/24 at 9 a.m. with Registered Nurse Quality (RNQ) 2, Pt 43’s “Physician Orders (PO),” dated 9/8/24 was reviewed. The PO indicated, “ ...ED Non-Violent/Non Self Destructive Restraint ... Indication for Restraint ... Impulsive. Observed disconnecting and/or removing Therapeutic devices (s) ... Observed trying to climb out of bed when instructed not to do so ... Restraint Device ...Soft Wrist Right ...Soft Wrist Left ... Additional Orders: Update patient’s Care Plan ...” RNQ 2 stated the PO indicated the restraint order was placed at 6:30 p.m. During a concurrent interview and record review on 9/17/24 at 9:05 a.m. with RNQ 2, Pt 43’s “Electronic Medical Record (EMR-an electronic record of health-related information on an individual),” dated 9/8/24 to 9/10/24, and “Interdisciplinary Care Plans (ICP),” dated 9/8/24 to 9/9/24 were reviewed. RNQ 2 stated Pt 43 was transferred to an inpatient bed on 9/8/24 at 8:49 p.m. from the Emergency Department (ED) and remained on non-violent restraints until 9/10/24 at 8:30 a.m. RNQ 2 stated the ICP indicated a non-violent restraints care plan was initiated on 9/9/24 at 1:37 p.m. (a lapse of 16 hours and 28 minutes). RNQ 4 stated a non-violent restraints care plan should have been initiated when the non-violent restraints were applied. RNQ 4 stated a care plan allowed LNs to know what interventions were needed for the patient. During an interview on 9/17/24 at 4:20 p.m. with the Chief Nursing Officer (CNO) and Quality Manager (QM) 1, QM 1 stated there was no policy on care plans. The CNO stated she expected a care plan for restraints to be initiated upon application. During a review of the facility’s policy and procedure (P&P) titled, “Restraints and Seclusion,” the P&P indicated, “ ...PURPOSE: To define [Name of Hospital] approach to the use of restraint and seclusion for patients in a way that protects the patient’s health and safety, and preserves their dignity, rights, and well-being ... Non-violent/Medical Behavior: Behavior resulting from a non-psychiatric medical condition and/or does not jeopardize the immediate safety of others but may result in harm to self. Restraint: Any manual method: physical or mechanical device, material, or equipment that immobilizes or reduces the patient’s ability to move their arms, legs, body, or head freely ... Procedure: ... Monitoring and Reassessment ...When Restraint or Seclusion is used, there must be documentation in the patient’s medical record of the following: ... Use of Restraint or Seclusion in the Plan of Care ...” During a review of a professional reference titled, “Nursing Process,” dated 4/10/23, retrieved from https://www.ncbi.nlm.nih.gov/books/NBK499937/, the Nursing Process indicated, “ ...Planning ...The planning stage is where goals and outcomes are formulated that directly impact patient care based on EDP guidelines. These patient-specific goals and the attainment of such assist in ensuring a positive outcome. Nursing care plans are essential in this phase of goal setting. Care plans provide a course of direction for personalized care tailored to an individual’s unique needs. Overall condition and comorbid conditions play a role in the construction of a care plan. Care plans enhance communication, documentation, reimbursement, and continuity of care across the healthcare continuum. Goals should be: 1. Specific; 2. Measurable or Meaningful; 3. Attainable or Action-Oriented; 4. Realistic or Results-Oriented; 5. Timely or Time-Oriented ...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 47205 Based on observation, interview and record review, the facility failed to ensure all licensed nurses adhered to the hospital’s policies and procedures (P&P), when: 1. Licensed Nurses (LNs) did not adhere to the hospital’s P&P “Pain Management Policy” for seven of 29 patients (Pt), Pt 5, Pt 10, Pt 26, Pt 27, Pt 38, Pt 45, and Pt 50. LNs did not reassess pain timely after administration of pain medication according to hospital policy. These failures placed Pt 5, Pt 10, Pt 26, Pt 27, Pt 38, Pt 45, and Pt 50 at risk for inadequate pain management or oversedation and could negatively affect the physical, emotional, and psychosocial (the influence of both physical and social factors on an individual) well-being of patients. 2. LNs did not adhere to P&P “Pressure Injury Prevention and Management Policy” for two of three patients (Pt 25 and Pt 49). LNs did not document turning patients every two hours per physician order. This failure had the potential for Pt 25 and Pt 49 to have further skin breakdown and new pressure injuries. 3. One of four patients (Pt 36) did not have documented fundal (top of uterus), or lochia (vaginal discharge after birth, bleeding) assessments by LNs after delivery in the Labor and Delivery (L&D) unit according to facility procedure. This failure placed Pt 36 at risk for uterine atony (loss of tone) and hemorrhage (dangerous complication of excessive bleeding). 4. Two of 13 patients (Pt 36 and Pt 38) did not have a head-to-toe assessment (complex multisystem assessment completed by the LN) completed in accordance with the facility’s P&P titled, “Documentation Policy.” This failure resulted in Pt 36 and Pt 38’s head to toe assessment to not be completed which had the potential for any changes to go undetected. 5. One of one patient (Pt 36) did not have vital signs (measurements are taken to help assess the general physical health of a person, give clues to possible diseases, and show progress toward recovery) assessments completed after an epidural (a procedure used to relieve pain during labor) placement in accordance with the facility’s P&P titled, “Epidural Management for the Laboring Patient Nursing Guidelines.” This failure had the potential to result in hypotension (low blood pressure-occurs when blood flows through your blood vessels at a lower-than-normal pressure), infection, and cardiac arrest (when the heart stops beating) leading to clinical deterioration and/or death. 6. LNs did not enter a physician verbal order for one of one patient (Pt 38) when a verbal order to discontinue magnesium sulfate (medication indicated for the prevention and control of seizures in preeclampsia-a serious blood pressure condition that develops during pregnancy) infusion was given by the nurse practitioner. This failure resulted in LNs not following physician orders and the potential for adverse outcomes for Pt 38. 7. Two of 11 patients (Pt 17 and Pt 20) did not have vital signs assessed and documented in accordance with hospital policy Standard of Care P&P, and Documentation P&P and/or professional standards . This failure had the potential to result in a change in condition for Pt 17 and 20 to be missed and acted on by the LN. 8. One of 11 patients (Pt 17) refused medication ordered by the physician and the LN did not notifying and document a notification to the physician per the hospital’s P&P titled “Documentation Policy.” This failure resulted in an ordered medication to not be administered, placing Pt 17 at risk for a missed change in Pt 17’s medical condition. Findings: 1. During a review of Pt 26’s “History and Physical [H&P- complete patient assessment by physician]”, dated 9/4/24, the “H&P” indicated, Pt 26 was admitted to the hospital as an inpatient on 9/4/24 at 7:24 p.m. for status post (after surgery) hardware infection. Pt 26 had a recent left tibia (long bone in lower leg) open reduction internal fixation (ORIF- a surgical procedure for repairing fractured bone using either plates, screws, or a rod) with an external (outside the body) frame attached to internal (inside the body) hardware (implant, such as a plate, rod, screw, or nail that is used to hold bones together). During a concurrent observation and interview on 9/10/24 at 3:07 p.m. with Pt 26 in Pt 26’s hospital room, Pt 26 was observed with his left leg elevated on a pillow. The top of Pt 26’s left leg right below his knee had a round metal frame encircling his leg, with metal pins puncturing his skin. Pt 26 stated he was in the hospital due to an infection in his left leg from a recent surgery. Pt 26 stated his leg was very painful at times. Pt 26 stated, nursing staff must be “very busy” because they are slow to answer his call light and bring him his pain medication. Pt 26 stated, he received both oral and intravenous (IV- in the vein) scheduled and as needed pain medication. Pt 26 stated he had scheduled pain medication every four hours. Pt 26 stated when his pain medication was late it was hard to keep his pain controlled. During a review of Pt 26’s “MO 1”, dated 9/5/24 at 10:05 a.m., the “MO 1” indicated, “ ... morphine [narcotic medication used for moderate to severe pain] ... 2 milligrams, [mg- a unit of measurement] ... Injection [administering a liquid] ... IV Push [IVP -pushing into intravenous line] ... Q2hr [every 2 hours] ... PRN [as needed] ... Pain Breakthrough [pain not controlled with scheduled medications] ...”. During a concurrent interview and record review on 9/12/24 at 3:15 p.m. with Registered Nurse Quality (RNQ) 1, Pt 26’s “Pain Assessment Flowsheet (PAF)”, and “Medication Administration Record [MAR- an electronic record of medications that were given]”, dated 9/9/24 were reviewed. The “PAF” indicated, Pt 26’s pain was assessed on 9/9/24 at 10:53 a.m. as a nine (severe). RNQ 1 stated, a pain score of 1-3 was mild pain, 4-6 was moderate pain and 7-10 was severe pain. The “MAR” indicated 2 mg morphine IVP was administered at 10:53 a.m. RNQ 1 stated, Pt 26’s pain was not reassessed until 9/9/24 at 1 p.m. and scored an eight. RNQ 1 stated, Pt 26 should have had a pain reassessment on 9/9/24 at 11:53 a.m. one hour after pain medication was administered. During an interview on 9/16/24 at 2:37 p.m. with Registered Nurse (RN) 2, RN 2 stated nursing staff were supposed to reassess and document pain after administration of medication within one hour. RN 2 stated reassessment was important because some patients do not respond to certain types of medications. RN 2 stated patients also needed to be monitored for sedation after certain types of pain medication administration, respirations, and heart rate needed to be closely monitored for the safety of the patient. During a review of Pt 27’s “H&P, dated 9/2/24, the “H&P” indicated, Pt 27 arrived in the ED with intractable (hard to control) back and pelvic (basin-shaped complex of bones that connects the trunk and the legs) pain. Pt 27 had a past medical history of recurrent hypercalcemia (high blood calcium), severe osteoporosis (bone mass and strength decreases) with multiple thoracolumbar fractures (area of the back between the ribcage and the lower back). T4, T12, (mid back) L1, L3, L4 (lower back), and occlusive deep vein thrombosis (DVT-blood clots form in deep veins). Pt 27 was admitted to the hospital as an inpatient on 9/1/24 at 10:31 p.m. with hypoxemic respiratory failure (not enough oxygen in the blood). During a concurrent interview and record review on 9/12/24 at 9:30 a.m. with RN 1, Pt 27’s “PAF”, and “MAR”, dated 9/7/24 were reviewed. The “PAF” indicated Pt 27’s pain was assessed on 9/7/24 at 5:32 a.m. as nine (severe). The “MAR” indicated, on 9/7/24 at 5:32 a.m. Pt 27 was administered 10 mg oxyCODONE by mouth. RN 1 stated Pt 27’s pain was reassessed on 9/7/24 at 8 a.m. as zero. RN 1 stated, Pt 27 should have had a pain reassessment on 9/7/24 at 6:32 a.m. one hour after pain medication was administered. RN 1 stated pain reassessments were important to evaluate the effectiveness of administered medications. During a review of Pt 27’s “MO 1”, dated 9/2/24 at 12:50 a.m., the “MO 1” indicated, “ ... oxyCODONE [narcotic medication for moderate to severe pain] ... 10 mg ... 2 tab ... Oral ... Q4hr [every 4 hours] ... PRN [as needed] ... Pain Severe ...”. During a concurrent interview and record review on 9/12/24 at 10 a.m. with RN 1, Pt 27’s “PAF”, and “MAR”, dated 9/7/24 were reviewed. The “PAF” indicated Pt 27’s pain was assessed on 9/7/24 at 5:32 a.m. as nine (severe). The “MAR” indicated, on 9/7/24 at 5:32 a.m. Pt 26 was administered 10 mg oxyCODONE by mouth. RN 1 stated Pt 27’s pain was reassessed on 9/7/24 at 8 a.m. as zero. RN 1 stated, Pt 26 should have had a pain reassessment on 9/7/24 at 6:32 a.m. one hour after pain medication was administered. RN 1 stated pain reassessments were important to evaluate the effectiveness of administered medications. During a review of Pt 27’s “MO 1”, dated 9/2/24 at 12:50 a.m., the “MO 1” indicated, “ ... oxyCODONE [narcotic medication for moderate to severe pain] ... 10 mg ... 2 tab ... Oral ... Q4hr [every 4 hours] ... PRN [as needed] ... Pain Severe ...”. During a review of Pt 5’s “H&P, dated 8/26/24, the “H&P” indicated, Pt 5 arrived in the Emergency Department (ED) on 8/25/24 at 6:33 p.m. with abdominal (stomach) pain. Pt 5 was admitted to the hospital as an inpatient on 8/25/24 at 11:58 p.m. with diverticulitis (small pouches in the intestines become inflamed or infected), with micro perforation (a very small hole/puncture), and sepsis (serious infection that can lead to lead to tissue damage organ failure or death). During a review of Pt 5’s “Medication Order (MO 1)”, dated 8/25/24 at 6:54 p.m., the “MO 1” indicated, “ ... Acetaminophen [a pain reliever medication] ... 1,000 milligrams [mg - a unit of measurement] ... 2 tab [tablets] ... Oral ... STAT [immediately] ...”. During a review of Pt 5’s “MO 2”, dated 8/25/24 at 7:42 p.m., the “MO 2” indicated, “ ... oxyCODONE [narcotic medication for moderate to severe pain] ... 10 mg ... 2 tab ... Oral ... STAT ...”. During a concurrent interview and record review on 9/16/24 at 4:31 p.m. with RNQ 1, Pt 5’s “PAF”, and “MAR”, dated 8/25/24 to 8/26/24 were reviewed. RNQ 1 stated Pt 5’s pain was assessed on 8/25/24 at 6:40 p.m. as 10 (severe). RNQ 1 stated, a pain score of 1-3 was mild pain, 4-6 was moderate pain and 7-10 was severe pain. The “MAR” indicated, on 8/25/24 at 6:58 p.m. Pt 5 was administered 1,000 mg acetaminophen. RNQ 1 stated Pt 5’s pain was reassessed on 8/25/24 at 8:13 p.m. as an eight (severe). RNQ 1 stated, Pt 5 should have had a pain reassessment on 8/25/24 at 7:58 p.m. one hour or less after pain medication was administered. During a concurrent interview and record review on 9/16/24 at 4:40 p.m. with RNQ 1, Pt 5’s “PAF”, and “MAR” dated 8/25/24 to 8/26/24 were reviewed. RNQ 1 stated, on 8/25/24 at 8:10 p.m. Pt 5 was administered 10 mg oxyCODONE for a pain score of 8. The “PAF” indicated, pain or sedation level (level of drug-induced sleep) was not assessed again until 8/26/24 at 2:32 a.m. The pain reassessment was documented as “no actual pain present”, no numerical score was associated with the pain reassessment. RNQ 1 stated a pain reassessment should have been completed on 8/25/24 at 9:10 p.m. one hour after administration of the narcotic medication. RNQ 1 stated pain reassessments were important to ensure patients were getting pain control as well as not being overly sedated by pain medications. During a review of Pt 10’s “H&P”, dated 9/9/24, the “H&P” indicated, Pt 10 was admitted to the hospital as an inpatient on 9/9/24 at 7:20 p.m. with acute cholecystitis (redness and swelling of gallbladder [pouch like organ in upper right of stomach]) and presumed gallstone pancreatitis (swelling of pancreas [organ behind stomach that produces digestive juices and hormones]) Pt 10 was admitted for laparoscopic cholecystectomy (small holes in stomach for small instrument to remove gallbladder). During a review of Pt 10’s “MO 1”, dated 9/13/24 at 6:06 p.m., the “MO 1” indicated, “ ... acetaminophen - HYDROcodone [narcotic medication] ... 325 mg [acetaminophen] 5 mg [HYDROcodone] ... 1 tab ... Oral ... Q4hr [every 4 hours] ... PRN [as needed] ... Pain Mild ... [1-3] ...”. During a concurrent interview and record review on 9/17/24 at 9:15 a.m. with RNQ 1, Pt 10’s “PAF”, and “MAR” dated 9/13/24 were reviewed. RNQ 1 stated, on 9/13/24 at 5:48 p.m. Pt 10 was administered 325 mg-5 mg acetaminophen HYDROcodone for a pain score of 3. The “PAF” indicated, on 9/13/24 at 8 p.m. a pain reassessment of three was documented. Pt 10’s “PAF” indicated a pain acceptable intensity score of 3. RNQ 1 stated a pain reassessment should have been completed on 9/13/24 at 6:48 p.m. one hour after administration of the narcotic medication. During a concurrent interview and record review on 9/13/24 at 9 a.m. with the Director of Women and Children Services (DWC) and Registered Nurse (RN) 4, Pt 38’s H&P was reviewed. The H&P indicated, Pt 38 was a 33-year-old, gravida (G- the total number of confirmed pregnancies) 4 para (P- the number of live births) 2 at 35.6 weeks gestation (the period of time when something is conceived and developed; normal gestation is 40 weeks). Pt 38 was admitted for severe preeclampsia (a serious blood pressure condition that develops during pregnancy) for a repeat cesarean section (C/S- the surgical delivery of a baby through a cut made in the birth parent’s abdomen and uterus). During a concurrent interview and record review on 9/13/24 at 9:05 a.m. with the DWC and RN 4, Pt 38’s “Medication Administration Record (MAR),” dated 9/12/24, and “Pain Assessment Flowsheet (PAF),” dated 9/12/24 were reviewed. The MAR indicated, “ ...acetaminophen-hydrocodone ... 325 [milligrams (mg-unit of measure)]-10 mg oral) ... 1 tab ... [every] 4 [hour] [as needed] ...” The MAR indicated Pt 38 was administered acetaminophen-hydrocodone 325 mg-10mg by mouth at 8:41 a.m. RN 4 stated the PAF indicated Pt 38 had a pain assessment at 8 a.m. and 2 p.m. which indicated Pt 38 had no pain. RN 4 stated Pt 38 did not have a pain assessment completed when Pt 38 was administered pain medication at 8:41 a.m. nor did Pt 38 have a pain reassessment within one hour of pain medication administration. The MAR indicated Pt 38 was administered acetaminophen-hydrocodone 325 mg-10mg by mouth at 3:35 p.m. with a pain score of 9 (severe) out of 10 (Mild Pain=score of 1-3, Moderate Pain=score of 4-6, Severe Pain=score of 7-10). RN 4 stated the PAF indicated Pt 38’s pain was not reassessed until 9:44 p.m. (a lapse of 6 hours and 9 minutes). RN 4 stated pain medication administered by mouth should be reassessed within the hour. RN 4 stated a pain assessment before administering pain medication was to make sure the appropriate pain medication is administered for the patient’s pain score. RN 4 stated there were different pain medications for different pain scores. RN 4 stated a pain assessment should have been reassessed within the hour after pain medication administration to make sure it was effective and there were no side effects (undesirable effect of a drug). The DWC stated she expected LNs to complete a pain assessment and/or reassessment when pain medication was administered. During a concurrent interview and record review on 9/13/24 at 2:02 p.m. with Shift Manager (SM) 2, Pt 45’s “Consult Note (CN),” dated 9/12/24 and “Face Sheet (FS-a document that contains a summary of a patients’ personal information), dated 9/13/24, were reviewed. The CN indicated, “ ... 77 [year-old] [female] [past medical history] [gastroesophageal reflex disease (GERD- a common condition in which the stomach contents move up into the esophagus)], [hypertension- when the pressure in your blood vessels is too high] ... epigastric [abdominal] pain 9/10/2024 ...” The FS indicated Pt 45 was admitted to the facility on 9/12/24 at 1:40 p.m. for a small bowel obstruction (a blockage in the small intestine that prevents food, liquid, gas, and stool from passing through normally). During a review of Pt 45’s physician “Medication Order (MO)”, dated 9/11/24 at 11:15 a.m., the MO indicated, “ ... morphine [narcotic medication used for moderate to severe pain] ... 4 mg ... Injection [administering a liquid] ... IV Push [IVP -pushing into intravenous line] ... Q4hr [every 4 hours] ... PRN [as needed] ... PRN reason ...Abdominal Pain ...”. During a concurrent interview and record review on 9/13/24 at 2:10 p.m. with SM 2, Pt 45’s “MAR,” dated 9/10/24 to 9/12/24, and “PAF,” dated 9/10/24 to 9/12/24, were reviewed. The MAR indicated Pt 45 was administered morphine 4 mg IVP on 9/10/24 at 8:50 p.m. and 9/11/24 at 1:37 a.m. The PAF indicated Pt 45’s had a pain assessment on 9/10/24 at 8:02 p.m. with a pain score of 5 (moderate) and the next pain assessment was 9/11/24 at 7:18 a.m. with no pain (a lapse of 11 hours and 16 minutes). SM 2 stated Pt 45 did not have a pain reassessment within 30 minutes to an hour to see if the pain medication was effective. SM 2 stated Pt 45 did not have a pain assessment before administering morphine 4 mg IVP on 9/11/24 at 1:37 a.m. and a pain reassessment was not completed within 30 minutes to an hour. The MAR on 9/11/24 at 11:18 a.m. indicated Pt 45 received morphine 4 mg IVP and a pain score of 9 (severe). SM 2 stated the PAF indicated Pt 45 did not have a pain reassessment within 30 minutes to an hour. The PAF indicated the next pain assessment was on 9/11/24 at 9:14 p.m. with no pain (a lapse of 9 hours and 56 minutes). The MAR on 9/11/24 at 8:14 p.m. indicated Pt 45 received morphine 4 mg IVP. SM 2 stated the PAF indicated Pt 45 did not have a pain assessment when morphine 4 mg IVP was administered on 9/11/24 at 8:14 p.m. The MAR indicated Pt 45 was administered morphine 4 mg IVP on 9/12/24 at 1:50 p.m. SM 2 stated the PAF indicated Pt 45 did not have a pain assessment when morphine 4 mg IVP was administered on 9/12/24 at 1:50 p.m. SM 2 stated the PAF indicated Pt 45 had a pain reassessment on 9/12/24 at 2:48 p.m. (a lapse of 58 minutes) with no pain. During a concurrent interview and record review on 9/13/24 at 2:25 p.m. with SM 2, Pt 45’s “MAR,” dated 9/13/24 and “PAF,” dated 9/13/24 were reviewed. The MAR at 6:16 a.m. indicated Pt 45 was administered hydromorphone (a medication to treat moderate to severe pain) 1 mg IVP with a pain score of 8 (severe). SM 2 stated the PAF indicated Pt 45 had a pain assessment at 9:50 a.m. (a lapse of 3 hours and 34 minutes) with a pain score of 5 (moderate). SM 2 stated Pt 45 did not have a pain assessment completed within 30 minutes to an hour after pain medication administration. The MAR at 10:45 a.m. indicated Pt 45 was administered hydromorphone 1 mg IVP with a pain score of 7 (severe). SM 2 stated the PAF indicated Pt 45 did not have a pain reassessment as of current time (2:33 p.m.). SM 2 stated Pt 45 did not have a pain reassessment completed within 30 minutes to an hour. During a concurrent interview and record review on 9/17/24 at 1:48 p.m. with RN 5, Pt 50’s “Emergency Department Note - Physician (EDNP),” dated 9/10/24 was reviewed. The EDNP indicated, “ ...a 73-year-old female patient with no known past medical history ... was brought in by [ambulance] from [Name of Shelter] with complaints of nausea, vomiting and headache ...” During a concurrent interview and record review on 9/17/24 at 1:48 p.m. with RN 5, Pt 50’s “MAR,” dated 9/10/24 and “PAF,” dated 9/10/24 were reviewed. The MAR at 8:15 a.m. indicated Pt 50 received acetaminophen 1,000 mg by mouth. RN 5 stated the PAF indicated Pt 50 had a pain assessment at 7:29 a.m. with a pain score of 4 (moderate) and 11:21 a.m. with no pain. RN 5 stated Pt 50 should have had a pain reassessment completed within one hour after pain medication administration. During an interview on 9/16/24 at 3:17 p.m. with Director of Patient Care Services (DPCS) 1, DPCS 1 stated, nursing staff were expected to reassess patients after pain medication was administered. DPCS 1 stated nursing staff were expected to complete a full pain assessment daily and with vital signs, every four hours. DPCS 1 stated nursing staff were expected to document pain assessments. During an interview on 9/16/24 at 3:25 p.m. with DPCS 3, DPCS 3 stated, nursing staff were expected to reassess patients within one hour or sooner after administration of pain medications. DPCS 2 stated nursing staff were expected to complete comprehensive, complete pain assessments and to document the pain assessments according to hospital policy. During an interview on 9/16/24 3:40 p.m. with DPCS 2, DPCS 2 stated, her expectation was for nursing staff to complete pain assessments every shift and within an hour after pain medications were administered. DPCS 3 stated, her expectation was for nursing staff to follow hospital policy for pain assessments. During an interview on 9/17/24 at 4:20 p.m. with the Chief Nursing Officer (CNO), the CNO stated, nursing staff were expected to reassess patients within one hour after administration of pain medications. The CNO stated nursing staff could speak to physicians for additional or different medications when pain was not controlled. The CNO stated nursing staff were expected to document responses to pain medications timely. During a review of the facility’s “P&P” titled, “PC.AD.1.24 Pain Management Policy,” dated 4/27/22, the “P&P” indicated “ ... Conduct an appropriate assessment and/or reassessment of a patient’s pain consistent with the scope of care, treatment, and service ... The 0-10 Numeric Rating scale shall be used to score pain as appropriate using the “Mild, Moderate, and Severe” pain indications referenced ... A focused reassessment for the presence and intensity of pain shall be performed as a component of the shift assessment ... and any intervention intended to lessen the patient’s pain (e.g., administration of pain medications ...) ... ongoing and dynamic process which shall take place within a clinically appropriate time frame ...”. During a professional reference review titled, “Pain management in hospitals: patients’ satisfaction and related barriers,” dated 9/25/18, (found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6207353/) indicated, “ ... Suboptimal pain control has been frequently reported in healthcare settings and documented to negatively impact patients’ health. Patients’ perception regarding pain management may influence their satisfaction regarding treatment ...”. During a professional reference review titled, “Acute Pain Management Pearls: A Focused Review for the Hospital Clinician,” dated 12/22/22, (found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9818465/) indicated, “ ... Uncontrolled pain worsens patient outcomes ... Uncontrolled acute pain triggers a complex neurohormonal cascade that is toxic to nearly every organ system, as evidenced by increased rates of renal [kidney] and gastrointestinal [stomach and intestine] dysfunction, infection, cardiopulmonary [heart and lungs] and thrombotic [blood clot] complications, impaired wound healing, adverse psychological effects, and poorer functional recovery and quality of life ... Acute pain management in hospitalized patients should therefore be a clinician and intuitional priority as a key driver of patient outcomes ...”. 2. During a concurrent interview and record review on 9/12/24 at 2:22 p.m. with RN 1, Pt 49’s “H&P,” dated 9/4/24, was reviewed. The “H&P” indicated Pt 49 was admitted to the hospital on 9/4/24 at 3:06 a.m. with a one-day history of being “found down [patient found on the ground]” Pt 49 was admitted for severe sepsis (life-threating infection), multiple pressure injuries (areas of damaged skin caused by prolonged pressure on the body), and metabolic encephalopathy (brain dysfunction caused by chemical imbalance, can cause confusion). During a review of “Physician Order (PO)”, dated 9/4/24, the “PO” indicated, “ ... Turn Patient ... Q2hr [every two hours] ...”. During a concurrent interview and record review on 9/12/24 at 2:27 p.m. with RN 1 Pt 49’s “Braden Assessment (Braden) [Braden Score - given to determine risk of PI, a score of less than 18 indicates a risk for PI]”, dated 9/4/24 to 9/9/24 was reviewed. The “Braden” indicated on 9/4/24 LNs scored Pt 49 a 12 (high risk) of developing a PI. The “Braden” indicated Pt 49 had very limited mobility (makes occasional changes in body position but unable to make big changes independently), was bedfast (confined to bed), had slightly limited sensory perception (ability to respond to pressure related discomfort), and had poor nutrition (never/rarely ate a complete meal). RN 1 stated the lower the Braden score the higher the chances a patient may develop a PI. RN 1 stated a limited mobility patient had a higher potential for PIs unless repositioned by staff timely. During a concurrent interview and record review on 9/12/24 at 2:35 p.m. with RN 1, Pt 49’s “Adult ADLs (ADL) [ADL-activities of daily living]” flowsheet, dated 9/4/24 to 9/10/24 were reviewed. The “ADL” indicated, Pt 49 was positioned by staff on 9/9/24 at 4 a.m. and then not positioned (turned) again until 9/10/24 at 8:01 a.m., 28 hours later. RN 1 stated Pt 49’s “ADL” had documentation on 9/9/24 at 8:05 a.m., and 9/9/24 at 8:30 p.m. indicating Pt 49 was on a low air loss mattress, but no turns were documented. RN 1 stated LNs documented Pt 49’s activity status as complete bedrest (staying in bed most of the time). RN 1 stated LNs documented 49’s activity assistance as “total assist [required full physical assistance for re-positioning, standing, turning, transfers, and/or mobility]”. RN 1 stated Pt 49 should have been re-positioned every two hours. RN 1 stated skin breakdown and PI could occur when patients were not turned or repositioned. During a concurrent interview and record review on 9/12/24 at 2:54 p.m. with RNQ 1, Pt 25’s “H&P,” dated 7/31/24, was reviewed. The “H&P” indicated Pt 25 was a 72-year-old patient admitted to the hospital on 7/31/24 at 4:15 p.m. for sepsis. During a review of “Physician Order (PO)”, dated 7/31/24, the “PO” indicated, “ ... Turn Patient ... Q2hr [every two hours] ...”. During a concurrent interview and record review on 9/12/24 at 2:54 p.m. with RN 1 Pt 25’s “Braden,” dated 9/1/24, was reviewed. The “Braden” indicated on 9/1/24 LNs scored Pt 25 a 13 (moderate risk) of developing a PI. RN 1 stated Pt 25 was scored an 8 (severe risk) when admitted to the hospital on 7/31/24. The “Braden” indicated Pt 25 had “very limited mobility,” was bedfast, had slightly limited sensory perception, and had inadequate nutrition (rarely ate a complete meal). RN 1 stated patients who had inadequate nutrition were at a higher risk for PI. During a concurrent interview and record review on 9/12/24 at 2:35 p.m. with RN 1, Pt 25’s “ADL” flowsheet, dated 9/1/24 to 9/10/24 were reviewed. The “ADL” indicated, Pt 25 was positioned by staff on 9/1/24, 9/3/24 and 9/9/24 at 6 p.m. and not repositioned again until 8 a.m. the following morning, 14 hours later. RN 1 stated Pt 25’s “ADL” had documentation on 9/1/24, 9/3/24 and 9/9/24 at 8 p.m. indicating Pt 25 was on a low air loss mattress, but no turns were documented. The “ADL” indicated Pt 25 was positioned by staff on 9/2/24 at 6 p.m. and not repositioned again until midnight, six hours later. RN 1 stated Pt 25 should have been re-positioned every two hours. RN 1 stated LNs documented Pt 25’s activity status as complete bedrest (staying in bed most of the time). RN 1 stated LNs documented Pt 25’s activity assistance as “total assist [required full physical assistance for re-positioning, standing, turning, transfers, and/or mobility]”. RN 1 stated skin breakdown and PIs could occur when patients were not turned or repositioned. During an interview on 9/16/24 at 3:15 p.m. with DPCS, DPCS 1 stated patients who are bedridden and were total assist patients had a higher potential for PI. DPCS 1 stated her expectation was for LNs to protect patients’ skin from PIs, by following the hospitals policy and procedure. During an interview on 9/17/24 at 4:30 p.m. with the CNO, the CNO stated LNs were expected to assess patients’ skin at least once per shift including under pressure reduction dressings. The CNO stated her expectation was for staff to reposition patients to prevent PIs. During a review of the hospital’s P&P titled, “Pressure Injury Prevention and Management Policy,” dated 6/23/21, indicated, “ ... RNs will complete a comprehensive skin assessment with each shift re-evaluating as needed ... Risk assessment includes determining a person’s risk for pressure ulcer developing using the appropriate Braden scale; preventative interventions will target risk factors as determined by risk assessment. ... When a patient is identified as High Risk (Braden score of less than or equal to 18: Order and initiate “Tissue Skin Integrity Care” plan ... Attachments: ... Braden Pressure Reduction Measure ... Initiate a turn schedule ... Turn patients at least every 2 hours ...”. During professional reference review titled, “The Braden Scale and How it Predicts Pressure Injury Risk”, dated 3/5/24, indicated, “ ...19-23 equals no risk, 15-18 equals mild risk, 13-14 equals moderate risk, 10-12 equals high risk, < 9 [< - less than] equals severe risk ...” for pressure injury. Each assessment category was scored one through four, with six categories. Category one sensory perception, two moisture, three activity, four mobility, five nutrition, and category six friction and shear. During a review of professional reference titled, “Turning and Repositioning Frequency to Prevent Hospital-Acquired Pressure Injuries Among Adult Patients: Systematic Review,” dated 2023, indicated “ ... Turning and repositioning is considered one of the strategies to reduce the incidence of pressure injuries (PI)s among hospitalized patients, as it helps to redistribute and minimize direct pressure on targeted skin and enhance blood perfusion in the affected areas ...”. 3. During a concurrent interview and record review on 9/12/24 at 4:10 p.m. with the Director of Women and Children Services (DWC) and Registered Nurse (RN) 4, Pt 39’s “History and Physical (H&P),” dated 9/6/24, was reviewed. The H&P indicated, “ ...31-year-old female [gravida-the total number of confirmed pregnancies] 6 [para- the number of live births] 3 at 23 weeks 5 days. Patient presents to labor and delivery complaining of mild abdominal pain and leaking from the vagina. ... Ultrasound [a procedure that uses high-energy sound waves to look at tissues and organs inside the body] was performed and patient was found to have a collection [a collection of fluid] under the placenta. This has concerns for placental abruption [a serious complication that occurs when the placenta separates from the uterine wall before birth] ... a history of previous cesarean section [C/S- the surgical delivery of a baby through a cut made in the birth parent’s abdomen and uterus] ...” During a concurrent interview and record review on 9/12/24 at 4:15 p.m. with the DWC and RN 4, Pt 39’s “Electronic Medical Record (EMR-an electronic record of health-related information on an individual),” dated 9/6/24, and “Fundal/Lochia (FL)” flowsheet, dated 9/6/24 were reviewed. RN 4 stated Pt 39 delivered at 10:04 a.m. The FL indicated, Pt 39 had fundal (top of uterus) and lochia (vaginal discharge after birth, bleeding) assessments at 10:37 a.m., 10:50 a.m., 11:09 a.m., 11:25 a.m., and 1 p.m. RN 4 stated Pt 39 should have received four more fundal and lochia assessments in the second hour after delivery. RN 4 stated fundal and lochia assessments after delivery were important to ensure the patient’s bleeding was under control and the fundus was firm. RN 4 stated the patient could hemorrhage (a loss of blood) at any time. The DWC stated she expected LNs to complete fundal and lochia assessments according to the facility procedure. During an interview on 9/17/24 at 10:10 a.m. with the DWC, the facility’s document, “Vital Signs, Fetal and Uterine Assessments,” undated, was reviewed. The document indicated, “ ...Immediate Vaginal Delivery and Recovery ... [Blood Pressure], [Pulse], [Respiration Rate], Uterus Tone, Bladder, Lochia, Perineum ... [every] 15 [minutes] [for] minimum 2 [hours] ...” The DWC stated the facility used Elsevier standards of practice. The DWC stated this document was a “policy” LNs followed. 4. During a concurrent interview and record review on 9/12/24 at 10:43 a.m. with the Director of Women and Children Services (DWC), Pt 36’s “History and Physical (H&P),” dated 9/6/24, was reviewed. The H&P indicated, “ ...28-year-old [gravida-the total number of confirmed pregnancies] 1 [para- the number of live births] 0 at 41.0 weeks gestation [the period of time when something is conceived and developed; normal gestation is 40 weeks] presenting for scheduled induction of labor [IOL- when a medical professional uses medication or other methods to start labor before it begins on its own] ...” During a concurrent interview and record review on 9/12/24 at 10:50 a.m. with the DWC, Pt 36’s “System Review” flowsheet, dated 9/9/24 to 9/10/24 were reviewed. The DWC stated, Pt 36 did not have a head to toe assessment completed and documented from 9/9/24 at 9:39 p.m. to 9/10/24 at 7 p.m. (a lapse of 21 hours and 21 minutes). The DWC stated LNs should be completing and documenting a patient’s head to toe assessment each shift. The DWS stated it was “important to document and validate you did it.” During a concurrent interview and record review on 9/13/24 at 9 a.m. with the DWC and Registered Nurse (RN) 4, Pt 38’s H&P was reviewed. The H&P indicated, Pt 38 was a 33-year-old, G4P2 at 35.6 weeks gestation. Pt 38 was admitted for severe preeclampsia (a serious blood pressure condition that develops during pregnancy) for a repeat C/S. During a concurrent interview and record review on 9/13/24 at 9:05 a.m. with the DWC and RN 4, Pt 38’s “System Review” flowsheet, dated 9/12/24 to 9/13/24 were reviewed. RN 4 stated, Pt 38 did not have a head to toe assessment completed and documented from 9/12/24 at 7:59 a.m. to 9/13/24 at 9:54 a.m. (a lapse of 25 hours and 55 minutes). RN 4 stated the LN should have completed and documented a head to toe assessment on the night shift of 9/12/24. During an interview on 9/17/24 at 4:20 p.m. with the Chief Nursing Officer (CNO), the CNO stated LNs should be completing and documenting a patient head to toe assessment once a shift or more frequently as needed. During a review of the facility’s P&P titled, “Documentation Policy,” approved 9/28/22, the P&P indicated, “ ...PURPOSE: To outline responsibilities related to documentation of patient care from admission through discharge ... All patients ...who occupy an inpatient bed will have admission data, assessment and plan of care completed ... Patients are reassessed a minimum of every shift and as needed by an RN ... OB System Assessment, (completed once per shift, and then updated as condition warrants) ...should be documented as indicated ...” 5. During a concurrent interview and record review on 9/12/24 at 10:43 a.m. with the Director of Women and Children Services (DWC), Pt 36’s “History and Physical (H&P),” dated 9/6/24, was reviewed. The H&P indicated, “ ...28-year-old [gravida-the total number of confirmed pregnancies] 1 [para- the number of live births] 0 at 41.0 weeks gestation [the period of time when something is conceived and developed] presenting for scheduled induction of labor [IOL- when a medical professional uses medication or other methods to start labor before it begins on its own] ...” During a concurrent interview and record review on 9/12/24 at 10:50 a.m. with the DWC, Pt 36’s “Electronic Medical Record (EMR-an electronic record of health-related information on an individual),” dated 9/9/24, and “Vital Signs (VS)” flowsheet, dated 9/9/24 were reviewed. The DWC stated, the EMR indicated, Pt 36 had an epidural placed at 9:15 a.m. The VS indicated vital signs were completed at 9:15 a.m., 9:30 a.m., 9:45 a.m., 10 a.m., 10:15 a.m., 10:30 a.m., 10:45 a.m., and 11 a.m. The DWC stated vital signs should have been completed every three minutes for fifteen minutes, then every five minutes for the next fifteen minutes, then every fifteen minutes for the next hour. The DWC stated vital signs should be assessed after an epidural placement due to a concern for the stability of the patient and possible hypotension. The DWC stated it was the LNs’ responsibility to document the patient’s vital signs assessment into the EMR. The DWC stated vital signs assessment was not completed according to the policy. During an interview on 9/17/24 at 4:20 p.m. with the Chief Nursing Officer (CNO), the CNO stated LNs should follow the department’s guidelines since it is evidenced based practice. During a review of the facility’s P&P titled, “MOD L&D 1.15 Epidural Management for the Laboring Patient Nursing Guidelines,” approved on 4/24/24, the P&P indicated, “ ... PURPOSE: The purpose of this is to provide guidelines for nursing practice and patient advocacy related to pregnant women receiving pain management though epidural analgesia ... PROCEDURE EPIDURAL INITIATION ...Assess and document baseline maternal vital signs ... Assess ...maternal vital signs ...once regional analgesia or anesthesia is initiated. Then every 3 minutes for the first 15 minutes, then every 5 for the next 15 [minutes], then every 15 minutes thereafter ...” 6. During a concurrent interview and record review on 9/13/24 at 9 a.m. with the DWC and Registered Nurse (RN) 4, Pt 38’s H&P was reviewed. The H&P indicated, Pt 38 was a 33-year-old, G4P2 at 35.6 weeks gestation. Pt 38 was admitted for severe preeclampsia (a serious blood pressure condition that develops during pregnancy) for a repeat C/S. During a concurrent interview and record review on 9/13/24 at 9:05 a.m. with the DWC and RN 4, Pt 38’s physician “Medication Order (MO),” dated 9/10/24, “Physician Notification” flowsheet, dated 9/11/24, “Medication Administration Record (MAR),” dated 9/11/24, and “Adult Activities of Daily Living (ADLs)” flowsheet, dated 9/11/24 were reviewed. RN 4 stated the MO indicated Pt 38 had an order for magnesium sulfate continuous infusion placed on 9/10/24 at 12:45 p.m. RN 4 stated the MO indicated magnesium sulfate infusion did not have a stop time to discontinue. The “Physician Notification” on 9/11/24 at 9:15 a.m. indicated, “ ...Physician Communication Comments ...[Physician] stated “[Discontinue Foley and [magnesium sulfate] at [3 p.m.]” ...” RN 4 stated the LN did not enter an order to discontinue magnesium sulfate infusion at the specified time. The MAR indicated, “ ...magnesium sulfate ...9/11/24 ... [3:34 p.m.] Rate Changed 50 [milliliter (mL-unit of measure)] / hr [hour] ...” RN 4 stated the LN did not change the rate to zero on the MAR to indicate the magnesium sulfate infusion had been stopped. The ADL on 9/11/24 at 3:34 p.m. indicated, “ ...Patient Rounding Comment ... [magnesium sulfate] checks, vitals, [magnesium sulfate discontinued] ...” RN 4 stated the LN should have entered the verbal order to discontinue magnesium sulfate infusion after speaking with the nurse practitioner. RN 4 stated LNs were not following the physician order if there was no stop time to discontinue magnesium sulfate infusion in the order. The DWC stated she expected LNs to enter physician orders into the patient’s EMR after receiving a verbal order. The DWC stated the LN should have entered zero on MAR to indicate the magnesium sulfate infusion was stopped. During an interview on 9/17/24 at 4:20 p.m. with the Chief Nursing Officer (CNO), the CNO stated LNs are expected to enter a new order or modify an order to reflect the verbal order received from the physician. During a review of the hospital’s P&P titled, “Order Policy and Clarification Procedure and Clarification Procedure,” approved 6/22/22, the P&P indicated, “ ...VERBAL & TELEPHONE ORDERS ... All verbal/telephone orders are entered directly into the [electronic health record] ... If a verbal or telephone order is obtained, the order is to be “read back” by the individual who is receiving the order, to the individual who is giving the order ...” 7. During a concurrent interview and record review on 9/12/24 at 4:41 p.m., of Pt 17’s “Admission Record (AR)” dated 9/11/24 with the Emergency Department Manager (EDM), the AR indicated ...”76-year-old ...was triaged (the sorting of patients (as in an emergency room) according to the urgency of their need for care) on arrival to the Emergency Department (ED) on 9/11/24 at 10:57 a.m. ...for permcath (a flexible tube used to access blood for dialysis treatment) issue ... and hypotension (low blood pressure) ...” EDM stated Pt 17 was sent to the ED from dialysis treatment (a treatment to cleanse the blood of wastes and extra fluids artificially through a machine when the kidney(s) have failed) at another facility for a defect to her perm cath. During a concurrent interview and record review on 9/12/24 at 4:41 p.m., of Pt 17’s “ED Note- Physician” dated 9/11/24 at 11:41 a.m., with the EDM, the ED Note indicated “ ...Chief Complaint: was at dialysis, did not finish, was told to come here that something was wrong with perm cath ...past medical history significant for CHF (congestive heart failure- a heart disorder which causes the heart to not pump the blood efficiently, sometimes resulting in leg swelling), hypertension (high blood pressure), ...ESRD (End Stage Renal Disease- kidney failure) on hemodialysis (a treatment to cleanse the blood of wastes and extra fluids artificially through a machine when the kidney(s) have failed) ...” During a concurrent interview and record review on 9/12/24 at 4:41 p.m., of Pt 17’s “Admission H&P (History and Physical- a medical exam that involves a physician gathering information about a patient, performing a physical exam, and documenting their findings)” dated 9/11/24 with EDM, the H&P indicated “ ...Additional Information: ...Malfunctioning dialysis catheter ...patient is currently [unstable] to get it changed ...IR [Interventional Radiology- a medical sub-specialty of radiology utilizing minimally-invasive image-guided procedures to diagnose and treat diseases in nearly every organ system.] notified ...will try to change it tomorrow ...dialysis can wait until a.m. ...Also since patients’ blood pressure has been very low and nonresponsive to IV [intravenous- within a vein] fluids patient would be ideally monitored in ICU setting ...patient will be admitted to ICU ... [Norepinephrine- is also indicated as an adjunct in the treatment of cardiac arrest and profound hypotension] ordered in case needed ...” During a concurrent interview and record review on 9/12/24 at 4:41 p.m., of Pt 17’s “Electronic Health Record (EHR)” with the EDM, the EHR indicated Pt 17’s vital signs (are measurements of the body’s basic functions, such as temperature, breathing rate, blood pressure, and pulse rate. They are used to assess a patient’s level of physical functioning and can help detect or monitor medical problems.) at 11:04 a.m., were “ ...Temperature 36.8°C, Heart Rate (HR): 140 bpm (bpm-beats per minute), Respiratory Rate (RR): 20, Blood Pressure (BP): 72/48, oxygenation level (SpO2- a measurement of how much oxygen the blood is carrying as a percentage): 100%...” EDM stated with abnormal numbers of elevated HR and low BP and Pt 17’s medical history, and ESI level 2 (patients who are triaged as an Emergency Severity Index (ESI) level 2 are considered high-risk and require immediate nursing assessment and treatment) she would expect a full set of VS be taken and documented “every 15 minutes.” EDM stated the EHR indicated the next set of VS were documented at “ ...11:56 a.m. BP: 75/41 ...” EDM stated a full set of VS, not just the BP should have been assessed and documented per facility P&P to ensure patients receive appropriate care while in the ED. During a concurrent interview and record review on 9/12/24 at 4:00 p.m., of Pt 20’s “Admission Record (AR)” dated 9/10/24 with the EDM, the AR indicated ...”76-year-old ...was triaged on arrival to the ED on 9/10/24 at 3:04 p.m. ...for possible stroke ... “ During a concurrent interview and record review on 9/12/24 at 4:00 p.m., of Pt 20’s “ED Note- Physician” dated 9/10/24 at 15:04 a.m., with the EDM, the ED Note indicated “ ...Chief Complaint: BIBA [brought in by ambulance] from home for possible stroke ...History of Present Illness: ...history of hypertension ...patient’s blood pressure ...was 295/80 ...it is currently [BP] 241/90 ...” During a concurrent interview and record review on 9/12/24 at 4:00 p.m., of Pt 20’s “Electronic Health Record (EHR)” with the EDM, the EHR indicated Pt 20’s vital signs taken at 3:30 p.m., were not complete, the temperature was not documented. EDM stated the triage nurse did not take a temperature on arrival to the ED as expected per facility policy. EDM stated the temperature was documented at 7:30 p.m. [4 hours after arrival to the ED and triage], and was not as expected. EDM stated a full set of VS, including the temperature is taken at time of triage to have a baseline (a set of initial measurements or observations that are used as a reference point for comparison and evaluation) to identify any abnormal values then taken at regular intervals to detect any patient change in condition. EDM stated MD orders are to be carried out, if not done or if a patient refuses care, the nurse should notify the provider and document the discussion. EDM stated Pt 20’s EHR did not show nursing documentation of RN 6’s notifying the EDMD 1 of Pt 20’s refusal to take an ordered medication [calcium gluconate]. During an interview scheduled for 9/17/24 at 8:00 a.m., with Registered Nurse (RN) 6 and primary RN assigned to care for Pt 17 during Pt 17’s ED visit on 9/11/24, RN 6 “respectfully declined to be interviewed.” 8. During an interview conducted via telephone on 9/12/24 at 1:50 p.m., with EDMD Medical Doctor (EDMD) 1, EDMD 1 stated he ordered the calcium gluconate infusion to treat the elevated potassium level after reviewing the results of Pt 20’s lab work. EDMD 1 stated the nurse may have notified him of Pt 20’s refusal to take the ordered infusion, but he did not document the patient’s refusal to take it. During an interview scheduled for 9/17/24 at 8:00 a.m., with Registered Nurse (RN) 6 and primary RN assigned to care for Pt 20 during Pt 20’s ED visit on 9/11/24, RN 6 “respectfully declined to be interviewed.” During a review of the Pt 20’s “Order Sheet” dated 9/10/24 at 20:55 PDT [8:55 p.m.), ...calcium gluconate, 1000 mg 50 mL IV Piggyback ...once scheduled, STAT, 30 min, 09/10/24 19:44 PDT [7:44 p.m.] ...” During a review of the Pt 20’s “Flowsheet Print Request” dated 9/10/24, the Flowsheet indicated “ ...calcium gluconate ...*Not Given: Refused ...” During a review of the Pt 20’s “Nursing Note Form-Text” dated 9/10/24 at 20:55 PDT [8:55 p.m.], the Nursing Note indicated “ ...Pt refusing medications, states “I don’t want anything foreign in my body, because of the medications they gave I ended up here.” Pt educated on importance of taking medication, pt refusing medications ...” During an interview on 9/17/24 at 4:20 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectation is that LNs are making sure [patient] needs are met and that the documentation reflects that [care provided or not provided]. During a review of the facility P&P “Triage Nurse Policy (MOD.ED.1.06) dated 4/24/24, the P&P indicated, “ ...Purpose: To outline the responsibilities and function of the Triage Nurse in the Emergency Department ...Supportive Data: ...Upon arrival an initial assessment is performed to determine the need for immediate treatment, or close observation based upon presenting clinical assessment by the primary triage nurse...Content: ...3. All patient conditions will be classified and prioritized as follows: ...ESI Level 2: the patient is assessed as high risk. The patient presents with a condition that has the potential for major life and organ threat. The patient’s condition may deteriorate if left unattended, and therefore should not wait ...Upon determination of an ESI Level 2 condition, the triage nurse will expedite placement of the patient in a treatment area securing additional resources as necessary ...5. If determined that the patient does not need immediate intervention or observation, complete an initial nursing history, allergies, vital signs ...6. All patients are monitored, reassessed, and have repeat of vital signs based on their acuity. The patient’s triage category may be upgraded based on this reassessment ...8. Documentation of the triage classification, assessment and all interventions performed are entered into the Emergency Department electronic documentation system ...” During a review of the facility P&P “Standard of Care Policy (ED.1.04) dated 10/23/22, the P&P indicated, “ ...I. Purpose: These are the fundamental components of care that are to be applied to any patient presenting for treatment to the ED. This standard of care must be used in conjunction with more specific protocols that are relevant to the patient’s chief complaint ...II. Policy: ...4. Vital signs and will be taken on all patients admitted to the ED. This includes a temperature ...BP, pulse, and respiratory rate. Repeat vital signs include BP, pulse, respiratory rate, and temperature as indicated ...The patient’s nurse is responsible for continually assessing the patient’s condition and obtaining vital signs as the situation warrants. Patient acuity will determine the frequency of vital signs. Abnormal vital signs will be checked prior to discharge, and persistent abnormalities will be brought to the physician’s attention ... Repeat vital signs to be measured and documented as follows ...ESI Level 2: Upon arrival to the ED, then and/or as situation warrants, but no less than every four hours...9 ....a. Documentation of any changes in patient status and physician notification when significant changes occur ...” During a review of the facility P&P “Documentation Policy (PC.AD.1.08) dated 3/23/23, the P&P indicated, “ ...II. Purpose: To outline responsibilities related to documentation of patient care from admission through discharge ...III. Policy: ...it should include ....care delivered (or not delivered); ...advice sought in decision making; and the patient’s response to treatment ...3. Charting by exception is to be utilized as a method of charting designed to minimize clerical activities; a notation (annotation) is made only when there is a deviation from the baseline or expected outcome, or when a procedure or expected activity is to be omitted ... 10 ... g. Changes in patient condition are documented within the appropriate HER system review; along with physician notifications ...””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 40644 Based on interview and record review, the facility failed to ensure medications were administered in accordance with physician medication orders and the facility’s policy and procedure (P&P) titled “Medication Administration Policy” when: 1. Licensed Nurses (LNs) did not administer dopamine (a medicine is used to treat low blood pressure) in accordance with physician orders for one of one sampled patient (Pt 42) when LNs administered dopamine continuous intravenous (IV) drip (the administration of a fluid into a blood vessel, usually over a prolonged period of time) for Pt 42 to treat hypotension (low blood pressure) and the dopamine dose rate was not titrated (the medication dose is either progressively increased or decreased in response to the patient’s status) in accordance with the physician medication order. This failure placed Pt 42 at risk of serious harm from fluctuating blood pressure. 2. LNs titrated an amino acids (used for nutritional support of newborn babies) IV infusion without a physician medication order for one of one sampled patient (Pt 41). This failure placed Pt 41 at risk for harm of nutritional deficiencies. Findings: 1. During a concurrent interview and record review on 9/13/24 a 10:36 a.m. with the Assistant Director of Women and Children Services (ADWC), Pt 42’s “History and Physical (H&P),” dated 9/6/24, the H&P indicated, Pt 42 was born on 9/6/24 at 10:04 a.m. by cesarean section (C/S- the surgical delivery of a baby through a cut made in the birth parent’s abdomen and uterus) at 23 weeks and 6 days gestation (the period of time when something is conceived and developed; normal gestation is 40 weeks). The ADWC stated Pt 42 was admitted to the Neonatal Intensive Care Unit (NICU- a hospital unit that provides specialized care for premature or sick newborn babies) due respiratory distress syndrome (RDS- a condition that makes it difficult for newborns to breathe due to immature lungs) and a premature baby (a baby born before 37 weeks of pregnancy). During a concurrent interview and record review on 9/13/24 at 10:40 a.m. with (ADWC), Pt 42’s physician “Medication Orders (MO),” dated 9/12/24, and “Medication Administration Record (MAR),” dated 9/12/24 were reviewed. The PO indicated, “ ...NICU dopamine [intravenous (IV-into the vein)] additive 400 [milligrams (mg-unit of measure)] + NICU D5W [a type of IV fluid that contains a 5% solution of dextrose (glucose) in water)] Premix Diluent 250 [milliliters (mL-unit of measure)] ... 9/12/24 [8:44 p.m.] ... Indication: hypotension ...Start at 5 [micrograms (mcg-unit of measure)] / [kilogram (kg-unit of measure)] / min [minute] ... Titrate by 1 mcg/kg/min every 20 min ... Maximum dose: 10 mcg/kg/min ... [10:34 p.m.] ... Start at 5 mcg/kg/min ... Titrate by 1 mcg/kg/min every 20 min ... Maximum dose: 20 mcg/kg/min ...” The MAR indicated, “ ... [9:40 p.m.] Begin Bag ...10 mcg/kg/min ... [10:35 p.m.] Rate Change ...20 mcg/kg/min ...” The ADWC stated the dopamine drip was not titrated by 1 mcg/kg/min every 20 minutes according to the MO. The ADWC stated the nurse practitioner was at bedside and instructed to change the rate to 10 mcg/kg/min instead of the ordered start rate of 5 mcg/kg/min. The ADWC stated the physician medication order should have been modified to reflect the start rate dose and not the maximum dose. The ADWC stated the physician medication order should reflect the administration of dopamine in the MAR. During a review of the facility’s P&P titled, “PC.AD.1.21 Medication Administration Policy,” approved 7/24/24, the P&P indicated, “ ...PURPOSE: Assure the safe and timely administration of medications throughout the organization ... POLICY ...Orders for Medications ...In accordance with standard practice, practitioner orders for the administration of drugs and biological must include at the least the following: Name of the patient; Age and weight of the patients, or other dose calculation requirements (e.g. titration parameters [how a medication dose is adjusted over time]), where applicable; Date and time of the order ... Drug name; Dose, frequency [the amount of times it should be completed or administered], and route [the location at which the drug is administered]; ... Exact strength [the amount of drug in a given dosage form] and concentration [the amount of active ingredient per total weight of a substance], when applicable; Quantity and/or duration, when applicable; Specific instructions for use, when applicable; and Name of the prescriber ... Basic Safe Medication Administration Practices ...Staff shall confirm the following prior to administering each medication: Patient identification ...The correct medication ...The correct dose: To ensure that the dosage matches the ordered dose and does not reflect an unsafe dosage level (i.e., a dose that is too high or too low); ...The correct route ...The appropriate time: To ensure adherence to the ordered frequency and time of administration ... All parts of the medication order shall be reviewed, including additional instructions and parameters for use ...” 2. During a review of Pt 41’s “History and Physical (H&P),” dated 9/10/24, the H&P indicated Pt 41 was born on 9/10/24 at 2:55 p.m. at 35 weeks and 6 days gestation. Pt 41 was admitted to the NICU for respiratory distress and sepsis evaluation (involves a combination of laboratory tests, imaging tests, and clinical findings). During a concurrent interview and record review on 9/13/24 at 11:35 a.m. with the Assistant Director of Women and Children Services (ADWC), Pt 41’s physician “Medication Orders (MO),” dated 9/10/24 to 9/11/24, and “Medication Administration Record (MAR),” dated 9/10/24 to 9/11/24 were reviewed. The MO indicated, “ ...Amino Acids ...glucose ...sterile water ...heparin ... ...9/10/24 [4:33 p.m.] Route of administration ...IV ... Rate ...9 ... Rate unit ... [milliliters (mL-unit of measure)] / hr [hour] ... 9/11/24 [5:28 p.m.] ... Rate ...3 ...” The MAR indicated Pt 41 was administered amino acid infusion on 9/10/24 at 4:57 p.m. at a rate of 9 mL/hr. The MAR indicated on 9/11/24 at 11:03 a.m. the rate was changed to 4 mL/hr. The ADWC stated there was no physician medication order to change the rate to 4 mL/hr. The MAR indicated on 9/11/24 at 2:03 p.m. the rate was changed to 3 mL/hr. The ADWC stated the MO indicated the rate change order was placed on 9/11/24 at 5:28 p.m. (a lapse of 3 hours and 25 minutes after the rate was changed). The ADWC stated the MO for amino acid infusion was not a titratable medication. The ADWC stated LNs should receive an order from the physician to modify the rate change each time. During a review of the facility’s P&P titled, “Medication Administration Policy,” approved 7/24/24, the P&P indicated, “ ...PURPOSE: Assure the safe and timely administration of medications throughout the organization ... POLICY ...Orders for Medications ...In accordance with standard practice, practitioner orders for the administration of drugs and biological must include at the least the following: Name of the patient; Age and weight of the patients, or other dose calculation requirements (e.g. titration parameters), where applicable; Date and time of the order ... Drug name; Dose, frequency, and route; ... Exact strength and concentration, when applicable; Quantity and/or duration, when applicable; Specific instructions for use, when applicable; and Name of the prescriber ... Basic Safe Medication Administration Practices ...Staff shall confirm the following prior to administering each medication: Patient identification ...The correct medication ...The correct dose: To ensure that the dosage matches the ordered dose and does not reflect an unsafe dosage level (i.e., a dose that is too high or too low); ...The correct route ...The appropriate time: To ensure adherence to the ordered frequency and time of administration ... All parts of the medication order shall be reviewed, including additional instructions and parameters for use ...””

“CONTENT OF RECORD: ORDERS DATED & SIGNED CFR(s): 482.24(c)(2) All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations. This Standard is not met as evidenced by: 49538 Based on interview and record review, the hospital failed to ensure physician telephone orders were authenticated (verified and signed) in patient’s medical records within 48 hours in accordance with approved hospital policy and procedures for one of one patient (Pt 36). This failure resulted in unverified physician orders and had the potential for inappropriate treatment and/or care of Pt 36. Findings: During a concurrent interview and record review on 9/12/24 at 10:43 a.m. with the Director of Women and Children Services (DWC), Pt 36’s “History and Physical (H&P),” dated 9/6/24, was reviewed. The H&P indicated, “ ...28 year old [gravida-the total number of confirmed pregnancies] 1 [para- the number of live births] 0 at 41.0 weeks gestation [the period of time when something is conceived and developed] presenting for scheduled induction of labor [IOL- when a medical professional uses medication or other methods to start labor before it begins on its own] ...” During a concurrent interview and record review on 9/12/24 at 10:50 a.m. with the DWC, Pt 36’s “Orders,” dated 9/6/24 was reviewed. The Orders indicated, “ ...OB Antepartum - Intrapartum ... Initiated and Electronically Signed by [Registered Nurse (RN) 7]-09/06/2024 [8:16 a.m.], Phone Read Back-Authentication ...” The DWC stated there was no physician signature for the telephone order received by RN 7. The DWC stated physician telephone orders required physician authentication within 48 hours. During a concurrent interview and record review on 9/12/24 at 10:55 a.m. with the DWC, Pt 36’s “Orders,” dated 9/9/24 was reviewed. The Orders indicated, “ ...Original order entered and electronically signed by [RN 8] on 09/09/2024 at [3:16 a.m.]. Phone Read Back-Authentication Required order by [MD] ... oxytocin [a synthetic hormone that helps speed up delivery or controls bleeding after childbirth] [intravenous] additive ...” The DWC stated there was no physician signature of the telephone order received by RN 8. During a review of the facility’s “Medical Staff Rules & Regulations,” dated 4/29/21, page 12 indicated, “ ...ORDERS ... All verbal orders for medications shall be authenticated, including the date and time of authentication, by the responsible or covering Practitioner within forty-eight (48) hours ...””

“CONTENT OF RECORD: ORDERS DATED & SIGNED CFR(s): 482.24(c)(2) All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations. This Standard is not met as evidenced by: 40644 Based on interview and record review, the hospital failed to ensure physician telephone orders were authenticated (verified and signed) in patient’s medical records within 48 hours in accordance with approved hospital policy and procedures for one of one patient (Pt 36). This failure resulted in unverified physician orders and had the potential for inappropriate treatment and/or care of Pt 36. Findings: During a concurrent interview and record review on 9/12/24 at 10:43 a.m. with the Director of Women and Children Services (DWC), Pt 36’s “History and Physical (H&P),” dated 9/6/24, was reviewed. The H&P indicated, “ ...28 year old [gravida-the total number of confirmed pregnancies] 1 [para- the number of live births] 0 at 41.0 weeks gestation [the period of time when something is conceived and developed] presenting for scheduled induction of labor [IOL- when a medical professional uses medication or other methods to start labor before it begins on its own] ...” During a concurrent interview and record review on 9/12/24 at 10:50 a.m. with the DWC, Pt 36’s “Orders,” dated 9/6/24 was reviewed. The Orders indicated, “ ...OB Antepartum - Intrapartum ... Initiated and Electronically Signed by [Registered Nurse (RN) 7]-09/06/2024 [8:16 a.m.], Phone Read Back-Authentication ...” The DWC stated there was no physician signature for the telephone order received by RN 7. The DWC stated physician telephone orders required physician authentication within 48 hours. During a concurrent interview and record review on 9/12/24 at 10:55 a.m. with the DWC, Pt 36’s “Orders,” dated 9/9/24 was reviewed. The Orders indicated, “ ...Original order entered and electronically signed by [RN 8] on 09/09/2024 at [3:16 a.m.]. Phone Read Back-Authentication Required order by [MD] ... oxytocin [a synthetic hormone that helps speed up delivery or controls bleeding after childbirth] [intravenous] additive ...” The DWC stated there was no physician signature of the telephone order received by RN 8. During a review of the facility’s “Medical Staff Rules & Regulations,” dated 4/29/21, page 12 indicated, “ ...ORDERS ... All verbal orders for medications shall be authenticated, including the date and time of authentication, by the responsible or covering Practitioner within forty-eight (48) hours ...””

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 41337 Based on observation, interview, and record review, the facility failed to maintain equipment in the kitchen to ensure an acceptable level of safety and quality when: 1a.The reach-in refrigerator # 27 was in need of a new gasket and was not holding the correct temperature, 1b. A small white home style refrigerator was not cooling. 1c. Reach-in refrigerator 16 had condensation dripping, 1d. Reach-in refrigerator 15 had a build-up of water on the bottom shelf. 1e. Metal shelves in two hot box warmers had coating that was peeling off. 1f. Deep fryer was not working and 3 of 6 convection ovens not working. These failures had to potential to affect the food production and the facilities ability to provide safe and sanitary food to 231 medically compromised patients who received food from the kitchen. Findings: During an observation in the kitchen and concurrent interview with the Senior Director of Food and Nutrition on September 10, 2024 at 2:44 pm, reach-in refrigerator #27 was in need of a new rubber gasket for the door to seal properly. It was not maintaining a safe temperature for food storage. The SDFN 1 stated that because of the issue with the gasket they do not store food in the refrigerator just non-perishable sodas. SDFN 1 stated a worked order was placed on April 27, 2024. During an observation in the kitchen on September 10, 2024, at 2:52 pm, a small white home style refrigerator was not working. The refrigerator was empty. In this same area there was 3 reach-in refrigerators, all three needed new gaskets. Refrigerator 15 had water collecting on the bottom shelf and refrigerator 16 had condensation dripping inside onto the food. During an observation in the kitchen and concurrent interview with the Senior Director of Food and Nutrition on September 10, 2024, at 2:55 pm, there were two commercial food warmers with wire shelves. The coating on the shelves was peeling off. SDFN 1 stated the shelves needed to be replaced. During an observation in the kitchen on September 10, 2024, at 3:11 pm, the deep fryer was not working. During an observation in the kitchen on September 10, at 3:14 pm, 3 of 6 convection ovens were not working. During an interview with the Director of Facilities (DOF 1) on September 11, 2024, at 9:40 am, DOF 1 stated he expects that equipment should be able to get fixed in a 30 day time frame, but usually that does not happen. During an interview with the Registered Dietitian 1 (RD1) on September 12, 2024, at 2:40pm, RD1 stated that all equipment in the kitchen should be working and if something is not working there should be a work order put in and it should be fixed as soon as possible or 30 day or less. During a review of the facility documents titled “Work Order Details”, dated April 9, 2024, “top right oven is not working or coming to temperature.. On June 19, 2024, “bottom left oven of the ovens is not working”. On June 21, 2024, “only 3 of 6 ovens working, please take a look at it since we use it on daily basis”. On August 27, 2024, “oven is not working”. On September 4, 2024, “left upper oven is not working”. During a review of the facility documents titled “Work Order Details”, dated April 27, 2024, “gasket in 027 fridge needs to be changed. Old ones are torn up.” On May 3, 2024, “2nd request gaskets on 2 of our fridges do not fit since being replaced this week, does not close completely”. On June 21, 2024, “checking on the status of gasket for fridge #27”. During a review of the FDA Federal Food Code, dated 2022, 4-501.11 indicated, “(A) EQUIPMENT shall be maintained in a state of repair and condition ... (B) EQUIPMENT components such as doors, seals, hinges, fasteners, and kick plates shall be kept intact, tight, and adjusted in accordance with manufacturer’s specifications.” In addition, “Proper maintenance of equipment to manufacturer specifications helps ensure that it will continue to operate as designed. Failure to properly maintain equipment could lead to violations of the associated requirements of the Code that place the health of the consumer at risk.””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 40644 Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when: 1. Multiple drawers in the food preparation areas of the kitchen had build-up of crumbs, one drawer had a binder with food crusts and personal items. According to the FDA Federal Food Code, all non-food contact surfaces of the kitchen should be kept clean. 2. The floor underneath the fixed equipment in the kitchen had a buildup of trash, food, grease, and black grime. There was a build-up of food in the floor drain that was under a reach- in refrigerator. According to the FDA Federal Food Code, all non-food contact surfaces of the kitchen should be kept clean. 3. Shelves in 3 reach-in refrigerators in the kitchen near the tray line area (where food is plated for the patients) were coated in metal chards and build-up of black dust like substance. The plate warmer had a build-up of food crumbs. A commercial food warmer (used to keep food warm prior to service) had a build-up of black and red grime and convection ovens had a build-up of red and black grime. According to the FDA Federal Food Code, all non-food contact surfaces of the kitchen should be kept clean. 4. Five (5) of 27 ice machines (IMs) on the facility main campus were observed to be visibly soiled and were not maintained according to facility P&P and manufacturer instructions for use (IFU)s . The ice machine in the main kitchen [IM 1] and another in the 3 West unit nourishment room [IM 2] had a pink or black slime build-up. The ice machine in the 4 North Medical Surgical pantry room [IM 3], had a black residue in the water catch sink area of the machine. The Ice machines in the Cardiovascular Intensive Care Unit (CVICU) and Critical Care Unit (CCU) (two of two (2) sampled ice machines were visibly soiled and covered in white colored stains. The ice machine in the CVICU ice machine [IM 4] had visible white-colored and textured splash stains on the stainless-steel surfaces and the water collection trays and black-colored debris was observed on white tissue after wiping the ice dispenser spout. The CCU ice machine [IM 5] had visible, pink-colored stains in the ice shoot and spray guard covering. 5. One of one surgical instrument trays was stored on a trash can, and not in accordance with standards published by the American National Standards Institute and the Association for the Advancement of Medical Instrumentation (ANSI/AAMI - a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals). 6. An Intravenous (IV) administration set (connects the bag of solution to the patient’s IV access site) was not labeled with date and time of initiation for two of two patients (Pt 36 and Pt 45) in accordance with hospital policy and procedure. 7. Expired formula and formula sterile water was found in the Emergency Department (ED) supply room. 8. Four (4) of 4 sampled pill crushers (a device that turns pills into powder) were not cleaned per manufacturer recommendation in the CVICU and CCU. The pill crushers were observed to be visibly soiled with white-colored chalk-like residue, and brown and orange-colored stains to metal pieces and throughout the device. 9. The hospital did not ensure two (2) “brand name” pouches (“ ...consists of a layer of highly absorbent material sandwiched between two layers of water-proof film ...”) used to “place individual instruments (soiled processable patient care equipment), or an entire instrument tray inside the “brand name” pack, add the specified amount of water to the absorbent layer, and seal with the peel away adhesive strip; this creates a water tight, moist atmosphere that will prevent organics (relating to or derived from living matter such as human skin and blood, and/or bacteria) from drying over an extended period of time ...” inside the red container were sealed as required per manufacturer instructions for use (IFUs). This failure resulted in the fluids leaking and pooling inside and at the bottom of the red biohazard collection tray (a rigid plastic container with clasp shut lid) used to store pouches on the unit for pick-up by the Sterile Processing Department (SPD) had the potential to harm patients; pre-soak cleansing is one of many steps in the reusable patient equipment sterilization process and harm staff from splash of contaminants to staff handling the red tray(s). 10. Licensed nurses (LNs) in the Emergency Department (ED) failed to discard sharps (medical devices like needles, scalpels, and other tools that cut or go into the skin) in a sharps container ( made from rigid puncture-resistant plastic or metal with leak-resistant sides and bottom, and a tight-fitting, puncture-resistant lid with an opening to accommodate depositing a sharp but not large enough for a hand to enter) when a used IV catheter insertion needle, a small plastic dark red fluid-filled container, and a binder with a red smudge was observed to be on top of a crash cart in an occupied patient room and an empty bag of IV fluids (liquids that are administered directly into a vein to replace water, sugar, and salt) was observed laying on the floor and not discarded in accordance with the expectations of the CNO, after use of inserting an intravenous (IV) catheter (a flexible tube that is inserted into the body to inject or withdraw fluids, or to keep a passage open) and obtain blood sample(s) into the sharps container (rigid plastic container used to safely lock the contaminated sharps while awaiting proper disposal) per facility P&P and nursing standard of practice. These failures had the potential to allow for the spread of infection to patients, visitors and staff coming to the hospital. 10. The hospital did not ensure staff in the CVICU followed manufacturer instructions when using specialized pouches for dirty surgical instruments. These failures resulted in the possibility of hazardous liquid leaking from the specialized pouch and not properly pre-soaking surgical instrument for subsequent processing. Findings: 1. During an observation in the kitchen on 9/10/24, at 2:44 p.m., a drawer in the food preparation area had food crumbs and a 3-ring binder with recipes was covered in a food spill and crusted with old food. A drawer on the station with the toaster had a build-up of food crumbs. During an observation in the kitchen on 9/10/24, at 3:04 p.m., a drawer near the plate warmer had a build-up of food crumbs. During an observation in the kitchen and concurrent interview with the Senior Director of Food and Nutrition (SDFN 1) on 9/10/24, at 3:14 p.m., a drawer near the food preparation station had personal items, a purse, and a cell phone. The SDFN stated that personal items should not be stored in the food production area. During an interview with the Registered Dietitian (RD) on 9/12/24, at 2:40 pm,p.m., RD 1 stated the drawers in the kitchen should be kept clean, with no food particles or personal items. During a review of the FDA Federal Food Code, dated 2022, 6-305.11 indicated, “Street clothing and personal belongings can contaminate food, food equipment, and food-contact surfaces. Proper storage facilities are required for articles such as purses, coats, shoes, and personal medications.” 2. During an observation in the kitchen on 9/10/24, at 2:44 p.m., the floor under the reach-in refrigerator #210 had a build-up of miscellaneous trash. During an observation in the kitchen on 9/10/24, at 2:52 p.m., there was a floor drain under 3 reach-in refrigerators and it had a build-up of food and trash. During an observation in the kitchen, on 9/10/24, at 3:04 p.m., the floor under the equipment of the cooking line (two ranges) had a build-up of food, trash and black grime and grease. During an interview with the SDFN 1, on 9/11/24, at 9:40 am, a.m., the SDFN 1 stated the floors under the equipment were not on the checklist that the RD uses when she inspects the kitchen, but it needs to be added. The RD stated the floor drain should be kept clean with no food build-up. During an interview with the RD 1, on 9/12/24, at 2:40 p.m., RD 1 indicated the floor under the equipment should always be kept clean. During a review of the facility policy titled “Cleaning of Food and Nonfood Contact Surfaces”, dated 9/22/21, indicated, nonfood contact surfaces of equipment ... shall be cleaned as often as necessary to keep the equipment free of accumulation of dust, dirt, food particles and other debris.” During a review of the FDA Federal Food Code, dated 2022, 4-601.11 indicated, “The objective of cleaning focuses on the need to remove organic matter from food-contact surfaces so that sanitization can occur and to remove soil from nonfood contact surfaces so that pathogenic microorganisms will not be allowed to accumulate and insects and rodents will not be attracted.” 3. During an observation in the kitchen on 9/10/24, at 2:52 p.m., 3 reach-in refrigerators had a build-up of metal shards and black dust on the shelves. During an observation in the kitchen on 9/10/24, at 3:04 p.m., the plate warmer had a build-up of food crumbs. During an observation in the kitchen on 9/10/24, at 3:11 p.m., the commercial food warmer had a build-up of red and black grime. During an observation in the kitchen on 9/10/24, at 3:14 p.m., 6 convection ovens had a buildup of red and black grime and food crumbs. During an interview with the RD 1 on 9/12/24, at 2:40 p.m., RD 1 stated equipment should be clean and have no build-up and no food. During an interview with the SDFN 1, on 9/12/24, at 4:51 p.m., SDFN 1 stated they do not currently have a deep cleaning schedule for equipment or the floors. They plan to include it on their current cleaning schedule. 4. During an observation in the kitchen and concurrent interview with the Maintenance Technician 1 (MT 1) on 9/11/24, at 10 a.m., inside the ice bin of ice machine number 1, around the ice chute, there was a brown build-up and calcium build-up. Inside the ice bin of ice machine number 2, there was a build-up of pink slime. Maintenance Technician (MT) 1 stated he empties the ice bins and cleans the inside of the bin with Clorox wipes. During an observation and concurrent interview with the Nurse Manager (NM 1) in the 3 west nourishment room, on 9/11/24, at 10:18 am, a.m., the ice chute of the ice machine had a pink slime build-up that was wipeable with a paper towel. NM 1 stated the ice is used for water pitchers for the patients. He stated 3 west is a unit for stroke (occurs when blood flow to the brain is disrupted, causing brain cells to die) and trauma patients. During an interview with MT 1, on 9/12/24, at 11:21 p.m., MT 1 stated he does not use any brushes to scrub the inside of the ice bin. MT 1 stated moving forward he plans to scrub them to remove the hard water stains and to ensure there is no build-up of any kind. During an interview with the RD 1, on 9/12/24, at 2:40 p.m., RD 1 indicated the ice machine should be kept clean and not have build-up inside or any discoloration. During a concurrent observation and interview on 9/10/24 at 3:46 p.m. in the 4 North Medical Surgical pantry room, the countertop water and ice dispensing machine was observed to have a black residue in the water catch sink area of the machine. The black residue was wipeable and felt slimy when touched with a white paper towel. The area around the water shoot had black flaky residue on the inside of the clear plastic housing for the water dispensing down spout. The Director of Patient Care Services (DPCS)2 stated, patients were given ice and water from the machine, and the black slimy residue could cause infection and/or illness. The DPCS 2 stated the machine was supposed to be cleaned by environmental services, but all staff were responsible to report unclean equipment. The DPCS 2 stated unclean equipment should not be used for patients. During a concurrent observation and interview on 9/10/24 at 2:50 p.m., with the Director of Critical Care (DCC), the Assistant Director of Critical Care (ADCC), and Shift Manager (SM) 1 in the CVICU, one of one (1) ice machines had visible white-colored and textured splash stains on the stainless-steel surfaces and the water collection trays and black-colored debris was observed on white tissue after wiping the ice dispenser spout. Both the DCC and ADCC stated their expectation was that the responsible parties for ensuring cleanliness and maintenance of the ice machines (environmental services (EVS) and maintenance departments, respectively) were following P&Ps and IFUs and staff were to alert the appropriate team to attend to the machine. The DCC stated the machine should have been free of stains and debris to prevent harboring bacteria that can increase the risk for patient harm of infection. During a concurrent observation and interview on 9/11/24 at 10:00 a.m., with DCC, ADCC and SM 2, one (1) of 1 ice machines on the Critical Care Unit (CCU) had visible, pink-colored stains in the ice shoot and spray guard covering. The DCC stated it was his expectation that the machines were maintained per facility P&Ps and manufacturer IFUs and that nursing staff would report the need for maintenance as needed. The DCC stated the ice machine should be free of any debris and be well maintained to prevent contamination and possible patient harm of infection. According to the manufacturer’s “Brand Name” 1, instruction manual, undated, page 11 indicated the ice machine in the CVICU required “ ...Cleaning/descaling and sanitizing ...Periodic cleaning/descaling and sanitizing of “brand name” ice and water dispenser and ice machine system is required to ensure peak performance and delivery of clean, sanitary ice. The recommended cleaning procedures that follow should be performed at least as frequently as recommended and more often if environmental conditions dictate ...” According to the manufacturer’s “Brand Name” 2, instruction manual, dated May 2001, page 18 indicated “ ...Maintenance and Cleaning should be scheduled at a minimum of twice per year. Sanitizing of the ice storage bin should be scheduled for a minimum of 4 times a year ...” During an interview with the Director of Infection Control (DIC 1), on 9/12/24, at 2:11 p.m., the DIC 1 stated the Environmental Services (EVS-housekeeping staff) are responsible for cleaning the outer surfaces of the ice machines, daily and that any maintenance or cleaning of internal parts of the ice machine; ice and waterspouts included is done by the maintenance department. The DIC 1 stated the expectation was, “If the staff see an issue with the ice machine, they will report it to be looked at as if you were to notice an IV leaking.” During an interview on 9/17/24 at 4:20 p.m., with the Chief Nursing Officer (CNO), the CNO stated the expectation is that ice machines need to be cleaned on a regular basis. The CNO stated, “We have “opportunities [for improvement] there.” According to the Centers for Disease Control (CDC), undated, retrieved 9/19/2/24 from https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html, “ Microorganisms have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface.)” During a review of the facility policy titled “Cleaning of Food and Nonfood Contact Surfaces”, dated September 22, 2021, indicated, nonfood contact surfaces of equipment ... shall be cleaned as often as necessary to keep the equipment free of accumulation of dust, dirt, food particles and other debris.” During a review of the FDA Federal Food Code, dated 2022, 4-602.11 indicated, “ ...ice makers, and ice bins must be cleaned on a routine basis to prevent the development of slime, mold, or soil residues that may contribute to an accumulation of microorganisms.” 5. During a concurrent observation and interview on 9/10/24 at 2:33 p.m., with the Sterile Processing Department Manager (SPDM), in the Sterile Processing Department (SPD) prep and pack area (an area of a health care facility where clean and disinfected devices are inspected, assembled into trays, and prepared for high-level disinfection and/or sterilization) there was a surgical instrument tray stored on a trash can. The SPDM validated the observation and stated a clean surgical instrument tray should not be stored on a trash can and was uncertain why it was there. The SPDM stated the hospital followed AAMI ST79 guidelines for instrument cleaning, disinfecting, sterilization, and storage, and the guidelines were not followed. The SPDM stated the potential for cross-contamination from the trash can to the surgical instrument tray was an infection risk and sent the surgical instrument tray back to the decontamination area for reprocessing. A policy was requested for cross-contamination reprocessing, the hospital did not provide a policy for this process. During an interview on 9/11/24 at 11:25 a.m., with the Infection Prevention Director (IPD), in the Infection Control Department, the IPD confirmed the hospital followed AAMI standards for sterile processing and validated AAMI standards were not followed for instrument processing/storage. The IPD stated clean and disinfected instruments stored on a trash can created cross-contamination with potentially infectious elements in the trash can such as blood, dirt, and other infectious material. 6. During a concurrent observation and interview on 9/10/24 at 2:40 p.m. with the Director of Women and Children Services (DWC), in Pt 36’s room, Pt 36 was observed to have oxytocin (a synthetic hormone that helps speed up delivery or controls bleeding after childbirth) continuous infusion through her peripheral intravenous line (IV-a soft, flexible tube placed inside a vein). The oxytocin administration set did not have a label containing the date and time of initiation. The DWC stated the oxytocin administration set did not have a label containing a date and time of initiation. The DWC stated each administration set should have a label with the date and time when the administration set was first used and when it expired. The DWC stated it was important to know when the administration set was hung and when it expired to not introduce any infection risk to the patient. The DWC stated she expected staff to label the administration set with the date and time it was hung and when it expired. During a concurrent observation and interview on 9/11/24 at 3:40 p.m. with the Emergency Department Manager (EDM), in Pt 45’s room, Pt 45 was observed to have a lactated ringer’s (LR-used to replace water and electrolyte loss in patients) continuous infusion through her IV. The LR administration set did not have a label containing the date and time of initiation. The EDM stated the LR administration set did not have a label containing a date and time of initiation. The EDM stated there should be a label with the date and time of initiation on the LR administration set. The EDM stated when the same administration set is used for a prolonged period it can cause problems like infection. During a review of the facility’s policy and procedure (P&P) titled, “CO.GL.2.024 Venous Access Device: Prevention, Insertion and Maintenance Policy, Procedure, and Protocol,” approved on 5/22/24, indicated “ ... PROCEDURE ... Maintenance ... Label all IV infusions with hang date, time, nurse initials ... Primary and secondary continuous administration sets: ... Replace primary continuous administration sets at least every 96 hours and [as needed] if compromised ...” 7. During a concurrent observation and interview on 9/11/24 at 3:20 p.m. with the EDM, in Supply Room A, bottles of [brand name] sterile water had an expiration date of 7/1/24 and bottles of [brand name] infant formula had an expiration date of 8/1/24. The EDM stated the bottles of [brand name] sterile water and [brand name] infant formula were expired. The EDM stated she expected the person who re-stocked the supply room to bring the oldest expiration date forward so it would be used first and new stock behind it. The EDM stated the expiration dates should have been checked by the person who restocked the supply room should have checked. The EDM stated it was everyone’s responsibility to check and remove expired formula. The EDM stated the facility staff should check the expiration date before giving to the patient for use. During an interview on 9/13/24 at 2:28 p.m. with the Infection Control Director (ICD), the ICD stated formula stored beyond the expiration date could have organisms that are overpowering it, and a baby should not have it. The ICD stated he expected formula to be taken out when it is going to be expired. The ICD stated central supply is supposed to take out and rotate the stock. The ICD stated nursing staff should check dates prior to giving formula. The ICD stated he expected staff to change out the expired items and not use them. During an interview on 9/17/24 at 4:20 p.m. with the CNO, the CNO stated there should not be expired formula in the supply room. 8. During an observation on 9/10/24 at 2:22 p.m., with the DCC, and the ADCC in the CVICU unit, two (2) of 2 pill crushers were observed to have white-colored, powder-like residue and orange and brown colored stains throughout the device. During an observation on 9/11/24 at 9:06 a.m., with DCC, ADCC and Shift Manager (SM) 1, on the Surgical ICU (SICU) unit, 2 of 2 pill crushers were observed to have white-colored powder-like residue and orange and brown colored stains throughout the device. During an interview on 9/10/24 at 2:22 p.m., with the DCC, on the unit, the DCC stated CVICU nurses were responsible to ensure the equipment used to crush medications for administration to patients are cleaned per facility policy and procedure (P&P). The DCC stated it was his expectation the pill crushers would be cleaned by the Licensed Nurses following the manufacturer’s IFUs and facility P&P. The DCC stated the potential harm to patients was possible contamination of the medication being given, placing the patient at risk for infection. According to Links Medical Products, undated, retrieved on 9/19/2024 from https://imgcdn.mckesson.com/CumulusWeb/Click_and_learn/IFU_Silent_Knight_Cleaning_Instructions.pdf indicated “(Brand Name) pill crusher cleaning and maintenance instructions ...is made entirely of non-rusting materials and may be cleaned regularly with a damp cloth. A facility approved disinfectant wipe may also be used when indicated. In instances when the Silent Knight Pill Crusher requires a more thorough cleaning, please follow the instructions below: ...” During an interview with the DIC 1, on 9/12/24 at 2:11 p.m., DIC 1 stated pill crushers were used by the nursing staff so they were responsible for cleaning the pill crushers. DIC 1 stated, “If its nursing equipment, no one else should “touch that.” 9. During a concurrent observation and interview on 9/10/24 at 2:22 p.m., with DCC, ADCC and SM 3, on the Surgical CVICU, in the biohazard room (room where potentially contaminated human blood and fluid soiled items are kept), the red, rigid plastic container had 2 “brand name” pouches containing cardiac pacer wires (wires used during open heart surgery to monitor heart rhythm and provide temporary pacing (a pacemaker is used to control or increase the heartbeat)) was inside the container and was unsealed. The water added by staff to activate the pre-cleaning soak leaked out of the unsealed pouches causing contaminated fluid to pool at the bottom of the red container and a used double A (AA) battery was observed floating in the fluid. SM 3 stated “brand name” pouches are to be sealed after fluid is added to pouch and after inserting the soiled reusable patient care equipment. The ADCC stated he and was not sure why the 2 pouches observed had not been sealed. The ADCC stated it was his expectation that staff follow facility P&P and manufacturer IFUs to ensure proper handling and initiation of the disinfection process and to prevent the risk of contamination to staff by accidental spill or spray of contaminated fluid when handling the red container. The ADCC stated the potential for harm to patients was that the sterilization process would be interrupted if the initial step in the process (pre-soak in the pouch) was not done properly and that used batteries were stored too close to the red container and possibly caused a battery to fall into the container. According to the “brand name” IFU document, version six (6), undated, the IFU indicated “ ...Instructions for Using Product ...Description of Use(s) ...Placing items into the “brand name” [pouch] after use will provide a humid environment delaying the drying of contaminants during transport prior to any required cleaning, disinfection, reprocessing and/or sterilization ...Steps for Use of Product ...4. Place items in the pouch. 5. Peel off the protective strip from the adhesive band. 6. Fold over the adhesive strip and press down firmly from the center outwards to ensure a watertight seal ...” During a review of facility P&P titled “ ...Surgical Instrument Point-of-Use and Pre-Cleaning” dated 8/23/23, the P&P indicated “ ...II. Procedure: Staff will pre-clean surgical instruments at the Point-of-Use immediately after the procedure and transport them in an appropriate container ...C. Pre-Treatment ...2. Prepare instruments in a manner which will maintain moisture and prevent organic soils from drying by one of the following methods: a. Use pre-treatment product according to manufacturer’s instructions, applying to all instruments ...b. Place items inside a package designed to maintain a moist atmosphere [(air that contains water vapor]DEFINE) (e.g., “brand name” pouch) ...D. Transport: Transport soiled instruments to the decontamination area in a closed rigid container with a tight-fitting and/or latching lid or enclosed transport cart. The container must be: 1. Leak proof 2. Puncture resistant ...” 10. During a concurrent observation and interview on 9/10/24 at 3:45 p.m., with Chief Nursing Officer/Interim Emergency Department (ED) Director and Quality Review RN (RNQ) 3, in ED section B (where lower acuity patients of Emergency Severity Index (ESI- is a 5-level emergency department triage algorithm that sorts patients into 5 groups from 1 (most urgent) to 5 (least urgent) Level 3 (urgent) are treated in section B. Three (3) patients were present in section B. The CNO stated this section has the capacity to take up to 4 patients. Neither the primary nurse assigned to patient care in section B or ED tech were present in section B during observation. A used IV catheter insertion needle, and a small plastic dark red fluid-filled container with a red smudge on a binder was observed to be on top of a crash cart (contains the equipment and medications that would be required to treat a patient in the first thirty minutes or so of a medical emergency) in an occupied room and IV tubing and empty bag of IV fluids (liquids that are administered directly into a vein to replace water, sugar, and salt) was observed to have tubing laying on the floor. The CNO stated the observations are not to her expectations. The CNO stated the sharps (IV catheter needle) should have been discarded in designated safe sharps containers immediately after use, the binder should have been cleaned using facility P&P for cleaning of possible blood contamination, and the IV tubing and IV fluid bag should not be used again and ideally, should have been discarded per facility P&P when infusion was complete. During an interview with the DIC 1, on 9/12/24 at 2:11 p.m., DIC 1 stated the was “no reason for sharps, to have been left on the crash cart” staff should “get rid of it right away and wipe the visible soiling on the binder [possible blood, red colored-smudge]” DIC 1 stated it is “standard operating procedure and should have been discarded appropriately and IVF tubing once completed discard right away.” DIC 1 stated the expectation is for staff to report and ensure the matter is resolved “If you see it, do something about it. Don’t just see it and walk away because not attending to the matter can affect staff and patient safety and can harm the patient by contamination of the debris.””

