Wynn Hospital

“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: 48296 Based on document review and interview, issues that were identified during a hospital investigation did not have actions for improvement developed or implemented. Findings include: -- Per review of facility investigative meeting minutes, the facility identified issues during a code blue event. There was no documentation that the issues identified had action plans developed or implemented. A thorough investigation was not completed. -- During interview of Staff A, Clinical Staff, on 10/2/2025 at 11:00 am, they confirmed the above finding.”

“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: 36617 Based on document review, observation, and interview, surgical services staff did not follow generally accepted standards of practice and/or facility policies and procedures (P&P). Specifically, 1) hand hygiene was not done as required. 2) Hair clipping in the operating room (OR) was not done as required. 3) Staff brought personal items into the OR. 4) Staff did not follow safety procedures with laser use. 5) The facility lacked a P&P pertaining to personal items in the OR and lacked instructions on laser use safety procedures. See Findings in Tag A0951.”

“CONTENT OF RECORD: INFORMED CONSENT CFR(s): 482.24(c)(4)(v) [All records must document the following, as appropriate:] Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent. This Standard is not met as evidenced by: 36617 Based on document review, medical record (MR) review, and interview, 8 of 10 MRs reviewed, Patient #1 - Patient #8, the facility failed to ensure properly executed informed consent forms were completed prior to a surgical procedure. Specifically, anesthesia consent forms lacked required information. Findings include: -- Review of the facility’s policy and procedure titled “Advanced Directives, Consents and Medical Decisions Management Plan,” dated 10/17/2024, stated “written consent document form must contain at least the following: if the procedure is non-emergent, and is expected to involve either local or general anesthesia, the name of all physician(s), dentist(s), and podiatrist(s) who are reasonably expected to be involved in the procedure(s) ... name, signature, and date of provider(s) performing the procedure ... every blank should be filled in before the patient or responsible person signs and it is witnessed.” -- Review of Patient #1’s MR revealed a Consent for Anesthesia Services Form had verbal consent documented by the patient’s sister on 8/30/2024. This form indicated the patient would receive general anesthesia (causes the patient to be completely asleep during the procedure). The consent form provided an area for a practitioner signature. It stated, “I consent to the anesthesia service checked above and authorize that it be administered by _____ ... “ The space for the practitioner’s name was left blank. -- Review of Patient #2’s MR revealed a Consent for Anesthesia Services Form signed by the patient on 4/3/2025. This form indicated the patient would receive general anesthesia. The consent form provided an area for a practitioner signature. It stated, “I consent to the anesthesia service checked above and authorize that it be administered by _____ ... “ The space for the practitioner’s name was left blank. -- Review of Patient #3’s MR revealed a Consent for Anesthesia Services Form signed by the patient on 3/14/2025. This form indicated the patient would receive general anesthesia. The consent form provided an area for a practitioner signature. It stated, “I consent to the anesthesia service checked above and authorize that it be administered by _____ ... “ The space for the practitioner’s name was left blank. -- Review of Patient #4’s MR revealed a Consent for Anesthesia Services Form signed by the patient on 4/2/2025. This form indicated the patient would receive general anesthesia, and a nerve block (injecting of local anesthetic near a nerve or group of nerves to temporarily block pain). The consent form provided an area for a practitioner signature. It stated, “I consent to the anesthesia service checked above and authorize that it be administered by _____ ... “ The space for the practitioner’s name was left blank. -- Review of Patient #5’s MR revealed a Consent for Anesthesia Services Form signed by the patient and interpreter from language line information added on 3/13/2025. This form indicated the patient would receive general anesthesia, nerve block and invasive monitoring via an arterial line (inserting a catheter into a patient’s artery to continuously monitor blood pressure). The consent form provided an area for a practitioner signature. It stated, “I consent to the anesthesia service checked above and authorize that it be administered by _____ ... “ The space for the practitioner’s name was left blank. -- Review of Patient #6’s MR revealed a Consent for Anesthesia Services Form signed by the patient on 4/9/2025. This