Lac/Harbor-UCLA Med Center

“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: 40483 Based on interview and record review, the hospital failed to ensure the nursing staff implemented the hospital’s procedure related to IV Catheter Insertion for one of three patients (Patient 1) when the nursing staff did not discontinue and re-site Patient 1’s IV 7 days. This failure had the potential for increased pain and an increased risk of infection for Patient 1. Findings: During a review of the hospital’s procedure titled, “IV catheter insertion” revised 9/15/25, the procedure showed ... in adults, peripheral IV’s /Peripheral IV locks are to be removed and re-sited every 7 days and immediately upon suspected contamination or complication. If on the 7th day, the patient refuses IV re-siting, or if sites for venous access are limited and no evidence of phlebitis or infection is present, peripheral vinous catheters can be left in place for longer periods, although the patient and the insertion sites should be closely monitored ....The reason for non re-siting shall be documented with every assessment. Due diligence must be practiced assessing the IV site for any signs of compromise. During a review of Patient 1’s medical record on 6/5/26 at 1124 hours, Patient 1’s medical record showed the patient was admitted to the hospital on 3/19/26. During a review of the H&P examination dated 3/19/26 at 0858 hours, the H&P showed Patient 1 started on latency IV antibiotics During a review of the Peripheral IV flowsheet, the flowsheet showed on 3/19/26, a 20-gauge peripheral IV was inserted in Patient 1’s right wrist at 0730 hours. The 20-gauge right wrist peripheral IV was documented as flushes easily, dressing clean dry and intact, well tolerated by patients. During a review of the new IV insertion flowsheet dated 4/1/26, it showed an 18-gauge peripheral IV was inserted in Patient 1’s left antecubital at 1100 hours. The peripheral IV was documented as new insertion site dressing dated, flushes easily with Normal Saline (mixture of salt and water), dressing clean dry and intact, well tolerated by the patient. During a concurrent interview and review of Patient 1’s medical record on 6/5/26 at 1124 hours, it was conducted with the Associate Nursing Director of Risk Management. The Associate Nursing Director of Risk Management reviewed and verified the hospital procedure titled IV Catheter Insertion, revised 9/15/25, pertained to Patient 1’s care. The Associate Nursing Director of Risk Management reviewed the initial IV insertion flowsheet dated 3/19/26, which showed a 20-gauge peripheral IV was placed in Patient 1’s right wrist at 0730 hours. The Associate Nursing Director of Risk Management stated based on the procedure, the IV removal date would be completed by 3/26/26, 7 days after insertion. The Associate Nursing Director of Risk Management reviewed the 20-gauge peripheral IV right wrist flowsheet, showed this 20-gauge peripheral IV was discontinued on 4/1/26 at 1100 hours, 6 days later. The Associate Nursing Director of Risk Management reviewed and verified a new IV insertion flowsheet dated 4/1/26, showed an 18-gauge peripheral IV was placed in Patient 1’s left antecubital at 1100 hours. The Associate Nursing Director of Risk Management stated the expectation was for the nursing staff to follow the hospital procedure for peripheral IV insertion. The Associate Nursing Director of Risk Management stated the purpose of re-siting the patient’s peripheral IV catheter every 7 days was to help reduce pain and reduce the patient’s risk of infection. The Associate Nursing Director of Risk Management stated changing the peripheral IV catheter every 7 days is evidenced based practice. The Associate Nursing Director of Risk Management stated it was a form of infection control, as our skin can have bacteria which could enter the IV site. The Associate Nursing Director of Risk Management stated reducing the possibility of infection was a form of safe care. The Associate Nursing Director of Risk Management verified there was no documented evidence that Patient 1 refused re-siting on day 7, no documentation with any notes, to keep same IV, and no documentation with every assessment of the peripheral IV catheter to show there was a rationale to keep the peripheral IV catheter in use and not replace it by the 7th day, 3/26/26 after 0730 hours. The initial peripheral IV catheter was on the right wrist of Patient 1 for a total of 13 days. During an interview on 6/9/26 at 1530 hours, the Director of Regulatory Affairs was made aware of the above findings.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 37663 Based on observation, interview, and record review the hospital failed to implement its P&P for Infection Prevention and Control as evidenced by: 1. Room A had a patient on contact precaution isolation for MDRO that did not have a signage to indicate the patient was on contact isolation precaution. 2. RN 3 was observed in Room B, a contact isolation room, standing at the patient’s bedside without wearing PPE for a VRE contact precaution. 3. RN 6 was observed going into Room C with signage on the door for contact precaution, not wearing PPE with a patient that had a tracheostomy on a ventilator and was on contact isolation for MRSA. 4. Patient 2 in room D 1 (a chemotherapy recipient) and Patient 3 in room D2 (on P.D.) were placed in one room, Room D with Patient 4 in room D3 who was positive for MRSA. Room D was a big room with 4 smaller rooms subdivided by curtains. 5. The nursing leaders and the staff failed to effectively communicate with the IPC practitioner for consultation of room placement of immunocompromised and contact isolation patients as necessary for infection control and HAI prevention. These failures increased the risk of spreading infectious microorganisms and potentially increased the risk of the immunocompromised and high-risk patients to acquire HAI infections. Findings: During a review of the hospital’s P&P titled “Management of Patients with MDRO and Clostridioides Difficile,” reviewed date 09/25, the P&P showed: All MDRO and C. Difficile- infected or colonized patients are to be placed in Contact Precautions. For patient with colonization or infection with Carbapenem-Resistant Enterobacterales (CRE), highly resistant pseudomonas aeruginosa, or Candida aureus- (CRE and C- auris) are MDROs that present unusually severe threat to patient safety given the limited capacity to treat these infections with antimicrobials. Any patients with infection or colonization with these pathogens must be placed in a private room promptly under Contact Precautions to minimize transmission to others. Cohorting of patients with CRE or C-Auris requires the consultation and approval of Infection Prevention and Control (IPC). All other patients with MRSA found on any culture for any other reason must be placed into Contact Precautions. * Infection Prevention and Control Strategies: - Hand Hygiene: is required with either soap and water or an alcohol base hand rub. - PPE: appropriate PPE is located near the patient rooms and stocked accordingly. Use appropriate PPE for contact with patients, equipment, and patient’s environment. Wear gloves (clean non-sterile gloves are adequate) and gown (clean non-sterile gown is adequate) if you enter the patient’s room. If it is a multi-bed patient room, it is acceptable to don gloves and gown just prior to entering the patient’s zone instead of the door. The patient’s zone is defined as 1) area within 3 feet of the patient 2) anything touching the patient regardless of distance to the patient such as but not limited to: IV lines/ pumps/ poles, endotracheal tubes/ ventilator to which it is attached, bedrails/bedside tables (even though does not technically touch the patient), bed sheets, wound vac, SCD, warmers, telemetry cables, or display monitors/ touch screens. Gloves are used when direct contact with the body fluids is anticipated and when touching a contaminated environment. A hand hygiene is to be performed before donning gloves and after gloves are removed. Gowns and gloves are required for any activity in the patient’s immediate environment. Never touch anything in the room with soiled hand or gloves. A surgical mask or N95 respirator should be worn by staff caring for the patients who have tracheostomy or a cough. The mask should continue to be worn until the patient is asymptomatic, or until tracheostomy is no longer necessary. Avoid self-contamination during or after removal of PPE. * Patient Placement: Every effort should be made to place the patient in a private room, as this is preferred for patients requiring Contact Precautions. When a private room is not available, the patient in a room with patient(s) who has infection or colonization with the same microorganisms, but with no other infection (cohorting). Signage for contact precaution will be placed on the wall above the head of the bed and at the door of each patient for patients in transmission-based precaution. * Duration of Precaution: All infected patients with MRSA, VRE, CRE, and C auris are considered positive for the lifetime of the patient. * If there are questions regarding a specific MDRO or patient placement, IPC should be consulted. Multi-Drug-Resistant Pathogen Cohorting Guide for Inpatients: - ESBL, MRSA, VRE: private room preferred, cohort with the same pathogen only. Can be in the same room as patients who do not need isolation. These patients, however, should not be moderately - severely immuno-compromised. - Immunocompromised patients include but not limited to: ... Those with malignancy, on cytotoxic chemotherapy, or immunotherapy within the last 4 months. Those with ESRD, or have undergone hemodialysis in the past 30 days. Review of the