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 37529 Based on observation, interview and record review, the hospital failed to comply with the regulatory requirements for EMTALA for five of 20 patients, Patients (Pts) 3, 4, 5, 6, and 7, when: 1. Patient 5 came to the ED by ambulance on 6/20/24 at 6:57 a.m., after having a witnessed fall at a homeless shelter, hitting her head, with unknown loss of consciousness. Pt 5 had a medical history of atrial fibrillation on blood thinners diabetes, a seizure disorder, and a past history of alcohol abuse. Pt 5 complained of pain in her head, left arm and leg. An MSE was initiated at 7:06 a.m. and orders for STAT (immediately, without delay) lab tests and computed tomography (CT scan) of head, neck and face were placed, and Pt 5 remained on the ambulance gurney until 8 a.m. Pt 5 was triaged at 8:02 a.m., assigned an ESI Level of 3. Urine tests for drugs and alcohol were negative. Pt 5 became agitated and angry, and at 10:55 a.m. Pt 5 was discharged to the street without the MSE being completed or pain addressed, and without follow up care arranged. (Refer to A 2406, Finding 1) 2. Patient 6 came to the ED on 8/13/24 at 2:48 p.m. with a chief complaint of psychiatric problem. Pt 6 was talking about brainwashing, mind control, and cyberstalking, and was triaged, assigned an ESI level of 2 and sent to the lobby to wait. An MSE was initiated over an hour later at 3:56 p.m., and Pt 6 remained in the lobby. There was no care documented after the MSE was initiated. Over two hours later at 6:23 p.m., a nurse went to get Pt 6 and could not locate him. Pt 6 was left unobserved in the lobby despite being paranoid and having delusions and left the hospital in unknown condition without the MSE being completed. There was no evidence of follow up. (Refer to A 2406, Finding 2) 3. Patient 7 came to the emergency department [ED] on 7/24/24 at 9 p.m. with a chief complaint of high blood pressure, was triaged and assigned an ESI level of 3. Pt 7’s blood pressure on arrival was 118/100 millimeters of mercury (mmHg). An MSE was initiated at 9:13 p.m., a discharge order was placed at 9:38 p.m., and Pt 7 was discharged from the hospital at 11:03 p.m., without having her chief complaint addressed or her vital signs rechecked prior to discharge. (Refer to A 2406, Finding 3) 4. Patient (Pt) 3 came to the Emergency Department (ED) on 3/10/24, with a chief complaint of “Alcohol Withdrawal, had tachycardia (high heart rate) and received Chlordiazepoxide (a medication used to treat anxiety, insomnia and symptoms of withdrawal from alcohol and Lorazepam (medication to treat anxiety and sleeping problems that are related to anxiety) when her blood alcohol level was 212.50 mg/dL., and was prescribed Chlordiazepoxide for home use. Pt 3 was discharged two hours later by herself still tachycardic and without being evaluated to ensure she was functionally stable prior to discharge. .(Refer to A 2407, Finding 1) 5. Pt 4, a homeless patient, was brought in by the ambulance to the ED on 8/9/24 for a chief complaint of increased blood glucose of 450 mg/dl (a blood sugar reading of 300 mg/dL or higher is considered dangerous and can lead to serious complications). Pt 4 was given a bolus (administration of a concentrated dose of a substance for immediate effect) of normal saline solution by the paramedics. In the ED, Pt 4 was placed in the lobby, labs were drawn, and no other interventions were done. Pt 4’s abnormal lab results were not addressed and Pt 4’s Blood Glucose was not checked prior to discharge. Pt 4’s discharge was not completed in accordance with the facility’s policy and procedure (P&P) titled, “AD 3.08 California Hospital Discharge Planning for Homeless Patient,” and Pt 4 was not offered a ride to the shelter or weather appropriate clothing, and access to prescribed medication was not arranged. (Refer to A 2407, Finding 2) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to provide an appropriate medical screening examination (MSE- an assessment performed by Qualified Medical Personnel [QMP] for the purpose of determining whether an emergency medical condition [EMC] exists) for three of 20 sampled patients, Patient (Pt) 5, Pt 6, and Pt 7 when: 1. Patient 5 came to the ED by ambulance on 6/20/24 at 6:57 a.m., after having a witnessed fall at a homeless shelter, hitting her head, with unknown loss of consciousness. Pt 5 had a medical history of atrial fibrillation on blood thinners diabetes, a seizure disorder, and a past history of alcohol abuse. Pt 5 complained of pain in her head, left arm and leg. An MSE was initiated at 7:06 a.m. and orders for STAT (immediately, without delay) lab tests and computed tomography (CT scan) of head, neck and face were placed, and Pt 5 remained on the ambulance gurney until 8 a.m. Pt 5 was triaged at 8:02 a.m., assigned an ESI Level of 3. Urine tests for drugs and alcohol were negative. Pt 5 became agitated and angry, and at 10:55 a.m. Pt 5 was discharged to the street without the MSE being completed or pain addressed, and without follow up care arranged. 2. Patient 6 came to the ED on 8/13/24 at 2:48 p.m. with a chief complaint of psychiatric problem. Pt 6 was talking about brainwashing, mind control, and cyberstalking, and was triaged, assigned an ESI level of 2 and sent to the lobby to wait. An MSE was initiated over an hour later at 3:56 p.m., and Pt 6 remained in the lobby. There was no care documented after the MSE was initiated. Over two hours later at 6:23 p.m., a nurse went to get Pt 6 and could not locate him. Pt 6 was left unobserved in the lobby despite being paranoid and having delusions, and left the hospital in unknown condition without the MSE being completed. There was no evidence of follow up. 3. Patient 7 came to the emergency department [ED] on 7/24/24 at 9 p.m. with a chief complaint of high blood pressure, was triaged and assigned an ESI level of 3. Pt 7’s blood pressure on arrival was 118/100 millimeters of mercury (mmHg). An MSE was initiated at 9:13 p.m., a discharge order was placed at 9:38 p.m., and Pt 7 was discharged from the hospital at 11:03 p.m., without having her chief complaint addressed or her vital signs rechecked prior to discharge. These failures resulted in a delay in identifying a potential emergency medical condition had the potential to result in negative outcomes for Pt 5, Pt 6, Pt 7. Findings: 1. During a review of Pt 5’s Patient Care Record (PCR- Record of pre-hospital care provided by Emergency Medical Services [EMS] personnel) dated 6/20/24, the PCR indicated Pt 5 had tripped and fell to the ground at the shelter and hit the left side of her forehead sustaining an abrasion and opening up a scab from a previous injury (two days prior) which was bleeding, and Pt 5’s left eye was swollen. Pt 5 agreed to be transported to the ED for further evaluation. The PCR indicated Pt 5 appeared intoxicated (drunk), was alert and oriented, and had a history of high blood pressure and diabetes and alcohol use. Pt 5 was placed in a C-collar (a neck brace used to support the neck and limit head movement) and was transported to the hospital arriving at 6:57 a.m. The PCR indicated vital signs on arrival were blood pressure 172/95, heart rate 77 beats per minute, respiratory rate 14 per minute, and oxygen saturation of 98% on room air. The PCR indicated the EMS staff stayed with Pt 5 until 8 a.m. when Pt 5 was put into an ED room. During a concurrent interview and record review on 8/20/24 at 11:40 a.m. with the ED clinical manager (EDM 2), Pt 5’s medical record was reviewed. Review of the face sheet (a document with information including patient’s demographic information, insurance information, emergency contacts name and phone number) dated 6/20/24, indicated Pt 5 was brought to the ED by ambulance on 6/20/24 at 7 a.m. with a chief complaint of “Fall; Head Injury.” The face sheet also indicated Pt 5 was homeless. During a concurrent interview and record review on 8/20/24 at 11:45 a.m. with EDM 2, Pt 5’s “ED Triage Form,” dated 6/20/24 at 8:02 a.m., was reviewed. The triage form indicated Pt 5 was triaged at 8:02 a.m. and assigned an Emergency Severity Index (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 is the most serious, in order to prioritize care) Level of 3. The triage note indicated Pt 5 complained of pain, level 4 (on a scale of 0-10, 0 is no pain, 10 is worse possible pain, 4 is moderate pain). EDM 2 stated before Pt 5 was triaged, the MSE was initiated, and orders were placed by the ED physician (MD 3) at 7:06 a.m. Review of the document “ED Note-Physician,” dated 6/20/24, at 8:31 a.m., indicated Pt 5 was seen by MD 3 at 7:06 a.m. The note indicated, “ ...Chief Complaint: BIBA [brought in by ambulance] from [Name of Shelter] after a witnessed GLF [ground level fall]. Pt significant history of ETOH [alcohol] abuse. Unknown LOC [loss of consciousness], dried blood noted to majority of left face, no active bleeding noted. Pt c/o (complains of) pain to left arm and leg ...History of Present Illness: ...Patient was reportedly previously hospitalized after being struck by a car. Earlier today, she fell while walking and struck the left side of her face ...reportedly opened up a previous scab on forehead. No reported blood thinners. Past history is significant of alcohol abuse ...” The ED Physician’s Note indicated Pt 5 had a past medical history which included atrial fibrillation (an arrhythmia that occurs when the upper chambers of the heart [atria] beat irregularly and fast), hypertension (high blood pressure), and a seizure (a sudden, uncontrolled burst of electrical activity in the brain. It can cause changes in behavior, movements, feelings, and levels of consciousness) disorder. The ED Physician’s note indicated Pt 5’s current medication list included Eliquis (a “blood thinner” to prevent blood clots), Keppra (to prevent seizures), metoprolol and lisinopril (to treat hypertension), and two medications to treat diabetes. MD 3 ordered a CT scan of the head, spine, face and jaw, a chest x-ray, and a urine test for drugs and alcohol. During a concurrent interview and record review on 8/20/24 at 11:55 a.m. with EDM 2, Pt. 5’s Nursing Note, dated 6/20/24, indicated at 8:15 a.m. “Pt cussing and yelling demanding help to urinate. Pt refusing VS [vital signs]. Pt placed on PureWick [an external urinary catheter] at this time. This RN [RN 1] assisting with trauma patient; will attempt assess and get VS after Pt calm.” At 9 a.m., “ ...Pt yelling out for help ...Pt still refusing to let RN get baseline VS for triage. Refusing to go to CT scan/XR [x-ray] until she gets pain medication ...Charge nurse and [Name of MD 3] made aware ...” The Nursing Note indicated at 9:17 a.m. Pt 5 was complaining of pain to her left arm and leg, and was agitated, frustrated, and angry. RN 1 was unable to assess Pt 5 or obtain vital signs, and at 9:45 a.m., RN 1 obtained a urine specimen from the Purewick cannister and sent it to the lab. The Nursing Note indicated at 10:30 a.m. Pt 5 was yelling and refused to let RN 1 assess her. At 10:48 a.m. RN 2 indicated, “[Name of MD 3] notified patient refusing everything until she gets pain meds. [Name of MD 3] states pt. to be d/c [discharged].” The Nursing Note indicated at 10:50 a.m. Pt 5 removed own C-collar and walked out of room. Pt 5 declined to let RN 1 clean her (Pt 5’s) face; refused to wait for discharge paperwork. The record indicated MD 3 placed a discharge order at 10:45 a.m. During a review of the lab test results dated 6/20/24 at 10:28 a.m., the lab results indicated no drugs or alcohol were present in Pt 5’s urine. During a concurrent interview and record review on 8/20/24 at 12 p.m. with EDM 2, Pt 5’s Nursing Note dated 6/20/24 at 11:03 a.m. was reviewed. The Nursing Note indicated at 11:03 a.m., RN 1 edited her pain assessment documentation from 8:02 a.m. At 8:02 a.m., RN 1 had indicated Pt 5 had “Actual or suspected pain,” and “Pain Score: 4.” At 11:03 a.m., RN 1 revised the 8:02 a.m. entry to indicate at 8:02 a.m. Pt 5 had “No actual or suspected pain,” and the 8:02 a.m. “Pain Score: 4” was lined through at 11:03 a.m. as an “ERROR.” RN 1 indicated at 11:03 a.m. (for the 8:02 a.m. pain assessment), “Pt complaining of pain but refusing to give any pain scale or answer questions regarding pain.” During a concurrent interview and record review on 8/20/24 at 12:05 p.m. with EDM 2, Pt 5’s “ED Discharge Form,” dated 6/20/24 at 11:01 a.m. indicated Pt. 5 was discharged to the “Street” at 10:55 a.m. The ED Discharge Form indicated at discharge Pt 5 had “No actual or suspected pain,” and “Pt refusing to state pain scale on discharge.” The record indicated Pt 5 did not have a primary care provider (PCP). During a concurrent interview and record review on 8/20/24 at 12:10 p.m. with EDM 2, Pt 5’s medical record dated 6/22/24 was reviewed. The record indicated Pt 5 came to the ED by ambulance on 6/22/24 at 8:19 a.m. after having a seizure. Review of the ED Note-Physician dated 6/22/24 at 8:23 a.m., indicated MD 3 saw Pt 5 at 8:20 a.m. and noted, “ ...Brought in by ambulance from a bus stop, had a 10 second seizure and sustained a right eyebrow laceration. Patient [Pt 5] was seen at [Name of Hospital] ED on 6/20/24 but signed out AMA [against medical advice] ...” EDM 2 verified Pt 5 was discharged on 6/20/24, she did not leave AMA. The record indicated on 6/22/24, Pt 5 was discharged in stable condition after imaging of her head and neck were negative and Pt 5 received intravenous medication for seizures. During a review of the hospital’s P&P titled, “Pain Management Policy,” dated 4/7/22, the P&P indicated, “ ...It is the policy of [Name of Hospital] to do the following: Conduct an appropriate assessment and/or reassessment of a patient’s pain consistent with the scope of care, treatment, and service provided in the specific care setting in which the patient is being managed. The 0-10 Numeric Rating Scale shall be used to score pain as appropriate using the Mild, Moderate, and Severe pain indications ... [Name of Hospital] requires that methods used to assess a patient’s pain are consistent with the patient’s age, condition, ability to understand ...Wong-Baker faces scale: used for pediatric, non-English speaking patients, any patient with limited communication, the verbally impaired patient, or those who prefer to point or motion at his/her pain level on a diagram ...” During a review of the hospital’s P&P titled, “Triage Nurse Policy [ED 1.06],” dated 4/24/24, the P&P indicated, “ ...In cases of apparent patient dissatisfaction intervene, if appropriate, and facilitate immediate communication with Department Director, House Supervisor, shift Manager, or Security Officer as needed ...” During a review of the professional reference titled,” Emergency Severity Index Handbook, Version 5,” dated 2023, the reference indicated, “ ...Patients presenting to the ED who have a past or current history of behavioral health issues or substance use are particularly susceptible to the effects of bias and stigma. Patients who are described as “difficult” are perceived similarly...” During a review of the research article titled, “A Qualitative Study of Emergency Physicians’ and Nurses’ Experiences Caring for Patients With Psychiatric Conditions and/or Substance Use Disorders,” Annals of Emergency Medicine, Volume 81, no. 6: June 2023, the article indicated, “ Our findings reveal a cyclical model of difficult care dynamics for emergency nurses and physicians caring for patients with psychiatric conditions and/or substance use disorders [SUDs]: often interconnected logistical, diagnostic, and emotional challenges in caring for these patients can create and reinforce negative attitudes and biases toward them, adversely influencing patient care ...” 2. During a concurrent interview and record review on 8/19/24 at 4:15 p.m. with the ED clinical manager (EDM 2), Patient (Pt) 6’s medical record was reviewed. Review of the Face Sheet dated 8/13/24 indicated Pt 6 came to the ED at 2:48 p.m. with a chief complaint of Psych Eval [Psychiatric Evaluation]. The face sheet also indicated Pt 6 was homeless. The ED Triage Form dated 8/13/24 at 2:55 p.m., indicated Pt 6 was triaged at 2:52 p.m. Pt 6’s chief complaint was, “Needs Psych Eval. Denies SI/HI [suicidal ideation- thoughts of self-harm or ending one’s life /homicidal ideation-thoughts of killing another person]. Talking about brainwashing and mind control, and cyberstalking.” The triage nurse obtained Pt 6’s heart rate and oxygen saturation, assigned an ESI Level 2, and Pt 6 was sent to the lobby to wait. Review of the ED Nursing Note dated 8/13/24, indicated at 3:38 p.m. “ ...Pt [6] called for vital signs. Pt [6] states ‘Please don’t read my mind it’s not nice.’ Attempted to de-escalate the situation. Pt begins to laugh out loud and then sits down. Vital signs obtained. Pt states he is not suicidal or homicidal ...” Pt 6 remained waiting in the lobby. Review of the ED MSE Note dated 8/13/24 indicated the MSE was initiated at 3:56 p.m. The note indicated, “ ...Pt is requesting an x-ray or MRI because he has heard about brainwashing and mind control and wants to make sure he does not have devices implanted in his mind. States he can hear his voice in his head. PMHx [Past Medical History]: schizophrenia [a chronic, severe mental disorder that affects the way a person thinks, acts, expresses emotions, perceives reality], ADHD [Attention Deficit Hyperactive Disorder- a mental health disorder that includes problems, such as difficulty paying attention, hyperactivity, and impulsive behavior.]. States he does not take his schizophrenia medication because it makes him severely ill. Admits to using cannabis. Medical Screening Exam Initiated: I have reviewed the patient’s chief complaint, vital signs, level of distress, current medications, as well as completed a focused, limited exam, further evaluation will be necessary in the emergency department to determine if an emergency medical condition exists ...” During a concurrent interview and record review on 8/19/24 at 4:20 p.m. with EDM 2, the record of Pt 6’s orders dated 8/13/24 indicated at 5:30 p.m. orders were placed by the ED physician for a urine drug and alcohol screen, blood alcohol level, a complete blood count (CBC), a Comprehensive Metabolic Panel (CMP), and a CT scan of the head or brain. Review of the medical record did not indicate any care was provided or contact made with Pt 6 after the physician initiated the MSE at 3:56 p.m. Review of the record indicated none of Pt 6’s orders were carried out. The ED Nursing Note dated 8/13/24 at 10 p.m., indicated at 6:23 p.m. the nurse called Pt 6 for care but was unable to find him in the lobby. The note indicated the nurse called Pt 6 again at 7:24 p.m., and at 8:50 p.m., but was not able to find Pt 6. Pt 6 did not have a phone to contact. Review of the ED Note-Physician dated 8/13/24 at 5:41 p.m. indicated, “ ...Differential Diagnosis: Acute psychosis, medication reaction, mood disorder secondary to substance use, metabolic encephalopathy, medication noncompliance, depression, suicidality ...” and the ED physician indicated, “Patient eloped from the emergency department while awaiting workup and evaluation.” Discharge diagnoses were Delusional Ideas, and Paranoia. During an interview on 8/21/24 at 1 p.m. with the Chief Nursing Officer (CNO- and also the acting ED Director), the CNO stated in May this year the ED implemented the practice of reassessing the patient’s vital signs every two hours for all patients who are waiting in the ED lobby regardless of what their ESI Level was on arrival. This reassessment can alert the staff to changes and can also establish contact with the patient in order to possibly prevent a patient from leaving unnoticed. During a review of the hospital’s P&P titled, “Triage Nurse Policy [ED 1.06],” dated 4/24/24, the P&P indicated, “ ...Upon arrival an initial assessment is performed to determine the need for immediate treatment, or close observation based upon presenting clinical assessment by the primary triage nurse ...All patient conditions will be classified and prioritized as follows- ESI Level 1: The patient is unstable and requires immediate life-saving interventions. ESI Level 2: The patient is assessed as high risk. The patient’s condition may deteriorate if left unattended, and therefore should not wait. Upon determination of an ESI Level 2 condition, the triage nurse will expedite placement of the patient in a treatment area securing additional resources as necessary ...” During a review of the professional reference titled,” Emergency Severity Index Handbook, Version 5,” dated 2023, the reference indicated, “ ...ESI level-2 patients remain a high priority, and placement and treatment should be initiated rapidly. ESI level-2 patients have the potential to be very ill and at high risk for decompensation...” 3. During a concurrent interview and record review on 8/19/24 at 3:45 p.m. with the ED clinical manager (EDM 2), Patient (Pt) 7’s medical record was reviewed. Review of the Patient Summary Report, dated 7/24/24 at 9 p.m., indicated Pt 7 came to the ED at 9 p.m. with a chief complaint of high blood pressure. Pt 7 stated she was at [Name of facility] for alcohol detox and her blood pressure had been elevated all day. Pt 7’s was prescribed Librium for withdrawal symptoms during the previous ED visit on 7/23/24 when Pt 7 was medically cleared for alcohol rehab. Pt 7’s vital signs at triage at 9:03 p.m. were, temperature 36.9 degrees centigrade, heart rate 94 beats per minute, respiratory rate 18 breaths per minute, oxygen saturation 100% on room air, and blood pressure 118/100 millimeters of mercury (mmHg- hospital reference range for the bottom number [the diastolic blood pressure, measures the pressure in the arteries between heartbeats] is 60=90 mmHg). Pt 7 was assigned an ESI Level 3. Review of the ED Note-Physician dated 7/24/24 at 9:39 p.m. indicated that Pt 7 was seen by the ED physician (MD 5) at 9:13 p.m. The note indicated Pt 7’s chief complaint that her blood pressure had been elevated all day. MD 5’s note indicated Pt 7’s complaint was of alcohol withdrawals and was requesting something to help her sleep. The ED Note indicated, “ ...Medical Decision-Making: History obtained from the patient. Prior medical records reviewed. High complexity medical decision making required given the nature of the patient’s chief complaint, history, physical exam, and breadth and severity of the differential diagnosis considered. I personally reviewed and interpreted vital signs, EKG, labs, imaging. Pt’s social determinants of health also considered. I then compiled the information to determine if the patient would benefit from admission/transfer, or if the patient is stable for discharge ...” EDM 2 verified that no EKG, imaging, or lab tests were ordered or done, and vital signs were taken once during Pt 7’s ED visit. During a concurrent interview and record review on 8/19/24 at 3:55 p.m. with EDM 2, Pt 7’s ED Note-Physician dated 7/24/24 indicated, “ ...Differential diagnosis includes but not limited to alcohol dependence, alcohol withdrawal, polysubstance use. Patient [7] has no other complaints besides wanting medical clearance for alcohol rehab ...Patient medically cleared ...Patient discharged in stable condition ...” The record indicated MD 5 placed a discharge order at 9:38 p.m., and prescribed melatonin (a supplement that can help a person fall asleep) for sleep. There was no mention in MD 5’s note addressing Pt 7’s stated chief complaint about her elevated blood pressure and Pt 7’s abnormal blood pressure reading in triage was not rechecked prior to Pt 7’s discharge at 11:03 p.m. EDM 2 stated abnormal vital signs should be rechecked prior to discharge. During a review of the hospital’s policy and procedure (P&P) titled, “Standard of Care Policy [ED 1.04],” dated 10/26/22, the P&P indicated, “ ...Vital signs will be taken on all patients admitted to the ED ...The patient’s nurse is responsible for continually assessing the patient’s condition and obtaining vital signs as the situation warrants. Abnormal vital signs will be checked prior to discharge, and persistent abnormalities will be brought to the physician’s attention ...Continued evaluation and care of the patient includes: a. Documentation of any changes in patient condition and physician notification ...b. Documentation of treatments, patient tolerance of the treatment, and outcomes ...c. Informing the patient and support persons of reasons for tests, treatment, and delays ...” During a review of the hospital’s P&P titled, “Medical Screening Examination [ED 1.03],” dated 9/28/22, the P&P indicated, “ ...State and Federal regulations require the provision of a medical screening examination to all patients presenting to the Emergency Department for care. The medical screening exam may include the provision of ancillary diagnostic services routinely available in the hospital if necessary to determine whether the individual has an emergency medical condition ...The determination of the patient’s presenting condition [i.e., emergent, or non-emergent] will be made for each patient. MSE- Each patient may be triaged to determine priority for medical screening. The MSE will be based on the patient’s condition and prior history and may include at least the following: a. Patient’s chief complaint, age, sex, duration of onset of chief complaint, date and time, level of distress, and any other pertinent medical history. b. Vital signs, general observation, and focused examination. c. Initiation and documentation of any necessary testing, treatments and/or procedures. The scope of the examination is tailored to the patient’s presenting symptoms and the medical history of the patient. The MSE is an ongoing monitoring process, which continues until a medical emergency condition is found not to exist or until appropriate steps to stabilize the presenting emergency medical condition begin...””

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to ensure an emergency medical condition was stabilized prior to discharge for two of 20 sampled patients, Patient 3 and Patient 4 when: 1. Patient (Pt) 3 came to the Emergency Department (ED) on 3/10/24, with a chief complaint of “Alcohol Withdrawal, had tachycardia (high heart rate) and received Chlordiazepoxide (a medication used to treat anxiety, insomnia and symptoms of withdrawal from alcohol and Lorazepam (medication to treat anxiety and sleeping problems that are related to anxiety) when her blood alcohol level was 212.50 mg/dL., and was prescribed Chlordiazepoxide for home use. Pt 3 was discharged two hours later by herself still tachycardic and without being evaluated to ensure she was functionally stable prior to discharge. This failure resulted in worsening of Pt 3’s condition and Pt 3 returned to the ED on 3/12/24 by ambulance after Pt 3 was found walking around not acting normal, had been drinking alcohol, mixing [name of mouthwash] shots, and taking Chlordiazepoxide. Pt 3 was placed on a 1799 hold (a 24-hour involuntary medical hold that can be placed on a patient in California by certain licensed staff and healthcare providers) and transferred to an inpatient psychiatric treatment center. 2. Patient (Pt) 4, a homeless patient, was brought in by the ambulance to the ED on 8/9/24 for a chief complaint of increased blood glucose of 450 mg/dl (a blood sugar reading of 300 mg/dL or higher is considered dangerous and can lead to serious complications). Pt 4 was given a bolus (administration of a concentrated dose of a substance for immediate effect) of normal saline solution by the paramedics. In the ED, Pt 4 was placed in the lobby, labs were drawn, and no other interventions were done. Pt 4’s abnormal lab results were not addressed and Pt 4’s Blood Glucose was not checked prior to discharge. Pt 4’s discharge was not completed in accordance with the facility’s policy and procedure (P&P) titled, “AD 3.08 California Hospital Discharge Planning for Homeless Patient,” and Pt 4 was not offered a ride to the shelter or weather appropriate clothing, and access to prescribed medication was not arranged. These failures resulted in Pt 4 experiencing worsening hyperglycemia and being brought back to the ED by ambulance after being found outside a convenience store with a blood sugar of 347 mg/dL, 11 hours after being discharged from the ED. Findings: 1.During a review of the hospital’s report of returns to Emergency Department (ED) within 48 hours (of a previous ED visit) for March 2024, the report indicated Pt 3 was a 29-year-old female who came to the ED at 3:49 p.m. on 3/10/24 with a chief complaint of “Alcohol withdrawal; STATES NEEDS TO DETOX” and was discharged on 3/10/24 at 8:59 p.m. The report indicated that Pt 3 was brought back to ED via ambulance on 3/12/24 at 8:48 p.m. with a chief complaint of “[Brought in by ambulance] from home for [ethanol alcohol] use.; [Emergency Medical Services - EMS] mentions pt reported physical abuse from live in [boyfriend] and [name of city] police were present.” During a concurrent interview and record review on 08/16/24 at 10:30 a.m. with the Emergency Room Manager (EDM) 1 and Quality Registered Nurse (RNQ) 1, Pt 3’s medical records for ED visits for dated 3/10/24 and 3/12/24 were reviewed. The “ED Note - Physician” dated 3/10/24, indicated, “ ... 29 [year old female] presents herself to the ED for alcohol withdrawals. Patient reports that she normally drinks 3 bottles of wine a night. However, her most recent intake was a tall can of beer about 2 days ago since she is trying to detox from it. Since then, she states she has been feeling shaky and feels as if she had a seizure the night prior. No other symptoms reported. She reports that she did try [Chlordiazepoxide (medication used to treat anxiety, insomnia, and symptoms of withdrawal from alcohol)] for her symptoms but states that it brought no relief. No other medical history ...Home medications ...acamprosate (This medication is used along with counseling and support to help people who are alcohol dependent not drink alcohol. Acamprosate works by restoring the natural balance of chemicals in the brain), sertraline (antidepressant) and trazodone (antidepressant) ...ED Course: Patient presents for the above reasons. Based on the patient’s ED work - up today, I believe discharge is the appropriate course of action. Patient was educated on their results and instructed to follow-up with the listed physician/clinic below in their discharge paperwork, and given return precautions if their symptoms continue or worsen ...Follow up... Follow with primary care physician ...within 3-5 days ... PCP NO KNOWN ...” The “Patient Summary Report” indicated Pt 3 arrived in the ED on 3/10/24 at 3:49 p.m. The patient was triaged at 3:52 p.m. and was assigned an emergency severity index (ESI) level 3 (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious). Patient received Lorazepam (medication to treat anxiety and sleeping problems that are related to anxiety) and Chlordiazepoxide at 6:05 p.m. The review of “ED triage form” indicated initial vital signs on 3/10/24 at 3:52 p.m. Heart Rate (HR) 150 beats per minute (bpm-normal values 60-100 bpm), Blood Pressure (BP) 141/99 millimeters of mercury (mm/Hg - Unit of pressure that is used to measure blood pressure; normal 120/80 mmHg). The review of “lab results” indicated complete blood count with differential (CBC- blood test that measures many different parts often used to help screen overall health and measures the number of types of blood cells), ethanol level and Comprehensive Metabolic Panel (CMP - a routine blood test that measures 14 substances in the blood to provide information about the body’s chemical balance and metabolism) were completed on 3/10/24 at 6:49 p.m. The lab results showed Ethanol level (measure the amount of alcohol in a person’s blood) 212.50 and Ethanol Percentage 0.21 at 6:49 p.m. The flow sheet titled “Vitals” indicated on 3/10/24 at 8:11 p.m. HR was 132, BP 135/89, oxygen saturation 96%. Review of the document titled “ED Discharge form-Text” dated 3/10/24 indicated “ ...Discharged from ED, Mode of discharge: Ambulatory; Mode of transportation: Private vehicle ...ED Discharged: Home ...ED Condition: Stable ... ED accompanied by: Self ...Discharge comments: See provider documentation for full assessment details, plan of care and discharge plan ...”. The “ED Note- Physician” dated 3/10/24 indicated Pt 3 was prescribed chlordiazepoxide to take at home and the record indicated patient was discharged at 8:59 p.m. on 3/10/24. The review of “Nursing note” dated 3/10/24 at 3:59 p.m. indicated “ ...Pt’s roommate came up to this [Registered Nurse] and stated pt told him she needs to be on a hold but “they [would not] put her on a hold because she [would not] get out of the car and walk in the building, then she got arrested but they didn’t press charges so now she is going to tell you she is coming in asking for alcohol pills but she needs to be on a hold.” Pt denies [suicidal ideation/homicidal ideation] to this [Registered Nurse] at this time. EDM 1 stated she was not able to find any documentation that physician was notified about the concerned shared by roommate with nurse regarding need for hold. EDM 1 stated discharge instructions indicate patient was discharged to self, left by herself in a private vehicle at 8:59 p.m. The EDM 1 stated the discharge instructions lists the patient’s condition as stable and no other documentation existed regarding patient’s mental capacity or ability to take care of herself. EDM 1 validated Pt 3 received Lorazepam and Chlordiazepoxide at 6:05 p.m., and Pt 3’s blood ethanol level was 212.50 at 6:49 p.m., three hours after arrival to ED. EDM 1 validated the discharge instructions to “follow up with NO Physician” in 3-4 days. EDM 1 stated ideally, they would discharge the patient with family or someone responsible to take care of the patient if they are not able to provide for themselves. EDM 1 stated the discharge instructions do not provide clear follow up instructions and needs to be worked on. EDM 1 stated the ED nurse does the assessment before discharge and would not have discharged the patient if they had any concerns. EDM 1 stated she cannot validate if the patient was functionally stable and ok to drive without having any documentation, however, they normally do not document the assessment before discharge and stated most likely the documentation is incorrect or missing regarding self-discharge in a private vehicle. EDM 1 stated HR greater than 130 prior to discharge was not concerning. During a concurrent interview and record review on 08/19/24 at 2:30 p.m. with the Emergency Room Medical Director (EDMD), EDM 1 and RNQ 1, Pt 3’s medical records dated 3/10/24 and 3/12/24 were reviewed. EDMD stated he has reviewed patient record for both ED visits. EDMD stated he was not sure why the discharge information lists “NO physician”. EDMD stated they do not update this information and this information gets pulled automatically. The EDMD stated he was not too concerned with “HR of 132 in otherwise healthy individual.” The EDMD stated before discharge they look at the patient to ensure that patient is functionally stable. The EDMD stated RN will assess and communicate with assigned provider as needed. The EDMD stated providers do not document functional stability of the patient but always assess before the discharge disposition. The EDMD stated the blood alcohol level of 212.50 could be where the patient normally lives. The EDMD stated that patient most likely did not drive herself upon discharge and stated the documentation was missing. During a review of Pt 3’s “EMS Patient Care Record (PCR)” dated 3/12/24, the PCR indicated, “ ... Pt is a 29-year-old female not acting right. Boyfriend called 911. On arrival found Pt in a trailer walking around not acting normal. Per boyfriend he called for possible overdose. Pt has been drinking alcohol today and taking shots of Listerine during the day. Pt states she is being mental abused by her boyfriend and he slapped her around about 3 weeks ago. Ceres PD was called, and they came out and did a report. Pt is not on 5150 hold, pt does not want to harm herself. Pt has no complaints during transport ...” During a concurrent interview and record review on 08/19/24 at 2:35 p.m. with EDM 1 and RNQ 1, Pt 3’s medical record dated 3/12/24 was reviewed. The document titled “Patient Summary Report” dated 3/12/24 indicated, Pt 3’s returned to ED by ambulance with diagnoses which included: Alcohol use, Poly pharmacy and Altered Mental Status on 3/12/24 at 8:48 p.m., and was triaged at 9:00 p.m. Review of “ED Note-Physician” dated 3/12/24 indicated, “ ...HISTORY OF PRESENT ILLNESS: 29-year-old female history of alcohol abuse recently evaluated on 3/10 for alcohol withdrawal presents to the ED for intoxication, brought in by initially called for domestic violence, reportedly had been slapped by the boyfriend, patient however denies this, denies any pain, patient had [Chlordiazepoxide] medication bottle next to her bedside, appears intoxicated able to provide city where she lives slurring speech ...no external sings of trauma concerning for ICH or fracture ...I was worried for the patient safety, so I have placed them under 1799 hold with plans for further evaluation ...Patient was seen taking unknown number of the [Chlordiazepoxide] medications despite medications ordered to be taken away from patient. Patient was monitored for period of time in the emergency department ...” Review of “Nursing Note” dated 3/12/24 at 11:39 p.m., indicated, “ ...Pt found with empty [Chlordiazepoxide] bottle states “It’s not a big deal I just took a couple...”. The record indicated after this, Pt 3 was placed on a 1799 hold on 3/12/24 at 11:57 p.m. and transferred to an inpatient psychiatric treatment center on 3/13/24 at 4:57 a.m. The EDM 1 stated she does not know how the patient was able to take [Chlordiazepoxide] in ED. EDM 1 stated medication should have been taken away from the patient. During a review of the facility’s P&P titled, “MOD COMP-RCC 5.16 EMTALA POLICY,” dated 4/24/24, indicated, “..To ensure individuals presenting to [hospital name]emergency department receive an appropriate Medical Screening Examination (MSE) and stabilizing treatment of appropriate transfer in accordance with Emergency Medical Treatment and Labor Act of 1986 (EMTALA) ...[hospital name] will provide an individual who is determined to have an Emergency Medical Condition further medical examination and treatment as is required to stabilize the Emergency Medical Condition, including admission for inpatient care, or arrange an appropriate transfer of the individual to another medical facility with the Capability to provide the stabilizing care ...” During a professional reference review retrieved from (https://www.ncbi.nlm.nih.gov/books/NBK547659/) titled, “Chlordiazepoxide”, dated 1/30/20, the reference indicated, “ ...Contraindications ... The use of benzodiazepines, including chlordiazepoxide, exposes individuals to the risk of misuse, abuse, and potential addiction, resulting in overdose or death. Benzodiazepine abuse and misuse often involve concurrent alcohol and illicit substances, contributing to a higher incidence of severe adverse outcomes. Before prescribing chlordiazepoxide and throughout treatment, evaluate each patient’s susceptibility to abuse, misuse, and addiction ... Patients should be informed about life-threatening adverse effects if combined with opiates, alcohol, and other CNS-depressant medications ...” 2. During a review of the hospital’s report of patients who returned to the ED within 48 hours of a previous ED visit for August 2024, the report indicated Pt 4 was a 32-year-old male who came to the ED at 4:41 p.m. on 8/9/24 with a chief complaint of “Increased blood sugar” and was discharged on 8/9/24 at 7:49 p.m., three hours and nine minutes later. The report indicated that Pt 4 returned to the ED on 8/10/24 at 6:44 a.m. with a chief complaint of “Increased Blood Sugar; DIABETIC”. During a review of Pt 4, “[Emergency Medical Services (EMS)] Patient Care Record (PCR)” dated 8/9/24, the PCR indicated, “ .... Address: Homeless ...dispatched code 3 ...male siting up talking to fire [department]... [Glasgow Coma Scale (GCS) is a system to “score” or measure how conscious you are. The score ranges from 3-15. Patients with scores of 3 to 8 are usually considered to be in a coma and 15 is the best you can get] GCS of 15. Pt stated he smoked meth and now his sugar is high [Blood glucose level (BGL)] 414 and pt stated his mouth is dry.... [arrival on site-Hospital name], charge [nurse] advised to take pt to triage. Report given to triage nurse ...Medication administration ...Normal Saline (mixture of sodium chloride and water) ...Intravenous (IV - Into or within a vein) ...500 milliliters (ml-unit of measurement) ...” During a concurrent interview and record review on 08/20/24 at 10:30 a.m. with the EDM 1 and RNQ 1, Pt 4’s record dated 8/9/24 was reviewed. The document titled “Patient Summary Report,” dated 8/9/24 indicated, Pt 4 arrived in the ED on 8/9/24 at 4:41 p.m., was triaged at 4:57 p.m. and emergency severity index (ESI) level 3 (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious) was assigned. The order was placed for Complete Blood Count with auto differential (CBC- blood test that measures many different parts often used to help screen overall health and measures the number of types of blood cells), Hemoglobin A1C (blood test that measures the average blood sugar level over the past three months), Basic Metabolic Panel (BMP- blood test that measures eight substances in the blood to evaluate various body functions and processes), and Beta Hydroxybutyrate (test used to detect ketones in blood or urine and monitor ketosis, metabolic state that occurs when your body burns fat for energy instead of glucose.) on 8/9/24 at 6:02 p.m. The patient was discharged on 8/9/24 at 7:49 p.m. Pt 4’s vital signs at 4:57 p.m. were normal. The review of “ED Note-Physician” dated 8/9/24 indicated, Pt 4 arrived with chief complaint “High blood sugar, 450. EMS administered 500 ml, [normal saline -(NS)], [blood glucose] after 350. Used meth today per patient. EMS IV pulled before coming out to ED lobby”. The document indicated “ ...Pt states that he has no current [Diabetes mellitus (DM - condition when body does not produce enough insulin, or the body’s cells do not respond to insulin)] medications, but used to be on Metformin and insulin. Unable to obtain further information and medical [history] due to pt’s medical status ...Physical exam...General: Patient is thin-appearing, cachectic, looking around, and not following instructions ...lab summary statements ...normal white blood cells (WBCs- are part of the body’s immune system. They help the body fight infection and other diseases) count 9.0, hemoglobin (Hb- is the protein contained in red blood cells that is responsible for delivery of oxygen to the tissues) is low at 8.6 with low [Mean corpuscula volume (MCV- measures the average size of your red blood cell, help identify anemia and other conditions) of 61.1 Platelets (are a blood component whose function is to react to bleeding from blood vessel injury by clumping, thereby initiating a blood clot) adequate at 338. Patient’s electrolytes show a low sodium (blood test measures the amount of sodium in your blood) of 129 but I believe this is due to elevated blood sugar of 314. Creatine (a lab test to assess kidney functions) is normal at 0.8 although [Blood Urea Nitrogen (BUN -test measures how much urea nitrogen is in your blood. It helps to determine if kidneys are working as they should is slightly up at 37 which may go along with some mild dehydration. Hemoglobin A1c is 9.1 showing poor control ...He is not willing to give much information and appears to be under the influence of methamphetamine. Physical exam shows him to be cachectic and somewhat pale appearing. His vitals sings were unremarkable ...He is microcytic anemic. His blood sugar is elevated at 314 consistent with his poor control. His BUN is elevated at 37 and EMS did give him a bolus ...I will be discharging him with prescription of metformin. He needs to work with his doctor at his clinic to control his anemia but more importantly he needs to be in a treatment program for his methamphetamine use and I have given him referrals ...” The review of “lab results for Beta Hydroxybutyrate” dated 8/9/24 at 6:02 p.m. also indicated 1.06 millimoles per liter (mmol/L) (normal 0.02 -0.27). EDM 1 stated she was unable to find any interventions done in ER besides lab draws. EDM 1 also validated no documentation regarding plan or rationale for high Beta Hydroxybutyrate level on provider note. EDM 1 also validated no blood glucose check was done during the entire ED stay and only documented glucose level in patient record is 314 from BMP that was done on 3/9/24 at 6:02 p.m. EDM 1 stated patient was treated by paramedics with fluid bolus and blood glucose check was completed by EMS, no other medications were administered in ED. The EDM 1 stated BG level of 314 is high and she could not provide an explanation as to why no other interventions were completed in ED to address blood glucose, to recheck the blood glucose level or to address the high Beta Hydroxybutyrate level in ED prior to discharge on 8/9/24 at 7:49 p.m. During a concurrent interview and record review on 08/20/24 at 10:40 a.m. with the Emergency Room Manager (EDM) 1 and Quality Registered Nurse (RNQ) 1, Pt 4’s record dated 8/9/24 was reviewed. The document titled “ED Discharge Form-Text” indicated, Pt 4 was discharged on 8/9/24, a Friday at 7:49 p.m., ED Disposition: discharge, ED discharged: home (although homeless). The EDM 1 stated although a shelter list was provided, the document does not reflect if the patient was offered or given taxi voucher or ride as needed to a shelter along with weather appropriate clothing. The EDM 1 stated the missing elements are required prior to discharge in accordance with hospital policy and state law concerning homeless patient discharge. The EDM 1 validated 8/9/24 was Friday, and stated she did not know what resources would be open/available to a patient upon discharge to pick up his medication or if the shelter accepts patients at nighttime. During a review of Pt 4’s “[Emergency Medical Services (EMS)] Patient Care Record (PCR) “ dated 8/10/24, the PCR indicated, “ ...32-year-old male outside of seven eleven shop with fire department crew by his side. Patient stated that he has been having diabetic issues, has been going in and out of [hospital name] for past few days. Patient reported he has not been able to take his medications. Patient also complaint of some left ankle pain, no obvious sign of trauma noted. Patient denies falls, stated he has been doing lot of walking. Patient admitted to weed and meth usage. Patient able to ambulate to gurney ...” During a concurrent interview and record review on 08/20/24 at 10:45 a.m. with the Emergency Room manager (EDM) 1 and Quality Registered Nurse (RNQ) 1, Pt 4’s record dated 8/10/24 was reviewed. The document titled, “Patient Summary Report” indicated patient returned to the ED on 8/10/24 at 6:44 a.m. Pt was triaged at 6:49 a.m. and ESI of 3 was assigned. The order was placed for chest X-ray (use to create picture of inside the body), Electrocardiogram (EKG - a test to record the electrical signals in the heart), X-ray ankle, Urinalysis (test that examines urine for physical properties, cells, organisms, and other substances), Troponin1(blood test to detect heart damage and diagnose heart conditions), CBC, and CMP were ordered. Pt 4 was also given Insulin Regular and Sodium Chloride IV and blood glucose levels. Review of document titled “ED Note- Physician” dated 8/10/24 indicated, “ ...Chief Complaint: [brought in by ambulance (BIBA)] for elevated blood sugar. Has [left] ankle pain, feels like a burning sensation. [fingerstick blood sugar (FSBS)] 345 ...Radiology/Diagnostic Results ...XR Ankle ..findings ...Impression: Negative Ankle/Foot ...Degenerative arthritic changes ...No fracture ...XR Chest ...Impression: Negative ...EKG ...Sinus, No PVCs, No obvious ST changes, No [bundle branch block (BBB - condition that occurs when the electrical signal that causes the heart to beat is blocked or delayed in one or both of the heart’s bundle branches )] “ The “lab results” dated 8/10/24 indicated glucose level at 6:59 a.m. 347, at 8:22 a.m. 382, at 10:36 a.m. 317, at 11:21a.m. 181. The “Medication Administration Record (MAR)” dated 8/10/24 indicated, Pt 4 received 5 units of insulin (medication used in the treatment and management of high blood sugar) at 10:41 a.m. and sodium chloride (used for replenishing fluid and for restoring and maintaining the concentrations of sodium and chloride) 0.9% 1000 ml at 10:29 a.m. Review of document titled “ED Discharged Form” dated 8/10/24 indicated, “ ED Disposition: Discharge Mode of discharge: Ambulatory ... Mode of transportation: Other: bus pass ...ED Discharged: Shelter ...ED condition: Stable ...ED Accompanied by: Self ...Discharge Comments: Clothes weather appropriate, gave sandwich and bus pass. The EDM 1 stated patient was discharged appropriately on 8/10/24 at 11:35 a.m. During a concurrent interview and record review on 08/20/24 at 11:00 a.m. with the Emergency Room manger (EDM) 1 and Quality Registered Nurse (RNQ), the P&P titled, “ AD 3.08 California Hospital Discharge Planning for Homeless Patient,” dated 6/22/22 was reviewed. The EDM 1 stated regarding Pt 4, she was not able to locate any documentation regarding referral or consult by a social worker. The EDM1 stated it was not the facility process to get a social worker consult for homeless discharges. The EDM 1 stated she was not able to find documentation of a full cognitive assessment as outlined in the policy. During a review of the facility’s policy and procedure (P&P) titled, “MOD COMP-RCC 5.16 EMTALA POLICY,” dated 4/24/24, the P&P indicated, “..To ensure individuals presenting to [hospital name] emergency department receive an appropriate Medical Screening Examination (MSE) and stabilizing treatment of appropriate transfer in accordance with Emergency Medical Treatment and Labor Act of 1986 (EMTALA) ...[hospital name] will provide an individual who is determined to have an Emergency Medical Condition further medical examination and treatment as is required to stabilize the Emergency Medical Condition, including admission for inpatient care, or arrange an appropriate transfer of the individual to another medical facility with the Capability to provide the stabilizing care ...” During a review of the facility’s P&P titled, “ AD 3.08 California Hospital Discharge Planning for Homeless Patient,” dated 6/22/22, the P&P indicated, “ ...Purpose of this policy is to ensure transition management and discharge planning for the homeless patient is conducted with dignity, respect and compassion, in accordance with regulatory requirements and accreditation standards to improve continuity of care and follow a process for discharge planning that will address health care needs of the homeless patient population in the State of California (State) ...This policy applies to Homeless Individual presenting to Hospitals in California and includes in patients, observation admissions and certain types of outpatients, including, outpatients in a bed and Emergency Department patients ...The discharge planning process will be individualized and will begin as soon as possible, in the Emergency Department once the homeless patient is medically stable, or upon direct admission as an Inpatient or Outpatient. If there are complex discharge needs, Hospital Case Management assistance must be requested. The Discharge Planning Checklist for homeless patient will be initiated at this to develop an initial discharge plan for homeless patients presenting to the Hospital with the goal of balancing available community resources with patient choice and continuity of care. Prior to discharge, an appropriate discharge plan for the post-hospital medical care will be completed and documented in the medical record ...the hospital will offer weather-appropriate clothing and/or shoes to the patient as provided in this policy ...Social services/designated trained staff will assess homeless patient’s ability to maintain mental cognition and stability post-hospitalization. The following are factors to be considered: history of frequent admissions, incarceration, interactions with law enforcement, associations with family or friends, frequents housing transitions, inconsistent locations for sleeping or food, ability to maintain/access public benefits and ability to maintain a treatment regimen ... Cognitive Assessment. When developing discharge plans, treating physicians, nurses, discharge planners and/or social workers will evaluate and document the patient’s mental status during their clinical examination or assessments over the course of the patient’s hospital stay to determine whether the patient is cognitively intact. The cognitive assessment will consider the homeless patient’s individual circumstances (i.e. the patient’s living arrangements and available support system post post-hospitalization) and details of the discharge plan what is to be implemented for the patients. The cognitive assessment will include the patient’s orientation to person, place, circumstances and time, ability to provider self-care, his or her ability carry out usual activities or to protect his or her rights, the ability to obtain follow-up medical/mental health care, food and shelter, and ability to negotiate the environment being discharge to. The assessment will be documented in the patient’s medical record ...Services offered to Homeless Patients Before Discharge ...Clothing...if the patient does not arrive with weather appropriate clothing, the hospital will offer weather appropriate clothing and encourage the patient to change in to weather-appropriate clothing before leaving the hospital ...””

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to ensure an emergency medical condition was stabilized prior to discharge for two of 20 sampled patients, Patient 3 and Patient 4 when: 1. Patient (Pt) 3 came to the Emergency Department (ED) on 3/10/24, with a chief complaint of “Alcohol Withdrawal, had tachycardia (high heart rate) and received Chlordiazepoxide (a medication used to treat anxiety, insomnia and symptoms of withdrawal from alcohol and Lorazepam (medication to treat anxiety and sleeping problems that are related to anxiety) when her blood alcohol level was 212.50 mg/dL., and was prescribed Chlordiazepoxide for home use. Pt 3 was discharged two hours later by herself still tachycardic and without being evaluated to ensure she was functionally stable prior to discharge. This failure resulted in worsening of Pt 3’s condition and Pt 3 returned to the ED on 3/12/24 by ambulance after Pt 3 was found walking around not acting normal, had been drinking alcohol, mixing [name of mouthwash] shots, and taking Chlordiazepoxide. Pt 3 was placed on a 1799 hold (a 24-hour involuntary medical hold that can be placed on a patient in California by certain licensed staff and healthcare providers) and transferred to an inpatient psychiatric treatment center. 2. Patient (Pt) 4, a homeless patient, was brought in by the ambulance to the ED on 8/9/24 for a chief complaint of increased blood glucose of 450 mg/dl (a blood sugar reading of 300 mg/dL or higher is considered dangerous and can lead to serious complications). Pt 4 was given a bolus (administration of a concentrated dose of a substance for immediate effect) of normal saline solution by the paramedics. In the ED, Pt 4 was placed in the lobby, labs were drawn, and no other interventions were done. Pt 4’s abnormal lab results were not addressed and Pt 4’s Blood Glucose was not checked prior to discharge. Pt 4’s discharge was not completed in accordance with the facility’s policy and procedure (P&P) titled, “AD 3.08 California Hospital Discharge Planning for Homeless Patient,” and Pt 4 was not offered a ride to the shelter or weather appropriate clothing, and access to prescribed medication was not arranged. These failures resulted in Pt 4 experiencing worsening hyperglycemia and being brought back to the ED by ambulance after being found outside a convenience store with a blood sugar of 347 mg/dL, 11 hours after being discharged from the ED. Findings: 1.During a review of the hospital’s report of returns to Emergency Department (ED) within 48 hours (of a previous ED visit) for March 2024, the report indicated Pt 3 was a 29-year-old female who came to the ED at 3:49 p.m. on 3/10/24 with a chief complaint of “Alcohol withdrawal; STATES NEEDS TO DETOX” and was discharged on 3/10/24 at 8:59 p.m. The report indicated that Pt 3 was brought back to ED via ambulance on 3/12/24 at 8:48 p.m. with a chief complaint of “[Brought in by ambulance] from home for [ethanol alcohol] use.; [Emergency Medical Services - EMS] mentions pt reported physical abuse from live in [boyfriend] and [name of city] police were present.” During a concurrent interview and record review on 08/16/24 at 10:30 a.m. with the Emergency Room Manager (EDM) 1 and Quality Registered Nurse (RNQ) 1, Pt 3’s medical records for ED visits for dated 3/10/24 and 3/12/24 were reviewed. The “ED Note - Physician” dated 3/10/24, indicated, “ ... 29 [year old female] presents herself to the ED for alcohol withdrawals. Patient reports that she normally drinks 3 bottles of wine a night. However, her most recent intake was a tall can of beer about 2 days ago since she is trying to detox from it. Since then, she states she has been feeling shaky and feels as if she had a seizure the night prior. No other symptoms reported. She reports that she did try [Chlordiazepoxide (medication used to treat anxiety, insomnia, and symptoms of withdrawal from alcohol)] for her symptoms but states that it brought no relief. No other medical history ...Home medications ...acamprosate (This medication is used along with counseling and support to help people who are alcohol dependent not drink alcohol. Acamprosate works by restoring the natural balance of chemicals in the brain), sertraline (antidepressant) and trazodone (antidepressant) ...ED Course: Patient presents for the above reasons. Based on the patient’s ED work - up today, I believe discharge is the appropriate course of action. Patient was educated on their results and instructed to follow-up with the listed physician/clinic below in their discharge paperwork, and given return precautions if their symptoms continue or worsen ...Follow up... Follow with primary care physician ...within 3-5 days ... PCP NO KNOWN ...” The “Patient Summary Report” indicated Pt 3 arrived in the ED on 3/10/24 at 3:49 p.m. The patient was triaged at 3:52 p.m. and was assigned an emergency severity index (ESI) level 3 (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious). Patient received Lorazepam (medication to treat anxiety and sleeping problems that are related to anxiety) and Chlordiazepoxide at 6:05 p.m. The review of “ED triage form” indicated initial vital signs on 3/10/24 at 3:52 p.m. Heart Rate (HR) 150 beats per minute (bpm-normal values 60-100 bpm), Blood Pressure (BP) 141/99 millimeters of mercury (mm/Hg - Unit of pressure that is used to measure blood pressure; normal 120/80 mmHg). The review of “lab results” indicated complete blood count with differential (CBC- blood test that measures many different parts often used to help screen overall health and measures the number of types of blood cells), ethanol level and Comprehensive Metabolic Panel (CMP - a routine blood test that measures 14 substances in the blood to provide information about the body’s chemical balance and metabolism) were completed on 3/10/24 at 6:49 p.m. The lab results showed Ethanol level (measure the amount of alcohol in a person’s blood) 212.50 and Ethanol Percentage 0.21 at 6:49 p.m. The flow sheet titled “Vitals” indicated on 3/10/24 at 8:11 p.m. HR was 132, BP 135/89, oxygen saturation 96%. Review of the document titled “ED Discharge form-Text” dated 3/10/24 indicated “ ...Discharged from ED, Mode of discharge: Ambulatory; Mode of transportation: Private vehicle ...ED Discharged: Home ...ED Condition: Stable ... ED accompanied by: Self ...Discharge comments: See provider documentation for full assessment details, plan of care and discharge plan ...”. The “ED Note- Physician” dated 3/10/24 indicated Pt 3 was prescribed chlordiazepoxide to take at home and the record indicated patient was discharged at 8:59 p.m. on 3/10/24. The review of “Nursing note” dated 3/10/24 at 3:59 p.m. indicated “ ...Pt’s roommate came up to this [Registered Nurse] and stated pt told him she needs to be on a hold but “they [would not] put her on a hold because she [would not] get out of the car and walk in the building, then she got arrested but they didn’t press charges so now she is going to tell you she is coming in asking for alcohol pills but she needs to be on a hold.” Pt denies [suicidal ideation/homicidal ideation] to this [Registered Nurse] at this time. EDM 1 stated she was not able to find any documentation that physician was notified about the concerned shared by roommate with nurse regarding need for hold. EDM 1 stated discharge instructions indicate patient was discharged to self, left by herself in a private vehicle at 8:59 p.m. The EDM 1 stated the discharge instructions lists the patient’s condition as stable and no other documentation existed regarding patient’s mental capacity or ability to take care of herself. EDM 1 validated Pt 3 received Lorazepam and Chlordiazepoxide at 6:05 p.m., and Pt 3’s blood ethanol level was 212.50 at 6:49 p.m., three hours after arrival to ED. EDM 1 validated the discharge instructions to “follow up with NO Physician” in 3-4 days. EDM 1 stated ideally, they would discharge the patient with family or someone responsible to take care of the patient if they are not able to provide for themselves. EDM 1 stated the discharge instructions do not provide clear follow up instructions and needs to be worked on. EDM 1 stated the ED nurse does the assessment before discharge and would not have discharged the patient if they had any concerns. EDM 1 stated she cannot validate if the patient was functionally stable and ok to drive without having any documentation, however, they normally do not document the assessment before discharge and stated most likely the documentation is incorrect or missing regarding self-discharge in a private vehicle. EDM 1 stated HR greater than 130 prior to discharge was not concerning. During a concurrent interview and record review on 08/19/24 at 2:30 p.m. with the Emergency Room Medical Director (EDMD), EDM 1 and RNQ 1, Pt 3’s medical records dated 3/10/24 and 3/12/24 were reviewed. EDMD stated he has reviewed patient record for both ED visits. EDMD stated he was not sure why the discharge information lists “NO physician”. EDMD stated they do not update this information and this information gets pulled automatically. The EDMD stated he was not too concerned with “HR of 132 in otherwise healthy individual.” The EDMD stated before discharge they look at the patient to ensure that patient is functionally stable. The EDMD stated RN will assess and communicate with assigned provider as needed. The EDMD stated providers do not document functional stability of the patient but always assess before the discharge disposition. The EDMD stated the blood alcohol level of 212.50 could be where the patient normally lives. The EDMD stated that patient most likely did not drive herself upon discharge and stated the documentation was missing. During a review of Pt 3’s “EMS Patient Care Record (PCR)” dated 3/12/24, the PCR indicated, “ ... Pt is a 29-year-old female not acting right. Boyfriend called 911. On arrival found Pt in a trailer walking around not acting normal. Per boyfriend he called for possible overdose. Pt has been drinking alcohol today and taking shots of Listerine during the day. Pt states she is being mental abused by her boyfriend and he slapped her around about 3 weeks ago. Ceres PD was called, and they came out and did a report. Pt is not on 5150 hold, pt does not want to harm herself. Pt has no complaints during transport ...” During a concurrent interview and record review on 08/19/24 at 2:35 p.m. with EDM 1 and RNQ 1, Pt 3’s medical record dated 3/12/24 was reviewed. The document titled “Patient Summary Report” dated 3/12/24 indicated, Pt 3’s returned to ED by ambulance with diagnoses which included: Alcohol use, Poly pharmacy and Altered Mental Status on 3/12/24 at 8:48 p.m., and was triaged at 9:00 p.m. Review of “ED Note-Physician” dated 3/12/24 indicated, “ ...HISTORY OF PRESENT ILLNESS: 29-year-old female history of alcohol abuse recently evaluated on 3/10 for alcohol withdrawal presents to the ED for intoxication, brought in by initially called for domestic violence, reportedly had been slapped by the boyfriend, patient however denies this, denies any pain, patient had [Chlordiazepoxide] medication bottle next to her bedside, appears intoxicated able to provide city where she lives slurring speech ...no external sings of trauma concerning for ICH or fracture ...I was worried for the patient safety, so I have placed them under 1799 hold with plans for further evaluation ...Patient was seen taking unknown number of the [Chlordiazepoxide] medications despite medications ordered to be taken away from patient. Patient was monitored for period of time in the emergency department ...” Review of “Nursing Note” dated 3/12/24 at 11:39 p.m., indicated, “ ...Pt found with empty [Chlordiazepoxide] bottle states “It’s not a big deal I just took a couple...”. The record indicated after this, Pt 3 was placed on a 1799 hold on 3/12/24 at 11:57 p.m. and transferred to an inpatient psychiatric treatment center on 3/13/24 at 4:57 a.m. The EDM 1 stated she does not know how the patient was able to take [Chlordiazepoxide] in ED. EDM 1 stated medication should have been taken away from the patient. During a review of the facility’s P&P titled, “MOD COMP-RCC 5.16 EMTALA POLICY,” dated 4/24/24, indicated, “..To ensure individuals presenting to [hospital name]emergency department receive an appropriate Medical Screening Examination (MSE) and stabilizing treatment of appropriate transfer in accordance with Emergency Medical Treatment and Labor Act of 1986 (EMTALA) ...[hospital name] will provide an individual who is determined to have an Emergency Medical Condition further medical examination and treatment as is required to stabilize the Emergency Medical Condition, including admission for inpatient care, or arrange an appropriate transfer of the individual to another medical facility with the Capability to provide the stabilizing care ...” During a professional reference review retrieved from (https://www.ncbi.nlm.nih.gov/books/NBK547659/) titled, “Chlordiazepoxide”, dated 1/30/20, the reference indicated, “ ...Contraindications ... The use of benzodiazepines, including chlordiazepoxide, exposes individuals to the risk of misuse, abuse, and potential addiction, resulting in overdose or death. Benzodiazepine abuse and misuse often involve concurrent alcohol and illicit substances, contributing to a higher incidence of severe adverse outcomes. Before prescribing chlordiazepoxide and throughout treatment, evaluate each patient’s susceptibility to abuse, misuse, and addiction ... Patients should be informed about life-threatening adverse effects if combined with opiates, alcohol, and other CNS-depressant medications ...” 2. During a review of the hospital’s report of patients who returned to the ED within 48 hours of a previous ED visit for August 2024, the report indicated Pt 4 was a 32-year-old male who came to the ED at 4:41 p.m. on 8/9/24 with a chief complaint of “Increased blood sugar” and was discharged on 8/9/24 at 7:49 p.m., three hours and nine minutes later. The report indicated that Pt 4 returned to the ED on 8/10/24 at 6:44 a.m. with a chief complaint of “Increased Blood Sugar; DIABETIC”. During a review of Pt 4, “[Emergency Medical Services (EMS)] Patient Care Record (PCR)” dated 8/9/24, the PCR indicated, “ .... Address: Homeless ...dispatched code 3 ...male siting up talking to fire [department]... [Glasgow Coma Scale (GCS) is a system to “score” or measure how conscious you are. The score ranges from 3-15. Patients with scores of 3 to 8 are usually considered to be in a coma and 15 is the best you can get] GCS of 15. Pt stated he smoked meth and now his sugar is high [Blood glucose level (BGL)] 414 and pt stated his mouth is dry.... [arrival on site-Hospital name], charge [nurse] advised to take pt to triage. Report given to triage nurse ...Medication administration ...Normal Saline (mixture of sodium chloride and water) ...Intravenous (IV - Into or within a vein) ...500 milliliters (ml-unit of measurement) ...” During a concurrent interview and record review on 08/20/24 at 10:30 a.m. with the EDM 1 and RNQ 1, Pt 4’s record dated 8/9/24 was reviewed. The document titled “Patient Summary Report,” dated 8/9/24 indicated, Pt 4 arrived in the ED on 8/9/24 at 4:41 p.m., was triaged at 4:57 p.m. and emergency severity index (ESI) level 3 (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious) was assigned. The order was placed for Complete Blood Count with auto differential (CBC- blood test that measures many different parts often used to help screen overall health and measures the number of types of blood cells), Hemoglobin A1C (blood test that measures the average blood sugar level over the past three months), Basic Metabolic Panel (BMP- blood test that measures eight substances in the blood to evaluate various body functions and processes), and Beta Hydroxybutyrate (test used to detect ketones in blood or urine and monitor ketosis, metabolic state that occurs when your body burns fat for energy instead of glucose.) on 8/9/24 at 6:02 p.m. The patient was discharged on 8/9/24 at 7:49 p.m. Pt 4’s vital signs at 4:57 p.m. were normal. The review of “ED Note-Physician” dated 8/9/24 indicated, Pt 4 arrived with chief complaint “High blood sugar, 450. EMS administered 500 ml, [normal saline -(NS)], [blood glucose] after 350. Used meth today per patient. EMS IV pulled before coming out to ED lobby”. The document indicated “ ...Pt states that he has no current [Diabetes mellitus (DM - condition when body does not produce enough insulin, or the body’s cells do not respond to insulin)] medications, but used to be on Metformin and insulin. Unable to obtain further information and medical [history] due to pt’s medical status ...Physical exam...General: Patient is thin-appearing, cachectic, looking around, and not following instructions ...lab summary statements ...normal white blood cells (WBCs- are part of the body’s immune system. They help the body fight infection and other diseases) count 9.0, hemoglobin (Hb- is the protein contained in red blood cells that is responsible for delivery of oxygen to the tissues) is low at 8.6 with low [Mean corpuscula volume (MCV- measures the average size of your red blood cell, help identify anemia and other conditions) of 61.1 Platelets (are a blood component whose function is to react to bleeding from blood vessel injury by clumping, thereby initiating a blood clot) adequate at 338. Patient’s electrolytes show a low sodium (blood test measures the amount of sodium in your blood) of 129 but I believe this is due to elevated blood sugar of 314. Creatine (a lab test to assess kidney functions) is normal at 0.8 although [Blood Urea Nitrogen (BUN -test measures how much urea nitrogen is in your blood. It helps to determine if kidneys are working as they should is slightly up at 37 which may go along with some mild dehydration. Hemoglobin A1c is 9.1 showing poor control ...He is not willing to give much information and appears to be under the influence of methamphetamine. Physical exam shows him to be cachectic and somewhat pale appearing. His vitals sings were unremarkable ...He is microcytic anemic. His blood sugar is elevated at 314 consistent with his poor control. His BUN is elevated at 37 and EMS did give him a bolus ...I will be discharging him with prescription of metformin. He needs to work with his doctor at his clinic to control his anemia but more importantly he needs to be in a treatment program for his methamphetamine use and I have given him referrals ...” The review of “lab results for Beta Hydroxybutyrate” dated 8/9/24 at 6:02 p.m. also indicated 1.06 millimoles per liter (mmol/L) (normal 0.02 -0.27). EDM 1 stated she was unable to find any interventions done in ER besides lab draws. EDM 1 also validated no documentation regarding plan or rationale for high Beta Hydroxybutyrate level on provider note. EDM 1 also validated no blood glucose check was done during the entire ED stay and only documented glucose level in patient record is 314 from BMP that was done on 3/9/24 at 6:02 p.m. EDM 1 stated patient was treated by paramedics with fluid bolus and blood glucose check was completed by EMS, no other medications were administered in ED. The EDM 1 stated BG level of 314 is high and she could not provide an explanation as to why no other interventions were completed in ED to address blood glucose, to recheck the blood glucose level or to address the high Beta Hydroxybutyrate level in ED prior to discharge on 8/9/24 at 7:49 p.m. During a concurrent interview and record review on 08/20/24 at 10:40 a.m. with the Emergency Room Manager (EDM) 1 and Quality Registered Nurse (RNQ) 1, Pt 4’s record dated 8/9/24 was reviewed. The document titled “ED Discharge Form-Text” indicated, Pt 4 was discharged on 8/9/24, a Friday at 7:49 p.m., ED Disposition: discharge, ED discharged: home (although homeless). The EDM 1 stated although a shelter list was provided, the document does not reflect if the patient was offered or given taxi voucher or ride as needed to a shelter along with weather appropriate clothing. The EDM 1 stated the missing elements are required prior to discharge in accordance with hospital policy and state law concerning homeless patient discharge. The EDM 1 validated 8/9/24 was Friday, and stated she did not know what resources would be open/available to a patient upon discharge to pick up his medication or if the shelter accepts patients at nighttime. During a review of Pt 4’s “[Emergency Medical Services (EMS)] Patient Care Record (PCR) “ dated 8/10/24, the PCR indicated, “ ...32-year-old male outside of seven eleven shop with fire department crew by his side. Patient stated that he has been having diabetic issues, has been going in and out of [hospital name] for past few days. Patient reported he has not been able to take his medications. Patient also complaint of some left ankle pain, no obvious sign of trauma noted. Patient denies falls, stated he has been doing lot of walking. Patient admitted to weed and meth usage. Patient able to ambulate to gurney ...” During a concurrent interview and record review on 08/20/24 at 10:45 a.m. with the Emergency Room manager (EDM) 1 and Quality Registered Nurse (RNQ) 1, Pt 4’s record dated 8/10/24 was reviewed. The document titled, “Patient Summary Report” indicated patient returned to the ED on 8/10/24 at 6:44 a.m. Pt was triaged at 6:49 a.m. and ESI of 3 was assigned. The order was placed for chest X-ray (use to create picture of inside the body), Electrocardiogram (EKG - a test to record the electrical signals in the heart), X-ray ankle, Urinalysis (test that examines urine for physical properties, cells, organisms, and other substances), Troponin1(blood test to detect heart damage and diagnose heart conditions), CBC, and CMP were ordered. Pt 4 was also given Insulin Regular and Sodium Chloride IV and blood glucose levels. Review of document titled “ED Note- Physician” dated 8/10/24 indicated, “ ...Chief Complaint: [brought in by ambulance (BIBA)] for elevated blood sugar. Has [left] ankle pain, feels like a burning sensation. [fingerstick blood sugar (FSBS)] 345 ...Radiology/Diagnostic Results ...XR Ankle ..findings ...Impression: Negative Ankle/Foot ...Degenerative arthritic changes ...No fracture ...XR Chest ...Impression: Negative ...EKG ...Sinus, No PVCs, No obvious ST changes, No [bundle branch block (BBB - condition that occurs when the electrical signal that causes the heart to beat is blocked or delayed in one or both of the heart’s bundle branches )] “ The “lab results” dated 8/10/24 indicated glucose level at 6:59 a.m. 347, at 8:22 a.m. 382, at 10:36 a.m. 317, at 11:21a.m. 181. The “Medication Administration Record (MAR)” dated 8/10/24 indicated, Pt 4 received 5 units of insulin (medication used in the treatment and management of high blood sugar) at 10:41 a.m. and sodium chloride (used for replenishing fluid and for restoring and maintaining the concentrations of sodium and chloride) 0.9% 1000 ml at 10:29 a.m. Review of document titled “ED Discharged Form” dated 8/10/24 indicated, “ ED Disposition: Discharge Mode of discharge: Ambulatory ... Mode of transportation: Other: bus pass ...ED Discharged: Shelter ...ED condition: Stable ...ED Accompanied by: Self ...Discharge Comments: Clothes weather appropriate, gave sandwich and bus pass. The EDM 1 stated patient was discharged appropriately on 8/10/24 at 11:35 a.m. During a concurrent interview and record review on 08/20/24 at 11:00 a.m. with the Emergency Room manger (EDM) 1 and Quality Registered Nurse (RNQ), the P&P titled, “ AD 3.08 California Hospital Discharge Planning for Homeless Patient,” dated 6/22/22 was reviewed. The EDM 1 stated regarding Pt 4, she was not able to locate any documentation regarding referral or consult by a social worker. The EDM1 stated it was not the facility process to get a social worker consult for homeless discharges. The EDM 1 stated she was not able to find documentation of a full cognitive assessment as outlined in the policy. During a review of the facility’s policy and procedure (P&P) titled, “MOD COMP-RCC 5.16 EMTALA POLICY,” dated 4/24/24, the P&P indicated, “..To ensure individuals presenting to [hospital name] emergency department receive an appropriate Medical Screening Examination (MSE) and stabilizing treatment of appropriate transfer in accordance with Emergency Medical Treatment and Labor Act of 1986 (EMTALA) ...[hospital name] will provide an individual who is determined to have an Emergency Medical Condition further medical examination and treatment as is required to stabilize the Emergency Medical Condition, including admission for inpatient care, or arrange an appropriate transfer of the individual to another medical facility with the Capability to provide the stabilizing care ...” During a review of the facility’s P&P titled, “ AD 3.08 California Hospital Discharge Planning for Homeless Patient,” dated 6/22/22, the P&P indicated, “ ...Purpose of this policy is to ensure transition management and discharge planning for the homeless patient is conducted with dignity, respect and compassion, in accordance with regulatory requirements and accreditation standards to improve continuity of care and follow a process for discharge planning that will address health care needs of the homeless patient population in the State of California (State) ...This policy applies to Homeless Individual presenting to Hospitals in California and includes in patients, observation admissions and certain types of outpatients, including, outpatients in a bed and Emergency Department patients ...The discharge planning process will be individualized and will begin as soon as possible, in the Emergency Department once the homeless patient is medically stable, or upon direct admission as an Inpatient or Outpatient. If there are complex discharge needs, Hospital Case Management assistance must be requested. The Discharge Planning Checklist for homeless patient will be initiated at this to develop an initial discharge plan for homeless patients presenting to the Hospital with the goal of balancing available community resources with patient choice and continuity of care. Prior to discharge, an appropriate discharge plan for the post-hospital medical care will be completed and documented in the medical record ...the hospital will offer weather-appropriate clothing and/or shoes to the patient as provided in this policy ...Social services/designated trained staff will assess homeless patient’s ability to maintain mental cognition and stability post-hospitalization. The following are factors to be considered: history of frequent admissions, incarceration, interactions with law enforcement, associations with family or friends, frequents housing transitions, inconsistent locations for sleeping or food, ability to maintain/access public benefits and ability to maintain a treatment regimen ... Cognitive Assessment. When developing discharge plans, treating physicians, nurses, discharge planners and/or social workers will evaluate and document the patient’s mental status during their clinical examination or assessments over the course of the patient’s hospital stay to determine whether the patient is cognitively intact. The cognitive assessment will consider the homeless patient’s individual circumstances (i.e. the patient’s living arrangements and available support system post post-hospitalization) and details of the discharge plan what is to be implemented for the patients. The cognitive assessment will include the patient’s orientation to person, place, circumstances and time, ability to provider self-care, his or her ability carry out usual activities or to protect his or her rights, the ability to obtain follow-up medical/mental health care, food and shelter, and ability to negotiate the environment being discharge to. The assessment will be documented in the patient’s medical record ...Services offered to Homeless Patients Before Discharge ...Clothing...if the patient does not arrive with weather appropriate clothing, the hospital will offer weather appropriate clothing and encourage the patient to change in to weather-appropriate clothing before leaving the hospital ...””

“PATIENT VISITATION RIGHTS CFR(s): 482.13(h) A hospital must have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital may need to place on such rights and the reasons for the clinical restriction or limitation .... This Standard is not met as evidenced by: 45580 Based on interview and record review, the hospital failed to allow family visitation of minor children under 12 years old when there was a previous exception made for minors under 12 years old to visit on 5/15/24 and no reason was given to justify the decision for the denial of visitation on 6/16/24 for one of three sampled patients (Pt) 3, in accordance with the hospital’s policy and procedures (P&P) . This failure resulted in Pt 3 to feel upset when he was not able to receive visitation on 6/16/2024 (Father’s Day) from his family which had the potential to affect Pt 3’s psychological well-being. Findings: During an interview on 6/17/24 at 3:33 p.m. with Family Member (FM) 1, FM 1 stated on 6/16/24 which was Father’s day, FM 1 spoke to House Supervisor (HS) 1 and had requested to visit Pt 3 with children who were under 12 years old. FM 1 stated there had been an exception made on 5/15/24 for the minor children to visit Pt 3 previously. FM 1 stated after she asked HS 1 if an exception could be made as it was Father’s day, HS 1 put her on hold and when HS 1 came back on the line, he stated Charge Nurse (CN) 1 said no, therefore his answer was no. FM 1 stated she was not given a reason why her request was denied and was upset her children could not visit Pt 3. During a review of Pt 3’s “Visitation Log (Log),” dated 5/15/24, the Log indicated Pt 3 had seven visitors on 5/15/24. The Log indicated, three visitors visited at various times after 10 a.m. in the morning and around 5:30 p.m., four different visitors checked in within minutes of each other to visit Pt 3. During a concurrent interview and record review on 6/19/24 at 11:25 a.m. with Registered Nurse Quality (RNQ) 1 and RNQ 5 present, Pt 3’s History and Physical (H&P-the complete assessment of a patient and their health problem(s)), dated 5/29/24 was reviewed. The H&P indicated, “ ...[Brought in by ambulance] from [name of long term care facility], receiving [intravenous (IV-in the vein)] fluids today, [patient] pulled IV out staff unable to insert new IV, [patient] having limited water and food intake. Altered mental status [times] 2 days ...History of present illness ...[history of] methamphetamine [a highly addictive drug that lets people stay awake for a long period of time] and heroin [a highly addictive and rapidly acting drug derived from a certain poppy plant] dependence, alcohol dependence, [coronary artery disease-blood vessels that carry blood and oxygen to the heart cannot deliver enough oxygen-rich blood to the heart] status post [coronary artery bypass grafting-heart bypass surgery, a medical procedure to improve blood flow to the heart] ...He was transferred to [name of hospital] [emergency room] due to concern for dehydration ...” During an interview on 6/21/24 at 10 a.m. with Registered Nurse (RN) 3, RN 3 stated visitation was from 10 a.m. to 10 p.m. and sometimes they were able to make exceptions if the family needed to visit sooner than 10 a.m. RN 3 stated the security at the front desk could call the department and ask if the family could visit outside of the normal visiting hours. RN 3 stated the age requirement for visitation was 12 years old and up. RN 3 stated exceptions for minor children and for possible end of life visitations was up to each department’s discretion. During an interview on 6/21/24 at 10:45 a.m. with the Chief Nursing Officer (CNO), the CNO stated patients were allowed two visitors on the inpatient side and one visitor in the Emergency Department (ED) but depending on the situation there could be exceptions made on a case-by-case basis. The CNO stated, “Hospital leadership encouraged nurses to step out of their box and work with patients and family.” The CNO stated if a child under 13 years old was allowed to visit previously, nurses needed to set up the expectations for visitation and follow through with communication. The CNO stated, “The importance of visitation for patients was literature showed when family were engaged in the patient’s care, from the mental and physical standpoint, the patient progressed in their care.” The CNO stated, “Family are the ones caring for the patients when they are discharged so it was a prime time to teach family during the visits.” The CNO stated HS 1 should have called her or the Administrator, they could have stopped the line and assisted with the family’s request. During a review of the hospital’s P&P titled, “PC.AD.1.37 Visitor Policy,” dated 9/27/23, the P&P indicated, “ ...Visitors play a vital role in our patients’ wellbeing as well as assisting in their recovery. The purpose of the Visitor Policy is to ...Ensure patient safety and highest quality of care is provided ...Ensure patients and their families or domestic partners are involved in their care, care planning and decision making as appropriate ...Promote patient/family centered care ...Improve patient and family satisfaction ...Patients have the right to receive visitors and designated person to support them while receiving care at [name of hospital] ...does not restrict, limit, or otherwise deny visitation privileges on the basis of race, color, national origin, religion, sex, sexual orientation, gender identity, or disability. Visitation may be delayed, altered, or refused based on the care needs of individual patients as deemed appropriate through agreement between the patient’s nurse and physician ...Two (2) visitors per patient can be accommodated at one time ...Inpatient visiting hours are from to 10:00am-10:00pm ...Children/minors age 12 or greater may visit a patient if they are accompanied and supervised by an adult ...reserves the right to impose age restriction visitation as recommended by the Medical Directors of [name of county] County during the flu season and other epidemics. Decisions to restrict or limit presence must be discussed with the patient ...” During a review of the hospital’s document titled, “Patients Rights,” dated 9/2014, the document indicated, “You have the right to ...Designate a support person and visitors of your choosing, if you have decision-making capacity, whether or not the visitor is related by blood, marriage, or registered domestic partner status, unless ... No visitors are allowed ...a health facility may establish reasonable restrictions upon visitation, including restrictions upon the hours of visitation and number of visitors. The health facility must inform you (or your support person, where appropriate) of your visitation rights, including any clinical restrictions or limitations. The health facility is not permitted to restrict, limit, or otherwise deny visitation privileges on the basis of race, color, natural origin, religion, sex, gender identity, sexual orientation, or disability ...Have your wishes considered, if you lack decision-making capacity, for the purposes of determining who may visit. The method of that consideration will comply with federal law and be disclosed in the hospital policy on visitation. At a minimum, the hospital shall include any persons living in your household and any support person pursuant to federal law ...” During a review of a professional resource from Front Public Health, an article titled, “An integrated review: connecting Covid-era hospital visiting policies to family engagement,” dated 9/2023, the article indicated, “ ...Family engagement has been identified as a construct that is vitally important to successful outcomes for patients, families, providers, hospitals, and communities. Hospitals often are the setting of new or worsening diagnoses for older and seriously ill patients. Family, as defined by the patient, refers to a trusted individual or group of individuals and does not necessarily reflect a legal relationship. Family engagement improves healthcare quality and safety and, therefore, patient outcomes in the hospital ...In addition to improving health outcomes for the patient, family engagement also benefits the hospital. Families provide information, context, care coordination, and help with the transition home ...Family engagement decreases readmission rates ...and reduces overall healthcare utilization ...increasing visitation times can lead to a positive effect on the patient’s physiological parameters ...Policies restricting family presence may lead to longer [intensive care unit] stays and delay decisions to limit treatment prior death ...Inconsistent visitor policies contribute to health inequities among minority older adults with limited English proficiency ...””