form indicated the patient would receive general anesthesia and nerve block. The consent form provided an area for a practitioner signature. It stated, “I consent to the anesthesia service checked above and authorize that it be administered by _____ ... “ The space for the practitioner’s name was left blank. -- Review of Patient #7’s MR revealed a Consent for Anesthesia Services Form signed by the patient on 4/1/2025. This form indicated the patient would receive general anesthesia. The consent form provided an area for a practitioner signature. It stated, “I consent to the anesthesia service checked above and authorize that it be administered by _____ ... “ The space for the practitioner’s name was left blank. -- Review of Patient #8’s MR revealed a Consent for Anesthesia Services Form signed by the patient 2/24/2025. This form indicated the patient would receive general anesthesia. The consent form provided an area for a practitioner signature. It stated, “I consent to the anesthesia service checked above and authorize that it be administered by _____ ... “ The space for the practitioner’s name was left blank. -- During interview of Staff A, Registered Nurse on 4/14/2025 at 9:00 am, they acknowledged the above findings.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 36617 Based on document review, observation, and interview, surgical services staff did not follow generally accepted standards of practice and/or facility policies and procedures (P&P). Specifically, 1) hand hygiene was not done as required. 2) Hair clipping in the operating room (OR) was not done as required. 3) Staff brought personal items into the OR. 4) Staff did not follow safety procedures with laser use. 5) The facility lacked a P&P pertaining to personal items in the OR and lacked instructions on laser use safety procedures. Findings related to (1) include: -- Review of the facility’s P&P titled “Hand Hygiene,” revised 10/2024, indicated handwashing or hand antisepsis is to be done immediately after glove removal. -- Per observation on 4/14/2025 at 9:40 am, Staff B, Registered Nurse (RN) removed their gloves in the OR and left the OR to get the patient supplies. Staff B did not perform handwashing/hand antisepsis after removing their gloves. This finding was confirmed by Staff B at the time of observation. -- Per observation on 4/14/2025 at 9:45 am, a surgical technologist removed their gloves and walked out into the core area (large hallway between ORs with clean and sterile supplies) to obtain surgical supplies for the upcoming case. They did not perform handwashing/hand antisepsis after removing their gloves. This finding was confirmed by Staff C, RN at the time of observation. Findings related to (2) include: -- Review of the facility’s P&P titled “Pre-Operative/Pre-Procedure Management,” revised 6/2024, indicated “should hair removal be recommended for a specific procedure, a clipper should be utilized ... When hair removal is required, it should be done as close to the start of surgery as possible. The removal of body hair is never to occur in the surgical suite, unless in a true emergent situation.” -- Per observation in the OR on 4/14/2025 at 10:45 am, a patient being prepared for brain surgery had their hair clipped in the OR suite prior to the surgery being performed. This finding was confirmed by Staff C, RN at the time of observation. -- Per interview of Staff D, Interim Director of Surgical Services on 4/10/2025 at 9:50 am, surgeons should only clip patients’ hair in the OR in an emergency situation or if patient was not prepped adequately. -- Per interview of Staff E, RN on 4/11/2025 at 1:55 pm, surgeons have been clipping patients hair around the surgical site in the OR suite. There is a spot in the timeout section of the medical record (MR) to document whether a patient was clipped in the OR. -- Per interview of Staff F, Chief of Surgery on 4/11/2025 at 4:00 pm, they were not aware that patients were being clipped in the OR and indicated they needed to be clipped in the pre-operative area. -- Per interview of Staff G, RN on 4/14/2025 at 10:20 am, there needs to be a provider order in the MR to clip patients in the pre-operative area. It is mostly being done in the OR. -- Per interview of Staff H, Nurse Manager on 4/14/2025 at 11:50 am, clipping of patients is mostly done in the OR. They are trying to have surgeons put in an order for it to be done in pre-op. -- During interview of Staff D on 4/14/2025 at 12:10 pm, they acknowledged the above findings. Findings related to (3) include: -- Per interview of Staff I, RN on 4/10/2025 at 10:50 am, a certified registered nurse anesthetist (CRNA) recently entered the OR suite for a procedure with a large purse and placed it on the anesthesia cart. -- Per interview of Staff E, on 4/11/2025 at 1:55 pm, anesthesia staff come into the OR with satchels, purses, coffee mugs, and briefcases. Staff E has not reported these concerns to administrative staff. -- Per