hospital’s P&P titled Infection Prevention and Control Plan or Scope of Service reviewed date 1/2026, showed the following: * The IPC Department maintains a system for the education, surveillance, prevention and control of infections among patients, employees and visitors, and addresses epidemiologically important issues as they relate to the organization and the community served. * The IPC Department strives to protect patients, visitors, and work force members from acquiring, transmitting infectious diseases in the hospital. All patient care and ancillary services are included in this program. Departments are responsible to develop policies and procedures relevant to the service they provide. * Communication: Clinical Medical Service under the leadership of the CMO, Nursing Services under the leadership of CNO and all ancillary care support personnel under the direction of the CEO, have a joint responsibility and obligation to protect the health of the patients, visitors and the health care workers. Each workforce member is individually responsible to know and adhere to the facility’s Infection Prevention and Control Plan, P&P aimed at improving patient safety and reducing risk for control of infections. During an observation on 3/16/25 at 0920 hours, at unit 6 with the Associate Nursing Director Clinical Risk, Assistant Nursing Director, Nurse Manager 3, Clinical Nursing Director 1 and RN 2. RN 2 was asked for the patients identified and placed on respiratory and contact isolation. RN 2 stated Rooms A, 7B, B, C, and 16 were on contact isolation and room 14 B was on airborne isolation. 1. During an observation on 3/16/26 at 0920 hours, Room 1 had 4 beds separated by curtains and occupied by 4 patients. A yellow sign for contact precaution isolation was observed hanging by the door. During an interview on 3/16/26 at 0945 hours, with RN 3, RN 3 stated they were the nurse for the patient in Room A. RN 3 identified the location of Room A and stated the patient was on contact isolation. RN 3 stated the patient had MDRO infection on the middle finger requiring packing and dressing of the wound. The Assistant Nursing Director was asked how the room would be identified as the designated contact isolation room out of the 4 small rooms. The Assistant Nursing Director stated there should be a sign on the whiteboard on the wall above the bed. However, there was no sign on the wall above the bed indicating contact precaution isolation for A. 2. During the observation on 3/16/26 at 0945 hours, 6W unit, Room B6, there was a signage of contact isolation precaution hanging by the door. Room B was a big room with 4 beds subdivided by curtains and was occupied by 4 patients. According to RN 2, the patient in Room B was tested positive for VRE in the urine. The Assistant Nursing Director stated the Room B was the room on the left side near the door designated for the patient on contact isolation. RN 4 was observed not wearing PPE standing at the bedside with the patient in the bed. The Assistant Nursing Director stated RN 4 should be wearing PPE when performing patient care with contact isolation patients. 3. During the observation on 3/16/26 at 0945 hours, at 6 W unit with RN 2. RN 2 stated the patient in Room C was on contact isolation for MRSA in the sputum. Room C was observed to have a yellow signage by the door indicating contact precaution. In the room the patient was observed holding a bedpan near the face, had a tracheostomy and was connected to a breathing machine. RN 6 was observed going inside the patient’s room not wearing any PPE. The Assistant Nursing Director called RN 6 and stopped the RN from entering the patient’s room on contact isolation. The Assistant Nursing Director verified the RN was going inside the contact isolation room not wearing PPE. 4. During the interview on 3/16/26 at 1515 hours, with the Associate Nursing Director Clinical Risk, Clinical Nursing Director 1, Associate Nursing Director IPC, and the Director of Regulatory Affairs, the Director of Regulatory Affairs stated Patient 2 received chemotherapy when admitted to the hospital, Patient 3 had peritoneal dialysis when the patient was admitted to the hospital, and Patient 4 was tested positive for MRSA when the patient was at the hospital. During a concurrent interview and record review of Patient 2, 3 and 4 on 3/16/25 at 1515 hours, with the Clinical Nursing Director 1. The medical records showed Patient 2 was admitted to Room D1 on 12/19/25 and was discharged on 1/22/26. Patient 3 was admitted to Room D2 on 1/17/26 and was discharged on 1/19/26. Patient 4 was admitted to Room D3 on 12/19/25 and was discharged on 1/19/26. Clinical Nursing Director 1 stated the reason the patients were placed at 6W instead of 5W specialty unit for chemotherapy, PD and transplant patients was that the 5E specialty unit for chemotherapy, PD, and transplant patients were temporarily closed on 12/23/25 after 2300 hours due to staffing. Because of the closure, the patients and the RNs were distributed between the 4W and 6W units. Clinical Nursing Director 1 stated 5E unit was reopened on 2/4/2026. The IPC Associate Nursing Director stated Patient 4 could not be cohorted in the same room (1 big room) with Patient 2 and Patient 3 who were immunocompromised patients. Patient 4 had MRSA in the blood and wound of the left lower extremity. 5. During an interview on 3/16/26 at 0930 hours, with the Clinical Nursing Director 1, Associate Nursing Director Clinical Risk and Director of Regulatory Affairs, Clinical Nursing Director 1 was asked regarding the closure of 5E on 12/23/25. Clinical Nursing Director 1 stated the patients receiving chemotherapy, PD, and kidney transplant were admitted to 5E depending on the patient’s condition. 5E was temporarily closed after 2300 hours on 12/23/25 due to staffing issues, the hospital wanted to make sure their patients were taken care of. During a concurrent tour at 6W unit and interview on 3/16/26 at 1400 hours, with Clinical Nursing Director 1, Clinical Nursing Director 1 stated CNs worked with Workflow (RN responsible for assigning patient rooms) to discuss patient placement needing contact isolation and chemotherapy. The CNs could also consult the IPC for patient assignment considering contact isolation and immunosuppressed patients. Clinical Director 1stated there was a plan from the administration specific for these patients who were to be admitted to other units. The leaders were informed about the plan. During a concurrent interview and record review on 3/16/26 at 1515 hours, Patients 2, 3’s medical records were reviewed with the Associate Nursing Director Clinical Risk, Clinical Nursing Director 1, Associate Nursing Director IPC, and the Director of Regulatory Affairs. The Associate Nursing Director IPC was asked about staff and unit leadership communication with IPC to consult regarding the patient room placement for contact isolation and immunosuppressed patients if acceptable. The Associate Nursing Director IPC stated she was not consulted regarding these patients for placement of immunosuppressed patients with patients on contact precaution/ isolation. During an interview on 3/17/26 at 1620 hours with Clinical Nursing Director 1, Associate Nursing Director Clinical Risk and Director of Regulatory Affairs, and Associate Nursing Director IPC, the findings were shared with the leadership team.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 39199 Based on interview and record review, the hospital failed to ensure the nursing staff reassessed and monitored one of seven sampled patients (Patient 2), when Patient 2 was restrained. This failure had the potential to place Patient 2 at risk for harm due to lack of required monitoring during restraint use. Findings: During a review of the hospital’s P&P titled “The Use of Restraints Including Seclusion,” dated February 2025, the P&P showed: - Restraints/Seclusion-Violent: Used in emergency situations when patients exhibit violent, aggressive, and/or destructive behaviors, which represents imminent risk of an individual’s self-harm or harm to others. - The RN’s specific responsibilities include completing and documenting an initial and ongoing reassessment and ensuring that patients in restraints/seclusions are appropriately monitored and receive necessary interventions. - Monitoring and assessment of patients in restraints or seclusion for violent behavior require direct patient care staff to monitor by observation, interaction, or direct examination upon initiation and every two hours, or sooner, for physical and psychological well-being, including but not limited to mental, respiratory, neurological, circulatory status, and skin integrity. During a review of Patient 2’s medical records on 2/25/26 at 0847 hours, with the Associate Nursing Director, the medical record showed Patient 2 was admitted to the hospital on 12/25/25, and discharged on 1/22/26. During a review of Patient 2’s physician’s order dated 12/29/25 at 0322 hours, the physician’s order showed an order to apply hard limb restraints to all four of Patient 2’s extremities. During a review of Patient 2’s medical record showed hard limb restraints were applied to all four extremities on 12/29/25 at 0323 hours, and discontinued on 12/29/25 at 0637 hours. During a review of Patient 2’s medical record, the patient’s medical record failed to show documented monitoring and reassessment of skin integrity and circulatory status during the restraint period from 0323 through 0637 hours on 12/29/25. During a concurrent interview and record review on 2/25/26 at 1223 hours, with the Associate Nursing Director, the Associate Nursing Director verified no documentation was present for skin integrity and circulatory assessments during the restraint episode.”