“CRITERIA FOR MEDICAL STAFF PRIVILEGING CFR(s): 482.22(c)(6) [The bylaws must:] Include criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges. For distant-site physicians and practitioners requesting privileges to furnish telemedicine services under an agreement with the hospital, the criteria for determining privileges and the procedure for applying the criteria are also subject to the requirements in §482.12(a)(8) and (a)(9), and §482.22(a)(3) and (a)(4). This Standard is not met as evidenced by: 11090 Based on interview and record review, the hospital failed to ensure medical staff followed Medical Staff Bylaws, Rules and Regulations for one of two Anesthesiologist (Anesthesia A) when Anesthesia A did not meet facility requirements for proctoring and administered General anesthesia instead of Spinal anesthesia to Patient 4. This failure resulted in Patient (Pt) 4 being administered General Anesthesia (a method of medically inducing loss of consciousness that renders a patient unrousable even with painful stimuli) instead of a Spinal Anesthesia (a technique where a local anesthetic is placed directly in the intrathecal space in the spine) while undergoing a total right hip arthroplasty (the surgical reconstruction or replacement of a joint). Findings: During a review of Pt 4’s “History and Physical (H&P),” dated 5/29/2024, Pt 4’s H&P indicated Pt 4 had diagnoses which included type 2 diabetes (is a disease in which blood glucose, or blood sugar, levels are too high), coronary artery disease ( is a type of heart disease where the arteries of the heart cannot deliver enough oxygen-rich blood to the heart), status post myocardial infarction (heart attack) with stent placement (is a tiny wire mesh tube that keeps an artery propped open to increase blood flow to the heart) and aortic valve replacement (is a surgery to replace a poorly working aortic valve with an artificial valve). Pt 4’s surgical consent signed by the patient on 5/29/2024 indicated, “... Total hip (right) arthroplasty... Pt 4’s consent for anesthesia, signed by the patient on 5/29/2024 consented to the following... General anesthesia, spinal anesthesia, regional block...” During an interview on 6/20/2024, at 4:47 p.m. with Pt 4’s surgeon (MD 1), MD 1 stated he likes to use spinal and regional blocks (local anesthetics are applied to a targeted set of nerves to block sensation and movement) for anesthesia because they “were good for patient recovery.” MD 1 recommended to anesthesiologist (Anesthesia A) to administer a spinal anesthesia to Pt 4 because of Pt 4’s “high risk” cardiac history. Anesthesia A made two to three unsuccessful attempts to insert the spinal anesthetic and instead had to administer a general anesthetic. MD 1 stated Anesthesia A was frequently not at the head of the table monitoring the patient’s status and pain level. MD 1 stated Anesthesia A was “walking around the Operating Room” MD 1 stated when Pt 4 started to move on the table during surgery, he yelled to Anesthesia A “what are you doing” as Anesthesia A ran back to the head of the table to give additional medication. MD 1 stated Anesthesia A told him he would administer a regional block (to provide more post-op pain control) to Pt 4 because of his inability to provide spinal anesthesia. The regional block was never administered. During an interview on 6/19/2024, at 3:17 p.m., with the Circulating Nurse RN (ORN 1), ORN 1 stated she remembered Pt 4’s surgery because of the special orthopedic instrumentation used during surgery. ORN 1 stated Anesthesia A attempted to insert the spinal anesthesia three to four times with all attempts unsuccessful. During a concurrent interview and record review on 6/19/2024 at 3 p.m., with the Director of the Medical Staff (DMS) on on 6/19/2024 at 3:00 p.m., the DMS reviewed Anesthesia A’s Medical Staff file. The DMS stated Anesthesia A applied for privileges in 2022, left for a few months after privileges were granted and was re-instated in 2023. The DMS was unable to find any documentation to support Anesthesia A had participated in any proctoring, concurrent or retrospective, or if proctoring was waived. The DMS stated, “He fell through the cracks.” The DMS stated all physicians and allied health professionals must make an application to be a member of the Medical Staff and must follow the requirements which required proctoring. During a review of a review the Anesthesia Record dated 5/29/2024 specific to Pt 4’s surgical procedure, the surgery started at 13:05 pm, and ended at 15:35 pm. Anesthesia A documented “attempted spinal anesthesia X 3.” No documentation that a Regional Block had been attempted or administered to Pt 4. During review of the facility’s current policy and procedure (P&P) titled, “Medical Staff Rules and Regulations”, “Proctorship”, dated 2/23/2022, the P&P indicated, “... All practitioners granted appropriate membership and privileges by the Governing Board at this facility shall be proctored regardless of board certification and/or prior experience. Proctorship shall be for a period specified according to specialty requirements. Proctored cases from other facilities may be considered under department chairman’s review. 1-a. Anesthesia proctor requirements: first three (3) cases including craniotomy, epidural, c-section and spinal anesthesia. A total of ten (10) cases must be completed within twelve (12) months of appointment...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 42321 Based on interview and record review the facility failed to follow its policy titled, “Documentation Policy” for one of twelve patients (Patient (Pt) 2) when Pt 2 had a change in condition (COC- clinically important deviation from a patient’s baseline in physical, cognitive, behavioral, or functional domains. “Clinically important” means a deviation that, without intervention, may result in complications or death) that required a doctor to be contacted and this was not done. This failure resulted in Pt 2 not having her COC addressed timely and had the potential to result in Pt 2’s medical condition to declined, which resulted in Pt 2 to be moved to the Intensive Care Unit (ICU- higher level of care for more critical patients). Findings: During a review of Pt 2’s Admission Record (AR), dated 4/15/24, the AR indicated Pt 2 was admitted on 4/8/24 at 5:43 p.m. and discharged on 4/12/24 at 11:59 p.m. Pt’s 2’s AR indicated Pt 2 was a 56 year old female with a chief complaint of ESRD (End Stage Renal Disease- a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life) on dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly). During a review of Pt 2’s History and Physical (H&P), dated 4/12/24, the H&P indicated Pt 2’s “CHIEF COMPLAINT: Rectal pain/Weakness HISTORY OF PRESENT ILLNESS: 56-year-old female with past medical history of hypertension (high blood pressure), COPD (Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lungs- oxygen levels 89-91% are normal for patients with COPD), PTSD (Post-traumatic stress disorder is a mental health condition that’s triggered by a terrifying event - either experiencing it or witnessing it), diabetes mellitus (DM- a disease of inadequate control of blood levels of glucose), ESRD on HD (Hemodialysis) MWF (Monday, Wednesday, Friday), missed her session on Monday, recurrent abscesses (occur when an area of tissue becomes infected and the body’s immune system tries to fight and contain it), who initially presented for evaluation of weakness and rectal pain. Has not been compliant with her home medications. This morning at approximately 1150, while eating lunch, patient’s oxygen requirements went up to 5 L (Liters-unit of measurement), sudden ALOC (altered level of consciousness) although per daughter, patient had been encephalopathic (appears confused, memory loss, personality changes) throughout the day. Rapid Response was called over head for unresponsiveness (not reacting to anyone). On BVM (bag valve mask- device that provides air to the patient) in route to ICU and hypotensive (low blood pressure), bradycardic (heart rate) in 40s, intubated (tube place in one’s mouth to secure patient’s airway is open and secured) and started on dopamine (medication- used to treat low blood pressure, low heart rate, and cardiac arrest). CODE STROKE (occurs when something blocks blood supply to part of the brain or when a blood vessel in the brain bursts) was initially activated but subsequently cancelled as she is moving all extremities, no obvious focal deficits and PERRL (pupils are equal, round and react to light) ...” During a concurrent interview and record review on 6/21/24, at 8:15 a.m., with Registered Nurse (RN) 2 and Shift Manager (SM) 1, Pt 2’s electronic medical record (EMR) for her admission starting 4/8/24 was reviewed. RN 2 stated she did not recall Pt 2 but was Pt 2’s nurse on the night 4/11/24 and the morning of 4/12/24. RN 2 stated she believes she incorrectly documented Pt 2’s vital signs at 8:57 p.m. on 4/11/24 when she typed in heart rate (HR) 123 and blood pressure (BP) of 56/60, she stated she would not have given any of her medications if this was accurate, she believed it should have been a BP of 123/56 and HR 60. RN 2 reviewed her note dated 4/12/24, at 5:53 a.m. which indicated Pt 2 had confusion and “Pt sees ants on the wall”. RN 2 stated Pt 2’s baseline earlier in her shift on 4/11/24 patient was alert and oriented and was not seeing anything and after reviewing Pt 2’s EMR Pt 2 had not had any confusion since admission on 4/8/24. RN 2 stated she was not quite sure why she placed Pt 2 on 5 liters nasal canula for oxygen around the same time as the confusion (no nursing note to explain this increase in oxygen). RN 2 stated she would consider this a change of condition (COC) since it was not her baseline but did not call the doctor. RN 2 stated when there is a COC she would notify the doctor, would worry the patient might be septic (widespread infection) and the doctor would have come and assessed the patient. SM 1 stated Pt 2 seeing things and needing her oxygen increased should have been considered a COC and a doctor should have been called. During a review of the flowsheet for Pt 2’s vital signs dated 4/11/24 at 7 a.m. to 4/12/24 9 p.m., the flowsheet indicated on 4/11/24 at 8:57 p.m. BP 56/60, HR 123; on 4/12/24 at 4 a.m. BP 135/72, HR 52, 91 % oxygen (O2) saturation (sats) on nasal cannula (number of liters not documented note on 4/11/24 at 8:31 p.m. Pt 2 was on 2 Liters (L) nasal cannula (NC)); 4/12/24 at 4:59 a.m. 91% O2 sats on 5 L NC; on 4/12/24 at 6:05 p.m. Pt 2 is 91% on 10 L oxygen mask. During a review of the hospital’s policy and procedure titled, “PC.AD.1.08 Documentation Policy,” date approved 9/28/22, indicated, “I. SCOPE: This policy applies to [name of hospital] and [name of behavioral center associated with hospital]. This policy applies to any department providing patient care. II. PURPOSE: To outline responsibilities related to documentation of patient care from admission through discharge. III. POLICY: ... the patient medical record reflects the complete picture of the patient’s health status, treatment, and progress from admission to discharge from which other health professionals can take over responsibility for the patient concerned ... 1. All Medical Record entries should be made as soon as possible after the care is provided, or an event or observation is made ... 3. Charting by exception is to be utilized as a method of charting designed to minimize clerical activities; a notation (annotation) is made only when there is a deviation from the baseline or expected outcome ... 10 ... g. Changes in patient condition are documented within the appropriate EHR system review; along with physician notifications ... Appendix A: ICU Documentation Protocol ... Reassessment is ongoing, based on patient condition ... as needed for significant changes from previous assessment, and per physician’s orders ... Examples of significant changes in condition that require a focused reassessment include (not an all inclusive list) Neuro Change in neuro status Resp Significant drop in O2 saturation ... CV Significant drop/increase in BP/HR/hemodynamics ... For new and/or abnormal findings, chart the finding, intervention, and response (if applicable) ...””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 42321 Based on interview and record review the hospital failed to ensure medications were administered in accordance with professional standards of practice for one of 12 sampled patients (Patient (Pt) 2), when Pt 2 was ordered Propranolol (blood pressure medication, a medication that lowers one’s blood pressure and heart rate) without blood pressure parameters for administration. Registered Nurse (RN) 2 administered Pt 2 Propranolol when Pt 2’s blood pressure was not within normal limits (blood pressure (BP) 90-140 on top; 60-90 on bottom; heart rate (HR) 60-100). This failure contributed to Pt 2’s blood pressure and heart rate to drop which resulted in Pt 2 to become unresponsive and had to be transferred to the intensive care unit (ICU- higher level of care). Findings: During a review of Pt 2’s Admission Record (AR), dated 4/15/24, the AR indicated Pt was admitted on 4/8/24 at 5:43 p.m. and discharged on 4/12/24 at 11:59 p.m. Pt’s 2’s AR indicated Pt 2 was a 56 year old female with a chief complaint of ESRD (End Stage Renal Disease- a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life) on dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly). During a review of Pt 2’s History and Physical (H&P), dated 4/12/24, the H&P indicated Pt 2’s “CHIEF COMPLAINT: Rectal pain/Weakness HISTORY OF PRESENT ILLNESS: 56-year-old female with past medical history of hypertension (high blood pressure), COPD (Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lungs), PTSD (Post-traumatic stress disorder is a mental health condition that’s triggered by a terrifying event - either experiencing it or witnessing it), diabetes mellitus (DM- a disease of inadequate control of blood levels of glucose), ESRD on HD (Hemodialysis) MWF (Monday, Wednesday, Friday), missed her session on Monday, recurrent abscesses (occur when an area of tissue becomes infected and the body’s immune system tries to fight and contain it), who initially presented for evaluation of weakness and rectal pain. Has not been compliant with her home medications. This morning at approximately 1150, while eating lunch, patient’s oxygen requirements went up to 5 L (Liters-unit of measurement), sudden ALOC (altered level of consciousness) although per daughter, patient had been encephalopathic (appears confused, memory loss, personality changes) throughout the day. Rapid Response was called over head for unresponsiveness (not reacting to anyone). On BVM (bag valve mask- device that provides air to the patient) en route to ICU and hypotensive (low blood pressure), bradycardic (heart rate) in 40s, intubated (tube place in one’s mouth to secure patient’s airway is open and secured) and started on dopamine (medication- used to treat low blood pressure, low heart rate, and cardiac arrest). CODE STROKE (occurs when something blocks blood supply to part of the brain or when a blood vessel in the brain bursts) was initially activated but subsequently cancelled as she is moving all extremities, no obvious focal deficits and PERRL (pupils are equal, round and react to light) ...” During a concurrent interview and record review on 6/20/24, at 3 p.m., with Registered Nurse (RN) 1, Pt 2’s Electronic health records (EHR) for her admission starting 4/8/24 were reviewed. RN 1 stated he was Pt 2’s day nurse on 4/12/24, RN 1 confirmed Pt 2 had an order for Propranolol (blood pressure medication) 20 mg (milligrams- unit of measurement) to be given twice daily and Methadone (scheduled II opioid analgesic, used for severe pain, and has high risk of abuse and addiction) 145 mg once daily. RN 1 stated vital signs at the beginning of his shift were BP 115/54, HR 52 and he did give Pt 2 her Propranolol and Pt 2’s Methadone at 9:32 a.m. and he remembers Pt 2 was stable at that time. RN 1 stated around lunch time the family came and tried to feed her and he was waved down by the daughter and when he entered the room Pt 2 was not responsive and he called for a rapid response. Pt 2’s EMRs indicated the next set of vs at 1:15 p.m. on 4/12/24 where BP was 78/26, HR 43, RR 14, RN 1 stated looking back at Pt 2’s vital signs prior to giving the propranolol and methadone he should have held the medications and called the doctor. RN 1 stated usually there are parameters on the blood pressure medications and knew they could affect her blood pressure and her heart rate. During a concurrent interview and record review on 6/21/24, at 8:20 a.m. with the Shift Manager (SM) 1for Medical Surgical floor, Pt 2’s EMR for her admission starting 4/8/24 was reviewed. SM 1 stated Pt 2’s Propranolol should not have been given if her HR was below 60 and the nurse should have contacted the doctor to see what the doctor wanted done. During a concurrent interview and record review on 6/21/24, at 9:47 a.m., with the Director of Pharmacy (DOP), Pt 2’s medication order for Propranolol and Pt 2’s vital signs were reviewed for Pt 2’s hospital stay starting 4/8/24. The DOP stated the order for Propranolol did not have parameters and the physician would be the one to request parameters be placed on this order. The DOP stated not all blood pressure medications will have parameters. The DOP stated when a medication is sent to the pharmacy as an order, it is reviewed by a pharmacist, they look at the home medication list, compare the name and dosage but do not look to see if the patient is still currently taking it or not. The DOP stated Propranolol affects the blood pressure and heart rate and both should be monitored and checked prior to giving this medication. The DOP stated if the HR is below 60 the nurse should contact the MD to see if the medication should be held or discontinued but not to give it until this is clarified with the MD. The DOP stated the hospital uses Lexicomp and when Propranolol is typed there is no black box warning, but the DOP knows there should be a black box warning (the most serious warning the food and drug administration can give for a medication) because it is a betablocker and stopping abruptly can cause heart issues. During an interview on 6/21/24, at 10:46 a.m., with the Chief Nursing Officer (CNO), the CNO stated, “I don’t think we set our nurses up for success, there was not a parameter on when to give or hold (referring to the giving of Propranolol)”. The CNO stated she thinks the nurse should have known no to give this medication based on Pt 2’s vital signs (BP 115/54, HR 52). The CNO stated, “I don’t know that the cause of the drop in Pt 2’s BP was due to this medication, but it definitely could have been or a cumulative effect” of the medications she was taking. Review of a professional referenced titled, “Medscape”, dated 2024 the following medication was reviewed and Medscape indicated, “Propranolol ... Indicated for management of hypertension ... Monitor Closely ... (with) insulin lispro ... Use Caution/Monitor: Non selective beta blockers delay recovery of normoglycemia after insulin induced hypoglycemia; however they also inhibit insulin secretion, so long term beta blocker Tx may result in reduced glucose tolerance ... Adverse Effects ... Bradycardia Hypotension ... Hyper/hypoglycemia ... Respiratory Distress ... Warnings Contraindications Asthma, COPD, Severe sinus bradycardia or 2/3 heart block ... Uncompensated congestive heart failure ... Cautions ... Use caution in bronchospastic disease, cerebrovascular insufficiency, congestive heart failure, diabetes mellitus, hyperthyroidism/thyrotoxicosis, liver disease, renal impairment, peripheral vascular disease ... May worsen bradycardia or hypotension; monitor HR and BP ... Mechanism of Action ... inhibition results in decreases in heart rate, myocardial contractility, myocardial oxygen demand, and blood pressure...” Review of a professional referenced titled, “Medscape”, dated 2024 the following medication was reviewed and Medscape indicated, “Methadone ... Classes: Opioid Analgesics ... Schedule II ... Pain Management Indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate ... Adverse Effects ... Bradycardia, Cardiac arrest, coma ... Myocardial infarction ... Respiratory arrest, Respiratory/Circulatory depression ... Sedation ... Mechanism of Action Narcotic agonist-analgesic of opiate receptors; inhibits ascending pain pathways, thus altering perception and response to pain; produces analgesia, respiratory depression, and sedation ... Cautions ... Serious, life-threatening, or fatal respiratory depression reported (see Black Box Warnings) ...” Review of a professional reference titled, “National Library of Medicine (NIH)” an article titled, “Nursing Rights of Medication Administration,” dated 9/4/23, retrieved from https://www.ncbi.nlm.nih.gov/books/NBK560654/ indicated, “ ... Nurses have a unique role and responsibility in medication administration, in that they are frequently the final person to check to see that the medication is correctly prescribed and dispensed before administration.[1] It is standard during nursing education to receive instruction on a guide to clinical medication administration and upholding patient safety known as the ‘five rights’ or ‘five R’s’ of medication administration. These ‘rights’ came into being during an era in medicine in which the precedent was that an error committed by a provider was that provider’s sole responsibility and patients did not have as much involvement in their own care.[2] The five traditional rights in the traditional sequence include: ‘Right patient’ ... ‘Right drug’ ... ‘Right Route’ - Medications can be given to patients in many different ways, all of which vary in the time it takes to absorb the chemical, time it takes for the drug to act, and potential side-effects based on the mode of administration ... It is crucial that nurses remain educated and up to date on newer medications or less commonly administered medications to learn how they are safely delivered to patients before being asked to do so in clinical practice. Additionally, nurses must have at least a minimal basic understanding of the physiology influencing drug absorption rates and time of drug onset, as these principles relate to medication administration ... ‘Right time’ ... ‘Right dose’ ... Medical errors are a reality that will inevitably occur, as nurses, patients, and medical personnel are human and, therefore, prone to error. Examples of human error are lack of medical knowledge, lack of attention to detail or care, failing to verify information in an effort to save time, disorganization of workplace or supplies, and miscommunication among healthcare professionals or with a patient. While human nature does account for the majority of circumstances that may incite potential for medication administration errors, administrative or environment-related errors may also explain ADEs, such as lack of labeling or inadequate labeling systems or overwhelming workload with limited staffing.[3] Errors are usually multifaceted and can occur at any point within the complex process of medication administration ... Patient safety and quality of care are essential components of nursing practice and priorities that demand consideration to enable the delivery of high-quality, patient-centered care, and overall well-being. Medical errors are unfortunately very common in clinical practice, and in addition to compromising a patient’s personal safety, they can also be extremely costly for hospitals. ADEs qualify as unintended injuries or insults directly related to medical interventions involving a drug resulting in disability at discharge, death, or extended hospital stay that is the result of health care management rather than by the patient’s underlying disease process.[5]...””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 42321 Based on observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment to avoid sources and transmission of infections for all patients, visitors, and staff when: 1. Two of the two endoscopes (a thin, flexible tube-like instrument equipped with a camera used to look at tissues inside the body) were not stored in an endoscope cabinet in accordance with facility policy and instruction for use (IFU). The two endoscopes were stored with the distal end (the part farthest from the origin) with camera touching the bottom of the cabinet (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect). 2. One of five staff members (RNM 1) was seen with their fingernails that passed the tips of RNM 1’s fingers. These failures placed staff and patients at risk of cross contamination, infection and potentially expose patients to hospital acquired infections. Findings: 1. During a concurrent observation and interview on 6/18/24 at 2:56 p.m., with the Director of Surgery (DOS) and the Registered Nurse Manager for Endo (RNM 1) in the clean endoscopy room, two endoscopes with the distal end of the scopes were touching the bottom of the endoscope cabinet. The DOS stated the hospital fixed the other cabinets in the endoscopy storage room so that none of the scopes would touch but that this cabinet was missed. The DOS stated he was aware that this was an issue that he felt was addressed on the prior survey but was not informed of this separate cabinet and had not looked for other cabinets. The DOS stated the scopes were not stored correctly and would get this issue fixed, it placed the safety of patients at risk due to possible cross contamination. During an interview on 6/21/24, at 10:46 a.m., with the Chief Nursing Officer (CNO), the CNO stated the facility has been auditing the scopes to make sure they are not touching nor touching the bottom of the cabinets but recognizes this cabinet was missed and the facility will need to broaden their observations of other areas that house scopes. The CNO stated when scopes touch the bottom or each other there is a risk of infection, a risk of the scope not being effective, scopes may get worn down and micro holes may form, and this is not what is best for the patients. During a review of facility’s document sterile processing manual procedure (SPMP) titled, “ST.P.1.34 Flexible Scopes”, with the approval date of 5/23/18, the SPMP indicated, “ ...Ensure cleaning and processing is conducted by the individuals who have received education and completed competency verification activities related to endoscope processing ....STORING ...Store mechanically processed flexible endoscopes in a cabinet that is both designed and intended for horizontal storage of flexible endoscopes or is of sufficient height, width, and depth to allow the endoscopes to hang vertically, without coiling and without touching the bottom of the cabinet ...” During a review of the [Endoscope Brand Name] IFU for “[Brand Name] Ultrasonic Gastrovideo Scope (special endoscope that uses high frequency sound waves to examine all major organ of digestive system)”, the IFU indicated, “...reprocessing and storage after use ...After using this instrument, reprocess and store it according to the instructions given ...Improper and/or incomplete reprocessing or storage can present an infection control risk ...Storage and Disposal ... Keep the reprocessed endoscope and accessories away from the contaminated equipment after cleaning and disinfection or sterilization. If the clean endoscope and accessories become contaminated between procedures, they could present an infection control risk to patients and/or operators in the subsequent procedures ...Hang the endoscope in the storage cabinet with the distal end hanging freely. Make sure that the insertion tube hangs vertically and as straight as possible ...” During a professional reference review retrieved from (https://www.aami.org/docs/default-source/bi-t/bit/drying-storing-endoscopes---bit-may-june-2020.pdf) titled, “ Drying and storage of Flexible Endoscopes: An Area of Growing Concern”, dated 2020, the reference indicated “ ...Store endoscopes and accessories in a manner that prevents recontamination, protects equipment from damage, and promotes drying ... Store processed flexible endoscopes in a cabinet of sufficient height, width and depth to allow flexible endoscopes to hang vertically without coiling or touching the bottom of the cabinet or in one designed and intended for horizontal storage...” 2.During a concurrent observation and interview on 6/18/24, at 3 p.m., with the Director of Surgery (DOS) and the Registered Nurse Manager (RNM 1), RNM 1 was observed having fingernails that went beyond her fingertips. RNM 1 stated she does do perform direct patient care when asked for assistance by her staff. RNM 1 stated the long nails could be an infection risk to the patients and put the patients at risk of being scratched. The DOS did not say anything just shook his head in agreeance with what RNM 1 stated. During an interview on 6/21/24, at 10:46 a.m., with the CNO, the CNO stated she expected her staff to follow the hospitals policies and for her leadership team to set the example to keep staff and patients safe. CNO stated having long nails puts the patient at risk of getting an infection because the nails can harbor bacteria and place the patient at risk of being scratched. During a review of the facility’s policy titled, “Hand Hygiene Policy,” approved on 10/26/22, indicated, “ ... II. PURPOSE: The purpose of this policy is to outline hand hygiene requirements to reduce the risk of infection transmission from patient to patient. Patient to health care provider and health care provider to patient. III. DEFINITIONS A. Hand hygiene means hand washing, antiseptic hand wash, antiseptic hand rub or surgical antisepsis.... IV. POLICY: The hospital has adopted the Centers for Disease Control and Prevention (CDC) Guidelines for hand hygiene in healthcare settings with enhanced comments from the World Health Organization (WHO) ... V. PROCEDURE: ... B. Fingernails Hands with long fingernails, artificial nails and nail tips carry higher bacterial and fungal counts. Natural nails of healthcare workers are to be kept short (less than ¼ inch) and should not extend beyond the fingertips. (Refer to Clinical Quality Policy MOD PC.AD.1.44, Artificial Nail Policy) ...” During a review of the facility’s policy titled, “Artificial Nail Policy,” approved 5/27/20, indicated, “ ... II. PURPOSE: The purpose of this policy is to define when artificial nails and/or nail polish may be worn by healthcare providers and facility staff. III. DEFINITIONS: ... D. “Healthcare providers and workers” means all paid and unpaid persons working in healthcare settings who have the potential for exposure to infectious materials, including contaminated medical supplies. Healthcare providers might include, but are not limited to: physicians, nurses, nursing assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, pharmacy personnel, laboratory personnel, autopsy personnel, students and trainees, contractual staff and persons, i.e., clerical, dietary, housekeeping, maintenance and volunteers not directly involved in patient care but potentially exposed to infectious agents that can be transmitted to and from the healthcare provider. IV. POLICY: The Hospital is committed to the prevention of healthcare-acquired infections. There is mounting evidence concerning the role of artificial nails in the transmission of infection. Data shows that wearers of artificial nails are unable to adequately wash their hands and remove transient flora compared to those without such nails. There is a tendency to harbor Pseudomonas and yeast beneath nails and on fingertips even after hand washing. Therefore, the Hospital prohibits the wearing of artificial nails/nail jewelry for all healthcare providers and workers, as defined above, who may touch a patient, or items a patient may use or touch. V. PROCEDURE: A. Nail Hygiene It is the responsibility of all direct patient care providers to maintain short (less than a ¼ inch long) fingernails. Nails should not extend beyond the tips of the fingers ...””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 42125 Based on observation, interview, and record review, the facility failed to have an effective governing body (GB) that is legally responsible for the conduct of the hospital when: 1. The hospital did not ensure credentialing and privileging were appropriately carried out for physicians and non-physician providers appointed to the medical staff for three of three patients (Patients 37, 38 and 39) when multiple staff were identified as part of the surgical team for the procedures for Patients 37, 38, 39 and were not identified as having approved surgical privileges and/or not listed as non-physician providers. (Refer to A044). 2. The medical staff was not accountable to the governing body (GB) for the quality of patient care services as evidenced by not determining competency of approved privileges, not tracking and monitoring adverse events associated with providers and not conducting proctoring and peer reviews for 30 of 30 physicians and non-physician providers. (Refer to A049) 3. The hospital did not have an organized medical staff responsible for the quality of medical care provided to patients when the GB failed to ensure medical staff followed Medical Staff Bylaws, Rules and Regulations, and considered California state law, in the approval of Certified Registered Nurse Anesthetists (CRNAs- a nurse trained to provide anesthesia ([specialized care before for surgery, pain management, critical care and emergencies]). CRNAs were inappropriately approved to the Medical Staff as licensed to independently diagnose, prescribe and administer anesthesia services without an order from a physician. Five of five CRNAs (CRNA 1, 2, 3, 4 and 5 ), provided care to five of five Patients (Pt- Pt 1, 2, 3, 4 and 5) with the same authority as an anesthesiologist (physician specialist who provides anesthesia medical care for surgery, pain management, critical care and emergencies who has full prescriptive, diagnostic, and therapeutic authority) and without physician orders, and had the potential to endanger all hospitalized patients requiring anesthesia services. (Refer to A338) Because of the serious actual harm to Patient 1 and the serious potential harm to Patients 2, 3 and 4 related to the unsafe practice of CRNAs providing anesthesia services outside of the scope of practice for CRNAs, and the hospital granting full prescriptive authority to CRNAs without having the authority to do so, and CRNAs diagnosing and treating patients without a physician order and establishing a treatment regimen which is outside of their scope of practice and the hospital not following Governing Body and Medical Staff bylaws in the credentialing and privileging process for CRNAs, an Immediate Jeopardy (IJ a situation in which the provider’s noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 5/23/24 at 10 a.m. with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditations Manager (AM) 1, and Accreditations Manager (AM) 2. The IJ (Immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 5/23/24 at 6:34 p.m. and it was unacceptable. The hospital submitted an IJ Plan of Removal (Version Two) on 5/26/24 at 10:44 a.m. which included actions to suspend the use of CRNAs until they could be credentialed and privileged according to GB and MS bylaws. The Plan of Removal was accepted on 5/28/24 at 11:30 a.m. with the CEO, CNO, DCQI and AM 1. On 5/29/24 at 6:15 p.m. the survey team validated that CRNAs were not working at this facility. The survey team validated all staff were educated on the IJ for the CRNAs and what to do if a CRNA comes to work; surgery schedules were reviewed to show no CRNAs were scheduled to provide anesthesia services; all staff in perioperative areas were aware that the CRNAs were only to use the approved order sets in the computer and all of the handwritten orders sets were removed from use. The IJ was removed onsite with the CEO, CNO, DCQI, AM 1 and AM 2 in attendance on 5/29/24 at 6:15 p.m. After removal of the IJ the hospital remained in substantial noncompliance. 3. The hospital did not have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections) and other infectious diseases. (Refer to A 747) Because of the potential of serious harm to all patients and the hospital lacking a comprehensive systemic approach to ensure effective infection control practices, surveillance, prevention monitoring and a system to maintain professional standards of practice, an Immediate Jeopardy (IJ- a situation in which the provider’s noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called on 5/21/24 at 11:30 a.m., under Code of Federal A-0750 §482.42(a)(3) with the Chief Executive Officer (CEO), Chief Operating Officer(COO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditation Manager (AM) 1, and AM 2. The IJ template was provided to the facility. The hospital submitted an acceptable IJ Plan of Removal (Version 2.2) on 5/24/24 at 8:00 a.m., which addressed the actions needed to remove the IJ situation. The IJ Plan of Removal included but was not limited to the following: 1) Reeducated and trained staff on manufacturer’s instructions for cleaning and disinfection, sterilization, and sanitary storage of surgical instruments, endoscopes, and arterial blood gas analyzers 2) Immediately removed unclean endoscopes and surgical instruments from use in procedures 3) Provided house-wide education to staff on hand hygiene, proper aseptic techniques for intravenous medication administration, and clean storage of patient supplies and equipment 3) Immediately cleaned and disinfected air vents, floor drain air gap, kitchen door frames, sinks, floors, rolling food carts and racks, and linen carts, and developed processes for recording and monitoring compliance. 4) Trained kitchen staff on manufacturer’s guidelines for use of kitchen disinfectant solutions and proper cool down processes for patient food items. 5) Dietary staff discontinued the practice of storing pots and pans used for patient food service wet 6) The Infection Preventionist increased surveillance by rounding daily in areas affected by the deficient practices. The components of the IJ Plan of Removal, training, and competencies of staff were validated onsite through observations, interviews, and record review. The IJ was removed onsite on 5/27/24 at 10:48 a.m. with the facility CNO and AM 2. 4. The hospital failed to ensure drugs and biologicals were controlled and distributed in accordance with state and federal statutes granting prescriptive authority, Medical Staff Bylaws, and credentialing standards for non-physician providers when the hospital granted CRNAs prescriptive authority without having the legal authority to do so; and the Pharmacy Department permitted CRNAs to write prescriptions; and filled medication orders written by CRNAs even when the CRNA was not acting according to a treatment regimen ordered by a physician; and did not have a system to double-check and ensure CRNAs could legally write prescriptions. (Refer to A 489) 5. The hospital failed to ensure the food and dietetic service department was organized in a manner appropriate to the scope and complexity of the food service operations and did not ensure the provision of dietetic services for the health and safety needs of patients was in compliance with the Condition of Participation for Food and Dietetic Services. (Refer to A 618) 6. The hospital failed to ensure effective maintenance of the physical plant when the dish machine was not working for approximately four months with no movement on the new dish machine when it was deemed non repairable, or timely acquisition of a temporary solution and there were multiple areas on the floor throughout the kitchen that had cracks and holes in the epoxy floor and missing or loose tiles. (Refer to A083) 7. The GB did not ensure a hospital wide data-driven quality assessment and performance improvement program. (Refer to A 263) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and professional manner.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 45580 Based on observation, interview, and record review, the hospital failed to protect and promote each patient’s rights when: 1. One of three sampled patients (Pt) 6 was not protected from abuse. Clinical service tech (CST) 1 pushed Pt 6 into the wall and Pt 6 sustained a broken clavicle. (refer to A145) 2. The [Brand name 1] warmer for pre moistened wipes were not used in accordance with the operating instructions leading to potential for fire or other hazards and did not ensure the right to a safe environment for patients. (refer to A144) 3. Informed consent was not provided for two of four sampled patients (Pt 6 and Pt 11). Pt 6 did not have a consent form for antipsychotic medications (a type of drug used to treat severe mental disorder in which a person loses the ability to recognize reality or relate to others) administered during his hospitalization. Pt 11 was not provided with an interpreter during consent for an epidural per the hospital’s policy and procedure (P&P). (refer to A131). 4. Two of three sampled patients (Pt 11 and Pt 12) preferred language was other than English and there was minimal (for informed consents) to no documentation an interpreter was used for either patient during their hospitalization. (refer to A117) 5. One of three sampled patients (Pt 8) was not provided care in accordance with the hospital P&P titled, “Restraints and Seclusion”. Pt 8 was placed in five-point restraints, which was not least restrictive, the physician’s order for four-point restraints was not followed and a physician did not perform a one-hour face to face after restraints were placed emergently. (refer to A154) The cumulative effect of these systemic problems resulted in the hospital’s inability to provide care in a safe setting.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 39795 Based on observation, interview, and record review, the hospital failed to have an effective on-going, hospital-wide data-driven Quality Assessment and Performance (QAPI) program when: 1. The hospital did provide evidence of a QAPI program for clinical nutrition and food services that accurately reflected the depth and complexity of the service. (Refer to A 273) 2. The infection preventionist (IP) was aware of infection control practices that did not meet the standard and failed to bring this to the attention QAPI program to implement an improvement project and QAPI was aware Certified Registered Nurse Anesthetists (CRNAs) were permitted to operate independently with full prescriptive and diagnostic authority for anesthesia services and failed to consider the scope of practice of CRNAs and whether this practice was consistent with Medical Staff Bylaws. (Refer to A 283) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and professional manner.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 42125 Based on observations, interview and record review, the hospital failed to have an organized medical staff responsible for the quality of medical care provided to patients when: 1. The Governing Body failed to ensure the medical staff followed Medical Staff Bylaws, Rules and Regulations, and California state law, when hospital approved Certified Registered Nurse Anesthetists (CRNAs- a nurse trained to provide anesthesia ([specialized care before for surgery, pain management, critical care and emergencies]) under the orders of a physician) to be added to the Medical Staff if they were licensed to independently diagnose, prescribe and administer provide anesthesia services without an order from a physician. Five of five CRNAs (CRNA 1, 2, 3, 4 and 5 ) non-physicians, provided care to 5 of 5 Patients (Pt- Pt 1, 2, 3, 4 and 5) with the same authority as an anesthesiologist (physician specialist who provides anesthesia medical care for surgery, pain management, critical care and emergencies who has full prescriptive, diagnostic, and therapeutic authority) to any patient without physician orders, and has the potential to endanger all hospitalized patients requiring anesthesia services. (Refer to A339) Because of the serious actual harm to Patient 1 and the serious potential harm to Patients 2, 3 and 4 related to the unsafe practice of CRNA (identifiers) providing anesthesia services outside of the scope of practice for CRNAs, and the hospital granting full prescriptive authority to CRNAs without having the authority to do so, and CRNAs diagnosing and treating patients without a physician order establishing a treatment regimen which is outside of their scope of practice and the hospital not following Governing Body and Medical Staff bylaws in the credentialing and privileging process for CRNAs, Immediate Jeopardy (IJ a situation in which the provider’s noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 5/23/24 at 10:00 a.m. with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditations Manager (AM) 1, and Accreditations Manager (AM) 2. The IJ (Immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 5/23/24 at 6:34 p.m. and it was unacceptable. The hospital submitted an IJ Plan of Removal (Version Two) on 5/26/24 at 10:44 a.m. which included actions to suspend the use of CRNAs until they could be credentialed and privileged according to GB and MS bylaws. The survey team validated all staff were educated on the IJ for the CRNAs and what to do if a CRNA comes to work; surgery schedules were reviewed to show no CRNAs were scheduled to provide anesthesia services; all staff in perioperative areas were aware that the CRNAs were only to use the approved order sets in the computer and all of the handwritten orders sets were removed from use. The IJ was removed onsite with the CEO, CNO, DCQI, AM 1 and AM 2 in attendance on 5/29/24 at 6:15 p.m. After removal of the IJ the hospital remained in substantial noncompliance. 2. The Medical Staff failed to follow Medical Staff Bylaws, rules and regulations; and failed to consider scope of practice state laws in recommending candidates to the medical staff for 25 of 25 physicians and non-physician providers. The hospital failed to appropriately credential and privilege 13 of 13 CRNAs, three of three surgeons, one of one anesthesiologist, seven of seven Physician Assistants and one of one Nurse Practitioner. (Refer to A341) 3. Medical staff department failed to follow policy and ensure all individuals providing medical care and services in the hospital privileges were recommended by the Medical Executive Committee (MEC - oversight of safe and appropriate patient care by physician and non-physicians) and approved by the Governing Board for 25 of 25 physician and non-physician providers. (Refer to A347) The cumulative effect of these systemic problems resulted in the inability of the hospital to ensure the provision of patient care in a safe setting.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 45580 Based on interview and record review, the hospital failed to have a well-organized and effective nursing service when: 1. Pt 29 was administered Labetalol (medication to slow heart rate and decrease blood pressure) outside the physician medication order parameters. Pt 29 had the potential for drop in blood pressure and heart rate leading to significant harm and adverse outcome. (Refer to 405) 2. Administration of Dexmedetomidine (medication to keep you asleep) continuous infusion was titrated (slowly increasing the dose of a medicine to see how your body will react to it) by RNs for Pt 35 at 0.2 [micrograms (mcg-unit of measurement) per kilogram (kg-unit of measurement) per hour (hour- time)] higher than the physician medication order to titrate administration at 0.1 mcg/kg/hr. Pt 35 was administered higher dose for titration than the physician order and had the potential for adverse outcome including hypotension (low blood pressure). (Refer to 405) 3. Registered Nurses administered insulin continuous intravenous drip (the administration of a fluid into a blood vessel, usually over a prolonged period of time) for Pt 36 to treat hyperglycemia and the insulin dose rate was not started in accordance with the physician medication order of Insulin Algorithm (guidance to assist nurses in titrating insulin dose to maintain a goal blood glucose level) despite being verified by two nurses. RNs did not follow the “Insulin Algorithm” and started insulin at a higher dose without first notifying the physician and obtaining a physician order. (Refer to 405) 4. Three of six patients (Patient (Pt) 11, Pt 12, and Pt 14) did not have vital signs assessed and documented in accordance with the hospital policy and/or professional standards. (Refer to 398) 5. One of two patients (Pt 11) did not have her pain assessed and documented while she was receiving epidural pain medication according to hospital policy. (Refer to 398) 6.One of two sampled patients (Pt 61) was not offered pain medication prior to the start of a large wound dressing according to the hospital’s pain policy and hand hygiene was not performed per hospital policy. (Refer to 398) The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care in a safe setting.”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 40903 Based on interview and record review, the hospital failed to ensure drugs and biologicals were controlled and distributed in accordance with state and federal statutes granting prescriptive authority, Medical Staff Bylaws, and credentialing standards for non-physician providers when the hospital granted CRNAs (a non-physician provider) prescriptive authority without having the legal authority to do so; and the Pharmacy Department permitted CRNAs to write prescriptions; and filled medication orders written by CRNAs even when the CRNA was not acting according to a treatment regimen ordered by a physician; and did not have a system to double-check and ensure CRNAs could legally write prescriptions. These failures were evidenced by: 1. CRNA 3 ordered medications for Patient 3 prior to operation, during operation and in the PACU (Post Anesthesia Care Unit; after surgery) and managed the adverse events from the procedure or the drugs without a treatment regimen ordered by a physician. Pharmacy processed and approved medication use, and orders sent to them electronically. 2. CRNA 1 ordered medications for Patient 4 using an unauthorized order form for PACU orders and did not follow GI specialists’ (a doctor specialized in stomach and colon disease) sedation plan (how to put patient to sleep or provide pain relief during procedure) and orders for medication use. Pharmacy approved CRNA 1’s medication access and did not address discrepancy on medications removed from ADM (Automated Dispensing Machine, a computerize machine that stored and tracked medication removal with authorized access). 3. CRNA 4 ordered medications for Patient 2 prior to procedure, during the procedure and in the PACU and Pharmacy processed and approved medication use, and orders sent to them electronically without a treatment plan ordered by a physician. 4. CRNA 6 ordered medication for Patient 5 during the procedure and for the PACU unit. Pharmacy processed and approved electronic medication orders despite risk factors related to patient age and kidney function. These failed practices did not comply with the requirement for safe pharmaceutical services, had the potential to cause harm, injury, and death to patients; and could contribute to the risk of drug diversion (drug loss). The cumulative effects of this systemic failure resulted in the hospital’s inability to ensure safe, legal, accountable, and quality pharmaceutical services.”

“FOOD AND DIETETIC SERVICES CFR(s): 482.28 The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company may be found to meet this Condition of Participation if the company has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company maintains at least the minimum standards specified in this section and provides for constant liaison with the hospital medical staff for recommendations on dietetic policies affecting patient treatment. This Condition is not met as evidenced by: 28773 Based on observation, staff interview, and review of hospital documents, the hospital failed to ensure the food and dietetic service department was organized in a manner appropriate to the scope and complexity of the food service operations by failure to ensure: 1. Full-time oversight by the Regional Director of Operations (RDO), a contracted service, to ensure food safety in accordance with 2022 Food and Drug Administration (FDA) Food Code standard of practice while acting as the Director of Food and Dietetic Services. (Refer to A-0620) 2. Effective organization of Food and Nutrition Services Department as evidenced by lack of operational oversight by a Registered Dietitian of food production and sanitation activities resulting in food safety hazards and an unsanitary kitchen environment . (Refer to A-0619) 3. Delayed nutrition assessment and medical nutrition therapy for three of seven sampled patients (Patients 49, 46, 53), in accordance with the hospital policy, all of whom had identified nutrition risk factors and ordered consults. (Refer to A-629) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of dietetic services for the health and safety needs of 358 patients admitted to the hospital in compliance with the Condition of Participation for Food and Dietetic Services.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 42321 Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections) and other infectious diseases, when: 1.Surgical instruments, endoscopes (a thin, flexible tube-like instrument equipped with a camera used to look at tissues inside the body), and blood gas machines (A specialized equipment that takes a blood sample and measures the oxygen, carbon dioxide and pH of the blood sample. The pH is a measure of acid-base balance of the blood) were not maintained, cleaned, and disinfected, and/or stored in accordance with policies and procedures, manufacturer’s guidelines, and standards established by nationally recognized organizations for perioperative practices and for the safe use and management of surgical instrumentation and medical devices. These failures had the potential to cause equipment or instrument failure and transmission of infectious diseases resulting in serious harm to patients. (Refer to A0750 findings 1- 4) 2. Sterile processing (SPD) and Endoscopy (Endo) Departments were not cleaned and maintained in a sanitary manner to prevent the generation and reproduction of molds (microscopic microorganism that live on plant or animal matter), bacteria (germs), and viruses (infectious organisms with both living and nonliving characteristics) within their environments and potential transmission of illnesses. (Refer to A0750 findings 6 and 7) 3. The kitchen responsible for patient food service was not maintained in a sanitary manner to prevent cross contamination (transfer of germs from one object to another) and foodborne illnesses (caused by consuming contaminated foods or beverages). Kitchen floors, sink backsplash, rolling and food racks, food carts, shelving, and door frames had black/ gray substances, rust, and/ or yellow sticky residue adhered to their surfaces. Pots and pans used for patient food service were stored wet and food trays were not cleaned per manufacturer’s guidelines. Kitchen staff did not follow proper cool down processes for patient food items and policies for hair coverings. (Refer to A0750 findings 14A through 14J.) 4. Staff did not perform hand hygiene and utilize Personal Protective Equipment (PPE- equipment worn to minimize exposure to hazards that cause serious workplace injuries) in accordance with policies and procedures and nationally recognized infection prevention and control guidelines, which had the potential to compromise the health and safety of patients, staff, and visitors. Proper eyewear was not worn in accordance with hospital policy and procedures for PPE in the operating rooms (ORs). Staff did not maintain appropriate nail length and hygiene to prevent patient exposure to hospital acquired infections (HAIs). (Refer to A750 findings 5, 9, 10, and 11) 5. Trash and patient supplies were not stored in accordance with policy and procedure and best infection control practice to prevent cross contamination. Linen carts were not covered. Miscellaneous supplies, gloves, and storage containers were stored in the splash zone of a handwashing sink in a procedure room. Trash bags overflowed out of a trash bin and piled up against the wall and the floor of the utility room. (Refer to A0750 findings 8, 13, and 14) 6. Hospital policy and procedure and best infection control practice was not followed during the cleaning an occupied patient room. The housekeeper reached into a disinfectant solution bucket with contaminated gloves and the mop head was not changed between the room’s bed A and bed B to prevent cross contamination. (Refer to A0750 finding 12) 7. The Infection Preventionist was not aware of the hospital-wide infection problems, did not have a systemic approach to track and monitor infection control practices and did not make rounds in all areas of the hospital. (Refer to A0750 finding 16) Because of the potential of serious harm and the hospital lacking a comprehensive systemic approach to ensure effective infection control practices, surveillance, prevention monitoring and a system to maintain professional standards of practice an Immediate Jeopardy (IJ- a situation in which the provider’s noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called on 5/21/24 at 11:30 a.m., under Code of Federal A-0750 §482.42(a)(3) with the Chief Executive Officer (CEO), Chief Operating Officer(COO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditation Manager (AM) 1, and AM 2. The IJ template was provided to the facility. The hospital submitted an acceptable IJ Plan of Removal (Version 2.2) on 5/24/24 at 8:00 a.m., which addressed the actions needed to remove the IJ situation. The IJ Plan of Removal included but was not limited to the following: 1) Reeducated and trained staff on manufacturer’s instructions for cleaning and disinfection, sterilization, and sanitary storage of surgical instruments, endoscopes, and arterial blood gas analyzers 2) Immediately removed unclean endoscopes and surgical instruments from use in procedures 3) Provided house-wide education to staff on hand hygiene, proper aseptic techniques for intravenous medication administration, and clean storage of patient supplies and equipment 3) Immediately cleaned and disinfected air vents, floor drain air gap, kitchen door frames, sinks, floors, rolling food carts and racks, and linen carts, and developed processes for recording and monitoring compliance. 4) Trained kitchen staff on manufacturer’s guidelines for use of kitchen disinfectant solutions and proper cool down processes for patient food items. 5) Dietary staff discontinued the practice of storing pots and pans used for patient food service wet 6) The Infection Preventionist increased surveillance by rounding daily in areas affected by the deficient practices. The components of the IJ Plan of Removal, training, and competencies of staff were validated onsite through observations, interviews, and record review. The IJ was removed onsite on 5/27/24 at 10:48 a.m. with the facility CNO and AM 2. The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality foods and patient care in a safe and sanitary environment.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 42125 Based on observation, interview and record review, the hospital failed to provide a well-organized surgical service in accordance with acceptable standards of practice when; 1. The hospital failed to ensure the surgery department kept an accurate roster of privileged surgeons and non-physicians approved to be in Operating Rooms when surgery staff did not follow policies and procedures and permitted unidentifiable, unqualified and/or unprivileged individuals and physicians to provide surgical care in the operating rooms. (Refer to A945) 2. The hospital failed to obtain a History and Physical (H&P-a term used to describe a doctor’s examination of the patient) updated within 24 hours of a surgery for one of two patients ((Pt) 12) in accordance with hospital policy and procedure. (Refer to A952) The cumulative effects of these systemic failures resulted in the hospital’s inability to ensure quality healthcare in a safe setting.”

“ANESTHESIA SERVICES CFR(s): 482.52 If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The service is responsible for all anesthesia administered in the hospital. This Condition is not met as evidenced by: 42125 Based on observation, interview and record review, the hospital failed to provide anesthesia services in a well-organized manner when the hospital failed to provide anesthesia services consistent with needs and resources when the hospital granted Certified Registered Nurse Anesthetists (CRNA) prescriptive authority and the ability to diagnose and treat patients without a treatment regimen ordered by a physician while providing anesthesia services and was not consistent with scope of practice laws and standards of practice for CRNAs. (Refer to A1002) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner.”

“EMERGENCY SERVICES CFR(s): 482.55 The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. This Condition is not met as evidenced by: 42125 Based on interview and record review, the hospital failed to ensure emergency needs of patients were met in accordance with acceptable standards of practice when emergency services provided in the hospital were not supervised by a qualified member of the medical staff for four of four patients (Patients 1, 2, 3 and 5). Patients 1, 2, 3 and 5 experienced code blue situations (term generally used to indicate a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) in the surgical and procedural areas of the hospital and the code blue was not supervised by a qualified member of medical staff and the code blue did not follow established guidelines for Advanced Cardiac Life Support (ACLS) published by the American Heart Association (AHA) and hospital policy and procedure. (Refer to A1111) The cumulative effect of these systemic problems resulted in the hospital’s inability to provide quality healthcare in a safe setting.”

“LICENSURE OF PERSONNEL CFR(s): 482.11(c) The hospital must assure that personnel are licensed or meet other applicable standards that are required by State or local laws. This Standard is not met as evidenced by: 28773 Based on interview and review of Hospital documents, the hospital failed to ensure: 1. The Regional Director of Operations (RDO) met the qualifications to fulfill the responsibilities of a dietetic service supervisor in accordance with the State of California Health and Safety Code (HSC) 1265.4b Statue. These requirements were not met when the RDO failed to receive at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming the role as a dietetic services supervisor at the health facility. 2. Oversight of food service operations by a Registered Dietitian (RD) for the purpose of providing guidance to the RDO and staff of the dietetic service at a sufficient duration and frequency in accordance with California Code of Regulations, Title 22 - General Acute Care Hospitals, 70275(a). These failures placed patients at risk for food borne illness (illness caused by food contaminated with bacteria, viruses, parasites, or toxins) due to lack of oversight of the food service operation by qualified staff for a hospital census of 358. Findings: During the survey from 5/13/24 to 5/14/24, observations, interviews and document reviews identified multiple concerns related to food production operations. The concerns included a lack of: Effective food safety and sanitation systems and practices in the kitchen (Cross Reference A620, A750); Maintenance of Food Service equipment (A701); Development of a Departmental QAPI (Quality Assurance Performance Improvement) program for the hospital’s food production operations. There was no evidence provided that patient meal satisfaction data was integrated into the hospital wide QAPI program. Additionally, there was no clinical nutrition QAPI program (Cross Reference A273). 1. According to the California Health and Safety Code (CA HSC) 1265.4(b), the dietetic services supervisor shall have completed one of seven recognized pathways, two of which include the completion of an education program approved by the Dietary Managers Association and successful completion of a certifying exam. In addition to the successful completion of a certifying exam the qualified manager must have received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility. During a review of the employee file for the Interim Director of Food and Nutrition Services, who also identified as the Regional Director of Operations (RDO), and concurrent interview on 5/22/24 at 12:01 p.m. in the presence of the Chief HR Officer (CHRO), Director of Professional Development & Education, Employee Labor Relations Manager and RDO, it was noted while the RDO received his Certified Dietary Manager credential from the Dietary Managers Association there was no evidence the RDO completed a six hour program specific to CCR Title 22 dietetic services regulations. The CHRO and RDO stated they were not aware of the HSC 1265.4 requirements. The RDO stated he thought he had some documentation to show he has completed that. During a review of the DFNS job description, authored by the food service contract company, undated, revealed the required qualifications listed in the job description were not consistent with the Health and Safety Code 1265.4, for the position responsible for the daily by operation of the food service. Review of the documentation of RDO continuing education and in-services showed there was nothing specific regarding Title 22 dietetic service requirements. 2. A Registered Dietitian/Nutritionist (RDN) is a health care professional educated in food and nutrition, who can translate scientific information into practical solutions. RDNs are food and nutrition experts with a minimum of a graduate degree from an accredited dietetics program and who completed a supervised practice requirement, passed a national exam and continue professional development throughout their careers. (Academy of Nutrition and Dietetics). The RDN has a scope of practice in California law. In contrast the CDM expertise is managing foodservice operations and ensuring food safety, usually in a healthcare facility. They are responsible for implementation of menus, foodservice purchasing, and food preparation. The CDM does not have a scope of practice in California Law. The California Code of Regulations, Title 22, Section 70271 defines dietetic services as the provision of safe, satisfying and nutritionally adequate food for patients. Additionally, Section 70275 states (a) A registered dietitian shall be employed on a full-time, part-time or consulting basis. Part-time or consultant services shall be provided on the premises at appropriate times on a regularly scheduled basis and of sufficient duration and frequency to provide continuing liaison with medical and nursing staffs, advice to the administrator, patient counseling, guidance to the supervisor and staff of the dietetic service, approval of all menus and participation in development or revision of dietetic policies and procedures and in planning and conducting in-service education programs. During a review of the Clinical Nutrition Manager job description, authored by the food service contract company, dated Jan 2019, signed by the CNM on 2/28/23, showed this position reports to the Director of Food and Nutrition Services (DFNS). The position’s supervisory responsibilities was limited to the clinical nutrition staff. The job description did not outline all the areas that the CNM was responsible for in relationship to California Code of Regulations, Title 22, such as guidance to the supervisor (DFNS) and the staff of dietetic services. During a review of the DFNS job description, authored by the food service contract company, undated, showed the DFNS reports to the Regional Director of Operations (RDO) of the contract company. There was no reporting to the hospital just the contract company. It showed the DFNS directs the operation of Food and Nutrition Services. The job description did not indicate this position received guidance from a Registered Dietitian (RD). During an interview with the RDO on 5/14/24 at 12:22 p.m., in the kitchen, the RDO stated the CNM is the Registered Dietitian that has oversight in the kitchen. During an interview with the CNM, on 5/14/24 at 12:47 p.m., she stated she is responsible for clinical nutrition and nutrition consults. CNM stated she reviews the therapeutic diets and looks over meal service. She informally ensures the patient menu is being followed and will modify menus if needed. The CNM stated she has not observed whether staff follows recipes during food production but thinks they do. The CNF has not reviewed or evaluated the department’s sanitation practices. The CNM stated she communicates with the Patient Services Manager about things regarding meal service.”

“MEDICAL STAFF CFR(s): 482.12(a) The governing body must: This Standard is not met as evidenced by: 42125 Based on interview and record review, the hospital’s Governing Body failed to ensure credentialing and privileging were appropriately carried out for physicians and non-physician providers appointed to the medical staff for three of three patients (Patients 37, 38 and 39) when multiple staff were identified as part of the surgical team for the procedures for Patients 37, 38, 39 and were not identified as having approved surgical privileges and/or not listed as non-physician providers. These failures resulted in the potential harm of physicians and non-physicians providing healthcare services to patients without first having the appropriate qualifications and approved privileges. Findings: During an interview and concurrent record review on 5/30/24, at 3:48 p.m., with Chief of Staff (COS, a Medical Doctor), accompanied by Accreditation Manager (AM 2), the hospital policies, and medical staff processes were discussed. The COS stated she was “familiar” and followed Medical Staff Bylaws (a set the framework for the working relationship of the medical staff, hospital administration and governing body, and assures legal protections were in place). The COS stated she participated in the following meetings: Credentialling Committee (CC), the first Thursday of each month, Medical Executive Committee (MEC) the 3rd Friday of each month and Governing Board (GB) the 4th Wednesday of each month. COS stated the CC, MEC and GB have “access” to the applicant’s file for review.” COS stated the “proof” of CC and MEC recommendations and GB approval were the dates entered into the meeting minutes. COS stated surgical providers participated in 3 months of proctoring and did not know the process for other departments. COS acknowledged the privilege process for applicants was not followed by the hospital. During an interview and concurrent record review on 5/30/24, at 3:48 p.m., with the COS, accompanied by Accreditation Manager (AM 2), the hospital policies, and medical staff processes were discussed. The COS stated Physician Assistants (PA, an Allied Health Professional, AHP) could work “anywhere” in the hospital. The COS acknowledged that medical staff approved and confirmed the competency, qualifications, and skills of all AHPs. The COS stated regardless of AHP’s specialty, they were required to provide medical care as “asked” by physician responsible for the AHP. During an interview on 5/31/24, at 10:22 a.m., with Governing Board Members (GBM), which included: Accreditation Manager (AM 1), Director of Clinical Quality and Performance Improvement (DCQI), Accreditation Manager (AM 2), Chief Nursing Officer (CNO), Chief of Staff (COS), and Chief Operating Officer (COO), the GBM described the current privileging process. The GBM indicated it was the “same for all applicants” who applied for privileges. The applicant privilege request was signed by the Chief of the Department. The GBM stated the COS had access to the applicant file and “looked at” it. The credentialling committee will “look over” the file; the MEC will “look at” the file and after the GB “looks at” it. The GBM stated the “basic stuff” was a background check, education, and experience. The GBM acknowledged individuals, who were not privileged, were providing medical care to patients. The GBM stated the current privileging process was “not appropriate” and had a “serious issue”. During an interview on 5/31/24, at 10:22 a.m., with Governing Board Members (GBM), which included: Accreditation Manager (AM 1), Director of Clinical Quality and Performance Improvement (DCQI), Accreditation Manager (AM 2), Chief Nursing Officer (CNO), Chief of Staff (COS), and Chief Operating Officer (COO), the GBM stated that CRNAs were contracted to provide anesthesia care and “cover the ORs”. The GBM stated the anesthesia services model was “CRNA based” with “supervision” by an anesthesiologist and defined physician supervision of a CRNA as “they always have to talk to a physician ...run it by the physician on call ...to help them”. During record review of two hospital’s provider logs, titled “Revised Med Staff Roster” and “Revised AHP Roster”, both dated from 5/2023 to 5/2024, the Medical Staff log listed 658 physician providers and the AHP log listed 121 AHP. Certified Registered Nurse Anesthetist or CRNA (Registered Nurse with specialized training that provides anesthesia services under the orders of a physician): 49 CRNA’s were privileged to diagnose, treat and prescribe without orders from a physician establishing a treatment protocol not required to have physician oversight, and were able to orders tests and drugs without an order from a physician establishing a treatment regimen. During an interview on 5/31/24, at 1:08 p.m., with Chief Operating Officer (CEO- responsible for hospital conduct and safety and care of patients), accompanied by Registered Nurse Quality (RNQ 2), the hospital policies, workflows, quality of care and medical staff role and responsibilities were discussed. The CEO stated he did not have a medical and clinical background and relied on physician’s judgement when making decisions. The CEO stated he was “not familiar with staffing privileges” and was unaware the process was “not complete”. The CEO stated he was not aware medical staff on rosters were not appropriately privileged according to Bylaws and had not been approved by the GB to provide medical services. The CEO stated the credentialling process needed to be addressed as soon as possible with a “thorough approach to the process”. The CEO acknowledged there were inappropriately privileged individuals providing medical care in the hospital. The CEO stated there was “a lot of clean-ups across the board” to be done at the hospital. During a concurrent record review and interview on 5/31/24, at 1:08 p.m., with Chief Executive Officer (CEO), accompanied by Registered Nurse Quality (RNQ 2), hospital policies, workflows, quality of care and medical staff were discussed. The CEO stated there were a number of physicians and non-physicians on the rosters (658 physicians and 121 AHPs) who were not privileged according to hospital’s Bylaws reviewed with during the medical staff interview, COS, SUR 3, SUR 5, SUR 8, CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6 and PA 7 or NP 2. The CEO was asked about unauthorized individuals in the OR, for Patients 37, 38 and 39. 1. During a review of the Pt 37’s nursing intra-operative notes, titled, “Surgical Documentation”, dated 6/24/23, at 3:54 p.m., the nurse documented medical providers who entered the operating room and provided surgical services to Pt 37 as follows: “Operating surgeons, SUR 3, and SUR 9, “Coronary Artery Bypass”. “Anesthesiologists, (ANS 4). “Medical Doctor (MD) 11 , “Assistant Provider, Intraoperative” for “Coronary Artery Bypass”, was not listed as a surgeon on the Medical Staff roster, but as an internal medicine doctor. “MD 12, “Assistant Provider, Intraoperative” for “Coronary Artery Bypass”, was not listed as a surgeon on the Medical Staff roster, but internal medicine doctor. “RNFA 1, “First Assistant” for “Coronary Artery Bypass”, was not listed on the APH Roster 2. During a review of the Pt 38’s nursing intra-operative (during surgery) notes, titled “Surgical Documentation”, dated 5/15/24, the nurse documented medical providers who entered the operating room and provided surgical services to Pt 38 as follows: “Operating surgeon, (SUR 5), listed on the medical staff roster. “Anesthesiologists, (ANS 1 and ANS 6). Both listed on the medical staff roster.” “Additional staff intraoperative” Physician Assistant (PA 8), listed on AHP roster with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging);” “Assistant Provider, Intraoperative” Nurse Practitioner, (NP 1) - not on the medical staff or AHP roster;” “Assistant Provider, Intraoperative” physician, (DO 1) - Not on the medical staff roster.” 3. During a record review of the Pt 39’s nursing intra-operative notes titled, “Surgical Documentation”, dated 12/13/2023, the nurse documented 21 different individuals entered the OR during Pt 39’s case-“ RNs- six total; Unknown status, the facility did npt provide documented evidence of employees working in the ORs; “Respiratory therapist -one. Unknown status, the facility did not provide documented evidence of employees working in the ORs. “Medical students-four. None were on a roster. “Vendor-- one.”Perfusionists-three. Unknown status, the facility did not provide documented evidence of employees working in the ORs. “Anesthesiologist - two (ANS 8, ANS 2, “Surgeons-- four. Primary surgeon (SUR 3) and 3 Assistant Providers (SUR 8, SUR 10, and SUR 11 “Coronary Artery Bypass”. “RNFA-- one. RNFA 1 “First Assistant” for “Coronary Artery Bypass - Not listed on the APH Roster. “Physician Assistant - one. PA 8 “Anesthesia Tech [assistant to anesthesiologist, require a licensed. But not allowed to practice in California]”. Listed on AHP roster as PA with a radiologist as the supervising physician. The CEO stated that it was “absolutely serious” to have individuals in the OR who did not have the appropriate privileges or could not be identified by staff. CEO stated there should have been “stop gap measures” to prevent unauthorized individuals from entering the OR. During record review of [Hospital] policy titled “Rules and Regulations of the Governing Board of [Hospital]”, June 13, 2022, indicated that the “Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... approved by the Governing Board ... The Governing Board shall have authority and responsibility for all appointments and reappointments of Medical Staff members, granting of clinical privileges, approving disciplinary actions, conducting investigations relating to quality of patient care and professional practice”. During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “ recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout [Hospital Name] Medical Center ... To provide professional performance and utilization of services within the scope of defined clinical privileges, through a systemic credentialing, review, appraisal, and improvement ... Comply with the policies, practices, and procedures at [Hospital Name] Medical Center, including the standards and recommendations by The Joint Commission, local, state, and/or federal laws, and regulations ... Adhere to responsibilities as outlined in sponsoring/supervision agreements to allied health professionals (if applicable) ... DUTIES AND AUTHORITY OF THE MEDICAL EXECUTIVE COMMITTEE. ...To fulfill Medical Staff accountability to the Governing Board for the medical care of patients at [Hospital Name] Medical Center ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership”.”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 42125 Based on interview and record review, the hospital failed to ensure the medical staff was accountable for the quality of care to patients when the Medical Executive Committee and Medical Staff Office did not ensure providers demonstrated competency for approved privileges and the medical services provided were not monitored and tracked for adverse events, proctoring and peer reviews not completed for 30 of 30 providers (non-physicians and physicians): 13 Certified Registered Nurse Anesthetist (CRNA- type of AHP, Registered Nurse with specialized training that provides anesthesia services under the orders of a physician), [CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18], four surgeons (SUR) [3, 5, 8 and Chief of Medical Staff (COS)], one anesthesiologist (ANS) [4], Seven Physician Assistants (PA- type of AHP, an individual with specialized training that provided medical care under the supervisor of a physician), [PAs 1, 2, 3, 4, 5, 6 and 7], one Nurse Practitioner (NP- type of AHP Registered Nurse with specialized training that provides medical care under the supervision of a physician), [NP 2]; and four providers were not on the AHP or medical staff rosters (ANS 5, NP 1, physician (DO 1). These failed practices of not proctoring, monitoring for competency, and tracking for adverse events may have contributed to unsafe medical care and missed opportunities to ensure patient safety and prevent patient harm. Findings: 1. During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and on 5/28/24, at 1:50 p.m., with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical staff manager, the hospital’s workflow, policies, patient record logs and staff files were discussed. The MST stated the newly approved privileged providers must have completed proctoring. The MST indicated medical staff Bylaws “expectation” was that all proctoring to be “direct” supervision and each specialty had its own requirements. The MST acknowledged proctoring of staff was not monitored and maybe not even done. The MST acknowledged there was no documented evidence that COS, SUR 3, SUR 5, SUR 8, CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6 and PA 7 or NP 2 completed all the required proctoring. During an interview on 5/30/24, at 3:00 p.m., with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), the hospital policies, workflow and OR staff were discussed. SUR 4 stated she “helps”’ the credentialing committee once a month. After privileges have been granted, proctoring occurred for medical staff. During an interview on 5/30/24, at 3:48 p.m., with Chief of Medical Staff (COS), accompanied by AM 2, hospital policies, and medical staff processes were discussed. The COS stated she was “familiar” and “follows” Medical Staff Bylaws. The COS stated surgical providers participate in 3 months of proctoring but did not know the process for other departments. The COS acknowledged the privilege process for staff was not followed. During three concurrent interviews and record reviews on 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1), accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and DCQI, on 5/29/24, at 10:10 a.m., with ANS 1, accompanied by DCQI, and on 5/29/24, at 4:14 p.m., with ANS 1, accompanied by RNQ 1, the hospital policies were discussed. ANS 1 indicated he was the Chief of the Anesthesia Department since September of 2023. ANS 1 stated his job as chief was to approve, monitor and sign-off on proctoring. ANS 1 described the proctoring process. ANS 1 and DCQI acknowledged proctoring was not done consistently. ANS 1 acknowledged that approved privileges and proctoring was not specific to case and procedures, nor the face-to-face proctoring was required. ANS 1 stated proctoring had been mostly retrospectively (after the fact), and if needed it was completed concurrently with the CRNA. ANS 1 stated CRNA competency can could be determined by the surgeon, chief of anesthesiology or the anesthesiologist in charge (AIC). ANS 1 stated the AIC could be an anesthesiologist or a CRNA. ANS 1 stated whether proctoring completed or not the case assignments could be simple, complex, or high-risk sick patients, including high-risk procedures that required specific skills. ANS 1 stated high-risk patients and procedures cases were “not part of proctoring”. ANS 1 stated the applicant had 12 months to complete proctoring. ANS 1 stated once proctoring requirement satisfied the applicant’s file would have been forwarded to Credential Committee (CC), Medical Staff Committee, and Governing Board (GB) for approval. During a concurrent interview and record review on 5/20/24, at 3:40 p.m., with CRNA 1, accompanied by Registered Nurse for Quality (RNQ 1), the medical records and workflow were reviewed with CRNA 1. CRNA 1 stated he finished nurse anesthetist education in December of 2023, and this was “first job” as a CRNA. CRNA 1 stated he started taking calls (available anesthesia emergencies) in the hospital at night in April 2024, and working full time in May of 2024. CRNA 1 stated he was not required to undergo proctoring because he was “comfortable without proctoring” and “started off by myself ...on my own”. CRNA 1 stated he turned in a months’ worth of case logs to the Chief of Anesthesia (ANS 1) for “retrospective” review. CRNA 1 state he has not had any direct supervision or one-on-one proctoring. CRNA 1 stated he could do “all cases” for anesthesia. CRNA 1 stated all CRNAs signed orders and assessments the same way as the physicians on anesthesia records, and a treatment regimen ordered by a physician was not required for orders, patient evaluations, procedures or anesthesia records. During an interview and concurrent record review on 5/20/24, at 5:12 p.m., with CRNA 5, accompanied by Patient Safety Officer (PSO), Patient 1’s (Pt 1) medical record, workflow and policies were reviewed, and discussed. CRNA 5 stated proctoring consisted of completing a form and turning it in for the Chief of the Anesthesia department (ANS 1) for a signature. CRNA 5 stated the proctoring was done “retrospectively” and could not recall any cases or procedures which were done with an anesthesiologist present. CRNA 5 stated that “schooling” for procedures and anesthesia was completed; thus, certification and proctoring was not required. CRNA 5 stated she completed her proctoring and needed to turn the “forms” into the Chief of Anesthesia. During an phone interview on 5/22/24, at 10:13 a.m., with CRNA 6, accompanied by Director of Clinical Quality Improvement (DCQI), the hospital policy, workflow and patient records were discussed. CRNA 6 stated he worked “independently” without regimen ordered by a physician. CRNA 6 stated he was proctored for “one case with ANS 1 [Chief of Anesthesia Department]” and after that was able to work independently. CRNA 6 stated his scope of practice is “whatever credentialing approved”. 2. During three concurrent interviews and record reviews on 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1), accompanied by RNQ 1, Medical Staff Manager and DCQI, on 5/29/24, at 10:10 a.m., with ANS 1, accompanied by DCQI, and on 5/29/24, at 4:14 p.m., with ANS 1, accompanied by RNQ 1, the hospital policies, patient (Pt) charts and workflow were discussed. ANS 1 indicated he was the Chief of the Anesthesia Department since September of 2023. ANS 1 stated his job as chief was to monitor and review adverse events related to anesthesia services. ANS 1 stated CRNA competency could be determined by the surgeon, chief of anesthesiology or the anesthesiologist in charge (AIC). ANS 1 stated the AIC could be an anesthesiologist or a CRNA. ANS 1 stated whether proctoring completed or not the case assignments could be simple, complex, or high-risk sick patients, including high-risk procedures that required specific skills. ANS 1 stated the anesthesia department was “currently discussing” which high risk, and high acuity patients should be assigned to CRNAs. ANS 1 stated he was “aware” of the anesthesia complications of Pt 1, Pt 2, and Pt 3, but had no knowledge of any other adverse events or deaths which involved anesthesia services. ANS 1 acknowledged Pt 1 had a “Code Blue [hospital designation for lifesaving interventions and medications]” and expired in the operating room (OR) on 4/11/2024. Pt 2 had a post-operative (after surgery) anesthesia emergency on 10/27/23. ANS 1 acknowledge Pt 2 was found to be “hypotensive, tachycardic with respiratory acidosis and Could be related to right lung intubation during the procedure”. Patient 3’s had intra-operative anesthesia “Code Blue” on 10/25/2023. ANS 1 indicated he was unaware of the Pt 5’s code and death in the OR on 11/15/2023 2023 or Pt 38’s code and death on 5/15/2024. During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with the MST, the hospital workflow, polices, patient record logs, death logs (list of patients that died in the hospital), and the medical staff files were discussed. MST stated they have reviewed “90%” (“%” means percent a fraction of 100) of the death records and the patient safety officer (PSO) had reviewed “all deaths” cases. MST indicated the death of an otherwise apparent healthy male (Pt 38) on 5/15/24 in the OR receiving anesthesia was not a reportable event. MST stated adverse events included mortality and morbidity. MST stated chiefs of departments, medical staff committees were “always monitoring safety”. During record review of hospital’s deaths logs, titled “Revised Death Log ... with MDs”, with date range of 5/2023 to 4/2024, the record indicated 904 deaths in the hospital and the common listed reason for the deaths included, “sepsis” (blood infection), “pneumonia” (lung infection), “cardiac arrest” (heart attack) and “respiratory failure” (breathing failure and disease). The OR logs indicated there were 357 cases of patients that “expired”. During a comparative record review of Operating Room (OR) case logs, titled “OR Log Revised”, dated from 2/2023 to 5/15/2024, and the “Revised Med Staff Roster” and “Revised AHP Roster”, dated 5/2023 to 5/2024, a sample staff names were compared to surgical patients that “expired [died]”, for example: SUR 3 was listed as the surgical provider for 19 deaths: Pt 1, Pt 37, Pt 39, Pt 69, Pt 70, Pt 71, Pt 72, Pt 73, Pt 74, Pt 75, Pt 76, Pt 77, Pt 78, Pt 79, Pt 80, Pt 102, Pt 103, and Pt 108. SUR 5 was listed as the surgical provider for 6 deaths: Pt 38, Pt 93, Pt 94, Pt 95, Pt 96 and 97. SUR 8 was listed as the surgical provider for 12 deaths: Pt 39, Pt 44, Pt 86, Pt 87, Pt 88, Pt 89, Pt 90, Pt 91, Pt 92, Pt 93, Pt 95, Pt 96, and Pt 97. COS (Chief Of Staff) was listed as the surgical provider for the deaths of Pt 81, Pt 82, Pt 83, Pt 84, and Pt 85. MD 11 was listed as the surgical provider for the deaths of Pt 39 (MD 11 was listed on the medical staff roster as internal medicine physician, not surgeon). MD 10 was listed as the surgical provider for the deaths of Pt 39 (MD 11 was listed on the medical staff roster as internal medicine physician, not surgeon). ANS 4 was listed as the anesthesia provider for 9 deaths: Pt 37, Pt 68, Pt 69, Pt 73, Pt 76, Pt 78, Pt 80, Pt 104, and Pt 105. ANS 5 was listed as the anesthesia provider for 10 deaths: Pt 64, Pt 66, Pt 67, Pt 97, Pt 98, Pt 99, Pt 100, Pt 101, Pt 104, and Pt 105 (ANS 5 was not on Medical Staff Roster). PA 2 was listed as the Physician Assistant, surgery provider, for five deaths: 41, Pt 43, Pt 44, Pt 47, Pt 48. PA 4 was listed as the physician assistant, surgery provider, two deaths: Pt 40 and Pt 67. CRNA 2 was listed as the anesthesia provider for 5 deaths: Pt 1, Pt 65, Pt 70, Pt 72, and Pt 113. CRNA 3 was listed as the anesthesia provider for 4 deaths: Pt 96, Pt 106, Pt 111, and Pt 118. CRNA 5 was listed as the anesthesia provider for one death: Pt 1. CRNA 6 was listed as the anesthesia provider for 3 deaths: Pt 5, Pt 94 and Pt 96. CRNA 18 was listed as the anesthesia provider for 3 deaths: Pt 112, Pt 115 and Pt 116 PA 8 was listed as additional staff intraoperative “Additional staff intraoperative” for Pt 39. On the AHP list with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging) PA 8 listed as an “Anesthesia Tech [assistant to anesthesiologist, not allowed to practice in California]” for Pt 37. PA 8 was listed on AHP roster as PA with a radiologist as the supervising physician. Nurse Practitioner 1 (NP 1) was listed as an “Assistant Provider, Intraoperative” for Pt 39, but was not listed on the medical staff or AHP roster. Physician, (DO 1) was listed as an “Assistant Provider, Intraoperative” for Pt 39 but was not listed on the medical staff. RN 1 was listed as RNFA registered nurse (RN), such as a RN First Assist (RNFA- RN with training that assists a surgeon during surgery), “First Assistant” for “Coronary Artery Bypass” for Pt 37 and Pt 39. RN 1 was not listed on the APH roster. During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the MST stated no physicians or providers on staff have had adverse events (when a medical or drug error contributed to harm) , 805 report (805 report, a mechanism in which hospital’s peer review bodies were required to report specific information regarding licensees to the Medical Board), diversion (drug loss or illegal use of drugs), peer review (medical peer review is the process by which health care professionals were evaluated for clinical performance) issues. MST stated if there was a “trend of greater than 3 cases” with concerns, then this will “trigger peer review” and will take “it seriously and review what needs to be reviewed”. MST stated if there was a concern with a provider, they would “go directly to the chief” of the department. MST stated the hospital did not have any record for 24 of 24 providers for opportunity for improvements. MST stated physician’s peer review, adverse events and report to the licensing boards were “protected because of 1157” (Code Section 1157, the California statute governing confidentiality of information generated during hospital medical peer review proceedings) and would not be released for review on any of 25 of 25 providers, COS, SUR 3, SUR 5, SUR 8, CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6 and PA 7 or NP 2. During a phone interview on 5/23/24, at 12:42 p.m., with the hospital administration team which included, Director of Clinical Quality and Performance Improvement DCQI, Chief Nursing Officer (CNO), Chief Executive Officer, (CEO) and Accreditation Manager, the team acknowledged that unprivileged providers and unsupervised AHPs, including CRNAs, were providing independent medical care without the appropriate physician involvement according to their respective scopes of practice and hospital policy. They were diagnosing and treating medical conditions, plus ordering, prescribing, and administering medications, treatments, and therapeutics to patients without a treatment regimen ordered by a physician or other physician involvement appropriate according to their respective scopes of practice and hospital policy. During record review of the hospital log, titled “Revised Med Staff Roster”, and “Revised AHP Roster” for date range of 5/2023 to 5/2024, the record listed 658 physician providers and 124 AHPs. The following providers did not have documented evidence of specific privileges and/or were not on the Medical Staff or AHP rosters and were listed on the “OR Log Revised”, 2/2023 to 5/15/2024 as part of a team with patient adverse events and death: During a comparative record review of Operating Room (OR) case logs; “MD 11 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon. MD 12 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon. ANS 5 was listed as the anesthesia provider for Pt 64, Pt 66, Pt 67, Pt 97, Pt 98, Pt 99, Pt 100, Pt 101, Pt 104 and Pt 105 but was not on Medical Staff Roster PA 8 was listed as Additional staff intraoperative “Additional staff intraoperative” for Pt 39. On the AHP roster with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging) PA 8 as listed as an “Anesthesia Tech [assistant to anesthesiologist, not allowed to practice in California]” for Pt 37. PA 8 was listed on AHP roster as PA with a radiologist as the supervising physician. Nurse Practitioner 1 (NP 1) was listed as an “Assistant Provider, Intraoperative” for Pt 39, but was not listed on the medical staff or AHP roster. Physician, (DO 1) was listed as an “Assistant Provider, Intraoperative” for Pt 39 but was not listed on the medical staff. During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with the MST, the MST acknowledged privileges were granted for specific specialties and if additional privileges were desired, the request must be submitted to medical staff for review and approval. The MST stated that names of individuals who were not on the AHP or Medical Staff Rosters, did not have privileges. DCQI stated it was a “mix-up”. During an interview and concurrent record review on 5/30/24, at 3:48 p.m., Chief of Medical staff (COS), accompanied by Accreditation Manager (AM 2), the hospital policies and medical staff processes were discussed. COS stated PA privileges were “bases on education”. COS stated PAs can work “anywhere” in the hospital. COS acknowledged that medical staff does confirm the competency, qualifications, and skills of AHPs. COS stated no matter the AHP’s specialty or employment status, (hospital employee or contract provider), whatever physician “asked” the AHP to provide the medical care, and the physician was “responsible” for the care the AHP’s provides. During an interview on 5/30/2, at 3:00 p.m., with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and OR staff were discussed. SUR 4 stated anesthesiologist cover trauma and direct codes, not CRNAs. SUR 4 stated the only non-surgeon physicians that come to the ORs are, “intensivist [ICU physician]”, who are called to the OR when assistance is needed running a code. SUR 4 indicated she was unaware that, non-surgeons, MD 11 and MD 12, were assisting in surgeries. During review of the medical staff logs indicated SUR 4 stated PA 8 was supervised by a radiologist, and “I don’t know why his name is on a cardiac case” and assisting in surgeries or anesthesia. SUR 4 stated the “surgery department does not oversight of the anesthesia service. SUR 4 stated RNFAs were nurses and employees of the hospital, and surgery does not control what nurses are in the OR. SUR 4 stated she had “no idea” who some of the providers were MD 15, NP 1 or DO 1 or why they were assisting the in surgery. SUR 3 stated “poor documentation” may be why unidentifiable individuals were present in the OR. There was no documented policy available that described the entrance of non-privileged OR staff, visitors, or bystanders to enter the operating rooms. During record review of [Hospital] policy titled “Rules and Regulations of the Governing Board of [Hospital]”, June 13, 2022, indicated that the “Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... approved by the Governing Board ... The Governing Board shall have authority and responsibility for all appointments and reappointments of Medical Staff members, granting of clinical privileges, approving disciplinary actions, conducting investigations relating to quality of patient care and professional practice ... All practitioners granted appropriate membership and privileges by the Governing Board at this facility shall be proctored regardless of board certification and/or prior experience. During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “ recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout [Hospital Name] Medical Center ... To provide professional performance and utilization of services within the scope of defined clinical privileges, through a systemic credentialing, review, appraisal, and improvement ... Comply with the policies, practices, and procedures at [Hospital Name] Medical Center, including the standards and recommendations by The Joint Commission, local, state, and/or federal laws, and regulations ... Adhere to responsibilities as outlined in sponsoring/supervision agreements to allied health professionals (if applicable) ... DUTIES AND AUTHORITY OF THE MEDICAL EXECUTIVE COMMITTEE. ...To fulfill Medical Staff accountability to the Governing Board for the medical care of patients at [Hospital Name] Medical Center ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership”. During record review of hospital titled, “AHP [Allied Health Professional] Rules and Regulations, version 2022” indicated that the “Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned ... Practitioners who desire to sponsor and supervise AHPs must apply and qualify for such sponsorship. Each AHP who is a Physician’s assistant must be supervised by a Physician having the following qualifications: a. Is a Physician currently licensed by the State of California; Identify a sponsoring and supervising Medical Staff Member, in good standing on the Active staff, who has Privileges in the appropriate Department, and who has agreed to assume ongoing responsibility for sponsorship and direct supervision of the AHP at all times. When the sponsoring and supervising Practitioner is not available, an alternate supervising Medical Staff Member meeting all the requirements of the sponsoring Member must be predesignated and must provide direct supervision at all times in place of the absent Practitioner. ... Restriction of the Privileges of the sponsoring and supervising Practitioner, in which case the Practice Prerogatives of the AHP shall be restricted accordingly.” During record review of [Hospital] policy titled, “MOD CLN.4.04 MOD Operative and Invasive Procedures Appropriateness Review (CO-5.007.MOD)”, approved 4/10/2024, stated the purpose of the policy was “to describe the minimum standards, review Cardiac Operative and Invasive procedures through effective use of evidence-based clinical criteria ... Quality Review ... The Facility shall conduct case reviews in accordance with the peer review and quality processes set forth in the Facility’s Medical Staff Bylaws and state statutes. During record review of California’s Business and Professions Code, CA BPC, 2725(b)(2), it stipulated that “Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, necessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician”. During review of California ‘s Business and Professions Code, CA BPC 2827, it stipulated, the “utilization of a nurse anesthetist to provide anesthesia services in an acute care facility shall be approved by the acute care facility administration and the appropriate committee, and at the discretion of the physician, dentist or podiatrist”.”

“CONTRACTED SERVICES CFR(s): 482.12(e) The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. This Standard is not met as evidenced by: 28773 Based on observation, interview and record review, the hospital failed to have an effective governing body (GB) responsible for services furnished in the hospital when the dish machine was not working for approximately four months with no movement on the new dish machine or implementation of a timely solution, when it was deemed not repairable. These failures reesulted in the pot and pan area being overused and containing black substances throughout the room, pans being stored wet, patient trays not being sanitized properly, patient meals being served on Styrofoam and plastic utensils which could affect the temperature of the food and could compromise the nutritional and medical status of the patients. Findings: 1. During the initial tour of the kitchen an observation of the lunch meal service on 5/13/24 at 11:44 a.m., in the presence of the Patient Services Supervisor (PSS), there was the trays for the patient meals going down the line. In lieu of a plate, for the main entrée, each tray had a Styrofoam clamshell “to go” type container. The PSS stated the dish machine went down a couple months ago so they only thing that is not disposable is the trays. During an observation and concurrent interview on 5/13/24 at 11:59 a.m., with Food Service Staff (FSS) 2 in the pot and pan room, he was currently washing all the pots and pans in the three-compartment sink. FSS 2 stated the dish machine had been down pretty much since November and it was a lot of work doing everything by hand. FSS 2 stated it was nonstop to keep up. During an interview with the of Regional Director of Operations (RDO) on 5/13/24 at 12:06 p.m., he stated the dish machine has been down for 14 weeks however they have just gotten capital approval to purchase a new one. RDO stated they had not gone to HCAI (California Department of Health Care Access and Information) to get approval yet. Stated it has taken so long since the dish machine was old, and it was difficult to get parts. RDO stated he had not thought about getting a temporary dish machine trailer while this was going on. During an observation and concurrent interview on 5/13/24 at 2:40 p.m., with FSS 1, in the pot and pan room, containing approximately five different sized containers of various sizes on the floor with many different utensils in them, one red bucket and approximately 15 to 20 large sheet pans stacked on each other with at least two cutting boards and five pans and a bowl on top of it on the ground. There were a couple carts with various pans, cutting boards and utensils on them. FSS 1 stated there are a lot of dishes to do by hand. FSS 1 stated the dishwasher has been down for months. At 2:44 p.m., FSS 1 stated the first sink could not hold water, so it was backing up more and hard to get everything cleaned. During an observation and concurrent interview on 5/13/24 at 2:49 p.m., with FSS 3, in the dish machine room. There were meal trays drying on the dish machine rack. FSS 3 stated they dry the trays there and the dish machine has been down since the beginning of the year or so. During an interview on 5/14/24 at 9:41 a.m., the Facility Services Manager (FSM), stated they maintained patient care equipment and provide services to the Food and Nutrition Department. The FSM stated if they need to get a vendor for a repair then they will coordinate and schedule it. The FSM stated they do preventative maintenance on equipment in the kitchen. The FSM stated there was parts no longer available for the dish machine. The FSM stated the vendor was last onsite last week continuing to repair. The FSM stated the maker of the dish machine has a propriety agreement, so it is hard to get parts. They have had third party vendor numerous times and it was a trial and error. The pump went down then it had a leak. The FSM stated the dish machine maker has been a challenging vendor and they are booked two to three months out. The FSM stated they are awaiting parts from another third-party vendor and that the administration may just get a replacement. During an interview with the Director of Facilities (DOF) on 5/14/24 at 3:55 p.m., DOF stated the dish machine is needing repair. DOF stated the process is that the contract food services company will get quotes of the new dish machine, then it goes to the administration for funding. DOF stated the dish machine has aged out and broken down. During an interview with the Contract Vendor Maintenance on 5/15/24 at 2:14 p.m., regarding the dish machine. The Contract Vendor Maintenance stated the hospital was told by the dish machine manufacturer that the dish machine is not repairable, and they just keep sinking money into it. He stated they knew it was not repairable back in February and on March 29th was the last time they were out there. The Contract Vendor Maintenance stated he was called back out May 7th and they ordered another part, but he was not sure why since they need to get a new one. Review of emails from IDNFS and Vendor for a dish machine quote is dated 3/15/24 at 7:05 a.m., showed that the Vendor was “glad to hear this project was back on!” and the link for the quote was dated 3/12/24. On 3/18/24 the IDNFS forwarded the quote to AA and Corporate Hospital Health Informatics Manager. Review of the emails from DOF to AA and Corporate Hospital employes and the Corporate Hospital Health Informatics Manager, dated 3/20/24 until 3/25/24, showed they were trying to figure out who had better pricing from the suppliers either Contract Food service company or themselves, last email showed once they got the “CER including construction and permitting completed, please send me a copy so I can discuss with Lisa”. Hospital was unable to demonstrate any movement or temporary solution for the dish machine forward prior to the survey entrance date or a temporary Review of a hospital document titled, Opinion of Probable Cost, dated 3/29/24, showed the project scope was the replacement of the existing dishwasher with a quote dated 3/22/24 from an architecture firm. The delay to move forward timely with a new dish machine or acquire a temporary dish machine trailer resulted in multiple infection control concerns in the kitchen that were identified during the survey on 5/13/24 to 5/14/24 During a review of the hospital policy and procedure titled “Utilities Management Plan”, dated approved 5/24/23, indicated the Utility Systems Program is designed to ensure continual availability of safe, effective equipment through a plan of planned maintenance, timely repair .... that could have an adverse impact on the safety of patients and staff as applied to the building and services provided at the hospital.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 45580 Based on interview and record review, the hospital failed to ensure patient’s rights were considered for two of three sampled patients ((Pt) 11 and Pt 12) when patients preferred language was other than English and there was minimal (for informed consents) to no documentation an interpreter was used for either patient during their hospitalization. These failures had the potential for patients whose preferred language was other than English to not receive and fully understand procedures and/or education provided to them and could result in negative health outcomes when bilingual staff who were not competent interpreters communicated with patients and did not use the interpreting system to communicate with patients in accordance with the hospital’s policies and procedures. Findings: 1. During a concurrent interview and record review on 5/15/24 at 9:31 a.m. with Quality Nurse (RNQ) 4, Pt 11’s “Electronic Health Record (EHR),” dated 5/14/24 and Pt 11’s “Face Sheet (FS-a document that contains a summary of a patient’s personal information and brief medical history),” ), “ dated 5/14/24 were reviewed. The EHR indicated Pt 11 was admitted on 5/14/24 at 9:36 a.m. for induction of labor (the use of medications or other methods to bring on labor) at 34.4 weeks (in month eight of pregnancy). RNQ 4 stated the FS indicated Pt 11’s preferred language was Spanish. During a concurrent interview and record review on 5/22/24 at 12 p.m. with RNQ 4, Pt 11’s “OB Anesthesia Flow Sheet (FS),” dated 5/15/24 was reviewed. RNQ 4 stated the FS indicated an epidural (a numbing medicine given by inserting a needle and a small, flexible tube into the lower part of a woman’s back) was placed at 12:38 p.m. During a concurrent interview and record review on 5/22/24 at 3:45 p.m. with RNQ 4, Pt 11’s “Discharge Instructions and Signature Page (DI),” dated 5/18/24 and Pt 11’s “Nurses Note (Note),” dated 5/18/24 were reviewed. RNQ 4 stated the DI indicated the instructions were in Spanish but there was no indication an interpreter was used to provide Pt 11 her discharge instructions. RNQ 4 stated the Note indicated, “Discussed discharge instructions with patient and patient verbalized understanding.” During a concurrent interview and record review on 5/22/23 at 4:00 p.m. with RNQ 4, Pt 11’s “Consent for Anesthesia (Consent),” dated 5/15/24 and Pt 11’s “EHR,” undated were reviewed. RNQ 4 stated the EHR indicated there was no documentation an interpreter was used during Pt 11’s hospitalization. RNQ 4 stated the anesthesiologist should have provided the informed consent and used an interpreter to consent for the anesthesia services to ensure the patient understood the procedure. RNQ 4 stated the Consent indicated an interpreter was not used to interpret the consent for the anesthesia, evidenced by the blank space where the interpreter utilized to interpret should have been documented. RNQ 4 stated the importance of utilizing an interpreter and/or interpreter services for consent forms was to explain the risks and benefits of the procedure and answer any questions the patient may have appropriately. During a review of Pt 11’s “Interdisciplinary Patient Education SMART Template (Template),” dated 5/15/24 to 5/18/24, the Template indicated, from 5/15/24 to 5/18/24, seven nurses documented, the “Barriers to Learning:-Language Barrier, Comments: Spanish speaking-RN speaks Spanish.” The Template indicated six bilingual staff who were not certified interpreters used their interpreting skills to communicate with Pt 11 during her hospital stay and did not document the interaction. The Template indicated one staff who was not bilingual, documented, the “Barriers to Learning:-Language Barrier, Comments: Spanish speaking-RN speaks Spanish.” During a review of the hospital’s policy and procedure (P&P) titled, “Interpretation Translation Services for Patients,” dated 3/27/19, the P&P indicated, ...[Hospital A] does not provide training in interpretation or translation competency ...A competent interpreter and translation shall be used whenever a language or communication barrier exists that indicates the patient has Limited English Proficiency (L.E.P) ... Bilingual employees or family members may interpret for simple instructions such as participation in activities of daily living, diet, exercise, pain rating ...Any time care is provided with the assistance of the [name of interpreting service] system or a bilingual individual, it will be documented in the Patient Care Record ...” 2. During a concurrent interview and record review on 5/15/24 at 10:00 a.m. with RNQ 4, Pt 12’s “FS,” dated 5/14/24 and Pt 12’s “History and Physical (H&P),” dated 5/3/24 was reviewed. The FS indicated Pt 12 was admitted on 5/14/24 at 7:54 a.m. and her preferred language was Spanish. The H&P indicated Pt 12 was admitted for repeat cesarean section (the surgical delivery of a baby through a surgical incision made in the mother’s abdomen). During a concurrent interview and record review on 5/20/24 at 12:30 p.m. with RNQ 4 and RNQ 5, Pt 12’s “EHR,” dated 5/14/24 to 5/16/24 was reviewed. RNQ 5 stated when an interpreter was used, the nurses could document this in the rounding comments and frequent assessments. The EHR indicated there was no documentation of interpreter use in the round comments or frequent assessments. RNQ 4 stated the EHR indicated there was no interpreter documentation besides the time when Pt 12 was consented for surgery, anesthesia, and blood products on 5/14/24. During a concurrent interview and record review on 5/20/24 at 1:00 p.m. with RNQ 4 and RNQ 5, Pt 12’s “DI,” dated 5/16/24 was reviewed. RNQ 4 stated the DI indicated the instructions were in Spanish but there was no indication an interpreter was utilized to provide Pt 12 her discharge instructions. During an interview on 5/30/24 at 2:39 p.m. with the CNO, the CNO stated her expectations of hospital staff was to utilize an interpreter prior to medication administration, consents, teaching, assessments, discharges, and plan of care for patients who were non-English speaking. The CNO stated hospital staff should be utilizing interpreters and documenting their use of an interpreter in the EHR. The CNO stated the importance of using an interpreter was to ensure patients were receiving the appropriate care, risks and benefits of procedures and medications were explained, and patients were receiving the appropriate education prior to discharge so they could take care of themselves at home. During a review of the hospital’s P&P titled, “Interpretation Translation Services for Patients,” dated 3/27/19, the P&P indicated, “PURPOSE: To provide interpretation/translation services to patients who do not speak English as their primary language and who have a limited ability to read, speak, or understand English so that the patient can participate in their care and communicate with their care providers ...Competency-Demonstrated proficiency in English and the other language. The ability to use the appropriate mode of interpreting ...and knowledge in both languages of specialized terms or concepts such as medical terminology, names of body parts, symptoms and injuries ...Bilingual-The ability to communicate effectively in a different language when communicating information directly in that language but may not be competent to interpret in and out of English. Likewise, they may not do written translation ...[Hospital A] does not provide training in interpretation or translation competency ...A competent interpreter and translation shall be used whenever a language or communication barrier exists that indicates the patient has Limited English Proficiency (L.E.P) ...[name of interpreting service] is the designated interpretation services at [Hospital A]. [name of interpreting service] has documented competent interpreters in multiple languages ...The [name of interpreting service] interpreter’s identification number will be documented on the consent form ...The [name of interpreting service] will be used for all informed consents, unless the Physician is bilingual and able to interpret the planned procedure adequately so that the patient completely understands the risks and benefits of the procedure to be performed. The Physician will document that he/she interpreted informed consent to the patient in the Patient Care Record ...The [name of interpreting service] system may be used for any routine procedures that does not require official informed consent but may be considered as invasive by the patient. Procedures may include insertion of urinary catheters, insertion of peripheral IVs, insertion of nasogastric tubes, laboratory blood draws ...The [name of interpreting service] system may also be utilized by health care providers in the admission and discharge process ...Bilingual employees or family members may interpret for simple instructions such as participation in activities of daily living, diet, exercise, pain rating ...Any time care is provided with the assistance of the [name of interpreting service] system or a bilingual individual, it will be documented in the Patient Care Record ...””