interview of Staff J, CRNA on 4/14/2025 at 10:30 am. Staff J indicated being trained at another facility, and they were allowed to bring personal items into the OR as long as they could be wiped down. Staff J brings their leather purse into the OR. -- During interview of Staff D, on 4/14/2025 at 12:10 pm, they acknowledged the above findings. Staff D indicated there is no P&P that addresses bringing personal items into the OR. Staff D stated, it is an AORN (Association of periOperative Registered Nurses) standard that personal items not be brought into the OR. (AORN develops and maintains standards and guidelines for perioperative nursing practice, ensuring patient safety and quality care.) Findings related to (4) include: -- Review of the facility’s education titled “Laser Safety in the Perioperative Suite,” dated 1/2023, laser safety signs must be placed at all entrances to alert anyone entering the OR that the laser is in use. All staff must use eye protection approved for the specific laser. This education does not instruct staff on what should be documented in the MR. -- Per review of facility P&Ps, they do not have a P&P to instruct staff on laser use. -- Per interview of Staff K, Operating Room Nurse Manager on 4/10/2025 at 9:40 am, safety is very important in the OR, all staff are educated. There is a laser cart in the hall and a check list that should be completed in the MR. All staff should wear laser goggles including, the patient. There should be a safety sign placed on the outside of the OR door to alert any staff who enter room. -- Per interview of Staff D, on 4/10/2025 at 9:50 am and 4/11/2025 at 3:30 pm, laser use in the OR requires a sign be placed on the door indicating laser in use. Safety goggles should be worn by all staff, sometimes surgeons opt not to. -- Per interview of Staff I, RN on 4/10/2025 at 10:50 am, there are precautions that should be taken when using lasers in the OR. There should be a sign on the door that the laser is in use, and all staff should wear goggles. During a few cases Staff I participated in, no one was wearing goggles and no sign was placed on the door. There is a place in the MR to document the laser safety measures taken and Staff I stated it is not always filled out. -- Per interview of Staff B, RN on 4/10/2025 at 11:20 am, other staff don’t always put the laser sign on the door to alert other staff prior to entering the room. -- Per interview of Staff L, Charge Nurse on 4/10/2025 at 2:35 pm, there is a laser safety cart available in the hall with goggles and signage for the door. Staff L does not think it is mandatory for everyone to wear goggles. -- Per interview of Staff E, RN on 4/11/2025 at 1:55 pm, there is a safety checklist used when a laser surgery is performed. There should be a sign posted on the door. Goggles are available, but you can’t force staff to wear them. -- During interview of Staff D, on 4/14/2025 at 12:10 pm, they acknowledged the above findings. Staff D indicated there is no P&P pertaining to the use of lasers in the OR.”

“PATIENT CARE ASSIGNMENTS CFR(s): 482.23(b)(5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the specialized qualifications and competence of the nursing staff available. This Standard is not met as evidenced by: 21072 Based on document review and interview, nursing staff in the neonatal intensive care unit (NICU) providing nursing care to babies on ventilators lacked evidence of ventilator training in 3 of 3 NICU nurses personnel files reviewed. Findings include: -- Per review of Staff A, B, and C’s personnel files, they lacked evidence of training on ventilators. -- Per interview of Staff C on 1/14/2025 at 9:16 am, the NICU can keep ventilated babies for up at 72 hours. Staff C recalled providing care to a baby on a ventilator. Staff C indicated they would like education related to taking care of babies on ventilators. -- Per interview of Staff D on 1/14/2025 at 9:42 am, the NICU can keep ventilated babies up to 3 days. Staff D stated they are not trained to take care of ventilators. -- Per interview of Staff E on 1/14/2025 at 10:34 am, if a baby is ventilated, respiratory therapy (RT) manages the ventilator and nursing cares for the baby. -- Per interview of Staff F on 1/15/2025 at 2:45 pm, some nurses are very comfortable taking care of ventilated babies and some are not. -- Per interview of Staff B on 1/15/2025 at 9:30 am, they described an instance of multiple births that occurred. The babies were on ventilators for approximately 6 hours. Respiratory therapy (RT) managed the ventilators and nursing staff monitored the babies. Staff B is not trained on ventilators. -- Per interview of Staff A, on 1/15/2025 at 10:40 am, they feel staff are not adequately trained to take care of ventilated babies. -- Per interview of Staff G and Staff H on 1/16/2025 at 8:55 am, there is no policy and procedure for ventilators specific to the NICU, additionally the NICU nurses do not receive ventilator training.”