“SAFETY POLICY AND PROCEDURES CFR(s): 482.26(b) [§482.26 Condition of Participation: Radiologic Services §. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications.] §482.26(b) Standard: Safety for Patients and Personnel The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel. This Standard is not met as evidenced by: 40483 Based on interview and record review, the hospital failed to follow the Standardized Work titled, “Computer Tomography Emergency Room 1 and 2,” for reviewing lab values for one of two sampled patients (Patient 2) and obtaining a communication order from the Ordering Physician or Radiology Resident when lab values were not within range, prior to proceeding with the CT scan. This failure resulted in Patient 2, who had severe renal impairment (GFR 15 mL/min, BUN 65 mg/dL, Creatinine 3.46 mg/dL), receiving IV contrast (Omnipaque/Iohexol) for a CT scan, which placed the patient at risk for and contributed to acute worsening of kidney function. Findings: During a review of the hospital’s Standardized Work titled, “Computer Tomography Emergency Room 1 and 2,” dated 8/9/2025, the Scandalized Work showed the staff who must adopt: Computed Tomography Technologist. Task description for exam preparation includes steps VIII (Step 8) for the CT technologist to check labs in the Patient’s Power Chart (GFR needs to be over 30) ... If lab values are not within range, communicate with the patient’s nurse or ordering physician (first choice), (the radiology resident is the second choice) and ask if you can proceed. A communication order is needed from ordering physician or radiology resident in a patient’s chart to proceed. During a review of the Monograph for Omnipaque (Iohexol) injection full prescription information dated 2024, the Monohraph for Omnipaque showed the indication for use in intravenous procedures including CT of the head and body in adults and pediatric patients. Warnings and Precautions include risks associated with section 5.4, Acute Kidney Injury (AKI), including renal failure, which may occur after the parenteral administration of Omnipaque (Iohexol). Risk factors include pre-existing renal impairment, dehydration, diabetes mellitus, and elderly age. During Patient 2’s medical records review on 1/22/26, Patient 2’s medical record showed the patient was admitted to the hospital on 11/12/25. During a review of the ED Triage Note dated 11/12/25 at 1015 hours, the Ed Triage Note showed Patient 2 was admitted to the ED with syncope and hypotension. The patient was alert and oriented time two upon arrival. The patient had a history of hypertension, renal disease, diabetes, and brain tumor. Patient 2 was given a triage level 2 and critical medical. Review of Patient 2’s labs dated 11/12/25 at 1038 hours, showed the following values: -Blood Urea Nitrogen (BUN) of 65 mg/dl (Normal: ~7-20 mg/dL). -Creatinine of 3.46 mg/dl (Normal: ~0.6-1.3 mg/dL). -GFR of 15 ml/minute (Normal: >90 mL/min). Review of the physician’s order dated 11/12/25 at 1039 hours, showed an order for a CT of the Abdomen and Pelvis with contrast for Patient 2. Review of the CT scans showed the CT of the Abdomen and Pelvis with contrast was conducted on 11/12/25 at 1056 hours. During a review of Patient 2’s MAR, the MAR showed iohexol (Omnipaque, a contrast agent) was given on 11/12/25 at 1057 hours. During a review of the History and Physical dated 11/12/25 at 1505 hours,the History and Physical showed Patient 2 had a history of Pituitary Adenoma, Diabetes Mellitus, Chronic Kidney Disease stage 4. During a review of the Internal Medicine Impatient Progress Note dated 11/16/25, the Internal Medicine Impatient Progress Note showed Acute on Chronic Kidney injury, worsening ....Baseline BUN and Creatinine (CR) appeared to be 40s-mid 50s and low to mid 2s. Fe Urea of 27.5%, indicative of pre-renal etiology; however, acute worsening likely contrast-induced kidney injury ....addendum by MD showed AKI or CKD might have component of dehydration; would provide gentle IVF hydration today ...Avoid nephrotoxic agents. During an interview with Pharmacist 1 on 1/23/26 at 1116 hours, Pharmacist 1 stated Omnipaque (iohexol) injection was an injectable contrast dye which was used for imaging such as a CT scan. The contrast dye made structures easier to see. Pharmacist 1 stated Omnipaque (iohexol) did have toxicity for the kidneys, it was a well-known nephrotoxic agent and could harm the kidneys. Pharmacist 1 also added, if the patient was dehydrated the contrast could harm the kidneys. Pharmacist 1 stated Omnipaque (iohexol) could cause Acute Kidney Injury (AKI). During an interview on 1/27/26 at 1003 hours, with CT Technologist 1, CT Technologist 1 stated he was familiar with performing an Abdominal CT with contrast. CT Technologist 1 stated the purpose for using contrast was to make imagines easier to see and enhance the viewing of structures. CT Technologist 1 was asked if the CT technologists reviewed a patient’s lab value such as BUN, Creatinine, and GFR before giving contrast to the patient. CT Technologist 1 stated they reviewed the physician’s order and would review them if the lab values were available, but for cases from the ED that were considered trauma, the lab value review was overridden, and the contrast scan proceeded. CT Technologist 1 stated a trauma coming from the ED could not wait for the lab results. CT Technologist 1 stated he could not recall Patient 2 or this incident but was stating what was done in the CT department as practice. During an interview and concurrent medical record review on 1/27/26 at 1530 hours, with the Director of Regulatory Affairs, the Standardized Work procedure/pathway was reviewed with the Director Regulatory Affairs. The Director of Regulatory Affairs stated this procedure/pathway was expected to be followed by the CT staff. The Director Regulatory Affairs reviewed the medical records for Patient 2 and was unable to find documentation to show the CT technologists had reviewed Patient 2’s lab values prior to giving Patient 2 IV contrast. The Director Regulatory Affairs was unable to find documentation to show the CT technologists had contacted the patient’s nurse, the ordering physician or the radiology resident and asked if they could proceed with the scan and give Patient 2 contrast IV. The Director Regulatory Affairs was unable to find documentation to show the CT technologists obtained a communication order from the ordering Physician or Radiology Resident in Patient 2’s medical record to proceed. The Director Regulatory Affairs stated there was no additional P&P or pathway available to guide CT technologists for what to do in the event of an emergency or trauma if a patient’s lab values were out of range for the use of IV contrast as documented in the standardized work procedure pathway. The Director Regulatory Affairs verified no additional policy, procedure or pathway to allow CT technologists to deviate from the Standardized Work procedure/pathway in case of emergency/trauma. During an interview on 1/27/26 at 1620 hours, with the Director Regulatory Affairs, the Director Regulatory Affairs was made aware of the above findings.”