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 45580 Based on observation, interview, and record review the hospital failed to ensure patients’ rights were provided to patients so they could make informed decisions about their care for two of four sampled patients ((Pt) 6 and Pt 11) when there was no consent form for antipsychotic medications (a type of drug used to treat severe mental disorder in which a person loses the ability to recognize reality or relate to others) administered to Pt 6 during his hospitalization and Pt 11 was not provided with an interpreter during consent for an epidural per the hospital’s policy and procedure. These failures resulted in administration of antipsychotic medications to Pt 6 without Pt 6 (or the responsible party) having the opportunity to weigh the benefits and risks of the medication and right to refuse treatment; and did not provide Pt 11 the opportunity to weigh the benefits and risks of the procedure in a language she understands and documented preference; these failures could cause avoidable and unnecessary mental and emotional distress. Findings: 1. During a concurrent interview and record review on 5/23/24 at 3:00 p.m. with the Assistant Director of Nursing (ADON), Pt 6’s “History and Physical (H&P-complete assessment of the patient and the problem), dated 12/29/23 was reviewed. The H&P indicated, “66-year-old female with history of schizophrenia [a serious mental disorder that affects how a person thinks, feel, and behave], hypertension [high blood pressure-when the pressure your blood vessels is too high] not compliant with any medication is admitted here on a 5150 hold [allows for a person with a mental illness to be involuntarily detained in a psychiatric hospital for a 72 hour period] for [danger to self/danger to others]. Currently patient is compliant. Patient denies any fever chills nausea vomiting, cough, shortness of breath, or any sick contacts.” During a concurrent interview and record review on 5/23/24 at 3:25 p.m. with the ADON, Pt 6’s “Physician Orders (PO),” dated 1/4/24 and 1/12/24 were reviewed. The ADON stated the PO indicated, on 1/4/24 at 2:22 p.m. haloperidol (medication used to treat nervous, emotional, and mental conditions) 5 milligrams (mg-unit of measure), Injection, Intramuscular, three times a day (TID) as needed (PRN) with comments from physician, “to be administered if patient refuses oral Depakote 500 mg.” The ADON stated the PO indicated on 1/12/24 at 11:22 a.m. paliperidone (medication used to treat schizophrenia) 9 mg equals 1 tablet, extended-release (slowly released into the body over a period of time) tablet, Oral, Daily, with physician comment, “please give first dose today.” The ADON stated the consent forms for the two medications were physical documents and were not able to be viewed via Pt 6’s electronic health record (EHR). During a review of Pt 6’s “Patient Consent to Receive Psychotropic Medications (Consents),” undated, the Consents for Pt 6 that were provided by the hospital did not have consent forms for haloperidol and paliperidone. During a review of Pt 6’s “Medication Administration Record (MAR),” dated 1/4/24 to 1/15/24, the MAR indicated on 1/4/24 at 9:44 p.m. Pt 6 was administered one dose of haloperidol. The MAR indicated from 1/12/24 to 1/15/24, Pt 6 was administered paliperidone daily. During an interview on 5/30/24 at 2:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectations for nursing staff was to ensure patients were consented appropriately for the psychotropic medications prescribed to them and the side effects monitored to ensure the safety of patients. The CNO stated her expectations of nursing staff was to follow hospital policies and procedures. During a review of the hospital’s policy and procedure (P&P) titled, “MOD DBHC.1.47 Monitoring of Psychiatric Medications,” dated 8/23/23, the P&P indicated, “ ...POLICY: It is the policy of [name of hospital] to maintain the right of the patients/conservator to be informed of the benefits and side effects each psychiatric medication intended to be prescribed for the treatment of their mental condition ...PURPOSE On admission, the attending psychiatrist will have a verbal discussion with their patient of the benefits and side effects of the proposed psychiatric medication/s and obtain a signed consent for each psychiatric medication on the medication consent form. The signed medications form will be filed in the patient’s chart ...The licensed nurse will review the medical record or medication record prior to administration of any psychiatric medications. If the patient/guardian/conservator has not given consent, notify the physician to obtain informed consent for the patient ...Medications may not be given without consent except for emergency medications. Refer to the informed consent policy ...DOCUMENTATION OF SIDE EFFECTS ...The licensed nurse will monitor the patient each shift for side effects of psychiatric drugs, and document the presence/absence of side effects in the progress notes ...The licensed nurse will notify they responsible physician for initial onset of symptoms, and when there is an increase in symptoms ...DOCUMENTATION OF MOOD/AFFECT ...The licensed nurse will document the patient’s progress daily ...Notify the MD if the patient is refusing medications and any other pertinent information related to the administering of psychiatric medications ...” During a review of the hospital’s P&P titled, “DBHC.1.04 Informed Consent to Receive Psychotropic Medications,” dated 2/28/18, the P&P indicated, “Any patient treated at [Hospital B] will be informed of his/her right to accept or refuse psychotropic medication(s) unless there has been an adjudication of lack of capacity to refuse, or the existence of an emergency. The patient is to be provided with information regarding his or her diagnosis and the risks, benefits and alternatives of the prescribed medication(s) ...PURPOSE: To provide guidelines of obtaining and documenting consent of psychotropic medications recommended to the patient ...Physician Responsibility ...Informed consent given by a patient to one psychiatrist may be honored by another psychiatrist ...A Psychotropic Medication Informed Consent (one per medication to include anticipated dosage) is to be signed by the patient and psychiatrist when initiating any new psychotropic medication, e.g., standard antipsychotics, atypical antipsychotics, antidepressants, mood stabilizers/anticonvulsants, anxiolytics, sedatives, benzodiazepines and sedative hypnotics ...The Psychotropic Medication Informed Consent Form shall be signed by all patients age 18 or over ...For the inpatients on temporary conservatorship/LPS Conservatorship, consent for treatment with psychotropic medication shall be obtained from the patient’s Conservator or Deputy Conservator ...Patients will be provided the following information in the patient’s own language ...Their diagnosis ...The risks and benefits and alternatives of the medication ...The type, dose, frequency, route and duration of the medication ...The possible side effects of these medications and the possibility of Tardive Dyskinesia must be discussed with patients receiving antipsychotics. The patient shall be advised that such side effects may include persistent involuntary movements of the face, mouth or extremities and that the symptoms are potentially irreversible, and may appear after medications have been discontinued ...The patient may withdraw consent to medication at any time. This withdrawal will be documented in the chart ...Nursing Responsibility ...A patient has the right to refuse medications unless the situation meets the definition of an emergency situation or the patient has had a Riese Hearing in which the court has determined that the patient does not have the capacity to make an informed decision regarding medications ...The nurse shall assure that the patient has given informed consent prior to administration of any psychotropic medication(s). Even if the medication has been ordered by the psychiatrist, the informed consent must be confirmed on the medical record prior to administration of the psychotropic medication(s) ...If a patient refuses medications, the psychiatrist shall be notified as soon as possible and the reason documented in the medical record ...When there is an order for a medication and on consent form is signed, the nurse shall notify the prescribing psychiatrist to confer with the patient.” 2. During a concurrent interview and record review on 5/15/24 at 9:31 a.m. with Quality Nurse (RNQ) 4, Pt 11’s “Electronic Health Record (EHR),” dated 5/14/24 and Pt 11’s “Face Sheet (FS), “ dated 5/14/24 were reviewed. The EHR indicated Pt 11 was admitted on 5/14/24 at 9:36 a.m. for induction of labor (the use of medications or other methods to bring on labor) at 34.4 weeks (meaning in month eight of pregnancy) for cholestasis (a liver problem in pregnancy). RNQ 4 stated the FS indicated Pt 11’s preferred language was Spanish. During a concurrent interview and record review on 5/22/24 at 12:00 p.m. with RNQ 4, Pt 11’s “OB Anesthesia Flow Sheet (FS),” dated 5/15/24 was reviewed. RNQ 4 stated the FS indicated an epidural (a numbing medicine given by inserting a needle and a small, flexible tube into the lower part of a woman’s back) was placed at 12:38 p.m. During a concurrent interview and record review on 5/22/23 at 4:00 p.m. with RNQ 4, Pt 11’s “Consent for Anesthesia (Consent),” dated 5/15/24 was reviewed. RNQ 4 stated the anesthesiologist should have provided the informed consent and used an interpreter to consent for the anesthesia services to ensure the patient understood the procedure. RNQ 4 stated the Consent indicated an interpreter was not used to interpret the consent for the anesthesia, evidenced by the blank space where the interpreter utilized to interpret should have been documented. RNQ 4 stated the importance of utilizing an interpreter and/or interpreter services for consent forms was to appropriately explain the risks and benefits of the procedure and answer any questions the patient may have. During an interview on 5/30/24 at 2:39 p.m. with the CNO, the CNO stated her expectations of hospital staff to utilize an interpreter should be prior to medication administration, consents, teaching, assessments, discharges, and plan of care for patients who were non-English speaking. The CNO stated hospital staff should be utilizing interpreters and documenting their use of an interpreter in the EHR. The CNO stated the importance of using an interpreter was to ensure patients were receiving the appropriate care, risks and benefits of procedures and or medications were explained, and patients were receiving the appropriate education prior to discharge so they could take care of themselves at home. During a review of the hospital’s P&P titled, “Informed Consent for Medical Treatment,” dated 11/30/22, the P&P indicated, “ ...every adult with decision making capacity has the fundamental right of self-determination over his or her body, which include the right to participate actively in decisions regarding his or her medical care and to decide whether to consent or to refuse to give consent for treatment or procedures recommended by his or her physicians ...Informed consent shall be obtained by the treating physician from the patient or an individual authorized to give such consent prior to initiating any invasive procedure ...The information that must be provided includes a description of: 1. The nature of the recommended treatment. 2. Its expected benefits or effects. 3. The associated risks and complications. 4. Any alternatives to the procedure, including refusing the treatment, and their expected benefits and associated risks ...An invasive procedure is any medical treatment or procedure which is not common, simple and low risk. Procedures that are considered to be “complicated” that require informed consent include ...Procedures that require anesthesia or moderate sedation ...” During a review of the hospital’s P&P titled, “Interpretation Translation Services for Patients,” dated 3/27/19, the P&P indicated, “PURPOSE: To provide interpretation/translation services to patients who do not speak English as their primary language and who have a limited ability to read, speak, or understand English so that the patient can participate in their care and communicate with their care providers ...Competency-Demonstrated proficiency in English and the other language. The ability to use the appropriate mode of interpreting ...and knowledge in both languages of specialized terms or concepts such as medical terminology, names of body parts, symptoms and injuries ...Bilingual-The ability to communicate effectively in a different language when communicating information directly in that language but may not be competent to interpret in and out of English. Likewise, they may not do written translation ...[Hospital A] does not provide training in interpretation or translation competency ...A competent interpreter and translation shall be used whenever a language or communication barrier exists that indicates the patient has Limited English Proficiency (L.E.P) ...[name of interpreting service] is the designated interpretation services at [Hospital A]. [name of interpreting service] has documented competent interpreters in multiple languages ...The [name of interpreting service] interpreter’s identification number will be documented on the consent form ...The [name of interpreting service] will be use for all informed consents, unless the Physician is bilingual and able to interpret the planned procedure adequately so that the patient completely understands the risks and benefits of the procedure to be performed. The Physician will document that he/she interpreted informed consent to the patient in the Patient Care Record ...The [name of interpreting service] system may be used for any routine procedures that does not require official informed consent but may be considered as invasive by the patient. Procedures may include insertion of urinary catheters, insertion of peripheral IVs, insertion of nasogastric tubes, laboratory blood draws ...The [name of interpreting service] system may also be utilized by health care providers in the admission and discharge process ...Bilingual employees or family members may interpret for simple instructions such as participation in activities of daily living, diet, exercise, pain rating ...Any time care is provided with the assistance of the [name of interpreting service] system or a bilingual individual, it will be documented in the Patient Care Record ...””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 49230 Based on observation, interview, and record review, the hospital failed to ensure one of the three sample [Brand name 1] warmers for pre moistened was used in accordance with the operating instructions when [Brand name 1] warmer was storing non compatible wipes. This failure had the potential for fire or other hazards and did not ensure the right to care in a safe environment. Findings: During an observation on 5/13/24 at 3:00 p.m. in Surgical Intensive Care unit (SICU -Unit that offers critical care treatment to unstable, severely, or potentially severely ill patients, who have life-threatening conditions and require comprehensive care, constant monitoring, and possible emergency interventions like surgery) with Registered Nurse Quality (RNQ 1), Registered Nurse (RN) 9, Registered Nurse Manager (RNM 2) and Director of Critical Care (DCC) observed [Brand name 1] warmer stocked with pre moistened wipes of [Brand name 1] and [Brand name 2]. Both [Brand name 1] wipes and [Brand name 2] wipes were stored right next to the warmer. During an interview on 5/13/24 at 3:15 p.m. with RNM 2, RNM 2 stated the SICU team used [Brand name 1] and [Brand name 2] wipes in the [Brand name 1] warmer. RNM 2 stated as far as he knew, both brand wipes were compatible with [Brand name 1] warmer. RNM 2 stated he was unable to comment how long the wipes could stay in the warmer before the wipes were required to be removed and discarded . RNM 2 stated wipes got used every day and had to be restocked every day. RNM 2 stated it was unusual for any wipes to stay in the warmer for more than 24 hours. RNM 2 stated he was not made aware of any issues with using [Brand name 2] wipes in the [Brand name 1] warmer. During an interview on 5/13/24 at 3:18 p.m. with RN 9, RN 9 stated she was the charge nurse for the shift. RN 9 stated both brand wipes were used with [Brand name 1] warmer and she was not made aware of any issues on the unit with using [Brand name 1] or [Brand name 2] wipes in the [Brand name 1 ] warmer. RN 9 stated staff would restock the warmer from the stock right next to the warmer with both types of wipes. During a review of [Brand name 1] “Warmer Operating Instructions”, undated, the “Warmer Operating Instructions” indicated, “ ...Please read and understand these instructions completely prior to operating the warmers ...IMPORTANT SAFETY INSTRUCTIONS This product is to be used SOLELY for warming premoistened cloth and hair care products manufactured by [Brand name 1] LLC. The warmer has been designed and safety tested to be used exclusively with these products. ANY other use of the warmer by the facility including, but not limited to, use with other bathing products, can result in overheating, fire or other hazardous conditions and is expressly forbidden ...” During a concurrent interview and record review on 5/14/24 at 2:10 p.m. with the Facilities Service Manager (FSM), “[Brand Name 1] Warmer Operating Instructions,” undated were reviewed. The FSM stated in reviewing the instructions, the warmer was designed for [Brand 1] wipes and clearly stated use of other products in this warmer could result in overheating, fire, and other hazards. During a concurrent interview and record review on 5/14/24 at 3:30 p.m. with the DCC, “[Brand Name 1] Warmer Operating Instructions,” undated were reviewed. The DCC stated he had reviewed the [Brand 1] Warmer Operating instructions. The DCC stated the SICU was not using the [Brand name 1] warmer in accordance with instructions for use. The DCC stated he understood the fire risk and risk for other hazards with the use of [Brand name 2] wipes in the [Brand name 1] warmer. The DCC stated the practice had been stopped and going forward, the SICU team will only use [Brand name 1] wipes with the [Brand name 1] warmer.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 45580 Based on observation, interview, and record review, the hospital failed to ensure patients were free from physical abuse for one of three sampled patients (Pt) 6 when Certified Service Tech (CST) 1 pushed Pt 6 into the wall. This failure resulted in Pt 6 sustaining a broken clavicle (collarbone) and placed all patients at Hospital B at risk for abuse. Findings: During a concurrent interview and record review on 5/23/24 at 2:58 p.m. with the Assistant Director of Nursing (ADON), Pt 6’s “Emergency Department Physician Note,” dated 12/28/23 was reviewed. The Note indicated, Pt 6 was “[brought in by ambulance] from [home] on 5150 hasn’t been taken meds for several months, bit room mate’s finger and threatened to kill him & herself/delusional. [blood pressure] 172/118, [heart rate] 114.” The Note indicated, Pt 6 was medically cleared after labs for urine drug screen, complete blood count (blood test measures the red blood cells which carry oxygen), comprehensive metabolic panel (blood test that gives information about the body’s fluid balance and electrolytes), and treponema pallidum (blood rest used to detect syphilis [bacterial sexually transmitted infection]) resulted. The Note indicated, “Medical Decision Making: Patient appears stable no acute distress nothing acute on labs or transplant.” The ADON stated there was nurse to nurse report from [Hospital A to Hospital B], and the physical 5150 hold went with Pt 6 to [Hospital B]. During a concurrent interview and record review on 5/23/24 at 3:40 p.m. with the ADON, Pt 6’s “Nurse Note,” dated 1/4/24 was reviewed. The Note indicated, “Patient was received in her room laying in bed. She was covered from head to toe in her blanket. Writer called her name several times but she did not respond. She was moving around under her blanket. Writer called out to her and introduced myself as her nurse for the night. I asked if I could check her vitals and she did not reply. I placed my hand on the outline of what appeared to be her right knee, as she was laying on her left side, she whipped out her leg and kicked me on my left hip. The CST was standing by at the doorway and we both immediately moved back and told her to stop ...After she kicked me, she was instructed to stay on the bed and not get off. She stayed on the bed ...Writer informed her she would be back to give her her medications Depakote [used to decrease mood swings and aggressive outbursts] 500 [milligrams (mg-unit of measure)] [and] Zyprexa [used to regulate mood, behaviors, and thoughts] 15 mg [by mouth]. She stated “I don’t want them, I don’t need them.” ... Writer informed her you are reiesed [when a patient is court ordered to receive intramuscular (IM-in the muscle) medications per the physician’s orders when they refuse their by mouth medications] if you refuse your medication you will be getting an injection as ordered by the doctor ... Writer pulled the oral meds and came to the patient with the medications and offered them to her. She sat up and stated. “I don’t take meds, I don’t want them” and covered herself back up. Writer told her I would be back with the medications ordered the injections Zyprexa 15 mg [and] Haldol [used to treat nervous, emotional, and mental conditions] 5 mg ...IM’s given after back up staff arrived. After we left her room, patient was instructed to stay in her room, but shortly after we left, she came out of her room and while she was walking out she walked past the CST in the hallway and then struck her in the head. Staff was called for and the patient was escorted to her room and write, and the manager went to talk to her, but she was belligerent and cursed at the manager and told us to get ...out of her room ...0600 oncall psychiatrist notified of the assaultive [physically aggressive] behavior patient had last night. Patient is already on [every] 5 [minute] rounds and is already on assaultive precautions ...” During a concurrent interview and record review on 5/23/24 at 3:45 p.m. with the ADON, Pt 6’s “Nurse Note,” dated 1/5/24 was reviewed. The Note indicated, “ ...After lunch patient approached this writer asking for pain medications, she showed to this writer her right shoulder. Noted big bruise and swollen shoulder when asked what happened she said they threw me on the wall and hit my shoulder and head”. Manager made aware and interview patient per manager patient reported “a female staff threw her against the wall and hit her shoulder and head and happened in the hallway last night”. Hospitalist made aware and [ordered] right shoulder Xray. Patient was also given ice pack and pain medication ...Medication given as ordered ...” During a concurrent interview and record review on 5/23/24 at 4:00 p.m. with the ADON, Pt 6’s “[X-ray] Shoulder Complete Right (Results),” dated 1/5/24 was reviewed. The Results indicated, “ ...Comminuted fracture [a bone that is broken in at least two places] of the distal right clavicle [collarbone] ...” The ADON stated when the x-ray results have been read, it pops up in the patient’s electronic health record (EHR) and the nurse notifies the physician of the results right away. During a concurrent interview and record review on 5/23/24 at 4:10 p.m. with the ADON, Pt 6’s “Nurse Note,” dated 1/5/24 was reviewed. The Note indicated, “[Patient] came back from [Hospital A] X-ray dept at around [7:10 p.m.]. She is calm, cooperative, and coherent at this time ...Pt verbalized “My shoulder hurts right now. It’s my fault though.” Pt declined to discuss further ...At around 10 pm, this writer received her X-ray results. [Patient] referred to [name of physician assistant] with orders made and carried out. [Patient] referred to [Hospital A] [emergency room (ER)] for Ortho Evaluation ...At [1:55 a.m.] [patient] came back from ER with new Orders. Sling was applied to her in the [emergency department (ED)]; On call Psychiatrist informed with orders made and carried out ...Monitor [one to one] by a sitter for safety ...” During a concurrent interview and record review on 5/24/24 at 1:35 p.m. with the Chief Human Resource Officer (CHRO), with RNQ 2 present, CST 1’s “Employee File,” undated was reviewed. The CHRO stated CST 1 was hired on 11/1/07, a background check was conducted on 10/23/07, CST 1’s most recent performance evaluation indicated satisfactory performance, Abuse prevention and reporting training was completed on 2/2/24 and CPI training was current with an expiration date on 11/17/24. During a concurrent interview and record review on 5/28/24 at 4:25 p.m. with Quality Nurse (RNQ) 3, Pt 6’s “Physician Discharge Note,” dated 2/9/24 was reviewed. The Note indicated, “Patient was provided with a safe secure environment ...During her stay here in the hospital she did have episodes of agitation requiring as needed medications. While she was here in the hospital patient did suspend injury to her clavicle. She was recommended and offered the use of sling which she ultimately refused to use however she did not have any significant complaints of pain. Patient is seen today on 2/9/2024, patient remains euthymic [a normal, mental state or mood], her mood remains stable and she continues to be free of any psychotic symptoms. It was agreed that she was appropriate discharged today home to her sister.” During an interview on 5/29/24 at 8 a.m. with the Director of Nursing (DON), the DON stated she tried to get ahold of CST 1, CST 2, RN 24, RN 27, and RN 28. The DON stated CST 2 and RN 28 were on vacation and only RN 24 returned her call and agreed to an interview. During a telephone interview on 5/29/24 at 8:50 a.m. with RN 24, present was RNQ 3, RN 24 stated he remembered Pt 6 and the incident involving Pt 6. RN 24 stated he has worked at the Hospital B for 1.5 years. RN 24 stated he worked on 1/4/24 and assisted RN 27 in managing the incident with Pt 6. RN 24 stated he came back from his break, saw RN 27 preparing the IM medications for Pt 6. RN 24 stated Pt 6 was agitated and non-sensical. RN 24 stated, “We went to the room with other staff members and IM medications were given without incident. We left the room and I returned to the nurse’s station. I heard a commotion and loud bang coming from the hallway. Other staff members went to the source of the noise, RN 27 followed him.” RN 24 stated he saw Pt 6 sitting on the floor and RN 27 and RN 24 assisted Pt 6 to get up and brought her back to her room. RN 24 stated he did not know what happened prior to the incident. RN 24 stated RN 27 asked Pt 6 what happened, Pt 6 was still very agitated and angry but not combative, so he left the room and RN 27 stayed with Pt 6. RN 24 stated he did not see the video footage of what happened prior to Pt 6 being found sitting on the floor of the hallway. During a telephone interview on 5/29/24 at 9 a.m. with RN 24, present was RNQ 3, RN 24 stated Pt 6 did not hit him and the next night after the incident, he was Pt 6’s primary nurse but she was coherent and talked to him about her past experiences. RN 24 stated while working at Hospital B, no patients has tried to hit him, only verbally. RN 24 stated if a patient tried to hit him, he would try to de-escalate the situation by finding out why the patient was trying to hit him, while trying to avoid the patient by leaving their room and asking for help. RN 24 stated if he witnessed abuse to a patient, he was required to report to the authorities and the manager and or director right away. RN 24 stated he has had abuse training yearly. During an interview on 5/29/24 at 11:20 a.m. with the DON, with RNQ 3 and the Patient Safety Officer (PSO) present, the DON stated she had a chance to review the video footage of what happened in the hallway with CST 1 and Pt 6. The DON stated her expectations for the staff at Hospital B was to take care of the patients and ensure the patients safety. The DON stated her expectations for staff when a patient became aggressive towards them was for staff to use de-escalation techniques. The DON stated an example of de-escalation was to distract, divert the patient and ask for someone who knew the patient and if those techniques were not effective call a Code Gray, call for help, and at night, there was a silent alarm code. The DON stated for CST 1, she should have been aware of her surroundings, and she should have removed herself from the situation and called for help. The DON stated CST 1’s response to Pt 6 was inappropriate. The DON stated CST 1 was placed on paid administrative leave pending the results of the investigation. The DON stated the California Department of Public Health (CDPH), leadership, and policy department were notified of the incident. The DON stated a Root Cause Analysis (RCA) was conducted and Crisis Prevention Intervention (CPI) trainers were providing bi-monthly training on how to de-escalate. The DON stated CST 1 was no longer on administrative leave and had returned to work. The DON stated the patient right to a safe environment was violated. During an interview and record review on 5/29/24 at 2:28 p.m. with the PSO, RNQ 2 was present, Pt 6’s “Root Cause Analysis (RCA),” undated was reviewed. The PSO stated she was informed a little late on 1/5/24 and the incident occurred on 1/4/24. The PSO stated she did not remember if she was texted about the incident, but she thought the incident happened after hours at which time she would have received an email. The PSO stated when she was informed of the incident, she called the after-hours Hotline to the Operations Counsel which gave her guidance on what to do. The PSO stated she was instructed to call [name of city] Police Department (PD) and the PD came out to obtain statements from those involved but she had not seen the report. The PSO stated she interviewed Pt 6, watched the video, and once she watched the video, CST 1 was placed on leave pending their investigation. The PSO stated she interviewed all staff who worked on 1/4/24 when this incident occurred. During an interview and record review on 5/29/24 at 2:45 p.m. with the PSO, RNQ 2 was present, Pt 6’s “Root Cause Analysis (RCA),” undated was reviewed. The PSO stated she wrote up the RCA, interviewed CST 1 and came up with an action plan. The PSO stated the action plan was to work with staff who were apart of a new committee called the Assault Review Committee (ARC), they are front line staff who offered improvement with communication with nurses, psychiatrists, and CSTs. The PSO stated the ARC felt they were escalating too fast with IM medications and/or too slow when the CST were not informing anybody of their patients’ behaviors. The PSO stated a lot of education was provided to include what behaviors to escalate and when. The PSO stated they were encouraging staff to be CPI trainers but as of yet they did not have any staff who would commit to the role but once they had CPI trainers, they planned to hold mock trials. The PSO stated this case did go through HR and CST 1 did not have previous experiences or altercations with patients and if the video was watched, CST 1 did not purposely push Pt 6, CST 1 got hit and she reacted. The PSO stated CST 1 did not recognize that Pt 6 was escalating and walking towards her in a hostile manner. The PSO stated another intervention implemented was the nurses and CSTs now had their own report sheets and were updated on each patient to include whether the patient had been assaultive or in isolation recently. The PSO stated CST 1 should have had a “refresher” course of the CPI training. During a review of the hospital’s document titled, “CST 1’s CPI training and Return to Work Date,” undated, the document indicated, CST 1 had retaken the CPI training on 4/18/24 and CST 1 returned to work on 2/13/24. During an interview on 5/30/24 at 10:38 a.m. with the PSO, with DC 2 present, the PSO stated the video footage of the incident with CST 1 and Pt 6 occurred on 1/4/24 at 9:30 p.m. The PSO stated at 9:30 p.m., CST 1 was sitting in a chair in the hallway and five staff members went to Pt 6’s room to administer the IM medication, at 9:32 p.m., five staff left the room, and CST 1 stayed in the hallway in her previous spot next to the double doors. The PSO stated at 9:33 p.m., Pt 6 came out of her room with a piece of paper, hit CST 1 on her face with the paper. The PSO stated CST 1 pushed Pt 6 to the wall causing Pt 6 to fall on the floor and Pt 6 was observed in a sitting position. The PSO stated RN 24 and two other nurses assisted Pt 6 to her room. The PSO stated Pt 6 stayed in her room for the night. The PSO stated on 1/5/24, the PSO and HR interviewed all staff involved and CST 1 was placed on leave. The PSO stated Pt 6 had an x-ray to her right shoulder after complaining of right shoulder pain on 1/5/24 and the x-ray showed fracture on the right clavicle. The PSO stated the incident was reported to CDPH on 1/9/24. The PSO stated CST 1 had no history of abuse or complaint against her and had been employed for 26 years. During an interview on 5/30/24 at 2:45 p.m. with Chief Nursing Officer (CNO), with Director of Clinical Quality Performance Improvement (DCQI) present, the CNO stated her expectations of staff were to keep patients safe and free from abuse. The CNO stated employees should always be aware and pay attention to their surroundings, so they are aware of what the patient was doing and where the patient was currently. The CNO stated she wanted patients to leave their hospitals injury free. During a review of the hospital’s policy and procedure (P&P) titled, “COMP-RCC 4.60 Reporting of Allegations of Patient Neglect or Physical or Sexual Abuse or Assault,” dated 2/28/24, the P&P indicated, “ ...The purpose of this policy is to ensure the safety of any individual in a [name of corporation] and to ensure that Administrator on Call immediately and effectively reports allegations of sexual or physical abuse, neglect or assault to the appropriate authorities ...This policy is intended to cover the reporting of allegations that could involve potential criminal conduct ... “Immediate” means at the time of witnessing conduct or receiving an allegation of conduct that is the subject of this policy. The requirement of this policy for “immediate notification” apply even if the incident occurs after hours and/or on weekends or holidays ... “Abuse” means any intentional action which harms another person. Abuse includes physical or sexual abuse ...The Administrator on Call (AOC) or designee of each [name of corporate] Facility is responsible for immediately responding to allegations of abuse, neglect or assault occurring in the [name of corporate] Facility so that the appropriate investigation of alleged criminal or other inappropriate conduct may be conducted ...Any [corporate name] employee ...who witnesses or receives an allegation of sexual, or physical abuse, neglect or assault on any patient, or of any other individual in the [name of corporate] Facility must immediately ensure the safety of that individual and must immediately make contact with the Facility AOC or designee. The Facility AOC or designee must verify the safety of the individual ...shall immediately (within 24 hours) report the event to the local police department and/or other appropriate authorities ...Operations Counsel will advise on reporting to authorities, including law enforcement, state licensing agencies, and other agencies as appropriate or required by Federal, state or local law or regulation ...Operations Counsel will also advise whether circumstances necessitate removal of personnel who are alleged to have engaged in the abusive behavior ...During the investigation, past event reports may be consulted to determine whether allegations against the same individual have been reported previously ...Operations Counsel is responsible for evaluating and coordinating all actions as appropriate to respond to the allegations and ensure the proper resolution of the matter ...a review of whether prior allegations have been made that could be similar to or related to the current allegations (nature/type of allegation; location of alleged event; hospital personnel involved) ...Coordinating with Human Resources Department and ...Employment Counsel on taking appropriate actions with respect to any ...employee or contractor ...ensure that the appropriate notification has been made to the patient/family as required ...the [corporate name] Facility leadership team is responsible for ensuring that all individuals adhere to the requirements of this policy ...noncompliance with this policy are reported to the Chief Compliance Officer ...All employees whose responsibilities are affected by this policy are expected to be familiar with the basic procedures and responsibilities created by this policy. Failure to comply with this policy will be subject to appropriate performance management pursuant to all applicable policies and procedures, up to and including termination ...””

“USE OF RESTRAINT OR SECLUSION CFR(s): 482.13(e) Patient Rights: Restraint or Seclusion. All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. This Standard is not met as evidenced by: 45580 Based on interview and record review, the hospital failed to protect and promote each patient’s rights for one of three sampled patients (Pt) 8 when the hospital policy and procedure (P&P) titled, “Restraints and Seclusion,” was not followed. Pt 8 was placed in five-point restraints, which was not least restrictive. The physician’s order for four-point restraints was not followed and a physician did not perform a one-hour face to face after restraints were placed emergently. These failures caused Pt 8 to be restrained more than the physician’s orders indicated and violated Pt 8’s patient rights to care in a safe setting. Findings: During a concurrent interview and record review on 5/14/24 at 2:03 p.m. with Quality Nurse (RNQ 4), Pt 8’s “Admission History and Physical (H&P),” dated 4/2/24 was reviewed. The H&P indicated, “Patient was placed on a 5150 for being a danger to self and danger to others and gravely disable ...Chief Complaint: “Getting healthier” ...Patient is a 22-year-old male with a prior psychiatric history significant for schizophrenia [a serious mental illness that affects how a person thinks, feels, and behaves] admitted to [Hospital B] on a 5150 for being a danger to self danger to others and gravely disabled. On psychiatric evaluation with the patient today he was seen in the seclusion room as he had to be placed in restraints due to self-injurious behavior wile in the inpatient psychiatric unit earlier this morning. Patient reports that he came to the hospital “to get healthier” and when asking as to what was occurring earlier this morning that resulted in him being placed in restraints he reports “I thought the gentleman in my room was my dad.” When asking as to why patient removed his right eye and significant injury to his left eye prior to his hospitalization he reports “because I was trying to get the pepper spray out of my eyes.” ...experiencing auditory hallucinations “that encourages me to hurt my eye” and he also endorses that these voices will tell him to harm others “but I would not act on it.” Patient at this time denies having any suicidal or homicidal thoughts and he has difficulty recalling his most recent prescribed medication ...” During a review of Pt 8’s “Nurse Note (Note),” dated 4/23/24, the Note indicated, at 9:20 p.m., “Patient became uncooperative, hitting himself, wanted to take off his affected eye. Spitting at staff. Uncooperative, agitated, standing up on bed. Took out bathroom magnet door and climb bed to cover ceiling light. Yelling and screaming.” During a review of Pt 8’s “Physician Orders (PO),” dated 4/23/24, the PO indicated, “Restraint Initiation Violent Adult routine, Imminent risk to self, No longer imminent risk to self, Hard limb, Restraint Points: 4 point restraint, All extremities at 9:30 p.m.” The PO indicated, at 9:32 p.m., “Restraint Monitoring Violent Adult, routine, [every] 15 [minutes]-[intermittent] for 4 [hours]” and on 4/24/24 at 1:32 a.m., “Contact Physician for Evaluation of Restraint [Renewal].” During a review of Pt 8’s “Nurse Note (Note),” dated 4/23/24, the Note indicated, at 10:35 p.m., “patient released from 5 point restraints. Patient agrees to be safe and denies thoughts of hurting self and others.” The note indicated Pt 8 was in 5 point restraints when the physician orders placed indicated 4 point restraints. During a review of Pt 8’s “Electronic Health Record (EHR),” dated 4/23/24, the EHR indicated there was no indication a physician performed a one-hour face to face after restraints were placed on Pt 8. During a review of the hospital’s P&P titled, “MOD CO 4.004 Restraints and Seclusion,” dated 4/24/24, the P&P indicated, “For Restraints used to manage Violent or Self-Destructive Behavior, a physician, or other LIP responsible for the care of the patient must evaluate the patient in-person within one hour of the initiation of Restraint or Seclusion. The in-person evaluation and documentation must include ...Evaluation of the patient’s immediate situation ...Patient reaction to the intervention ...Patient’s medical and behavioral condition ...The need to continue or terminate the Restraint or Seclusion ...” During an interview on 5/23/24 at 8:45 a.m. with the Assistant Director of Nursing (ADON), with RNQ 3 present, the ADON stated, when a patient was placed in 5 point restraints, the orders should match the correct restraints applied to the patient. The ADON stated the physician’s orders were not followed when the patient was placed in 5 point restraints and the physician orders indicated 4 points. The ADON stated every four hours the restraint orders were required to be renewed, the physician did not need to do a face to face for renewals and depended on the patient’s behaviors. The ADON stated the registered nurse (RN) reassessed the patient and if they felt the patient was not ready safety-wise to get out of the restraints, the RN updated the physician and renewal orders were placed. The ADON stated sometimes when there was an emergency, orders were obtained immediately from the physician with the reason for why the restraints were placed and physicians were not required to perform a one-hour face to face with the patient. During a review of the hospital’s policy and procedure (P&P) titled, “MOD CO 4.004 Restraints and Seclusion,” dated 4/24/24, the P&P indicated, “Violent/Self-destructive Restraint or Seclusion orders may be renewed with the following limits for up to a total of 24 hours ...4 hours for adults 18 years of age and older ...A face-to-face physical examination is required by the physician or LIP responsible for the care of the patient and authorized to order Restraints or Seclusion every 24 hours for violent/self-destructive Restraint to determine the clinical justification for the continued use ...” During an interview on 5/30/24 at 2:47 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectations of nurses were, nurses should follow and assess patients according to physician’s orders. The CNO stated the importance of following physician’s orders was nurses do not practice medicine, therefore when applying restraints to patients, the physician’s orders should be followed as prescribed, keeping patients and staff safe. The CNO stated her expectations were nurses should follow the hospital’s policies and procedures. During a review of the hospital’s policy and procedure (P&P) titled, “MOD CO 4.004 Restraints and Seclusion,” dated 4/24/24, the P&P indicated, “ ...PURPOSE: To define [name of Hospital] approach to the use of restraint and seclusion for patients in way that protects the patient’s health and safety, and preserves their dignity, rights, and well-being ...Licensed Independent Practitioner (LIP): For the purposes of this policy, a Licensed Independent Practitioner (LIP) is any practitioner permitted by State law and in (accordance with Facility policy) as having the authority to order Restraints or Seclusion for patients ...Restraint ...Any manual method: physical or mechanical device, material, or equipment that immobilizes or reduces the patient’s ability to move their arms, legs, body, or head freely ...A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition...It is the policy of this organization to limit the use of restraint or seclusion Violent or Self-Destructive Behavior: Behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others ...Note: Vest or belt type Restraints, and spit hood devices are prohibited in any population ...General Requirements ...Staff will apply Restraint or Seclusion only when less restrictive interventions are ineffective ...Staff will use the least restrictive form of Restraint or Seclusion that protects the physical safety of the patient, staff, or others ...Restraint and Seclusion require an order from a physician or other authorized LIP responsible for the care of the patient. The order must include reason for Restraint or Seclusion, type of Restraint, and duration of Restraint or Seclusion ...Staff must discontinue Restraint or Seclusion at the earliest possible time, regardless of the scheduled expiration of the order ...Authorizing and Ordering Restraints and Seclusion ...Staff will initiate or continue Restraint or Seclusion only upon the order of a physician or authorized LIP following the guidelines in this policy ...In an emergent situation, and when a physician or LIP is not readily available, a Registered Nurse competent in restraint usage may initiate restraint based on an appropriate assessment of patient needs. The comprehensive assessment shall include physical assessment to identify medical problems that may be causing a change in the patient’ s behavior ...The order must be obtained either during the emergency application of the restraints or immediately (defined as without time interval) after the restraint has been applied ...All Restraint or Seclusion orders must be dated and timed when signed by the physician or LIP responsible for the care of the patient and include: 1) criteria for release; 2) type of Restraint used; 3) reason for Restraints or Seclusion; 4) and specify duration of Restraint or Seclusion order ...Violent/Self-Destructive Restraints ...the patient who is simultaneously Restraints or Secluded is continually monitored by trained staff either in-person or through the use of both video and audio equipment that is in close proximity to the patient ...At [Hospital B], a patient in restraints is monitored at least every two hours or sooner according to patient needs ...1 hour face to face is required by the RN ...When Restraint or Seclusion is used, there must be documentation in the patient’s medical record of the following ...a description of the patient’s behavior and the intervention used ...Alternatives or other less restrictive interventions attempted ... the patient’s condition or symptom(s) that warranted the use of the Restraint or Seclusion ...The patient’s response to the intervention(s) used, including the rationale for continued use of the intervention ...Individual patient assessments and reassessments ...use of Restraint or Seclusion in the Plan of Care ...A patient in 3- or 4-point restraints shall have continuous observation/monitoring ...Monitoring must include, but is not limited to ...skin integrity ...level of distress and agitation ...behavior ...patient safety and comfort, during and after Restraint is removed ...Care will not be compromised by the use of Restraints ...ENFORCEMENT: All employees whose responsibilities are affected by this policy are expected to be familiar with the basic procedures and responsibilities created by this policy. Failure to comply with this policy will be subject to appropriate performance management pursuant to all applicable policies and procedures, up to and including termination ...””

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 28773 Based on interview and record review, the hospital failed to ensure specific program data requirements were met when the hospital failed to provide evidence of a Quality Assessment Performance Improvement (QAPI) program for clinical nutrition and food services that accurately reflected the depth and complexity of the service. These failures had the potential to result in suboptimal patient care and outcomes. Findings: During a review of closed medical records the hospital failed to ensure individual nutritional needs were met for three patients (Patients 49, 46, and 53) in a sample of seven patients reviewed for nutrition care when the Registered Dietitian failed to complete timely nutrition assessments. All three patients were identified at increased nutritional risk at the time of admission as evidenced by poor nutritional intake, weight loss and documented nutrition consults. (refer to A-0629) During an interview with the Clinical Nutrition Manager (CNM) on 5/17/24 at 12:05 p.m., CNM stated she does not evaluate the data since she knows they are short staffed of clinical Registered Dietitians (RD). CNM stated she does not collect, track or evaluate any type of data for Quality Assurance Performance Improvement for clinical nutrition. During an interview with the Regional Director of Operations (RDO) on 5/20/24 at 12:34 p.m., the RDO stated the CNM sits on Quality Committee so can speak with her about the QAPI program for the department. During an interview with the CNM and the RDO on 5/21/24 at 9:02 a.m., the CNM stated she would only attend the Quality Committee meetings if she was invited, and she had not attended. When asked about the QAPI measures that are done for Food and Dietetic Services, the CNM stated the only thing that is done is the Patient Satisfaction Scores regarding the patient experience and meals. The RDO stated the Director of the department (vacant position) attends Quality Committee. The RDO stated the departmental focus is limited to food service. The hospital was unable to demonstrate performance improvement activities related to clinical nutrition care. During a review of the hospital document titled, Food & Dietary - Quality of Food, dated March 2024, for the period of October 2023 to March 2024, evaluated the quality and temperature of the food. The submitted data indicated the current quality and temperature of food was ranked at the 56th percentile. The departmental goal was to achieve a ranking of greater than or equal to 75th percentile. The root cause analysis indicated the quality of the food was due to a lack of understanding by patient diet orders and restrictions. The departmental plan was to increase patient awareness of menu options through rounding. The temperature of the food was affected due to dish machine constantly out of service resulting in patient meals being served on Styrofoam. Additionally, isolation patients did not receive meal trays in a timely manner and as well as meals served on disposable which does not hold temperature. The action items indicated: 1. working with CNM to in-service all dining associates with the appropriate up to date education of diets along with scripting and menu processes and to work with nursing regarding patient preferences and timely delivery of isolation tray delivery. The responsible party was the patient services manager. 2. Daily supervisory rounding. The responsible party was director of the food and nutrition services, patient services manager and dietary supervisors. Both items showed the due date and status was on going. The hospital was unable to demonstrate implementation of the action plan. During an interview with Director of Clinical Quality Improvement (DCQI) on 5/31/24 starting at 9:05 a.m., DCQI stated when she looked at Food and Nutrition Services they did not have any QAPI. The committee also indicated the goal is to ensure all areas are represented. DCQI stated at the time she began working with the food and nutrition services, the contract representatives were provided the hospital QAPI plan as well as their patient satisfaction scores. The contract was also advised they would be held accountable for the patient satisfaction scores. The DCQI also indicated the expectation would be for the FANS department to develop and implement a plan for improvement and forward to the DCQI committee. The DCQI acknowledged this was not done. During a review of the Hospital policy and procedure titled with subject, “Quality Assessment Performance Improvement (QAPI)”, authored by the contracted food service company, revised 1/23, showed the hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program. It showed the Food and Nutrition Services Department must participate as part of the hospital’s QAPI program and have no less than TWO (2) active quality or performance-based measurements in place at any given time. It showed the Director and RD: to request to participate in the hospital’s quality program, attends quality meetings, works with the hospital’s QAPI team to assess QAPI opportunities and executes a minimum of two QAPI projects for Food and Nutrition Services department; provides the hospital Quality Department with a report of the QAPI projects that follows the hospital’s approved format for the QAPI program. During a review of the hospital’s document titled, “Performance Improvement Annual Appraisal & Quality Assessment and Performance Improvement Plan 2024-2026”, indicated, “Summary; This plan is a framework for an effective, comprehensive, data driven program that focuses on the indicators that reflect outcomes of care, quality and patient safety. ... The PI program is a hospital-wide program that monitors processes and functions to improve patient quality of care. It is designed to encourage prioritization and improvement in those areas where improvement opportunities exist.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 39795 Based on interview and record review, the hospital failed to take actions aimed at performance improvement when: 1. The infection preventionist (IP) was aware of infection control practices that did not meet the standard and failed to bring this to the attention of Quality Assurance and Performance Improvement (QAPI) program to implement an improvement project. 2. QAPI was aware Certified Registered Nurse Anesthetists (CRNAs) were permitted to operate independently with full prescriptive and diagnostic authority for anesthesia services and failed to consider the scope of practice of CRNAs and whether this practice was consistent with Medical Staff Bylaws. These failures resulted in the potential to allow unsafe practices to go unnoticed and uncorrected and increased the risk of negative patient outcomes such as illness, harm, and injury. Findings: 1. During an observation on 5/14/24 at 9:41 a.m., in the endoscopy storage room, two of two endoscopes (a thin, flexible tube-like instrument equipped with a camera used to look at tissues inside the body) were not stored in an endoscope cabinet in accordance with facility policy and the instructions for use (IFU). The two endoscopes were stored with the distal end (the part farthest from the origin) with the camera touching the bottom of the cabinet creating a potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect). During observation on 5/17/24 at 10:30 a.m., in the sterile processing department (SPD) decontamination area, surgical instruments were not processed in accordance with standards published by the Association for the Advancement of Medical Instrumentation (ANSI/AAMI -a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals) and the Centers for Disease Control and Prevention (CDC- a federal agency that focuses on controlling, containing, and eliminating diseases). Sterile Processing Technician (SPT) 1 did not scrub surgical instruments during the manual cleaning process (the first step in disinfection by which visible soil and gross debris are removed) and surgical instruments were stacked upon each other in trays, potentially damaging the surfaces of the instruments. During an observation on 5/17/24 at 11:30 a.m., in the SPD clean area, three of five procedure trays (container that holds surgical instruments), that were sterilized and ready for use in surgical procedures, were opened and examined and contained unclean and unsafe surgical instruments. One of 91 instruments in the “Major” tray (T-1) and three of 75 surgical instruments in the “Minor” tray (T-2) had discoloration and pitting (damage to the protective layer of surgical instruments) on the instruments. No chemical indicator (a device used to monitor whether the parameters to achieve sterilization have been met for a specific sterilization process) in T-1 was observed when opened. During an observation on 5/24/24 at 10:45 a.m., in the SPD clean area, one of 91 instruments in the “Major” tray (T-3) had red-brown residue (left over when a substance has been removed) on the shank (the extension from the handle to the working part of the instrument). This practice was not in accordance with ANSI/ AAMI which stated that surgical instruments should be free of residue, pitting, and corrosion (a process in which a solid is eaten away). The hospital’s policy was not followed when the requirement for a chemical indicator was not present inside T-1. These failures could result in use of surgical instruments that were not completely sterile, possible post- surgical infection to the patient, and instrument failure. During an observation on 5/13/24 at 1:55 p.m., one of three blood gas machines were not cleaned in accordance with manufacturer’s instructions and was observed to have dried blood on the sample port. (A blood gas machine is specialized equipment that takes a blood sample and measures the oxygen, carbon dioxide and pH of the blood sample. The pH is a measure of acid-base balance of the blood). During a concurrent observation and interview on 5/13/24, at 3:20 p.m., with the Shift Manager (SM) 1, while in Patient (Pt) 60’s room, Pt 60 was seen with intravenous (IV- through a vein) fluids running through a pump into her PICC line. One of Pt 60’s ports on her IV tubing was seen without a cap (curos disinfecting port protectors are alcohol-containing caps that twist onto IV access points for disinfection and protection) covering it and a new bag of caps hanging from the IV pole. SM 1 stated the ports should be capped to help prevent contamination of the port and then immediately placed one of the caps on the port. During a concurrent observation and interview on 5/14/24 at 10:23 a.m., with the sterile processing department manager (SPDM) and Assistant Director of Surgery (ADS), in the Endoscopy decontamination room, the ceiling air vent (Vent 1) had paint chipped along the edges of the vent and pieces of chipped paint were loos and ready to fall from the ceiling. Vent 1 was located directly above the sink used for manual cleaning and scrubbing of endoscopes. Vent 2 was directly across from Vent 1 and had grey matter build-up and appeared to be full of dust. Vent 2 was located above the adenosine triphosphate testing station (Point-of care testing for adenosine triphosphate (ATP), a marker of microbial contamination, to assess the effectiveness of manual cleaning. ATP testing has recently been shown to correlate with quality of endoscope cleaning). The SPDM & ADS validated the observations, and both stated both ceiling vents needed cleaning and repair to the paint around Vent1. The SPDM stated both vents needed cleaning and appeared dirty. The room’s log showed vents were being cleaned daily. These failures could potentially lead to cross-contamination. During an observation on 5/17/24 at 11:30 a.m., in the SPD decontamination area, the floors, walls, and air gap were visibly in poor condition, unsanitary and not maintained in accordance with hospital policy and procedure. The floor beneath the rinse sink had rust-colored deposits, paper trash and other debris in the drain. The floor and backboard underneath the decontamination sink were scuffed, moist, with porous (water and air can pass through) drywall and wood exposed. During concurrent observation and interview on 5/13/24 at 2:37 p.m., with the Director of Critical Care (DCC), in the Cardiac Intensive Care unit (CICU - Unit for critically ill patients [patients with vital organ dysfunction, high risk of imminent death if care is not provided] with heart, chest and blood vessel’s conditions), one of the two linen carts had linen stored and was not covered in accordance with the hospital policy. The linen cart had the plastic cover rolled on top of the cart and patient equipment was stored on top of the plastic cover exposing the clean linen (there was no signage to indicate the equipment was clean). The DCC stated the equipment should not be stored on top of linen carts as it had the potential for cross contamination and spread infections to critically ill patients. During observations on 5/15/24 at 1:10 p.m. and 5/27/24 at 8:10 a.m., three of 17 staff (Surgeon (SUR) 8, Resident Surgeon (RES) 1, and RES 2) were observed in the Operating rooms (ORs) not wearing appropriate eye wear as part of their surgical attire during surgical procedures. During an observation on 5/13/24, at 2:38 p.m., in Pt 61’s room, RN 11 changed Pt 61’s wound dressing and did not perform hand hygiene after removing dirty gloves and then placing clean gloves on and placing a clean dressing on Pt 61’s wound. During an observation on 5/15/24, at 1:02 p.m., while in the OR during Pt 21’s surgery, the anesthesiologist (ANS) 6 dropped a vial of medication, picked it up from the floor, tossed it, and then continued to give Pt 21 medication through her IV without performing hand hygiene and without cleaning the port on the IV site. During an observation on 5/15/24 at 2:27 p.m., in the Post Anesthesia Care Unit (PACU), RN 14 did not perform hand hygiene prior to putting on clean gloves in the PACU. During an observation on 5/24/24 at 12:50 p.m., HSK 1 cleaned bed B (the bed furthest from the door) of a two-bed room. HSK 1 collected the linen and discarded all trash in the room. Bags were replaced and the tops of the trash/ linen bin cleaned. Towels saturated with disinfectant solution were placed on furniture, bed, and tables. HSK 1 dusted the vents, furniture, walls, and window blinds then returned the soiled duster to the clean housekeeping cart. HSK 1 changed gloves and performed hand hygiene, then continued wiping all furniture and the bed. HSK 1 returned to the housekeeping cart wearing soiled gloves and retrieved two additional towels from the disinfectant solution bucket. HSK 1 squeezed the excess solution from the towels into the bucket, then cleaned the room’s sink and bathroom. HSK 1 changed gloves and performed hand hygiene, then mopped the innermost part of the room. HSK 1 used the same mop head to cross bed A’s floor space. During a concurrent observation and interview on 5/24/24 at 1:04 p.m., in the “soiled” utility closet on the fourth floor, with HSK 1, HSK 1 discarded trash bags. Trash bags were observed overflowing from the trash bin and piled up against the wall’s corner and floor. One trash bag was torn with trash (gloves, adult briefs, food items, etc.) exposed. HSK 1 stated the practice was to pile trash in a corner until collected by environmental services. During an interview on 5/29/24 at 3:16 p.m., with the Infection Preventionist (IP), the IP stated the infection prevention and control program reported surveillance data to the quality council committee monthly. The IP stated the surveillance data reported to quality included hospital associated infections (HAIs- CLABSI [central line blood stream infections], CAUTI [urinary tract infections from urinary catheters], MRSA [infections caused by type of bacteria], clostridium difficile [infection of the intestine]), surgical site infections (SSIs- colon [large intestine] and hysterectomy [removal of the uterus through the abdominal wall], and hand hygiene. The IP stated the infection control and quality programs participated in environmental care rounds (tours of the hospital grounds to help identify actual and potential issues that affect patient safety), but the IP department did not track or report its findings, since issues were usually addressed within short periods of time. The IP stated HAI and SSI data he collected and analyzed was what determined the effectiveness of the hospital’s infection prevention and control program and staff compliance with best practices. During a review of “[Name of hospital] Quality Council Open Session Minutes” (QC meeting minutes) dated 7/24/23, the “QC meeting minutes” indicated, “ ... Findings/ Conclusions/ Recommendations ... Quality Management ... Hand Hygiene ... 1MED, 3S [3 south], PAD, and ER [emergency room] not meeting goal ... Radiologist, MD [physician], and EVS [environmental services] need improvement ... Action/ Follow-Up [blank] ...” During a review of “[Name of hospital] Quality Council Open Session Minutes” (QC meeting minutes) dated 8/28/23, the “QC meeting minutes” indicated, “ ... New Business ... None Reported ...” During a review of “[Name of hospital] Quality Council Open Session Minutes” (QC meeting minutes) dated 11/27/23, the “QC meeting minutes” indicated, “ ... Findings/ Conclusions/ Recommendations ... Quality Management ... CLABSI 4 YTD, None in 3Qtr [third quarter] ... CDIFF 4 in Sept 2023 ... MERSA [MRSA] 1 in ICU [intensive care unit] ... Hand Hygiene ... Aug.2023 ... SICU [stepdown ICU], PAC, 2S [2 south], 3S, 1MED, MD, Radiologists, NP [nurse practitioner], PA [physician assistant] & Residents need improvement ... Sept. 2023 ... 2S, CCU [critical care unit], 1MED, 3W [3 west], Lab [laboratory], MD, NP, PA 7 Residents need improvement ... Will be getting names of providers/ staff that are repeat offenders and have one on one educational conversation .... Action/ Follow-up [blank] ...” During a review of “[Name of hospital] Quality Council Open Session Minutes” (QC meeting minutes) dated 1/22/24, the “QC meeting minutes” indicated, “ ... Findings/ Conclusions/ Recommendations ... Quality Management ... CLABSI 7 YTD/ 2 in Q4 ... CDIFF 21 YTD/ 3 in Q4 [fourth quarter] ... MRSA ... 0 in Q4 ... Hand Hygiene ... October 2023 Overall compliance by Unit ... CVICU [cardiovascular intensive care unit], 4S [4 south], 3S & 1Med need improvement ... October 2023 Overall compliance by Role ... MD, Radiologists, NP, PA & Residents need improvement ... November 2023 Overall compliance by unit ... SICU, 4S, PAC, 3S & 1M [blank] ... November 2023 Overall compliance by Role ... Other MD, MP, & Residents need improvement ... Will be getting names of providers/ staff that are repeat offenders and have one on one educational conversation .... Action/ Follow-up [blank] ...” During a review of “[Name of hospital] Quality Council Open Session Minutes” (QC meeting minutes) dated 3/25/24, the “QC meeting minutes” indicated, “ ... Findings/ Conclusions/ Recommendations ... Infection Control ... IPT Report 2023: 7 CAUTI, 9 CLABSI (due to Picc lines and Dialysis catheters), Hand Hygiene at 93%... IPT Report 2024 Running: Numbers Incorrect ... Action/ Follow-up [IP] to correct 2024 numbers and send updated version ... Quality Management ... Sepsis Mortality Rate 10.7%... Areas of Opportunity: CLABSI, CAUTI ... Action/ Follow-Up [blank] ...” During a review of “[Name of hospital] Infection Prevention and Control Committee Minutes” (IPCC meeting minutes) dated 3/27/24, the “IPCC meeting minutes” indicated, “ ... STERILE PROCESSING: Everything is running well, no failures ... EVS: Reviewed data: would like 50 observations, rounding on lower scoring areas, rounds on departments change monthly ...” During an interview on 5/31/24, at 9:05 a.m., with the Director of Clinical Quality and Improvement (DCQI), the DCQI stated the “Quality Assessment and Performance Improvement [QAPI] Plan” was a “living” document that was reviewed every “two years” but could be updated at any time. The DCQI stated the data collected from the Sterile Processing and Endoscopy Departments did not accurately reflect the scope and complexity of the departments, which contributed to missed opportunities for performance improvement in infection control practices. The DCQI stated, as a result of the recent findings, the “QAPI” plan had to be changed to include these high-risk areas. The DCQI stated she was not familiar with the type of standardized tools utilized by the infection control program for facility rounding and observations. 2. During a review of “Quality monthly Operations Reporting March YTD [year to date] 2024” indicated, “ ... AMI Mortality Rate ... State Average ... 0.93 ... Mar [march] 1.50 ... HF Mortality Rate ... State Average ... 0.61 ... MAR ... 1.32 ... COPD Mortality Rate ... State Average ... 0.32 ... MAR ... 1.20 ... Mortality O/E [O- observed deaths to E- expected deaths] Ratio ... State Average ... 1.00 ... O/E Achieved 1.07 ... Patient Safety and Complication Rate ... SURG- COMP [surgical complications] Death Rate among surgical inpt [inpatient] w/ [with] serious treatable complications per 1,000 elective surgical discharges or any surgery/procedure within 2 days YTD # [number] 65 ... Target 52 ... missed 13 ... Iatrogenic Pneumothorax [collapsed lung accidentally during a procedure] 3275 ... target 3274 ... missed 1 ... Postoperative hemorrhage [massive blood loss] or hematoma [clotted blood] rate involving a procedure to treat the hemorrhage or hematoma, following surgery per 1,000 surgical discharges... YTD# 701 ... Target 699 ... missed 2 ... Post-operative PE [pulmonary embolism- blood clot in lung or DVT [deep vein thrombosis- blood clot in vein] per 1,000 surgical discharges ... YTD # 719 ... Target 715 ... missed 4... “ During a review of “[Name of hospital] Quality Council Open Session Minutes” (QC meeting minutes) dated 11/27/23, the “QC meeting minutes” indicated, “ ... Findings/ Conclusions/ Recommendations ... Patient Safety ... PE: 2, Going for Peer review ... DVT: 1, Going for Peer review ... In-Hospital Mortality ... Currently in Red due to three system that pull data are not matching ... Action/ Follow-Up [blank] ...” During a review of “[Name of hospital] Quality Council Open Session Minutes” (QC meeting minutes) dated 1/22/24, the “QC meeting minutes” indicated, “ ... Findings/ Conclusions/ Recommendations ... In-Hospital Mortality ... Currently in Red due to three system that pull data are not matching ... Action/ Follow-Up [blank] ...” During a review of “[Name of hospital] Quality Council Open Session Minutes” (QC meeting minutes) dated 3/25/24, the “QC meeting minutes” indicated, “ ... Findings/ Conclusions/ Recommendations ... Areas of Opportunity ... No Immediate post-op note prior to patient transfer, “Yes” box not marked on Post- Anesthesiology Evaluation & Unable to locate Post Anesthesiology Evaluation in chart ... Action/ Follow-Up ... Quality is working with Anesthesia group to correct issues ...” During a review of “[Name of hospital] Performance Improvement Annual Appraisal & QAPI Plan” dated 2024- 2026, the “QAPI” plan indicated, “ ... The QAPI plan guides the organization’s performance improvement efforts ... The purpose of the Performance Improvement Plan at [name of hospital] is to ensure patients are provided high quality care in an environment of minimal risk ... The medical staff fulfils its joint executive responsibilities, along with the hospital’s governing body and administrative officials, for ensuring that the hospital- specific QAPI program is ... Ongoing, defined, implemented, and maintained ... Addresses hospital- specific priorities for improved quality of care and patient safety, and that all improvements are evaluated ... establishes clear expectations for safety in the hospital ... Mandatory Data Collection .... Pre-operative and post-operative diagnosis ... Adverse events to moderate or deep sedation ... The results of resuscitation ... Significant medication errors ... Patient perception of safety and quality of care, treatment, and services ... Avoidable Hospital Acquired Infections (HAI) ... Reducing Avoidable Patient Harm ... Patient Harm- Falls ... Sepsis ... Focus for 2024- 2026 as approved by the Board of Governors ... Focus on achieving or exceeding national benchmarks for all publicly reported measures ... Focus on decreasing hospital-wide mortality rate ... Focus in 2024-2026 is to reduce all HAIs ... Focus on maintaining a reduction of serious safety events ...””

“ELIGIBILITY & PROCESS FOR APPT TO MED STAFF CFR(s): 482.22(a) The medical staff must be composed of doctors of medicine or osteopathy. In accordance with State law, including scope of practice laws, the medical staff may also include other categories of physicians (as listed at §482.12(c)(1)) and non-physician practitioners who are determined to be eligible for appointment by the governing body. This Standard is not met as evidenced by: 42125 Based on observation, interview, and record review, the hospital and Governing Body failed to ensure medical staff followed Medical Staff Bylaws, Rules and Regulations, and California state law, when hospital approved Certified Registered Nurse Anesthetists (CRNAs- a registered nurse trained to provide anesthesia ([specialized care before for surgery, pain management, critical care and emergencies]) under the orders of a physician) to be added to the Medical Staff as if they were licensed to independently diagnose, prescribe and administer anesthesia services without an order from a physician. These failures allowed five of five CRNAs (CRNA 1, 2, 3, 4 and 5 ) non-physicians, to provide care to five of five Patients (Pt- Pt 1, 2, 3, 4 and 5) with the same authority as an anesthesiologist (physician specialist who provides anesthesia medical care for surgery, pain management, critical care and emergencies who has full prescriptive, diagnostic, and therapeutic authority) to any patient without physician orders and has the potential to endanger all hospitalized patients requiring anesthesia services. Because of the serious actual harm to Patient 1 and the serious potential harm to Patients 2, 3 and 4 related to the unsafe practice of CRNAs providing anesthesia services outside of the scope of practice for CRNAs, and the hospital granting full prescriptive authority to CRNAs without having the authority to do so, and CRNAs diagnosing and treating patients without a physician order and establishing a treatment regimen which is outside of their scope of practice and the hospital not following Governing Body and Medical Staff bylaws in the credentialing and privileging process for CRNAs, Immediate Jeopardy (IJ a situation in which the provider’s noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 5/23/24 at 10:00 a.m. with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditations Manager (AM) 1, and Accreditations Manager (AM) 2. The IJ (Immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 5/23/24 at 6:34 p.m. and it was unacceptable. The hospital submitted an IJ Plan of Removal (Version Two) on 5/26/24 at 10:44 a.m. which included actions to suspend the use of CRNAs until they could be credentialed and privileged according to GB and MS bylaws. Plan of Removal was accepted on 5/28/24 at 11:30 a.m. with the CEO, CNO, DCQI and AM 1. On 5/29/24 at 6:15 p.m. the survey team validated that CRNAs were suspended from working at this facility. The survey team validated all staff were educated on the IJ for the CRNAs and what to do if a CRNA comes to work; surgery schedules were reviewed to show no CRNAs were scheduled to provide anesthesia services; all staff in perioperative areas were aware that the CRNAs were only to use the approved order sets in the computer and all of the handwritten orders sets were removed from use.The IJ was removed onsite with the CEO, CNO, DCQI, AM 1 and AM 2 in attendance on 5/29/24 at 6:15 p.m. After removal of the IJ the hospital remained in substantial noncompliance. Findings: 1. During an interview and concurrent record review on 5/22/24, at 12:42 p.m. and 5/29/24., with the Medical Staff Team (MST) which included, Director of Clinical Quality and Performance Improvement (DCQI), and Medical Staff Manager, the hospital polices, processes, patient records and staff files were reviewed. The MST stated they “follow all regulations”. The MST stated CRNAs started applying for privileges at the hospital June 2023. The MST stated CRNAs were approved as “independent practitioners with full prescriptive authority. MST stated CRNAs were the “same ...physician ... anesthesiologist” and were “equivalent”. MST stated CRNAs authorized to write and orders any medication, treatment or therapeutic and it was within their “scope of practice”. The medical staff team acknowledged CRNAs were not employees of the hospital and worked as independent contractors. Medical Staff Team (MST) stated “CANA [ California Association of Nurse Anesthesiology, an advocacy group that supports nurse anesthetists] allows CRNA to work independently”, and “in the state of California” CRNAs had prescriptive authority. During a record review of hospital policy, titled “AHP [Allied Health Professional] Rules and Regulations, version 2022” indicated all AHPs required “direct supervision”. MST defined “supervision” for CRNAs as an “anesthesiologist was available to provide support ...and help”, if “requested” by the CRNA. The MST stated “new” regulations do not require CRNA to be supervised. MST stated that CRNAs were not required to have an anesthesiologist present to provide orders or medical direction for any aspect anesthesia services, including emergencies, obstetrics, life-threatening events, procedures, intensive care, or medical care of patients as required by hospital policy. During a review of Patient 1’s (Pt 1) medical record, titled “Consultation Notes”, written by Surgeon 3 (SUR 3, surgery doctor), dated 4/11/24, at 6:18 PM, the note indicated Patient 1 was re-admitted to the hospital with bowel obstruction (when the bowels blocked by food or scar tissues) and a planned surgery to repair hernia (bulging of an organ or tissue through an abnormal opening) and clear the bowel obstruction. During a record review of the Pt 1’s medical record titled, “History and Physical Admission Notes”, dated 4/11/24, at 2:00 a.m., written by Medical Doctor (MD 4), documented that Pt 1 presented to emergency department (ED) for “worsening nausea, vomiting ...abdominal pain ... The surgeon [SUR 3] was consulted ... and requested Nasogastric (NGT) placement ... It was attempted 4 times in ED but was unsuccessful.” MD 4 diagnosed Pt 1 with “bowel obstruction ... atrial fibrillation (irregular and rapid heart rhythm) ... planned to decrease heart rate with medications, and obtain cardiac tests, troponins (lab test that monitors heart muscle injury), and heart ECHO (test to evaluate heart function, rate, and rhythm).” During a record review of the Pt 1’s medical record, titled “Electrocardiogram (EKG- tracing of the heart’s rate and rhythm)”, dated 4/11/24 at 12:09 a.m., the EKG record indicated a heart rate of 148 (HR- normal 60 to 100) and “atrial fibrillation [A-fib-life threating rapid and irregular heartbeat and rhythm)”. During a record review of the Pt 1’s medical record, titled “Assessment- Gastrointestinal [stomach and intestine]” nursing evaluation, dated 4/11/24, at 6:30 a.m. and 8:30 a.m., on the day of surgery, the record indicated Pt 1’s stomach was tender, bloated, “distended, firm, rounded”. During a record review of the Pt 1’s medical record, titled “Computed Tomography” [CT- scans body parts for abnormalities] of the stomach and intestine, dated 4/10/24, at 11:42 p.m., the record indicted Pt 1 had a “bowel [intestine] obstruction...Significant dilatation [swelling] of the stomach with reflux [fluid] into the distal esophagus (a tube-like organ that connects mouth to the stomach)”. During a record review of the Pt 1’s medical record, titled “Preoperative (before surgery and anesthesia form titled “Anesthesiologist [physician that provides anesthesia] Evaluation”, dated 4/11/24, at 4:45 p.m., handwritten by CRNA 5, the record did not indicate if an anesthesiologist or other physician reviewed and evaluated Patient 1’s status prior to surgery and there is no documented evidence of a physician’s order for a treatment regimen including anesthesia services provided by a CRNA. During an interview and concurrent record review on 5/22/24, at 10:13 a.m., with CRNA 6, accompanied by scribe and Director of Clinical Quality Improvement (DCQI), the medical records of Patient 1 who had anesthesia and surgical services on 4/11/2024, was discussed. CRNA 6 stated he discussed the case with CRNA 5, and she was “conformable” with the acuity/illness of the patient. CRNA 6 stated SUR 3 ordered an NGT, but CRNA 5 was “not going to place an NGT ...not going to do it” to remove gastric fluid. CRNA 6 stated, he nor CRNA 5, spoke with SUR 3 about the CRNA 5’s refusal to place the NGT. CRNA 6 stated he helped CRNA 5 bring the patient into the OR to “hang-out”. CRNA 6 stated he left the OR before Pt 1 was intubated. After he gave report to anesthesiology (ANS 2) who was the AIC for the night shift. There was no documented evidence, why the placement of a gastric tube (NGT) into the mouth or nose to empty the stomach was not attempted or completed as ordered by physicians. There was no documented evidence CRNA reviewed Pt 1’s EKG or abdominal CT scans. There was no documented evidence CRNA 5 considered the recommendations of the admitting physician (MD 4) to obtain cardiac (heart) evaluation. There was no documented evidence CRNA 5 discussed the decision not to place a gastric tube to empty the stomach before surgery to decrease the risk of aspiration (life threatening event when stomach contents enter the lungs) or the anesthetic plan with the operating surgeon (SUR 3) and/or an anesthesiologist. During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with surgeon (SUR 3) and the Chief of Surgery (SUR 4), the records of surgical Patient 1’s (Pt 1) admission on 4/10/23 and hospital policies were discussed. Sur 3 stated the surgery was not an emergency and if the anesthesiologist had “cardiac concerns ... then they should have paused and proceeded with anesthesiologists’ recommendations” for cardiac work up prior to surgery. During an interview and concurrent record review on 5/20/24, at 5:12 p.m. with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1’s (Pt 1) medical record for the admission dates from 4/10/2024 to 4/11/24, and policies provided by the hospital, were reviewed, and discussed. On preoperative evaluation, the CRNA 5 stated she was “aware” of Pt 1’s findings by MD 4 and SUR 3 on cardiac work-up, the bowel obstruction and large collection of fluid in the stomach and esophagus. CRNA 5 indicated she was not in agreement with MD 4 and stated Pt 1 “looked great ... didn’t concern me ...not needed”. CRNA 5 stated she spent “35 minutes ...having a heart to heart” with Pt 1. CRNA 5 stated Pt 1 “seemed off ...confused ...rambled” during the pre-operative evaluation. CRNA 5 stated she consented Pt 1 for anesthesia. CRNA 5 stated she documented that NGT placement failed four times, but this occurred in the ED. CRNA stated she did not attempt to place an NGT in the Pt 1 prior to surgery. CRNA 5 stated the patient “refused” an NGT tube. CRNA 5 acknowledged she did not document patient refusal or confusion, nor discussed any concerns with the surgeon or anesthesiologist. CRNA 5 acknowledged she did not discuss MD 4s finding and plans for a cardiac work-up, or the abnormal EKG, or CT scans with the surgeon or anesthesiologist. During a concurrent interview and record review on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2) accompanied by Patient Safety Officer (PSO), the records of surgical Patient 1’s (Pt 1) admission on 4/10/2023 and the recommendation for cardiac workup by heart doctor were discussed. ANS 2 stated in “cases like this are elective, not an emergency”. ANS 2 stated if a patient has a “new onset A-fib” (a dangerous heart rhythm) and a physician recommends a cardiac work-up. The patient “need cardiac clearance before going to surgery”. ANS 2 indicated Pt 1 was at “high risk for aspiration”. Before surgery the stomach needed to be “decompressed” by placing a gastric tube to remove the contents of the stomach. ANS 2 stated to “protect the airway” and maintain patient breathing, the anesthesiologist should have proceeded with an “awake intubation”. During an interview and concurrent record review on 5/22/24, at 10:13 a.m., with CRNA 6, accompanied by scribe and Director of Clinical Quality Improvement (DCQI), the medical records of Patient 1 who had anesthesia and surgical services on 4/11/2024, was discussed. CRNA 6 stated he reviewed Pt 1’s chart and could recall the events without the chart. Sections of the chart were reviewed and read to CRNA 6. CRNA 6 stated he was the Anesthesiologist in Charge (AIC) for the day. CRNA 6 stated he assigned CRNA 5 to Pt 1’s case and assigned CRNA 2 to assist her after finishing a current case. CRNA 6 stated Pt 1’s case was not an emergency and “good to go” ahead with surgery. CRNA 6 stated he did not consult with the Chief of Anesthesia (ANS 1) or requested anesthesiologists’ presence for the case. During review of the Pt 1’s intraoperative (events during surgery) medical record, titled “Anesthesia Record” dated 4/11/24, at 7:09 p.m., handwritten by CRNA 5, the record indicated Pt 1 entered the operating room at 7:09 p.m. There was no documented evidence of an order from a physician for anesthesia services. The record indicated starting at 7:15 p.m., CRNA 5 procured, prescribed, and administered “High Risk Medications” (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing, lowered blood pressure, change of heart rate, and paralyzed the body’s movement as follow: Fentanyl (strong opioids/narcotics that can decrease or stop breathing), propofol (high risk sedative that can decrease or stop breathing), lidocaine (local anesthetic that can slow heart rate and breathing), rocuronium (medication that cause paralyses all muscle function, such as breathing), and etomidate (sedating medication that helps put a patient to sleep for surgery and could contribute to abnormal heart rates and low blood pressure). CRNA 5 did not document continuous monitoring of the blood pressure, heart rate, heart rhythm, oxygen saturation (estimated percent of oxygen in patient’s blood), respiratory rate, or the delivery of oxygen. Further review of the documented intra-operative events indicated that CRNA 5 attempted to intubate (place a breathing tube into the lungs) three times. There was no documented evidence, with each attempt, the presence of carbon dioxide (gas expelled during exhalation and indicates a breathing tube in the lungs), lung sounds of air flow, respiratory rate, delivery of oxygen or oxygen saturation (percent of oxygen in blood) indicating a successful intubation(s). There was no documentation of why CRNA 5 attempted to intubate Pt 1 three times. There was no documented evidence CRNA 5 recorded the medication used and response to interventions and treatment. There was no documented evidence CRNA 5 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines, medications, and procedures or anesthesia guidelines for securing an airway. At the end of anesthesia, medications (such as opioids, propofol, local anesthetics, heart medication, blood pressure medications and so forth) given to Pt 1 were not reconciled by CRNA 5. During an interview and concurrent record review on 5/20/24, at 5:12 p.m. with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1’s (Pt 1) medical record for the admission dates from 4/10/2024 to 4/11/24, and polies provided by the hospital, were reviewed, and discussed. Review of the Pt 1’s intraoperative (events during surgery) medical record, titled “Anesthesia Record” on 4/11/24 with CRNA 5, CRNA 5 stated that SUR 3 was “doing another case” when she started anesthesia for Pt 1. CRNA 5 stated that the “Chief CRNA [CRNA 6] helped” her with anesthesia care. After he left, CRNA 2 entered the Operating Room to help her. CRNA 5 acknowledged she did not document assistance from CRNA 6 or CRNA 2 on the intra-operative record. CRNA 5 indicated CRNA 6 was not present during intubation. CRNA 5 stated “within minutes of pushing [intravenous, IV] medications, patient vomited 1.5 liters [measurement of volume] of fluid ...fecal matter ...called for help”. CRNA 5 stated that she intubated Pt 1, but it was in the “esophagus, and tried again”. CRNA 5 stated ANS 2 intubated the patient. CRNA 5 acknowledged there was no documented evidence that ANS 2 intubated Pt 1. CRNA 5 acknowledged she documented that she intubated three times. CRNA 5 stated throughout the intra-operative period, there was “no gas exchange (evidence pt was receiving oxygen”, and “no CO2 (evidence of pt exhalation)” documented because of water in the CO2 line. During a record review of the Pt 1’s medical record, “Code Blue Record [events, medications and treatment during cardiopulmonary resuscitation, life saving measures], dated 4/11/24 from 7:40 to 8:25 p.m., and handwritten by a nurse. The nursing documentation indicated “medications administered by Anesthesia team, see OR (Operating Room, surgery room) record ... intubated time: see anesthesia record” written by CRNA 5. The Code Blue record indicated that there were “multiple intubation [place a breathing tube to deliver oxygen and respirations] attempts during and before code”. The nurse documented medications in the follow order: i. Epinephrine 1 mg (used IV in emergency when heart or breathing stops) given at 7:40 PM, 7:42 PM, 7:43 PM, 7:44 PM, 7:46 PM ii. Sodium Bicarbonate 50 meq (the treatment of metabolic acidosis or when acids build up in body; “meq” is Milliequivalent, a unit of measure) and Calcium Chloride 1 gm (used for emergency treatment of high potassium and magnesium level in the blood) were given at 7:47 PM. iii. Epinephrine 1mg given at 7:48 PM iv. Vasopressin 20 Units given at 7:52 PM v. Epinephrine 1 mg given and Sodium Bicarbonate 50 meq given at 7:55 vi. Epinephrine 1mg given at 7:56 PM vii. Bicarbonate 50 meq given at 7:57 viii. Epinephrine 1mg given at 7:59 PM, 8:01 PM, 8:08 PM, 8:24 PM, 8:24 PM During the Code Blue here was no documented evidence of heart rhythm, respiratory rate, or deliverance of oxygen by CRNA 5 or the nursing staff. The following was documented periodically: Blood pressure (BP- normal average 120/80), heart rate (HR- normal 60-100 beats per minute, bpm) and oxygen saturation. (SpO2- estimated percent of oxygen in the blood, normal 95 to 100%) SpO2 90% at 7:56 p.m., 100% at 8:02 p.m. and 94% at 8:06 p.m. 85% at 8:03 p.m., BP 67/29 at 7:44 p.m., 92/46 at 7:55 p.m., 174/146 at 8:01 p.m., 173/77 at 8:02 p.m., 159/27 at 8:09 p.m., 208/157 at 8:12 p.m., 200/140 at 8:16 p.m., HR bpm was 81 at 8:01 p.m., 128 at 8:02 p.m. 129 at 8:03 p.m., 134 at 8:09 p.m., 159 at 8:12 p.m., 138 at 8:16 p.m. There was no documented heart rhythm for any of the heart rates. At 8:19 p.m. was the last recorded BP 127/40 and HR 150. At 8:25 p.m. compressions stopped and SURG 3 sopped the lifesaving measures. The Code Blue record further indicated the SUR 3 arrived at code event at approximately 8 PM and the ICU team (Intensive Care Unit; specialized team that treated critical patients) and MD 3 arrived at 8:03 PM. The code blue record indicated at 8:11 p.m., Pt 1 was “bronch (a long tube-like probe with a light and camera at the end, was used to look for issues)” to investigate Pt 1’s lungs and found the breathing tube in the esophagus. Further review of the code blue sheet documentation indicated no documented evidence CRNA 5 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines, medications, and procedures or anesthesia guideline for securing an airway. During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with surgeon (SUR 3) and the Chief of Surgery (SUR 4), the records of surgical Patient 1’s (Pt 1) admission on 4/10/23 and hospital policies were discussed. SUR 3 stated there was “no anesthesiologist in the room”. SUR 3 stated he was “unaware” Pt 1 was in the OR and was called to the operating room (OR, surgery room) 25 minutes after the patient was put to sleep, and the anesthesiologist (ANS 2) arrived about the same time. SUR 3 stated the patient was in “distress” had a “pulse” and there were “bowel fluids” on the floor. SUR 3 stated he put a camera into the patient’s lung and determined the breathing tube was “in the esophagus”. SUR 3 stated two CRNAs were “grappling” with the airway and the patient lost her pulse. SUR 3 indicated that an ICU physician arrived in the OR and determined that ETT was in the esophagus. SUR 3 stated the ICU physician intubated the patient. SUR 3 stated the case was reviewed and discussed to determine the root cause of the events. SUR 3 stated the CRNA told him “Patient refused the NG tube”. SUR 4 stated there was recommendation for Pt 1’s abdomen to be “decompressed [contents emptied]” by placing an NGT and do an awake intubation. SUR 3 stated that from his “understanding”, CRNAs were “not independent” and “supported” by the anesthesiologists. SUR 3 stated, it was his “opinion”, if an anesthesiologist wasn’t available, the “case stops and can’t proceed”. During an interview on 5/20/24, at 5:12 p.m., and concurrent record review of code blue record events, with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1’s (Pt 1) medical record for the admission dates from 4/10/2024 to 4/11/24, and polies provided by the hospital, were reviewed, and discussed. CRNA 5 stated ANS 2 and SUR 3 entered the OR room at the “same time”. CRNA 5 stated SUR 3 “Bronch” and established that the breathing tube was “in the esophagus and removed it”. CRNA 5 stated she reintubated Pt 1 and “tube in [the trachea, windpipe]”, and was in the “right place, and was holding it in place with her hand so it would not move”. CRNA 5 acknowledged, after confirmation breathing tube had been confirmed and in the correct position, it was secured. CRNA 5 acknowledged the intensive care physician (MD 3), arrive in the OR after ANS 2 and SUR 3. CRNA 5 stated MD 3 “Bronch” the patient and determined the tube was “in the esophagus”, removed the tube and reintubated Pt 1. CRNA 5 stated SUR 3 and MD 3 stopped the lifesaving efforts at 8:25 p.m. During a concurrent interview and record review on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2) accompanied by Patient Safety Officer (PSO), the records of surgical Patient 1’s (Pt 1) admission on 4/10/2023 and hospital policies were discussed. ANS 2 stated he was familiar with some of the events of Pt 1’s care. ANS 2 stated he started at 7:00 p.m. on 4/11/2024 and was the Anesthesiologist In Charge (AIC) for the evening. ANS 2 stated he received hand-off from the daytime AIC (CRNA 6), and Pt 1’s case was in progress in OR. ANS 2 stated CRNA 6 “did not mention” concerns or problems” or the acuity (how critical the medical issues were) of Pt 1. ANS 2 indicated he was called to help with Pt 1 in the OR and when he arrived, it was “chaotic”. ANS 2 stated SUR 3 was in the OR and informed the CRNA 5 the breathing “tube was in the esophagus”. After, the CRNA had reintubated the patient. ANS 2 stated the SpO2 (oxygen levels) was not improving and there were no CO2 readings [sign of breathing, exhaling]. ANS 2 stated CRNA 5 oversaw the case and there were 2-3 CRNA “managing the airway”, so he did not help intubate the patient. ANS 2 stated CRNA 5 “assured me” the ETT was in the “right place”. ANS 2 stated that he asked the CRNA to reassess the breathing tube because the patient had “no pulse and low blood pressure ...patient crumbling”. ANS 2 stated the intensive care medical doctor (MD 3) was called to help. MD 3 “discovered the ETT was in the esophagus”, removed the tube and replaced it. ANS 2 stated the patient “deteriorated”, and there was nothing more that could be done. During a concurrent interview and record review of Pt’1 code blue record, on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2), accompanied by Patient Safety Officer (PSO), ANS 2 stated “I tried to run the code”, but other people giving medication orders, and the CRNA was in charge, and did not know what medications the patient received. ANS 2 stated he inserted an IV line but did not assist in the management of the airway. During an interview and concurrent record review on 5/22/24, at 10:13 a.m., with CRNA 6, accompanied by scribe and Director of Clinical Quality Improvement (DCQI), the medical records of Patient 1 who had anesthesia and surgical services on 4/11/2024, was discussed. CRNA 6 stated when he arrived, there were “many individuals” in the room and it was “pure chaos”. There were gastric contents “a lot on the floor” and Pt 1 had “soft vital signs [ flags or signs of patient deterioration] ... some SPO2 [readings of oxygen content of blood]”. CRNA 6 stated he noted there was, “no CO2 reading” on the monitors, and “no” signs indicating air exchange and the breathing tube was in the lungs. CRNA 6 stated CRNA 5 was managing the airway, and “assured” him it was in the lungs. CRNA 6 stated CRNA 5 explained there was “no CO2” because of fluid in the CO2 line. CRNA 6 acknowledged fluid can clog the tube that connects the patient to the machine that measured CO2. But CRNA 6 stated it was “fast and easy” to change the tube to a clean one. CRNA stated that “basic knowledge” is “knowing the anesthesia tools and machine”, and how they work and use them. During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with Surgeon (SUR 3) and the Chief of Surgery (SUR 4), the records of surgical Patient 1’s (Pt 1) admission on 4/10/23 and hospital policies were discussed. SUR 4 stated the surgery department was “not involved” with CRNAs. SUR 4 stated surgeons were “not responsible” for CRNAs and did not provide “supervision ...direction ... orders” for them. CRNAs were “supervised” by anesthesiologist, and not the surgeons. SUR 4 indicated if there was a code blue in the OR, the physician directed the code, and the anesthesiologist would be called. If there is no physician, the CRNA will start it. SUR 4 indicated the death of the patient had resulted in “corrective actions as quick as possible” of CRNAs providing anesthesia care independently in surgical cases. SUR 4 stated CRNA will provide anesthesia services for “small cases”. An anesthesiologist should have provided anesthesia care for ill patients and “complex cases”. During an interview and concurrent record review on 5/20/24, at 5:12 p.m. with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1’s (Pt 1) medical record for the admission dates from 4/10/2024 to 4/11/2024, and policies provided by the hospital, were reviewed, and discussed. CRNA 5 stated she had been a nurse anesthetist for one year. CRNA stated that AANA (American Association of Nurse Anesthetists’, a professional organization) and the hospital bylaws determined the “scope of practice” of nurse anesthetist. CRNA 5 stated that CRNAs were “independent and not medically supervised or directed” by a physician and were the “responsible provider” of medical care. CRNA 5 indicated CRNAs provided anesthesia care and procedures to patients without physician orders. CRNA 5 stated CRNAs could run codes (direct staff to provide emergent lifesaving measures) and order medications and procedures. CRNA 5 stated anesthesiologist were “available”, if the CRNA “asks for help”, and each CRNA determines when and if an anesthesiologist was required in a case. CRNA 5 stated the CRNAs are “very, very similar” and “at the end of the day deliver” anesthesia care was provided the same way as a physician. During a concurrent interview and record review on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2) accompanied by Patient Safety Officer (PSO), the records of surgical Patient 1’s (Pt 1) admission on 4/10/2023 and hospital policies were discussed. ANS 2 stated he had been an anesthesiologist for 25 years and has specialized training for heart cases. ANS 2 indicated the hospital bylaws defined the role and scope of practice of CRNAs. ANS 2 stated CRNAs “practice independently ...practice on own”, write orders, and prescribe medications. ANS 2 stated anesthesiologist are “not responsible” for the medical care provided by CRNAs. ANS 2 stated an anesthesiologist’s participation in a case is “loose supervision” and the anesthesiologist does not provide medical direction, oversight, or orders for CRNAs. ANS 2 stated he “assumed CRNAs are competent”. During an interview and concurrent record review on 5/22/24, at 5:10 p.m., with anesthesiologist (ANS 3) accompanied by Patient Safety Officer (PSS), the medical records for anesthesia care and hospital policies were reviewed and discussed. ANS 3 stated has “never worked with CRNAs ... never taken responsibility for the patient care of CRNA ... never provide orders for CRNAs”. ANS 3 stated, if he is available will help other anesthesia providers, physicians and CRNAs. ANS 3 stated, CRNAs “do not ask me for help”. ANS 3 stated if there was a code (emergency life-saving interventions) in the operating room (OR), the anesthesia provider would document the events, medications, interventions, and treatments, during the code or right after it. ANS 3 stated the nursing staff will also document the events on the “Code Bule Record” form per policy. During a concurrent interviews and record review in the following 3 days with Chief of Anesthesia (ANS 1) on: 1. 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1) accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and Director of Clinical Quality and Performance Improvement (DCQI), and 5/29/24, at 10:10 a.m., with ANS 1 accompanied by DCQI, 3. 5/29/2024 at 4:14 p.m. with ANS 1 accompanied by RNQ 1, the hospital policies, processes, and patient medical records (Pt 1, 2, 3, 4, 5 and 38) were discussed. ANS 1 stated the anesthesia department followed ASA (American Society of Anesthesiology) guidelines and ACLS guidelines for patient care and documentation. During review of the Pt 1’s intraoperative (events during surgery) medical record, titled “Anesthesia Record” dated 4/11/24, at 7:09 p.m., and “Code Blue Record”, dated 4/11/24, were discussed with ANS 1. ANS 1 stated that he was familiar with Patient 1 and reviewed the records and care provided by CRNA 5. ANS 1 stated CRNAs are “qualified to run a code” order medications and direct medical care. ANS 1 stated the “primary” anesthesia provider for Pt 1 was the CRNA 5. If the CRNA 5 had “any concerns with a case will discuss with an anesthesiologist.” 2. During a review of the Patient 2’s medical record, titled “Consultation Progress Note”, written by MD 5, dated 10/26/23, at 10:56 PM, the record indicated Patient 2 had a history of dementia (problem with memory and forgetfulness; impaired ability to think or make decisions), diabetes (blood sugar disease), heart disease with CAD (Coronary Artery Disease caused by the clogged arteries), lung disease (breathing difficulties), high blood pressure and chronic pain and was approved to go to surgery for hip fracture on 10/26/23 after a fall at home. During a record review of the Patient 2’s medical record, titled “Preoperative Anesthesiologist Evaluation” (evaluation before surgery by physician that provides anesthesia), dated 10/26/23, at 4:25 p.m., handwritten by CRNA 4 there was no documented evidence of an order by a physician for anesthesia services. During a record review of the Patient 2’s intraoperative (events during surgery) record, titled “Anesthesia Record”, dated 10/26/23, timed from 4:33 p.m. to 5:50 p.m., handwritten by CRNA 4 the record indicated that CRNA 4 provided anesthesia services during surgery without the medical orders from an anesthesiologist or other physician. The record indicated during the intra-operative period CRNA 4 procured, prescribed, and administered “High Risk Medications” (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing, lowered blood pressure, change of heart rate, and paralyzed the body’s movement. The medications administered by CRNA 4 were as follow: i. Sevoflurane anesthesia medical gas (volatile anesthetic that provides hypnosis, amnesia during surgery and can decrease blood pressure and heart rate) ii. Fentanyl (strong opioids/narcotics that can decrease or stop breathing), iii. Propofol (high risk sedative that can decrease or stop breathing), iv. Lactated Ringers IV fluid (a type of fluid with electrolytes, given IV, Into the Vein) v. Pocuronium (medication that cause paralyses all muscle function, such as breathing), vi. Precedex (sedating medication that can slow the heart rate, and lower blood pressure), vii. Sugammadex (reveres paralyses caused by rocuronium), viii. Decadron (steroid that cause mood changes and increase blood sugars). ix. Zofran (Ondansetron, anti-nausea drug) x. Ancef (antibiotic) Further review of the documented intra-operative events, the medication use, and response to interventions and treatment were not completed. The record did not have documented evidence if the breathing tube was removed after surgery was completed. There was no documented evidence of the Patient 2’s physical status, mental status, blood loss, hydration, or respiratory effort at the end of surgery. The record for intraoperative medication use (such as opioids, propofol, local anesthetics, heart medication, blood pressure) were not reconciled by CRNA 4. The record indicated Patient 2 was transferred to PACU with “No Complication”. During a record review of the Patient 2’s medical record, titled “Anesthesiology Evaluation, Post Anesthesia Evaluation” (events after surgery), dated 10/25/23 at 8:30 p.m., signed by CRNA 4, the record indicated CRNA 4 checked the “yes” box indicating the Patient 2’s status was “within expected parameters ... respiratory function, respiratory rate, oxygenation (SpO2, breathing well), pulse (heart rate), blood pressure, mental status, temperature, pain, hydration”. There was no documented evidence CRNA 4 notified an anesthesiologist of Patient 2’s the perioperative outcome and complications or evaluated Pt 2 in the PACU and determined Pt 2 recovered from anesthesia. In a telephone interview with CRNA 4, on 5/29/24, at 1:40 p.m., CRNA 4 acknowledged he provided anesthesia services to Patient 2 and was allowed to order medications and tests in the PACU as needed. CRNA 4 stated the hospital allowed them to prescribe controlled medications and practice independently. CRNA 4 stated his workflow was to sign and leave the PACU Evaluation sheet for nurses to fill in. CRNA 4 could recall he dropped off Pt 2 in PACU with no apparent issues. During record review of the PACU (Post Anesthesia Care Unit, where patient transferred after surgery to recover from anesthesia) nursing documentation, titled “Communication and Notification”, dated 10/26/23, starting at 6:00 p.m., the nursing note indicated Patient 2’s abnormal respiratory rate (RR) of 26 and SPO2 at 91% (RR, how fast one breath, Normal range was 12-16 breaths per minute; “SPO2” is oxygen level in the blood, the normal level is between 96 to 99%, “%” or percent is a unit of measure) while on supplemental oxygen. The record further indicated while in PACU, Patient 2’s vital signs (clinical measurements, specifically heart rate, temperature, respiration rate, and blood pressure, that indicate the state of a patient’s essential body functions) needed an urgent response and medical intervention. The records indicated Patient 2’s Respiratory rate increased as high as 34, HR increased as high as 202 (heart Rate or Heartbeat, normal between 60-100 beats per minute), blood pressure dropped as low as 82/52 (or BP, the normal is 120/80). There is no documented evidence CRNA 4 returned to the Patient 2’s bedside to address Patient 2’s emergent medical needs. During a record review of Patient 2’s medical record, titled “Physician Progress Note” and “Discharge Summery”, dated 10/27/23 at 2:47 p.m. and 10/31/23 at 10:48 a.m., respectively, written by ICU physician (MD 5), the notes indicated MD 5 cared for Patient 2 in the ICU. The notes indicated “Postop (after surgery) found to be hypotensive (low blood pressure), tachycardic (irregular heartbeat) with respiratory acidosis (when lung unable to remove or exhale extra gases such as carbon dioxide [CO2] from lung). The Note written by MD 5 indicated “chest x-ray (picture or images of inside body taken a special machine) found volume loss on the left side suggestive of right lung intubation (when a tube placed inside the breathing airway into the left lung; breathing tube was only providing oxygen to the right lung; with normal intubation, placing of the breathing tube, must supply the right and the left lungs). The record further indicated “Acute hypercapnic respiratory failure (when lung unable to exhale CO2 gases and end up increasing the level in the blood and causing breathing failure) after the surgery: Could be related to right lung intubation during the procedure.” The record additionally indicated during surgery, Patient 2 suffered, “Acute blood loss anemia: related to surgical intervention and IV fluids. During review of Patient 2’s medical record, titled “Orders”, dated 10/26/23, with the time frame of 5:03 PM to 6:14 PM, the records indicated CRNA 4, ordered the nurses to administer “High Risk Medications” (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing including opioid (drugs as narcotic that could affect mental and breathing issues) pain medications called fentanyl (strong opioid drug which could affect and suppress breathing) and Dilaudid (or hydromorphone, a strong opioids/narcotics that can decrease or stop breathing). The CRNA 4 additionally orders medications to prevent nausea including Reglan 10mg (anti-nausea drug with warning risk on elderly with higher doses due to side effects). There was no documented evidence CRNA 4 discussed the medications orders for Patient 2 with an anesthesiologist or other physican, considered Pt 2’s past medical history or post-operative emergent medical condition. The record under “Orders” indicated CRNA 4 was described in Electronic Medical Record (EMR) as the “Ordering Physician”, “Responsible Provider”, “Supervising Provider: none listed”, and a “Doctor Cosign: Not required”. CRNA 4 was authorized by the hospital to place orders for medication, treatments, and studies for patient care and nurses to administer without a physician establishing a treatment regimen. During a concurrent interviews and record review in the following 3 days with Chief of Anesthesia (ANS 1) on 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1) accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and Director of Clinical Quality and Performance Improvement (DCQI), 5/29/24, at 10:10 a.m., with ANS 1 accompanied by DCQI, 5/29/2024 at 4:14 p.m. with ANS 1 accompanied by RNQ 1, the hospital policies, processes, and patient medical records, including Pt 2, were discussed. During an interview and concurrent record review on 5/22/24, at 5:10 p.m., with anesthesiologist (ANS 3), accompanied by Patient safety officer (PSS), the medical records of Patient 2 (Pt 2) and hospital policies were reviewed and discussed. ANS 3 stated recently the hospital has transitioned to a CRNA and anesthesiologist-based service. ANS 3 stated has “never worked with CRNAs ... never taken responsibility for the patient care of CRNA ... never provided orders for CRNAs”. ANS 3 stated if he was available, he would help other anesthesia providers, physicians and CRNAs. ANS 3 stated CRNAs “do not ask me for help”. During review of Pt 2’s chart, ANS 3 could recall his participation in the care. ANS 3 recalled that he was “passing through the PACU”. Pt 2 was not doing well, and the nurses asked him to help stabilize the patient until the ICU team arrived. ANS 3 stated he does not “recall” writing orders, and “clearly would have done the same orders, clearly the patient wasn’t stable”. ANS 3 indicated he did not speak to or see CRNA 4 who provided anesthesia care at Pt 2’s bedside. During a concurrent interview with ANS 3 on 5/22/24, at 5:10 p.m., and record review of the Patient 2’s medical record, titled “Anesthesiology Evaluation, Post Anesthesia Evaluation”, ANS 3 acknowledge Pt 2’s post anesthesia evaluation box was “checked yes” by the CRNA 4, indicating patient had no post-operative concerns. ANS 3 stated Pt 2 would “not have looked normal ... or stable” with hypotension (know blood pressure), tachycardia (fast heart rate), tachypnea (fast respiratory rate), low oxygen saturation and change of consciousness. In a telephone interview with CRNA 4, on 5/29/24, at 1:40 p.m., CRNA 4 acknowledged he provided anesthesia services to Patient 2 and was allowed to order medications and tests in the PACU as needed. CRNA 4 stated the hospital allowed them to order controlled medications and practice without physician’s order. CRNA 4 stated his workflow was to signs and leaves PACU Evaluation sheet for nurses to fill in. CRNA 4 could recall he dropped off Pt 2 in PACU with no apparent issues and events happed when he was already out of the hospital. During an interview on 5/29/24 at 6:13 p.m. with AM 1, AM 1 stated a request was made for a meeting with the DCIQ to review RCA for Pt 2 and Pt 3. A requested was made to assist with scheduling a meeting with CRNA 3, CRNA 4, ANS 6 and any PACU nurses that was working with Pt 2. The request was made for any surgeon for either of these cases. AM 1 stated said none of them have been available. Multiple attempts were made to interview CRNA 3, ANS 6, CRNA 4, MD 1 regarding the care and medical record of Pt 2. All attempts were unsuccessful. 3. During review of Patient 3’s medical record, titled “Final Report”, dated 10/13/23, at 12:48 PM, written by Medical Doctor 7 (MD 7) in ICU (Intensive Care Unit), the record indicated Patient 3 was admitted to hospital for elective knee surgery, but the surgery was not performed due to “anaphylactic shock ( a type of allergic reaction), cardiac arrest (heart stopped beating), and acute respiratory failure with hypoxia (unable to breath with drop in blood oxygen)” right after anesthesia induction (start of anesthesia which uses drugs called anesthetics to keep patient comfortable and prevent from feeling pain during medical procedures). During a record review of the Patient 3’s medical record, titled “Preoperative Evaluation (before surgery and anesthesia [anesthesia uses drugs called anesthetics to keep patient comfortable and prevent from feeling pain during medical procedures]), dated 10/13/23, and no time stamp, handwritten by CRNA 3, the record indicated Patient 3 was having knee surgery and at minimal risk for anesthesia complications. The record did not show documented evidence of respiratory rate (normal 12 -16 breaths per minute), heart rate (normal 60-100), blood pressure (normal 120/80), mental status, or oxygen saturation (percent of oxygen blood, normal 95-100%, breathing air well). The record did not indicate an examination of the extremities or abdomen (stomach) area. The record and the anesthesia plan did not show documented evidence that CRNA 3 considered Patient 3’s diabetes (blood sugar disease) diagnosis and history of pain medication use. The record did not show documented evidence that CRNA 3 was enacting a treatment regimen ordered by a physician. Review of Patient 3’s paper record, titled “Anesthesia Record” (record of medications given and monitoring performed during the surgery when the patient was put to sleep), dated 10/13/23, written by CRNA 3, the record indicated a wide range of medications administered during the period of 7:06 AM to 8:45 AM on 10/13/23. The following medications marked as given: i. Sevoflurane Anesthesia gas (an inhalation gas used to put patient to sleep during surgery and can decrease blood pressure and heart rate), ii. Fentanyl 100 mcg (“mcg”, microgram, a unit of measure; opioid pain medication that can decrease or stop breathing), iii. Versed (midazolam) 2 mg (“mg” or milligram, a unit of measure; a sedative and anti-anxiety medication; slow heart rate and lower blood pressure), iv. Propofol a total of 200 mg (high risk sedative that can decrease or stop breathing), v. Anectine 100mg (succinylcholine; a muscle paralyzing agent; cause paralyses all muscle function, such as breathing), vi. Albumin 25%- 25 mL (a human blood component; “%” or percent was a measure of concentration and “mL” is milliliter, a measure of volume), vii. Ancef (or cefazolin, an antibiotic) 2 gm, viii. Norepinephrine (or Levophed, used to raise the blood pressure) no dosage indicated, ix. Epinephrine (used to treat low blood pressure and allergic reaction) entered as “100” for the dosage, x. Hydrocortisone (a steroid, anti-inflammation drug) 100 mg, xi. Epinephrine IV drip; No marked dosage or concentration, xii. IV fluid, Lactated Ringers 3 liter (“liter” is measure of volume, xiii. Benadryl (or Diphenhydramine, used for allergy) 100mg, xiv. Famotidine 20mg (ulcer medication, also used for allergy), xv. Tranexamic acid (or TXA- used to stop or prevent bleeding) 1 gm. The record did not indicate anthere was a treatment regimen ordered by a physician for Patient 3. The record indicated during the intra-operative period CRNA 3 procured, prescribed, and administered “High Risk Medications” (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing, lowered blood pressure, change of heart rate, and paralyzed the body’s movement as follow: Propofol (high risk sedative that can decrease or stop breathing), an anesthesia gas called Sevoflurane (volatile anesthetic that provides hypnosis, amnesia during surgery and can decrease blood pressure and heart rate), succinylcholine (medication that cause paralyses all muscle function, such as breathing), versed (sedating medication slow heart rate, and low blood pressure) and fentanyl (a powerful opioid that could contribute to stopped breathing) Further review of the documented intra-operative events, the medication use response to interventions and treatment, were not completed, unclear and/or illegible. The document timeline after 7:15 a.m., there was no documented presence of carbon dioxide (gas expelled during exhalation and indicates a breathing tube in the lungs), respirations (breathing in oxygen and breathing out carbon dioxide), ventilation (machine delivery of oxygen and respirations), oxygen saturation (percent level of blood oxygen), and heart rhythm. During a record review of the Patient 3’s intraoperative record (record from inside Operating Room), titled “Anesthesia Record”, dated 10/13/23, with anesthesia time from 7:06 a.m. to 8:45 a.m., signed and written by CRNA 3, the record indicated “CPR [cardiopulmonary resuscitation, life saving measures to restart the heartbeat]” were started around 7:30 a.m. The record indicated a breathing tube was insert by CRNA 3. The record indicated CRNA 3 administered multiple medications during CPR, but many entries were illegible. The record did not show response to interventions. The record did not show any documented evidence of difficulties with placing the breathing tube or supplying oxygen to Patient 3. After 7:15 a.m., there was no documented evidence of the presence of carbon dioxide (gas expelled during exhalation and indicates a breathing tube in the lungs), respirations, ventilation (machine delivery of oxygen and respirations), oxygen saturation (percent level of blood oxygen), or heart rhythm. CRNA 3 did not document if Patient 3’s breathing tube was removed. There was no documented evidence of Patient 3’s status before leaving the Operating Room (OR, Surgery room). There was no evidence that a physician assumed responsibility for the code as required by hospital policy. There is no documented evidence CRNA 3 followed ACLS (Advanced Cardiac Life Support, life saving measures and medications) per hospital policy. Review of Patient 3’s medical record, titled “Code Blue Record” ( Code blue, a medical emergency that requires immediate intervention when breathing or heart stopped working in a patient), hand recorded by the OR nurse, dated 10/13/23, with time range of 7:36 a.m. to 8:15 a.m., the record indicated that at CPR started at 7:36 AM, and after two minutes, a recorded Heart Rate (HR or heartbeat) of 123 and a normal blood pressure range was recorded. The record written by OR nurse, documented from 7:38 a.m. to 815 a.m., CRNA 3 continued to give medication in rapid succession as follows: At 7:47 Am- Epinephrine drip (given as ongoing infusion) 7:53 AM- Vasopressin 3 units 7:54 AM Phenylephrine 200 mg IV 7: 56 AM - Atropine 0.4 mg IV 7:57 AM- Levophed 4mg drip 7:57 AM- Hydrocortisone 100mg IV 0800 AM- HR 131 and BP was 180/85 08:03 AM- Albumin 25%- 50 mL 8:12 AM- Sodium Bicarbonate 1 amp 8:15 AM- Pepcid 20 mg IV 8:29 AM- “Patient transferred to PACU in stable but critical condition.” The documented code blue record did not provide any evidence that CRNA 3 followed hospital’s policy and the ACLS guidelines on medications and procedures for code blue. During a review of Patient 3’s medical record, titled “Orders” (medication, tests, and treatment orders), dated 10/13/23, the record indicated CRNA 3 was described in Electronic Medical Record (EMR) as the “Ordering Physician”, “Responsible Provider”. In addition, CRNA 3 wrote “Orders” for Patient 3 to receive “routine Fresh Frozen Plasma” (FFP- blood product given to patients with abnormal clotting or active bleeding and can have life-threatening reactions) for “active bleed” and “angioedema [systemic swelling under the skin]” outside of a treatment regimen ordered by a physician. The record further indicated a verbal order to nursing staff in PACU to start a “routine” infusion of “Norepi (or Norepinephrine, medication to increase blood pressure)” outside of a treatment regimen ordered by a physician. There was no documented evidence Patient 3 had surgery or bleeding or other conditions for which the Food and Drug Administration (FDA, a federal agency that regulates drug use) has approved those medications to treat. During Review of Patient 3’s medical Record, titled “SOAP Note” (SOAP stands for Subjective, Objective, Assessment and Plan, a format to explain facts and events in the medical record), dated 10/15/23, at 9: 32 AM, written by Certified Registered Nurse Anesthetic 3 (CRNA 3), the note indicated Patient 3 experienced low blood pressure and an apparent allergic reaction after anesthesia induction (means putting patient to sleep by use of drugs to prevent from feeling pain during the procedure or surgery while monitoring the breathing) in preparation for surgery. CRNA 3’s note indicated prior to start of anesthesia, an antibiotic called “Ancef”, and a steroid called “Decadron” (medication used to reduce inflammation) was administered concurrently. The CRNA note described the medications use and events during emergency resuscitation (medical efforts to start the heartbeat and breathing) of Patient 3. The CRNA 3’s documented intra operative events indicated that there were difficulties with the airway and had to “pin the tongue ... and perform a digit intubation ...ventilation proved challenging ...with peak pressures exceeding 50 [resistance to giving oxygen via a breathing tube. Allowing pressures over 40 can cause lung injury] to the patient”. CRNA 3 documented that “successful return of spontaneous circulation was achieved after one round [one dose] of epinephrine and chest compressions. The CRNA’s note further indicated when Resident 3 was transferred to PACU (Post-Anesthesia Care Unit; a hospital that stabilized the patient right after the surgery) “The patient still had significant tongue swelling ... In response, I gave 1 gram of Tranexamic Acid (also known as TXA, a drug used to treat bleeding or control bleeding) and ordered FFP (Fresh Frozen Plasma; a blood product given for bleeding or at risk of bleeding) as well as relevant lab test and imaging.” The note did not describe the clinical reason for use of TXA and FFP in the setting of apparent allergic reaction, or how those medications were administered in the course of carrying out a treatment regimen ordered by a physician. During review of the Patient 3’s medical record, titled “Consultation Note”, dated 10/16/23, at 11:31 a.m., written by MD 7, the record indicated Patient 3 suffered a “Pneumothorax [puncture of the lung], right” as evidenced on chest x-ray. The record further indicated “Review of OR records do not show any clear cardiac arrest records etc. and raises suspicion of anaphylaxis or at least a drug reaction”. There was no documented evidence of a lung procedures to cause pneumothorax, except for intubation performed by CRNA 3 on 10/13/23. During three concurrent interviews and record review 1. on 5/22/2024 at 9:40 a.m., with Chief of Anesthesia (ANS 1, accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and Director of Clinical Quality and Performance Improvement (DCQI), 2. on 5/29/2024 at 10:10 a.m. with ANS 1 accompanied by DCQI, and 3. on 5/29/2024 at 4:14 p.m. with ANS 1 accompanied by RNQ 1, hospital policies, processes, and patient medical records, including Pt 3, were discussed. The ANS 1 stated that he was familiar with Patient 3 and reviewed the records and care provided by CRNA 3. Patient 3’s intra-operative anesthesia record, Code Blue records, post anesthesia records, and PACU order and labs were reviewed with ANS 1. ANS 1 acknowledged CRNA 3’s anesthesia records were incomplete. ANS 3 acknowledged that CRNA 3 ordered TXA, FFP and albumin for an allergic reaction. ANS 1 stated he had “never heard” of treating allergic reactions in this manner. ANS 1 indicated he was “unsure” what “FDA [Federal Drug Administration, approves the safe effective use of medication] approval” meant. ANS 1 stated he “did not know” if FFP, TXA and albumin was FDA approved for allergic reactions. ANS 1 stated the primary provider was CRNA 3 and “qualified to run a code” order medications and direct medical care. ANS 1 stated if the CRNA 3 had “any concerns with a case” would have discussed with an anesthesiologist. Review of American Heart Association guidelines for Advanced Cardiopulmonary Life Support (ACLS) and emergency cardiovascular care, last revised on 2020, the ACLS guidelines, last accessed on 6/8/24, via https://cpr.heart.org/en/resuscitation-science/cpr-and-ecc-guidelines/adult-basic-and-advanced-life-support , the section on medication management in cardiac arrest indicated “it is reasonable to administer epinephrine 1 mg every 3 to 5 min for cardiac arrest ... Vasopressin alone or vasopressin in combination with epinephrine may be considered in cardiac arrest but offers no advantage as a substitute for epinephrine in cardiac arrest ... Routine administration of calcium for treatment of cardiac arrest is not recommended ... Routine use of sodium bicarbonate is not recommended for patients in cardiac arrest.” The guideline also emphasized to treat reversible causes of cardiac arrest. Review of the facility’s policy, titled “Code Blue-Code White Procedure”, last approved on 11/30/22, the policy indicated the code team will consist of nursing, respiratory therapist, and emergency department physician, Hospitalist (doctors that work only in hospital), attending physician (the main doctor) or physicians trained in advanced life support. The policy further indicated “the physician assumes responsibility for the code. ER physician may call unit to verify need to response.” The policy further included an attachment on how to manage the after-surgery code blue following the heart surgery. The Policy attachment indicated “DO NOT GIVE EPINEPHRINE unless a senior doctor advises this.” During an interview on 5/29/24 at 6:13 p.m. AM 1, AM 1 a request was made for a meeting with the DCIQ to review RCA for Pt 2 and Pt 3. A requested was made to assist with scheduling a meeting with CRNA 3, CRNA 4, ANS 6 and any PACU nurses that was working with Pt 2. The request was made for any surgeon for either of these cases. AM 1 stated said none of them have been available. 4. During a review of Patient (Pt) 4’s “History and Physical (H&P)”, dated 5/15/24, written by Medical Doctor 1 (MD 1), the “H&P” indicated Pt 4 was a 71 year old with past medical history of Hiatal Hernia (when part of the stomach stick out up into the chest through the sheet of muscle called the diaphragm), Hypertension (high blood pressure inside vessels in the body), and Sleep Apnea (serious sleep disorder that happens when breathing stops and starts while you are asleep). The H&P indicated Pt 4 presented to the facility on 5/15/24 for planned Esophagogastroduodenoscopy/Colonoscopy (or EGD - a lighted camera on the end of a tube passed down throat to visualize inside body and stomach; Colonoscopy a procedure using long flexible tube with camera to check inside the entire large intestine) procedure. During an interview with CRNA 1, on 5/15/24, at 12:18 p.m., CRNA 1 stated all CRNAs worked independently and had the anesthesiologist in charge available if they had any questions or for an emergency Code Blue event. CRNA 1 stated he could order any labs, give narcotics, and order testing as needed for patient condition without a treatment regimen ordered by a physician preoperative (before surgery), intra-operative (during surgery) and post anesthesia care unit (PACU - Specialized unit where patients are sent after surgery to recover from anesthesia and wake up). CRNA 1 stated he did not need an individualized treatment regimen ordered by a physician for every patient before providing anesthesia services. CRNA 1 stated he only discussed cases if there was anything unusual or patient was not a candidate for Moderate Sedation (A drug-induced state of sleep but able to communicate with doctors). CRNA 1 sated if the cases were booked in endoscopy with Anesthesia, then CRNA could decide anesthesia plan for the patients and only needed to discuss with physician performing the procedure if there were any concerns. During an observation of Pt 4’s EGD/Colonoscopy procedure, with RNQ 1, on 5/15/24, at 12:42 p.m., CRNA 1 was observed administering propofol (medication used for induction and maintenance of general anesthesia) to Pt 4 during the procedure without a treatment regimen ordered by a physician. During a concurrent review of Pt 4’s medical record, titled “History and Physical/Admission Note” (H&P), written by MD 1, with RNQ 1, on 5/16/24, at 9:30 a.m., the H&P record was dated 5/15/24 indicated “Sedation plan ...Sedation/Analgesia [class of drugs, designed to relieve pain]: Moderate Sedation ...” During a concurrent interview and record review on 5/16/24, at 9:34 a.m., with RNQ1, Pt 4’s “physician orders- For use during gastrointestinal (GI) endoscopy [EGD/Colonoscopy] procedure” written by Medical Doctor (MD)1 on 5/15/24 were reviewed. The “physician orders- For use during GI endoscopy [EGD/Colonoscopy] procedure” indicated the following orders: i. “ ...Atropine (medication for heart rhythm problem) ...Entered and Electronically signed by: [MD1] on 05/15/2024 09:28 [a.m.]. Order details: 0.5 milligram (mg - unit of measurement =1.25 milliliter (mL- Unit of measurement), Injection, Intravenous (IV- administers fluids, medications, and nutrients directly into vein) Push ...Comment: Atropine 0.5 mg IV push [a process of introducing a medication or fluid substance directly into the bloodstream via the venous system] every 5 minutes [as needed] for [slower than normal heart rate] as directed by Physician. For use during GI endoscopy procedure only ...” ii. “Diphenhydramine (medication to relieve symptoms of allergy, hay fever, and the common cold) ... Entered and Electronically signed by: [MD1] on 05/15/2024 09:28 [a.m.]... Order details: 50mg = 1 ml, Injection, IV Push as directed ...Comment: PRN (as needed) as physician instruction during endoscopy. For use during GI endoscopy procedure only ...” iii. “Fentanyl (medication used for pain relief and anesthesia) ...Entered and Electronically signed by: [MD 1] on 5/15/24 09:28 [a.m.]. Order details: 1 mL, Injection, IV push, [every two minutes] - [as needed] for Sedation ...Comment: prn moderate sedation as directed by Physician. For use during GI endoscopy procedure only ...” iv. “Flumazenil (medication use to treat drowsiness caused by sedatives following surgery or drug overdose). Entered and electronically signed by: [MD 1] on 5/15/24 09:28 [a.m.] ...Order details: 0.2mg = 2 mL, IV, One Time Unscheduled ...Comment: flumazenil 0.2 mg IV push every minute prn over-sedation. For use during GI endoscopy procedure only ....” v. “Meperidine (pain medication to treat moderate to severe pain) ...Entered and Electronically signed by: [MD 1] on 5/15/24 09:28 [a.m.]. Order detail: 25 mg= 1 mL, IV Push, [every two minutes], PRN: Sedation ...Comment: prn moderate sedation as directed by Physician. For use during GI endoscopy procedure only ...” vi. “Midazolam (medication used to produce sleepiness or drowsiness and relieve anxiety before surgery or certain procedure) ... Entered and Electronically signed by: [MD 1] on 5/15/24 09:28 [a.m.]. Order detail: 2 mg = 2 mL, IV Push, [Every two minutes], PRN: Sedation ...Comment: prn moderate sedation as directed by Physician. For use during GI endoscopy procedure only. vii. “Naloxone (medication to treat narcotic overdose in an emergency) ... Entered and Electronically signed by: [MD 1] on 5/15/24 09:28 [a.m.]. Order detail:0.4 mg = 1 mL, IV, As Directed ...Comment: Give [brand name, a medication that reverses the effects of opioids] 0.4mg iv push [Every three minutes as needed] narcotic depression. For use during GI endoscopy procedure only ...”. RNQ 1 stated she was unable to find order for propofol (a sedative drug used to put the patient to sleep) to be used for Pt 4 during procedure by MD 1 or any other physician in Pt 4’s medical record. During a record review of the Pt 4’s preoperative medical record, (before surgery and anesthesia), titled “Anesthesiologist [physician that provides anesthesia] Evaluation”, dated 5/15/24, at 12:20 p.m., handwritten by CRNA 1 there was no documented evidence of vital signs (weight, blood pressure, heart rate and rhythm, respiratory rate, oxygen saturation (estimate percent of oxygen in the blood) nor an examination of the abdomen (stomach). CRNA 1 documented “reviewed” for documentation requirements of vitals, medical problems, past surgical history, laboratory values and review of systems (patient subjective complaints by body part). There was no documented evidence CRNA 1 reviewed Pt 4’s past medical history of sleep apnea (periods of not breathing during sleep), high blood pressure, home medications, obesity at 246 pounds, breast cancer or breast surgery. There is no documented evidence CRNA 1 considered the patient’s high risk for respiratory distress or failure when choosing anesthesia medications, nor that CRNA 1 was following a treatment regimen ordered by a physician. During a record review of the Pt 4’s intra-operative medical record (events during procedure), titled “Anesthesia Record”, dated 5/15/24, at 12:38 p.m., handwritten by CRNA 1, the record indicated CRNA 1 provided anesthesia services during procedure without a treatment regimen ordered by a physician. The record indicated during the intra-operative period CRNA 1 procured, prescribed, and administered “High Risk Medications” (drugs with highest risk of causing significant patient harm or death) as follow: fentanyl (strong opioids/narcotics that can decrease or stop breathing) and propofol (high risk sedative that can decrease or stop breathing), versed (sedative drug used to put patient to sleep and forget and decrease breathing). The record further indicated the use of lidocaine (local anesthetic that can slow heart rate and breathing) and Robinul (or glycopyrrolate, used to reduce stomach secretions and slow heart rate) and Reglan (metoclopramide, anti-nausea medication). Further review of the documented intra-operative events, the medication use response to interventions and treatment were not completed. Documentation was illegible or absent for respiratory rate, oxygen saturation, oxygen deliver, and carbon dioxide (gas expelled during exhalation and indicates a breathing tube in the lungs). At the end of anesthesia care, medications (such as opioids, propofol, local anesthetics, and so forth) were not reconciled by CRNA. During a concurrent interview and review of Pt 4’s record, titled “Routine Post -Anesthesia orders for PACU/POCU”, on 5/15/24, at 1:35 p.m., with Registered Nurse (RN) 6, the record appeared to be a photocopy of an order set that have been modified with handwritten orders and crossed out orders, signed by CRNA 1 under the column that states physician. RN 6 stated these were valid PACU orders and all CRNAs use this document for PACU orders. RN 6 stated CRNAs gave orders for medications and PACU nursing team will administer after pharmacy verified the orders. RN 6 stated nurses could remove medication from Automated Dispensing Machine (ADM, a computerized medication storage unit that tracked medication removal) when orders not quickly processed by pharmacy by putting CRNA as the ordering provider in the ADM. The document “Routine Post -Anesthesia orders for PACU/POCU” listed orders for ondansetron (Zofran, anti-nausea drug), IV fluid Lactated Ringers, and three hand-written orders as follow: 1. Labetalol 5 mg (“mg” is milligram, a unit of measure; med used to lower blood pressure) for SBP (or Systolic Blood Pressure; the pressure blood pushing against artery walls when the heart beats; normal level is between 120-129) more than 180; every 10 minutes up to 20 mg total dose. 2. Hydralazine (drug to treat high blood pressure) 5mg if Heart Rate (or heartbeat; normal level is between 60-100 beats per minute) less than 60; as needed; SBP more than 180; every 10 minutes up to 20 mg total dose. 3. Fentanyl 25 mcg (“mcg” is microgram, a unit of measure) IV for mild to moderate pain; every 10 minutes up to 100 mcg total dose. RN 6 stated these orders were all valid order and if Pt 4 needed these medications she would administer as needed. RN 6 validated no signature by any physician and only CRNA1 signature on the document “Routine Post-Anesthesia Orders for PACU/POCU”. During a concurrent interview and record review on 5/16/24, at 9:30 a.m., with RNQ 1, Pt 4’s “Post-Anesthesia Evaluation” dated 5/15/24, signed by CRNA 1 was reviewed. The “Post-Anesthesia Evaluation” indicated that evaluation form was not filled out, no marking or comments indicating any system was assessed. The document only had signature, date, and time. No assessment documented or any notes indicating it was completed. The record had no documented evidence that CRNA 1 evaluated Pt 4 during the post-operative period or determined if Pt 4’s had stable vital signs (blood pressure, heart rate, respiration, oxygen saturation), any pain, confusion and sufficiently recovered from anesthesia to go home. RNQ1 stated unable to tell if the assessment was completed. During a concurrent interview and record review on 5/20/24 at 3:40 p.m., with CRNA 1 and RNQ 1, Pt 4’s “Anesthesia Evaluation” was reviewed. CRNA 1 validated that there was no treatment regimen ordered by a physician for Pt 4. CRNA 1 validated that Pt 4’s was only evaluated by him for anesthesia. CRNA 1 stated all cases booked under endoscopy department are assumed to be MAC and he could independently decide what medication to order and administer to the patients without following a treatment regimen ordered by a physician. CRNA 1 stated he only communicated with the surgeon or anesthesia in charge his plan for anything unusual and Pt 4 did not require anything unusual. During a concurrent interview and record review on 5/20/24, at 3:40 p.m., with CRNA 1 and accompanied by Registered Nurse for Quality (RNQ 1), the medical records dated 5/15/2024 for Patient 4’s outpatient procedure and policy were reviewed with CRNA 1. During the record review of the Pt 4’s preoperative (before surgery and anesthesia) record, titled “Anesthesiologist [physician that provides anesthesia] Evaluation”, CRNA 1 stated he did not recall care he provided to Pt 4 that occurred a few days before the interview. CRNA 1 stated the “endo [examination to the upper and lower GI track] cases are very fast” and to be “efficient” he wrote “reviewed” on the pre-op sections, and anesthesia paperwork was completed during the case. CRNA 1 stated CRNA’s “decides” on the anesthesia plan, medications for patients “not the surgeon”, and if are any concerns will speak with the anesthesiologist or a colleague. CRNA 1 indicated to be “efficient” he wrote “reviewed” on the pre-op sections, and anesthesia paperwork was completed during the case. During a concurrent interview and record review on 5/20/24, at 3:40 p.m., with CRNA 1 and accompanied by RNQ 1, the medical records dated 5/15/2024 for Patient 4’s outpatient procedure and policy were reviewed with CRNA 1. The review of the Pt 4’s intra-operative record (event during the procedure), titled “Anesthesia Record”, the CRNA 1 acknowledged his intra-operative anesthesia record was incomplete. CRNA 1 stated monitoring and documenting patient’s respiratory rate, oxygen (O2) delivery method, and patient status were not required. CRNA 1 acknowledged for a 30-minute case, he obtained, prescribed, and administered high risk medications-- Propofol 200mg, versed 2mg, glycopyrrolate and Reglan to an elderly pt with obstructive sleep apnea and hypertension who did not have a history of medication tolerance or use. CRNA 1 acknowledged he was not aware of Pt 4’s past medical history, and the medications administered placed the Pt 4 at risk for respiratory complications and death. During a concurrent interview and record review on 5/20/24, at 3:55 p.m. with CRNA 1 and RNQ1, Pt 4’s “Routine Post -Anesthesia orders for PACU/POCU” were reviewed. CRNA 1 stated these were standard orders that one of the Anesthesiologists had written down and all CRNAs use the same orders as needed for their patients. The CRNA 1 stated photocopies of this form used and signed under the column where it stated “physicians’ signature” for all endo patients. CRNA 1 stated he was unaware if this order set with handwritten modification was approved for use by any of the hospital committees. During a concurrent interview and record review on 5/20/24 at 4:10 p.m. with CRNA 1 and RNQ1, Pt 4’s “Post-Anesthesia Evaluation”, dated 5/15/24 was reviewed. The “Post- Anesthesia Evaluation” indicated it was signed by CRNA 1 on 5/15/24 at 1:45 p.m. The “Post- Anesthesia Evaluation” had section to evaluate respiratory function, cardiovascular function (pulse and blood pressure in normal limit), mental status (arousable and able to follow commands), Temperature (with in normal limits) pain (with in expected parameters), nausea (no nausea and vomiting), hydration (appears adequately hydrated) and space to write additional comments. The “Post- Anesthesia Evaluation” indicated no marking, no assessment documented for any systems and appeared blank. CRNA 1 stated “post anesthesia evaluation” was completed by the PACU RN. CRNA 1 stated he just signed it and left it for PACU RNs to fill out evaluation before discharge. CRNA 1 stated PACU RNs would call him if they had any concerns with the patients before discharge. During a review of the facility’s policy and procedure titled, “OR.1.29 Provision of Anesthesia Services”, dated 10/27/21, the “P&P” indicated, “ ...A post-anesthesia evaluation must be completed and documented no later than 48 hours after surgery or a procedure requiring anesthesia services. The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation must be completed and documented by any practitioner who is qualified to administer anesthesia as noted in this section of the policy. The evaluation may not begin until the patient is sufficiently recovered from the acute administration of the anesthesia to participate in the evaluation, (e.g., answer questions appropriately, perform simple tasks, etc.) The evaluation can occur in the PACU/ICU or other designated recovery location ...The elements of an adequate post-anesthesia evaluation should be clearly documented and conform to current standards of anesthesia care, including ...Respiratory function, including respiratory rate, airway patency [the ability of the airway to remain open and allow for adequate airflow], and oxygen saturation ...Cardiovascular function, including pulse rate and blood pressure ...Mental status ...Temperature ...Pain ...Nausea and vomiting ...Post-operative hydration ....Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary ...” During an interview and concurrent record review on 5/21/24, at 2:30 p.m. with Medical Doctor (MD 1) accompanied by Quality Registered Nurse (RNQ 1), the medical records of Patient 4 (Pt 4) admitted to the facility on 5/15/24 was reviewed and discussed. MD 1 stated she did not supervise, provide medical direction, or write orders for CRNAs. MD 1 stated the “anesthesia department is in charge of CRNAs and monitoring”. MD 1 stated that, “I don’t think CRNA can diagnosis, prescribe, write orders.” MD 1 stated if CRNA were providing anesthesia care, she would have had a “conversation” with CRNA, but the anesthesiologist was “responsible for the care provided by CRNAs”. During a concurrent interview and record review on 5/21/24, at 2:51 p.m., with MD 1, Pt 4’s physician orders and medical records were reviewed. MD 1 stated she was familiar with Pt 4 and was the physician performing EGD/Colonoscopy. MD 1 stated plan for anesthesia and intraoperative orders belonged to anesthesia department. MD 1 stated she “have no oversight of the CRNA or Anesthesiologist, not my job”. MD 1 stated she would not be involved with ordering medications when anesthesia provider was present for the case. MD 1 stated PACU order and assessment should have come from person administering Anesthesia. Physician orders placed by MD 1 for Pt 4 for use during GI procedure was reviewed. MD 1 stated those orders were for only moderate sedation and if she did her own sedation without anesthesia provider, then the nursing staff used those orders. MD 1 stated If anesthesia was involved, they would do their own sedation. MD 1 stated If insurance did not cover or if the patient did not want anesthesia, then these orders was placed for use during GI procedure instead of anesthesia services. MD 1 stated she did not provide any orders for CRNAs and CRNAs supposed to get order and support from their supervising anesthesiologist. During an interview on 5/16/24 at 3:50 p.m. with Chief of Anesthesia (ANS 1), ANS 1 stated CRNAs are the primary responsible for patients and assume liability if they are providing anesthesia services. ANS 1 stated CRNAs performed interviews with the patient, they come up with the anesthesia plan and they wrote PACU orders. ANS 1 stated patient with American Society of Anesthesiologists (ASA) I & II category (classification uses a grading system of “I” [one] through “V” [five], with “I” identify a person in good health and “V” as a person with a severe, life-threatening condition) did not get reviewed. ANS 1 stated patient with ASA III or higher get reviewed and evaluated by Anesthesia in charge. ANS 1 stated CRNAs are privileged to do all anesthesia cases like anesthesiologist. ANS 1 stated Anesthesiologist did the high-risk cases. During an interview with ANS 1, on 5/29/24, at 10:10 a.m., the ANS 1 stated post-Anesthesia evaluation should have been completed prior to discharge and should have been completed by CRNA and/or MD Anesthesiologist, not by PACU RN. ANS 1 stated MD or CRNA would have discussed the transition plan as needed for the patients in PACU with nursing staff. ANS 1 stated if the patient met all parameters, then the anesthesia provider would check the box, or add additional charting as needed per patient assessment. ANS 1 stated the correct process was to fill out the form when the patient was ready for discharge. ANS 1 stated PACU RN should have called either CRNA or Anesthesiologists if any concerns with patient condition. ANS 1 stated without comments or marking on the form it would be considered incomplete. During a joint interview with ADOP, RPH 1 and RPH 3, on 5/30/24, between 11:03 a.m. to 12:07 p.m., when asked if a respiratory rate (breathing pattern) was required to be monitored when a provider administered a combination of opiates (a substance used to treat pain or cause sleep) benzodiazepine (sedative drugs that could affect breathing) and high dose propofol in span of 15-20 minutes to an elderly patient with history of sleep apnea, RPH 3 responded “it must be monitored” and stated there was a need to look into these practices as a team of nursing, pharmacy and providers. 5. During review of Patient 5’s medical record, titled “History and Physical/Admission Notes”, dated 11/15/23, written by Medical Doctor 10 (MD 10), the record indicated Patient 5 was a 91 year old with diagnosis of end-stage renal disease on dialysis (kidney was not working well and blood had to be filtered by a machine called dialysis) was admitted to hospital to be evaluated for rectal (or rectum) bleeding and anemia (low blood counts). The record further indicated the heart doctor recommended “conservative treatment” due to age and other medical conditions. During a review of the Pt 5’s medical record, titled “Code Record, Code Blue, Rapid assessment Team Record”, dated 11/19/23 at 1:46 p.m., the record indicated a rapid response was called at 12:25 p.m. because of “unexpected/uncontrolled bleeding” and “active, massive rectal bleeding”. The chart indicated Pt 5 had a low blood pressure, fast heart rate and fast breathing. Pt 5 was transferred to ICU. She was given intravenous (IV- fluid via a vein) fluids and blood transfusions. During a record review of the Pt 5’s medical record, titled “preoperative (before surgery and anesthesia form titled “Anesthesiologist [physician that provides anesthesia] Evaluation”, dated 11/19/23, at 11:00 a.m., handwritten by CRNA 6, the record indicated CRNA 6 provided a pre-operative evaluation. CRNA 6 indicated Pt 5 was ill and suffering from low blood pressure, fast heart rate, low blood counts and gastrointestinal (GI- stomach and intestine) bleeding. CRNA 6 indicated Pt 5 was at risk for anesthesia complications. The record did not have documented evidence of an examination of the abdomen (stomach) area or extent of active GI bleeding. When making an anesthesia plan, there was no documented evidence CRNA 6 considered the patients active medical problems or was following a treatment regimen ordered by a physician. During a record review of the Pt 5’s intraoperative (events during surgery) medical record, titled “Anesthesia Record”, dated 11/19/23, with anesthesia time range of 12:28 p.m. to 1:32 p.m., and surgery time 12:42 to 12:59 p.m., handwritten by CRNA 6, the record indicated that CRNA 6 provided anesthesia services during surgery without a treatment regimen ordered by a physician. The handwritten record was difficult to read and illegible to detail of dose and drug name. The record indicated during the intra-operative period CRNA 6 procured, prescribed, and administered “High Risk Medications” (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing, lowered blood pressure, change of heart rate, and paralyzed the body’s movement as follow: Propofol (high risk sedative that can decrease or stop breathing), an anesthesia gas called Sevoflurane (volatile anesthetic that provides hypnosis, amnesia during surgery and can decrease blood pressure and heart rate), and glycopyrrolate (medication to decrease secretions. It can decrease or stop heartbeat, and not used in patients that are bleeding with heart problems). Further review of the documented intra-operative events, glycopyrrolate was given. The record indicated right after glycopyrrolate administration, Pt 5’s heart rate and blood pressure were not recorded, and “CPR [cardiopulmonary resuscitation, lifesaving efforts]” was started. The record indicated a breathing tube was inserted at 1:00 p.m. during CPR, the chart indicated CRNA 6 prescribed and administered multiple medications, but the names and times were illegible. The response to interventions and treatment were not documented or illegible. The “code called [death of the patient] at 1:32 p.m. ...no pulse, no CO2 [carbon dioxide, gas exhaled when breathing]”. The record indicated Pt 5 expired in the OR. However, the record also indicated CRNA 6 continued to record blood pressures at 1:30 p.m., 1:35 p.m. and 1:40 p.m. CRNA also documented, “procedure completed ...returned to PACU ...w/ VSS (Vital Signs Stable; that is, normal blood pressure, heart rate, breathing, oxygenation) ...report given to the PACU nurse. There was no documented evidence by CRNA 6 and who assisted him with Pt 5’s code. There was no documented evidence CRNA 6 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines, medications, and procedures. At the end of anesthesia intraoperative care, medications (such as opioids, propofol, local anesthetics, heart medication, blood pressure and so forth) were not reconciled by CRNA 6. During a review of the Pt 5’s medical record, titled “Nursing/Clinical Info”, dated 11/19/23 at 8:43 p.m., the nurse documentation indicated two anesthesiologists (ANS 3 and ANS 6) and a CRNA entered the operating room to assist in Pt 5’s code. The OR nurse documented ANS 3 and ANS 6 attempted to place “central lines [large IV line placed in the neck]”. At 1:32 p.m., the OR nurse documented that ANS 3, ANS 6, and MD 8 ended life saving measures “due to no pulse and no ETCO2 [carbon dioxide gas expelled when exhaling]”. There was no documented evidence that ANS 3 or ANS 6 wrote a note regarding the participation in Pt 5’s care, medical interventions, nor the patient’s response. There was no documented evidence of a title “Code Blue Record” form completed per policy. During a review of the Pt 5’s medical record, titled, “Nursing Surgical Documentation”, dated 11/19/23, at 8:43 p.m., the OR (Operating Room) nurse documented the GI Physician (MD 6), entered at 12:28 p.m. The nurse documented that the procedure was “attempted”, from 12:42 to 12:46 p.m. and again at 12:50 p.m. to 12:58 p.m. but “unable to complete due to patient blood pressure and bradycardia [low heart rate]” and “patient [was] intubated”. The OR nurse documented at 1:00 p.m., the “code” started, and “additional help for code” from two Anesthesiologists (ANS 3 and ANS 6) and another CRNA, started to arrive at 12:59 p.m. The OR nurse documented that the “Intraoperative Procedure Not Performed”. During a record review of the Pt 5’s medical record, titled, “Nursing/Clinical Info”, dated 11/19/23, at 8:43 p.m., the nursing documentation indicated that Pt 5 became “hypotensive [low blood pressure] and bradycardic [slow heart rate, below 60] despite medical interventions by CRNA 6 ... At 12:58 the nursing staff called for anesthesia help and the Charge Nurse for the OR”. The record indicated Anesthesiologists (ANS 3 and ANS 6) and another CRNA arrived to help. The OR nurse documented “Intervention medications initiated by anesthesia team at 12:59 p.m. which included 8 rounds of Epinephrine (helped raise the blood pressure), 5 rounds of bicarb (“bicarb” is same as Sodium Bicarbonate, used to help with blood acidity), 2 doses of CaCl (“CaCl” same as Calcium Chloride, a high dose of calcium used to reverse high potassium level in body), 4 doses of atropine (drug used to treat slow heartbeat), 1 dose of vasopressin (drug used to raise blood pressure), fluid bolus (giving IV fluid), and Epi drip( infusion of Epinephrine)”. The OR nurse documented that ANS 3, ANS 6, and MD 6 ended life saving measures “due to no pulse and no ETCO2.” There was no documented evidence of a titled “Code Blue Record” form was completed per policy. There was no documented evidence indicating the amount, dose, or times of medications, nor patient response to treatment, such as blood pressure, heart rate, heart rhythm, respiration, oxygen levels, etc. There was no documented evidence CRNA 6 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines, medications, and procedures. During a concurrent interview with CRNA 6 on 5/22/24, at 10:13 AM, and record review of the Pt 5’s medical records titled “Anesthesia Record”, handwritten by CRNA 6, the nursing “Surgical Documentation”, dated 11/19/23, at 8:43 p.m., and the “Nursing/Clinical Info” dated 11/19/23, CRNA 6 stated he was not in agreement with the nursing entries indicating Pt 5 became unstable during the case, the procedure was “attempted”, but was “unable to complete” due to Pt 5’s low blood pressure and heart rate. CRNA 6 stated he recalled Pt 5, and there were “no problems” during the case. The times and events were reviewed with CRNA 6 verbally. CRNA 6 stated the times and events in the records were correct and stated he was able to get the patient “comfortable” with medications. CRNA 6 indicated, he obtained and administered propofol to Pt 5 and a few minutes later gave Glycopyrrolate. The record indicated the blood pressure and heart rate dropped. Over a two-minute period, the Medical Doctor (MD 8) was able to “place a scope” and examine Pt 5’s esophagus and stomach. After over another two minutes, MD 8, was able to “place a scope” and examine Pt 5’s rectum colon. CRNA 6 stated “at the end of the case”, Pt 5 lost pulses and blood pressure. CRNA 6 stated he ordered and administered medications to treat Pt 5’s blood pressure and loss of pulse (heartbeat). CRNA 6 acknowledged Pt 5 expired in the OR. During a review of the Pt 5’s medical record, titled “Gastrointestinal [stomach and intestine] procedure Note”, written by GI physician (MD 6), dated 11/19/23, at 4:32 p.m., the record indicated Pt 5 had an upper (stomach) GI and lower (rectum and colon) GI procedures, from start to finish, was “completed” in four minutes and there were “no complications”. MD 6 indicated that “patient became hypotensive and bradycardic at the end of the procedure. A code blue was called after termination of the procedure and CPR was initiated ... CPR efforts continued for 35 minutes ...The patient was declared expired at 1:32 p.m.”. During a review of the Pt 5’s medical record, titled “Anesthesiology Evaluation, Post Anesthesia Evaluation” (events after surgery), dated 11/19/23, not timed, was signed by CRNA 5. There was no documented evidence that CRNA 6, explained the outcome of Pt 5’s status in the operating room or follow-up events. During a concurrent interview with CRNA 6 on 5/22/24, at 10:13 a.m., and review of the Pt 5’s medical record, titled “Anesthesiology Evaluation, Post Anesthesia Evaluation”, CRNA 6 acknowledged he ordered post-op medications and signed the form before seeing Pt 5 and before the patient died in the OR. During a review of Pt 5’s medical record, titled “Orders”, dated 11/19/23, written by CRNA 6, the record indicated CRNA 6 was the “Ordering Physician”, “Responsible Provider”, and was authorized by the hospital to place orders for medication, treatments, and tests without a treatment regimen ordered by a physician. The record indicated CRNA 6 ordered the nurses in PACU to administer “High Risk Medications” (drugs with highest risk of causing significant patient harm or death) that could have contributed to patient compromise: Demerol (opioid pain medication, not recommended for elderly and kidney disease), morphine (opioid pain drug with risk of accumulation in kidney disease) , Dilaudid (strong opioids/narcotics that can decrease or stop breathing), Versed for agitation (strong sedative, with risk of breathing problem ) and Phenergan ( treatment for nausea and vomiting with risk associated with injection and breathing issues when used with opioids). There was no documentation CRNA 6 considered Pt 5’s past medical history of renal disease, low blood pressure, age, active bleeding, or potential post-operative medical condition when placing the orders. There was no documented evidence CRNA 6 discussed the medications orders was following a treatment regimen ordered by a physician when he ordered medications for Pt 5. During an interview and concurrent record review on 5/22/24, at 10:13 a.m., with CRNA 6, accompanied by scribe and Director of Clinical Quality Improvement (DCQI), CRNA 6 stated he participated in the care of Pt 5 and was able to discuss the care. CRNA 6 stated the anesthetist can diagnose, prescribe medications, order labs, order treatments, and render medical services to patients; it was all “within [CRNAs] scope of practice” and there are “no limitations” inside the hospital. CRNA 6 indicated he works “independently” without physician orders. CRNA 6 stated sometimes he acted as the “AIC, anesthesiologist in charge”. CRNA 6 stated CRNAs have “independent practice” and the role of the anesthesiologist was to be “available anytime as a resource”. CRNA 6 stated that his usual practice was that he obtained his patient “case list” at the beginning of the day, “without seeing the patients”, wrote “standard orders” for all the cases, and completed the pre-op, intra-op and postop notes before the cases started and without receiving an order for a treatment regimen from a physician. CRNA 6 stated this was an “efficient” use of time. During record review of [Hospital] policy titled, “OR.1.29 Provision of Anesthesia Services”, approved 10/27/2021, stated the purpose of the policy was “to establish a consistent standard-of-care for patients receiving anesthesia services ... The director of anesthesia services is responsible for ... Evaluating the quality and appropriateness of the anesthesia patient care ... The anesthesia service is responsible for developing policies and procedures governing the provision of all categories of anesthesia services ... Individuals Permitted to Administer Anesthesia ... Only those individuals privileged by the medical staff shall be permitted to administer anesthesia. These individuals may include A qualified anesthesiologist, A Doctor of Medicine or osteopathy (focuses on your whole body, including the soft tissues [such as muscles, ligaments and tendons], the spine and nervous system, other than an anesthesiologist); A dentist, oral surgeon, or podiatrist (a person who treats the feet) who is qualified to administer anesthesia under State law ... The privileges granted must be in accordance with State law and organization policy. Review of American Heart Association guidelines for Advanced Cardiopulmonary Life Support (ACLS) and emergency cardiovascular care, last revised on 2020, the ACLS guidelines, last accessed on 6/8/24, via https://cpr.heart.org/en/resuscitation-science/cpr-and-ecc-guidelines/adult-basic-and-advanced-life-support , the section on medication management in cardiac arrest indicated “it is reasonable to administer epinephrine 1 mg every 3 to 5 min for cardiac arrest ... Vasopressin alone or vasopressin in combination with epinephrine may be considered in cardiac arrest but offers no advantage as a substitute for epinephrine in cardiac arrest ... Routine administration of calcium for treatment of cardiac arrest is not recommended ... Routine use of sodium bicarbonate is not recommended for patients in cardiac arrest.” The guideline also emphasized to treat reversible causes of cardiac arrest. During record review of [Hospital] policy titled, “CO-5.007 Operative and Invasive Procedures Appropriateness Review”, approved 10/24/2018, described “the minimum standards for prospective and retrospective review of the appropriateness of operative and invasive procedures through effective use of evidence-based clinical criteria, to appropriately and accurately identify performance trends and patterns, and to monitor and improve ... Hospital’s Peer Review Committee is responsible for providing oversight and peer review of the Operative and Invasive Procedures provided at the Hospital to confirm appropriateness of the Procedures being performed ... Physician documentation that validates the appropriateness of the procedure, including but not limited to: patient clinical condition, non-invasive study results, findings from diagnostic procedures ... shall provide a summary of its findings to the Hospital’s Medical Executive Committee (MEC), which shall report such findings to the Hospital Governing Board”, as outlined in Medical Staff Bylaws. Review of the facility’s policy, titled “Code Blue-Code White Procedure”, last approved on 11/30/22, the policy indicated the code team will consist of nursing, respiratory therapist, and emergency department physician, Hospitalist (doctors that work only in hospital), attending physician (the main doctor) or physicians trained in advanced life support. The policy further indicated “the physician assumes responsibility for the code. ER physician may call unit to verify need to response.” The policy further included an attachment on how to manage the after-surgery code blue following the heart surgery. The Policy attachment indicated “DO NOT GIVE EPINEPHRINE unless a senior doctor advises this.” During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that... “Recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout [Hospital name] Medical Center ... To provide professional performance and utilization of services within the scope of defined clinical privileges, through a systemic credentialing, review, appraisal, and improvement ... Comply with the policies, practices, and procedures at [Hospital name] Medical Center, including the standards and recommendations by The Joint Commission, local, state, and/or federal laws, and regulations ... Adhere to responsibilities as outlined in sponsoring/supervision agreements to allied health professionals (if applicable) ... Only members who hold a medical staff appointment or temporary privileges are eligible to render medical care at [Hospital name] Medical Center ... Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership.” During record review of [Hospital] policy titled, “MEDICAL STAFF RULES AND REGULATIONS”, approved Governing Board, August 24, 2022, indicated that the authorized individual shall write the order, followed by the name of the Practitioner, date and time, name, and signature of the writer ... “AHP [Allied Health Professional] Rules and Regulations, version 2022” indicated that the “Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned.”

“MEDICAL STAFF CREDENTIALING CFR(s): 482.22(a)(2) The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations. A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section. This Standard is not met as evidenced by: 42125 Based on interview and record review, the Medical Staff failed to follow Medical Staff Bylaws, rules and regulations; and failed to consider scope of practice state laws in recommending candidates to the medical staff for 25 of 25 physicians and non-physician providers. The hospital failed to appropriately credential and privilege 13 of 13 CRNAs, three of three surgeons, one of one anesthesiologist, seven of seven Physician Assistants and one of one Nurse Practitioner. These failures resulted in the potential harm of approving medical staff privileges to provide healthcare services to patients who may not be qualified to do so. Findings: During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical Staff Manger, the hospital workflow, polices, patient record logs and staff files were discussed and reviewed. The MST stated the privileging process started with applicants completed an application and specify specialty on the request form. The MST stated according to Bylaws, the granted privileges were based on experience, certification, education, and skill sets as determined by case logs (the number of times provider performed certain tasks or surgery) from school and/or prior jobs, in addition to professional references and criminal background check. The MST stated all the paperwork is placed in the applicant’s file and was passed to the Chief of Department the candidate applied to. The MST acknowledged applicants usually request every privilege listed on the form and the Chief of the Department approved privileges requested usually without stipulation. The MST stated approved privileges should have correlated with education, experience, and the case log. The MST stated the new applicant file was “available” for Governing Board (GB- hold the ultimate responsibility for the hospital’s compliance), the credential committee (CC- review candidate application files and provided recommendations to the GB), and MEC to view. During record review of the privileging staff records the following were noted: “ CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17, and 18 were authorized to diagnosis, order treatments, medications, and therapeutics for patients without a treatment regimen ordered by a physician when they did not have a medical license. “ CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17, and 18 were not required to have physician orders to provide anesthesia care, medications, treatments, and therapeutics. “ CRNA 1, CRNA 2, CRNA 5, CRNA 6, CRNA 13. CRNA 18, PA 1, PA 5, and SUR 8 had procedure logs for privileges, but they did correlate with privileges. “ CRNAs 6, 11, 13 and 17 did not have primary verification of nurse anesthetist education. “ CRNA 3, CRNA 4, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 17, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6, PA 7, and NP 2 did not have signed service agreements by supervising physicians. “ PA 6, PA 7, NP 2, SUR 3, SUR 5, and COS did not have documented evidence of procedures logs required for privileges. “ CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6, PA 7, NP 2, COS, SUR 3, SUR 5, and SUR 8 did not have documented evidence of the “direct” supervised proctoring for privileges required by Medical Staff bylaws. “ CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6, PA 7, NP 2, COS, SUR 3, SUR 5, and SUR 8 did not have documented evidence of professional references. During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the hospital workflow, polices, patient record logs and staff files were discussed and reviewed. The MST stated that they could not determine competency, training, or experience for each provider’s approved privilege for medical services of the 25 of 25 privileging files. The MST stated that they could not determine competency, training or experience because of limited information, confusing entries, and unfamiliar terms. The team acknowledged that the approved privileges were not always consistent with case logs, education, and experience. The MST acknowledged some staff files did not contain case logs from prior employment, school, or residency, professional references, signed service agreements by the supervising physicians. The MST stated case logs were not always obtained for all candidates, education was not always obtained from a primary source, and professional references were only checked if needed by the chief of the department. The MST stated if an AHP or Registered Nurse (RN), such as a RN First Assist (RNFA- RN with training that assists a surgeon during surgery), were employed by the hospital, the medical staff team should have had information regarding scope of practice, education, qualifications, or training. The MST stated the information was needed to be obtained from Human Resources. During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the MST stated there was no written documentation that the CC, MEC or GB reviewed and discussed each applicant’s competency, education, training, certification, or experience. The MST stated the privileging form is approved and signed by the Chief of the Department. The MST acknowledged if the required documents were not present, such as professional references, certifications, case logs, education and training, the privileges would still be granted. The MST indicated there was no documented evidence that each candidate’s file was discussed and recommended by the CC or MEC to the GB. The MST acknowledged there was no documented evidence the GB approved each provider. During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the MST stated CRNAs started applying for privileges at the hospital in June 2023. The MST stated CRNAs were approved as “independent practitioners” with full prescriptive authority. The MST stated CRNAs were the “same as a physician ... anesthesiologist” and were “equivalent”. During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the hospital policy titled, “AHP Rules and Regulations, version 2022” was reviewed which indicated all AHPs required “direct supervision”. The MST stated the definition of “supervision” for CRNAs was that an “anesthesiologist was available to provide support ...and help ... if” requested by the CRNA. The MST stated “new” hospital regulations did not require CRNA to be supervised. The MST indicated that CRNAs were not required to have physician orders or for any aspect of providing anesthesia services, including emergencies, life-threatening events (known as “Code Blue” at the hospital), procedures, or medical care of patients. During two concurrent interviews and record review on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, the MST stated CRNAs were permitted prescribe medication without the physician orders required for CRNAs to act within the scope of their practice The MST stated CRNAs could diagnosis, write orders for any medication, treatment or therapeutics and it was within their “scope of practice”. During a phone interview on 5/23/24, at 12:42 p.m., with the hospital administration team which included, Director of Clinical Quality and Performance Improvement DCQI, Chief Nursing Officer (CNO), Chief Executive Officer, (CEO) and Accreditation Manager, the team acknowledged that unprivileged providers and unsupervised AHPs, including CRNAs, were providing independent medical care. They were diagnosing and treating medical conditions, plus ordering, prescribing, and administering medications, treatments, and therapeutics to patients. During an interview on 5/30/24, at 3:48 p.m., with Chief Of Medical Staff (COS), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and medical staff processes were discussed. The COS stated she was “familiar” and “follows” Medical Staff Bylaws. The COS stated she reviewed the applicants’ files for “red flags”, background check and if “certification match with residency”. The COS stated the “proof” of CC and MEC recommendations and GB approval were the dates entered into the meeting minutes. The COS acknowledged there was no documented evidence of MEC recommendations and GB approval for each candidate. The COS stated she “relies on” the department chiefs to determine and approve physician and AHP applicants for privileges. The COS stated approval of PA privileges were “based on education” while PAs were employed by the hospital and their practice were determined by the hospital. The COS stated PA who provide surgical services should have had specific privileges areas of the surgical services. The COS stated PAs had privilege to work “anywhere” in the hospital. The COS acknowledged that medical staff did not confirm the competency, qualifications, and skills of AHPs. The COS stated, no matter the AHP’s specialty or employment status, whatever physician “asked” the AHP to provide medical care, was “responsible” for the care the AHP’s providers. During a concurrent interviews and record review on the following 3 days with Chief of Anesthesia (ANS 1): 1. 5/22/24, at 9:40 a.m., with ANS 1, accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and DCQI, 2. 5/29/24, at 10:10 a.m., with ANS 1 accompanied by DCQI, 3. 5/29/24, at 4:14 p.m., with ANS 1 accompanied by RNQ 1, the hospital policies, workflow, and patient medical records were discussed. ANS 1 described the privilege process. ANS 1 stated after education, case logs, criminal background, resume and application have been gathered by medical staff team, the information was passed to the chief of anesthesia. ANS 1 stated if there were any “concerns” he would call references and interviewed the applicant. ANS 1 and DCQI acknowledged the applicant case logs were not always available for review for privileging. ANS 1 stated he would signed the privilege forms for approval. ANS 1 acknowledged approved privileges may not have been consistent with logs, education, or experience. ANS 1 stated CRNA competency could be determined by the surgeon, chief of anesthesiology or the Anesthesiologist In Charge (AIC). ANS 1 stated the AIC could be an anesthesiologist or a CRNA. ANS 1 stated once proctoring requirement satisfied the applicant’s file would have been forwarded to Credential Committee (CC), Medical Staff Committee, and Governing Board (GB) for approval. During an interview on 5/30/24, at 3:00 p.m., with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and OR staff were discussed. SUR 4 stated some of her responsibilities as “Chief” was to ensure that surgical workflow and department services “flow well ...coordinate patient care ...communicate with staff”. In addition, SUR 4 stated she reviewed surgical providers applications files for education background, case logs, training, and experience. SUR 4 stated one of her duties was to recommend surgical provider applicants for staff privileges. SUR 4 stated that she was “absolutely not” involved with the anesthesiology departments approval of privileges for anesthesiologist or CRNAs. SUR 4 stated she “helps”’ the credentialing committee once a month. During record review of [Hospital] policy titled “Rules and Regulations of the Governing Board of [Hospital]”, June 13, 2022, indicated that the “Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... approved by the Governing Board ... The Governing Board shall have authority. and responsibility for all appointments and reappointments of Medical Staff members, granting of clinical privileges, approving disciplinary actions, conducting investigations relating to quality of patient care and professional practice”. During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “ recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout [Hospital Name] Medical Center ... To provide professional performance and utilization of services within the scope of defined clinical privileges, through a systemic credentialing, review, appraisal, and improvement ... Comply with the policies, practices, and procedures at [Hospital Name] Medical Center, including the standards and recommendations by The Joint Commission, local, state, and/or federal laws, and regulations ... Adhere to responsibilities as outlined in sponsoring/supervision agreements to allied health professionals (if applicable) ... DUTIES AND AUTHORITY OF THE MEDICAL EXECUTIVE COMMITTEE. ...To fulfill Medical Staff accountability to the Governing Board for the medical care of patients at [Hospital Name] Medical Center ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership”. During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “Medical staff membership (1) to have a current unrestricted California license to practice medicine, dentistry, or podiatry; (2) to maintain an unrestricted Drug Enforcement Administration certificate ...only members who hold a medical staff appointment or temporary privileges are eligible to render medical care at [Hospital name] The Governing Board grants appointments to the medical staff ... Every member practicing the medical profession at [Hospital name] shall exercise those clinical privileges specifically granted by the Governing Board.. Hold a current, unrestricted license, certificate or other appropriate legal credential ... the authorized individual shall write the order ... Practitioners are legally and professionally responsible for the ongoing monitoring and appropriate adjustment of the duration and dose of the medications ordered in the Hospital”. During record review of [Hospital] policy titled, “MEDICAL STAFF RULES AND REGULATIONS”, approved Governing Board, August 24, 2022, indicated that, prescribing providers “maintain an unrestricted Drug Enforcement Administration certificate ...authorized individual shall write the order, followed by the name of the practitioner, date and time, name, and signature of the writer”. During record review of hospital titled, “AHP [Allied Health Professional] Rules and Regulations, version 2022” indicated that the “Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned ... Practitioners who desire to sponsor and supervise AHPs must apply and qualify for such sponsorship. Each AHP who is a Physician’s assistant must be supervised by a Physician having the following qualifications: a. Is a Physician currently licensed by the State of California; Identify a sponsoring and supervising Medical Staff Member, in good standing on the Active staff, who has Privileges in the appropriate Department, and who has agreed to assume ongoing responsibility for sponsorship and direct supervision of the AHP at all times. When the sponsoring and supervising Practitioner is not available, an alternate supervising Medical Staff Member meeting all the requirements of the sponsoring Member must be predesignated and must provide direct supervision at all times in place of the absent Practitioner. ... Restriction of the Privileges of the sponsoring and supervising Practitioner, in which case the Practice Prerogatives of the AHP shall be restricted accordingly.” During record review of [Hospital] policy titled, “PHARM.1.04 Controlled Substances Policy Schedule II - V, approved: 6/23/2021, indicated that “Issuing, Dispensing and Distributing Controlled Substances ...Only licensed personnel per state law and regulation may have access to controlled substances ... Strict accountability shall be maintained and recorded for all controlled substances”. During record review of [Hospital] policy titled, “OR.1.29 Provision of Anesthesia Services”, approved 10/27/2021, stated the purpose of the policy was “to establish a consistent standard-of-care for patients receiving anesthesia services ... The director of anesthesia services is responsible for ... Evaluating the quality and appropriateness of the anesthesia patient care ... The anesthesia service is responsible for developing policies and procedures governing the provision of all categories of anesthesia services ... Individuals Permitted to Administer Anesthesia ... Only those individuals privileged by the medical staff shall be permitted to administer anesthesia. These individuals may include A qualified anesthesiologist, A Doctor of Medicine or osteopathy (other than an anesthesiologist); A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law ... The privileges granted must be in accordance with State law and organization policy. The type and complexity of procedures for which the practitioner may administer anesthesia, or supervise another practitioner supervising anesthesia, must be specified in the privileges granted to the individual practitioner”. During record review of California (CA) Business and Professions Code, (BPC) 2826, it stipulated that a “Nurse anesthetist’ means a person who is a registered nurse licensed by the board who has met standards for certification from the board”. During record review of California’s Business and Professions Code, CA BPC, 2725(b)(2), it stipulated that “Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, necessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician”. During review of California ‘s Business and Professions Code, CA BPC 2827, it stipulated, the “utilization of a nurse anesthetist to provide anesthesia services in an acute care facility shall be approved by the acute care facility administration and the appropriate committee, and at the discretion of the physician, dentist or podiatrist”. During review of California ‘s Business and Professions Code, CA BPC 2833.5, it stipulated that “the practice of nurse anesthetist does not confer authority to practice medicine or surgery”.”