“INTEGRATION OF EMERGENCY SERVICES CFR(s): 482.55(a)(2) [If emergency services are provided at the hospital --] (2) The services must be integrated with other departments of the hospital. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the nursing staff completed the admission history and basic admission information within 24 hours of admission and performed a timely fall risk scale for one of four sampled patients (Patient 2) as per the hospital’s P&P when Patient 2 was admitted to the step-down level of care. This failure had the potential to result in substandard care for the patient. Findings: Review of the hospital’s P&P titled Assessment, Reassessment, and Data Collection dated 1/18/24, showed the following: 1. Admission History and Basic Admission Information a. Initiated when accepting a newly admitted patient. b. Collected within two hours for all admitted patients. c. Completed within 24 hours of admission including at a minimum: i. Language & interpreter needs ii. General information iii. Medication history & compliance iv. Allergies v. Transfusion history vi. Nutrition vii. Malnutrition screening tool (MST) viii. Social history ix. Domestic violence screening x. Psychosocial stressors xi. Advance directive xii. Discharge needs xiii. Suicide screening xiv. Initial infectious screening xv. Immunization screening xvi. Basic admission information 2. Baseline/Initial Assessment: head-to-toe physical assessment based on age, condition, diagnosis, and care setting. a. Initiated when accepting a newly admitted patient. b. Collected and documented within two hours for all admitted patients. c. Subsequent head-to-toe physical assessment shall be performed for all admitted patients at a minimum of once per shift within the first two hours of the beginning of the assigned shift. d. Including at a minimum.... “fall risk scale” On 8/6/25 at 1013 hours, the Adult ED was toured with the Nursing Quality Director and Nurse Manager 1. During the tour RN 1 was interviewed. RN 1 stated she was assigned to be a charge nurse today. RN 1 stated patients who were boarding in ED after the admission order, received the level of care as the physician’s order. On 8/6/25, Patient 2’s medical record was reviewed with the Nursing Quality Director and Clinical Nursing Director. Patient 2’s medical record showed Patient 2 arrived at the ED on 8/4/25. Review of the physician’s order dated 8/5/25 at 0542 hours, showed to admit Patient 2 to step-down level of care. 1. On 8/6/25 at 1127 hours, an interview and concurrent medical record review was conducted with the Clinical Nursing Director in the presence of the Nursing Quality Director. The Clinical Nursing Director stated the elements of the admission assessment and initial assessment were already initiated during ED stay. The documented assessment could be found in different ED documentation forms. During the concurrent medical record review with the Clinical Nursing Director and Nursing Quality Director, not all the elements of the General Information were documented. The following elements were not able to be found in Patient 2’s medical record: * Sensory changes * Patient/Caregiver instructed to only take prescribed hospital medications while hospitalized * Patient desires family or patient representative to be notified on admission * Transfusion history * Malnutrition screening tool * Psychosocial stressors * Advance directive 2. Review of Patient 2’s medical record titled Adult Systems Assessment dated 8/6/25 at 0600 hours, showed Patient 2’s initial head-to-toe assessment was performed after the admission order. Further review of Patient 2’s medical record showed the fall risk score was performed on 8/6/25 at 1900 hours (13 hours later). On 8/6/25 at 1415 hours, the Nursing Quality Director, Clinical Nursing Director, and Assistant Hospital Administrator verified the above findings.”

“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: 37663 Based on interview and record review, the hospital failed to ensure one of four sampled patients (Patient 4) had a completed list of medications listed on the Psychiatric Medications Advisement form and documentation of Patient 4’s refusal to sign the Psychiatric Medication Advisement form. This failure posed the increased risk for the patient to have lack of knowledge and understanding of the risk and benefits of the medications. Findings: Review of the hospital’s P&P titled Medication Advisement for Involuntary Patients dated August 2024 showed in part: * Policy: Psychiatric patients must be given oral and written information about the proposed course of treatment with a psychotropic medication before the medication is administered, except in emergency situations. If different and/or additional psychotropic medication is proposed, the patients must be given oral and written information about this medication before it is administered, except in emergency situations. Documented advisement about the proposed course of the treatment is required for the following categories of medications: - Neuroleptics (antipsychotics) - Antidepressants - Mood stabilizer - Antiparkinson medications - Anticonvulsant - Minor tranquilizer The oral advisement shall be performed by the patient’s physician and shall consist of a full explanation of the treatment with each proposed psychotropic medication, including: - The nature of patient’s mental condition. - The reason for taking the medication, including the likelihood of the patient’s improving or not improving without the medication. - A statement that the patient may withdraw his/her consent at any time. The patient should be advised that he or she may withdraw the consent by stating such intention to any member of the treating staff. - The reasonable alternative treatments available, if any. - The name and type of medication, range of frequency of administration, range of dosage amount including the use of PRN orders, method of medication administration, and duration of taking the medications. - The probable side effects of the medication that are known to commonly occur and any particular side effects likely to occur to the particular patient. The possible additional side effects that may occur in patents taking the medication longer than three months. If applicable, the patient must be advised that such side effects may include persistent involuntary movement the face or mouth and might also include similar movement of the hands and feet, and that these symptoms of tardive dyskinesia are potentially irreversible and may appear after the medication has been discontinued. - The right to refuse medication. If the patient agrees with the administration of the proposed psychotropic medication, he/she should sign the Psychiatric Medication Advisement form (M11141) indicating that he/she has received the required information about the proposed treatment with the particular psychotropic medication and has consented to the medication. The patient may later withdraw consent and refuse the administration of psychotropic medication, in which case no medication may be administered unless an emergency exists, or an order of incapacity is issued by the judge. Psychotropic medications may be administered to an involuntary patient if the patient is given the above-referenced medication-advisement information, and does not refuse the medication, even if the patient does not expressly agree to sign the medication advisement form. The physician providing the medication-advisement information should document the patient’s refusal to sign the medication advisement form, which should be placed in the medical record. A copy of the medication advisement form should be given to the patient. * Procedure: - The physician is responsible for discussing with and offering written materials to the patient about the proposed course of treatment with psychotropic medication(s). This should be documented in the medical record. - The physician shall document on the Psychiatric Medications Advisement form the specific name of the proposed psychotropic medication(s) in the fields provided on the form. - The physician shall obtain the signature of the patient or his/her conservator, if any consenting to the medication, and then shall sign, date, and time the Psychiatric Medication Advisement form. - If the patient does not refuse the medication but does not wish to sign the Psychiatric Medication Advisement form, the physician shall: documentation on the form that the patient declined to sign the form; and sign, date, and time the form. - The completed Psychiatric Medication Advisement form shall be placed in the patient’s medical record. - A copy of the Psychiatric Medication Advisement form shall be given to the patient. - The fact that the information has or has not been given shall be indicated in the patient’s medical record. If the information has not been given, the designation person shall document in the patient’s medical record the justification for not providing the information. On 3/5/25 at 0956 hours, interview and concurrent review of Patient 4’s closed medical record was conducted with the Assistant Hospital Administrator, Psychiatry Chair, Health Facility Consult, Mental Health SW II, Psych SW 1, and Psych SW 2. Patient 4’s closed medical record showed Patient 4 was admitted to the Psych ED on 1/16/25, on a 5150 hold. The patient was admitted to the Psych unit on 1/20/25, and discharged on 2/14/25. On 3/5/25 at 1014 hours, interview with the Psychiatric Chair about Patient 4’s psychotropic medication regimen. The Psychiatric Chair stated the patient received Risperdal (antipsychotic) for poor emotional regulation common problem with intellectual disability. The Psychiatric Chair added Risperdal was changed to injectable medication Invega Sustenna (extended-release antipsychotic medication). Review of the Discharged Summary dated 2/14/25, showed “stopped Risperdal 2 mg/2 mg (2/4-2/12), given conversion to LAI (long-acting injection) ...s/p Invega Sustenna 234 mg IM on 2/10, Invega Sustenna 156 mg IM ordered for 2/13.” Review of Patient 4’s Psychiatric Medication Advisement showed the physician signed on 1/16/25 at 1836 hours, for the following medication of risperidone (as same as Risperdal), Haldol (antipsychotic medication), olanzapine (antipsychotic medication), lorazepam (an antianxiety medication), and Benadryl (an antihistamine). Review of Patient 4’s EMAR showed the following: * The order for Thorazine (antipsychotic medication) 50 mg po every morning and HS. Patient 4 received Thorazine 50 mg on the following dates: - 1/18/25 at 1100 and 2118 hours. - 1/19/25 at 1042 hours. - 1/2025 at 0908 hours. * On 1/21/25 at 1118 hours, Thorazine 75 mg po every morning and evening. Patient 4 received Thorazine 75 mg po on the following dates: - 1/2125 at 2145 hours. - 1/22/25 at 1009 and 2048 hours. - 1/23/25 at 0946 and 2047 hours The Health Facility Consult was asked about the psychiatric medications listed on the Psychiatric Medications Advisement Form and the documentation of the physician for the patient’s refusal to sign. The Health Facility Consult could not show the complete list of the psychotropic medications and physician’s documentation that Patient 4 refused to sign the Psychiatric Medications Advisement Form.”