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 42125 Based on interview and record review, Medical staff department failed to follow policy and ensure all individuals providing medical care and services in the hospital privileges were recommended by the Medical Executive Committee (MEC - oversight of safe and appropriate patient care by physician and non-physicians) and approved by the Governing Board. The failure to appropriately privilege and approve medical staff privileges allowed 25 of 25 physicians and non-physicians (AHP- Advance Health care Providers): 1. Thirteen Certified Registered Nurse Anesthetist (CRNA- type of AHP, Registered Nurse with specialized training that provides anesthesia services under the orders and discretion of a physician), [CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18]. 2. Four surgeons (SUR) ]3, 5 and Chief of Medical Staff (COS)]; 3. One anesthesiologist (ANS) [4]; 4. Seven physician Assistants (PA- type of AHP, an individual with specialized training that provided medical care under the supervisor of a physician), [PAs 1, 2, 3, 4, 5, 6 and 7]; 5. One Nurse Practioner (NP- type of AHP Registered Nurse with specialized training that provides medical care under the supervision of a physician), [NP 2]; and 6. Four providers were not on the AHP or medical staff rosters (ANS 5, NP 1, physician (DO 1), and RN registered nurse (RN) 1, (listed as First Assist [RNFA- RN with training that assists a surgeon during surgery]) to furnish medical care, surgical services , anesthesia services and/or emergency medical to patients which they may not have been qualified to do so and placed all patients’ health and safety in jeopardy. Findings: During two concurrent interviews and record reviews on 5/22/2024 at 12:42 p.m. and 5/28/2024 at 1:50 p.m. with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical Staff manger, hospital workflow, polices, patient record logs and staff files were discussed. MST explained privileging process that the hospital is supposed to follow. The applicant completes an application and request privileges listed on the privilege form. The MST indicated privileges are to be granted are based on experience, education and skill sets as determined by case logs from school and/or prior jobs. The hospital Bylaws also require evaluation references and criminal background. The applicant’s privilege request form is approved and signed by the Chief of the Department. All the paperwork is placed in the applicant’s file, and it is “available” for the credential committee (CC), Medical Staff Committee (MEC) and Governing Board (GB). MST indicated the privileges for each candidate is not discussed or approved by the CC, MEC or GB. The team indicated there is no written documentation by the CC, MEC or GB regarding each applicant and privileges requested. MST stated “sometimes, someone” places dates on the privilege forms, but MST does not know who the individual is. MST stated only the Chief of the Department signs the privilege form for approval and this becomes the record of provider privileges. The MST stated the official active date of providers privileges is determined by the “date” listed in the meeting “minutes”, and a letter is sent to the provider. MST stated “all” applications are processed the “same way”. MST acknowledged 25 of 25 privileged files for COS, SUR 3, SUR 5 SUR 8, CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, ANS 4, PA 1, PA 2, PA 3, PA 4, PA 5, PA 6 and PA 7 or NP 2 did not have written recommendations from CC and MEC, nor written approval by the MEC. During record review of the hospital titled log, “Revised Med Staff Roster 5/2023 to 5/2024 “ listed 658 physician providers, and the hospital titled logs “Revised AHP Roster 5/2023 to 5/2024 listed 124 AHPs: “ Nurse Practitioner 1 (NP 1) was listed as an “Assistant Provider, Intraoperative” for Pt 39. NP 1 was not listed on the medical staff or AHP roster. “ Physician, (DO 1) was listed as an “Assistant Provider, Intraoperative” for Pt 39. DO 1was not listed on the medical staff. “ ANS 5 provided anesthesia services to patients and anesthesia call (available for emergencies) 9/24/23, 9/27/23, 10/23-25/23. ANS 5 was not listed on the Medical staff Roster. “ CRNA 20 provided anesthesia call on 12/16/23. CRNA 20’s appointment date on the AHP roster was 4/4/24. During two concurrent interviews and record reviews on 5/22/2024 at 12:42 p.m. and 5/28/2024 at 1:50 p.m. with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical Staff manger, MST stated that names of individuals listed who were not AHP or Medical Staff Rosters did not have privileges or were unfamiliar to medical staff. DCQI stated it was a “mix-up”. MST acknowledge privileges were granted for specific specialties and if additional privileges were desired, and requested must be submitted to medical staff for review and approval. During record review of the hospital titled log, “Revised Med Staff Roster 5/2023 to 5/2024 “ listed 658 physician providers, and the hospital titled logs “Revised AHP Roster 5/2023 to 5/2024 listed 124 AHPs. During a comparative record review of Operating Room (OR) case logs titled, “OR Log Revised”, dated 2/2023 to 5/15/2024 and record review of the hospital log, titled “Revised Med Staff Roster”, and “Revised AHP Roster” for date range of 5/2023 to 5/2024, the record listed 658 physician providers and 124 AHPs. The following providers were listed as surgical staff providers, but did not have documented evidence specific privileges and/or were not on the Medical Staff or AHP rosters a as follows: “ MD 11 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon. “ MD 12 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon. “ ANS 5 was listed as the anesthesia provider for Pt 64, Pt 66, Pt 67, Pt 97, Pt 98, Pt 99, Pt 100, Pt 101, Pt 104 and Pt 105 but was not on Medical Staff Roster “ PA 8 was listed as Additional staff intraoperative “Additional staff intraoperative” for Pt 39. On the AHP roster with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging) “ PA 8 as listed as an “Anesthesia Tech [assistant to anesthesiologist, not allowed to practice in California]” for Pt 37. PA 8 was listed on AHP roster as PA with a radiologist as the supervising physician. “ Nurse Practitioner 1 (NP 1) was listed as an “Assistant Provider, Intraoperative” for Pt 39, but was not listed on the medical staff or AHP roster. “ Physician, (DO 1) was listed as an “Assistant Provider, Intraoperative” for Pt 39 but was not listed on the medical staff. “ RN 1 was listed as RNFA, “First Assistant” for “Coronary Artery Bypass” for Pt 37 and Pt 39. RN 1 was not listed on the APH roster. During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with the MST, the MST acknowledged privileges were granted for specific specialties and if additional privileges were desired, the request must be submitted to medical staff for review and approval. The MST stated that names of individuals who were not on the AHP or Medical Staff Rosters, did not have privileges. DCQI stated it was a “mix-up”. During a phone interview on 5/23/2024 at 12:42 p.m., with the CDPH District Office hospital administration team which included, DCQI, Chief Nursing Officer (CNO), Chief Executive Officer, (CEO) and Accreditation Manager, the team acknowledged that medical staff were “not” being appropriately credentialed for privileges, and it there was an “opportunity” to correct it. During a concurrent interviews and record review on the following 3 days with Chief of Anesthesia (ANS 1): 1. 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1), accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and Director of Clinical Quality and Performance Improvement (DCQI), 2. 5/29/24, at 10:10 a.m., with ANS 1, accompanied by DCQI, and 3. 5/29/2024 at 4:14 p.m. with ANS 1, accompanied by RNQ 1, the hospital policies, workflow, and patient medical records were discussed. ANS 1 stated his job as chief was to approve anesthesia applicant files for privileges, monitor and sign-off on proctoring, monitor and review adverse events related to anesthesia services. ANS 1 stated after education, case logs, criminal background, resume and application have been gathered by medical staff team, the information was passed to the chief of anesthesia. ANS 1 stated if there were any “concerns” he will call references and interviewed the applicant. ANS 1 and DCQI acknowledged the applicant case logs were not always available for review for privileging. ANS 1 stated he signed the privilege forms for approval. ANS 1 acknowledged approved privileges may not have been consistent with logs, education, or experience. ANS 1 stated the applicant had 12 months to complete proctoring. ANS 1 stated once proctoring requirement satisfied the applicant’s file would have been forwarded to Credential Committee (CC), Medical Staff Committee, and Governing Board (GB) for approval. During a phone interview on 5/23/24, at 12:42 p.m., with the hospital administration team which included, Director of Clinical Quality and Performance Improvement DCQI, Chief Nursing Officer (CNO), Chief Executive Officer, (CEO) and Accreditation Manager, the team acknowledged that unprivileged providers and unsupervised AHPs, including CRNAs, were providing independent medical care. They were diagnosing and treating medical conditions, plus ordering, prescribing, and administering medications, treatments, and therapeutics to patients. During an interview and concurrent record review on 5/30/2024 at 3:48 p.m. Chief of Medical Staff (COS), accompanied by Accreditation Manager (AM 2), hospital policies, and medical staff processes were discussed. COS stated she is “familiar” and “follows” with Medical Staff Bylaws. COS stated she participates in the following meetings-- Credentialling committee (CC), the first Thursday of each month, Medical Executive Committee (MEC) the 3rd Friday of each month and Governing Board (GB) the 4th Wednesday of each month. COS stated the CC, MEC and GB have “access” to the applicant’s file for review. COS states application files are reviewed by the department chairs. COS stated she “relies on” the department chiefs to determine and approve physician and AHP applicants for privileges. COS indicated she reviews the applicants’ files for “red flags”, background check and if “certification match with residency”. COS acknowledged the privileging process for applicants is not followed. During an interview and concurrent record review on 5/30/2024 at 3:48 p.m. COS chief of medical staff (COS), accompanied by Accreditation Manager (AM 2), hospital policies, and medical staff processes were discussed. COS acknowledged she was not aware which AHP, including surgical assistants, are eligible for privileges. COS stated PA are “not independent”. COS stated, PAs who are employed by a medical group will submit an application to medical staff. The applications are reviewed by the chief of the department. COS stated approval of PA privileges are “based on education”. On the other hand, PAs employed by the hospital, their practice is determined by the hospital. COS stated PA who provide surgical services should have specific privileges, where they can work, for example trauma, general surgery, cardiovascular, orthopedics. COS stated if a nurse (RN) or other AHP is a hospital employee, the hospital has jurisdiction over reviewing qualification, training, and monitoring, Medical staff does not approve the privilege forms. COS stated Registered Nurse First Assistants (RNFA) were nurses and employed by the hospital. The hospital is responsible for privileges and practice, not medical staff. COS stated first assists, RNFAs should have “specific training”. COS indicated the hospital determines their training. During an interview on 5/30/2024 at 3:00 p.m. with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and OR staff were discussed. SUR 4 stated some of her responsibilities as “Chief” is to review surgical providers applications files for education background, case logs, training, and experience. SUR 4 stated she will recommend applicants for staff privileges. SUR 4 stated she “helps”’ the credentialling committee once a month. After privileges have been granted, proctoring occurs for medical staff. During record review of [Hospital] policy titled “Rules and Regulations of the Governing Board of [Hospital]”, June 13, 2022, indicated that the “Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... approved by the Governing Board ... The Governing Board shall have authority. and responsibility for all appointments and reappointments of Medical Staff members, granting of clinical privileges, approving disciplinary actions, conducting investigations relating to quality of patient care and professional practice”. During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “ recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout [Hospital Name] Medical Center ... To provide professional performance and utilization of services within the scope of defined clinical privileges, through a systemic credentialing, review, appraisal, and improvement ... Comply with the policies, practices, and procedures at [Hospital Name] Medical Center, including the standards and recommendations by The Joint Commission, local, state, and/or federal laws, and regulations ... Adhere to responsibilities as outlined in sponsoring/supervision agreements to allied health professionals (if applicable) ... DUTIES AND AUTHORITY OF THE MEDICAL EXECUTIVE COMMITTEE. ...To fulfill Medical Staff accountability to the Governing Board for the medical care of patients at [Hospital Name] Medical Center ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership”. During record review of [Hospital] policy titled, “MOD CLN.4.04 MOD Operative and Invasive Procedures Appropriateness Review (CO-5.007.MOD)”, approved 4/10/2024, stated the purpose of the policy was “to describe the minimum standards, review Cardiac Operative and Invasive procedures through effective use of evidence-based clinical criteria ... Quality Review ... The Facility shall conduct case reviews in accordance with the peer review and quality processes set forth in the Facility’s Medical Staff Bylaws and state statutes. During record review of [Hospital] policy titled, “CO-5.007 Operative and Invasive Procedures Appropriateness Review”, approved 10/24/2018, described “the minimum standards for prospective and retrospective review of the appropriateness of operative and invasive procedures through effective use of evidence-based clinical criteria, to appropriately and accurately identify performance trends and patterns, and to monitor and improve ... Hospital’s Peer Review Committee is responsible for providing oversight and peer review of the Operative and Invasive Procedures provided at the Hospital to confirm appropriateness of the Procedures being performed ... Physician documentation that validates the appropriateness of the procedure, including but not limited to: patient clinical condition, non-invasive study results, findings from diagnostic procedures ... shall provide a summary of its findings to the Hospital’s Medical Executive Committee (MEC), which shall report such findings to the Hospital Governing Board”, as outlined in Medical Staff Bylaws. During record review of [Hospital] policy titled, “MEDICAL STAFF RULES AND REGULATIONS”, approved Governing Board, August 24, 2022, indicated that, prescribing providers “maintain an unrestricted Drug Enforcement Administration certificate ...authorized individual shall write the order, followed by the name of the practitioner, date and time, name, and signature of the writer”. During record review of hospital titled, “AHP [Allied Health Professional] Rules and Regulations, version 2022” indicated that the “Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned ... Practitioners who desire to sponsor and supervise AHPs must apply and qualify for such sponsorship. Each AHP who is a Physician’s assistant must be supervised by a Physician having the following qualifications: a. Is a Physician currently licensed by the State of California; Identify a sponsoring and supervising Medical Staff Member, in good standing on the Active staff, who has Privileges in the appropriate Department, and who has agreed to assume ongoing responsibility for sponsorship and direct supervision of the AHP at all times. When the sponsoring and supervising Practitioner is not available, an alternate supervising Medical Staff Member meeting all the requirements of the sponsoring Member must be predesignated and must provide direct supervision at all times in place of the absent Practitioner. ... Restriction of the Privileges of the sponsoring and supervising Practitioner, in which case the Practice Prerogatives of the AHP shall be restricted accordingly.” During record review of California (CA) Business and Professions Code, (BPC) 2826, it stipulated that a “Nurse anesthetist’ means a person who is a registered nurse licensed by the board who has met standards for certification from the board”. During record review of California’s Business and Professions Code, CA BPC, 2725(b)(2), it stipulated that “Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, necessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician”. During review of California ‘s Business and Professions Code, CA BPC 2827, it stipulated, the “utilization of a nurse anesthetist to provide anesthesia services in an acute care facility shall be approved by the acute care facility administration and the appropriate committee, and at the discretion of the physician, dentist or podiatrist”. During review of California ‘s Business and Professions Code, CA BPC 2833.5, it stipulated that “the practice of nurse anesthetist does not confer authority to practice medicine or surgery”.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 49230 Based on observation, interview, and record review the hospital failed to ensure hospital policies and procedures (P&P) were followed when: 1. Three of six sampled patients (Patient (Pt) 11, Pt 12, and Pt 14) did not have vital signs assessed and documented in accordance with the hospital policy and/or professional standards. 2. One of two sampled patients (Pt 11) did not have her pain assessed and documented while she was receiving epidural pain medication according to hospital policy. 3. One of two sampled patients (Pt 61) was not offered pain medication prior to the start of a large wound dressing according to the hospital’s pain policy and hand hygiene was not performed per hospital policy. These failures placed patients at risk for decline and increased pain which could cause patients to experience pain, suffering, and delayed interventions. 4. Two of three sampled patients (Pt 11 and Pt 12) when patients preferred language was other than English and there was minimal (for informed consents) to no documentation an interpreter was used for either patient during their hospitalization in accordance with the hospital policy. These failures had the potential for patients whose preferred language was other than English to not receive and fully understand procedures and/or education provided to them and could result in negative health outcomes when bilingual staff who were not competent interpreters communicated with patients and did not use the interpreting system to communicate with patients. 5. Two of four sampled patients (Pt 6 and Pt 11) when there was no consent form for antipsychotic medications (a type of drug used to treat severe mental disorder in which a person loses the ability to recognize reality or relate to others) administered to Pt 6 during his hospitalization and Pt 11 was not provided with an interpreter during consent for an epidural per the hospital’s P&P. These failures resulted in administration of antipsychotic medications to Pt 6 without Pt 6 (or the responsible party) having the opportunity to weigh the benefits and risks of the medication and right to refuse treatment; and did not provide Pt 11 the opportunity to weigh the benefits and risks of the procedure in a language she understands and documented preference; these failures could cause avoidable and unnecessary mental and emotional distress. 6. One of three sampled patients (Pt 8) when the hospital P&P titled, “Restraints and Seclusion,” was not followed. Pt 8 was placed in five-point restraints, which was not least restrictive, the physician’s order for four-point restraints was not followed and a physician did not perform a one-hour face to face after restraints were placed emergently. This failure caused Pt 8 to be restrained more than the physician’s orders indicated and violated Pt 8’s patient rights. Findings: 1a. During a concurrent interview and record review on 5/15/24 at 9:31 a.m. with Quality Nurse (RNQ) 4, Pt 11’s “Electronic Health Record (EHR-electronic version of a patient’s medical history),” dated 5/14/24 was reviewed. The EHR indicated Pt 11 was admitted on 5/14/24 at 9:36 a.m. for induction of labor (the use of medications or other methods to bring on labor) at 34.4 weeks (in month eight of pregnancy) for cholestasis (a liver problem in pregnancy). During a concurrent interview and record review on 5/22/24 at 12 p.m. with RNQ 4, Pt 11’s “EHR,” dated 5/15/24, Pt 11’s “Vital Signs (VS),” dated 5/15/24 and the hospital’s policy and procedure (P&P) titled, “L&D.1.15 Epidural Management for the Laboring Patient,” dated 1/25/23 were reviewed. The EHR indicated Pt 11 had an epidural placed at 12:38 p.m. The VS indicated vital signs were taken at 12:30 p.m., 12:45 p.m., 12:47 p.m., 1 p.m., 1:15 p.m., 1:30 p.m., 1:45 p.m., 2 p.m., 2:30 p.m., 3:53 p.m., and 4 p.m. RNQ 4 stated the pulse oximetry was not documented and monitored prior to and after the epidural placement. The P&P indicated, “Vital Signs: include assessment of maternal heart rate, respiratory rate, blood pressure, pulse oximetry, and fetal well-being ... Assess ...maternal vital signs, signs of high spinal or ascending block, perception and level of pain relief once regional analgesia or anesthesia is initiated. Then every 3 minutes for the first 15 minutes, then every 5 for the next 15 min, then every 15 minutes thereafter ...” RNQ 4 stated the vital signs were not assessed and documented according to the P&P when the pulse oximetry was not documented, and the frequency was not assessed according to the P&P. RNQ 4 stated the importance of assessing a patient’s vital signs during a procedure was to ensure the patient was tolerating the procedure and or medications. RNQ 4 stated monitoring the patient’s pulse oximetry could help assist the nurse to determine if the patient was overly sedated and intervene if needed. During a concurrent interview and record review on 5/22/24 at 2:25 p.m. with RNQ 4, Pt 11’s “VS,” dated 5/16/24 and the hospital’s reference obtained from the American College of Obstetricians and Gynecologists (ACOG) titled, “Postpartum Care of the Mother,” undated was reviewed. The VS indicated Pt 11 delivered at 6:28 p.m., documented vital signs started at 6:45 p.m., 7 p.m., 7:42 p.m., and the 8:42 p.m. RNQ 4 stated the ACOG indicated, “Blood pressure levels and pulse should be monitored at least every 15 minutes for 2 hours, but more frequently and for longer duration if there are complications.” RNQ 4 stated the first two hours after delivery the vital signs were not assessed and documented according to the ACOG guidelines. 1b. During a concurrent interview and record review on 5/22/24 at 10:53 a.m. with RNQ 4, Pt 12’s “Face Sheet (FS-a document that contains a summary of a patient’s personal information and brief medical history),” dated 5/14/24 and Pt 12’s “History and Physical (H&P),” dated 5/3/24 was reviewed. The Face Sheet indicated Pt 12 was admitted on 5/14/24 at 7:54 a.m. The H&P indicated Pt 12 was admitted for repeat cesarean section (the surgical delivery of a baby through a cut made in the mother’s abdomen). During a concurrent interview and record review on 5/22/24 at 10:53 a.m. with RNQ 4, Pt 12’s “Physician Orders (PO),” dated 5/14/24 and Pt 12’s “VS,” dated 5/14/24 were reviewed. RNQ 4 stated the PO indicated, “Vital Signs every 15 minutes for 1 hour, then every 1 hour for 5 hours then per post-op protocol.” The VS indicated at 11:10 a.m., 11:15 a.m., 11:20 a.m., 11:25 a.m., 11:30 a.m., 11:35 a.m., 11:40 a.m., 11:45 a.m., 11:50 a.m., 11:55 a.m., 12 p.m., 12:15 p.m., 12:30 p.m., 12:45 p.m., 1 p.m., 1:33 p.m., 2:45 p.m., 5:10 p.m., and 9 p.m. RNQ 4 stated Pt 12’s hourly vital signs for five hours was completed late. RNQ 4 stated the importance of following physician’s orders was to ensure the patient was recovering and there was no decline in the patient’s health after birth. 1c. During a concurrent interview and record review on 5/21/24 at 3:42 p.m. with RNQ 4, Pt 14’s “H&P,” dated 4/9/24 was reviewed. RNQ 4 stated the H&P indicated, Pt 14 was delivered at 9:49 a.m. by vaginal birth at 40.4 weeks gestation and admission diagnoses of respiratory insufficiency, suspected transposition of the Great Arteries, Suspected ectodermal dysplasia, and sepsis evaluation. During a concurrent interview and record review on 5/21/24 at 3:55 p.m. with RNQ 4, Pt 14’s “PO,” dated 4/8/24 was reviewed. RNQ 4 stated the PO indicated, “For full term babies, assess and document vital signs [every] 30 [minutes] [times] 4 from time of birth, then [every] 1 [hour-intermittent] [times] 2, the [every] 8 [hour-intermittent].” During a concurrent interview and record review on 5/21/24 at 4:20 p.m. with RNQ 4, Pt 14’s “VS,” dated 4/9/24 was reviewed. RNQ 4 stated the VS indicated the first vital signs were documented at 9:50 a.m., then 10:10 a.m., and 10:50 a.m. RNQ 4 stated the fourth vital sign was missing and the first three vital signs were not assessed every 30 minutes according to the physician orders. RNQ 4 stated the importance of assessing and documenting a newborn’s vitals was to ensure the baby was stable or declining. During a concurrent interview and record review on 5/21/24 at 4:25 p.m. with RNQ 4, Pt 14’s “Physical Assessment (PA),” dated 4/9/24 was reviewed. RNQ 4 stated the PA indicated there was no full physical assessment documented for Pt 14 within two hours after birth. During a concurrent interview and record review on 5/22/24 at 10:19 a.m. with Director of Women and Childrens (DWC), Pt 14’s “PA,” dated 4/9/24 was reviewed. DWC stated in labor and delivery (L&D) the nurses only complete a focused physical assessment and not a full physical assessment. The DWC stated the first full physical assessment would be completed in Postpartum Unit (department where mother and baby are transferred after delivery). During a review of the hospital’s reference from Guidelines for Perinatal Care, 8th Edition titled, “Newborn Vitals & Assessments,” dated 9/2017 and the hospital’s “Labor and Delivery RN Skill Assessment and Competency Validation (Comp),” dated 9/18/2023, the reference indicated, “Stable Term Transitional [Vital Signs] Well Baby Care ...1st [vital sign (VS)] within 15 [minutes] of birth (axillary [temperature], [pulse], [respirations] ...Initial Assessment within 2 [hours] of birth then [every] shift.” The Comp indicated, “ ...Newborn assessment following delivery ...Performs Initial Physical Assessment, including vital signs initial [every] 30 [minutes] [times] 4. Documents findings appropriately ...” During an interview on 5/30/24 at 2:35 p.m., with the Chief Nursing Officer (CNO), the CNO stated her expectations for vital signs for patients was to follow evidence-based practice and for each department, the specific professional standard followed. The CNO stated there were opportunities for tightening up their policies and have conversations about what best practices meant to the hospital. During a review of the hospital’s policy and procedure (P&P) titled, “L&D.1.15 Epidural Management for the Laboring Patient,” dated 1/25/23, the P&P indicated, “PURPOSE: The purpose of this policy is to provide guidelines for nursing practice and patient advocacy related to pregnant women receiving pain management through epidural analgesia ...Vital Signs: include assessment of maternal heart rate, respiratory rate, blood pressure, pulse oximetry, and fetal well-being ...it is the responsibility of the registered nurse to communicate the patient’s need for pain management. The primary care provider and/or anesthesia provider may determine that epidural analgesia is contraindicated in certain conditions ...A qualified, credentialed, license anesthesia-care provider is responsible for the following (the non-anesthetist registered nurse may not perform these tasks): 1. Obtain informed consent from the patient. 2. Insertion of the epidural catheter. 3. Verification of correct catheter placement. 4. Initial injection and/or initiation of a continuous infusion of analgesia. 5. Connecting epidural catheter. 6. Re-bolus of an epidural catheter. 7. Manipulate patient-controlled epidural analgesia (PCEA) doses or dosage intervals. 8. Increase or decrease the rate of the continuous infusion ...During the care of the pregnant woman, the registered nurse may perform the following: 1. Witness the informed consent. 2. Monitor the patient’s vital signs, level of consciousness, mobility, and perception of pain and level of pain relief. 3. Monitor the fetal heart rate. 4. Stop the infusion if there is a safety concern or the woman has given birth. 5. Replace the infusion if there is a safety concern or the woman has given birth ...PROCEDURE EPIDURAL INITIATION ...Assess and document baseline maternal vital signs and fetal heart rate patter ...Perform a “Time Out” prior to procedure and document in medical record ...Remain in the patient’s room throughout the procedure ...Assess ...maternal vital signs, signs of high spinal or ascending block, perception and level of pain relief once regional analgesia or anesthesia is initiated. Then every 3 minutes for the first 15 minutes, then every 5 for the next 15 min, then every 15 minutes thereafter. The frequency of subsequent assessment should be based on maternal-fetal response to medication, maternal-fetal condition, and the stage of labor ...re-bolus ...Assess for complications that may be associated with epidural initiation ...Continue to evaluate maternal pain level with ongoing patient assessments. Educate patient regarding her increased risk for falls. Patients on bed rest should be assisted to change position every half-hour ...Document all interventions, assessments, and education in the electronic medical record ...” 2. During a concurrent interview and record review on 5/22/24 at 2:40 p.m. with RNQ 4, Pt 11’s “Pain Assessments (PA),” dated 5/15/24 and 5/16/24 were reviewed. The PA indicated on 5/15/24 at 11:26 a.m., Pt 11 was administered fentanyl (pain medication) 100 micrograms (mcg-unit of measure) and there was no reassessment of Pt 11’s pain until 2 p.m., a time lapse of two hours and 34 minutes. The PA indicated on 5/16/24 at 7:37 p.m., Pt 11 was administered hydrocodone with acetaminophen (used to relieve moderate to severe pain) and ibuprofen (used to treat pain, fever and swelling) for pain but Pt 11’s pain assessment was not assessed. RNQ 4 stated Pt 11’s pain should have been assessed to obtain a baseline, so when Pt 11’s pain was reassessed, the nurse would know if the pain medications helped with Pt 11’s pain. RNQ 4 stated the importance of assessing and reassessing a patient’s pain was to ensure the pain medication or intervention implemented was working. During an interview on 5/30/24 at 2:37 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectations of staff when pain medication was given was, the patient’s pain should be assessed and within an hour of the pain medication administration, the patient’s pain should be reassessed. The CNO stated the importance of reassessing a patient’s pain was to ensure the patient’s pain was under control and monitoring the patient’s response to pain medications such as low blood pressure or lower respiratory rate. During a review of a professional resource from Johns Hopkins Medicine, an article titled, “Pain Management,” dated November 2017, the article indicated, “Pain assessment is done upon admission, at least every shift and as needed. If pain medication is administered, the patient is reassessed within 60 minutes ...” During a review of the hospital’s P&P titled, “PC.AD.1.24 Pain Management Policy,” dated 4/27/22, the P&P indicated, “ ...Critical Note: Recommend the use of pain assessment/reassessment and sedation scales in the electronic health record (EHR) ...PURPOSE: To assure that patients receive assessment and management of their pain consistent with the scope of care, treatment, and service provided by the organization in its various care settings ...Nursing will follow hospital approved procedure and skill resource manual for the care of the patient ...experiencing pain ...Patients have the right to pain management ...Conduct an appropriate assessment and/or reassessment of a patient’s pain consistent with the scope of care, treatment, and service provided in the specific care setting in which the patient is being managed ...The 0-10 Numeric Rating scale shall be used to score pain as appropriate using the “Mild, Moderate, and Severe” pain indications ...Assess the patient’s response to care, treatment, and service implemented to address pain ...The Richmond Agitation and Sedation Scare (RASS) is a validated and reliable method to assess patients’ level of sedation ...When assessment and documentation of pain is completed, a RASS should be completed and documented ...Treat the patient’s pain ...A focused reassessment for the presence and intensity of pain shall be performed as a component of the shift assessment for inpatients and following any interventions intended to lessen the patient’s pain ...Such reassessment is dynamic and ongoing process which shall take place within a clinically appropriate time frame, depending on the type of intervention, the route of medication administration, the clinical condition and age of the patient ...” 3.During a review of Pt 61’s Admission Record (AR) dated 4/23/24 at 5:51 a.m., the AR indicated Pt 11 was a 59-year-old female admitted on 4/22/24 at 7:41 p.m. with a chief complaint of Necrotizing Fasciitis (A serious bacterial infection that destroys tissue under the skin. The condition spreads quickly. Symptoms include blisters, fever, fatigue, and pain worse than a person would expect based on the wound’s appearance.) During a concurrent observation and interview on 5/13/24, at 2:38 p.m., with Pt 61 and RN 11, while in Pt 61’s room RN 11 was seen changing Pt 61’s dressing to her right inner thigh. Pt 61 stated her pain level was a 10/10 and the last time she received pain medication was approximately three hours ago. RN 11 stated she believed Pt 61 had break through pain medication and would offer it to her after she was finished changing Pt 61’s dressing. RN 11 was seen removing the dressing from Pt 61’s right inner thigh and at 2:39 p.m. removed her dirty gloves and place clean blue gloves on without performing hand hygiene in-between. RN 11 was then observed cleaning Pt 61’s open wound and stated Pt 61’s order was to clean with normal saline (sterile solution), place 4x4’s (sterile gauze pad), abd pad (Abdominal gauze pads, known as ABD pads, are non-woven, thick, and absorbent) and tape daily. At that time the Director of Medical Surgical area (DMS) entered the room and observed RN 11 clean Pt 61’s wound and RN 11 removed her dirty gloves and placed clean gloves on without hand hygiene. DMS stated she did see this since RN 11 had to reach over the DMS at Pt 61’s sink to grab the clean gloves from the box. After placing the clean gloves on RN 11 placed a clean dressing on Pt 61’s thigh. DMS stated the expectation is that hand hygiene be done when dirty gloves are removed and clean ones being placed on, this is an infection control risk to the patient and staff when hand hygiene is not done appropriately it can spread germs. DMS stated Pt 61’s pain should have been addressed prior to starting Pt 61’s dressing change. During a review of the hospital’s P&P titled, “PC.AD.1.24 Pain Management Policy,” dated 4/27/22, the P&P indicated, “ ...Critical Note: Recommend the use of pain assessment/reassessment and sedation scales in the electronic health record (EHR) ...PURPOSE: To assure that patients receive assessment and management of their pain consistent with the scope of care, treatment, and service provided by the organization in its various care settings ...Nursing will follow hospital approved procedure and skill resource manual for the care of the patient ...experiencing pain ...Patients have the right to pain management ...Conduct an appropriate assessment and/or reassessment of a patient’s pain consistent with the scope of care, treatment, and service provided in the specific care setting in which the patient is being managed ...The 0-10 Numeric Rating scale shall be used to score pain as appropriate using the “Mild, Moderate, and Severe” pain indications ...Assess the patient’s response to care, treatment, and service implemented to address pain ...” During a review of the facility’s policy titled, “Hand Hygiene Policy,” approved on 10/26/22, indicated, “ ... II. PURPOSE: The purpose of this policy is to outline hand hygiene requirements to reduce the risk of infection transmission from patient to patient. Patient to health care provider and health care provider to patient. III. DEFINITIONS A. Hand hygiene means hand washing, antiseptic hand wash, antiseptic hand rub or surgical antisepsis.... IV. POLICY: The hospital has adopted the Centers for Disease Control and Prevention (CDC) Guidelines for hand hygiene in healthcare settings with enhanced comments from the World Health Organization (WHO) 1. Hand hygiene and healthcare.... Indications for hand washing and hand antisepsis include At the beginning of the workday. Before entering and when exiting a patient’s room or cubicle.... Between patients and a multi bedroom. Before and after direct contact with patient blood, body fluids or equipment, and environmental items touched by patients. Before handling medication or food. Before and after eating and drinking and smoking. After coughing and sneezing and using the restroom. Prior to donning gloves and after removing gloves... G. Decontaminate hands after contact with body fluid or excretions, mucous membranes, non-intact skin and wound dressings if hands are not visibly soiled. H. Decontaminate hands if moving from a contaminated body site to a clean body site during patient care... K. Decontaminate hands after moving gloves. NOTE: gloves are not a substitute for hand hygiene...” 4a. During a concurrent interview and record review on 5/15/24 at 9:31 a.m. with RNQ 4, Pt 11’s “EHR,” dated 5/14/24 and Pt 11’s “FS, “ dated 5/14/24 were reviewed. The EHR indicated Pt 11 was admitted on 5/14/24 at 5:19 a.m. for induction of labor at 34.4 weeks. RNQ 4 stated the FS indicated Pt 11’s preferred language was Spanish. During a concurrent interview and record review on 5/22/24 at 12:00 p.m. with RNQ 4, Pt 11’s “OB Anesthesia Flow Sheet (FLS),” dated 5/15/24 was reviewed. RNQ 4 stated the FLS indicated an epidural (a numbing medicine given by inserting a needle and a small, flexible tube into the lower part of a woman’s back) was placed at 12:38 p.m. During a concurrent interview and record review on 5/22/24 at 3:45 p.m. with RNQ 4, Pt 11’s “Discharge Instructions and Signature Page (DI),” dated 5/18/24 and Pt 11’s “Nurses Note (Note),” dated 5/18/24 were reviewed. RNQ 4 stated the DI indicated the instructions were in Spanish but there was no indication an interpreter was used to provide Pt 11 her discharge instructions. RNQ 4 stated the Note indicated, “Discussed discharge instructions with patient and patient verbalized understanding.” During a concurrent interview and record review on 5/22/23 at 4:00 p.m. with RNQ 4, Pt 11’s “Consent for Anesthesia (Consent),” dated 5/15/24 and Pt 11’s “EHR,” undated were reviewed. RNQ 4 stated the EHR indicated there was no documentation an interpreter was used during Pt 11’s hospitalization. RNQ 4 stated the anesthesiologist should have provided the informed consent and used an interpreter to consent for the anesthesia services to ensure the patient understood the procedure. RNQ 4 stated the Consent indicated an interpreter was not used to interpret the consent for the anesthesia, evidenced by the blank space where the interpreter utilized to interpret should have been documented. RNQ 4 stated the importance of utilizing an interpreter and/or interpreter services for consent forms was to explain the risks and benefits of the procedure and answer any questions the patient may have appropriately. During a review of Pt 11’s “Interdisciplinary Patient Education SMART Template (Template),” dated 5/15/24 to 5/18/24, the Template indicated, from 5/15/24 to 5/18/24, seven nurses documented, the “Barriers to Learning:-Language Barrier, Comments: Spanish speaking-RN speaks Spanish.” The Template indicated six bilingual staff who were not certified interpreters used their interpreting skills to communicate with Pt 11 during her hospital stay and did not document the interaction. The Template indicated one staff who was not bilingual, documented, the “Barriers to Learning:-Language Barrier, Comments: Spanish speaking-RN speaks Spanish.” During a review of the hospital’s P&P titled, “Interpretation Translation Services for Patients,” dated 3/27/19, the P&P indicated, ...[Hospital A] does not provide training in interpretation or translation competency ...A competent interpreter and translation shall be used whenever a language or communication barrier exists that indicates the patient has Limited English Proficiency (L.E.P) ... Bilingual employees or family members may interpret for simple instructions such as participation in activities of daily living, diet, exercise, pain rating ...Any time care is provided with the assistance of the [name of interpreting service] system or a bilingual individual, it will be documented in the Patient Care Record ...” 4b. During a concurrent interview and record review on 5/15/24 at 10:00 a.m. with RNQ 4, Pt 12’s “FS,” dated 5/14/24 and Pt 12’s “H&P,” dated 5/3/24 was reviewed. The FS indicated Pt 12 was admitted on 5/14/24 at 7:54 a.m. and her preferred language was Spanish. The H&P indicated Pt 12 was admitted for repeat cesarean section (the surgical delivery of a baby through a surgical incision made in the mother’s abdomen). During a concurrent interview and record review on 5/20/24 at 12:30 p.m. with RNQ 4 and RNQ 5, Pt 12’s “EHR,” dated 5/14/24 to 5/16/24 was reviewed. RNQ 5 stated when an interpreter was used, the nurses could document this in the rounding comments and frequent assessments. The EHR indicated there was no documentation of interpreter use in the round comments or frequent assessments. RNQ 4 stated the EHR indicated there was no interpreter documentation besides the time when Pt 12 was consented for surgery, anesthesia, and blood products on 5/14/24. During a concurrent interview and record review on 5/20/24 at 1 p.m. with RNQ 4 and RNQ 5, Pt 12’s “DI,” dated 5/16/24 was reviewed. RNQ 4 stated the DI indicated the instructions were in Spanish but there was no indication an interpreter was utilized to provide Pt 12 her discharge instructions. During an interview on 5/30/24 at 2:39 p.m. with the CNO, the CNO stated her expectations of hospital staff was to utilize an interpreter prior to medication administration, consents, teaching, assessments, discharges, and plan of care for patients who were non-English speaking. The CNO stated hospital staff should be utilizing interpreters and documenting their use of an interpreter in the EHR. The CNO stated the importance of following hospital policy regarding the use of an interpreter was to ensure patients were receiving the appropriate care, risks and benefits of procedures and medications were explained, and patients were receiving the appropriate education prior to discharge so they could take care of themselves at home. During a review of the hospital’s P&P titled, “Interpretation Translation Services for Patients,” dated 3/27/19, the P&P indicated, “PURPOSE: To provide interpretation/translation services to patients who do not speak English as their primary language and who have a limited ability to read, speak, or understand English so that the patient can participate in their care and communicate with their care providers ...Competency-Demonstrated proficiency in English and the other language. The ability to use the appropriate mode of interpreting ...and knowledge in both languages of specialized terms or concepts such as medical terminology, names of body parts, symptoms and injuries ...Bilingual-The ability to communicate effectively in a different language when communicating information directly in that language but may not be competent to interpret in and out of English. Likewise, they may not do written translation ...[Hospital A] does not provide training in interpretation or translation competency ...A competent interpreter and translation shall be used whenever a language or communication barrier exists that indicates the patient has Limited English Proficiency (L.E.P) ...[name of interpreting service] is the designated interpretation services at [Hospital A]. [name of interpreting service] has documented competent interpreters in multiple languages ...The [name of interpreting service] interpreter’s identification number will be documented on the consent form ...The [name of interpreting service] will be used for all informed consents, unless the Physician is bilingual and able to interpret the planned procedure adequately so that the patient completely understands the risks and benefits of the procedure to be performed. The Physician will document that he/she interpreted informed consent to the patient in the Patient Care Record ...The [name of interpreting service] system may be used for any routine procedures that does not require official informed consent but may be considered as invasive by the patient. Procedures may include insertion of urinary catheters, insertion of peripheral IVs, insertion of nasogastric tubes, laboratory blood draws ...The [name of interpreting service] system may also be utilized by health care providers in the admission and discharge process ...Bilingual employees or family members may interpret for simple instructions such as participation in activities of daily living, diet, exercise, pain rating ...Any time care is provided with the assistance of the [name of interpreting service] system or a bilingual individual, it will be documented in the Patient Care Record ...” 5a. During a concurrent interview and record review on 5/23/24 at 3:00 p.m. with the Assistant Director of Nursing (ADON), Pt 6’s “H&P-), dated 12/29/23 was reviewed. The H&P indicated, “66-year-old female with history of schizophrenia [a serious mental disorder that affects how a person thinks, feel, and behave], hypertension [high blood pressure-when the pressure your blood vessels is too high] not compliant with any medication is admitted here on a 5150 hold [allows for a person with a mental illness to be involuntarily detained in a psychiatric hospital for a 72 hour period] for [danger to self/danger to others]. Currently patient is compliant. Patient denies any fever chills nausea vomiting, cough, shortness of breath, or any sick contacts.” During a concurrent interview and record review on 5/23/24 at 3:25 p.m. with the ADON, Pt 6’s “Physician Orders (PO),” dated 1/4/24 and 1/12/24 were reviewed. The ADON stated the PO indicated, on 1/4/24 at 2:22 p.m. haloperidol (medication used to treat nervous, emotional, and mental conditions) 5 milligrams (mg-unit of measure), Injection, Intramuscular, three times a day (TID) as needed (PRN) with comments from physician, “to be administered if patient refuses oral Depakote 500 mg.” The ADON stated the PO indicated on 1/12/24 at 11:22 a.m. paliperidone (medication used to treat schizophrenia) 9 mg equals 1 tablet, extended release (slowly released into the body over a period of time) tablet, Oral, Daily, with physician comment, “please give first dose today.” The ADON stated the consent forms for the two medications were physical documents and were not able to be viewed via Pt 6’s electronic health record (EHR). During a review of Pt 6’s “Patient Consent to Receive Psychotropic Medications (Consents),” undated, the Consents for Pt 6 that were provided by the hospital did not have consent forms for haloperidol and paliperidone. During a review of Pt 6’s “Medication Administration Record (MAR),” dated 1/4/24 to 1/15/24, the MAR indicated on 1/4/24 at 9:44 p.m. Pt 6 was administered one dose of haloperidol. The MAR indicated from 1/12/24 to 1/15/24, Pt 6 was administered paliperidone daily. During an interview on 5/30/24 at 2:30 p.m. with the CNO, the CNO stated her expectations for nursing staff was to ensure patients were consented appropriately for the psychotropic medications prescribed to them and the side effects monitored to ensure the safety of patients. The CNO stated her expectations of nursing staff was to follow hospital policies and procedures. During a review of the hospital’s P&P titled, “MOD DBHC.1.47 Monitoring of Psychiatric Medications,” dated 8/23/23, the P&P indicated, “ ...POLICY: It is the policy of [name of hospital] to maintain the right of the patients/conservator to be informed of the benefits and side effects each psychiatric medication intended to be prescribed for the treatment of their mental condition ...PURPOSE On admission, the attending psychiatrist will have a verbal discussion with their patient of the benefits and side effects of the proposed psychiatric medication/s and obtain a signed consent for each psychiatric medication on the medication consent form. The signed medications form will be filed in the patient’s chart ...The licensed nurse will review the medical record or medication record prior to administration of any psychiatric medications. If the patient/guardian/conservator has not given consent, notify the physician to obtain informed consent for the patient ...Medications may not be given without consent except for emergency medications. Refer to the informed consent policy ...DOCUMENTATION OF SIDE EFFECTS ...The licensed nurse will monitor the patient each shift for side effects of psychiatric drugs, and document the presence/absence of side effects in the progress notes ...The licensed nurse will notify they responsible physician for initial onset of symptoms, and when there is an increase in symptoms ...DOCUMENTATION OF MOOD/AFFECT ...The licensed nurse will document the patient’s progress daily ...Notify the MD if the patient is refusing medications and any other pertinent information related to the administering of psychiatric medications ...” During a review of the hospital’s P&P titled, “DBHC.1.04 Informed Consent to Receive Psychotropic Medications,” dated 2/28/18, the P&P indicated, “Any patient treated at [Hospital B] will be informed of his/her right to accept or refuse psychotropic medication(s) unless there has been an adjudication of lack of capacity to refuse, or the existence of an emergency. The patient is to be provided with information regarding his or her diagnosis and the risks, benefits and alternatives of the prescribed medication(s) ...PURPOSE: To provide guidelines of obtaining and documenting consent of psychotropic medications recommended to the patient ...Physician Responsibility ...Informed consent given by a patient to one psychiatrist may be honored by another psychiatrist ...A Psychotropic Medication Informed Consent (one per medication to include anticipated dosage) is to be signed by the patient and psychiatrist when initiating any new psychotropic medication, e.g., standard antipsychotics, atypical antipsychotics, antidepressants, mood stabilizers/anticonvulsants, anxiolytics, sedatives, benzodiazepines and sedative hypnotics ...The Psychotropic Medication Informed Consent Form shall be signed by all patients age 18 or over ...For the inpatients on temporary conservatorship/LPS Conservatorship, consent for treatment with psychotropic medication shall be obtained from the patient’s Conservator or Deputy Conservator ...Patients will be provided the following information in the patient’s own language ...Their diagnosis ...The risks and benefits and alternatives of the medication ...The type, dose, frequency, route and duration of the medication ...The possible side effects of these medications and the possibility of Tardive Dyskinesia must be discussed with patients receiving antipsychotics. The patient shall be advised that such side effects may include persistent involuntary movements of the face, mouth or extremities and that the symptoms are potentially irreversible, and may appear after medications have been discontinued ...The patient may withdraw consent to medication at any time. This withdrawal will be documented in the chart ...Nursing Responsibility ...A patient has the right to refuse medications unless the situation meets the definition of an emergency situation or the patient has had a Riese Hearing in which the court has determined that the patient does not have the capacity to make an informed decision regarding medications ...The nurse shall assure that the patient has given informed consent prior to administration of any psychotropic medication(s). Even if the medication has been ordered by the psychiatrist, the informed consent must be confirmed on the medical record prior to administration of the psychotropic medication(s) ...If a patient refuses medications, the psychiatrist shall be notified as soon as possible and the reason documented in the medical record ...When there is an order for a medication and on consent form is signed, the nurse shall notify the prescribing psychiatrist to confer with the patient.” 5b. During a concurrent interview and record review on 5/15/24 at 9:31 a.m. with RNQ 4, Pt 11’s “EHR,” dated 5/14/24 and Pt 11’s “ FS,” dated 5/14/24 were reviewed. The EHR indicated Pt 11 was admitted on 5/14/24 at 5:19 a.m. for induction of labor at 34.4 weeks. RNQ 4 stated the FS indicated Pt 11’s preferred language was Spanish. During a concurrent interview and record review on 5/22/24 at 12:00 p.m. with RNQ 4, Pt 11’s “OB Anesthesia Flow Sheet (FLS),” dated 5/15/24 was reviewed. RNQ 4 stated the FLS indicated an epidural (a numbing medicine given by inserting a needle and a small, flexible tube into the lower part of a woman’s back) was placed at 12:38 p.m. During a concurrent interview and record review on 5/22/23 at 4:00 p.m. with RNQ 4, Pt 11’s “Consent for Anesthesia (Consent),” dated 5/15/24 was reviewed. RNQ 4 stated the anesthesiologist should have provided the informed consent and used an interpreter to consent for the anesthesia services to ensure the patient understood the procedure. RNQ 4 stated the Consent indicated an interpreter was not used to interpret the consent for the anesthesia, evidenced by the blank space where the interpreter utilized to interpret should have been documented. RNQ 4 stated the importance of utilizing an interpreter and/or interpreter services for consent forms was to appropriately explain the risks and benefits of the procedure and answer any questions the patient may have. During an interview on 5/30/24 at 2:39 p.m. with the CNO, the CNO stated her expectations of hospital staff to utilize an interpreter per the hospital’s, an interpreter should be utilized prior to medication administration, consents, teaching, assessments, discharges, and plan of care for patients who were non-English speaking. The CNO stated hospital staff should be utilizing interpreters and documenting their use of an interpreter in the EHR. The CNO stated the importance of using an interpreter was to ensure patients were receiving the appropriate care, risks and benefits of procedures and or medications were explained, and patients were receiving the appropriate education prior to discharge so they could take care of themselves at home. During a review of the hospital’s P&P titled, “Informed Consent for Medical Treatment,” dated 11/30/22, the P&P indicated, “ ...every adult with decision making capacity has the fundamental right of self-determination over his or her body, which include the right to participate actively in decisions regarding his or her medical care and to decide whether to consent or to refuse to give consent for treatment or procedures recommended by his or her physicians ...Informed consent shall be obtained by the treating physician from the patient or an individual authorized to give such consent prior to initiating any invasive procedure ...The information that must be provided includes a description of: 1. The nature of the recommended treatment. 2. Its expected benefits or effects. 3. The associated risks and complications. 4. Any alternatives to the procedure, including refusing the treatment, and their expected benefits and associated risks ...An invasive procedure is any medical treatment or procedure which is not common, simple and low risk. Procedures that are considered to be “complicated” that require informed consent include ...Procedures that require anesthesia or moderate sedation ...” During a review of the hospital’s P&P titled, “Interpretation Translation Services for Patients,” dated 3/27/19, the P&P indicated, “PURPOSE: To provide interpretation/translation services to patients who do not speak English as their primary language and who have a limited ability to read, speak, or understand English so that the patient can participate in their care and communicate with their care providers ...Competency-Demonstrated proficiency in English and the other language. The ability to use the appropriate mode of interpreting ...and knowledge in both languages of specialized terms or concepts such as medical terminology, names of body parts, symptoms and injuries ...Bilingual-The ability to communicate effectively in a different language when communicating information directly in that language but may not be competent to interpret in and out of English. Likewise, they may not do written translation ...[Hospital A] does not provide training in interpretation or translation competency ...A competent interpreter and translation shall be used whenever a language or communication barrier exists that indicates the patient has Limited English Proficiency (L.E.P) ...[name of interpreting service] is the designated interpretation services at [Hospital A]. [name of interpreting service] has documented competent interpreters in multiple languages ...The [name of interpreting service] interpreter’s identification number will be documented on the consent form ...The [name of interpreting service] will be used for all informed consents, unless the Physician is bilingual and able to interpret the planned procedure adequately so that the patient completely understands the risks and benefits of the procedure to be performed. The Physician will document that he/she interpreted informed consent to the patient in the Patient Care Record ...The [name of interpreting service] system may be used for any routine procedures that does not require official informed consent but may be considered as invasive by the patient. Procedures may include insertion of urinary catheters, insertion of peripheral IVs, insertion of nasogastric tubes, laboratory blood draws ...The [name of interpreting service] system may also be utilized by health care providers in the admission and discharge process ...Bilingual employees or family members may interpret for simple instructions such as participation in activities of daily living, diet, exercise, pain rating ...Any time care is provided with the assistance of the [name of interpreting service] system or a bilingual individual, it will be documented in the Patient Care Record ...” 6. During a concurrent interview and record review on 5/14/24 at 2:03 p.m. with RNQ 4, Pt 8’s “Admission H&P,” dated 4/2/24 was reviewed. The H&P indicated, “Patient was placed on a 5150 for being a danger to self and danger to others and gravely disable ...Chief Complaint: “Getting healthier” ...Patient is a 22-year-old male with a prior psychiatric history significant for schizophrenia [a serious mental illness that affects how a person thinks, feels, and behaves] admitted to [Hospital B] on a 5150 for being a danger to self danger to others and gravely disabled. On psychiatric evaluation with the patient today he was seen in the seclusion room as he had to be placed in restraints due to self-injurious behavior wile in the inpatient psychiatric unit earlier this morning. Patient reports that he came to the hospital “to get healthier” and when asking as to what was occurring earlier this morning that resulted in him being placed in restraints he reports “I thought the gentleman in my room was my dad.” When asking as to why patient removed his right eye and significant injury to his left eye prior to his hospitalization he reports “because I was trying to get the pepper spray out of my eyes.” ...experiencing auditory hallucinations “that encourages me to hurt my eye” and he also endorses that these voices will tell him to harm others “but I would not act on it.” Patient at this time denies having any suicidal or homicidal thoughts and he has difficulty recalling his most recent prescribed medication ...” During a review of Pt 8’s “Nurse Note (Note),” dated 4/23/24, the Note indicated, at 9:20 p.m., “Patient became uncooperative, hitting himself, wanted to take off his affected eye. Spitting at staff. Uncooperative, agitated, standing up on bed. Took out bathroom magnet door and climb bed to cover ceiling light. Yelling and screaming.” During a review of Pt 8’s “PO,” dated 4/23/24, the PO indicated, “Restraint Initiation Violent Adult routine, Imminent risk to self, No longer imminent risk to self, Hard limb, Restraint Points: 4 point restraint, All extremities at 9:30 p.m.” The PO indicated, at 9:32 p.m., “Restraint Monitoring Violent Adult, routine, [every] 15 [minutes]-[intermittent] for 4 [hours]” and on 4/24/24 at 1:32 a.m., “Contact Physician for Evaluation of Restraint [Renewal].” During a review of Pt 8’s “Nurse Note (Note),” dated 4/23/24, the Note indicated, at 10:35 p.m., “patient released from 5 point restraints. Patient agrees to be safe and denies thoughts of hurting self and others.” The note indicated Pt 8 was in 5 point restraints when the physician orders placed indicated 4 point restraints. During a review of Pt 8’s “EHR,” dated 4/23/24, the EHR indicated there was no indication a physician performed a one-hour face to face after restraints were placed on Pt 8. During a review of the hospital’s P&P titled, “MOD CO 4.004 Restraints and Seclusion,” dated 4/24/24, the P&P indicated, “For Restraints used to manage Violent or Self-Destructive Behavior, a physician, or other LIP responsible for the care of the patient must evaluate the patient in-person within one hour of the initiation of Restraint or Seclusion. The in-person evaluation and documentation must include ...Evaluation of the patient’s immediate situation ...Patient reaction to the intervention ...Patient’s medical and behavioral condition ...The need to continue or terminate the Restraint or Seclusion ...” During an interview on 5/23/24 at 8:45 a.m. with the ADON, with RNQ 3 present, the ADON stated, when a patient was placed in 5-point restraints, the orders should match the correct restraints applied to the patient. The DON stated the physician’s orders were not followed when the patient was placed in 5-point restraints and the physician orders indicated 4 points. The ADON stated every four hours the restraint orders were required to be renewed, the physician did not need to do a face to face for renewals and depended on the patient’s behaviors. The ADON stated the registered nurse (RN) reassessed the patient and if they felt the patient was not ready safety-wise to get out of the restraints, the RN updated the physician and renewal orders were placed. The ADON stated sometimes when there was an emergency, orders were obtained immediately from the physician with the reason for why the restraints were placed and physicians were not required to perform a one-hour face to face with the patient. During a review of the hospital’s P&P titled, “MOD CO 4.004 Restraints and Seclusion,” dated 4/24/24, the P&P indicated, “Violent/Self-destructive Restraint or Seclusion orders may be renewed with the following limits for up to a total of 24 hours ...4 hours for adults 18 years of age and older ...A face-to-face physical examination is required by the physician or LIP responsible for the care of the patient and authorized to order Restraints or Seclusion every 24 hours for violent/self-destructive Restraint to determine the clinical justification for the continued use ...” During an interview on 5/30/24 at 2:47 p.m. with the CNO, the CNO stated her expectations of nurses were, nurses should follow and assess patients according to physician’s orders. The CNO stated the importance of following physician’s orders was nurses do not practice medicine, therefore when applying restraints to patients, the physician’s orders should be followed as prescribed, keeping patients and staff safe. The CNO stated her expectations were nurses should follow the hospital’s policies and procedures to ensure the safety of patients. During a review of the hospital’s P&P titled, “MOD CO 4.004 Restraints and Seclusion,” dated 4/24/24, the P&P indicated, “ ...PURPOSE: To define [name of Hospital] approach to the use of restraint and seclusion for patients in way that protects the patient’s health and safety, and preserves their dignity, rights, and well-being ...Licensed Independent Practitioner (LIP): For the purposes of this policy, a Licensed Independent Practitioner (LIP) is any practitioner permitted by State law and in (accordance with Facility policy) as having the authority to order Restraints or Seclusion for patients ...Restraint ...Any manual method: physical or mechanical device, material, or equipment that immobilizes or reduces the patient’s ability to move their arms, legs, body, or head freely ...A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition...It is the policy of this organization to limit the use of restraint or seclusion Violent or Self-Destructive Behavior: Behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others ...Note: Vest or belt type Restraints, and spit hood devices are prohibited in any population ...General Requirements ...Staff will apply Restraint or Seclusion only when less restrictive interventions are ineffective ...Staff will use the least restrictive form of Restraint or Seclusion that protects the physical safety of the patient, staff, or others ...Restraint and Seclusion require an order from a physician or other authorized LIP responsible for the care of the patient. The order must include reason for Restraint or Seclusion, type of Restraint, and duration of Restraint or Seclusion ...Staff must discontinue Restraint or Seclusion at the earliest possible time, regardless of the scheduled expiration of the order ...Authorizing and Ordering Restraints and Seclusion ...Staff will initiate or continue Restraint or Seclusion only upon the order of a physician or authorized LIP following the guidelines in this policy ...In an emergent situation, and when a physician or LIP is not readily available, a Registered Nurse competent in restraint usage may initiate restraint based on an appropriate assessment of patient needs. The comprehensive assessment shall include physical assessment to identify medical problems that may be causing a change in the patient’ s behavior ...The order must be obtained either during the emergency application of the restraints or immediately (defined as without time interval) after the restraint has been applied ...All Restraint or Seclusion orders must be dated and timed when signed by the physician or LIP responsible for the care of the patient and include: 1) criteria for release; 2) type of Restraint used; 3) reason for Restraints or Seclusion; 4) and specify duration of Restraint or Seclusion order ...Violent/Self-Destructive Restraints ...the patient who is simultaneously Restraints or Secluded is continually monitored by trained staff either in-person or through the use of both video and audio equipment that is in close proximity to the patient ...At [Hospital B], a patient in restraints is monitored at least every two hours or sooner according to patient needs ...1 hour face to face is required by the RN ...When Restraint or Seclusion is used, there must be documentation in the patient’s medical record of the following ...a description of the patient’s behavior and the intervention used ...Alternatives or other less restrictive interventions attempted ... the patient’s condition or symptom(s) that warranted the use of the Restraint or Seclusion ...The patient’s response to the intervention(s) used, including the rationale for continued use of the intervention ...Individual patient assessments and reassessments ...use of Restraint or Seclusion in the Plan of Care ...A patient in 3- or 4-point restraints shall have continuous observation/monitoring ...Monitoring must include, but is not limited to ...skin integrity ...level of distress and agitation ...behavior ...patient safety and comfort, during and after Restraint is removed ...Care will not be compromised by the use of Restraints ...ENFORCEMENT: All employees whose responsibilities are affected by this policy are expected to be familiar with the basic procedures and responsibilities created by this policy. Failure to comply with this policy will be subject to appropriate performance management pursuant to all applicable policies and procedures, up to and including termination ...””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 49230 Based on interview and record review, the hospital failed to ensure registered nurses (RNs) administered medications in accordance with physician orders for three of three patients, (Patient [Pt] 29, Pt 35, and Pt 36 when: 1. Pt 29 was administered Labetalol (medication to slow heart rate and decrease blood pressure) outside the physician medication order parameters. Pt 29 had the potential for drop in blood pressure and heart rate leading to significant harm and adverse outcome. 2. Administration of Dexmedetomidine (medication to keep you asleep) continuous infusion was titrated (slowly increasing the dose of a medicine to see how your body will react to it) by RNs for Pt 35 at 0.2 [micrograms (mcg-unit of measurement) per kilogram (kg-unit of measurement) per hour (hour- time)] higher than the physician medication order to titrate administration at 0.1 mcg/kg/hr. Pt 35 was administered higher dose for titration than the physician order and had the potential for adverse outcome including hypotension (low blood pressure). 3. Registered Nurses administered insulin continuous intravenous drip (the administration of a fluid into a blood vessel, usually over a prolonged period of time) for Pt 36 to treat hyperglycemia and the insulin dose rate was not started in accordance with the physician medication order of Insulin Algorithm (guidance to assist nurses in titrating insulin dose to maintain a goal blood glucose level) despite being verified by two nurses. RNs did not follow the “Insulin Algorithm” and started insulin at a higher dose without first notifying the physician and obtaining a physician order. These failures resulted in not providing the medication as written by physicians and placed patients at risk of harm, injury, and adverse outcomes. Findings: 1. During a review of Pt 29’s “Admission H&P EMR *Final Report*”, dated 5/12/24, the “Admission H&P EMR *Final Report*” indicated, Pt 29 was a 74 year old male with history of Coronary artery disease (CAD - condition which limits blood flow in your coronary arteries, which deliver blood to your heart muscle), Coronary artery bypass grafting (CABG-heart bypass surgery, is a medical procedure to improve blood flow to the heart), hypertension (high blood pressure), hyperlipidemia (condition in which there are high levels of fat particles (lipids) in the blood). Pt 29 was transferred to the hospital from another hospital on 5/18/24. During review of Pt 29’s physician “Medication Orders” dated 4/29/24, the “Medication Order” for “labetalol (medication to slow heart rate and decrease blood pressure)” indicated, “ ...Labetalol 5 mg/ml injection..[every ]2 (hr - hours) [as needed] Blood Pressure ...Order comments: First-line for [Systolic blood pressure - First number of the blood pressure, pressure caused by heart contracting and pushing ] greater than 160. Hold for heart rate less than 60”. During a concurrent interview and record review on 5/23/24 at 8:55 a.m. with the Quality Registered Nurse (RNQ) 5, Pt 29’s physician “Medication Orders” dated 4/29/24, “medication administration record (MAR)” for labetalol on 5/4/24 at 4:27 a.m. and patient vitals four hours before and after the administration of labetalol were reviewed. The MAR indicated Pt 29 was administered labetalol by RN 26 on 5/4/24 at 4:27a.m. The review of Pt 29’s vitals on 5/4/24 indicated SBP was between 120-140 four hours before the administration. The next documented vitals after the administration of labetalol was on 5/4/27 at 5:00 a.m. indicated SBP down to 107 from 120-140 before the administration of labetalol on 5/4/24 at 4:27 a.m. RNQ 5 stated physician medication order clearly states labetalol is to be administered for SBP greater than 160. RNQ 5 stated she was not able to find any documentation in Pt 29’s medical record that indicated SBP greater than 160 during the time of the administration of labetalol on 5/4/24 at 4:27 a.m. RNQ 5 stated there were no notes by nurses or physicians in the patient medical record regarding the administration of labetalol. RNQ 5 stated she was not able to comment on the rationale for administration of labetalol. During a concurrent interview and record review on 5/23/24 at 9:15 a.m. with the Director of Critical Care (DCC), the DCC stated he had reviewed the chart for Pt 29 and was not able to find any documentation that supports the administration of labetalol on 5/4/24 at 4:27 a.m. The DCC stated administration of labetalol was not done in accordance with physician medication order. The DCC stated he was unable to find SBP greater than 160 before the administration of labetalol on 5/4/24 at 4:27 a.m. During a review of the facility’ policy and procedure (P&P) titled, “PC.AD.1.08 Documentation Policy”, with an approval date of 9/8/22, the P&P indicated, “ ...Purpose ...To outline responsibilities related to documentation of patient care from admission through discharge ...Clinical Documentation is taken to mean a process of recording and communicating a written rationale of intervention, and as such becomes part of the patient medical record ....The patient medical record reflects the complete picture of the patient’s health status, treatment and progress from admission to discharge from which other health professionals can take over responsibility for the patient concerned and for the retrieval of data for research and management. It should include a comprehensive assessment; identified problems; expected outcomes; the plan of care and care delivered (or not delivered); teaching given; advice sought in decision-making; the patient’s response to treatment; discharge and plans for ongoing care ...Charting by exception is to be utilized as a method of charting designed to minimize clerical activities; a notation (annotation) is made only when there is a deviation from the baseline or expected outcome, or when a procedure or expected activity is to be omitted ...Clinical record is taken to mean a record reflecting the complete picture of the patient’s health status, treatment and progress from admission to discharge ...” During a review of the facility’s policy and procedure (P&P) titled, “PC.AD.1.21 Medication Administration Policy”, with an approval date of 2/23/23, the P&P indicated, “ ...Basic Safe Medication Administration Practices ...Staff shall confirm the following prior to administering each medication ...Patient identification ...The patient’s name and medical record number are used to identify the patient when administering medications ...Identifiers must be confirmed using the patient’s wrist band, patient’s identification card, patient’s statement (when possible) or other means outlined in the hospital’s policy ...The correct medication ...To ensure that the medication being given to the patient matches that ordered for the patient ...The correct dose ...To ensure that the dosage of the medication matches the ordered dose and does not reflect an unsafe dosage level ...Cardiac and blood pressure monitoring is required for any continuous intravenous or intravenous push medication that directly affects the cardiovascular system ...” 2. During a review of Pt 35’s “Admission H&P EMR *Final Report*”, dated 5/12/24, the “Admission H&P EMR *Final Report*” indicated, Pt 35 was a 72 year old female with history of hypertension (high blood pressure), diabetes (chronic disease that occurs either when the body does not produce enough insulin or when the body cannot effectively use the insulin it produces), hyperlipidemia (condition in which there are high levels of fat particles (lipids) in the blood) present to hospital from nursing home with altered mental status. Pt 35 was in hypoxic respiratory failure (happens when you don’t have enough oxygen in your blood)) and hypercapnic respiratory failure ( presence of too much carbon dioxide in blood) requiring intubation (flexible plastic tube into the trachea to maintain an open airway). During review of Pt 35’s Physician “Medication Orders “dated 5/12/24, the “Medication order” for dexmedetomidine indicated, “ ...dexmedetomidine (medication to keep you asleep) IV (intravenous - medical technique that administers fluids, medications and nutrients directly into a person’s vein) additive 400 [Microgram]mcg +NS 0.9% (solution of salt and water mixed with medication to administer IV) Premix Diluent 100 [Milliliter (mL- unit of measurement)]..Indications: For sedation ...Start at 0.7mcg/kg/hr ...TITRATE by 0.1 mcg/kg/hr every 15 minute until goal ([Richmond Agitation-Sedation Scale - RASS is a medical scale used to measure the agitation or sedation level of a person ]-2) is achieved ...” During a concurrent interview and record review on 5/28/24 at 4:35 p.m. with the Quality Registered Nurse (RNQ) 1, Pt 35’s “Medication Administration Record (MAR),” dated 5/13/24 and Physician “Medication Orders” for dexmedetomidine dated 5/12/24 were reviewed. The MAR indicated on 5/13/24 at 11:00 a.m. medication administration dose was titrated from 0 mcg/kg/hr to 0.2 mcg/kg/hr. The MAR indicated dexmedetomidine medication administration does was titrated to 0 mcg from 1 mcg/kg/hr on 5/13/24 at 3:40 a.m. The RNQ 1 stated physician “Medication Order” states to start medication administration at 0.7 mcg/kg/hr and titration by 0.1 mcg/kg/hr. RNQ 1 stated titration dose of dexmedetomidine on 5/13/24 at 11:00 a.m. was done at higher rate than the 0.1 mcg/kg/hr. RNQ 1 stated she was unable to find any documentation in the medical record by nurses or physicians that supports this titration. During a concurrent interview and record review on 5/28/24 at 4:45 p.m. with the DCC, the DCC stated he had reviewed the medical record for the Pt 35. The DCC stated the titration for dexmedetomidine on 5/13/24 at 11:00 a.m. was not done in accordance with physician medication orders and stated, “it does not make any sense”. The DCC stated he was unable to find any documentation by a nurse or by physician that reflects the rationale for titration outside the physician order. The DCC stated it appears that medication was stopped and restarted outside the physician medication administration order. During a review of the facility’ policy and procedure (P&P) titled, “MOD CO.2.034 High Alert Medication Administration Double Checks and Other Safety Precautions”, with an approved date of 1/26/22, the P&P indicated, “ ...The purpose of this evidence based policy is to increase safety by avoiding preventable injuries associated with high alert medication and to provide standardized drug safety practices for “high alert” medications ... “High Alert Medications” mean medication that bear a heightened risk of causing significant patient harm when they are used in error... “Independent Double Check” means a procedure in which two practitioners separately check (alone and apart from each other, then compare results ) each component of prescribing, dispensing , and verifying the high-alert medication before administering it to the patient ...The following should be verified independently but are not limited to...For all medication, is the following correct when compared to the prescriber’s order?...Patient ...Medication ...This includes viewing the vial or packaging and verifying the strength/concentration and formulation ...Dose - This includes a review of pertinent laboratory or other values, dose calculations. Also, if draw into syringe, the dose or amount drawn up ... Are there parameters (such as hold parameters) or special instructions?...This procedure will be followed when ...Initiating a drug from Independent Double Check High Alert Medication list...High Alert Medication ...Moderate Sedation Agents ...for continuous IV infusion (e.g. dexmedetomidine ...) ...Independent Double Check?...Yes ...Summary Of Requirements ...Two nurses shall perform an independent double check anytime nurse prepares a dose of a continuous IV infusion for moderate sedation ...Two nurses shall perform an independent double check with every new bag and at handoff ...” 3. During a review of Pt 36’s “Final Report -Family Medicine Service Admission H&P”, dated 5/11/24, the “Final Report -Family Medicine Service Admission H&P” indicated, Pt 36 was a 56 year old male with history of type 2 diabetes (when body does not produce enough insulin - a hormone that regulates the movement of sugar into the cells. And cells respond poorly to insulin and take in less sugar) and hypertension (high blood pressure) who was brought in by ambulance to the Emergency Department (ED) for shortness of breath on 5/11/24 and was found to have large pneumonic infiltrate (something denser than air like pus or blood seen on imaging studies of lungs, associated with conditions like infection of lungs) with sepsis (serious condition in which the body responds improperly to an infection and the infection-fighting processes turn on the body, causing the organs to work poorly). During review of Pt 36’s Physician “Medication Orders “dated 5/13/24, the “Medication order” for insulin indicated, “ ...Insulin regular (medication used to control blood sugar) IV (intravenous - medical technique that administers fluids, medications and nutrients directly into a person’s vein) additive 100 unit(s) (unit of measurement)+NS 0.9% (solution of salt and water mixed with medication to administer IV) Premix diluent 100 [milliliter (ml -unit of measurement)] 100 ml, IV, Titrate, Start date 5/13/24 ...order comment: Initiate Insulin Infusion with ALGORITHM 1 [Table with 4 levels, each level have blood glucose (BG) value ranges and required insulin dose adjustment for that BG value range next to it. Instructions with algorithm which dose level to start and how to move up or down dosage based on BG level] ...” During a review of facility’s “ ...Insulin Algorithm”, the “insulin algorithm indicated”, “ ...Goal blood glucose (BG) 140-180 [milligram (mg-unit of measurement) per deciliter (dL- unit of measurement of volume)] ...” During a concurrent interview and record review on 5/28/24 at 4:00 p.m. with the Quality Registered Nurse (RNQ) 1, Pt 36’s “Medication Administration Record (MAR),” dated 5/13/24, physician “Medication Order” for insulin dated 5/13/24 and lab results for blood glucose dated 5/13/24 were reviewed. The MAR indicated Insulin IV administration to Pt 36 was started on 5/13/24 at 6:56 a.m. at the dose rate of 6 units/hour (hr - Unit of measurement for time). The MAR indicated insulin dose rate was started at 6 units/hour by RN 13 and dose rate was witnessed/verified by RN 14. The lab results for blood glucose on 5/13/24 at 6:27 a.m. indicated blood glucose level of 357. The physician “Medication order” for insulin “ALOGORITHM 1” indicated for blood glucose of 357 insulin should be started at 4 units/hour. RNQ 1 stated insulin was started at the higher dose at 6 units/hour. RNQ 1 stated unable to find any documentation in the medical record why the administration dose for insulin was started at a higher dose of 6units/hour than the physician ordered “ALGORITHM 1” dose of 4 units/hour. The RNQ 1 stated she was unable to find any other physician order to start insulin higher than the Physician “Medication order” for insulin “ALOGORITHM 1”. During an interview on 5/28/24 at 4:30 p.m. with the Director of Critical Care (DCC), the DCC stated he had reviewed the medical record for Pt 36. The DCC stated insulin dose rate was started at incorrect dose and he was not able to find any documentation that reflect the need for higher starting dose at 6 units/hour than the Physician “Medication Order” for insulin “ALOGORITHM” 1 of 4 units/hour. The DCC stated insulin administration requires independent double check (where two individuals separately check (alone and apart from each other, then compare results) the medication before administration to a patient) and both nurses missed this and insulin was started at a higher dose. The DCC stated insulin it is important to ensure correct dosage to avoid fluctuations in blood sugar and any harm to patient by administering wrong dose. During an interview on 5/30/24 at 2:45 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectations of staff when high alert medications were given was, the staff was performing independent double check “where two nurses separately check right medication, right dose, right patient and then compare with each other” the medication before administration to a patient. CNO stated it was her expectation that staff was following the hospital policy. The CNO stated it was important to ensure medications were administered in accordance with physician orders and safely. During a review of the facility’ policy and procedure (P&P) titled, “MOD CO.2.034 High Alert Medication Administration Double Checks and Other Safety Precautions”, with an approved date of 1/26/22, the P&P indicated, “ ...The purpose of this evidence based policy is to increase safety by avoiding preventable injuries associated with high alert medication and to provide standardized drug safety practices for “high alert” medications ... “High Alert Medications” mean medication that bear a heightened risk of causing significant patient harm when they are used in error... “Independent Double Check” means a procedure in which two practitioners separately check (alone and apart from each other, then compare results ) each component of prescribing, dispensing , and verifying the high-alert medication before administering it to the patient ...The following should be verified independently but are not limited to...For all medication, is the following correct when compared to the prescriber’s order?..Patient..Medication..This includes viewing the vial or packaging and verifying the strength/concentration and formulation ...Dose - This includes a review of pertinent laboratory or other values, dose calculations. Also, if draw into syringe, the dose or amount drawn up ... Are there parameters (such as hold parameters) or special instructions?...This procedure will be followed when ...Initiating a drug from Independent Double Check High Alert Medication list ...High Alert Medication Insulin ...Independent Double Check?...Yes ...Summary Of Requirements ...Ensure the correct type and concentration of Insulin is dispensed and administered. Refer to additional policies regarding U-500 Insulin ...Two nurses shall perform an independent double check anytime insulin drip is initiated or adjusted ...””

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 40903 Based on interview and record review, the hospital failed to ensure drugs and biologicals were controlled and distributed in accordance with state and federal statutes granting prescriptive authority, Medical Staff Bylaws, and credentialing standards for non-physician providers when the hospital granted CRNAs (a non-physician provider) prescriptive authority without having the legal authority to do so; and the Pharmacy Department permitted CRNAs to write prescriptions and filled medication orders written by CRNAs even when the CRNA was not acting according to a treatment regimen ordered by a physician; and did not have a system to double-check and ensure CRNAs could legally write prescriptions. These failures were evidenced by: 1. CRNA 3 ordered medications for Patient 3 prior to operation, during operation and in the PACU (Post Anesthesia Care Unit; after surgery) and managed the adverse events from the procedure or the drugs without a treatment regimen ordered by a physician. Pharmacy processed and approved medication use, and orders sent to them electronically. 2. CRNA 1 ordered medications for Patient 4 using an unauthorized order form for PACU orders and did not follow GI specialists’ (a doctor specialized in stomach and colon disease) sedation plan (how to put patient to sleep or provide pain relief during procedure) or orders for and medication use. Pharmacy approved CRNA 1’s medication access and did not address discrepancy on medications removed from ADM (Automated Dispensing Machine, a computerize machine that stored and tracked medication removal with authorized access). 3. CRNA 4 ordered medications for Patient 2 prior to procedure, during the procedure and in the PACU and Pharmacy processed and approved medication use, and orders sent to them electronically. 4. CRNA 6 ordered medication for Patient 5 during the procedure and for the PACU unit. Pharmacy processed and approved electronic medication orders despite risk factors related to patient age and kidney function. These failed practices did not comply with the requirement for safe pharmaceutical services, had the potential to cause harm, injury and death to patients; and could contribute to the risk of drug diversion (drug loss). Findings: 1. During review of Patient 3’s medical record, titled “Final Report”, dated 10/13/23, at 12:48 PM, written by Medical Doctor 7 (MD 7) in ICU (Intensive Care Unit), the record indicated Patient 3 was admitted to hospital for elective knee surgery, but the surgery was not performed due to “anaphylactic shock ( a type of allergic reaction), cardiac arrest (heart stopped beating), and acute respiratory failure with hypoxia (unable to breath with drop in blood oxygen)” right after anesthesia induction (start of anesthesia which uses drugs called anesthetics to keep patient comfortable and prevent from feeling pain during medical procedures) in the Operating Room (OR). During a review of the Patient 3’s electronic order record, titled “Orders”, dated 10/13/23, at 5:39 AM, the record listed medication orders prior to surgery ordered by Certified Registered Nurse Anesthetic 3 (CRNA 3) as follow: acetaminophen 1000 mg IV (same as Tylenol in IV form for pain; “mg” is milligram, a unit of measure), celecoxib 200 mg capsule (a pain medication that reduced inflammation), gabapentin 400 mg capsule( a pain medication help with nerve pain) and IV fluid called Lactated Ringers (an IV fluid used to replace water and electrolyte loss in patients). The orders were verified by a pharmacist on 10/13/23, at 5:44 AM. The document further indicated “Doctor Cosign: Not Required”. During a review of the Patient 3’s electronic medication order records, dated 10/13/23, at 8:43 AM, the record indicated CRNA 3 entered and electronically signed an order for propofol IV (a sedative medication given intravenously or “IV” into the Vein) and verified by a pharmacist on 10/13/23 at 8:47 AM. During Review of Resident 3’s medical Record, titled “SOAP Note” (SOAP stands for Subjective, Objective, Assessment and Plan, a format to explain facts and events in the medical record), dated 10/15/23, at 9: 32 AM, written by Certified Registered Nurse Anesthetic 3 (CRNA 3), the note indicated Patient 3 experienced low Blood Pressure (or BP, means the force of blood pushing against the walls of arteries with each heart beats blood pumped into the arteries) and an apparent allergic reaction after anesthesia induction (means putting patient to sleep by use of drugs to prevent from feeling pain during the procedure or surgery while monitoring the breathing) in preparation for surgery. CRNA 3’s note indicated prior to start of anesthesia, an antibiotic called “Ancef” (or cefazolin, used to prevent or treat infection), and a steroid called “Decadron” (medication used to reduce inflammation) was administered concurrently. The CRNA note described the medications used and events during emergency resuscitation (medical efforts to start the heartbeat and breathing) of Patient 3. The CRNA’s note further indicated when Resident 3 was transferred to PACU (Post-Anesthesia Care Unit; a hospital that stabilized the patient right after the surgery) “The patient still had significant tongue swelling ... In response, I gave 1 gram of Tranexamic Acid (also known as TXA, a drug used to treat bleeding or control bleeding) and ordered FFP (Fresh Frozen Plasma; a blood product given for bleeding or at risk of bleeding) as well as relevant lab test and imaging.” The note did not describe the clinical reason for use of TXA and FFP in the setting of apparent allergic reaction and was not approved by a medical doctor or surgeon. Further review of Patient 3’s medication uses and removal report from the ADM (Automated Dispensing Machine- an electronic drug storage unit), dated 10/13/23, the record indicated CRNA 3 removed tranexamic acid 1000 mg (“mg” or milligram, a unit of measure) from the ADM in the Operating Room (OR, surgery room), on 10/13/23, at 9:10 AM for administration in the PACU. The record did not show if an order for TXA was written and approved by a medical doctor or verified by pharmacy. During a review of the Patient 3’s electronic medication order records, dated 10/13/23, at 9:35 AM, the record indicated CRNA 3 gave a verbal order to a Registered Nurse for an IV (Intravenous, Into the Vein) medication called norepinephrine (drug used to increase and maintain blood pressure) for low blood pressure in the PACU unit. The record indicated “Responsible Party” was CRNA 3. The order was electronically verified and approved for use by pharmacist on 10/13/23, at 9:37 AM. During a review of Patient 3’s medication use and removal record from the ADM (Automated Dispensing Machine- an electronic drug storage unit), dated 10/13/23, the record indicated CRNA 3 removed controlled (opioid narcotic drugs with restrictive use and prescribing authority) medications including fentanyl IV (a strong opioid medication), midazolam IV (a sedative medication), and propofol IV (sedative medication) on 10/13/23, at 7:00 AM, in addition to non-controlled medications for use in the Operating Room (OR). Review of Patient 3’s paper record, titled “Anesthesia Record” (record of medications given and monitoring performed during the surgery when the patient was put to sleep), dated 10/13/23, written by CRNA 3, the record indicated a wide range of medications administered during the time period of 7:06 AM to 8:45 AM on 10/13/23. The following medications marked as given: i. Sevoflurane Anesthesia gas (an inhalation gas used to put patient to sleep during surgery), ii. Fentanyl 100 mcg (“mcg”, microgram, a unit of measure; opioid pain medication), iii. Versed (midazolam) 2 mg (“mg” or milligram, a unit of measure; a sedative and anti-anxiety medication), iv. Propofol a total of 200 mg, v. Anectine (succinylcholine; a muscle paralyzing agent) 100 mg, vi. Albumin 25%- 25 mL (a human blood component; “%” or percent was a measure of concentration and “mL” is milliliter, a measure of volume) vii. Ancef (or cefazolin, an antibiotic) 2 gm, viii. Norepinephrine (or Levophed, used to raise the blood pressure) no dosage indicated, ix. Epinephrine (used to treat low blood pressure and allergic reaction) entered as “100” for the dosage, x. Hydrocortisone (a steroid, anti-inflammation drug) 100 mg, xi. Epinephrine IV drip; No marked dosage or concentration, xii. IV fluid, Lactated Ringers 3 liter (“liter” is measure of volume), xiii. Benadryl (or Diphenhydramine, used for allergy) 100mg, xiv. Famotidine 20mg (ulcer medication, also used for allergy), xv. Tranexamic acid (or TXA- used to stop or prevent bleeding) 1 gm, The medications used in the OR and subsequent emergency code were overlapped and it was unclear or out of sequence. CRNA 3 was not available to comment on the sequence of events. The record did not indicate any physician involvement. During a joint interview with ADOP, RPH 1 and RPH 3, on 5/30/24, between 11:03 AM to 12:07 PM, the RPH 3 stated the intra-op (inside surgery room) records of medication use was not online (available in computer) and was only available after it was scanned in the medical records. When asked if pharmacy would have questioned use of TXA in setting on an allergic reaction without bleeding incident, RPH 3 stated she will “definitely questioned” the use due to risk and complications when TXA was not used based on standards of practice and approved indication. When asked if pharmacy would question use of epinephrine in the setting of having heartbeat and reasonable blood pressure, RPH 3 stated “no, not indicated” to give epinephrine, and the record of use needed to be reviewed. When asked how the reports of the drug allergy or reaction was processed by pharmacy, RPH 3 stated the allergy reported via electronic reporting system or pharmacy find it when reversal drugs used to counter allergy. RPH 3 stated the hospital was not able to review or find every single drug related allergy happening in the hospital. RPH 3 stated the providers could enter the drug reaction in the computer system. Review of the hospital’s record on Patient 3’s “Adverse Drug Reaction (ADR) Report”, dated 10/13/23, reviewed by a pharmacist, the record indicated the “action” taken with drug reaction was “Patient was given CPR, epinephrine, dexamethasone, tranexamic acid (TXA), and three liters of normal saline (salt solution in IV form).” The record further indicated “Ordering Doctor: Unknown.” The record indicated Ancef was the probable cause of the drug reaction. The record did not address if a medical doctor reviewed the ADR event and the conclusion. 2. During a review of Patient 4’s “History and Physical (H&P)”, dated 5/15/24, the “H&P” indicated Patient 4 was a 71 year with a past medical history of hiatal hernia (when part of the stomach stick out up into the chest through the sheet of muscle called the diaphragm), hypertension (high blood pressure inside vessels in the body), sleep apnea (serious sleep disorder that happens when breathing stops and starts while you are asleep). Patient 4 presented to the hospital on 5/15/24 for planned Esophagogastroduodenoscopy (EGD - The test involves an endoscope, a lighted camera on the end of a tube, which is passed down throat to visualize esophagus, stomach and tube connecting stomach to the middle part of the small intestine)/Colonoscopy (procedure done using long flexible tube with camera to check inside the entire large intestine) procedure. During review of Patient 4’s medical record, titled “Anesthesia Record”, dated 5/15/24, handwritten by CRNA 1, the record indicated CRNA 1 used propofol 200 mg (one vial, “mg” or milligram, a unit of measure) and Versed 2 mg (midazolam, a sedative controlled drug) in addition to ondansetron 4 mg (or Zofran, anti-nausea drug), metoclopramide 10mg (or Reglan, drug to treat nausea), and Robinul (or glycopyrrolate, used to reduce salivary secretions during surgery) medications during a 37 minutes endoscopy procedure (a procedure to look inside the stomach and colon via a tube with camera on it). In an interview with CRNA 1, on 5/20/24, at 4:30 PM, the CRNA 1 stated he hand pushed (via a syringe) 200 mg dose of propofol in the span of 15-20 minutes. The CRNA 1 stated the dosage was a standard dose and he decided to use propofol and versed combination for sedation as opposed to Gastroenterologist (or GI) specialist (doctor specialized in stomach disease) order for Versed and fentanyl (an opioid pain medication) for sedation during the procedure. CRNA 1 stated he was aware of sedative medication risks with Sleep Apnea diagnosis (serious sleep disorder in which breathing repeatedly stops and starts) which he did not address during pre-procedure notes for Patient 4. CRNA 1 stated he could have done a better job in documenting pre-procedure assessments and review of Patient 4. CRNA 1 acknowledged he did not follow the surgeon’s sedation plan and medication use for the procedure. CRNA 1 stated all CRNAs work independently and an anesthesia in charge was available if they had any questions or help with emergency code blues (code blue when patient stop breathing and heart stopped). CRNA 1 stated he was authorized to order any labs, administer, and prescribe narcotics, without physician co-signature in preoperative (before surgery), intra-operative (during surgery) and post anesthesia care unit (PACU - Specialized unit where patients are sent after surgery to recover from anesthesia and wake up). Further review of Patient 4’s medication uses and removal report from the ADM (Automated Dispensing Machine- an electronic drug storage unit with electronic tracking of drug use), dated 5/15/24, the record indicated CRNA 1 removed two vials of propofol 200mg from ADM on 5/15/24, at 12:24 PM. The ADM record did not show any waste or return of the extra bottle of propofol in Patient 4’s ADM report. In a concurrent interview and record review, with Assistant Director of Pharmacy (ADOP), and review of CRNA 1’s propofol removal from ADM for Patient 4, on 5/30/24, at 11:00 AM, the ADOP stated the discrepancy in propofol use and removal from the ADM often required deeper dive into the overall use of medication during the whole shift. ADOP stated not all medication and narcotics used by CRNA’s were audited for accountability. ADOP stated the weekly spot check of anesthesia record was focused on propofol and controlled medications. The ADOP could not provide a document that CRNA 1 returned the extra unused propofol vial to the ADM under Patient 4 records. During a concurrent interview with Registered Nurse 6 (RN 6) and review of Patient 4’s medical record, titled “Physician Orders: Routine Post-Anesthesia Orders for PACU/POCU” [PACU or Post Anesthesia Care Unit; POCU or Post Operation Care Unit), dated 5/15/24, at 1:35 PM, signed by CRNA 1, the paper-based record stamped with word “Faxed” (faxed to pharmacy), indicated orders for ondansetron (Zofran, anti-nausea drug), IV fluid Lactated Ringers, and three hand-written orders as follow: i. Labetalol 5 mg (“mg” is milligram, a unit of measure; med used to lower blood pressure) for SBP (or Systolic Blood Pressure; the pressure blood pushing against artery walls when the heart beats; normal level is between 120-129) more than 180; every 10 minutes up to 20 mg total dose. ii. Hydralazine (drug to treat high blood pressure) 5mg if Heart Rate (or heartbeat; normal level is between 60-100 beats per minute) less than 60; as needed; SBP more than 180; every 10 minutes up to 20 mg total dose. iii. Fentanyl 25 mcg (“mcg” is microgram, a unit of measure) IV for mild to moderate pain; every 10 minutes up to 100 mcg total dose. The order sheet was noted by a nurse and did not have clear direction on how to use the blood pressure medications sequentially. The orders were not documented in the Electronic Medical Record for verification and approval by a pharmacist. RN 6 stated no physician signature needed when CRNA’s signed the order. RN 6 stated if pharmacy did not verify the orders in timely manner, the nurses could get the drugs from the ADM by override function under the patient’s name. In an interview with CRNA 1, on 5/20/24, at 3:25 PM, the CRNA 1 confirmed he signed the PACU order sheet for Patient 4 and stated the order sheet was a pre-printed form used by all CRNA’s for transfer to post operative recovery area or PACU. The CRNA acknowledged that the pre-copied handwritten orders may not be appropriate for every patient. The CRNA stated Patient 4’s order for fentanyl probably was not needed as the endoscopy procedure (look inside stomach and colon) was not a painful procedure. The CRNA stated the order sheet filled out by nurses by putting the CRNA’s name responsible for the case and then signed by CRNA. In an interview with CRNA 1, on 5/20/24, at 3:57 PM, the CRNA 1 stated he practiced independently and had authority to prescribe, put orders in the computer, and order any medication needed to care for the surgical patients in their care. In an interview with Director of Pharmacy (DOP), in the Pharmacy, on 5/20/24, at 11:33 AM, the DOP stated the hospital had instituted restricted system on use on propofol and the drug was kept in the ADM with authorized access. The DOP stated most Operating Rooms (OR) had ADM stocked with medications and narcotics needed during the surgery. The DOP stated anesthesia providers, including CRNA’s, were given ADM access to remove the medications during the surgery. The DOP stated the pharmacy did not have much control and did not review all medications used or prescribed during surgery in the OR. In an interview with Director of Pharmacy (DOP), in the Pharmacy, on 5/20/24, at 11:38 AM, the DOP stated the pharmacy performed random audits of anesthesia records for controlled drug medication used during the surgery. The DOP stated a report with outliers and unresolved cases go to a hospital committee called “Drug Diversion Prevention Committee” and the committee made the final decision on how to address the drug loss, discrepancy, and provider access. In an interview with Pharmacy Technician (PharmTech) responsible for controlled drug audits, on 5/29/24, at 2:19 PM, PharmTech stated on weekly basis he reviewed handful of random anesthesia records with focus on narcotics and propofol use. PharmTech stated he matched the ADM removal with paper form of the anesthesia records. If no match discovered, he requested clarification from the provider and documented his finding in a tracking sheet for pharmacy management for follow up. PharmTech stated he had noticed more propofol discrepancy in the surgery areas. Review of facility’s meeting minutes from “Drug Diversion Prevention Committee”, dated 3/26/24, the record indicated the facility reported “excessive dispensing of propofol” and “#25 vials of propofol 200 mg were unaccounted for” on CRNA 17 and “21 vials of propofol 200mg were unaccounted for” on CRNA 2. The record contributed the unaccounted loss of propofol to workflow practices rather than diversion. The record indicated the CRNA’s were required to complete ADM re-training. In an interview with Registered Nurse 7 (RN 7), in the endoscopy PACU, on 5/20/24, at 5:05 PM, RN 7 stated after procedure a paper copy of orders signed by CRNA were faxed to pharmacy for input. RN 7 stated the nursing staff had access to most medications via override (override means the nurse could remove from the drug from ADM without order reviewed or verified by pharmacy) for urgent needs of the patients for pain, nausea, blood pressure control medications. During a review of facility’s undated document, titled “Override Meds List” (approved medication list that could be removed from ADM without pharmacist verification process), for PACU unit, provided by the facility on 5/22/24, the record included list of medications including labetalol, hydralazine, fentanyl, propofol, and midazolam as they were used during procedure and those listed in the PACU order sheet by CRNA 1. During a concurrent interview and record review of the hospital’s medication override and control policy, with ADOP and RPH 1, on 5/30/24, at 10:30 AM, RPH 1 stated as the nursing staff or providers removed medication via override, the ADM system tracked the use and matched it with existing orders in the Electronic Medical Record. RPH 1 stated the unresolved medication use without a doctor order was logged in the hospital’s error reporting system or if the pharmacy saw a concern or trend in override. ADOP stated the non-controlled medications (regular non-narcotic prescription drugs) override without an order was not tracked unless it was a high-cost drug. The ADOP stated the ADM machines were inspected by pharmacy on quarterly basis for accuracy of contents and expiration date of drugs (when drug no longer good to be used). RPH 1 stated the hospital had approved areas that were not required to have drug orders approved by pharmacy prior to removal from ADM, the approved areas were designated by hospital policy when the provider or doctor had control of ordering and administration inclding Operating Room (OR). Review of hospital policy, titled “Dispensing Medication from [ADM]”, last revised on 2/18/18, the policy on section related to “override” indicated “Override Medications - Override function built into Omnicell machines that allow a nurse to remove a medication from the Automatic Dispensing Cabinet (ADCs) even if the order has not yet been added to the patient’s profile by Pharmacy. Medications available via the critical override function in the ADCs shall be limited to urgent and emergent drugs which may result in patient harm or suffering due to a delay in administration. These override lists shall be reviewed, revised, and approved at least every 3 years by the Infection, Pharmacy and Therapeutics Committee (I, P&T- a committee that oversea pharmacy and drug use): 1. Physician orders for medication administration must be reviewed by a pharmacist prior to administration of the medication. 2. Exceptions to the requirement for pharmacist review of physician orders for medication administration include: When the physician controls the ordering, preparation, and administration of the medication; examples are the operating room, endoscopy suite (where colonoscopy performed), Cath lab (a cardiac room for heart procedures), emergency room, or during a bedside procedure.” The policy did not include the PACU as an area with override of medication without pharmacy order verification. 3. During a review of the Patient 2’s medical record, titled “Consultation Progress Note”, written by MD 5, dated 10/26/23, at 10:56 PM, the record indicated Patient 2 had a history of dementia (problem with memory and forgetfulness; impaired ability to think or make decisions), diabetes (blood sugar disease), heart disease with CAD (Coronary Artery Disease caused by the clogged arteries), lung disease (breathing difficulties), chronic pain and was approved to go to surgery for hip fracture on 10/26/23 after a fall at home. During review of Patient 2’s medical record, titled “Orders”, dated 10/26/23, with the time frame of 5:03 PM to 6:14 PM, the records indicated CRNA 4, ordered the nurses to administer “High Risk Medications” (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing including opioid (drugs as narcotic that could affect mental and breathing issues) pain medications called fentanyl (strong opioid drug which could affect and suppress breathing) and Dilaudid (or hydromorphone, a strong opioids/narcotics that can decrease or stop breathing). The CRNA 4 additionally orders medications to prevent nausea including Reglan 10mg (or metoclopramide, anti-nausea drug with high risk on use in elderly with higher doses due to side effects). There was no documented evidence CRNA 4 discussed the medications orders for Patient 2 with an anesthesiologist, considered Patient 2’s past medical history or post-operative emergent medical condition. The record under “Orders” indicated CRNA 4 was described in Electronic Medical Record (EMR) as the “Ordering Physician”, “Responsible Provider”, “Supervising Provider: none listed”, and a “Doctor Cosign: Not required”. CRNA 4 was authorized by the hospital to place orders for medication, treatments, and studies without restrictions for patients care and nurses to administer. Review of Patient 2’s medical record, titled “Orders”, for PACU unit, dated 10/26/24, the record indicated orders were written by CRNA 4, and verified by a pharmacist through Electronic Medical Records as follow: i. Acetaminophen 1000 mg (Ofirmev a pain medication in IV form), ii. Zofran 4mg IV (Ondansetron - anti-nausea medication) first choice, iii. Metoclopramide 10mg IV (anti-nausea medication) second choice, iv. Fentanyl 25-50 mg (opioid pain medication) for mild to moderate pain, v. Hydromorphone 0.5 mg (Dilaudid, Strong Opioid pain medication) for severe pain, vi. Lactated Ringers IV solution ongoing infusion. There was no documentation if Pharmacist questioned the use of Reglan in a 77-year-old patient. During a record review of the Patient 2’s medical record, titled “Preoperative Anesthesiologist Evaluation” (evaluation before surgery by physician that provides anesthesia), dated 10/26/23, at 4:25 p.m., handwritten by CRNA 4, the record indicated CRNA provided a pre-operative evaluation without a physician. The anesthesia evaluation plan by CRNA 4 did not address assessment of Patient 2’s history of heart attack and use of blood thinner called Plavix (clopidogrel, by thinning blood could cause internal bleeding) before a major surgery. There was no documented evidence CRNA 4 discussed the patient status or plan of care with an anesthesiologist. There was no documented evidence if CRNA 4 contacted pharmacy for risks involved with use of Plavix prior to surgery. 4. During review of Patient 5’s medical record, titled “History and Physical/Admission Notes”, dated 11/15/23, written by Medical Doctor 10 (MD 10), the record indicated Patient 5 was a 91 year old with diagnosis of end-stage renal disease on dialysis (kidney was not working well and blood had to be filtered by a machine and process called dialysis) was admitted to hospital to be evaluated for rectal (or rectum) bleeding and anemia (low blood counts). The record further indicated the heart doctor recommended “conservative treatment” due to age and other medical conditions. During a review of Patient 5’s medical record, titled “Orders”, dated 11/19/23, written by CRNA 6, the record indicated CRNA 6 was the “Ordering Physician”, “Responsible Provider”, “Supervising Provider: none listed”, and did not require a “Doctor Cosign: Not required” was authorized by the hospital to place orders for medication, treatments, and tests without restrictions. The record indicated CRNA 6 ordered the nurses in PACU to administer “High Risk Medications” (drugs with highest risk of causing significant patient harm or death) that could have contributed to patient compromise: Demerol (opioid pain medication, not recommended for elderly and kidney disease), morphine (opioid pain drug with risk of accumulation in kidney disease) , Dilaudid (strong opioids/narcotics that can decrease or stop breathing), Versed for agitation (strong sedative, with risk of breathing problem ) and Phenergan ( treatment for nausea and vomiting with risk associated with injection and breathing issues when used with opioids). There was no documentation CRNA 6 considered Patient 5’s past medical history of renal disease, low blood pressure, age, active bleeding, or potential post-operative medical condition when placing the orders. There was no documented evidence CRNA 6 discussed the medications orders for Patient 5 with an anesthesiologist before ordering them. Review of Patient 5’s medical record, titled “Orders”, for PACU unit, dated 11/19/23, the record indicated orders were written by CRNA 6, and verified by a pharmacist through Electronic Medical Records as follow: 1. Meperidine 12.5 mg IV (Demerol, an Opioid pain medication, not recommended for elderly and kidney disease), 2. Midazolam 2mg IV (versed, a strong sedative with risk of breathing issues) for agitation, 3. Hydromorphone 0.5 mg IV (Dilaudid, a strong opioid pain medication) with no pain level assessment for administration, 4. Morphine 2 mg IV (opioid pain medication with risk of accumulation in older people with kidney disease), 5. Promethazine 12.5 mg IM (or Phenergan, injected into muscle, with high risk of injection site damage and breathing issues when used with opioids), 6. Ondansetron 4mg IV (Zofran, an anti-nausea drug), 7. Normal Saline IV (salt solution for infusion), The record did not indicate if there was a pharmacy intervention to question use and dosages of high-risk drugs in the 91-year-old sick elderly. In a concurrent interview and record review, with RPH 1 , on 5/20/24, at 5:15 PM, in pharmacy office, RPH 1 stated the pharmacy staff verified orders electronically and/or based on paper-based orders for appropriateness, dose range and drug-drug interactions. RPH 1 was able to process and verify PACU order set, including fentanyl, written by a CRNA 21, in the computer system with no alert by the computer system if they were authorized to prescribe medications including narcotic controlled medications. RPH 1 stated Pharmacist can verify and authorize medication orders from any provider privileged by hospital’s medical staff. RPH 1 was not familiar how medical staff granted privilege to prescribe prescription medications including controlled narcotic drugs. In a joint interview with DOP and RPH 1, in the pharmacy office hallway, on 5/20/24, at 6:02 PM, the DOP stated the pharmacy relied of hospital’s credential and privilege system to check provider’s qualification and up to date licenses to practice and prescribe drugs. The DOP stated, the pharmacy assumed the provider’s DEA and California license to prescribe were routinely checked for updated status. RPH 1 stated the scope of practice by mid-level providers (non-physician providers authorized to provide care and prescribe) were not limited to drug class and computer allowed the pharmacist to verify their orders. In a telephone interview and concurrent record review, with DOP and RPH 1, on 5/22/24, at 12:30 PM, the DOP stated all order sets were reviewed and approved by hospital committees including Pharmacy and Therapeutic Committee (P&T committee; had oversight of safe medication use and policies). The DOP was not aware of altered PACU order sheet with handwritten orders used by CRNA’s. The DOP stated the original order set was approved in 2014 by P&T as noted at the bottom of the order sheet. The DOP stated the pharmacy encouraged all providers to use the electronic medication ordering for a safer and efficient system to verify and timely processing. In an interview with RPH-2 on 5/28/24, at 4:30 PM, in the pharmacy, RPH 2 stated her understanding was that the providers that prescribed medications had to practice within their scope and certification allowed by the law. RPH 2 stated she had verified orders written by CRNA. RPH 2 stated she had never spoken to a CRNA and assumed they had some type of agreement that allowed them to prescribe medication. During a joint interview with ADOP, RPH 1 and RPH 3, on 5/30/24, between 11:03 AM to 12:07 PM, the RPH 3 stated the intra-op (inside surgery room records and drug records) records of medication use was not online (available in computer) and was only available after use and administration or when it was scanned in the medical records. When asked if pharmacy would question use of epinephrine in the setting of having heartbeat and reasonable blood pressure, RPH 3 stated “no, not indicated” to give epinephrine, and the code record needed to be reviewed. When asked if a respiratory rate (breathing pattern) was required to be monitored when a provider administered a combination of opiates, benzodiazepine (sedative drugs that could affect breathing) and high dose propofol in span of 15-20 minutes to an elderly patient with history of sleep apnea, RPH 3 responded “it must be monitored” and stated there was a need to look into these practices as a team of nursing, pharmacy and providers. Review of the facility’s policy, titled “Controlled Substance Diversion Prevention and Detection”, last approved on 2/28/24, the policy on controlled substance access indicated “If users with Automated Dispensing Machine have changes in employment, contract status or ... privileges which would preclude them from having access to medications, the user’s access shall be promptly deactivated.” The policy further indicated “propofol shall be kept physically secure and only accessible to Authorized Personnel, and waste shall be rendered non retrievable.” The policy on section “controlled Substance Surveillance and Audits” indicated “Anesthesia ... other infusions utilizing controlled substances shall be audited to ensure ordering, administration and wastage is properly documented.” The policy’s Appendix A indicated review of Controlled and Non-controlled (medications) overrides from Automated Dispensing Machine (ADM) overrides transactions reports to ensure appropriateness and that there was an order for the medication. The frequency of the review was listed as “daily”. Review of the facility’s policy, titled “Pharmacy Control Processes”, last approved on 2/28/24, the policy indicated “Before dispensing or removing medication from floor stock or from an Automated Dispensing Machine, a pharmacist shall review all medication orders or prescriptions unless a licensed independent practitioner controls the ordering, preparation, and administration of medication or when delay would harm a patient in an urgent situation, including sudden changes in patients clinical status ... Medications available for override from an Automated Dispensing Machine shall be limited to only those medications when a delay in administration would harm the patient in an urgent situation, including sudden changes in a patient’s clinical status.” Review of facility’s policy, titled “Scope of Services: Pharmacy Department”, dated 9/23/20, the policy indicated “The pharmacy department shall provide drug distribution and clinical services to all hospitals hospitalized patients ... as determined by medical staff. Drug distribution system and control of pharmaceuticals shall be in compliance with state and federal laws and regulations and meet the standards of practice as defined by American Society of Health System pharmacists. The goal of pharmacy service is to ensure safe, effective, rational, and cost-effective use of drugs.” Review of Food and Drug Administration (or FDA- federal agency who approve drugs and prescribing information) drug information web site called “DailyMed” on propofol (brand name Diprivan), last accessed on 5/29/24 indicated “DRUG ABUSE AND DEPENDENCE: There are reports of the abuse of propofol for recreational and other improper purposes, which have resulted in fatalities and other injuries. Instances of self-administration of DIPRIVAN by health care professionals have also been reported, which have resulted in fatalities and other injuries. Inventories of DIPRIVAN should be stored and managed to prevent the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting.””

“ORGANIZATION CFR(s): 482.28(a) Organization This Standard is not met as evidenced by: 28773 Based on interview and record review, the facility failed to ensure effective organization of the Food and Nutrition Services Department as evidenced by lack of operational oversight by a Registered Dietitian. This lack of oversight resulted in food safety hazards as evidenced by improper handling of foods associated with foodborne illness (an illness that comes from eating contaminated food) and an unsanitary kitchen environment as evidenced by greater than three areas in the pot and pan room covered with a black substance. This had the potential to place the 358 patients admitted to the hospital at an increased risk for foodborne illness. (Reference to A0620, A0750, A0701) Findings: During a review of the Academy of Nutrition and Dietetics, showed a Registered Dietitian/Nutritionist (RDN) is a health care professional educated in nutrition and foods who can translate scientific information into practical solutions. RDNs are food and nutrition experts with a minimum of a graduate degree from an accredited dietetics program and who completed a supervised practice requirement, passed a national exam, and continued professional development throughout their careers. (Academy of Nutrition and Dietetics). During multiple observations in the kitchen from 5/13/24 to 5/14/24, concerns were identified in relationship to the provision of patient food services in accordance with standards of practice. The concerns included: food safety and sanitation practices in the kitchen such as but not limited to: a black substance on surfaces throughout the pot and pan room and walk-in refrigerator; staff not following cleaning procedures in the pot and pan room; improper cooling of leftover food, d. cooking equipment stored wet-nested; food trays and carts were not appropriately cleaned. (Reference to A0620, A0750); non-functional dish machine (Reference to A0701); lack of a Departmental QAPI (Quality Assurance Performances Improvement) program for food services. The Food and Nutrition Services Department conducted data gathering , with respect to patient meal satisfaction, which demonstrated a need for improvement. During a review of the Food and Nutrition Services QAPI report dated March 2024, showed patients had 23.67% meal satisfaction. There was no evidence the data was acted upon, or the information was integrated into the hospital wide QAPI program. There was no development of a clinical nutrition QAPI program. (Reference to A0273). During an interview on 5/13/24 at 11:33 a.m., the Patient Services Supervisor (PSS), stated the position of Director of Food and Nutrition Services (DFNS) was vacant and the Regional Director of Operations (RDO) came in on Wednesdays. During an interview on 5/13/24 at 12:06 p.m., in the kitchen, the RDO stated as of three weeks ago, the DFNS position became vacant. The RDO stated he was not a RDN, rather was a Certified Dietary Manager (CDM). During an interview with the RDO on 5/14/24 at 12:22 p.m., in the kitchen, he stated the Clinical Nutrition Manager (CNM), a Registered Dietitian, has oversight in the kitchen. During an interview with the CNM, on 5/14/24 at 12:47 p.m., she stated she is responsible for clinical nutrition and nutrition consults. CNM stated she looks over the therapeutic diets and looks over meal service. She informally ensures the menu is followed by observation of meal service and will modify menus if needed. Stated she has not observed whether staff follows recipes during food production but thinks they do. CNM stated she has not observed food production activities, looked at sanitation or done any type of sanitation audit in the kitchen. The CNM stated her food service evaluation is limited to communication with the Patient Services Manager about issues regarding meal service. During an interview with the RDO on 5/14/24 at 4:12 p.m., the RDO stated the Executive Chef oversees the kitchen and the sanitation and food safety falls under this direction. During a review of the hospital organizational chart, revised 4/24/24, showed the DFNS reported to the Associate Administrator (AA). Review of the departmental organizational structure titled, “FNS Management Organizational Chart”, undated, showed the DNFS supervised the Executive Chef, Patient Services Manager, Retail/Café Manager, Clinical Nutrition Manager, Behavioral Health Chef/Manager. On the chart there is not direct line from the clinical nutrition manager to food and dietetic services operations. During a review of the Clinical Nutrition Manager job description, authored by the food service contract company, dated Jan 2019, signed 2/28/23, showed the CNM reports to the DFNS. It showed the CNM is responsible to direct the functions of clinical nutrition services (such as nutrition assessment, nutrition counseling/consultation, performance improvement) and the management of the clinical nutrition team to ensure high quality nutrition care is provide to patients. The responsibilities and essential functions of the CNM did not direct any responsibility for oversight of food services. Additionally, the RDN is the profession with the most education and experience to provide guidance and oversight to the CDM and foodservice operations. The CDM does not have the education or professional skill set to supervise the RDN. During a review of the Director of Food and Nutrition Services (DFNS) job description, authored by the food service contract company, undated, showed the DFNS reports to the RDO. It showed the DFNS solely directs the operation of Food and Nutrition Services. The organizational structure and position description did not support regular consultative guidance to the DFNS, dietetic service staff or the Administrator (Reference to A0023).”

“DIRECTOR OF DIETARY SERVICES CFR(s): 482.28(a)(1) The hospital must have a full-time employee who- (i) Serves as director of the food and dietetic services; (ii) Is responsible for daily management of the dietary services; and (iii) Is qualified by experience or training. This Standard is not met as evidenced by: 28773 Based on observation, interview and record review, the hospital failed to ensure comprehensive oversight by the Regional Director of Operations (RDO), a contracted service, to ensure food safety in accordance with standards of practice as evidenced by lack of: 1. A full-time Director of Food Services. The RDO, was acting as the Director of Food Services, however, was not at the hospital full-time. 2. Effective daily management of Food and Dietetic Services related to food safety and sanitation within food and dietetic services such as: lack of food safety and sanitation systems that included: a. a black substance on surfaces throughout the pot and pan room and walk-in refrigerator, b. staff not following cleaning procedures in the pot and pan room, c. improper cooling of leftover food, d. cooking equipment stored wet-nested, e. food trays and carts were not appropriately cleaned. (Reference to A0750) 3. Involvement and effective integration of Food and Nutrition Services with the hospital’s QAPI (Quality Assurance Performance Improvement). (Reference to A0273) These failures resulted in potential for the growth of microorganisms and cross contamination that placed the 358 patients admitted to the hospital at risk of foodborne illness (illness caused by food contaminated with bacteria, viruses, parasites, or toxins), and for patient’s nutritional needs to not be met in a timely manner. Findings: 1. During an interview on 5/13/24 at 11:33 a.m., the Patient Services Supervisor (PSS), stated the Director of the department was gone and the Regional Director (RDO) came in weekly, on Wednesdays. During an interview on 5/13/24 at 12:06 p.m., with the Regional Director of Operations (RDO) of the contract food service company, in the kitchen, the RDO stated he was currently the acting or interim director of food and nutrition services. The RDO stated he is onsite at the hospital two to three days a week. The RDO stated a new director would start on 6/3/24. As of 5/31/24 the hospital was unable to provide documentation of the information. During a review of the Director of Food and Nutrition Services (DFNS) job description, authored by the food service contract company, undated, showed the DFNS reports to the RDO. It showed the DFNS is intended as a full-time position with the responsibility to direct the daily operation of Food and Nutrition Services. 2. During multiple observations in the kitchen between 5/13/24 and 5/14/24, concerns were identified including: lack of food safety and sanitation systems that included: a. a black substance on surfaces throughout the pot and pan room and walk-in refrigerator, b. staff not following cleaning procedures in the pot and pan room, c. improper cooling of leftover food, d. cooking equipment stored wet-nested, e. food trays and carts were not appropriately cleaned. a. An observation on 5/13/24 at 2:50 p.m., showed a three (3)-compartment sink, housed in the pot and pan dish room within the kitchen, was used for cleaning cooking equipment. The environment in the pot and pan room was moist, such that surfaces were wet including the floor, the metal backsplash of the sink, and the sheet metal that covered the wall behind the sink. There was a significant amount of black residue on surfaces throughout the pot and pan room, including on the sheet metal covering the wall behind the sink, on metal backsplash behind the sink, on the wall between the pot and pan room passageway frame and the metal backsplash, and on a square metal plate with a rough surface attached to the wall by passageway. In addition, the wall behind the sink was visible through two holes in the metal backsplash, larger than the size of a quarter. A black substance was visible on the wall through the holes in the backsplash. An observation and interview with Food Service Utility Staff (FSUS) 1, on 5/13/24 at 3:21 p.m., who was working in the pot and pan room, stated when he cleaned the backsplash and metal covering on the walls, he used “degreaser”. FSUS1 provided the container of chemical labeled “D9.6 Foam Free Oven & Fryer Cleaner”, which he stated he used to clean these areas. When FSUS1 was asked how he cleaned the wall behind the backsplash which was visible through the two holes. FSUS1 stated water did get into the holes but he did not know how it was possible to clean the wall behind the backsplash. Review of “[product brand] D9.6 Foam Free Oven & Fryer Cleaner” manufacturer description, showed the product was “a ready-to-use liquid oven cleaner and general degreaser that effectively cleans greasy ... Can be used to clean ovens, grills, hoods, and deep fryers”. During an observation on 5/14/24 at 9:35 a.m. in the presence of the Patient Services Manager (PSM), showed staff in the pot and pan room using the 3-compartment sink to wash cooking equipment. The black residue remained on surfaces including the metal wall and backsplash behind the sink, the wall behind the backsplash, which was visible through two holes in the backsplash, the wall between the pot and pan passageway frame and the metal backsplash, and the square metal plate with a rough surface attached to the wall by passageway. During a concurrent interview on 5/14/24 at 9:35 a.m., the Patient Services Manager (PSM) stated the pot and pan room was cleaned daily by kitchen staff. PSM also stated an outside vendor “takes care of” the black on the walls. When PSM was asked the product kitchen staff used to clean the pot and pan room surfaces, she stated staff used detergent and quaternary ammonia sanitizer (Quat - a type of chemical that is used to kill bacteria, viruses and mold) for cleaning all areas in the kitchen. During an interview on 5/14/24 at 9:40 a.m., the Executive Chef (EC) stated there was a contract with an outside vendor to clean the pot and pan room once a month. EC stated kitchen staff did not clean walls in the pot and pan room. b. During an interview on 5/13/24 at 3:00 p.m., the RDO stated there was a deep cleaning of the kitchen once a week. When the RDO was asked if there was documentation to show when cleaning was completed, RDO stated he would ask EC if there was a log to show document the completion of cleaning tasks. While the cleaning log was requested, it was not provided. c. During a review of the 2022 US Food and Drug Administration (FDA) Food Code, showed Potentially Hazardous Foods (PHFs) are those capable of supporting bacterial growth associated with foodborne illness. These foods require time/temperature control (TCS) for food safety. Protein and starch-based foods such as cooked eggs, meat and pasta are considered PHFs. TCS foods require specific temperature controls as specified intervals to mitigate the bacterial growth. Hot foods must reach a temperature of 135 degrees Fahrenheit (F) to 70 degrees F within two hours and to 41 degrees F or below within an additional 4 hours. Food prepared from room temperature items, such as cooked and rinsed pasta must reach a temperature of 41 degrees F or below within 4 hours. During an observation on 5/13/24 at 12:09 p.m., showed racks of raw and cooked food inside walk-in refrigerator “Diet 075”. On one rack was a metal pan containing scrambled eggs. The pan was warm to the touch and a label on the cover of the pan showed the dated 5/13-5/15. Another pan on the rack contained cooked breakfast sausage and a label on the cover of the pan also showed the dates 5/13-5/15. The temperature of the food was measured with a food thermometer. The eggs were 91.6 degrees Fahrenheit (F) and the sausage was 72.3 degrees F. During a concurrent interview and review of the cooling log with Dietary Supervisor (DS) 1 on 5/13/24, DS1 stated the scrambled eggs and breakfast sausage were leftovers from the breakfast tray line that morning and the items were placed in the refrigerator around 10:30 a.m. DS1 stated the leftovers were good to use for three days. DS1 stated cooked, cooling food was monitored for appropriate cooldown on a log. DS1 looked at the cooling log and confirmed the scrambled eggs and breakfast sausage were not on the log. DS1 stated the scrambled eggs and breakfast sausage were not being monitored for appropriate cooldown. During a review of the “Cooling Log” showed documentation of multiple food items from 5/9/24 to 5/13/24. It was noted scrambled eggs and sausage were not documented on the cooling log on 5/13/24. During an interview with concurrent review of the cooling log hanging on the wall, on 5/14/24 at 9:36 a.m., with Food Service Staff 4 (FSS), he stated he made a macaroni salad and put it on the cooling log. He stated he cooked the macaroni noodles then did an ice bath to cool it then took temperatures. FSS 4 stated he put that temperature on the log and only placed it on the bottom part of the log since he was making it for macaroni salad. FSS 4 stated he had four hours to get it to 41 degrees after the salad was prepared. FSS 4 confirmed what was on the log was five hours not four hours. During an interview on 5/14/24 at 4:40 p.m., PSM and RDO stated leftover food should not be stored for later use, including leftover food from trayline food service. During a review of the “Cooling Log” showed documentation of multiple food items from 5/9/24 to 5/13/24. One item documented on 5/9/24 included “Hoisin Pork”. The first cooling temperature documented for the pork was 91 degrees F. Another food documented on the log on 5/9/24 was rice. The first cooling temperature documented was 75 degrees F. During an interview with RDO and EC on 5/20/24 at 1:15 p.m., RDO stated it did not appear cooling was documented correctly for the Hoisin pork and the rice. RDO stated the starting cooling temperature was not documented. RDO stated cooldown documentation was supposed to start when the cooked food was 140 degrees F. During a further review of the Cooling Log showed “Mac Salad” was documented for cooling on 5/13/24. The first temperature documented was 75 degrees F at 11 a.m., and the second temperature documented was 38 degrees F at 4 p.m. During an interview with RDO and EC on 5/20/24 at 1:15 p.m., RDO stated the cooling for the Mac Salad was not documented appropriately. RDO confirmed there was 5 hours between the first and last temperature and the last temperature should have been measured at four hours to determine proper cooling. EC stated he checked logs daily. EC stated the incorrect cooling documentation on the Cooling Log were things that “caught his eye” but he did not notice cooling was not documented correctly on this cooling log. RDO and EC stated if corrective action was taken regarding improper cooling, the expectation was to document the action taking on the log. It was noted there was no corrective action documented on the Cooling Log. During a review of the “Food Safety Quick Check” report dated 5/14/24, showed documentation of a kitchen inspection conducted by PSM. The document showed a photo of the cooling log with entries from 5/9/24 to 5/14/24 which included the Hoisin Pork and rice on 5/9/24, and Mac Salad on 5/13/24. Documentation on the report read “Food handler is able to describe steps needed to be taken if the temperature of the cold food is warmer than 41F, or if hot food is cooler than 135F ... Cooling logs are in place and completed to the end of the cooling cycle.” PSM did not indicate on the report that staff did not follow proper cooling procedures according to the cooling documentation. d. During an observation on 5/13/24 at 2:40 p.m., showed metal pans of various sizes used for cooking and serving food stored on racks in the food preparation area. The pans were stacked and nested in one another. The pans appeared and felt wet. A spot check of more than 15 pans stacked and nested were significantly wet on the inside surface. During an observation and concurrent interview with the RDO on 5/13/24 at 2:45 p.m., showed the pot and pan room, was filled with soiled utensils stacked on racks, a countertop, and on the floor. RDO stated all pans should be air dried in the pot and pan room. RDO confirmed the pans stored on the racks in the food preparation area were wet. During an observation and concurrent interview with FSS 3, on 5/13/24 at 2:49 p.m., FSS 3 stated there was no room for all the equipment to air dry. During an observation and interview on 5/13/24 at 2:49 p.m., FSS 3 was working in the pot and pan room, washing cooking equipment. FSS 3 stated there was no room for all the equipment to air dry. During a review of the hospital’s policy and procedure titled “F018-Sanitizing Food Contact Surfaces” approved 9/22/21, showed after sanitizing food contact surfaces, do not store or stack wet food contact equipment, such as pots and pans; allow to air dry. e. During an interview with a concurrent observation with FSS 3 on 5/13/24 at 3:30 p.m., in the dish machine room, FSS 3 was cleaning meal carts. FSS 3 stated he rinses the carts with water then uses Virex ® (according to the manufacturer’s label, Virex is an “all purpose disinfectant cleaner”) to wipe them down. The Virex® is in a bucket or bin and then he wipes the entire cart and allows to air dry. FSS 3 stated the chemical is changed every two hours. FSS 3 stated he also cleans patient meal trays with the Virex®. FSS 3 stated the process is to use soap and water in a bin then put it in the bin with the Virex and then air dries the trays. FSS 3 stated they used to use a quaternary ammonium product but awhile back they changed to the Virex®. FSS 3 showed surveyor the Virex in the dispenser in the chemical room in the dish machine room in the kitchen. During an observation on 5/14/24 at 12:24 p.m., showed multiple containers of J-512 Sanitizer (according to the manufacturer this is a no rinse sanitizer for food contact surfaces) stored on a rack in the kitchen and available for use. During an interview on 5/14/24 at 2:52 p.m., Infection Preventionist (IP) stated cleaning and disinfecting procedures needed approval. IP stated the chemical “Virex®” was not for use on patient food trays. IP stated this chemical could leave trace elements on the surface of the trays. He stated this chemical was typically used for patient care areas such as beds, high touch areas, and patient side tables. IP stated the patient food trays should be sanitized and the sanitizing process should not be substituted. During an interview on 5/14/24 at 4:15 p.m., RDO stated the use of “Virex®” for patient trays was a “business” decision due to supply chain issues. RDO stated the prior executive chef made the decision to use the chemical for patient trays. During an interview on 5/20/24 at 1:30 p.m., RDO stated a food tray was a food-contact surface. During a review of the hospital’s policy and procedure titled “F018-Sanitizing Food Contact Surfaces” approved 9/22/21, showed each work area shall be equipped with sanitizing solution. Two sanitizers were mentioned including “J-512 Sanitizer” and “Foodbuy-approved no-rinse sanitizing disposable wipes”. Procedures showed to sanitize food contact surfaces after they have been thoroughly washed and rinsed. During a review of the manufacturer’s instructions for “Virex®”, showed “a potable water rinse is required for food contact surfaces.” During an interview on 5/20/24 at 12:34 p.m., with the RDO and Accreditation Manager 2 (AM2) as the scribe, the surveyor asked the hospital to describe the evaluation of foodservice operations. The RDO stated internal inspections or audits were done monthly, food safety quick checks done weekly then they have an outside third-party vendor audit done semi-annual or annually. RDO stated there is an Operations Business Excellence Review done quarterly. He stated the monthly food safety reviews were completed, on a rotating basis, by different management staff from the hospital’s food services department. When asked about the quarterly Operations Business Excellence Review, RDO stated there was food safety and sanitation components which is done by the director of food services. Surveyor asked for documentation of all types of audits done for food services. Only food safety quick check reports were received. During a review of the daily “Food Safety Quick Check” reports, there were six completed (dated 4/15, 4/18, 4/19, 4/22, 4/25, 4/29/24) prior to the start of the survey. Only one was completed by the prior director. These were the only audits provided to the surveyor. 3. During an interview with concurrent record review of the electronic patient records (Patient 49, 46, and 53) with the Clinical Nutrition Manager (CNM) on 5/17/24 at 12:12 p.m., the CNM stated the Clinical RDs have been short staffed. The CNM stated the Clinical RDs fill out a productivity log that tracks the patients they see and asked if the patients they see are assessed timely. The CNM stated she has not evaluated the data that she collects. The CNM stated she does not collect or do any evaluation of anything for QAPI for clinical nutrition services. (Reference to A0629) During a review of the hospital policy and procedure titled “Quality Assessment Performance Improvement (QAPI)”, authored by the contracted food service company, revised 1/23, showed the hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program. It showed the Food and Nutrition Services Department must participate as part of the hospital’s QAPI program and have no less than TWO (2) active quality or performance-based measurements in place at any given time. It showed the Director and RD: to request to participate in the hospital’s quality program, attends quality meetings, works with the hospital’s QAPI team to assess QAPI opportunities and executes a minimum of two QAPI projects for Food and Nutrition Services department; provides the hospital Quality Department with a report of the QAPI projects that follows the hospital’s approved format for the QAPI program.”