“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: 22553 Based on interview and record review, the hospital failed to ensure two LVNs performed patient care under the RN supervising as per the hospital’s nursing policy for three of four sampled patients (Patients 1, 2, and 3). This failure created the increased risk to the safety of patients. Findings: Review of the hospital’s Nursing Policy Manual-Assignment of Patient Care revised 9/18/18, showed the care of each patient is under the supervision and direction of a Registered Nurse. The assigned staff member will provide director and indirect patient care activities/tasks as delegated within their scope of practice. Review of the Class Specification Bulletin for Licensed Vocational Nurse I revision 4/25/73, showed LVN I ‘s normally work under the supervision of a registered nurse or physician and administer care for the patient ordered by the physician or contained in a nursing care plan. Review of the hospital’s P&P titled Assessment, Reassessment, and Data Collection dated 1/18/24, showed the following: - Physical assessment is defined as this portion includes a head-to-toe body system evaluation involving systematic and continuous collection, analysis, and communication of data following the nursing process; utilize critical thinking to interpret the data collected in developing, guiding, and prioritizing a patient-centered individualized plan of care. - Documentation: all aspects of patient care shall be documented in the EHR in accordance to the nursing process following the specified time within the care setting, and/or unit reassessment frequency parameters. Review of the Table 1 - Reassessment Frequency Parameters of the Nursing Policy No. 030 -Assessment, Reassessment, and Data Collection showed these assessments shall be done at a minimum as described for a 12-hour shift. The parameters for med/surg unit include neurological, cardiovascular, neurovascular, respiratory, GI/GU, integumentary, IV site with continuous infusion, dressing and wounds, level of activity, and response to pain management. On 3/5/25 at 0942 hours, Patients 1, 2 and 3’s closed medical records were reviewed the Director Nursing Quality Admin, 4 East Nursing Manager, and Accreditation & Reg. Compliance, Coordinator. 1. Patient 1’s closed medical record showed Patient 1 was admitted to the hospital on 12/20/24 to the Med/Surg unit. The medical record showed on 1/23/25 at 0810 hours, LVN 1 documented the Adult Systems Assessment, the assessment of the patient’s baseline/initial assessment for the following: neurological, respiratory, cardiovascular, edema assessment, gastrointestinal, genitourinary, integumentary, incision/wound/skin abnormality. LVN 1 signed on the perform and verify section without a RN review. 2. Patient 2’s closed medical record showed Patient 2 was admitted to the hospital on 1/15/25. The medical record review showed LVN 1 documented on 1/23/25 at 0919 hours, the patient’s assessment including neurological, respiratory, breathing sounds assessment, cardiovascular, edema assessment, gastrointestinal, genitourinary, integumentary, and incision/wound/skin abnormality. LVN 1 documented the Perform and Verify completed on 1/23/25 at 0919 hours. The area for Reviewed by RN was blank. 3. Patient 3’s closed medical record showed Patient 3 was admitted to the hospital on 2/13/25. The medical record review showed LVN 2 documented on 3/3/25 at 0842 hours, the LVN assessed the patient’s Adult Systems Assessment including neurological, respiratory, cardiovascular, pulses, neurovascular, edema assessment, gastrointestinal, genitourinary, musculoskeletal assessment, integumentary, and incision/wound/skin abnormality. LVN 2 documented the Perform and Verify completed on 3/3/25 at 0842 hours. The area for Reviewed by RN was blank. The Director Nursing Quality Admin confirmed the findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(i) The use of restraint or seclusion must be-- (i) in accordance with a written modification to the patient’s plan of care. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the care plan was updated to reflect the use of violent restraints for one of five sampled patients (Patient 1). This failure created the risk of substandard outcomes for the patient. Findings: Review of the hospital’s P&P titled the Use of Restraints Including Seclusion dated December 2019 showed the patient’s plan of care will be modified as appropriate. On 10/28/24, an interview and concurrent review of Patient 1’s medical record was conducted with the Director of Nursing Quality and Accreditation Coordinator 1. Patient 1’s medical record showed the patient visited the ED on 10/17/24, and admitted to the hospital on 10/25/24. Review of Patient 1’s medical record showed the following: * On 10/17/24 at 1802 hours, the hard restraints for all four extremities were initiated for the patient by the Behavioral Response Team and discontinued by the nursing staff at 2123 hours. * On 10/22/24 at 0900 hours, the hard restraints for all four extremities were initiated for the patient by the Behavioral Response Team and discontinued by the nursing staff at 1035 hours. * On 10/23/24 at 1100 hours, the hard restraints for all four extremities were initiated for the patient by the Behavioral Response Team and discontinued by the nursing staff at 1545 hours. Review of the Plan of Care dated 10/17/24, showed the risk for injury related to the restraints was activated. However, further review of Patient 1’s medical record failed to show the patient’s care plan was updated to address the use of violent restraints on 10/22 and 10/23/24. On 10/29/24 at 0951 hours, the Director of Nursing Quality verified the above findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(8) Unless superseded by State law that is more restrictive-- (i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours: (A) 4 hours for adults 18 years of age or older; (B) 2 hours for children and adolescents 9 to 17 years of age; or (C) 1-hour for children under 9 years of age; This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the use of hard restraints was not exceed four hours for one of five sampled patients (Patient 1). This failure posed the risk of substandard outcomes to the patient. Findings: Review of the hospital’s P&P titled the Use of Restraints Including Seclusion dated December 2019 showed the orders for the restraints and/or seclusions for the patients with violent behavior management needs are limited to four hours for adults (18 years of age and over). On 10/28/24, an interview and concurrent review of Patient 1’s medical record was conducted with the Director of Nursing Quality and Accreditation Coordinator 1. Patient 1’s medical record showed Patient 1 visited the ED on 10/17/24, and admitted to the hospital on 10/25/24. Review of the Restraint Episode showed on 10/23/24, the hard restraints for all four extremities were initiated for Patient 1 by the Behavioral Response Team at 1100 hours and discontinued by the nursing staff at 1545 hours (or four hours and 45 minutes). On 10/29/24 at 0951 hours, the Director of Nursing Quality verified the above findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the monitoring and assessment were consistently performed as per the hospital’s P&P for one of five sampled patients (Patient 1). This failure posed the risk of substandard outcomes to the patient. Findings: Review of the hospital’s P&P titled the Use of Restraints Including Seclusion dated December 2019 showed the section for Monitoring and Assessment for Restraint or Seclusion for Violent, for direct patient care, the staff are to monitor by observation, interaction, or direct examination upon initiation and as follows: - Every 15 minutes for signs of any injury to restraint site including restraint type and location; respiratory rate; and behavioral health patient’s activity. - Every two hours or sooner for nutrition and hydration; range of motion and extremity movement; hygiene and elimination; readiness for discontinuation of restraints; physical and psychological well-being including but not limited to mental, respiratory, neurological, circulatory status, and skin integrity. On 10/28/24, an interview and concurrent review of Patient 1’s medical record was conducted with the Director of Nursing Quality and Accreditation Coordinator 1. Patient 1 medical record showed the patient visited the ED on 10/17/24 and was admitted to the hospital on 10/25/24. 1. Review of Patient 1’s medical record showed on 10/17/24, the hard restraints for all four extremities were initiated for the patient by the Behavioral Response Team at 1802 hours and discontinued by the nursing staff at 2123 hours. a. Review of the Respiratory Rate showed on 10/17/24, the RR was measured every 15 minutes when Patient 1 was on hard restraints. However, there was no documented RR on 10/17/24 at 2015 hours. b. On 10/28/24 at 0940 hours, an interview was conducted with the Director of Nursing Quality. When asked, the Director of Nursing Quality stated the readiness for discontinuation of the restraints would be assessed under the goal criteria for releasing restraints as the goal was either met or not met. Review of the Restraint Episode dated 10/17/24, showed the goal criteria for releasing restraints were assessed at 1815 hours (or upon initiation) and 2123 hours (upon discontinuation). However, further review of Patient 1’s medical record failed to show the readiness for discontinuation of restraints was assessed every two hours or less as per the hospital’s P&P. 2. Review of Patient 1’s medical record showed on 10/23/24, the hard restraints for all four extremities were initiated for the patient by the Behavioral Response Team at 1100 hours, and discontinued by the nursing staff at 1545 hours. a. Review of the Respiratory Rate showed on 10/23/24, the RR was not measured every 15 minutes when Patient 1 was on hard restraints. There was no documented Patient 1’s RR between 1100 hours to 1215 hours and 1245 hours to 1409 hours. There was no documented Patient 1’s RR between 1409 hours to 1545 hours (upon discontinuation). b. Review of the Restraint Episode dated 10/23/24, showed there was no documented evidence showing the patient’s behavioral health patient’s activity was monitored from 1330 hours to 1545 hours (or upon discontinuation). c. Review of the Restraint Episode dated 10/23/24, showed the goal criteria for releasing restraints were assessed at 1000 hours upon initiation. However, further review of Patient 1’s medical record failed to show the readiness for discontinuation of restraints were assessed every two hours or less as per the hospital’s P&P, until the restraints were discontinued at 1545 hours. On 10/29/24 at 0951 hours, the Director of Nursing Quality verified the above findings.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 22553 Based on interview and record review, the hospital failed to ensure the nursing staff conducted the pain assessment for one of five sampled patients (Patient 1) as per the hospital’s P&P. This failure posed the potential to result in poor health outcomes to the patient. Findings: Review of the hospital’s P&P titled Assessment, Reassessment, and Data Collection, Policy dated 1/18/24, showed the following: * The provision of care, treatment, and services to the hospital patients includes the reassessment of the patient’s condition and response to interventions. * Patient assessment, reassessment, and screenings shall be performed by a RN. * The reassessment is subsequent to admission and baseline/initial assessment, completed in accordance with unit frequency parameters. * The data collection includes subject and objective data, including vital signs such as temperature, respiratory rate, heart rate, blood pressure, and pain level using an age or condition appropriate pain scale. * The reassessment frequency parameters for adult ICU patients include to reassess the vital signs including pain every two hours. The response to pain management is to be reassessed when the condition warrants and as ordered. Review of the hospital’s P&P titled Pain Management dated October 2021 showed the following: * The provider or RN is responsible for determining the appropriate screening tool/scale to be used, which includes - Numerical rating scale: a numeric pain assessment tool in which patients are asked to verbally rate their current pain intensity on a scale of zero to 10 with zero being no pain and 10 being the worst possible pain. - Critical-care Pain Observation Tool (CPOT): a behavioral scale used to quantify pain by using four categories: facial expression, body movements, muscle tension, and compliance with the ventilator or vocalization of the extubated patient. Presence of pain is suspected when the CPOT score is greater than two or when the CPOT score increases by two or more. * The patients’ response to pain intervention shall be evaluated and documented in a timely manner. * When pain is present, a detailed assessment shall be performed to include the following parameters: pain intensity, pain quality, location, onset, duration, variation, and patterns, alleviating and aggravating factors, present pain management regimen and its effectiveness, and patient’s pain goal. * The ongoing assessment of pain is part of the vital sign measurement at intervals depending on the unit’s routine assessment schedule, per patient’s request, and/or necessity. * The assessment and reassessment regarding pain management will be entered in the electronic medical record. On 10/17/24 at 0938 hours, an interview and concurrent review of Patient 1’s closed medical record was conducted with the Director of Nursing Quality Admin and Nursing Health Coordinator. Patient 1’s closed medical record showed Patient 1 admitted to the adult ICU on 9/17/24 at 1411 hours. The patient was transferred to the step-down unit on 9/18/24 at 2310 hours. Review of the documentation for pain assessment and management showed the following: * On 9/17/24 at 1406 hours, the patient’s CPOT score was 7. The pain location was unable to be assessed. The patient was restless and unwilling to follow commands. * On 9/17/24 at 1702 hours, the patient’s pain level was 10 out of 10. There was no documentation of pain location, quality, or pain pattern. The MAR showed documented hydromorphone (a highly potent opioid medication) 0.2 mg IVP was adminstered to the patient. * On 9/17/24 at 1720 hours, the patient’s pain level was 10 out of 10. The sections of pain quality and acceptable pain were blank. * On 9/17/24 at 1824 hours, the patient’s pain level was 10 out of 10. The patient had pain to the head and the pain was constant. The sections of pain quality and acceptable pain were blank. The MAR showed the patient received oxycodone (a potent opioid medication) 5 mg orally on 9/17/24 at 1824 hours. * On 9/17/24 at 1900 hours, the patient’s pain level was zero. There was no documented evidence the nursing staff conducted the pain assessment for the patient from 9/17/24 at 1915 hours to 9/18/24 at 0142 hours, and on 9/18/24 from 0415 hours to 0800 hours. * On 9/18/24 at 1812 hours, the patient’s pain level was nine out of 10 and the patient’s acceptable pain level was three out of 10. The section of pain pattern was blank. The patient was given an oral analgesic pain medication. * On 9/18/24 at 2325 hours, the patient’s pain level was eight out of 10. The sections of pain location, quality, and pattern were blank. The Director of Nursing Quality Admin confirmed the findings. On 10/17/24 at 1500 hours, during an interview with the Director of Nursing Quality Admin for the adult ICU patient’s pain management and frequency of pain reassessment, the Director of Nursing Quality Adm stated for IV pain medication, the pain reassessment is conducted within 30 minutes. The Director of Nursing Quality Adm confirmed the hospital’s P&P related to Assessment, Reassessment, and Data Collection was not specified to reassess the pain in 30 minutes after the administration of IV pain medication.”

“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: 22553 Based on record review and interview, the hospital failed to ensure the nursing staff administered the pain medication for one of five sampled patients (Patient 1) as per the physician’s order. This failure created the risk of poor health outcomes for the patient. Findings: Review of the hospital’s P&P titled Pain Management dated October 2021 showed to provide guidelines on the Pain Management Program including treatment. The pain management will utilize the inpatient pain management order set embedded in the EHR to maximize non-pharmacological and non-opioid treatment options. The initial screening, assessment, reassessment, treatment, and patient/family education regarding pain management will be entered in the electronic medical record. The treatment plan shall state objectives by which the treatment plan can be evaluated, such as pain relief. On 10/17/24 at 0938 hours, an interview and concurrent review of Patient 1’s closed medical record was conducted with the Director of Nursing Quality Admin and Health Facility Consultant. Patient 1’s closed medical record showed Patient 1 admitted to the adult ICU on 9/17/24 at 1411 hours. Review of the MAR Summary dated 9/17/24, showed Patient 1 had two pain medications ordered as follows: * Oxycodone 5 mg oral Q 4 hours, as needed for pain level from 5 to 10. * Hydromorphone 0.2 mg IVP, as needed for breakthrough pain that was unrelieved by non-opioids and oral opioids (of ordered). Review of the pain assessment dated 9/17/24 at 1702 hours, showed Patient 1’s pain level was 10 out of 10. Review of the MAR showed hydromorphone 0.2 mg IVP was administered to the patient on 9/17/24 at 1702 hours. Review of the pain assessment showed on 9/17/24 at 1720 hours, the patient’s pain level was 10 out of 10 which was the same pain level before the hydromorphone was administered to the patient. There was no documented evidence the nursing staff reported this treatment result to the provider for further management plan. Review of the pain assessment showed on 9/17/24 at 1824 hours, Patient 1’s pain level was 10 out of 10. Review of the MAR showed on 9/17/24 at 1824 hours, oxycodone 5 mg was administered to the patient orally. However, there was no documented evidence to show the reason why hydromorphone was administered to Patient 1 on 9/17/24 at 1702 hours, not following the physician’s order to administer hydromorphone for the breakthrough pain that was unrelieved by oral opioids. The Director of Nursing Quality Admin confirmed the findings.”

“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: 35310 Based on interview and record review, the hospital failed to comply with the 24 CFR 489.24, special responsibilities of Medicare hospitals in emergency cases. This failure had the potential to result in poor health outcomes and serious adverse events to the patients receiving the ED services. services. Findings: 1. The hospital failed to ensure the necessary stabilizing treatments were provided within the capabilities of the hospital for six of 20 sampled patients (Patients 1, 11, 12, 15, 16, and 19). Cross reference to A2407. 2. The hospital failed to ensure the ED staff completed the EMTALA Transfer Form when transferring one of 20 sampled patients (Patient 14) to other facility. Cross reference to A2409.”