“THERAPEUTIC DIETS CFR(s): 482.28(b), (b)(1) §482.28(b) Menus must meet the needs of patients. (1) Individual patient nutritional needs must be met in accordance with recognized dietary practices. This Standard is not met as evidenced by: 28773 Based on interview and review of medical records and hospital documents, the hospital failed to ensure individual nutritional needs were met for three patients (Patients 49, 46, and 53) in a sample of seven patients reviewed for nutrition care when the Registered Dietitian failed to complete timely nutrition assessments. All three patients were identified at increased nutritional risk at the time of admission as evidenced by poor nutritional intake, weight loss and documented nutrition consults. The failure to ensure patients nutritional needs are met, and in a safe and timely manner, could negatively impact the health and safety of medically fragile patients. Findings: During a review of the August 2019 Journal of Clinical Medicine, showed Malnutrition is a common condition in hospitalized patients that is often underdiagnosed and undertreated. Hospital malnutrition has multifactorial (involving or depending on several factors) causes and is associated with negative clinical and economic outcomes. There is growing evidence for the efficiency and efficacy (ability to produce a desired or intended result) of nutritional support in the medical inpatient population. Early start of nutritional support (within 48 h ours after hospital admission) is recommended to maintain or improve patient’s nutritional and functional status and prevent sarcopenia (muscle wasting). Continued nutritional intervention is known to increase patients’ quality of life and nutritional and functional status, and in the older (greater than 65 years) polymorbid patients (patients with multiple medical diagnosis) it results in lower mortality (death) rates. During an interview on 5/17/24 at 11:09 a.m., the Clinical Nutrition Manager (CNM) stated the hospital policy for Nutrition Assessments specified physician ordered consults were to be seen within 24 hours, nursing consults within 48 hours, and patients who continued to be hospitalized on day seven (7). CNM stated nursing does the nutrition screen. Those patients with a Malnutrition Screening Score of two or above would automatically trigger as a nursing consult and those patients would need to be seen within 48 hours. During a review of the Academy of Nutrition and Dietetics Evidence Analysis Library regarding Nutrition Screening Adults/Nutrition Screening Adults (NSA) Systematic Review (2016-2018), indicated the Malnutrition Screening Tool (MST) is a simple, quick, valid, and reliable tool developed for use in adult hospitalized patients, now used to identify patients at risk for malnutrition. Patients are considered to be at risk for malnutrition if they receive a score of two or more (Ferguson et al, 1999). 1. During the closed (discharged from the hospital) electronic medical record review for Patient 49, the Admission Record, indicated Patient 49 was admitted to the hospital on 2/28/24, with a chief complaint of end stage renal disease (final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). Patient 49 was also on hemodialysis (a treatment to filter wastes and water from your blood). Review of the Admission H&P (History and Physical) Final Report dated 2/29/24, indicated Patient 49 had a past medical history of diabetes (a disease in which the body’s ability to produce or respond to the hormone insulin is impaired resulting from abnormal metabolism of carbohydrates and ele vated levels of blood glucose or blood sugar), hypertension (high blood pressure) and patient was “eating supper” when she started to “choke and cough”. During an interview with the CNM in conjunction with review of the closed medical record for Patient 49 on 5/17/24 at 11:15 a.m., the CNM stated Patient 49 had at MST score of three, dated 2/29/24 at 1:24 p.m. The MST indicated Patient 49 also had a weight loss of 24-33 pounds. Review of the physician’s orders, showed a dietary consult ordered secondary to nutritional risk factors documented, dated 2/29/24 at 4:01 p.m. A review of the Nutrition Assessment dated 3/4/24, showed the Registered Dietitian (RD) documented it was an initial assessment, consult and the referral source was a nurse. RD documented the current nutrition risk level was moderate. The RD documented the current diet order was nothing by mouth and the prior diet was a cardiac (heart), renal (kidney), no added salt, chopped and the patient oral intake was 41% for four meals. The nutrition diagnosis was inadequate oral intake related to poor appetite as evidenced by oral intake less than 50%. The RD documented a proposed order for Nepro (nutrition supplement for patients with renal disease) twice a day with meals. Review of the physician orders dated 3/5/24, Nepro twice a day with meals. The CNM confirmed the nutrition assessment was late, despite being an ordered consult, and the patient should have been seen on 3/2/24. The CNM stated they only have coverage for one RD on the weekend and the RD will only focus on the enteral (nutrition through a tube), parenteral (nutrition through the vein) and physician consults. The CNM stated they are usually short staffed with 3.5 Full time RDs and need 4.5, as they also cover for another hospital. 2. During the review of the admission H&P dated 10/14/23 indicated Patient 46 came to emergency room with weakness and confusion with a past medical history of Chronic Obstructive Pulmonary Disease (COPD -chronic inflammatory lung disease that causes obstructed airflow from the lungs), pneumonia (infection that inflames the air sacs in one or both lungs) in June with bronchoscopy (a technique used to look at your air passages with a small camera that is located at the end of a flexible tube) with biopsy positive for lung cancer and no treatment to date. The physician documented under assessment/plan, “10. probably moderate protein calorie malnutrition “ (protein calorie malnutrition refers to a nutritional status in which reduced availability of nutrients leads to changes in body composition and function). During an interview with the CNM in conjunction with review of the closed medical record for Patient 46 on 5/17/24 at 11:28 a.m., Patient 46 was admitted to the hospital on 10/14/23. Review of the Nutrition Screen dated 10/15/23, showed MST score of 3, recent unintended weight loss and poor appetite. Review of the orders dated 10/15/23 requested a dietary consult secondary to the documented nutritional risk factors. Review of the Nutrition Assessment dated 10/18/23, showed it was an initial assessment, consult. The RD documented there was a wound care note on 10/16/23 with coccyx ( small triangular bone at base of spinal column) community acquired unstageable pressure injury (type of bed sore that occurs due to prolonged pressure on a specific area of the skin and it is a full thickness tissue loss where the depth of the wound or bed sore is completely obscured by the eschar or dead tissue in the wound bed) and a stage two community acquired pressure injury (partial thickness loss of dermis [middle layer of skin] presenting as a shallow open ulcer with a red or pink wound bed, without slough [nonviable tissue that occurs as a byproduct of the inflammatory process] or bruising) to right upper buttock. RD documented Patient 46 weighed 33.7 kg (74 pounds) and a body mass index of 12 (BMI under 18.5 indicate underweight). RD documented malnutrition assessment and patient meets criteria for severe protein calorie malnutrition (context: chronic) as evidenced by BMI of 12, disease burden/information - lung cancer and community acquired pressure injuries, reduced variable (not consistent) oral intake and weight loss of 5.3kg (14%) in four months). RD recommended Ensure Plus High Protein (Nutrition supplement) four times a day, Juven® (wound healing supplement) daily. The CNM stated the nutrition assessment was supposed to be one day earlier. 3. During a review of the admission H&P dated 2/8/24, indicated Patient 53 came in with shortness of breath and had a history of diagnoses including hypertension, atrial fibrillation (irregular and often very rapid heart rhythm). The emergency room workup showed the symptoms to be consistent with pneumonia (an infection in the lungs). During an interview with the CNM in conjunction with a review of the closed medical record for Patient 53, on 5/17/24 at 12:05 p.m., Patient 53 was admitted to the hospital on 2/8/24. Review of the orders dated 2/8/24, requested a dietary consult secondary to documented nutritional risk factors documented. Review of the nutrition screen dated 2/8/24 showed a MST score of 3 with based on a history of decreased appetite and potential weight loss. Review of the Nutrition Assessment dated 2/11/24, RD documented it was the initial assessment, requested as a nursing consult. RD documented the nutrition diagnosis was inadequate oral intake related to patients’ mentation (ability, activity or result of using your mind to think) as evidenced by oral intake less than 25%. The RD documented the nutrition plan to monitor patient: diet/supplement tolerance, oral intake, calorie and protein intake, lab results, weight. The CNM confirmed the nutrition assessment was supposed to be done on Saturday 2/10/24 but it was the weekend. The CNM stated the RDs fill out a productivity log and they usually see 10 to 15 patients a day. The productivity log monitors the patients that are seen, and if patient is seen timely. The CNM stated she does not evaluate the data since she knows they are short staffed. CNM stated she does not collect, track or evaluate any type of data for Quality Assurance Performance Improvement for clinical nutrition. On 5/17/24 at 11:25 a.m., CNM stated corporate has been recruiting for the hospital and starting on 5/20/24 a new RD will start for the other hospital they provide coverage. (Reference to A0273) During the review of the hospital policy and procedure titled “F&N.1.79 Nutrition Screening, Prioritization and Assessment (D003A)”, approved 5/27/20, indicated nursing will do the initial screening within 24 hours of admission and based on the results a nutrition consult will be automatically generated. It indicated the RD acts on consults using the prioritization table. The prioritization table indicated a Registered Dietitian would assess the patient by the next day for physician referral, new enteral nutrition order or new parenteral orders. The table also indicated patients would receive a nutrition assessment within two days as a result of a nurse referral for a MST score of two or greater, a pressure injury stage two or greater, or a BMI less than 18. During a review of the hospital policy and procedure titled, “F&N.1.59 Nutrition Care Process (Screening Assessment and Prioritizing)”, approved 11/28/18, revealed it was not consistent with the policy titled F&N.1.79 Nutrition Screening, Prioritization and Assessment. It indicated different levels of care with nutrition assessment and reassessment time frames that were different time frames than the other hospital policy.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 42321 Based on observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment to avoid sources and transmission of infections for all patients, visitors, and staff when: 1. Two of two endoscopes (a thin, flexible tube-like instrument equipped with a camera used to look at tissues inside the body) were not stored in an endoscope cabinet in accordance with facility policy and the instructions for use (IFU). The two endoscopes were stored with the distal end (the part farthest from the origin) with the camera touching the bottom of the cabinet creating a potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect). 2. Surgical instruments were not processed in accordance with standards published by the American National Standards Institute and the Association for the Advancement of Medical Instrumentation (ANSI/AAMI -a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals) and the Centers for Disease Control and Prevention (CDC- a federal agency that focuses on controlling, containing, and eliminating diseases). Sterile Processing Technician (SPT) 1 did not scrub surgical instruments during the manual cleaning process (the first step in disinfection by which visible soil and gross debris are removed) and surgical instruments were stacked upon each other in trays, potentially damaging the surfaces of the instruments. 3. Three of five procedure trays (container that holds surgical instruments), that were sterilized and ready for use in surgical procedures, were opened and examined and contained unclean and unsafe surgical instruments. On 5/17/24, one of 91 instruments in the “Major” tray (T-1) and three of 75 surgical instruments in the “Minor” tray (T-2) had discoloration and pitting (damage to the protective layer of surgical instruments) on the instruments. No chemical indicator (a device used to monitor whether the parameters to achieve sterilization have been met for a specific sterilization process) in T-1 was observed when opened. On 5/24/24, one of 91 instruments in the “Major” tray (T-3) had red-brown residue (left over when a substance has been removed) on the shank (the extension from the handle to the working part of the instrument). This practice was not in accordance with ANSI/ AAMI which stated that surgical instruments should be free of residue, pitting, and corrosion (a process in which a solid is eaten away). The hospital’s policy was not followed when the requirement for a chemical indicator was not present inside T-1. These failures could result in use of surgical instruments that were not completely sterile, possible post- surgical infection to the patient, and instrument failure. 4. One of three blood gas machines were not cleaned in accordance with manufacturer’s instructions and was observed to have dried blood on the sample port. (A blood gas machine is specialized equipment that takes a blood sample and measures the oxygen, carbon dioxide and pH of the blood sample. The pH is a measure of acid-base balance of the blood). 5. One of three patients (Pt 60) was observed to have a peripherally inserted central catheter line (PICC line -small, thin plastic tube that is placed in a vein and threaded into the large vein outside of the heart) and the intravenous (IV - through the vein) hub did not have a sterile cap in place to prevent contamination of this hub per hospital policy and procedure. 6. Air vents in the Endoscopy decontamination room directly above the clean scope testing counter were observed to have gray matter build-up, chipped paint, and were not routinely maintained in accordance with the hospital’s policy. The room log showed vents were being cleaned daily. These failures could potentially lead to cross-contamination. 7. In the Sterile Processing Department (SPD) decontamination area, the floors, walls, and air gap were visibly in poor condition, unsanitary and not maintained in accordance with hospital policy and procedure. The floor beneath the rinse sink had rust-colored deposits, paper trash and other debris in the drain. The floor and backboard underneath the decontamination sink were scuffed, moist, with porous (water and air can pass through) drywall and wood exposed. 8. One of the two linen carts had linen stored and was not covered in accordance with the hospital policy. The linen cart had the plastic cover rolled on top of the cart and patient equipment was stored on top of the plastic cover exposing the clean linen (there was no signage to indicate the equipment was clean). 9. Three of 17 staff (Surgeon (SUR) 8, Resident Surgeon (RES) 1, and RES 2) were observed in the Operating rooms (ORs) not wearing appropriate eye wear in accordance with the hospital’s policy. 10. Three of 10 staff members (Registered Nurse (RN) 11, RN 14 and Anesthesiologists (ANS) 6) did not perform hand hygiene during patient care: RN 11 changed Pt 61’s wound dressing and did not perform hand hygiene after removing dirty gloves and then placing clean gloves on and placing a clean dressing on Pt 61’s wound; RN 14 did not perform hand hygiene prior to putting on clean gloves in the Post Anesthesia Care Unit (PACU); ANS 6 dropped a vial of medication and picked it up from the floor, tossed it and then continued to give Pt 21 medication through her IV without performing hand hygiene and without cleaning the port on the IV site in accordance with hospital policy and procedures. 11. Two of 10 staff members (RN 12 and RN 13) were seen with their fingernails painted and multiple chips and nails that passed the tips of RN 12’s fingers, which could potentially expose patients to hospital acquired infections and did not follow the hospital’s policy and procedures. 12. One of two “soiled” utility rooms on the fourth floor was observed to have trash that was not disposed of in a clean and sanitary manner to prevent cross contamination when trash bags overflowed out of the trash bin, some bags were torn and open (gloves, adult briefs, food items, etc.) were seen coming out of one of the trash bags and were piled up against the wall and the floor. 13. In the Endoscopy procedure room, miscellaneous supplies, gloves, biohazard bags and a storage box were stored within the designated splash zone of the handwashing sink and leading to potential risk for cross contamination. 14. In the kitchen responsible for patient food storage, preparation, and service : 14.A A black substance was on surfaces throughout the pot and pan room where food preparation utensils and equipment were cleaned; the facility did not follow the recommendations of the Infection Preventionist and the contracted service, who found the substance to be mold; and the facility did not follow their policy and procedures for monitoring and maintaining a clean kitchen ; 14. B. A Black substance was on the surface of the walk-in food storage refrigerator door frame and rubber gasket (a rubber strip around the circumference of the door and/or door frame to help produce an air-tight seal to keep the outside temperatures from entering while simultaneously keeping cool air inside) which was not in accordance with the facility’s Sanitation Program policy and procedure. 14.C. Floors in food preparation areas were dirty and were in poor condition and maintenance of the floor was not in accordance with policy and procedure and standards of practice. 14. D. Walk-in refrigerator food storage shelving was not clean and in poor condition and not in accordance with the facility’s policy and procedure for kitchen sanitation and maintenance. 14. E. Walk-in food storage refrigerator fan guards were not clean and were not maintained in accordance with the facility’s policy and procedure for maintenance and sanitation of the kitchen. 14. F. Food was not cooled safely in accordance with the facility’s food handling policy and procedure. 14. G. Cooking equipment was stored wet-nested (when items such as pots and pans are wet and stacked, preventing them from drying, and creating a condition for microbial growth) and not in accordance with the facility’s sanitizing policy and procedure for sanitizing food contact surfaces. 14. H. Food service trays were not cleaned in accordance with the facility’s policy and procedure as well as the manufacturer’s instructions for the chemical used; 14. I. Food service carts were not cleaned appropriately and had yellow residue on the inside and outside surfaces and were not cleaned in accordance with the facility’s policy and procedure as well as the manufacturer’s instructions for the chemical used; and 14. J. Staff facial hair was not covered which was not in accordance with the facility’s policy and procedure for staff personal hygiene. 15. The Infection Preventionist was not aware of the hospital-wide infection problems, did not have a systemic approach to track and monitor infection control practices and did not make rounds in all areas of the hospital. As a result of these failures all patients, visitors and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections and illnesses. Because of the serious potential harm related to staff in many areas and departments of the hospital not practicing standards of infection control to reduce infections and cross contamination, such as endoscopes not being properly stored, surgical instruments not being appropriately processed and disinfected, the environment of hospital areas being visibly unsanitary, specialized equipment not being properly disinfected and maintained, staff not adhering to perioperative surgical attire requirements, hand hygiene procedures not being followed and a hospital-wide infection control program not having a systematic method to track, monitor, and surveil infection control practices to reduce the sources of infection and prevent cross contamination, an Immediate Jeopardy (IJ- a situation in which the provider’s noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called on 5/21/24 at 11:30 a.m., under Code of Federal A-0750 §482.42(a)(3) with the Chief Executive Officer (CEO), Chief Operating Officer(COO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Accreditation Manager (AM) 1, and AM 2. The IJ template was provided to the facility. The hospital submitted an acceptable IJ Plan of Removal (Version 2.2) on 5/24/24 at 8:00 a.m., which addressed the actions needed to remove the IJ situation. The IJ Plan of Removal included but was not limited to the following: 1) Reeducated and trained staff on manufacturer’s instructions for cleaning and disinfection, sterilization, and sanitary storage of surgical instruments, endoscopes, and arterial blood gas analyzers ( measures the amount of oxygen and carbon dioxide in the blood) 2) Immediately removed unclean endoscopes and surgical instruments from use in procedures 3) Provided house-wide education to staff on hand hygiene, proper aseptic techniques (a method used to prevent contamination with micro-organisms) for intravenous medication administration, and clean storage of patient supplies and equipment 3) Immediately cleaned and disinfected air vents, floor drain air gap, kitchen door frames, sinks, floors, rolling food carts and racks, and linen carts, and developed processes for recording and monitoring compliance. 4) Trained kitchen staff on manufacturer’s guidelines for use of kitchen disinfectant solutions and proper cool down processes for patient food items. 5) Dietary staff discontinued the practice of storing pots and pans used for patient food service wet 6) The Infection Preventionist increased surveillance by rounding daily in areas affected by the deficient practices. The components of the IJ Plan of Removal, training, and competencies of staff were validated onsite through observations, interviews, and record review. The IJ was removed onsite on 5/27/24 at 10:48 a.m. with the facility CNO and AM 2. Findings: 1. During a concurrent observation and interview on 5/14/24 at 9:41 a.m., with Clinical Resource Specialist Registered Nurse (CRS), Sterile Processing Department Manager (SPDM), and Quality Nurse (RNQ) 1 in the endoscopy storage room (ESR), two endoscopes with the distal end of the scopes were touching the bottom of the endoscope cabinet. The CRS & SPDM validated the observation and stated would need to review the policy. During an interview on 5/14/24 at 10:25 a.m., with the Director of Surgery (DOS), the DOS stated the scopes were not stored in accordance with the Instructions for Use (IFU) and potential for patient safety risk through cross-contamination. The DOS stated staff had been made aware of the inappropriate storage of endoscopes and the department would be reminded of the importance of safely storing scopes “freely hanging” to ensure the distal end of the scope did not touch the bottom of the cabinet. During an interview on 5/15/24 at 9:55 a.m., with Registered Nurse Manager (RNM 1), RNM 1 stated scopes should be hung freely, and distal end should not touch any surfaces with or without a tip guard (help protect the delicate components of scope) on distal end. RNM 1 stated endoscopy staff members were made aware of the correct storage requirement and were re-educated on the importance of storing correctly to prevent infections. During a review of facility’s document sterile processing manual procedure (SPMP) titled, “ST.P.1.34 Flexible Scopes”, with the approval date of 5/23/18, the SPMP indicated, “ ...Ensure cleaning and processing is conducted by the individuals who have received education and completed competency verification activities related to endoscope processing ....STORING ...Store mechanically processed flexible endoscopes in a cabinet that is both designed and intended for horizontal storage of flexible endoscopes or is of sufficient height, width, and depth to allow the endoscopes to hang vertically, without coiling and without touching the bottom of the cabinet ...” During a review of the [Endoscope Brand Name] IFU for “[Brand Name] Ultrasonic Gastrovideo Scope (special endoscope that uses high frequency sound waves to examine all major organ of digestive system)”, the IFU indicated, “...reprocessing and storage after use ...After using this instrument, reprocess and store it according to the instructions given ...Improper and/or incomplete reprocessing or storage can present an infection control risk ...Storage and Disposal ... Keep the reprocessed endoscope and accessories away from the contaminated equipment after cleaning and disinfection or sterilization. If the clean endoscope and accessories become contaminated between procedures, they could present an infection control risk to patients and/or operators in the subsequent procedures ...Hang the endoscope in the storage cabinet with the distal end hanging freely. Make sure that the insertion tube hangs vertically and as straight as possible ...” During a professional reference review retrieved from (https://www.aami.org/docs/default-source/bi-t/bit/drying-storing-endoscopes---bit-may-june-2020.pdf) titled, “ Drying and storage of Flexible Endoscopes: An Area of Growing Concern”, dated 2020, the reference indicated “ ...Store endoscopes and accessories in a manner that prevents recontamination, protects equipment from damage, and promotes drying ... Store processed flexible endoscopes in a cabinet of sufficient height, width and depth to allow flexible endoscopes to hang vertically without coiling or touching the bottom of the cabinet or in one designed and intended for horizontal storage...” 2. During a concurrent observation and interview on 5/17/24 at 10:30 a.m., in the SPD decontamination area, with the Sterile Processing Department Manager (SPDM) and SPT 1, SPT 1 demonstrated the manual cleaning of surgical instruments before sterilization (process of making something free from germs). SPT 1 pulled a “Laparoscopic GYN [gynecologic]” tray (a set of instruments used to operate and examine abdominal, pelvic, and reproductive organs) from the cart and removed the camera and scope from the instrument tray. SPT 1 submerged the instrument tray in water mixed with an enzymatic detergent (special cleaner to breakdown soil and stains) solution. The hinged instruments (two-piece instrument attached by a joint that allows limited movement) remained strung on the instrument stringer (adjustable tool designed for organizing ring-handled instruments and keep hinged instruments in an open position during sterilization). The instruments soaked in the water solution for two minutes, then SPT 1 transferred the instrument tray to the rinse sink filled with tap water. The instrument tray soaked in the tap water for one minute before transfer into the ultrasonic cleaner (a machine that uses high frequency sound to agitate fluid, with a cleaning effect). Pockets of water from the contaminated sink pooled on the sink’s surfaces, backsplash, handle, and floor. The instrument tray was removed from the ultrasonic cleaner and set near the automatic washer for cleaning. The instruments were not opened, inspected, nor manually scrubbed during this process. The instruments were stacked upon each other in the tray. Other trays were observed being washed that had instruments stacked upon each other. SPDM stated she expected staff to manually clean and inspect all instruments, regardless of not being used in any particular procedure. The SPDM stated it was important to manually scrub the instruments under water to remove any tissue or debris that may adhere to instruments during surgery. The SPDM stated instruments should be opened and evenly spread apart in the trays to be adequately washed and prepared for sterilization. The SPDM stated instruments stacked upon each other disrupted the cleaning process of the automated washers and increased the risk of damaging the instruments. The SPDM stated the sink and surrounding area should be disinfected between each wash to prevent cross contamination (transfer of germs from one object to another) and transmission (spread) of disease. The SPDM stated SPT 1 did not follow policy and procedure during the cleaning process of the surgical instruments. SPT 1 denied any error in her cleaning procedures and stated she followed the cleaning process as trained. During an interview on 5/20/24 at 3:45 p.m., with the Infection Preventionist (IP), the IP stated enzymatic detergents removed “the majority” of biological remains (tissue and/ or bioburden [germs living on a surface]) left on surgical instruments and equipment however, the cleaning process used a three step approach to ensure instruments were cleaned and prepared for sterilization by 1) manual cleaning (physical action to wipe, scrub, and/or flush to remove gross organic material); 2) ultrasonic cleaning; and 3) automated cleaning (machine washed and rinsed, thermal rinse included), and thus rendered safe to handle before sterilization. The IP stated instruments had to be scrubbed to ensure bioburden was not left behind to eliminate the risk of cross contamination (that could lead to transmission of infection) and instrument failure. The IP stated unclean instruments could not be properly sterilized. The IP also stated the cleaning environment should remain dry, clean, and sanitary to prevent moisture build up, mold spores, and germs from reproducing. During a review of the professional reference titled “ANSI/ AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities”, dated 2017, the professional reference indicated, “ ... Instrument damage is often due to care and handling issues ... Keeping the instrumentation in an orderly fashion will help prevent instrument damage ... The first and most important step in reprocessing reusable medical devices is thorough cleaning and rinsing. Cleaning removes microorganisms and other organic and inorganic materials ... All microorganisms in health care facilities should be considered potentially pathogenic ... Medical devices, instruments, and equipment used in patient care become contaminated with microorganisms and should be decontaminated ... To ensure patient safety, a reusable device needs to be capable of being thoroughly cleaned and sterilized... Because effective sterilization depends on minimizing the contamination present on items before the sterilization cycle, thorough cleaning procedures are essential during pre-sterilization processing... instruments should be presoaked as soon as possible after use with a product intended to loosen soil... The presoak solution manufacturer’s written IFU should be reviewed and followed for the correct dilution, temperature, and contact time ... Presoaking instruments moistens and loosens the soil, thus making the cleaning step more effective and efficient. Thorough rinsing removes potentially harmful residues and blood and other potentially infectious material... The volume and temperature of water used in the cleaning sink or other cleaning container is very important for the efficacy of the process. The appropriate dilution should be calculated according to the volume of the sink to ensure consistent and accurate cleaning solution concentration ... clean immersible devices under water to minimize aerosolization (disperse a substance) ... clean devices that cannot be immersed in a manner that will not produce aerosols ... Position devices to prevent damage. Heavy devices should be placed on the bottom. Position items such as rigid sterilization container and basins to avoid the accumulation and retention of water ...” During a review of the professional reference titled, “CDC Cleaning Guideline for Disinfection and Sterilization in Health Care Facilities (2008)” dated 9/18/2016, indicated, “Cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Also, if soiled materials dry or bake onto the instruments, the removal process becomes more difficult and the disinfection or sterilization process less effective or ineffective. Surgical instruments should be presoaked or rinsed to prevent drying of blood and to soften or remove blood from the instruments ... With manual cleaning, the two essential components are friction and fluidics. Friction (e.g., rubbing/scrubbing the soiled area with a brush) is an old and dependable method. Fluidics (i.e., fluids under pressure) is used to remove soil and debris from internal channels after brushing and when the design does not allow passage of a brush through a channel. When a washer-disinfector is used, care should be taken in loading instruments: hinged instruments should be opened fully to allow adequate contact with the detergent solution; stacking of instruments in washers should be avoided; and instruments should be disassembled as much as possible ...” During a review of the professional reference titled, “There’s More to Keeping Scopes and Other Tools in Good Working Order Than Just Thorough Reprocessing,” dated 10/10/2007, the reference indicated, “ ...If it’s properly cared for, an instrument should last about 20 years. That’s if. There are many opportunities for and causes of damage. The top three: misuse (the instrument isn’t used as intended by its design), abuse (dumping, stacking, and improperly cleaning and sterilizing instruments) and exposure (to chemicals and detergents, including saline, chlorine bleach, blood and even water) ...Stainless steel can corrode by pitting, crevice corrosion and stress corrosion cracking (also known as hydrogen cracking). This is usually caused by exposure to blood ...The effect is deep pockets or pits that look like black holes on the surface. You can’t repair pitting- rather, you have to replace instruments when pitting occurs ...” During a review of the hospital’s policy and procedure (P&P) titled “PC.AD.1.11 Guidelines for Cleaning, Disinfection & Sterilizing Patient Care Environment & Equipment Policy” dated 9/28/22, indicted, “ ... Accumulation of dust, soil, and microbial contaminants on environmental surfaces may create a reservoir of microorganisms, that when transmitted via hands or equipment can contribute to hospital associated infections ... Failure to properly store supplies, disinfect, or sterilize reusable medical equipment intended for use with patient care can potentially introduce pathogenic microorganisms to patient and cause infections... Critical Items... Objects that enter sterile tissue or the vascular system are defined by the CDC as critical items. They carry a high risk of infection if they become contaminated. Critical items must be sterile ... Examples of critical items include but are not limited to the following: surgical instruments... Cleaning is the removal of organic and inorganic material from objects and surfaces. This is normally accomplished by using detergents or enzymatic products. Thorough cleaning is necessary before disinfection and sterilization because organic and inorganic materials that remain on the surface of instruments interfere with the effectiveness of these processes ... Decontamination is the use of physical or chemical means to remove, inactivate, or destroy microorganisms on a surface or item so they are not infectious and the surface or item is rendered safe for handling, use, or disposal ... Sterilization is the complete destruction of all microbial life. It is accomplished by either a physical or chemical process such as steam under pressure, dry heat, and low temperature gas plasma (ionized gases generated under deep low pressure conditions). All items that enter sterile tissue or the vascular system must be sterile, (i.e., implants, surgical instruments, etc.). (Critical items) ...” During a review of the hospital’s P&P titled “ST.P.1.36 MOD ST.P.1.36 Sterilization” dated 4/24/19, indicated, “ ... the SPD will provide for the terminal sterilization of reusable medical devices using saturated steam under pressure and Sterrad [machine used to sterilize medical devices] ... It is recognized that efficacy of the sterilization process is dependent upon proper cleaning, assembly wrapping, and sterilizer loading ... Preparation of items for sterilization ... Items must be: Thoroughly cleaned and decontaminated ... Correctly assembled ... Loaded such that all surfaces will be directly exposed to sterilant ...” 3. During concurrent observation and interview on 5/17/24 at 11:30 a.m., in the SPD clean area, with the SPDM, Sterile Processing Department Supervisor (SPDS), and Director of Surgery (DOS), the SPDM and the SPDS demonstrated the “Instrument Quality Check Process.” SPDM opened “T-2” tray that was sterilized and stored for use. The “T-2” tray contained a total of 75 surgical instruments. The following surgical instruments were observed to have brown and white discoloration, notches and pitting: one towel clip perf 5.25 (perforating clamp used for grasping tissue, securing towels or drapes, and holding or reducing small bone fractures), one knife handle #7, and one knife handle #3 (used for holding sharp blades; #7 is used for more delicate cuts). The SPDS inspected the instruments and stated discoloration was caused by hard water which stained the instruments. The SPDS stated the hospital struggled to maintain water quality. The DOS stated the notches (indentation and/ or groove) and pitting noted on the instruments were acceptable and could be disinfected with the facility’s current practice for processing surgical instruments. The DOS stated pitting did not pose an infection control risk for patients. The SPDS opened “T-1” tray for inspection of surgical instruments, and there was an orange chemical indicator (used to monitor whether the parameters to achieve sterilization have been met for a specific sterilization process) outside the tray and once the tray was opened, a chemical indicator could not be found in the tray. The SPDS stated when auditing a tray, he ensured there was a chemical indicator outside the tray, which should be orange and once he opened the tray, he checked to see if there was another chemical indicator inside as well. The SPDS stated there should have been a chemical indicator inside the tray. The SSPD stated the importance of the chemical indicator was to ensure the surgical instruments were appropriately sanitized. The SPDS stated if there was no chemical indicator in the tray, the instruments could possibly not have been sanitized appropriately. During a concurrent observation and interview on 5/17/24 at 11:45 p.m., in SPD, with the SPDS, the SPDS removed instruments from the “T-1” tray and inspected the instruments. The “T-1” tray contained 91 instruments. The SPDS held up one retractor Richardson 1.5 x 2 blade 9.75 (surgical instrument used during procedures, such as for chest or abdomen, to grasp soft tissue using the curved blade) which had red-brown residue on the instrument. The SPDS stated the residue could potentially cause an infection to a patient if used on the patient during surgery. The SPDS stated the surgical instruments should be thoroughly cleaned and there should not be any staining or residue left on the instruments after they have been thoroughly cleaned and sanitized. The SPDS stated the importance of cleaning surgical instruments appropriately was to prevent infections. During an interview on 5/20/24 at 3:45 p.m., with the IP, the IP stated the purpose for chemical indicators was to make sure steam reached the instruments during the sterilization process. The IP stated all trays should have indicators to ensure the instruments were sterilized. The IP stated instruments went through a rigorous process of sterilization and pitting and/ or corrosion did not pose an infection control risk, rather corrosion increased the risk for the instruments to become non-functional or cause the instrument to fail during a surgical procedure. During an interview on 5/24/24 at 10:08 a.m. with SPT 2, SPT 2 stated sterile processing technicians were trained to inspect instruments before instruments were packaged and sterilized. SPT 2 stated it was expected for technicians who packaged instruments to remove instruments from trays if the instruments had functional issues, pitting, or residue. SPT 2 stated it was uncertain why stained and pitted instruments were found in “T-1” and “T-2.” During a concurrent observation and interview on 5/24/24 at 10:45 a.m., in the SPD clean area, with SPDS, SPDS opened “T-3” tray that was sterilized and stored for use. The “T-3” tray contained a total of 75 surgical instruments. One needle holder mayo- hegar 8.0 (used to drive curved needles during surgery) had red-brown residue on the shank. The residue material lifted when scratched with fingernail. The SPDS validated the instrument was not properly sterilized. During an interview on 5/29/24 at 3:16 p.m., with the Infection Preventionist (IP), the IP stated residue left on an instrument did not increase the risk for transmission of diseases. The IP stated residue was caused by steam during the sterilization process and risk of infection for patients was low. The IP stated “hardwater” caused the residue stains on instruments. The IP did not comment on the residue material lifted from the instrument. During a review of the professional reference titled, “ANSI/ AAMI ST79:2017,” indicated, “ ... have a process in place to identify instruments in need of repair/maintenance and removal from service ... inspected for cleanliness, flaws, and damage... Surgical instruments and other medical devices and equipment could pose a significant risk of transmitting infection to patients or health care personnel if they are not properly decontaminated and then disinfected... Instruments should be carefully inspected for flaws, damage, debris, detergent residue, and completeness ... and replace them as often as needed ... Adherence to the manufacturer’s written IFU for detergents and other aspects of the cleaning and decontamination process can help avert damage to instruments, prolong their use life, and prevent the creation of crevices in which debris can collect. Ensuring the completeness of instrumentation helps reduce the number of lost instruments and instrument parts. Drying instruments before they are packaged can reduce the incidence of wet packs after sterilization and can help prevent corrosion of instruments ... “ During a review of the hospital’s P&P titled “ST.P.1.36 MOD ST.P.1.36 Sterilization” dated 4/24/19, indicated, “ ... it is recognized that efficacy of the sterilization process is dependent upon proper cleaning, assembly wrapping, and sterilizer loading... Items must be... Thoroughly cleaned and decontaminated ... a chemical indicator will be used in each package and each sterilized load. Chemical indicator will be read and interpreted as part of non-implant and implant load release criteria ...” 4. During a concurrent observation and interview on 5/13/24 at 1:55 p.m. with RNQ 1, Registered Nurse (RN 5) & Director of Critical Care (DCC) in respiratory supply room in the Critical Care Unit (CCU - Unit cater to patients with severe or life-threatening illnesses and injuries, which require constant care, close supervision from life support equipment and medication in order to ensure normal bodily functions) a [brand name] blood gas system was observed. Sample port for the [brand name] blood gas system and surface area directly below it appeared soiled and appeared to have dried blood on it. The RN 5 validated the observation and stated the sample port looks soiled and needed cleaning. The RN 5 stated Respiratory Therapists (RT - specialized healthcare practitioner trained in critical care and cardio-pulmonary medicine in order to work therapeutically with people who have acute critical conditions, cardiac and pulmonary disease) were responsible for maintaining blood gas system and she was not able to speak to the process for cleaning. During a concurrent observation and interview on 5/13/24 at 2:00 p.m., with the DCC, the DCC stated [brand name] blood gas system was observed with sample port and surface area below appeared to have dried blood on it. The DCC stated [brand name] blood gas system was maintained by the RT team. The DCC stated the sample port and surface area below “appears dirty and would definitely be a concern”. The DCC stated that he would have expected that CCU team to escalate the concern to the RT team. The DCC stated the risk for cross contamination increased when there is soiled equipment next to the workstation. During a concurrent observation and interview on 5/13/24 at 2:10 p.m., with the Director of Respiratory Therapy (DRT) in the respiratory supply room in the CCU, the sample port for the [brand name] blood gas system and surface area directly below appeared soiled and appeared to have dried blood on it. The DRT stated sample port was where syringes with blood gets attached and dried blood was from running the sample on the sample port. The DRT stated Respiratory Therapist (RT) assigned to CCU on each shift was responsible to make sure the blood gas systems were clean, calibrated, and ready to use. The DRT stated outside of sample port and area around it should be clean and without any dried blood. The DRT stated the facility have extra sample ports readily available and sample ports were very easy to change. The DRT stated it was not acceptable to have dried blood on the sample port and external areas of the blood gas system. The DRT stated, “it looks filthy, needs to be clean”. The DRT stated the unclean blood gas system could be a concern for infection and cross contamination. During a concurrent interview and record review on 5/14/24 at 3:20 p.m. with the DRT, facility’s [brand name] blood gas system’s operator guide, undated, was reviewed. The operator guide indicated, “ ...Cleaning and Disinfecting the Exterior Surfaces: Clean the exterior surfaces as needed to remove dust, dirt, and splatters from the surfaces, and disinfect the surfaces ... Follow this procedure to clean and disinfect exterior surfaces ...Moisten the cloth with the sodium hypochlorite (bleach) solution so that the cloth is wet but not dripping ....Wipe the exterior surfaces of the system with the wet cloth and then thoroughly dry the surfaces ...”. The DRT stated sample port should not be left with blood on it. The DRT stated dirty sample port with blood or dried blood on it was not acceptable. The DRT stated it was not acceptable to have blood splatters or dried blood on any equipment as it could potentially cause contamination and spread diseases. During a review of facility’s competency document titled “[brand name] blood gas system Initial Training”, dated 5/14/24, the document indicated, “ ...Routine procedures ... Review how to replace the sample port ... Maintenance ...Clean and disinfect the exterior surfaces ...” 5.During a review of Pt 60’s Admission Record (AR) dated 5/13/24, the AR indicated Pt 60 was admitted on 5/12/24 at 12:39 p.m. with the following diagnosis symptomatic anemia (not having enough healthy red blood cells or hemoglobin to carry oxygen to the body’s tissues, may cause lethargy, weakness, and tiredness). During a concurrent observation and interview on 5/13/24, at 3:20 p.m., with the Shift Manager (SM) 1, while in Pt 60’s room, Pt 60 was seen with intravenous (IV- through a vein) fluids running through a pump into her PICC line. One of Pt 60’s ports on her IV tubing was seen without a cap (curos disinfecting port protectors are alcohol-containing caps that twist onto IV access points for disinfection and protection) covering it and a new bag of caps hanging from the IV pole. SM 1 stated the ports should be capped to help prevent contamination of the port and then immediately placed one of the caps on the port. During a review of the facility’s policy titled, “Central Line-Associated Bloodstream Infection (CLABSI) Prevention Bundle & Line Necessity Protocol - Adult,” date approved 1/22/20, indicated, “I. Scope This policy applies to [name of hospital], its employees, Medical Staff, and contractors, regardless of service location, who provide treatment for patients who require a central venous catheter (thin flexible tube that is inserted into a vein to draw blood and give treatments). II. Purpose Many patients require the placement of central line catheters. These patients are at risk for development of Central venous catheter associated blood stream infection (CVCBSI) and complications which increase morbidity, mortality, and healthcare costs. The purpose of this policy is to outline the evidence-based clinical practice guidelines that Hospital shall follow to reduce the incidence of CVCBSI ... C. After Insertion 1. Document the site, time and date of placement. 2. Disinfect catheter hubs, needleless connectors and injection ports before accessing the catheter. a. Before accessing catheter hubs or injection ports, clean them (for at least 15 seconds with a scrubbing motion and allowed to completely dry) with an appropriate aseptic (chlorhexidine 70% alcohol, povidone iodine or an iodophor) to reduce contamination... 3. Daily review of the line for Necessity/ Remove nonessential catheters... 5. Replacement of administration sets... d. The end of the administration set should be protected with a new sterile cap when not in use. e. Label all administration sets with expiration date...” 6. During a concurrent observation and interview on 5/14/24 at 10:23 a.m., with the SPDM and Assistant Director of Surgery (ADS) in the Endo decontamination room (room where used endoscopes are brought in for manual cleaning after being used), the ceiling air vent (Vent 1) had paint chipped along the edges of the vent and pieces of chipped paint were loose and ready to fall from the ceiling. Vent 1 was located directly above the sink used for manual cleaning and scrubbing of endoscopes. Vent 2 was directly across from Vent 1 and had grey matter build-up and appeared to be full of dust. Vent 2 was located above the adenosine triphosphate testing station (Point-of care testing for adenosine triphosphate (ATP), a marker of microbial contamination, to assess the effectiveness of manual cleaning. ATP testing has recently been shown to correlate with quality of endoscope cleaning). The SPDM & ADS validated the observations, and both stated both ceiling vents needed cleaning and repair to the paint around Vent1. The SPDM stated both vents needed cleaning and appeared dirty. The SPDM stated Plant services took care of the vent and environmental services (EVS) were responsible for daily cleaning including terminal cleaning (the process to thoroughly clean and disinfect an area of the hospital) of Endo decontamination room. The SPDM stated dirty vents could lead to cross contamination during the cleaning process of endoscopes. During an interview on 5/14/24 at 10:24 a.m. with the ADS, the ADS stated Vent 1 and Vent 2 both needed cleaning, and it was unacceptable to have paint chipped and dust build-up on Vents in cleaning areas. The ADS stated EVS, and plant services were responsible for the maintenance and cleaning of the vents. During a concurrent observation and interview on 5/14/24 at 10:25 a.m. with the DOS, in the Endo decontamination room, Vent 1 & Vent 2 were observed. The DOS stated both vents were dirty. The DOS stated chipped pain and dust build-up was not acceptable and “vents could use cleaning”. The DOS stated plant services team were responsible for the vents and he was not able to speak to the maintenance schedule for the vents or how often the plant services team checked and maintained the vents to make sure they were not dirty. During a concurrent observation and interview on 5/14/24 at 10:28 a.m. with the Manager of Facilities Services (FSM), in the Endo decontamination room, the FSM stated the vents needed cleaning and paint needed to be fixed. FSM stated both Vent 1 and Vent 2 were dirty. During an interview on 5/14/24 at 2:10 p.m. with the Manager of facilities services (FSM), the FSM stated he has been working at the facility for the last 5 years. The FSM stated he was made aware of the dirty vents in the Endo decontamination room earlier in the day on 5/14/24. The FSM stated the vents needed cleaning and the condition of the vents was not acceptable per facility standards. The FSM stated he was called to Endo decontamination room on 5/14/24 around 10:30 a.m. and noticed the dirty vents. The FSM stated Vent 1 with chipped paint all around it and above the sink was a supply vent and Vent 2 above the testing station was return vent. The FSM stated EVS team is responsible for wiping the vents down as part of the daily cleaning and if the EVS observed anything unusual, then the expectation was to inform the facilities team to clean, and his team will assist with cleaning. The FSM stated EVS team, or any staff of the facility can place a work order to notify Facilities Services team and then his team would assist with cleaning of the Vents. The FSM stated no work orders were placed and should have been filled out. The FSM stated dirty vents could potentially add contaminants or chipped paint may fall and add debris in the cleaning process of endoscopes. During an Interview on 5/15/24 at 3:15 p.m. with Operations Manager for Housekeeping (EVSM), EVSM stated he has been in his role for year and half. EVSM stated he was familiar with the Endoscopy procedure area. EVSM validated Vent 1 and Vent 2 in Endo decontamination room were not clean and had gray matter was probably accumulated dust and debris. EVSM stated the dirty vents could lead to infection and chipped paint could fall in during the cleaning process of endoscopes. EVSM stated the Endo decontamination room gets terminally cleaned every day, even if the Endo area was closed and the room was not being used. EVSM stated vents cleaning daily was part of the daily terminal cleaning and his team kept logs. VSM stated his expectation was that if the EVS team was not able to get vent dust off and clean, then they should have been putting in work order for facilities team to assist with cleaning. EVSM stated he was not aware of any work orders filled out for the Endo decontamination room. During a concurrent interview and record review on 5/15/24 at 3:20 p.m. with EVSM, the facility’s “Endoscopy Terminal Cleaning Log”, dated 4-28-24 to 5-13-24 was reviewed. The “Endoscopy Terminal log” indicated Endo decontamination room’s vent was marked as dust off every day since 4/28/24 to 5/13/24. EVSM validated the record and stated although logs were filled out, the Vent 1 and Vent 2 were not cleaned, and he was unable to tell the last date both vents were cleaned. EVSM stated vents were not cleaned in accordance with the facility’s expectation. The EVSM stated the amount of gray matter present on the vents and chipped paint “does not happen overnight.” 7. During concurrent observation and interview on 5/17/24 at 11:30 a.m., in the SPD decontamination area, with SPDM, the air gap on the floor beneath the rinse sink had rust- colored deposits, paper trash and other debris in the drain. The floor and backboard underneath the decontamination sink were scuffed, moist, with porous (water and air can pass through) drywall and wood exposed. SPDM stated she was not aware of the rust- colored deposits on the air gap and there should not have been trash in the drain. The SPDM stated environmental services was responsible for cleaning floors in SPD. The SPDM stated she was not aware of the condition of the backboards. The SPDM validated the area was not sanitary. During an interview on 5/20/24 at 3:35 p.m., with the IP, the IP stated the porous materials such as the exposed backboards and flooring in SPD could not be properly cleaned and disinfected. The IP stated the greatest concern was moisture. The IP stated the moist area had the potential to grow mold and attract bugs. During a review of the professional reference titled, “Association for the Advancement of Medical Instrumentation (AAMI),” dated 2017, the professional reference indicated, “ ... General facility design requirements. All surfaces (e.g., floors, walls, ceilings, cabinets) should be durable, smooth, and cleanable ... all processing work areas should conform to the following recommendations ... Surfaces that are durable, smooth, and cleanable allow for ease of cleaning and assist in preventing buildup of dirt and debris in crevices ...” During review of the hospital’s “Environmental Services Duty List # 125- Sterile Processing / Pharmacy”, undated, indicated, “ ... SPD Core Areas ... Terminal Clean Daily ... Procedure C- (Detail Cleaning) ... Sanitize ALL horizontal surfaces ... Dust mop the floor ... damp mop floor ...” During review of the hospital’s P&P titled “PC.AD.1.11 Guidelines for Cleaning, Disinfecting & Sterilizing Patient Care Environment & Equipment Policy” dated 9/28/22, indicated, “ ... Accumulation of dust, soil, and microbial contaminants on environmental surfaces may create a reservoir of microorganisms, that when transmitted via hands or equipment can contribute to hospital associated infections ... References ... [CDC] Guidelines for Environmental Infection Control in Healthcare Facilities ...” During a review of the professional reference titled “CDC Guidelines for Environmental Infection Control in Health-Care Facilities” last updated 12/14/23, indicated, “ ...Infection-control strategies and engineering controls, when consistently implemented, are effective in preventing opportunistic, environmentally-related infections in immunocompromised populations ... Continued compliance with existing environmental infection control measures will decrease the risk of health-care associated infections among patients, especially the immunocompromised, and health-care workers ... The potential presence of dust and moisture and their contribution to health-care associated infections ... activities that dampen any structure, area, or item made of porous materials or characterized by cracks and crevices (e.g., sink cabinets in need of repair, carpets, ceilings, floors, walls, vinyl wall coverings, upholstery, drapes, and countertops) ... Molds grow and proliferate on these surfaces when they become and remain wet.” 8. During a concurrent observation and interview on 5/13/24 at 2:37 p.m., with the DCC and RNQ 1 in the Cardiac Intensive Care unit (CICU - Unit for critically ill patients [patients with vital organ dysfunction, high risk of imminent death if care is not provided] with heart, chest and blood vessel’s conditions), the plastic cover to the clean linen cart was rolled on top of the cart and patient equipment, such as wheel chair accessories, were stored on top of the plastic cover exposing the clean linen. No signage was visible to indicate the equipment was clean. The DCC stated the equipment should not be stored on top of linen carts as it had the potential for cross contamination and spread infections to critically ill patients. The DCC stated linen carts should always be kept covered in accordance with facility’s policy. During a concurrent interview and record review on 5/14/24 at 3:30 p.m., with the DCC, the facility’s policy and procedure (P&P) titled, “PC.G.1.17 Linen Policy”, with an approval date of 2/27/19 was reviewed. The P&P indicated, “ ...Linen carts will be kept covered at all times during transportation and when they are in the corridors ...”. During a professional reference review retrieved from (https://www.cdc.gov/healthcare-associated-infections/hcp/cleaning-global/appendix-d.html), titled, “Linen and laundry management”, dated 3/19/2024, the reference indicated, “ ...Best practices for management of clean linen ...Sort, package, transport, and store clean linens in a manner that prevents risk of contamination by dust, debris, soiled linens or other soiled items ...” During a review of the facility’s P&P titled, “PC.AD.1.11 Guidelines for Cleaning, Disinfecting & Sterilizing Patient Care Environment & Equipment Policy” dated approved on 9/28/22, indicated, “PURPOSE: [name of hospital] is dedicated to minimizing the risk of hospital-acquired infections by establishing guidelines for the cleaning and disinfection of shared equipment. This policy provides guidelines for the recognition of clean or soiled equipment and guidelines for storage or treatment after use. The following procedures define and establish standards for assuring that non-critical items (defined by the Centers for Disease Control (CDC) as items that come into contact with intact skin but not mucous membranes) and other shared patient care equipment is clean before use and that all used or contaminated equipment is appropriately cleaned before reuse ... POLICY STATEMENT: A. Accumulation of dust, soil, and microbial contaminants on environmental surfaces may create a reservoir of microorganisms, that when transmitted via hands or equipment can contribute to hospital associated infections. B. Failure to properly store supplies, disinfect, or sterilize reusable medical equipment intended for use with patient care can potentially introduce pathogenic microorganisms to patient and cause infections ... C. Non-critical Items ... 2. Soiled environmental surfaces can be a source of contamination to hands or other objects which may have contact with the patient. Use Super Sani-cloth? wipes, (purple top) or other hospital-approved detergent-disinfectant regularly to clean and disinfect surfaces ... B. Storage 1. Clean equipment is stored in the clean equipment area and/or a patient room that has been disinfected. Equipment that is in continuous use and cleaned after each use may also be stored here. Equipment will not be stored on or immediately around the sink to avoid splash contamination. All other equipment that is not clean or cannot be cleaned immediately after use shall be placed in the dirty equipment area or sent to Sterile Processing using the point of use process ... 3. Soiled equipment is stored in the soiled or “dirty” area ...” 9. During a review of Pt 21’s Admission Record (AR), dated 5/18/23, at 8:23 a.m., indicated Pt 21 was admitted on 5/15/24 at 10 a.m. and discharged on 5/17/24 at 3:40 p.m. During a review of Pt 21’s Operative Report (Report), dated 5/15/24, the Report indicated Pt 21’s Preoperative diagnosis was symptomatic cystocele (when the bladder and vaginal wall fall into the vaginal opening) and rectocele (when the rectum bulges into the front of the vagina) without urinary incontinence (the loss of bladder control). Pt 21 was taken to the Operating Room (OR) to have her symptomatic cystocele and rectocele repaired. During an observation on 5/15/24, at 1:10 p.m., while in the OR for Pt 21’s surgery, SUR 8 wore his personal glasses in the OR throughout the whole surgery. During an interview on 5/15/24, at 2:30 p.m., with the DOS, the DOS stated he was aware that Surgeon (SUR) 8 wore his personal glasses in the OR’s during surgery and SUR 8 was educated on the proper eyewear for the ORs, but he could not force SUR 8 to follow the policy. During concurrent observation and interview on 5/27/24 at 8:10 a.m., in OR 7, with the DOS, SUR 8, RES 1, and RES 2 performed an “Arthrotomy Right Knee, Open Repair of Patellar” procedure (open incision to explore the knee joint and kneecap) for Pt 27. SUR 8, RES 1, and RES 2 wore personal eyeglasses as part of their surgical attire and personal protective equipment. The DOS stated all staff in the ORs were expected to wear eye protection as part of their surgical attire in accordance with hospital requirements. The DOS stated physicians were reminded of hospital policy and were encouraged to wear protective eyewear during surgical procedures but have not complied. During a review of Pt 27’s “Final Operative Report”, dated 5/27/24, the Report indicated, “ ...Arthrotomy right knee open repair of patellar ... anterior incision [cut in front of knee] carried out ... The arthrotomy opened, copious [large amount] lavage [washing out] carried out ...” The Report indicated during the procedure a large amount of fluid was used to wash out Pt 27’s operative site, which could cause splashing and cross contamination. During a review of the facility’s policy titled, “OR.1.04 MOD OR.1.04 Attire - Standards,” approved 11/20/19, indicated, “PURPOSE: To provide a safe environment for surgical patients through control and prevention of infection. POLICY: To provide guidelines for OR personnel and others who work within the semi-restricted and restricted area of the surgical environment. PROCEDURE: A. All individuals who enter the semi-restricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite ... E. Protective barriers are to be used to reduce the risk of exposure to potentially infectious materials ... 2. Protective eyewear or face shields must be worn when splashing or spraying is likely. a. Required when in the scrub role [to clean with hard rubbing]. b. Required when splashing or spraying is likely when in the circulating role [moves from place to place]. c. Protective eyewear or face shields that become contaminated should be discarded or decontaminated promptly according to manufacturers’ written instructions. 10. During a review of Pt 61’s “AR” dated 4/23/24 at 5:51 a.m., the “AR” indicated Pt 61 admitted on 4/22/24 at 7:41 p.m. with a chief complaint of Necrotizing Fasciitis (A serious bacterial infection that destroys tissue under the skin. The condition spreads quickly. Symptoms include blisters, fever, fatigue, and pain worse than a person would expect based on the wound’s appearance.) During a concurrent observation and interview on 5/13/24, at 2:38 p.m., with Pt 61 and RN 11, while in Pt 61’s room, RN 11 was observed changing Pt 61’s dressing to her right inner thigh. RN 11 was observed removing the dressing from Pt 61’s right inner thigh and at 2:39 p.m. removed her dirty gloves and placed clean blue gloves on without first performing hand hygiene. RN 11 was then observed cleaning Pt 61’s open wound and stated Pt 61’s order was to clean with normal saline (sterile solution), place 4x4’s (sterile gauze pad), abd pad (Abdominal gauze pads, known as ABD pads, are non-woven, thick, and absorbent) and tape daily. At that time the Director of Medical Surgical area (DMS) entered the room and observed RN 11 clean Pt 61’s wound and RN 11 removed her dirty gloves and placed clean gloves on without first performing hand hygiene. DMS stated she did see this since RN 11 had to reach over the DMS at Pt 61’s sink to grab the clean gloves from the box. After placing the clean gloves on, RN 11 placed a clean dressing on Pt 61’s thigh. DMS stated the expectation is that hand hygiene be done when dirty gloves are removed and clean ones are then put on. DMS stated this was an infection control risk to the patient and staff when hand hygiene was not done appropriately; it could spread germs. During a review of Pt 21’s AR, dated 5/18/23, at 8:23 a.m., indicated Pt 21 was admitted on 5/15/24 at 10:00 a.m. and discharged on 5/17/24 at 3:40 p.m. During an observation on 5/15/24, at 1:02 p.m., while in the OR for Pt 21’s surgery, the anesthesiologist (ANS) 6 was seen dropping a vial of medication on the floor, picking it up, tossing into waste bin and continued to administer Pt 21 medication through her IV site without performing hand hygiene and without cleaning the hub of Pt 21’s IV site. During an observation on 5/15/24 at 2:27 p.m., in the Post Anesthesia Care Unit (PACU), with RNQ 3 present, RN 14 did not use hand sanitizer prior to putting on gloves. RNQ 3 confirmed RN 14 did not perform appropriate hand hygiene prior to putting on gloves. RNQ 3 stated RN 14 should have used hand sanitizer prior to putting on gloves. During an interview on 5/20/24 at 4:20 p.m. with the IP, the IP stated staff should be using hand hygiene when coming into contact with the environment and when coming and going into patient rooms. The IP stated, “The importance of hand hygiene was what you don’t see could harm you.” The IP stated there was always a possibility of infection without proper hand hygiene. During a review of the facility’s policy titled, “Hand Hygiene Policy,” approved on 10/26/22, indicated, “ ... II. PURPOSE: The purpose of this policy is to outline hand hygiene requirements to reduce the risk of infection transmission from patient to patient. Patient to health care provider and health care provider to patient. III. DEFINITIONS A. Hand hygiene means hand washing, antiseptic hand wash, antiseptic hand rub or surgical antisepsis.... IV. POLICY: The hospital has adopted the Centers for Disease Control and Prevention (CDC) Guidelines for hand hygiene in healthcare settings with enhanced comments from the World Health Organization (WHO) 1. Hand hygiene and healthcare.... Indications for hand washing and hand antisepsis include At the beginning of the workday. Before entering and when exiting a patient’s room or cubicle.... Before and after direct contact with patient blood, body fluids or equipment, and environmental items touched by patients. Before handling medication or food ... Prior to donning gloves and after removing gloves... C. If hands are not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands in all other clinical situations. D. Decontaminate hands before having direct contact with patients ... G. Decontaminate hands after contact with body fluid or excretions, mucous membranes, non-intact skin and wound dressings if hands are not visibly soiled. H. Decontaminate hands if moving from a contaminated body site to a clean body site during patient care. I. Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient... K. Decontaminate hands after moving gloves. NOTE: gloves are not a substitute for hand hygiene...” 11. During a concurrent observation and interview on 5/17/24, at 12:40 p.m., RN 12 was observed having fingernails that went beyond her fingertips with chipped nail polish on multiple fingernails. RN 12 was preparing to place a PICC line in Pt 62. RN 12 stated she was still previously on vacation and picked up a shift to work today, so her fingernails were longer, and her nail polish was chipped in multiple places. RN 12 stated she knew this was an infection control issue but reiterated that she was technically still on vacation. During a concurrent observation and interview on 5/17/24, at 12:45 p.m., RN 13 was observed having chipped gel fingernail polish. RN 13 stated she was aware that this was an infection risk and had planned on getting them redone yesterday but that her child was sick, and she did not have the time before she came to work. During a review of the facility’s policy titled, “Hand Hygiene Policy,” approved on 10/26/22, indicated, “ ... II. PURPOSE: The purpose of this policy is to outline hand hygiene requirements to reduce the risk of infection transmission from patient to patient. Patient to health care provider and health care provider to patient. III. DEFINITIONS A. Hand hygiene means hand washing, antiseptic hand wash, antiseptic hand rub or surgical antisepsis.... IV. POLICY: The hospital has adopted the Centers for Disease Control and Prevention (CDC) Guidelines for hand hygiene in healthcare settings with enhanced comments from the World Health Organization (WHO) ... V. PROCEDURE: ... B. Fingernails Hands with long fingernails, artificial nails and nail tips carry higher bacterial and fungal counts. Natural nails of healthcare workers are to be kept short (less than ¼ inch) and should not extend beyond the fingertips. (Refer to Clinical Quality Policy MOD PC.AD.1.44, Artificial Nail Policy) ...” During a review of the facility’s policy titled, “Artificial Nail Policy,” approved 5/27/20, indicated, “ ... II. PURPOSE: The purpose of this policy is to define when artificial nails and/or nail polish may be worn by healthcare providers and facility staff. III. DEFINITIONS: A. “Artificial nails” means any material applied or added to natural nails to augment or enhance (strengthen and lengthen) the wearer’s own fingernails, including wraps, acrylics, extenders, overlays, gels, tips, and any item that is glued or pierced through the nail. B. “Natural nails” means nails without artificial covering other than fresh nail polish. C. “Nail polish” means nail polish that is not obviously chipped or worn. D. “Healthcare providers and workers” means all paid and unpaid persons working in healthcare settings who have the potential for exposure to infectious materials, including contaminated medical supplies. Healthcare providers might include, but are not limited to: physicians, nurses, nursing assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, pharmacy personnel, laboratory personnel, autopsy personnel, students and trainees, contractual staff and persons, i.e., clerical, dietary, housekeeping, maintenance and volunteers not directly involved in patient care but potentially exposed to infectious agents that can be transmitted to and from the healthcare provider. IV. POLICY: The Hospital is committed to the prevention of healthcare-acquired infections. There is mounting evidence concerning the role of artificial nails in the transmission of infection. Data shows that wearers of artificial nails are unable to adequately wash their hands and remove transient flora compared to those without such nails. There is a tendency to harbor Pseudomonas [a condition that can affect your skin, blood, lungs, parts of your body] and yeast beneath nails and on fingertips even after hand washing. Therefore, the Hospital prohibits the wearing of artificial nails/nail jewelry for all healthcare providers and workers, as defined above, who may touch a patient, or items a patient may use or touch. V. PROCEDURE: A. Nail Hygiene It is the responsibility of all direct patient care providers to maintain short (less than a ¼ inch long) fingernails. Nails should not extend beyond the tips of the fingers. Nail polish, if worn, must be of a clear or light color and free of cracks or chips. Dark colors may obscure the space underneath the tip of the nail, reducing the likelihood of careful cleaning. Chipped nail polish is not permissible ...” 12. During a concurrent observation and interview on 5/24/24 at 1:04 p.m., in the “soiled” utility closet on the fourth floor, with HSK 1, HSK 1 discarded trash bags. Trash bags were observed overflowing from the trash bin and piled up against the wall’s corner and floor. One trash bag was torn with trash (gloves, adult briefs, food items, etc.) exposed. HSK 1 stated the practice was to pile trash in a corner until collected by environmental services. During an interview on 5/24/24 at 1:35 p.m., with EVSL, the EVSL stated environmental services staff collected trash bins throughout the day as they made rounds to all the floors. The EVSL validated trash “piled up” occasionally if environmental services were delayed. The EVSL stated the trash bin should be emptied before trash reached the top of the bin to prevent overflow and cross contamination of the environment. During a review of the professional reference titled “CDC Infection Control I. Regulated Medical Waste” dated 1/8/24, indicated, “ ... Medical wastes require careful disposal and containment before collection and consolidation for treatment. OSHA [Occupational Health and Safety Administration- US government agency responsible for safe and healthy working conditions] has dictated initial measures for discarding regulated medical-waste items. These measures are designed to protect the workers who generate medical wastes and who manage the wastes from point of generation to disposal ... All bags should be securely closed for disposal ... Health-care facilities are instructed to dispose medical wastes regularly to avoid accumulation. Medical wastes requiring storage should be kept in labeled, leak-proof, puncture-resistant containers under conditions that minimize or prevent foul odors. The storage area should be well ventilated and be inaccessible to pests ...” During a review of “Occupational Safety and Health Standard 1910.141- Sanitation” accessed 6/7/24, indicated, “ ... Waste Disposal ... Any receptacle used for putrescible solid or liquid waste or refuse shall be so constructed that it does not leak and may be thoroughly cleaned and maintained in a sanitary condition. Such a receptacle shall be equipped with a solid tight-fitting cover, unless it can be maintained in a sanitary condition without a cover. This requirement does not prohibit the use of receptacles which are designed to permit the maintenance of a sanitary condition without regard to the aforementioned requirements ... All sweepings, solid or liquid wastes, refuse, and garbage shall be removed in such a manner as to avoid creating a menace to health and as often as necessary or appropriate to maintain the place of employment in a sanitary condition ...” 13. During a concurrent observation and interview on 5/15/24 at 1:30 p.m. in Endoscopy procedure room with RNQ 1 & CRS, physician (MD) 1 washed his/her hands and water splashed on the items stored right next to sink. The handwashing sink had box of gloves, biohazard bags, and a metal box with supplies stored on top of the sink in the splash zone. The metal box was covering part of the sink. The glove box, and biohazard bags had splashes of liquid on it. The CRS stated procedure room 4 had limited space and the Endo team was using the metal box and sink space for storage. The CRS stated biohazard bags were being used for specimen cups for procedures scheduled in the room. The CRS stated the sink was used for hand washing and validated gloves, biohazard bags and metal box were all in the splash zone and got splashed on during hand hygiene. The CRS stated there was a risk for infection and cross contamination with supplies stored in the splash zone and will work with leadership team to find a better storage solution. During an interview on 5/15/24 at 1:35 p.m. with RNM1, RNM1 stated she was made aware of the storage of gloves, biohazard bags, and other storage in the splash zone next to the sink, covering part of the sink space. RNM1 stated storing supplies in the splash zone was not acceptable and understood the risk for cross contamination, risk for spreading infections. RNM 1 stated supplies will be removed immediately from the splash zone. During an interview on 5/30/24 at 2:17 p.m. with the Chief Nursing Officer (CNO), the CNO stated it was her expectation that staff was doing their best to ensure patient safety. The CNO stated it was her expectation that no supplies are stored around the sink in the splash zone to reduce any risk of cross contamination. 14. A. An observation on 5/13/24 at 2:50 p.m., in the kitchen, showed a manual ware washing sink housed in the pot and pan dishroom, was being used for cleaning cooking equipment. The environment in the pot and pan room was moist, such that surfaces were wet including the floor, the metal backsplash of the sink, and the sheet metal that covered the wall behind the sink. There was a significant amount of black residue on surfaces throughout the pot and pan room, including on the sheet metal covering the wall behind the sink, on metal backsplash behind the sink, on the wall between the pot and pan room passageway and the metal backsplash, and on a square metal plate with a rough surface attached to the wall by passageway. In addition, the wall behind the sink was visible through two holes, larger than the size of a quarter, in the metal backsplash. A black substance was visible on the wall through the holes in the backsplash. In addition, the pot an pan room was filled with soiled utensils stacked on racks, a countertop, an on the floor. During an interview on 5/13/24 at 3 p.m., the Regional Director of Operations (RDO) stated there was a deep cleaning of the kitchen once a week. When the RDO was asked if there was documentation to show when cleaning was completed, RDO stated he would ask Executive Chef (EC) if there was a log documenting the completion of cleaning tasks. While the cleaning log was requested, it was not provided. During concurrent observation and interview with Food Service Staff (FSS) 1 on 5/13/24 at 3:21 p.m., showed FSS1 was working in the pot and pan room. FSS1 stated the walls in the pot and pan room were supposed to be cleaned daily but sometimes they were not cleaned. FSS1 stated there was not always enough time to clean the walls due to the large amounts of items which had to be washed manually because the dish machine was not working (Cross-reference AF01). FSS1 stated when he cleaned the backsplash and metal covering on the walls, he used “degreaser”. FSS1 provided the container of chemical labeled “D9.6 Foam Free Oven & Fryer Cleaner”, which he stated he used to clean these areas. When FSS1 was asked how he cleaned the wall behind the backsplash which was visible through the two holes, FUS1 stated water did get into the holes but he did not know how it was possible to clean the wall behind the backsplash. Review of “[product brand] D9.6 Foam Free Oven & Fryer Cleaner” manufacturer description, showed the product was “a ready-to-use liquid oven cleaner and general degreaser that effectively cleans greasy and carbonized soils ... Can be used to clean ovens, grills, hoods and deep fryers”. An observation on 5/14/24 at 9:35 a.m., showed staff in the pot and pan room using the manual dish washing sink to wash cooking equipment. The black residue remained on surfaces including the metal wall and backsplash behind the sink, the wall behind the backsplash, which was visible through two holes in the backsplash, the wall between the pot and pan passageway frame and the metal backsplash, and the square metal plate with a rough surface attached to the wall by passageway. During a concurrent interview on 5/14/24 at 9:35 a.m., the Patient Services Manager (PSM) stated the pot and pan room was cleaned daily by kitchen staff. PSM also stated an outside vendor “takes care of” the black on the walls. When PSM was asked the product kitchen staff used to clean the pot and pan room surfaces, she stated staff used detergent and quaternary ammonia sanitizer (Quat) for cleaning all areas in the kitchen. During an interview on 5/14/24 at 9:40 a.m., EC stated there was a contract with an outside vendor to clean the pot and pan room once a month. EC stated kitchen staff did not clean walls in the pot and pan room. During an interview on 5/14/24 at 2:52 p.m., the IP stated he was a microbiologist and Certified Instrument Specialist (CIS, a specialty certification for Sterile Processing professionals in healthcare). IP stated he managed the hospital’s infection control program which included but was not limited to providing education to staff and initiating infection control projects. IP stated he was part of the team for conducting rounds in the kitchen, but he was not an expert in Food and Nutrition Services. IP stated he did not have any other involvement with the kitchen unless he received questions, which he explained were usually questions regarding feeding patients on isolation precaution (used to reduce transmission of microorganisms in healthcare settings. These measures are designed to protect patients, staff, and visitors from contact with infectious agents). IP stated the expectation was for FNS (Food and Nutrition Services) staff to identify issues which may require IP guidance. During the interview on 5/14/24 at 2:52 p.m., IP was shown photos taken on 5/13/24 of the black residue on surfaces in the pot and pan room. IP stated the black residue was likely mold and the room had to be cleaned and sanitized properly. IP stated the FNS department did not contact him regarding the black substance, but they should have contacted him for guidance. During an interview on 5/14/24 at 4:30 p.m., the Associate Administrator (AA) stated maintenance of the Ansul system (a pre-engineered, automatic fire suppression system that can tackle large, hazardous fires without human intervention) for the stove hood was the only outside vendor contract for the kitchen he was aware of. During an interview on 5/14/24 at 5:10 p.m., the Facilities Services Manager (FSM) and the Director of Facilities (DOF) provided invoices which showed an outside vendor cleaned the kitchen just over one month ago. FSM and DOS stated the cleaning was a “one time deal” because it was identified by RDO, the Associate Administrator (AA), and himself that the FNS department needed help with cleaning. FSM stated to his recollection this was the only time an outside vendor was in the kitchen to clean and he had worked at the facility since 2009. A document review showed the “Daily Report” dated 4/3/24 and 4/4/24, showed an outside vendor was onsite in the kitchen to clean areas in the kitchen. During an interview on 5/20/24 at 1:00 p.m., EC stated he and the “sous chef” (typically a chef who is ranked second in command of a kitchen) were responsible for holding staff accountable for cleaning according to the cleaning schedule. EC stated there was supposed to be a log to document cleaning, but logs were not being used. Review of the “Master Cleaning Schedule ... Cleaning Frequency - Pot Room Area” dated 2023, showed walls in the pot and pan room were to be cleaned monthly. During an interview on 5/20/24 at 12:35 p.m., RDO described nonregulatory interval inspections/audits conducted in the kitchen. He stated there was a monthly inspection done by a member of FNS management. RDO stated these inspections were now being done weekly and referred to as “Food Safety Quick Checks” which were a shorter version of the monthly audits. RDO stated these checks included looking at sanitation and cleanliness in the kitchen. RDO stated the Director of FNS received the reports from these audits and they were also available to leadership. RDO stated the audits could be made available to Quality if FNS needed assistance with issues. Review of the “Food Safety Quick Check” report dated 5/14/24, showed documentation of a kitchen inspection conducted by PSM. The report showed areas in the kitchen inspected and corresponding comments regarding issues identified and corrective action taken. The areas inspected included “Food Storage ... Preparation and Work Areas ... Food Handing ... and Handwashing.” While it was observed there was black residue on surfaces throughout the pot and pan room, the report did not show the pot and pan room was inspected and the black residue in the pot and pan room was not documented . During an interview with RDO on 5/20/24 at 1:40 p.m., RDO stated the pot and pan room was cleaned by kitchen staff using detergent and quat sanitizer. When RDO was asked how the wall behind the backsplash was cleaned, he stated the wall was cleaned “to the best of our ability”. RDO stated the black residue was not mold and an environmental testing was done about a month ago and the report did not show the black residue was mold. RDO stated the black residue was just grease and grime and he knew it was only grease and grime through “experience”. Review of the document titled “[Company Name] Mold Survey Report” dated 3/12/24, showed the mold growth in “tray wash station grout ... pot room sink wall ... pot room sink grout”. Recommendations in the report included “that the areas of concern be thoroughly cleaned with a biocide cleaner (a cleaner used to destroy, make harmless or control a harmful organism). Excess moisture in the area should be monitored to avoid future mold growth.” During an interview on 5/20/24 at 3:45 p.m. IP stated Mold Survey Report was shared with the IPC department; however, they did not do anything with the report details unless there were major infection control concerns. The IP stated that the results of the Mold Survey Report only affected 10 percent of the environment of the hospital. IP stated results of the report were reported in the Environment of Care meeting and carried through to the board of governors. Review of the “Infection Prevention & Control Committee Minutes” dated 3/27/24, showed the Director of FNS was not listed under the present members. The minutes did not show infection control in the FNS department was reviewed including the Mold Survey Report. During an interview on 5/21/24 at 1:00 p.m., the DOF stated a company was hired in March to conduct an environment evaluation of the kitchen due to the former Director of FNS (DFNS) identifying a black substance on surfaces around the kitchen. The contracted environmental company took samples of areas in the kitchen, as guided by the DFNS. DOF stated the Mold Survey report dated 3/12/24 was from the contracted environmental company. DOF stated a contracted cleaning company was hired as a result of the Mold Report and to mitigate the issue. The cleaning took place from 3/25/24 to 4/4/24. DOF stated he was aware of the recommendation on the Mold Report including the recommendations to clean areas of concern with a biocide cleaner and excess moisture in the area should be monitored to avoid future mold growth. DOF stated he felt the staff in the kitchen used the water hoses excessively in the pot room. DOF stated his Facilities team did not monitor for reoccurring mold growth after the cleaning was completed on 4/4/24. During an interview on 5/30/24 at 2:24 p.m., the Environmental Specialist (ES) stated he took samples in the kitchen on 3/12/24. ES stated he only took samples in grouted areas in the dishwashing rooms. ES stated he saw black on the walls in the pot room but did not take a sample to test because FSM said it was grease build-up. ES stated the samples showed mildew growth, and stated mildew was a type of mold. ES stated some mildew growth was to be expected in the kitchen. ES stated, however, when he was on site it was evident the dishwashing areas had to be cleaned better and he verbally recommended to FSM that kitchen staff had to do a better job cleaning the areas. ES stated staff used hot water in the pot room which was the best mold growing environment. ES stated a biocide cleaner including a cleaner which contained bleach could be an effective cleaner. Review of an e-mail documentation from IP to the Accreditation Manager (AM) dated 3/15/24 and was referred to as documentation for a mock survey conducted by IP and AM, did not show the black residue in the pot and pan room was addressed and indicated the overall kitchen was “functional and clean.” Review of the hospital’s policy and procedure titled “F&N.1.67 Sanitation Program” approved on 5/22/19, showed the Food Service Director and/or Operations Manager monitors sanitizing schedules and procedures. Equipment, walls, floors, and storage are routinely cleaned and with appropriate sanitizing compounds. All kitchen and kitchen areas shall be kept clean. Review of the hospital’s policy and procedure titled “Policy #F014 ... Area and Equipment Cleaning” revised 1/23, showed the Director is to assign daily cleaning responsibilities in each position workflow. The Director is to file and retain records for 3 months (Equipment Cleaning Log). 14.B. During an observation in the kitchen on 5/13/24 at 3:09 p.m., showed the door frame and rubber gasket for walk-in refrigerator (Diet 074) had a significant amount of black residue on the surface which extended from the bottom of the door frame to the top of the door frame. In addition, there was black residue imbedded in the crevices of the rubber gasket attached to the refrigerator door. When the surfaces were wiped with a paper towel, black residue wiped off easily. During an interview on 5/14/24 at 5:06 p.m., IP was shown a photo, taken by the surveyor on 5/13/24, showing the black residue around the door of walk-in refrigerator Diet 074. IP stated the residue was likely mold if it was a moist environment. Review of the “Food Safety Quick Check” report dated 5/14/24, showed documentation of a kitchen inspection conducted by PSM. The report showed areas in the kitchen inspected and corresponding comments. The areas inspected included “Food Storage ... Preparation and Work Areas ... Food Handing ... and Handwashing.” Under the Food Storage section, PSM documented temperature logs were filled out correctly and there was no evidence of outdated or expired food. PSM did not show that the cleanliness or the condition of the refrigerators were inspected. During an interview with RDO on 5/20/24 at 1:40 p.m., RDO stated the black residue on the walk-in refrigerator gasket and door frame was just dirt and grime and he knew it was just dirt and grime from “experience”. RDO stated the black residue was not mold because there was an environment testing done about a month ago and the report did not show mold. When RDO was asked what areas in the kitchen were tested for mold, RDO stated he needed to refer to the report. Review of the document titled “[Company Name] Mold Survey Report” dated 3/12/24, did not indicate walk-in refrigerator areas were tested for mold. During an interview on 5/30/24 at 2:24 p.m., the Environmental Specialist (EC) stated he took the samples in the kitchen on 3/12/24. EC stated he only took samples in grouted areas in the dishwashing rooms. EC stated he did not look in or take samples in the refrigerator areas. Review of the hospital’s policy and procedure titled “F&N.1.67 Sanitation Program” approved on 5/22/19, showed the Food Service Director and/or Operations Manager monitors sanitizing schedules and procedures. Equipment, walls, floors, and storage areas are routinely cleaned and with appropriate sanitizing compounds. All kitchen and kitchen areas shall be kept clean. 14.C. During an initial tour kitchen observation on 5/13/24 at 12:25 p.m., there was old dirt and debris on the floors between equipment and on the other side there was a food preparation table in the middle of the kitchen. The kitchen equipment was not spaced very close together. The Epoxy flooring ( type protection of synthetic resin floor system that is laid on top of concrete substrates as a form of protection) had cracks and holes. During an interview with the RDO on 5/13/24 at 2:55 p.m., RDO confirmed and acknowledged the old dirt and debris on the floor. Review of the hospital’s policy and procedure titled “F&N.1.67 Sanitation Program” approved on 5/22/19, showed all kitchen and kitchen areas shall be kept clean. During a review of the 2022 Food and Drug Administration (FDA) Food Code, Section 6-201.11 Floors, Walls, and Ceilings., showed floors shall be designed, constructed, and installed so they are smooth and easily cleanable; Section 6-501.11 Repairing, showed physical facilities shall be maintained in good repair; and Section 6-501.12 Cleaning, Frequency and Restrictions, showed physical facilities shall be cleaned as often as necessary to keep them clean. 14.D. Food Storage Racks in Walk-in Refrigerator in Poor Condition and Not Clean An observation in the kitchen on 5/13/24 at 11:45 a.m., showed the inside of walk-in refrigerator “Diet 074” contained multiple large metal rolling racks which held food such as produce. There was thick, sticky, white residue on the surface of the racks, more so on one rack toward the back of the cooler. Containers and boxes of food items came into contact with the white residue. In addition, on the rack surfaces, there was orange residue, resembling rust. When the rack surfaces were wiped with a paper towel, white, dark black, and orange residue transferred to the paper towel. During an interview on 5/13/24 at 2:20 p.m., EC was asked who was responsible for cleaning storage racks in walk-in refrigerator Diet 074. EC stated an outside company was contracted to deep clean the kitchen and it was at least three months since the contracted company cleaned the kitchen. EC also stated kitchen staff deep cleaned the refrigerators monthly. During an interview on 5/14/24 at 4:15 p.m., when RDO was asked who was responsible for cleaning the shelving in the walk-in refrigerator, RDO stated “Facilities” was responsible for cleaning fixed and large, heavy equipment. RDO stated Facilities was responsible for contacting a third-party vendor if needed. During an interview on 5/20/24 at 1:45 p.m., RDO stated the master cleaning schedule which showed refrigerator cleaning monthly, was at a minimum time-frame guidance for cleaning the refrigerator. RDO stated staff would not wait monthly to clean the refrigerator if it was soiled in between the monthly timeframe. RDO stated the refrigerator should be cleaned more often when needed. RDO stated the shelving walk-in refrigerator Diet 074 was not in satisfactory condition because even if the shelving was cleaned, it did not look the way it should. Review of an e-mail documentation from IP to AM dated 3/15/24 and was referred to as documentation from a mock survey, showed “the refrigerated storage had many shelves rusting, consider replacing”. Review of the Local Service Level Agreement between the hospital and the contracted food service dated 10/1/19 showed the contracted food service was responsible for cleaning equipment and refrigerators. Review of the hospital’s policy and procedure titled “F&N.1.67 Sanitation Program” approved on 5/22/19, showed the Food Service Director and/or Operations Manager monitors sanitizing schedules and procedures. Equipment, walls, floors, and storage are routinely cleaned and with appropriate sanitizing compounds. All kitchen and kitchen areas shall be kept clean. All utensils, counters, shelves, and equipment shall be kept clean, maintained in good repair and shall be free from corrosion. 14.E. During an observation in the kitchen on 5/13/24 at 11:45 a.m., showed three fans located inside walk-in refrigerator Diet 074 . The fans had fan guards covering each of the fans which were running, and the guards had a layer of gray, fuzzy material on the surface. The layer of gray, fuzzy material was especially thick on the entire surface of one of the three fan guards. During an interview on 5/13/24 at 2:20 p.m., EC was asked who maintained the fans walk-in refrigerator Diet 074. EC stated the fans, including the fan guards, were cleaned by an outside vendor. During an interview on 5/14/24 at 1:39 p.m., FSM stated third party vendors (also referred to as an outside vendor; a vendor a facility does business with) did not really go into the kitchen. Review of the hospital’s policy and procedure titled “F&N.1.67 Sanitation Program” approved on 5/22/19, showed the Food Service Director and/or Operations Manager monitors sanitizing schedules and procedures. Equipment and storage areas are routinely cleaned. All kitchen and kitchen areas shall be kept clean. All equipment shall be kept clean. 14.F. During an observation in the kitchen on 5/13/24 at 12:09 p.m., showed racks of raw and cooked food inside walk-in refrigerator “Diet 075”. On one rack was a metal pan containing scrambled eggs. The pan was warm to the touch and a label on the cover of the pan showed the dates 5/13-5/15. Another pan on the rack contained cooked breakfast sausage and a label on the cover of the pan also showed the dates 5/13-5/15. The temperature of the food was measured with a food thermometer and the eggs were 91.6 degrees Fahrenheit (F; a scale of temperature on which water freezes at 32 degrees and boils at 212 degrees under standard conditions) and the sausage was 72.3 degrees F. During a concurrent interview with Dietary Supervisor (DS) 1 on 5/13/24 at 12:10 p.m., DS1 stated the scrambled eggs and breakfast sausage were leftovers from the breakfast trayline that morning and the items were placed in the refrigerator around 10:30 a.m. DS1 stated the leftovers were good to use for three days. DS1 stated cooked, cooling food was monitored for appropriate cooldown on a log. DS1 looked at the cooling log with documentation from 5/9/24 to 5/13/24, and confirmed the scrambled eggs and breakfast sausage were not on the log. DS1 stated the scrambled eggs and breakfast sausage were not being monitored for appropriate cooldown. Review of the “Cooling Log” on 5/13/24 at 12:15 p.m., showed documentation of multiple food items from 5/9/24 to 5/13/24. It was noted scrambled eggs and sausage were not documented on the cooling log on 5/13/24. During an interview on 5/14/24 at 4:40 p.m., PSM and RDO stated leftover food was not stored for later use, including leftover food from trayline food service. Review of the “Cooling Log” showed documentation of multiple food items from 5/9/24 to 5/13/24. One item documented on 5/9/24 included “Hoisin Pork”. The first cooling temperature documented for the pork was 91 degrees F. Another food documented on the log on 5/9/24 was rice. The first cooling temperature documented was 75 degrees F. During an interview with RDO and EC on 5/20/24 at 1:15 p.m., RDO stated it did not appear cooling was documented correctly for the Hoisin pork and the rice. RDO stated the starting cooling temperature was not documented. RDO stated cooldown documentation was supposed to start when the cooked food was 140 degrees F. Further review of the Cooling Log showed “Mac Salad” was documented for cooling on 5/13/24. The first temperature documented was 75 degrees F at 11 a.m., and the second temperature documented was 38 degrees F at 4 p.m. During an interview with RDO and EC on 5/20/24 at 1:15 p.m., RDO stated the cooling for the Mac Salad was not documented appropriately. RDO confirmed there was 5 hours between the first and last temperature and the last temperature should have been measured at four hours to determine proper cooling. EC stated he checked logs daily. EC stated the incorrect cooling documentation on the Cooling Log were things that “caught his eye” but he did not notice cooling was not documented correctly on this cooling log. RDO and EC stated if corrective action was taken regarding improper cooling, the expectation was to document the action taken on the log. It was noted there was no corrective action documented on the Cooling Log for incorrect cooling of the Mac Salad. Review of the “Food Safety Quick Check” report dated 5/14/24, showed documentation of a kitchen inspection conducted by PSM. The document showed a photo of the cooling log with entries from 5/9/24 to 5/14/24 which included the Hoisin Pork and rice on 5/9/24, and Mac Salad on 5/13/24. Documentation on the report read “Food handler is able to describe steps needed to be taken if the temperature of the cold food is warmer than 41F, or if hot food is cooler than 135F ... Cooling logs are in place and completed to the end of the cooling cycle.” PSM did not indicate on the report that staff did not follow proper cooling procedures according to the cooling documentation . Review of the hospital’s policy and procedure titled “B007-Food Handling Guidelines (HACCP)” approved 11/17/21, showed when cooling of potentially hazardous cooked foods, food shall be cooled from 140 degrees F to 70 degrees F within two hours and from 70 degrees F to 41 degrees F within an additional four hours for a total cooling time of six hours or less. Use the Cooling Log form to document the temperature of the food at the following times: when placed in cooling equipment, and then at 1.5 hours, 2 hours, and 6 hours after placing in cooling equipment. Foods that have not cooled to 70 degrees F within 2 hours of being placed in the cooling equipment or 41 degrees F at the end of the 6-hour period must be discarded. 14.G. An observation on 5/13/24 at 2:40 p.m., showed metal pans of various sizes used for cooking and serving food stored on racks in the food preparation area. The pans were stacked and nested in one another. The pans appeared and felt wet. A spot check of more than 15 pans stacked and nested were significantly wet on the inside surface. A consecutive observation and interview with the RDO on 5/13/24 at 2:45 p.m., showed the pot and pan room was filled with soiled utensils stacked on racks, on a countertop, and on the floor . RDO stated all pans should be air dried in the pot and pan room. RDO confirmed the pans stored on the racks in the food preparation area were wet. During an observation and interview on 5/13/24 at 2:49 p.m., FSS 3 was working in the pot and pan room, washing cooking equipment. FSS 3 stated there was no room for all the equipment to air dry. Review of the hospital’s policy and procedure titled “F018-Sanitizing Food Contact Surfaces” approved 9/22/21, showed after sanitizing food contact surfaces, do not store or stack wet food contact equipment, such as pots and pans; allow to air dry. 14.H. During an interview and concurrent observation with FSS 3 on 5/13/24 at 3:30 p.m., in the dish machine room, FSS 3 cleaned meal carts. FSS 3 stated he rinsed with the carts with water, then used Virex (according to the manufacturer’s label, Virex is an “all purpose disinfectant cleaner”) to wipe them down, then allowed the carts to air dry. FSS 3 stated he also cleaned the meal trays with the Virex. FSS 3 stated the process for cleaning the meal trays was to first clean the trays with soap and water. Next FSS 3 stated he placed the trays in a bin with the Virex solution. Then FSS 3 stated he air dried the trays. FSS 3 stated they used to use a quaternary ammonium product to sanitize the trays, then a while back the process changed and Virex was used instead. FSS 3 showed surveyor the Virex in the dispenser in the chemical room located in the dish machine room in the kitchen. An observation on 5/14/24 at 12:24 p.m., showed multiple containers of J-512 Sanitizer stored on a rack in the kitchen and available for use. During an interview on 5/14/24 at 2:52 p.m., IP stated cleaning and disinfecting procedures needed approval. IP stated the chemical “Virex” was not for use on patient food trays. IP stated this chemical could leave trace elements on the surface of the trays. He stated this chemical was typically used for patient care areas such as beds, high touch areas, and patient side tables. IP stated the patient food trays should be sanitized and the sanitizing process should not be substituted. During an interview on 5/14/24 at 4:15 p.m., RDO stated the use of “Virex” for patient trays was a “business” decision due to supply chain issues. RDO stated the prior executive chef made the decision to use the chemical for patient trays. During an interview on 5/20/24 at 1:30 p.m., RDO stated food tray and the food carts were food-contact surfaces. Review of the hospital’s policy and procedure titled “F018-Sanitizing Food Contact Surfaces” approved 9/22/21, showed each work area shall be equipped with sanitizing solution. Two sanitizers were mentioned including “J-512 Sanitizer [according to the manufacturer this is a no rinse sanitizer for food contact surfaces]” and “Foodbuy-approved no-rinse sanitizing disposable wipes”. Procedures showed to sanitize food contact surfaces after they have been thoroughly washed and rinsed . Review of the hospital’s policy and procedure titled “F013 - Cleaning of Food and Nonfood Contact surfaces” approved 9/22/21, showed to prevent cross-contamination, kitchenware and food-contact surfaces of equipment shall be washed, rinsed, and sanitized after each use. Review of the manufacturer’s instructions for “Virex”, indicated “a potable water rinse is required for food contact surfaces.” 14.I. A concurrent observation and interview on 5/13/24 at 3:30 p.m., with the RDO showed 16 enclosed, plastic, rolling tray carts stored by the trayline, toward the front of the kitchen. Six carts were randomly checked, and each cart had dark yellow discoloration throughout the inside surface as well as the outside surface. When the areas with the yellow discoloration were wiped with a wet, white paper towel, the yellow residue wiped off onto the towel. The RDO stated the carts were cleaned and sanitized in the dish machine area and were transferred to the front of the kitchen after they were cleaned. RDO stated “Virex” was used to clean the carts. When RDO was asked about the yellow residue on the carts, he stated the carts were stained. When RDO was shown the yellow residue wiped off, RDO stated “can always do a better job cleaning”. Review of the hospital’s policy and procedure titled “F018-Sanitizing Food Contact Surfaces” approved 9/22/21, indicated each work area shall be equipped with sanitizing solution. Two sanitizers were mentioned including “J-512 Sanitizer [according to the manufacturer this is a no rinse sanitizer for food contact surfaces]” and “Foodbuy-approved no-rinse sanitizing disposable wipes”. Procedures showed to sanitize food contact surfaces after they have been thoroughly washed and rinsed . Review of the hospital’s policy and procedure titled “F013-Cleaning of Food and Nonfood Contact Surfaces” approved on 9/22/21, showed the chemical appropriate for multiple nonfood-contact surfaces was “Glance HC Glass & Multicleaner [manufacturer claims this is a non-streaking, quick-drying, ammoniated glass cleaner. It can be used for glass, sinks, countertops, stainless steel, and many other washable surfaces”. According to the 2022 Federal Food Code, equipment food-contact surfaces are to be clean to sight and touch. In addition, nonfood-contact surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of soil residues. 14.J. During a concurrent observation and interview on 5/24/24 at 10:54 a.m., with RDO, in the kitchen, two food service staff were observed to have beards and no beard net was worn by either staff. The RDO stated if a beard was more than a half an inch, the staff was required to wear a beard net. The RDO stated he did not measure the staffs’ beards. During a concurrent observation and interview on 5/24/24 at 11:33 a.m., with the IDFNS, in the kitchen, Food Service Staff (FSS) 5 was prepping food and observed to have a beard with no beard net. The Executive Chef (EC) was prepping food and observed to have a beard with no beard net worn . The IDFNS stated the observations were true. During a concurrent observation and interview on 5/24/24 at 11:41 a.m., with FSS 7, in the kitchen, FSS 7 was observed to have a beard and no beard net was worn. FSS 7 stated he has worked in the kitchen for four months prepping and cooking food and during that time he was not required to wear a beard net. FSS 7 stated he was not aware of the requirements to wear beard nets while prepping food in the kitchen but did state during orientation he was educated about the dress code in the kitchen. During an observation on 5/24/24 at 11:48 a.m., in the kitchen, FSS 6 was observed to have a beard with no beard net. FSS 6 did not provide food preparation, but he was observed walking in and out of the kitchen area while performing his job duties. During an interview on 5/24/24 at 11:40 a.m., with the RDO, the RDO stated the EC was responsible to ensure staff wore beard nets if their beard was longer than half an inch. The RDO stated the importance of a beard net was to avoid cross contamination and should be worn for the same reason hair nets were worn while in the kitchen. During a review of the hospital’s policy and procedure (P&P) titled, “F&N.1.61 Personal Hygiene,” dated 5/22/19, the P&P indicated, “ ...Employees will practice good personal hygiene habits at all times while on duty ...Establish standard work attire or uniform, appropriate footwear and personal grooming guidelines for Food Service Personnel ...To prevent food borne illness or contamination ...Dress code policy will be enforced as outlined in the employee handbook ...Hair nets and/or caps worn at all times when working in the following food service areas: kitchen, retail, and dish room ...Beards and mustaches that are not closely cropped and neatly trimmed shall be covered ...” 15. Review of EOC (Environment of Care) round (rounds conducted by a team, usually on a scheduled basis, to ensure the safety and well-being of patients, staff, and visitors. These rounds may focus on maintenance of the environment, versus infection control, in the facility) documentation showed the last EOC round related to the kitchen was conducted in February 2024. The document did not indicate who was present during the rounds. It was noted there were no documented sanitation/infection control issues in the kitchen. Review of the policy and procedure titled “INF.1.19 Infection Prevention Annual Plan 2024” dated 1/26/23, showed the Infection Prevention Plan provides a description of the interdisciplinary and systematic approach developed to protect patients, visitors, employees from communicable pathogens (includes such things as bacteria, viruses, and fungi). The plan serves as the prevention, identification, and monitoring of health care associated infections through ongoing surveillance, current evidence-based intervention, education, and evaluation. The Infection Prevention Committee (IPC) is responsible for implementing the Infection Control Program. Standing reports should be presented by the operational leader of that department. Six IPC meetings required per calendar year. IPC will be compromised of members including a member from Dietary. While meeting minutes from the last six IPC meetings were requested, only January 2024 and March 2024 were provided. Review of the “Infection Prevention & Control Committee Minutes” dated 1/24/24 and 3/27/24, showed the Director of FNS was not listed under the present members. There was no mention of the FNS department in the IPC minutes. During review of the hospital’s document “INF.1.19 Infection Prevention Annual Plan 2024”, indicated, “ ... the infection prevention plan provides a description of the interdisciplinary and systematic approach developed to protect patients, visitors, employees of (name of facility/ health system) from communicable pathogens, The plan serves as the foundation for the prevention, identification, and monitoring of health care associated infections through ongoing surveillance, current evidenced- based intervention, education, and evaluation... Prioritized Goals for 2024 ... To identify and reduce the risks of acquiring and transmitting infections among patients, employees, physicians, other licensed independent practitioners, contract service workers, volunteers, students, and visitors by pursuing sound infection control practices, such as aseptic technique, standard precautions, and other isolation as appropriate... To limit the transmission of infections associated with procedures... To limit the transmission of infections associated with the use of medical equipment, devices, and supplies ... To prevent the transmission of infectious diseases among patients, licensed independent practitioners, and staff ... To meet patient expectations of a safe care environment ...””