“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: 35310 Based on interview and record review, the hospital failed to ensure the necessary stabilizing treatments were provided within the capabilities of the hospital for six of 20 sampled patients (Patients 1, 11, 12, 15, 16, and 19) as evidenced by: 1. The ED staff did not ensure the pain management for Patients 1, 11, 12, 15, 16, and 19 as per the hospital’s P&P. 2. The ED staff did not conduct the reassessments, including the vital signs every four hours for Patient 19 as per the hospital’s P&P. These failures had the potential to result in poor health outcomes and serious adverse events to the patients receiving the ED services. Findings: 1. Review of the hospital’s P&P titled Pain Management dated October 2021 showed the following: * When pain is present, a detailed assessment shall be performed to include the following parameters: - Pain intensity - Pain quality - Location - Onset, duration, variation, and patterns - Alleviating and aggravating factors - Present pain management regimen and its effectiveness - Use of any Complementary and Alternative Medicine (CAM) for pain management - Patient’s pain goal (including pain intensity and goals related to function, activity, and quality of life) * Reassessment will be done as indicated by persistence of pain, initiation of potentially painful procedures, changes in medical status, and/or after any interventions provided for pain management (pharmacological/non-pharmacological interventions). The following will be reported immediately to the Provider: - Uncontrolled pain - Pain intervention that do not achieve patient’s pain goal in a timeframe appropriate to the intervention - New or worsening pain - Adverse effects of pain medication a. Review of Patient 1’s closed medical record was initiated on 8/29/24. Patient 1’s medical record showed Patient 1 arrived in the ED on 8/20/24 at 1700 hours. Review of the ED Triage/Intake dated 8/20/24 at 1726 hours, showed Patient 1 had pain to the head and the patient’s pain level was seven out of 10 (on a scale of 0 to 10 with 0 = no pain and 10 = worst possible pain). However, further review of Patient 1’s medical record failed to show Patient 1’s pain goal. Review of the physician’s order dated 8/20/24 at 1734 hours, showed to administer acetaminophen (a pain medication) 650 mg by mouth. Review of the Medication Administration Record showed on 8/20/24 at 1802 hours, Patient 1 was administered with acetaminophen 650 mg by mouth. However, further review of Patient 1’s medical record failed to show documented evidence of reassessing the patient’s pain after administering the acetaminophen to the patient as per the hospital’s P&P. b. Review of Patient 11’s closed medical record was initiated on 8/29/24. Patient 11’s medical record showed Patient 11 arrived in the ED on 6/25/24 at 0937 hours. Review of the Vital Signs dated 6/25/24 at 1006 hours, showed Patient 11 had abdomen pain and the patient’s pain level was five out of 10. However, further review of Patient 11’s medical record failed to show Patient 11’s pain onset, duration, variation, patterns, alleviating and aggravating factors, and pain goal were assessed. In addition, there was no documented intervention for the pain until Patient 11 had no answer for a call at 2003 hours. c. Review of Patient 12’s closed medical record was initiated on 8/29/24. Patient 12’s medical record showed Patient 12 arrived in the ED on 8/20/24 at 1526 hours. Review of the ED Triage/Intake dated 8/20/24 at 1532 hours, showed Patient 12 had the right flank pain and the patient’s pain level was 10 out of 10. However, further review of Patient 12’s medical record failed to show Patient 12’s pain onset, duration, variation, patterns, alleviating and aggravating factors, and pain goal were assessed. In addition, there was no documented intervention for the pain until Patient 12 had no answer for calls at 1640 hours. d. Review of Patient 15’s closed medical record was initiated on 8/30/24. Patient 15’s medical record showed Patient 15 arrived in the ED on 7/19/24 at 1011 hours. Review of the ED Triage/Intake dated 7/19/24 at 1054 hours, showed Patient 15 had rectal pain and the patient’s pain level was 10 out of 10. However, further review of Patient 15’s medical record failed to show Patient 15’s pain onset, duration, variation, patterns, alleviating and aggravating factors, and pain goal were assessed. In addition, there was no documented intervention for the pain until Patient 15 had no answer for calls at 1320 hours. e. Review of Patient 16’s closed medical record was initiated on 8/30/24. Patient 16’s medical record showed Patient 16 arrived in the ED on 7/25/24 at 1415 hours. Review of the ED Triage/Intake dated 7/25/24 at 1430 hours, showed Patient 16 came to the ED for leg pain. The ED Triage/Intake showed the Pain Assessment section showing the preferred pain tool was the numeric rating scale. However, further review of Patient 16’s medical record failed to show documented evidence of pain assessment and management. f. Review of Patient 19’s closed medical record was initiated on 8/30/24. Patient 19’s medical record showed Patient 19 arrived in the ED on 7/13/24 at 1216 hours. Review of the ED Triage/Intake dated 7/13/24 at 1225 hours, showed Patient 19 had chest pain and the patient’s pain level was four out of 10. However, further review of Patient 19’s medical record failed to show Patient 19’s pain onset, duration, variation, patterns, alleviating and aggravating factors, and pain goal were assessed. Review of the Vital Signs dated 7/13/24 at 2121 hours, showed Patient had chest pain and the patient’s pain level was four out of 10. However, there was no documented intervention for the pain until Patient 19 signed the AMA at 2220 hours. 2. Review of the hospital’s P&P titled Triage and Medical Screening Examination dated November 2023 showed triage priority is based on the router nurse’s perceived urgency of a patient’s need for medical evaluation and/or treatment following initial assessment. Patient acuity is determined at the time of triage in accordance with the Emergency Severity Index (ESI). Review of the hospital’s P&P titled Nursing Documentation dated November 2023 showed patients in the waiting room must have a reassessment completed a minimum of every two hours for ESI level 2, four hours for ESI level 3, and every 8 hours for ESI levels 4 and 5. Review of Patient 19’s closed medical record was initiated on 8/30/24. Patient 19’s medical record showed Patient 19 arrived in the ED on 7/13/24 at 1216 hours. Review of the ED Triage/Intake dated 7/13/24 at 1225 hours, showed Patient 19’s vital signs were taken and the patient was triaged with the acuity level (or ESI level) “3.” Review of the Medical Screening Exam dated 7/13/24 at 1236 hours, showed Patient 19’s ESI level was “3.” Review of the Vital Signs dated 7/13/24 at 1957 hours (seven hours and 32 minutes later), showed Patient 19’s vital signs were taken. On 8/29/24 at 1348 hours, Clinical Nursing Director 1 was interviewed. When asked, Clinical Nursing Director 1 stated patient whose acuity level was with ESI level 3, should be assessed every four hours, including the vital signs. On 8/30/24 at 1300 hours, the above findings were shared and verified with Clinical Nursing Director 1.”

“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: 35310 Based on interview and record review, the hospital failed to ensure the ED staff completed the EMTALA Transfer Form when transferring one of 20 sampled patients (Patient 14) to other facility. This failure had the potential to result in poor clinical outcomes and serious adverse events to the patients receiving ED services. Findings: Review of Patient 14’s closed medical record was initiated on 8/30/24. Patient 14’s medical record showed Patient 14 came to the ED on 8/20/24, and was transferred or discharged to other facility on 8/22/24 at 1807 hours. On 8/30/24 at 1300 hours, Clinical Nursing Director 1 was interviewed. When asked, Clinical Nursing Director 1 stated the transfer form should be completed hospital-wide, including the ED. Patient 14’s transfer form was requested. However, Clinical Nursing Director 1 stated she was not able to locate the form. On 8/30/24, Clinical Nursing Director 1 verified Patient 14’s transfer form was missing in Patient 14’s medical record. Review of the EMTALA Transfer From showed the following: “I acknowledge that I have been informed of the risk and consequences potentially involved in the transfer, the possible benefits of continuing treatment at this hospital, and the alternative (if any) to the transfer I am requesting. I hereby release the attending provider, any other providers involved in the patient’s care, the hospital and its agents and employees, from all responsibility for ill effects which may results from the transfer.””

“PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES CFR(s): 482.13(a)(2)(ii) At a minimum: The grievance process must specify time frames for review of the grievance and the provision of a response. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to ensure the hospital’s P&P was implemented for one of two sampled patients (Patient 1) related to the investigation not being thoroughly completed prior to having NA 1 return to provide the patient care after an allegation of physical assault was reported to the hospital involving Patient 1 and NA 1. This failure increased the risk of substandard care to the patients. Findings: Review of the hospital’s P&P titled Patient Complaints and Grievances dated December 2022 showed the purpose is to describe the process for receiving, investigating, and responding to complaints or grievance. A complaint is defined as a verbal complaint of concern or dissatisfaction made by a patient or the patient’s legally authorized representative that can be resolved at the time of the complaint by staff present. A grievance is defined as a written or verbal complaint that is made by a patient or the patient’s authorized representative regarding patient care, abuse or neglect. Any verbal complaint that can not be resolved time of complaint, is postponed for later resolution, is referred to other staff for later solution, or required investigation, is considered a grievance. Review of the hospital’s P&P titled Guidelines for Addressing Allegations of Inappropriate Behavior Toward a Patient dated October 2022 showed the facility will evaluate all allegations, observations, and suspected cases of abuse that occurs in the facility and report such incidents in accordance with the provisions of the policy and guidance. Further review of the P&P showed any workforce member who is informed by a patient or visitor of reasonable suspicion of abuse of any kind will report it to the supervisor or manager. An interview will take place as soon as possible after the complaint by a manager, administrator, or risk management to determine the details of the complaint. Any reasonable suspicion of inappropriate conduct will be referred to the Sheriff’s department. During an investigation, the workforce member or other person will be removed from providing patient care, treatment, or services to the patient as appropriate. On 8/30/24 at 1052 hours, an interview was conducted with the Director of Regulatory Affairs, Clinical Nursing Director II, House Supervisor 1, and NA 1. The Director of Regulatory Affairs stated on 8/17/24 at approximately 1100 hours, Patient 1’s family member stated the patient alleged a staff member had hit her during the night shift. When asked, the Director of Regulatory Affairs stated the patient pointed and identified NA 1 as the staff member who had hit her. House Supervisor 1 stated NA 1 worked on the dayshifts. House Supervisor 1 was notified and spoke to the patient’s family member. The patient’s family member shared the patient alleged she was shoved into the bed’s side rail by a staff member. House Supervisor 1 stated NA 1 was removed from the patient care at that time. House Supervisor 1 stated House Supervisor 1 was in communication with the Risk Manager who was Clinical Nursing Director II, CNO, and COO via email and text messages regarding this case. House Supervisor 1 stated House Supervisor 1 was instructed by the CNO and COO to complete an investigation. House Supervisor 1 stated House Supervisor 1 was told to have NA 1 come back to provide patient care if the allegation of assault was not substantiated. When asked, House Supervisor 1 stated he spoke with Patient 1 when the sheriff arrived. According to Patient 1, the staff member was “rough with me”. House Supervisor 1 stated House Supervisor 1 spoke to the sheriff and determined no allegation of abuse or assault had occurred for Patient 1 by NA 1. Review of the investigation data showed affidavits were gathered by House Supervisor 1 for NA 1 on 8/17/24. The Director of Regulatory Affairs stated NA 1 was returned to provide the patient care on 8/17/24 at 1830 hours. However, further interview and record review showed NA 2, who was with Patient 1 on the night shift on 8/16 to 8/17/24, was not interviewed as part of the investigation findings prior to making a determination of assault on Patient 1. When asked, the Director of Regulatory Affairs stated House Supervisor 1 was communicating with the risk management staff all the findings of the investigation. The Director of Regulatory Affairs stated House Supervisor 1 notified the risk management staff of returning NA 1 to provide the patient care and the risk management staff agreed with the determination. The above concern for not conducting a thorough investigation was shared with the Director of Regulatory Affairs, Clinical Nursing Director II, and House Supervisor 1. The Director of Regulatory Affairs stated the hospital deviated from their normal practice and after the joint decision that no assault had happened, there still was an opportunity to get more information and investigate further.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 36703 Based on observation, interview, and record review, the hospital failed to ensure the nursing services were provided to two of two sampled patients (Patients 1 and 2) as evidenced by: 1. Patient 1’s RASS and restraint assessments were inconsistent, and the nursing staff did not provide the accurate clinical status to justify the use of non-violent restraints for Patient 1. 2. RN 1 failed to accurately document Patient 2’s restraint assessments after providing care for the patient. These failures increased the risk of substandard outcome for the patients in the hospital. Findings: Review of the hospital’s P&P titled The Use of Restraints Including Seclusion dated December 2019 showed a restraint is any manual method or physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move the arms, legs, body, or head freely. Restraints will be implemented in the least restrictive manner possible and used only when least restrictive measures have been found to be ineffective to protect the patient and others from harm. Restraints 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. 1. Review of the Richmond Agitation Sedation Scale (RASS) showed the scoring system on a RASS assessment is as follows: - A score of +4 means the patient is combative and described as overtly combative, violent, and an immediate danger to staff. - A score of +3 means the patient is very agitated, pulling or removing tubes or catheters, and aggressive. - A score of +2 means the patient is agitated, has frequent non-purposeful movement, and is fighting the ventilator. - A score of +1 means the patient is restless and anxious, but the movements are not aggressive or vigorous. - A score of 0 means the patient is alert and calm. - A score of -1 means the patient is drowsy and not fully alert but has sustained awakening. - A score of -2 means the patient is lightly sedated and briefly awakens with eye contact to voice for less than ten seconds. - A score of -3 means the patient is moderately sedated and has movement or eye opening to voice, but no eye contact. - A score of -4 means the patient is deeply sedated and has no response to voice, but movement or eye opening to physical stimulation. - A score of -5 means the patient is unarousable with no response to voice or physical stimulation. On 8/29/24, review of Patient 1’s open medical record was initiated. Patient 1’s medical record showed the patient was admitted to the hospital on 7/13/24. Patient 1 was intubated and on a ventilator. Review of the physician’s order dated 7/15/24 at 1208 hours, showed to place Patient 1 on the non-violent restraints on the left and right wrists as the patient was “unable to follow directions, unsafe.” Review of the Restraint Episode showed Patient 1 was restrained on the left and right wrists at the following times on 7/15/24: - At 1254 hours, Patient 1’s BUE soft wrist restraints were initiated due to the patient’s behaviors of “interfering with medical care, devices, tubes/drains”. The goal criteria for releasing restraints were “Medical devices, tubes, and dressing removed”. - At 1400 and 1600 hours, Patient 1’s BUE soft wrist restraints were continued for the same reason. - At 2000 hours, the reason for requiring the BUE soft wrist restraints was “Behavior interfering with medical care, devices, tubes/drains. Unable to follow instruction; unsafe”. However, review of Patient 1’s RASS assessments showed Patient 1’s RASS score were -4, or deeply sedated, continuously on 7/15/24 from 1100 to 1700 hours. At 1900 and 2000 hours, Patient 1’s RASS score was -5 or unarousable. 2. On 8/29/24 at 1003 hours an observation in the ICU was conducted. RN 1 was observed providing care to Patient 2 in Room A. Patient 2 was observed lying in bed with two padded siderails. Patient 2’s eyes were closed. RN 1 approached Patient 2 and communicated she would be providing oral care to the patient. Patient 2 opened and closed his eyes intermittently while receiving oral care. Patient 2 appeared calm and followed simple directions to open or close his mouth. Patient 2 was not observed with restraints and his limbs were free. Review of Patient 2’s open medical record was initiated on 8/30/24 at 0900 hours with the Director of Nursing Quality and RN 3. Patient 2’s medical record showed the patient was admitted to the hospital on 8/23/24, for symptoms of alcohol withdrawal and trauma. Review of the Restraint Episode dated 8/29/24 at 1000 hours, showed Patient 2 was in four-point soft restraints for the behaviors interfering with medical care, devices, tubes/drains, being unable to follow the instructions, and being unsafe. The restraint behavior description showed Patient 2 was attempting to pull the lines and tubes, and get out of bed. The above concerns were shared and acknowledged by the Patient Safety Officer, Director of Nursing Quality, and RN 3.”

“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: 36703 Based on interview and record review, the hospital failed to ensure the hospital’s P&P related to education and training was implemented when NA 1 did not complete the annual abuse training as per the hospital’s P&P. This failure increased the risk of substandard care to the patients. Findings: Review of the hospital’s P&P titled Department Policy and Procedure Manuals dated July 2022 showed under the Education, Training and Competency Determination section, the Re-Orientation would be performed annually. On 8/30/24 at 1131 hours, an interview and concurrent review of NA 1’s training records was conducted with the Senior Staff Analyst. Review of the Re-Orientation Handbook, including “Abuse Prevention, Sexual Abuse, Sexual Coercion (Inappropriate Behavior Toward a Patient)” was not completed annually for NA 1. NA 1 had the abuse training from the Re-Orientation Handbook on 8/21/22 and 8/30/24. The Senior Staff Analyst was informed of and acknowledged the above findings.”