“SURGICAL PRIVILEGES CFR(s): 482.51(a)(4) Surgical privileges must be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privileges of each practitioner. This Standard is not met as evidenced by: 42125 Based on interview and record review, the hospital failed to ensure the surgery department kept an accurate roster of privileged surgeons and non-physicians approved to be in Operating Rooms when surgery staff did not follow policies and procedures and permitted unidentifiable, unqualified and/or unprivileged individuals and physicians to provide surgical care in the operating rooms. These failures to ensure all surgical patients received surgical care from qualified, competent, and experienced surgeons, anesthesiologist, and Allied Health Providers (AHP- nonphysician provider), may have contributed to patient harm and placed surgical patients in jeopardy of receiving safe medical care. Findings: During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with surgeon (SUR) 3 and the Chief of Surgery (SUR) 4, the records of surgical patients, hospital policies and workflow were discussed. Surgeon (SUR) 3 stated that from his “understanding”, Certified Registered Nurse Anesthetists, CRNA (type of AHP, Registered Nurse with specialized training that provides anesthesia services under the orders of a physician), were “not independent” and “supported” by the anesthesiologists. SUR 3 stated, it was his “opinion”, if an anesthesiologist wasn’t available, the “case stops and can’t proceed”. SUR 4 stated the surgery department is “not involved” with CRNAs. SUR 4 stated surgeons are “not responsible” for CRNAs and do not provide “direction ... orders” for them. During two concurrent interviews and record review on 5/22/24 at 12:42 p.m. and 5/28/24 at 1:50 p.m. with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical Staff Manger, hospital workflow, polices, patient record logs and staff files were discussed and reviewed. MST explained the privileging process. The MST indicated, according to Bylaws, granted privileges are based on experience, certification, education, and skill sets as determined by case logs from school and/or prior jobs. MST indicated approved privileges should correlate with education, experience, and case. MST stated the file is “available” for Governing Board (GB- hold the ultimate responsibility for the hospital’s compliance) , the credential committee (CC- review candidate application files and provided recommendations to the GB ), and MEC to review and recommend. During record review of the privileging staff records who provided surgical services, including non-physician anesthesia providers, the following were noted: CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 did not have DEA (Drug Enforcement Administration licensee which authorized providers to prescribe, procure and administer medications) licenses, but were allowed to prescribe, procure, and administer controlled substances without a treatment regimen ordered by a physician. CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 were authorized to diagnosis, order treatments, medications and therapeutics for patients and nurses to instate, but did not have a medical license. CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 were not required to have physician orders to provide anesthesia care, medications, treatments, and therapeutics. CRNA 1, CRNA 2, CRNA 5, CRNA 6, CRNA 13. CRNA 18, Physician Assistants (PA- type of AHP, an individual with specialized training that provides medical under the supervisor of a physician ) 5, and SUR 8 had procedure logs for privileges, but they did not correlate with requested or chief approved privileges. PA 2, PA 3, PA 4, PA 5, PA 6, and PA 7 did not have signed service agreements by supervising physicians. CRNA 3, CRNA 4, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 17 PA 6, PA 7, NP 2, SUR 3, SUR 5, and Chief of Medical Staff (COS) did not have documented evidence of procedures logs required for privileges. COS, SUR 3, SUR 5 SUR 8, CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, PA 2, PA 3, PA 4, PA 5, PA 6, and PA 7 did not have documented evidence of professional references that were required. CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 17, CRNA 13, CRNA 18, PA 2, PA 3, PA 4, PA 5, PA 6, PA 7, COS, SUR 3, SUR 5, and SUR 8 did not have documented evidence of the required “direct” supervised proctoring required for privileges. CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, CRNA 18, ANS 4, PA 2, PA 3, PA 4, PA 5, PA 6, PA 7, COS, SUR 3, SUR 5, and SUR 8 did not have documented evidence of professional references. MD 11 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon. MD 12 was listed as the surgical provider and in operative reports for Pt 37 but was listed on the medical staff Roster as internal medicine physician, not surgeon. PA 8 was listed as additional staff intraoperative “Additional staff intraoperative” for Pt 39. On the AHP list with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging) and not a surgeon as the supervising physician. PA 8 listed as an “Anesthesia Tech [assistant to anesthesiologist, not allowed to practice in California]” for Pt 37. PA 8 was listed on AHP roster as PA with a radiologist as the supervising physician. Nurse Practitioner 1 (NP 1) was listed as an “Assistant Provider, Intraoperative” for Pt 39, but was not listed on the medical staff or AHP roster. Physician, (DO 1) was listed as an “Assistant Provider, Intraoperative” for Pt 39 but was not listed on the medical staff. RN 1 was listed as RNFA registered nurse (RN), such as a RN First Assist (RNFA- RN with training that assists a surgeon during surgery), “First Assistant” for “Coronary Artery Bypass” for Pt 37 and Pt 39. RN 1 was not listed on the APH roster. During two concurrent interviews and record reviews on 5/22/24, at 12:42 p.m., and 5/28/24, at 1:50 p.m., with MST, MST acknowledge privileges were granted for specific specialties and if additional privileges were desired, and requested must be submitted to medical staff for review and approval. MST stated that names of individuals listed who were not AHP or Medical Staff Rosters did not have privileges or were unfamiliar to medical, was a “mix-up”. During a concurrent interviews and record review on the following 3 days with Chief of Anesthesia (ANS 1): 1. 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1) and accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and DCQI, 2. 5/29/24, at 10:10 a.m., with ANS 1 and accompanied by DCQI, 3. 5/29/2024 at 4:14 p.m. with ANS 1 and accompanied by RNQ 1, the hospital policies, and patient medical records were discussed. ANS 1 stated CRNA competency could be determined by the surgeon, chief of anesthesiology or the Anesthesiologist in Charge (AIC- a anesthesiologist or CRNA). During an interview on 5/30/2024 at 3:48 p.m. Chief of Medical Staff (COS), accompanied by Accreditation Manager (AM 2), hospital policies, and medical staff processes were discussed. COS acknowledged the privileging process for applicants is not followed. COS acknowledged she was not aware which AHP, including surgical assistants, are eligible for privileges. COS stated PA are “not independent”. COS stated, PAs who are employed by a medical group will submit an application to medical staff. The applications are reviewed by the chief of the department. COS stated approval of PA privileges are “based on education”. On the other hand, PAs employed by the hospital, their practice is determined by the hospital. COS stated PA who provide surgical services should have specific privileges, where they can work, for example trauma, general surgery, cardiovascular, orthopedics. COS stated PAs can work “anywhere” in the hospital. COS acknowledged that medical staff does confirm the competency, qualifications, and skills of AHPs. COS stated, no matter the AHP’s specialty or employment status, (hospital employee or contract provider), whatever physician “asked” the AHP to provide medical care, is “responsible” for the care the AHP’s provides. During an interview on 5/30/2024 at 3:48 p.m. with COS accompanied by Accreditation Manager (AM 2), hospital policies, and medical staff processes were discussed. COS stated she is “familiar” and “follows” with Medical Staff Bylaws. COS stated if a nurse (RN) or other AHP are hospital employees, the hospital has jurisdiction over reviewing qualification, training, and monitoring. Medical staff does not approve their privilege forms. COS stated Registered Nurse First Assistants (RNFA) were nurses and employed by the hospital. The hospital is responsible for privileges and practice, not medical staff. COS stated first assists, RNFAs should have “specific training”. COS indicated the hospital determines their training. During an interview on 5/30/2024 at 3:00 p.m. with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and OR staff were discussed. SUR 4 stated some of her responsibilities as “Chief” is to ensure that surgical workflow and department services “flow well ...coordinate patient care ...communicate with staff”. In addition, SUR 4 reviews surgical providers applications files for education background, case logs, training, and experience. SUR 4 stated she will recommend applicants for staff privileges. SUR 4 stated she “helps”’ the credentialing committee once a month. During a review of the Pt 37’s nursing intra-operative notes, titled, “Surgical Documentation”, dated 6/24/23, at 3:54 p.m., the nurse documented medical providers who entered the operating room and provided surgical services to Pt 37 as follow: Operating surgeons, SUR 3, and SUR 9, “Coronary Artery Bypass”. Anesthesiologists, (ANS 4). Medical Doctor (MD) 11 , “Assistant Provider, Intraoperative” for “Coronary Artery Bypass”, was not listed as a surgeon on the Medical Staff roster, but internal medicine doctor. MD 12, “Assistant Provider, Intraoperative” for “Coronary Artery Bypass”, was not listed as a surgeon on the Medical Staff roster, but internal medicine doctor. RNFA 1, “First Assistant” for “Coronary Artery Bypass”, was not listed on the APH Roster. The nursing documented that “PATIENT EXPIRED. During record review of the titled document, “Operative/Procedure Report”, dated 6/24/2023 at 3:54 p.m. for Pt 37., written by the operating surgeon (SUR 3), SURG 3 indicated the following individuals were members of the operative team surgeons, SUR 3, SUR 9, and SUR 8. SUR 3 wrote “ we invited the cardiologist [MD 12] and elicit his help ...aid in decompression of the left ventricle [heart chamber] ... intensivist [MD 11] came to the operating room and assistance ...weaning the patient from cardiopulmonary bypass ... all attempts of salvaging the patient have been futile and the patient ...expired “ in the OR. During a review of the Pt 38’s nursing intra-operative (during surgery) notes, titled “Surgical Documentation”, dated 5/15/24, the nurse documented medical providers who entered the operating room and provided surgical services to Pt 38 as follow: Operating surgeon, (SUR 5), listed on the medical staff roster. Anesthesiologists, (ANS 1 and ANS 6). Both listed on the medical staff roster. Additional staff intraoperative” Physician Assistant (PA 8), listed on AHP roster with a supervising radiologist (medical doctor diagnoses and diseases using medical imaging) and not a surgeon as the supervising physician. Assistant Provider, Intraoperative” Nurse Practitioner, (NP 1) was not on the medical staff or AHP roster. Assistant Provider, Intraoperative” physician, (DO 1) was not on the medical staff roster. During a record review of the Pt 39’s nursing intra-operative notes titled, “Surgical Documentation”, dated 12/13/2023, the nurse documented those 21 different individuals entered the OR during Pt 39’s case: six RNs, one Respiratory Therapist, four medical students, one vendor, three perfusionists, two anesthesiologists (ANS 8, ANS 2), four surgeons (SUR, SUR 8, SUR 10 and SUR 11), and one RNFA 1 who was not listed on the APH roster. During an interview on 5/30/24 at 3:00 p.m. with SUR 4 accompanied by AM 2, hospital policies, workflows, some of the findings for Patients 37, 28 and 39 records, and OR staff were discussed. SUR 4 stated the only non-surgeon physicians that come to the ORs are, “intensivist [ICU physician]”, who would be called to the OR to assist the anesthesiologist in a code. SUR 4 indicated she was unaware that, non-surgeons, MD 11, and MD 12 were assisting in surgeries. PA 8 was listed as a “Anesthesia Tech” and surgical “Assistant Provider. SUR 4 stated PA 8 was supervised by a radiologist, and “I don’t know why his name is on a cardiac case” and assisting in surgeries or anesthesia. SUR 4 stated the “surgery department does not oversight of the anesthesia service”. SUR 4 stated RNFAs are nurses and employees of the hospital, and surgery does not control what nurses are in the OR. SUR 4 stated she has “no idea” who some of the providers were-- MD 15, NP 1 or DO 1-- or why they were assisting in surgeries. SUR 3 stated “poor documentation” may be why unidentifiable individuals were present in the OR. There was no documented policy available that described the entrance of non-privileged OR staff, visitors, or bystanders to enter the operating rooms. During record review of [Hospital] policy titled “Rules and Regulations of the Governing Board of [Hospital]”, June 13, 2022, indicated that the “Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... approved by the Governing Board ... The Governing Board shall have authority and responsibility for all appointments and reappointments of Medical Staff members, granting of clinical privileges, approving disciplinary actions, conducting investigations relating to quality of patient care and professional practice”. During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “ recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout [Hospital Name] Medical Center ... To provide professional performance and utilization of services within the scope of defined clinical privileges, through a systemic credentialing, review, appraisal, and improvement ... Comply with the policies, practices, and procedures at [Hospital Name] Medical Center, including the standards and recommendations by The Joint Commission, local, state, and/or federal laws, and regulations ... Adhere to responsibilities as outlined in sponsoring/supervision agreements to allied health professionals (if applicable) ... DUTIES AND AUTHORITY OF THE MEDICAL EXECUTIVE COMMITTEE. ...To fulfill Medical Staff accountability to the Governing Board for the medical care of patients at [Hospital Name] Medical Center ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board.” During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “only members who hold a medical staff appointment or temporary privileges are eligible to render medical care at [Hospital name] ... The Governing Board grants appointments to the medical staff ... Medical staff membership (1) to have a current unrestricted California license to practice medicine, dentistry, or podiatry; (2) to maintain an unrestricted Drug Enforcement Administration certificate ... Every member practicing the medical profession at [Hospital name] shall exercise those clinical privileges specifically granted by the Governing Board”. During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “Medical staff membership (1) to have a current unrestricted California license to practice medicine, dentistry, or podiatry; (2) to maintain an unrestricted Drug Enforcement Administration certificate ...only members who hold a medical staff appointment or temporary privileges are eligible to render medical care at [Hospital name] The Governing Board grants appointments to the medical staff ... Every member practicing the medical profession at [Hospital name] shall exercise those clinical privileges specifically granted by the Governing Board ... Hold a current, unrestricted license, certificate or other appropriate legal credential ... the authorized individual shall write the order, followed by the name of the Practitioner, date and time, name, and signature of the writer ... Practitioners are legally and professionally responsible for the ongoing monitoring and appropriate adjustment of the duration and dose of the medications ordered in the Hospital”. During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “ recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a “practitioner” ... who provides defined direct patient care services ... consistent with applicable law, these bylaws and the medical staff rules and regulations ...Authorized Categories ... Categories of AHPs presently providing patient care services in the Hospital are as follows: (1)Certified Registered Nurse Anesthetist, (2)Certified Nurse Midwife, (3)Clinical Psychologist, (4)Dental Assistant, (5)Nurse Practitioner, (6)Oral Surgery Assistant, (7)Orthopedic Technologist, (8)Pathology Assistant, (9)Perfusionist, (10)Physician Assistant, (11)Surgical Scrub Second Assistant AHPs are not eligible for medical staff membership”. During record review of hospital titled, “AHP [Allied Health Professional] Rules and Regulations, version 2022” indicated that the “Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned ... Practitioners who desire to sponsor and supervise AHPs must apply and qualify for such sponsorship. “During record review of [Hospital] policy titled, “CO-5.007 Operative and Invasive Procedures Appropriateness Review”, approved 10/24/2018, described “the minimum standards for prospective and retrospective review of the appropriateness of operative and invasive procedures through effective use of evidence-based clinical criteria, to appropriately and accurately identify performance trends and patterns, and to monitor and improve ... Hospital’s Peer Review Committee is responsible for providing oversight and peer review of the Operative and Invasive Procedures provided at the Hospital to confirm appropriateness of the Procedures being performed ... Physician documentation that validates the appropriateness of the procedure, including but not limited to: patient clinical condition, non-invasive study results, findings from diagnostic procedures ... shall provide a summary of its findings to the Hospital’s Medical Executive Committee (MEC), which shall report such findings to the Hospital Governing Board”, as outlined in Medical Staff Bylaws. During record review of [Hospital] policy titled, “MOD CLN.4.04 MOD Operative and Invasive Procedures Appropriateness Review (CO-5.007.MOD)”, approved 4/10/2024, stated the purpose of the policy was “to describe the minimum standards, review Cardiac Operative and Invasive procedures through effective use of evidence-based clinical criteria ... Quality Review ... The Facility shall conduct case reviews in accordance with the peer review and quality processes set forth in the Facility’s Medical Staff Bylaws and state statutes ... The Facility shall review, at minimum ...the OR/procedure room or other vascular complications requiring treatment ... Bleeding events with treatment or drop of > 3gm/dL ...Dissection or perforation ...Infections ...Return to the OR/procedure room for re-operations ... Cases with Mortality”. During record review of [Hospital] policy titled, “CO.2.010.05 Disclosure of Outcomes to Patients”, approved 7/22/2020, indicated that “unanticipated outcomes of care, including errors, also referred to as preventable events ... Patients and, when appropriate, their families shall be promptly informed about the outcomes of care, including preventable events. All preventable events resulting in harm or shall be disclosed to the patient”.”

“HISTORY AND PHYSICAL CFR(s): 482.51(b)(1) Prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies: (i) A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration, and except as provided under paragraph (b)(1)(iii) of this section. This Standard is not met as evidenced by: 42125 Based on interview and record review the hospital failed to obtain a History and Physical (H&P-a term used to describe a doctor’s examination of the patient) updated within 24 hours of a surgery for one of two patients (Pt), Pt 12, in accordance with hospital policy and procedure. The failure to assess the appropriateness of the surgery and determine the surgical needs of Pt 12 prior to surgery, placed Pt 12 at risk for potential complication and harm. Findings: During a concurrent interview and record review on 5/22/24 at 10:53 a.m. with RNQ 4, Pt 12’s “Face Sheet (FS-a document that contains a summary of a patient’s personal information and brief medical history),” dated 5/14/24 and Pt 12’s “History and Physical (H&P),” dated 5/3/24 was reviewed. The Face Sheet indicated Pt 12 was admitted on 5/14/24 at 7:54 a.m. The H&P indicated Pt 12 was admitted for repeat cesarean section (the surgical delivery of a baby through a cut made in the mother’s abdomen). RNQ 4 stated she could not find an updated H&P for Pt 12. RNQ 4 stated there should be an updated H&P on the day of surgery, but it was not done. RNQ 4 stated the importance of an updated H&P was to ensure Pt 12’s health information was still the same or had changed since the previous H&P. During an interview on 5/30/24 at 3:00 p.m. with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), SUR 4 stated all surgeons were expected to complete the following for surgical patients: write in-patient pre-surgical consults, “activate” surgical orders, obtain a consent after the surgeon has discussed the risk and benefits of surgery, mark the surgical sight, complete a time-out in the OR, “immediately, within an hour” complete an operative procedure note before the patient is transferred to the next level of care and post operative notes. SUR 4 stated, if there was an intra-operative death, the surgeon was “responsible to write a full note ...code participation was noted” and describe the patient’s outcome. During a review of hospital’s policy and procedure (P&P) titled, “Rules and Regulations of the Governing Board of [Hospital A]”, June 13, 2022, the P&P indicated, the “Governing Board shall organize the physicians and other practitioners granted clinical privileges at the Hospital ... define which Medical Staff members and qualified medical professionals are authorized and required to perform the treatment ... Recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations ... Governing Board’s duty to protect patients and all other individuals at the Hospital ... QUALITY OF PROFESSIONAL SERVICES AND PATIENT CARE EVALUATION ... ensure appropriate professional care to Hospital patients ...” During a review of the hospital’s P&P titled, “MEDICAL STAFF RULES AND REGULATIONS”, dated August 24, 2022, the P&P indicated, “ ...When a medical history and physical examination is completed within the 30 days before admission, an updated medical record entry documenting an examination for any changes in the patient’s current condition must be completed. This updated examination must be completed and documented by a physician in the patient’s medical record within 24-hours after admission, but before a surgical invasive procedure, even if the surgery or procedure occurs less than 24-hours after admission or registration. The practitioner completing the update is responsible for ensuring the history and physical documented in the medical record is complete and accurate ...Any staff member failing to provide a complete history and physical within 24-hours after admission shall be subjected to automatic suspension for medical record deficiencies pursuant to Medical Staff Bylaws ...Prior to commencing surgery the person responsible for administering anesthesia, or the surgeon if a general anesthetic is not to be administered, shall verify the patient’s identity, the site and side of the body to be operated on, and ascertain that it is recorded in the patient’s medical record and re-evaluate the patient’s vital signs immediately prior to moderate or deep sedation use and before anesthesia induction ...” During a review of the hospital’s P&P titled, “CO-5.007 Operative and Invasive Procedures Appropriateness Review”, dated 10/24/2018, the P&P indicated, “ ...the minimum standards for prospective and retrospective review of the appropriateness of operative and invasive procedures ...””

“DELIVERY OF ANESTHESIA SERVICES CFR(s): 482.52(b) Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of pre-anesthesia and post-anesthesia responsibilities. The policies must ensure that the following are provided for each patient: This Standard is not met as evidenced by: 42125 Based on interview and record review, the hospital failed to provide anesthesia services consistent with needs and resources when the hospital granted Certified Registered Nurse Anesthetists (CRNA) prescriptive authority and the ability to diagnose and treat patients without a treatment regimen ordered by a physician while providing anesthesia services and was not consistent with scope of practice laws and standards of practice for CRNAs. These failures resulted in CRNAs providing anesthesia services to patients for which they could possibly not be qualified to provide. Findings: During a joint interview with DOP and RPH 1, in the pharmacy office hallway, on 5/20/24, at 6:02 PM, the DOP stated the pharmacy relied of hospital’s credential and privilege system to check provider’s qualification and up to date licenses to practice and prescribe drugs. The DOP stated, the pharmacy assumed the provider’s DEA and California license to prescribe were routinely checked for updated status. RPH 1 stated the scope of practice by mid-level providers (non-physician providers authorized to provide care and prescribe) were not limited to drug class and computer allowed the pharmacist to verify their orders. During a concurrent interview and record review on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2) accompanied by Patient Safety Officer (PSO), patient records, workflow and hospital policies were discussed. ANS 2 indicated the hospital bylaws defined the role and scope of practice of CRNAs. ANS 2 stated CRNAs “practice independently ... practice on own”, write orders, and prescribe medications. ANS 2 stated anesthesiologist are “not responsible” for the medical care provided by CRNAs. ANS 2 stated an anesthesiologist’s participation in a case is “loose supervision” and the anesthesiologist does not provide medical direction, oversight, or orders for CRNAs. During an interview and concurrent record review on 5/21/2024 at 2:30 p.m. with Medical Doctor (MD 1) accompanied by Quality Registered Nurse (RNQ 1), the medical records and workflow were reviewed and discussed. MD 1 stated she does not provide medical direction or write orders for CRNAs. MD 1 stated the “anesthesia department is in charge of CRNAs and monitoring”. MD 1 stated that, “I don’t think CRNA can diagnosis, prescribe, write orders.” MD 1 indicated if CRNA is providing anesthesia care, she will have a “conversation” with CRNA, but the anesthesiologist is “responsible for the care provided by CRNAs”. During a concurrent interviews and record review on the following 3 days with Chief of Anesthesia (ANS 1): 1. 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1), accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and Director of Clinical Quality and Performance Improvement (DCQI), 2. 5/29/24, at 10:10 a.m., with ANS 1, accompanied by DCQI, and 3. 5/29/24 at 4:14 p.m. with ANS 1, accompanied by RNQ 1, the hospital policies, workflow, and patient medical records were discussed. ANS 1 stated the “ primary” anesthesia provider can be a CRNA or anesthesiologist. ANS 1 stated CRNAs are “independent”, and do not require physician review, direction, or orders. ANS 1 CRNAs are authorized to diagnosis, determine the treatment plan, write orders for medications, treatments and therapeutics for patients and nurses to instate. ANS 1 CRNAs are “qualified to run a code” order medications and direct medical care. ANS 1 explained the “supervising” anesthesiologist’s role is to be “available to help” the CRNA if specifically asked by the CRNA. ANS 1 stated that a CRNA will determine if anesthesiologist needs to be present, and if the CRNAs have “any concerns” an anesthesiologist will be an “available” resource. ANS 1 indicated the anesthesiologist is not responsible for the medical care CRNAs provide or be responsible for signing orders. During two concurrent interviews and record review on 5/22/24 at 12:42 p.m. and 5/28/24 at 1:50 p.m. with the medical staff team (MST) which included the Director of Clinical Quality and Performance Improvement (DCQI) and Medical Staff Manger, hospital workflow, polices, patient record logs and staff files were discussed and reviewed. MST indicated CRNAs are approved as “independent practitioners with full prescriptive authority. MST stated CRNAs are the “same as a physician ... anesthesiologist” and are “equivalent”. MST acknowledged there was no documented evidence Governing Board (GB- hold the ultimate responsibility for the hospital’s compliance), approved CRNAs hospital privileges to provide patient care. During record review of the privileging staff records the following were noted: “ CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 did not have DEA (Drug Enforcement Administration licensee which authorized providers to prescribe, procure and administer medications) licenses, but were allowed to prescribe, procure, and administer controlled substances without orders from a physician establishing a treatment regimen. “ CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 were authorized to diagnosis, order treatments, medications and therapeutics for patients and nurses to instate without orders from a physician establishing a treatment regimen but did not have a medical license. “ CRNAs 1, 2, 3, 4, 5, 6, 8, 10, 11, 12, 13, 17 and 18 were not required to have physician orders to provide anesthesia care, medications, treatments, and therapeutics. “ CRNA 1, CRNA 2, CRNA 3, CRNA 4, CRNA 5, CRNA 6, CRNA 8, CRNA 10, CRNA 11, CRNA 12, CRNA 13, CRNA 17, and CRNA 18 did not have documented evidence of the required “direct” supervised proctoring required for privileges. During two concurrent interviews and record reviews on 5/22/24 at 12:42 p.m. and 5/28/2024 at 1:50 p.m. with MST, MST stated CRNAs are not required to have individual DEA numbers and according to “title 22 regulations and 1301.22 [ Federal regulation practitioner that allows an agent or employee with a DEA to prescribe medications ], CRNA are allowed to use the hospital DEA number”. Medical staff team stated “CANA [California Association of Nurse Anesthesiologist, an advocacy group that supports nurse anesthetists] allows CRNAs to work independently, and “in the state of California” CRNAs have prescriptive authority. MST stated CRNAs can diagnosis, write orders any medication, treatment or therapeutic. It is within their “scope of practice”. MST acknowledged that CRNAs are not employees of the hospital and work as independent contractor. MST acknowledged none of the CRNAs ordering, prescribing, procuring, and administering medications had a DEA license. MST indicated, anesthesiologists are not required to sign an attestation, swearing that he/she was present for key portions of anesthesia care and procedures. The hospital policy titled, “AHP [Allied Health Professional] Rules and Regulations, version 2022” was reviewed with MST which indicated all AHPs required “direct supervision”. MST stated the definition of “supervision” for CRNAs was that an “anesthesiologist was available to provide support ...and help ... if” requested by the CRNA. The MST stated “new” hospital regulations did not require CRNA to be supervised. MST indicated that CRNAs were not required to have an anesthesiology present to provide orders or medical direction for any aspect an anesthesia, including emergencies, or life-threatening events, procedures, or medical care of patients. During an interview and concurrent record review on 5/22/24 at 5:10 p.m., with anesthesiologist (ANS 3) accompanied by Patient safety officer (PSS), medical records of Patient 2 (Pt 2), workflow and hospital policies were reviewed and discussed. ANS indicated recently the hospital transitioned to a CRNA and anesthesiologist-based service. ANS 3 stated has “never worked with CRNAs ... never taken responsibility for the patient care of CRNA ... never provide orders for CRNAs”. ANS 3 indicated, if he is available will help other anesthesia providers, physicians and CRNAs. But he stated, CRNAs “do not ask me for help”. During an interview on 5/30/2024 at 3:00 p.m. with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflow and OR staff were discussed. SUR 4 stated that she is “absolutely not” involved with the anesthesiology departments approval of privileges for anesthesiologist or CRNAs. SUR 4 stated anesthesiologist cover trauma and direct codes (life-saving medical interventions and medications), not CRNAs. During a concurrent interview and record review on 5/20/24 at 3:40 p.m., with CRNA 1 and accompanied by nurse of Quality (RNQ 1), the medical records, workflow and policy were reviewed with CRNA 1. CRNA 1 stated this was his “first job” as a CRNA. CRNA 1 stated he started taking call (available for emergencies) in the hospital at night in April 2024, and working fulltime in May of 2024. CRNA 1 stated he can do “all cases” for anesthesia. CRNA 1 stated the CRNA the plan of care and medication are “decided by the CRNA”, not the surgeon. CRNA 1 indicated CRNAs sign as the physician on anesthesia records, and an anesthesiologist signature is not required on orders, patient evaluations, procedures, or anesthesia records. CRNA 1 acknowledge he does not have a DEA license. CRNA 1 stated he has the “authority” to “optimize” patients and write orders for medications, labs, treatments, and procedures. During an interview and concurrent record review on 5/20/2024 at 5:12 p.m. with CRNA 5, accompanied by a scribe, Patient Safety Officer (PSO), medical records for the admission, workflows, and polies were reviewed, and discussed. CRNA 5 that AANA (American Association of Nurse Anesthetists’, an advocacy group for nurse anesthetists) and the hospital bylaws determined the “scope of practice” of nurse anesthetist. CRNA 5 stated that CRNAs are “independent and not medically supervised or directed” by a physician and are the “responsible provider” of medical care. CRNAs bill as an “independent” physician provider. CRNA indicated CRNA write orders and do not require a physician signature or approval. CRNAs provide anesthesia care and procedures to patients without physician orders or direction. CRNA 5 stated she does not have a DEA license, because CRNAs “are not required to have DEA”. CRNA 5 stated that CRNAs are authorized to use the hospital DEA to order medications with “no limitations”. CRNA 5 indicated CRNA 5 stated CRNAs can directs the medical care of codes and order medications and procedures. CRNA 5 stated anesthesiologist are “available”, if the CRNA “asks for help”, and each CRNA determines when and if and anesthesiologist is required in a case. CRNA 5 stated the CRNAs are “very, very similar” and “at the end of the day deliver” anesthesia care by CRNAs is the “same” as a physician. During a phone interview on 5/22/2024at 10:13 a.m., with CRNA 6, accompanied by scribe and Director of Clinical Quality Improvement (DCQI), the hospital policy, workflow and patient records were discussed. CRNA 6 stated he was the “Chief CRNA”. CRNA 6 stated the anesthetist can diagnose, prescribe, and order medications, order labs, order treatments, and render medical services to patients; it is all “within [CRNAs] scope of practice” and there are “no limitations” inside the hospital. CRNA 6 indicated he works “independently” without physician orders, supervision, or directions. CRNA 6 stated CRNAs have “independent practice” and the role of the anesthesiologist is to be “available anytime as a resource”. CRNA 6 acknowledged he does not have a DEA license. During a phone interview on 5/29/24 at 1:40 p.m. with CRNA 4, CRNA 4 stated he has been working at the hospital since July 2023. CRNA 4 stated CRNA’s practice independently both in the hospital and outside of the hospital in places like surgery center. CRNA 4 stated he does not review cases with an anesthesiologist, and it was not the practice at the hospital. CRNA 4 stated he can adjust anesthesia plan for patients independently. CRNA 4 stated he does not have DEA license but can order medications and testing as deemed necessary for patients. During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “only members who hold a medical staff appointment or temporary privileges are eligible to render medical care at [Hospital name] The Governing Board grants appointments to the medical staff ... Medical staff membership (1) to have a current unrestricted California license to practice medicine, dentistry, or podiatry; (2) to maintain an unrestricted Drug Enforcement Administration certificate ... Every member practicing the medical profession at [Hospital name] shall exercise those clinical privileges specifically granted by the Governing Board ... the authorized individual shall write the order, followed by the name of the Practitioner, date and time, name, and signature of the writer ... All drugs and medications administered to patients shall have been approved by the Federal Drug Administration or listed in the latest edition of United States Pharmacopeia, National Formulary, American Hospital Formulary Service or A.M.A. Drug Evaluations ... Investigational or experimental drugs shall be used only under the direct supervision of a Physician Member of the Medical Staff, who is responsible for securing the necessary consents ... Practitioners are legally and professionally responsible for the ongoing monitoring and appropriate adjustment of the duration and dose of the medications ordered in the Hospital”. During record review of [Hospital] policy titled, “OR.1.29 Provision of Anesthesia Services”, approved 10/27/2021, stated the purpose of the policy was “to establish a consistent standard-of-care for patients receiving anesthesia services ... The director of anesthesia services is responsible for ... Evaluating the quality and appropriateness of the anesthesia patient care ... The anesthesia service is responsible for developing policies and procedures governing the provision of all categories of anesthesia services ... Individuals Permitted to Administer Anesthesia ... Only those individuals privileged by the medical staff shall be permitted to administer anesthesia. These individuals may include A qualified anesthesiologist, A Doctor of Medicine or osteopathy (other than an anesthesiologist); A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law ... The privileges granted must be in accordance with State law and organization policy. The type and complexity of procedures for which the practitioner may administer anesthesia, or supervise another practitioner supervising anesthesia, must be specified in the privileges granted to the individual practitioner”. During record review of [Hospital] policy titled, “PHARM.1.04 Controlled Substances Policy Schedule II - V, approved: 6/23/2021, indicted that “Issuing, Dispensing and Distributing Controlled Substances ...Only licensed personnel per state law and regulation may have access to controlled substances ... Strict accountability shall be maintained and recorded for all controlled substances”. During record review of [Hospital] policy titled, “MEDICAL STAFF RULES AND REGULATIONS”, approved Governing Board, August 24, 2022, indicated that, prescribing providers “maintain an unrestricted Drug Enforcement Administration certificate ...authorized individual shall write the order, followed by the name of the Practitioner, date and time, name, and signature of the writer”. During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “ recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital ... Clinical Privileges/Privileges: Specified diagnostic and therapeutic services that may be exercised by authorized individuals on approval of the Governing Board ... Allied Health Professional (AHP): An individual, other than a “practitioner” as defined below, who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in the area of his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership. ...Allied Health Professional (AHP): An individual, other than a “practitioner” ... who provides defined direct patient care services in the hospital under a defined degree of supervision, exercising judgment in his documented professional competence, consistent with applicable law, these bylaws and the medical staff rules and regulations. AHPs are not eligible for medical staff membership”. During record review of hospital titled, “AHP [Allied Health Professional] Rules and Regulations, version 2022” indicated that the “Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned”. During record review of California (CA) Business and Professions Code, (BPC) 2826, it stipulated that a “Nurse anesthetist’ means a person who is a registered nurse licensed by the board who has met standards for certification from the board”. During record review of California’s Business and Professions Code, CA BPC, 2725(b)(2), it stipulated that “Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, necessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician”. During review of California ‘s Business and Professions Code, CA BPC 2827, it stipulated, the “utilization of a nurse anesthetist to provide anesthesia services in an acute care facility shall be approved by the acute care facility administration and the appropriate committee, and at the discretion of the physician, dentist or podiatrist”. During review of California ‘s Business and Professions Code, CA BPC 2833.5, it stipulated that “the practice of nurse anesthetist does not confer authority to practice medicine or surgery”.”

“SUPERVISION OF EMERGENCY SERVICES CFR(s): 482.55(b)(1) The emergency services must be supervised by a qualified member of the medical staff. This Standard is not met as evidenced by: 42125 Based on interview and record review, the hospital failed to ensure emergency services provided in the hospital were supervised by a qualified member of the medical staff for four of four patients (Patients 1, 2, 3 and 5) when Patients 1, 2, 3 and 5 experienced code blue situations (term generally used to indicate a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) in the surgical and procedural areas of the hospital and the code blue was not supervised by a qualified member of medical staff and the code blue did not follow established guidelines for Advanced Cardiac Life Support (ACLS) published by the American Heart Association (AHA) and hospital policy and procedure. These failed practices may have contributed to unsafe emergency care practices, medication use and patient harm. Findings: During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with Surgeon (SUR 3) and the Chief of Surgery (SUR 4), the records of surgical Patient 1’s (Pt 1) admission on 4/10/23 and hospital policies were discussed indicated if there was a code blue in the OR, the physician directed the code, and the anesthesiologist would be called. If there is no physician, the CRNA will start it. During a concurrent interviews and record review on the following 3 days with Chief of Anesthesia (ANS 1): 1. 5/22/24, at 9:40 a.m., with Chief of Anesthesia (ANS 1), accompanied by Quality Registered Nurse (RNQ 1), Medical Staff Manager and Director of Clinical Quality and Performance Improvement (DCQI), 2. 5/29/24, at 10:10 a.m., with ANS 1, accompanied by DCQI, and 3. 5/29/2024 at 4:14 p.m. with ANS 1, accompanied by RNQ 1, the hospital policies, workflow, and patient medical records were discussed. ANS 1 stated the anesthesia department followed ASA (American Society of Anesthesiology) guidelines and ACLS guidelines for patient care and documentation. ANS 1 stated CRNAs are “independent”, and do not require physician review, supervision, direction, or orders. ANS 1 CRNAs are “qualified to run a code” order medications and direct medical care. ANS 1 stated that CRNA would determine if anesthesiologist needs to be present, and if the CRNAs have “any concerns” an anesthesiologist would be an “available” resource. ANS 1 indicated the anesthesiologist is not responsible for the medical care CRNAs provide or responsible for signing orders. During an interview on 5/30/24 at 3:00 p.m. with the Chief of Surgery (SUR 4), accompanied by Accreditation Manager (AM 2), hospital policies, workflows, patient records, and OR staff were discussed, SUR 4 stated if there is a code in the OR, the CRNA may start it, but the anesthesiologist “runs” the code. If additional physician hands are needed, an intensive care (ICU- critical care unit) physician is called to the OR to assist. SUR 4 indicated intensive care doctors who are called to assist with codes enter the OR. During a joint interview with ADOP, RPH 1 and RPH 3, on 5/30/24, between 11:03 AM to 12:07 PM, the RPH 3 stated the intra-op (inside surgery room records and drug records) records of medication use was not online (available in computer) and was only available after use and administration or when it was scanned in the medical records. When asked if pharmacy would have questioned use of TXA in setting on an allergic reaction without bleeding incident, RPH 3 stated she would “definitely questioned” the use due to risk and complications when TXA was not used based on standards of practice and approved indication. When asked if pharmacy would question use of epinephrine in the setting of having heartbeat and reasonable blood pressure, RPH 3 stated “no, not indicated” to give epinephrine, and the code record needed to be reviewed. When asked how the reports of the drug allergy or reaction was processed by pharmacy, RPH 3 stated the allergy reported via electronic reporting system or pharmacy find it when reversal drugs used to counter allergy. RPH 3 stated the hospital was not able to review or find every single drug related allergy happening in the hospital. RPH 3 stated the providers could enter the drug reaction in the computer system. 1. During a review of Patient 1’s (Pt 1) medical record, titled “Consultation Notes”, written by Surgeon 3 (SUR 3, surgery doctor), dated 4/11/24, at 6:18 PM, the note indicated Patient 1 was re-admitted to the hospital with bowel obstruction (when the bowels blocked by food or scar tissues) and recurrence of large paraoesophageal hernia (when stomach protrudes up into the chest through the sheet of muscle called the diaphragm in the body) and a planned surgery to repair hernia and clear the bowel obstruction. During review of the Pt 1’s intraoperative (events during surgery) medical record, titled “Anesthesia Record” dated 4/11/24, at 7:09 p.m., handwritten by CRNA 5, the record indicated Pt 1 entered the operating room at 7:09 p.m. and CRNA 5 provided anesthesia services during surgery without orders from a physician. There was no documented evidence that additional CRNAs, or a physician entered the OR with CRNA 5 and Pt 1. The record indicated starting at 7:15 p.m., CRNA 5 procured, prescribed, and administered “High Risk Medications” (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing, lowered blood pressure, change of heart rate, and paralyzed the body’s movement. CRNA 5 did not document continuous monitoring of the blood pressure, heart rate, heart rhythm, oxygen saturation (estimated percent of oxygen in patient’s blood), respiratory rate, or the delivery of oxygen. Further review of the documented intra-operative events indicated that CRNA 5 attempted to intubate (place a breathing tube into the lungs) three times. There was no documented evidence, with each attempt, the presence of carbon dioxide (gas expelled during exhalation and indicates a breathing tube in the lungs), lung sounds of air flow, respiratory rate, delivery of oxygen or oxygen saturation (percent of oxygen in blood) indicating a successful intubation(s). There was no documented evidence CRNA 5 recorded the medication used and response to interventions and treatment. There was no documented evidence CRNA 5 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines. During an interview and concurrent record review on 5/20/24, at 5:12 p.m. with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1’s (Pt 1) medical record for the admission dates from 4/10/24 to 4/11/24, and policies provided by the hospital, were reviewed, and discussed. Review of the Pt 1’s intraoperative (events during surgery) medical record, titled “Anesthesia Record” on 4/11/24 with CRNA 5, CRNA 5 stated “within minutes of pushing [intravenous, IV] medications, patient vomited 1.5 liters [measurement of volume] of fluid ...fecal matter ...called for help”. CRNA 5 stated that she intubated Pt 1, but it was in the “esophagus, and tried again. CRNA 5 acknowledged she documented that she intubated three times. CRNA 5 stated throughout the intra-operative period, there was “no gas exchange (evidence pt was receiving oxygen”, and “no CO2 (evidence of pt exhalation)”. During a record review of the Pt 1’s medical record, “Code Blue Record [events, medications and treatment during cardiopulmonary resuscitation, life saving measures], dated 4/11/24 from 7:40 to 8:25 p.m., and handwritten by a nurse. The nursing documentation indicated “medications administered by Anesthesia team, see OR (Operating Room, surgery room) record ... intubated time: see anesthesia record” written by CRNA 5. The Code Blue record indicated that there were “multiple intubation [place a breathing tube to deliver oxygen and respirations] attempts during and before code.” The nurse documented medications in the follow order: i. Epinephrine 1 mg (used IV in emergency situation when heart or breathing stops) given at 7:40 PM, 7:42 PM, 7:43 PM, 7:44 PM, 7:46 PM ii. Sodium Bicarbonate 50 meq (the treatment of metabolic acidosis or when acids build up in body; “meq” is Milliequivalent, a unit of measure) and Calcium Chloride 1 gm (used for emergency treatment of high potassium and magnesium level in the blood) were given at 7:47 PM. iii. Epinephrine 1mg given at 7:48 PM iv. Vasopressin 20 Units given at 7:52 PM v. Epinephrine 1 mg given and Sodium Bicarbonate 50 meq given at 7:55 vi. Epinephrine 1mg given at 7:56 PM vii. Bicarbonate 50 meq given at 7:57 viii. Epinephrine 1mg given at 7:59 PM, 8:01 PM, 8:08 PM, 8:24 PM, 8:24 PM During the Code Blue here was no documented evidence of heart rhythm, respiratory rate, or deliverance of oxygen by CRNA 5 or the nursing staff. The following was documented periodically: Blood pressure (BP- normal average 120/80), heart rate (HR- normal 60-100 beats per minute, bpm) and oxygen saturation. (SpO2- estimated percent of oxygen in the blood, normal 95 to 100%) SpO2 90% at 7:56 p.m., 100% at 8:02 p.m. and 94% at 8:06 p.m. 85% at 8:03 p.m., BP 67/29 at 7:44 p.m., 92/46 at 7:55 p.m., 174/146 at 8:01 p.m., 173/77 at 8:02 p.m., 159/27 at 8:09 p.m., 208/157 at 8:12 p.m., 200/140 at 8:16 p.m., HR bpm was 81 at 8:01 p.m., 128 at 8:02 p.m. 129 at 8:03 p.m., 134 at 8:09 p.m., 159 at 8:12 p.m., 138 at 8:16 p.m. There was no documented heart rhythm for any of the heart rates. At 8:19 p.m. was the last recorded BP 127/40 and HR 150. At 8:25 p.m. compressions stopped and SURG 3 sopped the lifesaving measures. The Code Blue record further indicated the SUR 3 arrived at code event at approximately 8 PM and the ICU team (Intensive Care Unit; specialized team that treated critical patients) and MD 3 arrived at 8:03 PM. Further review of the code blue sheet documentation indicated no documented evidence CRNA 5 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines, medications, and procedures or anesthesia guideline for securing an airway. During a concurrent interview and record review on 5/17/24, at 2:30 p.m. with surgeon (SUR 3) and the Chief of Surgery (SUR 4), the records of surgical Patient 1’s (Pt 1) admission on 4/10/23 and hospital policies were discussed. SUR 3 stated there was “no anesthesiologist in the room” when he arrived in the OR. SUR 3 stated the patient was in “distress” had a “pulse” and there were “bowel fluids” on the floor. SUR 3 stated he put a camera into the patient’s lung and determined the breathing tube was “in the esophagus”. SUR 3 stated two CRNAs were “grappling” with the airway and the patient lost her pulse. Later, SUR 3 indicated that an ICU physician arrived in the OR and determined that ETT was in the esophagus. SUR 3 stated the ICU physician intubated the patient. SUR 3 stated the case was reviewed. SUR 4 stated there was an order to “decompressed [contents emptied]” by placing an NGT and do an awake intubation. SUR 3 stated that from his “understanding”, CRNAs were “not independent” and “supported” by the anesthesiologists. SUR 3 stated, it was his “opinion”, if an anesthesiologist wasn’t available, the “case stops and can’t proceed”. During an interview on 5/20/24, at 5:12 p.m., and concurrent record review of code blue record events, with CRNA 5, accompanied by Patient Safety Officer (PSO), the Patient 1’s (Pt 1) medical record for the admission dates from 4/10/24 to 4/11/24, and polies provided by the hospital, were reviewed, and discussed. CRNA 5 stated that CRNAs were “independent and not medically supervised or directed” by a physician and were the “responsible provider” of medical care. CRNA 5 stated she was “in charge of the code”. CRNA 5 stated that she “started pushing epi” and ordered the nurses to give “plenty of epi(epinephrine), vasopressin, bicarb (Sodium Bicarbonate)”. CRNA 5 acknowledged on the anesthesia record and code sheet there was no ongoing data recorded reflecting-- blood pressure, respiratory rate, cardiac rhythm and rhythm, pulse. oxygen saturation, oxygen delivery, carbon dioxide-- when she was giving medication orders and directions. CRNA 5 stated cardiac monitoring and rhythm strips are not used in the operating room or during codes. CRNA 5 stated per ACLS, heart compression rates were 126 to 150 per minute, as the nurse recorded. CRNA 5 acknowledged during a code and intra-operative events, it was necessary to document patient status, vitals, medications and response to procedures and medications. CRNA acknowledged this type of information was required on the intraoperative anesthesia record. CRNA 5 stated vital signs and medications were not documented by the CRNA, “It was the nurse’s job”. CRNA 5 stated it was the nurse’s responsibility to recorded intra-operative events, “not my shortfall ...can’t do other’s jobs”. CRNA 5 indicated after her attempts to intubate on two separate occasions SUR 3 and MD 3 determined the tube was “in the esophagus”, removed the tube and reintubated Pt 1 with success. CRNA 5 stated SUR 3 and MD 3 stopped the lifesaving efforts at 8:25 p.m. During a concurrent interview and record review on 5/21/24, at 1:00 p.m. with anesthesiologist (ANS 2) accompanied by Patient Safety Officer (PSO), the records of surgical Patient 1’s (Pt 1) admission on 4/10/2023 and hospital policies were discussed. ANS 2 stated he was familiar with some of the events of Pt 1’s care. ANS 2 indicated he was called to help with Pt 1 in the OR and when he arrived, it was “chaotic”. ANS 2 stated SUR 3 was in the OR and informed the CRNA 5 the breathing “tube was in the esophagus”. ANS 2 stated CRNA 5 oversaw the case and there were 2-3 CRNA “managing the airway”, so he did not help intubate the patient. ANS 2 stated “I tried to run the code”, but other people giving medication orders, and the CRNA was in charge. ANS 2 stated he did not know what medications the patient had received. After, the CRNA had reintubated the patient. ANS 2 stated the SpO2 (oxygen levels) was not improving and there were no CO2 readings [sign of breathing, exhaling]. ANS 2 stated CRNA 5 “assured me” the ETT was in the “right place”. ANS 2 stated that he asked the CRNA to reassess the breathing tube because the patient had “no pulse and low blood pressure ...patient crumbling”. ANS 2 stated the intensive care medical doctor (MD 3) was called to help. MD 3 “discovered the ETT was in the esophagus”, removed the tube and replaced it. ANS 2 stated the patient “deteriorated”, and there was nothing more that could be done. ANS 2 stated he “assumed CRNAs are competent.” During a record review of the Pt 1’s medical record, titled “Operative/Procedure Reports”, dated 4/11/24, at 8:29 p.m., was written by the intensive care physician (doctor trained to care for critically ill patients) Medical Doctor 8 (MD 8), the record indicated MD 8 was in the operating room during the Pt 1’s code and placed a breathing tube into Pt’s 1 lungs to supply oxygen. MD 8 documented that there was a “massive aspiration with large amount of gastric [stomach] content in the lungs bilaterally ... Unfortunately, patient remained in asystole and passed away, time of death is 08:29 pm”. 2. During a review of the Patient 2’s medical record, titled “Consultation Notes” Progress Note”, written by MD 5, dated 10/26/23 at 10:56 PM, the record indicated Patient 2 had a history of dementia (problem with memory and forgetfulness; impaired ability to think or make decisions), diabetes (blood sugar disease), heart disease with CAD (Coronary Artery Disease caused by the clogged arteries), lung disease (breathing difficulties), high blood pressure and chronic pain was approved to go to surgery for hip fracture on 10/26/23 after a fall at home. During a record review of the Patient 2’s intraoperative (events during surgery) record, titled “Anesthesia Record”, dated 10/26/23, timed from 4:33 p.m. to 5:50 p.m., handwritten by CRNA 4 the record indicated that CRNA 4 provided anesthesia services during surgery without the medical orders or direction from a physician. During record review of the PACU (Post Anesthesia Care Unit, where patient transferred after surgery to recover from anesthesia) nursing documentation, titled “Communication and Notification”, dated 10/26/23, at 5:55 p.m., five minutes after CRNA 4 dropped Pt 2 into the PACU, starting at 6:00 p.m., the nursing note indicated Patient 2’s abnormal respiratory rate (RR) of 26 and SPO2 at 91% (RR, how fast one breath, Normal range was 12-16 breaths per minute; “SPO2” is oxygen level in the blood, the normal level is between 96 to 99%, (“%” or percent is a unit of measure) while on supplemental oxygen. The record further indicated while in PACU, Patient 2’s vital signs (clinical measurements, specifically heart rate, temperature, respiration rate, and blood pressure, that indicate the state of a patient’s essential body functions) needed an urgent response and medical intervention. The records indicated Patient 2’s Respiratory rate increased as high as 34, HR increased as high as 202 (heart Rate or Heartbeat, normal between 60-100 beats per minute), blood pressure dropped as low as 82/52 (or BP, the normal is 120/80) which resulted in respiratory acidosis (accumulation of acid in the blood and life threatening due to ineffective breathing), and respiratory failure (unable to breath). There is no documented evidence Patient 2’s orthopedic surgeon (SURG 8) evaluated and provided emergent medical care to Patient 2 in the PACU. After 5:55 p.m. there is no documented evidence CRNA 4 returned to the Patient 2’s bedside to address Patient 2’s emergent medical needs. During a record review of Patient 2’s medical record, titled “Physician Progress Note” and “Discharge Summery”, dated 10/27/23 at 2:47 p.m. and 10/31/23 at 10:48 a.m., respectively, written by ICU physician (MD 5), the notes indicated MD 5 cared for Patient 2 in the ICU. The notes indicated “Postop (after surgery) found to be hypotensive (low blood pressure), tachycardic (irregular heartbeat) potassium of 7.2 (normal potassium blood level is between 3.5 to 5; high level can damage the heart or cause heart attack), with respiratory acidosis (when lung unable to remove or exhale extra gases such as carbon dioxide [CO2] from lung). The Note written by MD 5 indicated “chest x-ray (picture or images of inside body taken a special machine) found volume loss on the left side suggestive of right lung intubation (when a tube placed inside the breathing airway into the left lung; breathing tube was only providing oxygen to the right lung; with normal intubation, placing of the breathing tube, must supply the right and the left lungs) during procedure, patient was transferred to ICU”. The record further indicated “Acute hypercapnic respiratory failure (when lung unable to exhale CO2 gases and end up increasing the level in the blood and causing breathing failure) after the surgery: Could be related to right lung intubation during the procedure.” The record additionally indicated during surgery, Patient 2 suffered, “Acute blood loss anemia: related to surgical intervention and IV fluids. received 2 units PRBC (Packed Red Blood Cell, or PRBC is unit of blood given; 2 bags of blood)”. The record further indicated Patient 2 “eventually got extubated (breathing tube removed)”. In a telephone interview with CRNA 4, on 5/29/24, at 1:40 p.m., CRNA 4 indicated CRNAs are independent and do not require physician orders or supervision. CRNA 4 acknowledged he provided anesthesia services to Patient 2 and was allowed to order medications and tests as needed. CRNA 4 stated he does not review his cases with anesthesiologist and was not the practice at the hospital. CRNA 4 stated he does remember Pt 2 but unable to comment on details without looking at the Pt 2’s medical record. CRNA 4 stated he remembers that he transferred Pt 2 to PACU and left the Pt 2 without any distress. 3. Review of Patient 3’s, titled “Anesthesia Record” (record of medications given and monitoring performed during the surgery when the patient was put to sleep), dated 10/13/23 was written by CRNA 3. The record indicated Pt 3 was having knee surgery. Before surgery started and after CRNA 3 started giving medications, the record indicated “CPR [cardiopulmonary resuscitation, life saving measures to restart the heartbeat]” were started around 7:30 a.m. The record indicated a wide range of medications were administered during the period of 7:06 AM to 8:45 AM on 10/13/23. The following medications marked as given: i. Sevoflurane Anesthesia gas (an inhalation gas used to put patient to sleep during surgery and can decrease blood pressure and heart rate), ii. Fentanyl 100 mcg (“mcg”, microgram, a unit of measure; opioid pain medication that can decrease or stop breathing), iii. Versed (midazolam) 2 mg (“mg” or milligram, a unit of measure; a sedative and anti-anxiety medication; slow heart rate and lower blood pressure), iv. Propofol a total of 200 mg (high risk sedative that can decrease or stop breathing), v. Anectine 100mg (succinylcholine; a muscle paralyzing agent; cause paralyses all muscle function, such as breathing), vi. Albumin 25%- 25 mL (a human blood component; “%” or percent was a measure of concentration and “mL” is milliliter, a measure of volume), vii. Ancef (or cefazolin, an antibiotic) 2 gm, viii. Norepinephrine (or Levophed, used to raise the blood pressure) no dosage indicated, ix. Epinephrine (used to treat low blood pressure and allergic reaction) entered as “100” for the dosage, x. Hydrocortisone (a steroid, anti-inflammation drug) 100 mg, xi. Epinephrine IV drip; No marked dosage or concentration, xii. IV fluid, Lactated Ringers 3 liter (“liter” is measure of volume, xiii. Benadryl (or Diphenhydramine, used for allergy) 100mg, xiv. Famotidine 20mg (ulcer medication, also used for allergy), xv. Tranexamic acid (or TXA- used to stop or prevent bleeding) 1 gm. The record further indicated surgery was never started. The record indicated that CRNA 3 provided anesthesia services in the OR without the medical orders or direction from an anesthesiologist. The document timeline after 7:15 a.m., did not document presence of carbon dioxide (gas expelled during exhalation and indicates a breathing tube in the lungs), respirations (breathing in oxygen and breathing out carbon dioxide), ventilation (machine delivery of oxygen and respirations), oxygen saturation (percent level of blood oxygen), and heart rhythm. The record did not show any documented evidence on difficulties with placing the breathing tube or supplying oxygen to Patient 3. There is no documented evidence CRNA 3 followed ACLS (Advanced Cardiac Life Support, life saving measures and medications) per hospital policy. Review of Patient 3’s medical record, titled “Code Blue Record” ( Code blue, a medical emergency that requires immediate intervention when breathing or heart stopped working in a patient), hand recorded by the OR nurse, dated 10/13/23, with time range of 7:36 a.m. to 8:15 a.m., the record indicated that at CPR started at 7:36 AM, and after two minutes, a recorded Heart Rate (HR or heartbeat) of 123 and a normal blood pressure range was recorded. The record written by OR nurse, documented from 7:38 a.m. to 815 a.m., CRNA 3 continued to give medication in rapid succession as follows: At 7:47 Am- Epinephrine drip (given as ongoing infusion) 7:53 AM- Vasopressin 3 units 7:54 AM Phenylephrine 200 mg IV 7: 56 AM - Atropine 0.4 mg IV 7:57 AM- Levophed 4mg drip 7:57 AM- Hydrocortisone 100mg IV 0800 AM- HR 131 and BP was 180/85 08:03 AM- Albumin 25%- 50 mL 8:12 AM- Sodium Bicarbonate 1 amp 8:15 AM- Pepcid 20 mg IV 8:29 AM- “Patient transferred to PACU in stable but critical condition.” The documented code blue record did not provide any evidence that CRNA 3 followed hospital’s policy and the ACLS guidelines on medications and procedures for code blue. During a review of Patient 3’s medical record, titled “Orders” (medication, tests, and treatment orders), dated 10/13/23, the record indicated CRNA 3 was described in Electronic Medical Record (EMR) as the “Ordering Physician”, “Responsible Provider”, “Supervising Provider: none listed”, and a “Doctor Cosign: Not required”. In addition, CRNA 3 wrote “Orders” for Patient 3 to receive “routine Fresh Frozen Plasma” (FFP- blood product given to patients with abnormal clotting or active bleeding and can have life-threatening reactions) for “active bleed” and “angioedema [systemic swelling under the skin]”. The record further indicated a verbal order to nursing staff in PACU to start a “routine” infusion of “Norepi (or Norepinephrine, medication to increase blood pressure)”. There was no documented evidence Patient 3 had surgery or bleeding. There was no documented evidence that CRNA 3 discussed his medications orders with anesthesiologist or another physician for giving blood products for reasons unapproved by Food and Drug Administration (FDA, a federal agency that regulate the drug use and approve indication for use of medications). During Review of Resident 3’s medical Record, two days after anesthesia record titled, “SOAP Note” (SOAP stands for Subjective, Objective, Assessment and Plan, a format to explain facts and events in the medical record), dated 10/15/23, at 9: 32 AM, written CRNA 3. The note indicated Patient 3 experienced low Blood Pressure (or BP, means the force of blood pushing against the walls of arteries with each heart beats blood pumped into the arteries) and an apparent allergic reaction after anesthesia induction (means putting patient to sleep by use of drugs to prevent from feeling pain during the procedure or surgery while monitoring the breathing) in preparation for surgery. The CRNA 3’s documented intra operative events indicated that there were difficulties with the airway and had to “pin the tongue ... and perform a digit intubation ...ventilation proved challenging ...with peak pressures exceeding 50 [resistance to giving oxygen via a breathing tube. Allowing pressures over 40 can cause lung injury] to the patient”. CRNA 3 documented that “successful return of spontaneous circulation was achieved after one round [one dose] of epinephrine and chest compressions. The CRNA’s note further indicated when Resident 3 was transferred to PACU (Post-Anesthesia Care Unit; a hospital that stabilized the patient right after the surgery) “The patient still had significant tongue swelling ... In response, I gave 1 gram of Tranexamic Acid (also known as TXA, a drug used to treat bleeding or control bleeding) and ordered FFP (Fresh Frozen Plasma; a blood product given for bleeding or at risk of bleeding) as well as relevant lab test and imaging.” The note did not describe the clinical reason for use of TXA and FFP in the setting of apparent allergic reaction and was not approved by a medical doctor or surgeon. During review of the Patient 3’s medical record, titled “Consultation Note”, dated 10/16/23, at 11:31 a.m., written by MD 7, the record indicated Patient 3 suffered a “Pneumothorax [puncture of the lung], right” as evidenced on chest x-ray. The record further indicated “Review of OR records do not show any clear cardiac arrest records etc. and raises suspicion of anaphylaxis or at least a drug reaction”. There was no documented evidence of a lung procedures to cause pneumothorax, except for intubation performed by CRNA 3 on 10/13/23. On 5/20/24 at 10:30 a.m. 5/17/24 at 8:30 a.m., 5/24/24 at 4:00 p.m. and 5/29/24 at 8:13 p.m., the hospital’s, Accreditation Manager, attempted to schedule an interview with CRNA, but she stated he has not been available. 4. During review of Patient 5’s medical record, titled “History and Physical/Admission Notes”, dated 11/15/23, written by Medical Doctor 10 (MD 10), the record indicated Patient 5 was a 91 year old with diagnosis of end-stage renal disease on dialysis (kidney was not working well and blood had to be filtered by a machine called dialysis) was admitted to hospital to be evaluated for rectal (or rectum) bleeding and anemia (low blood counts). The record further indicated the heart doctor recommended “conservative treatment” due to age and other medical conditions. During a record review of the Pt 5’s intraoperative (events during surgery) medical record, titled “Anesthesia Record”, dated 11/19/23, with anesthesia time range of 12:28 p.m. to 1:32 p.m., and surgery time 12:42 to 12:59 p.m., was handwritten by CRNA 6. The record indicated that CRNA 6 provided anesthesia services during surgery without the medical orders or direction from an anesthesiologist. The handwritten record was difficult to read and illegible to detail of dose and drug name. The record indicated during the intra-operative period CRNA 6 procured, prescribed, and administered “High Risk Medications” (drugs with highest risk of causing significant patient harm or death) that could have contributed to suppressed breathing, lowered blood pressure, change of heart rate, and paralyzed the body’s movement as follow: Propofol (high risk sedative that can decrease or stop breathing), an anesthesia gas called Sevoflurane (volatile anesthetic that provides hypnosis, amnesia during surgery and can decrease blood pressure and heart rate), and glycopyrrolate (medication to decrease secretions. It can decrease or stop heartbeat, and not used in patients that are bleeding with heart problems). Further review of the documented intra-operative events, glycopyrrolate was given. The record indicated right after glycopyrrolate administration, Pt 5’s heart rate and blood pressure were not recorded, and “CPR [cardiopulmonary resuscitation, lifesaving efforts]” was started. The record indicated a breathing tube was insert at 1:00 p.m. during CPR, the chart indicated CRNA 6 prescribed and administered multiple medications, but the names and times were illegible. During a record review of the Pt 5’s medical record, titled, “Nursing/Clinical Info”, dated 11/19/23, at 8:43 p.m., the nursing documentation indicated that Pt 5 became “hypotensive [low blood pressure] and bradycardic [slow heart rate, below 60] despite medical interventions by CRNA 6 ... The record indicated Anesthesiologists (ANS 3 and ANS 6) and another CRNA arrived to help. The OR nurse documented “Intervention medications initiated by anesthesia team at 12:59 p.m. which included 8 rounds of Epinephrine (helped raise the blood pressure), 5 rounds of bicarb (“bicarb” is same as Sodium Bicarbonate, used to help with blood acidity), 2 doses of cacl (“cacl” same as Calcium Chloride, a high dose of calcium used to reverse high potassium level in body), 4 doses of atropine (drug used to treat slow heartbeat), 1 dose of vasopressin (drug used to raise blood pressure), fluid bolus (giving IV fluid), and Epi drip( infusion of Epinephrine)”. The OR nurse documented that ANS 3, ANS 6, and MD 6 ended life saving measures “due to no pulse and no ETCO2.” There was no documented evidence of a title “Code Blue Record” form was completed per policy. There was no documented evidence indicating the amount, dose, or times of medications, nor patient response to treatment, such as blood pressure, heart rate, heart rhythm, respiration, oxygen levels, etc. There was no documented evidence CRNA 6 followed hospital policy to follow ACLS (Advanced Cardiac Life Support) guidelines, medications, and procedures. During an interview with CRNA 6 on 5/22/24, at 10:13 AM, and record review of the Pt 5’s medical records titled “Anesthesia Record”, the nursing “Surgical Documentation”, dated 11/19/23, at 8:43 p.m., and the “Nursing/Clinical Info” dated 11/19/23 were discussed with CRNA 6. CRNA 6 stated the anesthetist can diagnose, prescribe medications, order labs, order treatments, and render medical services to patients; it was all “within [CRNAs] scope of practice” and there are “no limitations” inside the hospital. CRNA 6 indicated he works “independently” without physician orders, supervision, or directions. CRNA 6 stated he was not in agreement with the nursing entries indicating Pt 5 became unstable during the case, the procedure was “attempted”, but was “unable to complete” due to Pt 5’s low blood pressure and heart rate. CRNA 6 stated he recalled Pt 5, and there were “no problems” during the case. CRNA 6 indicated, he obtained and administered propofol to Pt 5 and a few minutes later gave Glycopyrrolate. The record indicated the blood pressure and heart rate dropped. CRNA 6 stated “at the end of the case”, Pt 5 lost pulses and blood pressure. CRNA 6 indicated he ordered and administered medications to treat Pt 5’s blood pressure and loss of pule (heartbeat). CRNA 6 acknowledged Pt 5 expired in the OR. During record review of [Hospital] policy titled “Rules and Regulations of the Governing Board of [Hospital]”, June 13, 2022, indicated the “Governing Board’s duty to protect patients and all other individuals at the Hospital ... QUALITY OF PROFESSIONAL SERVICES AND PATIENT CARE EVALUATION ... ensure appropriate professional care to Hospital patients. “ Recognizing that the Medical Staff is responsible for the quality of patient care in the Hospital and must accept and assume this responsibility, subject to the ultimate authority of the Hospital Governing Board, and that the best interests of the patient are better protected by concerted effort, the Medical Staff is hereby organized in conformity with these Bylaws and Rules and Regulations. ... GOALS OF MEDICAL STAFF ... To assure quality and appropriateness of healthcare services rendered throughout...” During record review of [Hospital] policy titled “Medical Staff Bylaws”, approved Governing Board, August 24, 2022, indicated that “Medical staff membership (1) to have a current unrestricted California license to practice medicine, dentistry, or podiatry; (2) to maintain an unrestricted Drug Enforcement Administration certificate ...only members who hold a medical staff appointment or temporary privileges are eligible to render medical care at [Hospital name] The Governing Board grants appointments to the medical staff ... Every member practicing the medical profession at [Hospital name] shall exercise those clinical privileges specifically granted by the Governing Board... Hold a current, unrestricted license, certificate, or other appropriate legal credential ... the authorized individual shall write the order, followed by the name of the Practitioner, date and time, name, and signature of the writer ... All drugs and medications administered to patients shall have been approved by the Federal Drug Administration or listed in the latest edition of United States Pharmacopeia, National Formulary, American Hospital Formulary Service or A.M.A. Drug Evaluations ... Investigational or experimental drugs shall be used only under the direct supervision of a Physician Member of the Medical Staff, who is responsible for securing the necessary consents ... Practitioners are legally and professionally responsible for the ongoing monitoring and appropriate adjustment of the duration and dose of the medications ordered in the Hospital.” Review of American Heart Association guidelines for Advanced Cardiopulmonary Life Support (ACLS) and emergency cardiovascular care, last revised on 2020, the ACLS guidelines, last accessed on 6/8/24, via https://cpr.heart.org/en/resuscitation-science/cpr-and-ecc-guidelines/adult-basic-and-advanced-life-support , the section on medication management in cardiac arrest indicated “it is reasonable to administer epinephrine 1 mg every 3 to 5 min for cardiac arrest ... Vasopressin alone or vasopressin in combination with epinephrine may be considered in cardiac arrest but offers no advantage as a substitute for epinephrine in cardiac arrest ... Routine administration of calcium for treatment of cardiac arrest is not recommended ... Routine use of sodium bicarbonate is not recommended for patients in cardiac arrest.” The guideline also emphasized to treat reversible causes of cardiac arrest. Review of the facility’s policy, titled “Code Blue-Coe White Procedure”, last approved on 11/30/22, the policy indicated the code team will consist of nursing, respiratory therapist, and emergency department physician, Hospitalist (doctors that work only in hospital), attending physician (the main doctor) or physicians trained in advanced life support. The policy further indicated “the physician assumes responsibility for the code. ER physician may call unit to verify need to response.” The policy further included an attachment on how to manage the after-surgery code blue following the heart surgery. The Policy attachment indicated “DO NOT GIVE EPINEPHRINE unless a senior doctor advises this.” During record review of hospital titled, “AHP [Allied Health Professional] Rules and Regulations, version 2022” indicated that the “Supervising Practitioner Responsibilities. All AHPs currently admitted to the AHP staff, with the exception of Clinical Psychologists, are considered dependent and, accordingly, require direct supervision which shall be provided by the sponsoring Practitioner according to the Rules and Regulations of the Medical Staff and the Department, if any, to which the AHP is assigned ... Practitioners who desire to sponsor and supervise AHPs must apply and qualify for such sponsorship. Each AHP who is a Physician’s assistant must be supervised by a Physician having the following qualifications: a. Is a Physician currently licensed by the State of California; Identify a sponsoring and supervising Medical Staff Member, in good standing on the Active staff, who has Privileges in the appropriate Department, and who has agreed to assume ongoing responsibility for sponsorship and direct supervision of the AHP at all times. When the sponsoring and supervising Practitioner is not available, an alternate supervising Medical Staff Member meeting all the requirements of the sponsoring Member must be predesignated and must provide direct supervision at all times in place of the absent Practitioner. ... Restriction of the Privileges of the sponsoring and supervising Practitioner, in which case the Practice Prerogatives of the AHP shall be restricted accordingly.” During record review of [Hospital] policy titled, “PC.AD.1.08 Documentation Policy”, approved 9/28/2022, stated that “handwritten entries, by all personnel, will be legibly written with indelible, black, or blue ink and signed by the staff member delivering care ... The patient medical record reflects the complete picture of the patient’s health status, treatment, and progress from admission to discharge ... The medical record will reflect the identity of the patient, the primary and consulting physicians, and all members of the health team that have participated in care delivery ... All Clinical Staff Members are responsible for documentation of clinical care given and ensuring that the standard of that documentation meets all legal and professional requirements. Documentation shall be completed timely”. During record review of [Hospital] policy titled, “PHARM.1.04 Controlled Substances Policy Schedule II - V, approved: 6/23/2021, indicated that “Issuing, Dispensing and Distributing Controlled Substances ...Only licensed personnel per state law and regulation may have access to controlled substances ... Strict accountability shall be maintained and recorded for all controlled substances ...””

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 40644 Based on observation, interview, and record review, the hospital failed to comply with the regulatory requirements for EMTALA for two of 21 patients, Patient (Pt) 1 and Pt 2 when: 1. Pt 1 was transported to Hospital A Emergency Department (ED) on 1/22/24 at 1:31 p.m. by ambulance with a chief complaint of seizures (sudden, uncontrolled body movements and changes in behavior that occur because of abnormal electrical activity in the brain). There was no documented evidence Pt 1 was triaged (the sorting of patients according to the urgency of their need for care) or physically assessed and per the paramedic (PMC), Pt 1 continued to have seizures while in the ED. The PMC informed Registered Nurse (RN) 1 about Pt 1’s change in condition and was told by RN 1 to treat his patient. By this time Pt 1 had been in the ED for close to an hour with no interventions to prevent further seizures and the PMC made the decision to transport Pt 1 to Hospital B. (Refer to A2406, Finding 1) 2. Pt 2 came into the ED at Hospital A on 12/27/23 at 6:19 p.m. with abdominal cramping, stating she was pregnant. Pt 2 was triaged by an RN, then sent to wait in the waiting room. She did not receive an MSE and left the hospital without being seen to determine if she had an EMC. (Refer to A2406, Finding 2) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 40644 Based on observation, interview, and record review, Hospital A failed to provide an appropriate medical screening examination (MSE- an assessment performed by Qualified Medical Personnel [QMP] for the purpose of determining whether an emergency medical condition [EMC] exists) within the capability of the hospital’s emergency department (ED) for two of 21 patients (Patient (Pt) 1 and Pt 2) when: 1. Pt 1 was transported to Hospital A Emergency Department (ED) on 1/22/24 at 1:31 p.m. by ambulance with a chief complaint of seizures (sudden, uncontrolled body movements and changes in behavior that occur because of abnormal electrical activity in the brain). There was no documented evidence Pt 1 was triaged (the sorting of patients according to the urgency of their need for care) or physically assessed and per the paramedic (PMC), Pt 1 continued to have seizures while in the ED. The PMC informed Registered Nurse (RN) 1 about Pt 1’s change in condition and was told by RN 1 to treat his patient (Pt 1). By this time Pt 1 had been in the ED for close to an hour with no interventions to prevent further seizures and the PMC made the decision to transport Pt 1 to Hospital B. This failure resulted in Pt 1 not having the hospital address a recognized emergency condition (seizures), a delay in providing an appropriate MSE and providing stabilizing measures and prompted a decision to be transported to Hospital B where Pt 1 was admitted as an inpatient for three days. 2. Pt 2 came into the ED at Hospital A on 12/27/23 at 6:19 p.m. with abdominal pain, stating she was pregnant. Pt 2 was triaged by an RN, then sent to wait in the waiting room. She did not receive an MSE and left the hospital without being seen by a medical provider. This failure resulted in not providing Pt 2 the benefit of being examined by a qualified medical professional in order to determine if an EMC existed and could possibly lead to harm to Pt 2 and Pt 2’s unborn baby. Findings: 1. During a review of Pt 1’s “[name of ambulance service] Record”, dated 1/22/24, the Record indicated a call was received at 12:48 p.m. and at 1:05 p.m., the emergency medical services (EMS) crew made contact with Pt 1. The Record indicated, “ ...arrived on scene, [patient] found postictal [a period that begins when a seizure subsides and ends when the patient returns to baseline] in his bed. Per wife, [patient] had about 9 seizures before we arrived on scene that lasted about 15 seconds each, which started 2 hours ago. [Patient] has a history of seizures and was unable to take his seizure medications because he was vomiting last night ...” The Record indicated, at 1:19 p.m., Pt 1’s pulse (the number of times the heart beats in a minute) was 80, blood pressure (BP-the pressure the heart exerts to push blood out of the heart and into the body) was 233/140 (normal BP is less than 120/80), 100% oxygen saturation (a measurement of how much oxygen blood is carrying as a percentage of the maximum it could carry), respirations (the number of breaths a person takes per minute) were 20, Glasgow Coma Scale (GCS-assesses patients according to responsiveness of eye-opening, motor, and verbal responses) of 13 (normal is 15), and blood sugar was 81. The Record indicated, a peripheral intravenous line (IV-a tube inserted into the vein to administer fluids or medications) was initiated with three failed attempts due to “poor veins”. During a tour of the ED on 3/6/24 at 11:51 a.m. with the ED Director (DED) and Quality Review Nurse (QRN) 1, the DED stated, “Until actual handoff to a medical provider, the paramedics are responsible for the patient.” During a concurrent interview and record review on 3/7/24 at 11:15 a.m. with the DED, Pt 1’s “Electronic Medical Record (EMR-an electronic collection of medical information about a person),” dated 1/22/24 was reviewed. The EMR indicated Pt 1 was a 39-year-old male brought in by ambulance at 1:31 p.m. to Hospital A. The DED stated Pt 1 was not triaged and did not have vital signs assessed while in the ED. The DED stated Pt 1 was assigned to the hallway, waiting for a room. During a concurrent interview and record review on 3/7/24 at 11:20 a.m. with the DED, Pt 1’s “Nursing Note (NN),” dated 1/22/24 was reviewed. The DED stated at 2:30 p.m., the NN indicated, “Paramedic was with [patient] on the wall waiting for a bed to become available. Shortly after his arrival paramedic informed me [patient] was having another seizure. I informed him I had no nursing staff to care for [patient] at this time and asked him to [continue] to care for his [patient] and treat the [patient] per his protocol and asked him to start an IV on the [patient]. [RN 5] spoke with medic and informed him we were moving [patients] around to get [patient] bedded. When I went to find medic in the hallway to tell him what room to go to, he had left the building with the [patient].” The DED stated the paramedic should have communicated to the Charge Nurse he was taking Pt 1 to another hospital. During a concurrent interview and record review on 3/7/24 at 11:35 a.m. with the DED, Pt 1’s EMR, dated 1/22/24 was reviewed. The DED stated, “In this case, there was no formal process for triaging Pt 1 on the wall (indicating patient and paramedic were waiting in the hallway for room placement) and the ED healthcare staff lacked documentation of triage.” The DED stated the ED’s process for when a patient came through by ambulance, the patient was not triaged until the patient was roomed and hand off was given between the medic and RN. The DED stated once hand off was completed, the RN triaged the patient. During a concurrent interview and record review on 3/7/24 at 11:45 a.m. with the DED, Pt 1’s “ED Discharge Form (Form),” dated 1/22/24 was reviewed. The DED stated the Form indicated at 3:36 p.m., Pt 1 was discharged from [name of Hospital A], with no actual or suspected pain, ED disposition was left without being seen, mode of transportation was ambulance, ED Condition was unknown, and Discharge comments were “See Ad Hoc Note”. During an interview on 3/8/24 at 4:30 p.m. with the PMC, the PMC stated on 1/22/24 he and his partner were called to Pt 1’s home due to Pt 1 having seizures. The PMC stated Pt 1 had a seizure while they were about to buckle Pt 1 onto the gurney and another seizure enroute to Hospital A. The PMC stated while enroute to Hospital A, he called the med net radio (system in place to inform the ED, EMS was enroute and the condition of the patient, so as to give ED healthcare staff prior knowledge and preparation for the patient’s arrival) to inform the healthcare staff, he was transporting Pt 1 to the ED, but no one answered the radio. The PMC stated once he arrived at Hospital A, he informed RN 1 about Pt 1’s seizures and RN 1 told him to hold the wall (wait for a room in the hallway) with a few other EMS crews who were there with their patients. The PMC stated while they were holding the wall, Pt 1 had another seizure and he informed RN 1 of Pt 1’s change in condition. The PMC stated RN 1 told him, “I don’t have the staff to help, treat your patient.” The PMC stated he walked back to Pt 1 and Pt 1 had another seizure which lasted 30 seconds, then 15 minutes later another seizure, followed by another seizure where Pt 1 did not come out of the postictal phase. The PMC stated other nurses in the ED witnessed Pt 1 have seizures while they were in the ED, and nothing was done. The PMC stated after Pt 1 had his last seizure, the PMC took Pt 1 back to the ambulance and administered midazolam (a drug used to treat anxiety and to relax muscles) intramuscular (IM-injected into the muscle). The PMC stated after being in the ED for close to an hour with no medical interventions provided to Pt 1, for the safety of Pt 1 he made the decision to take Pt 1 to Hospital B. During an interview on 3/11/24 at 10:46 a.m. with RN 1, RN 1 stated when Pt 1 came into the ED by ambulance, there were no rooms available, so she told the PMC and Pt 1 to hold the wall along with three to four other EMS crews. RN 1 stated based on Pt 1’s acuity, she would have roomed Pt 1 first. RN 1 stated an actively seizing patient was considered an emergency and required an IV, medication, oxygen, and protection of the patient’s airway. RN 1 stated Pt 1 was in the postictal phase on arrival to the ED and did not require immediate medical attention. RN 1 stated when a patient came to the ED, they treated what they saw, and the physician entered the orders. RN 1 stated the importance of the physician assessing the patient was to assess the patient’s signs and symptoms and place orders. RN 1 stated the medic should have the patient attached to monitoring equipment while in the ED so she could see Pt 1’s vitals when checking on patients while they are holding the wall. During a concurrent interview and record review on 3/11/24 at 11 a.m. with RN 1, Pt 1’s “NN,” dated 1/22/24 was reviewed. The NN indicated, “Paramedic was with [patient] on the wall waiting for a bed to become available. Shortly after his arrival paramedic informed me [patient] was having another seizure. I informed him I had no nursing staff to care for [patient] at this time and asked him to [continue] to care for his [patient] and treat the [patient] per his protocol and asked him to start an IV on the [patient] ...When I went to find medic in the hallway to tell him what room to go to he had left the building with the [patient].” The NN indicated there was no indication a physician was informed about Pt 1’s condition. RN 1 stated she did not see Pt 1 have a seizure in the ED. RN 1 stated the medic did not inform her they were leaving the ED. During a concurrent interview and record review on 3/11/24 at 11:15 a.m. with RN 1, Pt 1’s “EMR,” dated 1/22/24 was reviewed. RN 1 stated the EMR indicated Pt 1 was registered at 1:31 p.m. and at 2:30 p.m. she made her note but “it was probably a good 15 minutes after medic and Pt 1 had left the ED, so they were in the ED for about 45 minutes prior to leaving the ED.” During an interview on 3/11/24 at 11:28 a.m. with RN 5, RN 5 stated she remembered Pt 1 and this particular day in the ED she was called to help a nurse stabilize a patient. RN 5 stated there were EMS crews waiting and she was working with RN 1 to move patients around so Pt 1 could be roomed. RN 5 stated she informed Pt 1 and the medic they were moving patients in the ED to provide a room for Pt 1. RN 5 stated when she gave the medic an update on getting Pt 1 a room, Pt 1 did not have seizure activity and he looked fine. RN 5 stated Pt 1 required a room and if he was actively seizing, she would have put him in a room but there were no rooms available. RN 5 stated a seizing patient required oxygen and suction as well as any medications the physician ordered for the seizures. RN 5 stated the importance of getting the patient assessed by a physician was to obtain orders for treatment of the patient and if she witnessed the patient actively seizing, she would have gotten an order from a physician to treat the patient. During a telephone interview on 3/11/24 at 1:50 p.m. with RN 2, RN 2 stated she remembered on 1/22/24, the ED was busy, and several EMS crews were holding the wall. RN 2 stated she received a phone call from the EMS liaison from Hospital B informing her, Pt 1 was enroute to Hospital B due to Hospital A’s inability to care for Pt 1. RN 2 stated she spoke to RN 1 to find out what was going on and they both went to look for Pt 1, but Pt 1 was no longer there. During an interview on 3/11/24 at 2:21 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectations for patients who came to the ED were greeted by healthcare staff, registered immediately, obtained the patients chief complaint and vitals, and triaged as quickly as possible. The CNO stated the MSE should be initiated within 20 minutes and if the patient required a bed, the patient was immediately roomed if they had an open room. The CNO stated vital signs should be taken with ESI assignment during triage. The CNO stated her expectations of care for a seizing patient were to room the pt, maintain the patient’s airway and a physician should have assessed Pt 1 and initiated the MSE immediately to obtain medication orders and administer medications. The CNO stated for Pt 1, once Pt 1 was in the ED, Pt 1 was the hospital’s responsibility and they needed to collaborate with the EMS crew. During an interview on 3/11/24 at 2:37 p.m. with the ED Medical Director (EMD), the EMD stated once a patient was within 250 yards of the ED, the patient was their patient. The EMD stated they made it a goal to see patients right away, especially patients who arrived by ambulance because they were generally more acute (signs and symptoms that begin and worsen quickly). The EMD stated the ED physicians took turns initiating MSEs on patients and often times he did not wait for the patient to be roomed, often he would see the patients on the gurney and placed orders. The EMD stated the patients who were holding the wall should be treated like any other patient who walked into the ED to request medical care. The EMD stated it was his preference to obtain the patient’s medical history and chief complaint from the medic and if the patient had a medical emergency, the Charge Nurse (CN) should inform one of the physicians to assess the patient right away, even if the patient was still on the gurney. During a review of Pt 1’s “EMR” from Hospital B, dated 1/22/24, the EMR from Hospital B indicated Pt 1 was brought in by ambulance (BIBA) with EMS personnel and triaged at 2:39 p.m. with an acuity of 1. The EMR from Hospital B indicated Pt 1’s chief complaint was seizure, “BIBA from home then [Hospital A] for seizures; per medic family stated [patient] has been vomiting and unable to take seizure meds.” The EMR indicated Pt 1’s prehospital blood sugar was 87, EMS medication given was midazolam 5 milligrams (mg-unit of measure), pulse 71, blood pressure 239/170, and oxygen saturation was 97% on 2 liters (L-the flow of oxygen) via nasal cannula (NC-a thin, flexible tube with two prongs that go inside your nostrils to deliver oxygen). Pt 1 was admitted to Hospital B where he stayed for 3 days. During a review of the hospital’s policy and procedure (P&P) titled, “MOD COMP-RCC 5.16 EMTALA POLICY,” dated 9/28/22, the P&P indicated, “ ...The purpose of this policy is to set forth policies and procedures for Hospital’s use in complying with the requirements of the Emergency Medical Treatment and Labor Act (EMTALA) ...If an individual comes to the Emergency Department ...The Hospital will provide as appropriate medical screening examination within the capability of the Hospital’s Dedicated Emergency Department, including ancillary services routinely available, to determine whether or not an emergency medical condition exists ...The Hospital will ...provide to an individual who is determined to have an emergency medical condition such further medical examination and treatment as is required to stabilize the emergency medical condition ...Triage ...As soon as practical after arrival, individuals who come to the Emergency Department should be triaged in order to determine the order in which they will receive a medical screening examination ...Triage is not a medical screening examination, as it does not determine the presence or absence of an emergency medical condition, but rather ...order in which individuals will receive a medical screening examination ...The Hospitals’ Chief Nursing Officer and Chief Medical Officer are responsible for assuring that this policy is implemented and followed, and that instances of noncompliance with this policy are reported immediately to the Compliance Officer ...All Hospital staff and Medical staff whose responsibilities are affected by this policy are expected to be familiar with the basic procedures and responsibilities created by this policy. Failure to comply with this policy will be subject to appropriate performance management pursuant to all applicable policies and procedures ...” During a review of the hospital’s P&P titled, “ED.1.06 Triage Nurse Policy,” dated 9/28/22, the P&P indicated, “ ...To outline the responsibilities and function of the Triage Nurse in the Emergency Department ...The triage nurse is utilized in most high-volume emergency departments to provide safety for ambulatory patients presenting unaccompanied, requesting care. Upon arrival an initial assessment is performed to determine the need for immediate treatment, or close observation based upon presenting clinical assessment by the primary triage nurse ...Greet all patients entering the ambulatory entrance of the Emergency Department and obtain brief initial assessment ...Chief complaint ...Brief history of problem ...Make a determination based on initial assessment as to the need for immediate intervention ...All patient conditions will be classified and prioritized as follows ...ESI Level 1: the patient requires immediate medical care ...ESI Level 2: the patient is assessed as high risk ...ESI Level 3: the patient is assessed as stable. The patient’s vital signs are within the accepted normal parameters for age and not within the danger zone ...ESI 4: the patient is assessed as stable. These patients are predicted to use one (1) resource to reach disposition ...ESI Level 5: the patient is assessed as stable. The patient is predicted to use no resources ...If determined that the patient is in need of immediate interventions or observation, transport the patient immediately to a designated treatment area ...Notify the charge nurse ...If determined that the patient does not need immediate interventions or observation, complete an initial nursing history, allergies, vital signs, and initiate appropriate order per protocol ... The patient’s triage category may be updated based on this reassessment ...Documentation of the triage classification, assessment, and all interventions performed are entered into the Emergency Department electronic documentation system ...” During a professional reference review from the Morbidity and Mortality Weekly Report an article titled, “Seizure- or Epilepsy-Related Emergency Department Visits Before and During the Covid-19 Pandemic-United States, 2019-2021,” dated 5/27/22, the article indicated, “ ...Seizures generally account for approximately 1% of all emergency department visits. Persons of any age can experience seizures, and outcomes might range from no complications for those with a single seizure to increased risk for injury, comorbidity [when a person has more than one disease or condition at the same time], impaired quality of life, and early mortality [death] for those with epilepsy [seizure disorder] ...” During a professional reference review from the National Library of Medicine, the article titled, “Seizure,” dated Jan 2024, the article indicated, “ ...For the patient with generalized convulsive status epilepticus [a seizure that lasts longer than five minutes or having more than one seizure within a five-minute period], immediate treatment of the seizures should begin while stabilization and other diagnostic procedures commence. Supportive care with attention to airway, breathing, and circulation issues are vital. Benzodiazepines [drug used to relax muscles and prevent seizures] ... are acceptable as the first-line medications for continuing seizures ...Respiratory depression [when breathing too slowly, preventing proper gas exchange in the lungs] is a common side effect, and patients will need careful monitoring ...” During a professional reference review from the Institute of Medicine Committee on the Public Health Dimensions of the Epilepsies, the article titled, “Epilepsy Across the Spectrum: Promoting Health and Understanding,” dated 2012, the article indicated, “ ...In seeking treatment for epilepsy and its comorbidities, patients and families interact with primary care, emergency, and specialist physicians, as well as a range of other health professionals ...Teams should comprise professionals assembled and prepared to meet the diverse needs of individual patients ...Negative perceptions of people with epilepsy among health professionals contribute to stigma and can affect quality of care ...” 2. During a concurrent interview and record review on 3/8/24 at 9:08 a.m. with the Director of Women and Children’s Services (DWC), Pt 2’s “EMR,” dated 12/27/23 was reviewed. The document titled “ED Triage Form” dated 12/27/23 at 6:19 p.m. by RN 1 indicated Pt 2 was a 27-year-old woman who came to the ED complaining of abdominal cramping for the last 3 days. Pt 2 described her pain level as 8 out of 10, with 1 being the least pain and 10 being the most pain. The document titled, “Depart Summary (verified) indicated Pt 2’s “ED Discharge Time: 12/27/23 [9:34 p.m.]. The DWC stated she was unable to find any documentation to indicate a physician treated the patient during her ED stay or that any care was provided. During a concurrent interview and record review on 3/8/24 at 9:35 a.m. with RN 5, Pt 2’s “EMR,” dated 12/27/23 was reviewed. RN 5 opened the EMR for Pt 2 and attempted to find evidence that Pt 2 had a MSE within the capability of the hospital’s ED by a QMP. RN 5 stated she was unable to locate any note in the EMR to indicate Pt 2 was medically screened. During a concurrent interview and record review on 3/11/24 at 11:08 a.m. with RN 4, Pt 2’s “EMR,” dated 12/27/23 and the hospital’s “Emergency Department - Daily Staffing Schedule (Staffing Schedule),” dated 2/27/24 were reviewed. RN 4 stated the EMR indicated she did the triage for Pt 2. RN 4 reviewed the Staffing Schedule and stated there were 17 nurses working at the time Pt 2 came to the ED, not including trauma nurse. RN 4 reviewed the “ED launch point” document and stated the document indicated the attempts to call (by calling the patient’s name in the waiting room) Pt 2 to be seen by the physician. The document indicated Pt 2 checked in to the ED at 6:12 p.m. with abdominal cramping, abdominal pain - Pregnancy, and was sent to the waiting room wait to be seen by a physician. The document indicated attempts to call Pt 2 to be seen at 7:13 p.m., 8:59 p.m., and 9:24 p.m. and indicated, “NA” (no answer when called.) The Discharge Disposition indicated Pt 2 went “Home/self-care” and her length of stay in the ED was recorded as 3 hours and 22 minutes. RN 4 stated the expectation was a patient should be seen by a provider within 30 minutes of arrival. RN 4 stated her concern for this patient was that she, “would wonder if she was miscarrying.” During an interview on 3/11/24 at 2:07 p.m. with the CNO, the CNO stated her expectation of the triage nurse was to “greet, register, get the chief complaint, get vitals, and get MSE done within 20 minutes.” She stated they “have a lot of work to do in the triage area.” During an interview on 3/11/24 at 2:36 p.m. with the EMD, the EMD stated “ ...The patients are all our (the hospital) responsibility even before they come through the door. It’s important to do the MSE right away ...” During a phone interview on 3/11/24 at 11:30 a.m. with Pt 2, Pt 2 stated she was not examined by anyone while in the ED. She left the waiting room after “a long time.” Pt 2 stated she was having abdominal cramping and she was 6 weeks pregnant at that time. Pt 2 stated she had experienced “a little bleeding” but decided it would be better to go to her own doctor the next day, because it was taking so long to see the doctor in the ED. During a review of the hospital’s P&P titled, “ED.1.03 Medical Screening Examination,” dated 9/28/22, the P&P indicated, “ ...III. PROCEDURE ...B. 3. The scope of the examination is tailored to the patient’s presenting symptoms and the medical history of the patient. The MSE is an ongoing monitoring process, which continues until a medical emergency condition is found not to exist or until appropriate steps to stabilize the presenting emergency medical condition begin ...” During a professional reference review from the Emergency Nurses Association titled, “A Triage Tool For Emergency Care,” dated 2020, the document indicated, “ ...Females with abdominal pain or vaginal bleeding should be carefully assessed and vital signs obtained if there is no obvious life threat. Pregnancy history and last menstrual period should always be ascertained from all females of childbearing age ... in early pregnancy, the triage nurse should assess for signs and symptoms of ectopic pregnancy and spontaneous abortion ...””