“INFORMED CONSENT CFR(s): 482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. This Standard is not met as evidenced by: 48296 Based on document review, medical record review, and interview in 4 of 11 medical records reviewed, Patient #1, Patient #6, Patient #7, and Patient #11, the facilty failed to ensure properly executed informed consent forms were completed. Specifically, anesthesia consent forms lacked required information. Findings include: -- Review of the facility’s policy and procedure titled, “Advanced Directives, Consents and Medical Decisions Management Plan,” dated 10/17/2024, indicated “written consent document form must contain at least the following: if the procedure if non-emergent, and is expected to involve either local or general anesthesia, the name of all physician(s), dentist(s), and podiatrist(s) who are reasonably expected to be involved in the procedure(s) ... name, signature, and date of provider(s) performing the procedure ... every blank should be filled in before the patient or responsible person signs and it is witnessed”. -- Review of Patient # 1’s medical record, revealed a Consent for Anesthesia Services Form signed by the patient on 12/24/2024. This form indicated the patient would receive monitored anesthesia care (a form of anesthesia). The consent form provided an area for a provider signature. It stated “I consent to the anesthesia service checked above and authorize that it be administered by _____”. The space for the provider name was left blank. -- Review of Patient # 1’s medical record, revealed a Consent for Anesthesia Services Form signed by the patient on 12/26/2024. This form indicated the patient would receive monitored anesthesia care. The consent form provided an area for a provider signature “I consent to the anesthesia service checked above and authorize that it be administered by _____”. The space for the provider name was left blank. -- Review of Patient # 6’s medical record, revealed a Consent for Anesthesia Services Form signed by the patient on 12/24/2024. This form indicated the patient would receive general anesthesia, post op (operative) ventilator (a device that assists in breathing) support, and invasive monitoring via an arterial line (catheter inserted into an artery that provides continuous blood pressure monitoring). The consent form provided an area for a provider signature. It stated “I consent to the anesthesia service checked above and authorize that it be administered by _____”. The space for the provider name was left blank. -- Review of Patient # 7’s medical record, revealed a Consent for Anesthesia Services Form signed by the patient on 12/26/2024. This form indicated the patient would receive general anesthesia and invasive monitoring via an arterial line. The consent form provided an area for a provider signature. It stated “I consent to the anesthesia service checked above and authorize that it be administered by _____”. The space for the provider name was left blank. -- Review of Patient # 11’s medical record, revealed a Consent for Anesthesia Services Form signed by the patient’s sibling (authorized by the patient) on 1/10/2025. This form indicated the patient would receive general anesthesia. The consent form provided an area for a provider signature. It stated “I consent to the anesthesia service checked above and authorize that it be administered by _____”. The space for the provider name was left blank. -- Per interview of Staff G, on 1/16/2025 at 9:00 am, they acknowledged the above findings.”

“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: 32908 Based on medical record (MR) review and interview, in 1 MR (Patient #4) of 4 MRs reviewed, the medical care provided was inconsistent with generally acceptable standards of professional practice. Specifically, the MR lacked documentation that a practitioner physically assessed the patient who was experiencing an elevated heart rate (HR), elevated respirations, and pain (possible gastrointestinal discomfort) over a prolonged period of time. This lack of documentation and physical assessment could affect the quality of care provided to patients. Findings include: -- Per MR review, Patient #4 was admitted on 8/10/2024 after presenting to the emergency department with shortness of breath. Past medical history included Trisomy 7 (a chromosomal condition where a person has three copies of chromosome 7 instead of two), congenital glaucoma, seizure disorder, intellectual disability, nonverbal at baseline, and chronic upper and lower extremity contractures. Admission diagnoses included shortness of breath, aspiration pneumonia and dysphagia (difficulty swallowing). On 8/13/2024 a Rapid Response was called for the patient being unresponsive. After assessment and interventions, the patient was stabilized and transferred to the intermediate medical care unit (IMCU). After a 10-day stay in IMCU, the patient was transferred to a medical/surgical unit on 8/23/2024. This same day the patient had percutaneous endoscopic gastrostomy (PEG) tube placement (a feeding tube surgically placed into the stomach through the abdomen). Tube feedings were started, and the patient seemed to be tolerating them. On 8/25/2024 at 12:00 pm, nursing documented HR = 134, respirations = 25, blood pressure (BP) = 90/54, oxygen saturation (SpO2) = 100%. On 8/25/2024 at 1:14 pm, provider documented patient with past medical history significant for Trisomy/Epilepsy, admitted with recurrent aspiration pneumonia, weight loss and poor PO (by mouth) intake. Due to malnourished state and concern for nutritional status, patient underwent PEG tube placement 8/23/2024. Patient examined at bedside, resting in bed comfortably, tolerating tube feedings, hypoglycemia resolved. No fever or chills. Vital signs, lab work reviewed, case discussed with primary nurse. On 8/25/2024 the following vital signs and pain assessments were documented by nursing: - 2:00 pm - HR = 120, respirations = 22, SpO2 = 100%. - 3:00 pm - HR = 124, respirations = 24, SpO2 = 57%. - 4:00 pm - HR = 113, respirations = 17, BP =106/79, SpO2 = no documentation. - 5:00 pm - HR = 98, respirations = 23, SpO2 = no documentation. - 6:00 pm - HR = 112, respirations = 23, SpO2 = no documentation. - 7:04 pm - medicated with Tylenol, patient yelling out which indicative of pain/repositioned, continued to moan. - 7:07 pm - SpO2 = 100 % on room air, patient at rest. - 7:20 pm - shift assessment (in part). Sinus tachycardia (heart is beating faster than normal). Abdomen; flat, gastrostomy tube, bowel sounds (all quadrants) active, abdominal tenderness, soft, passing flatus (gas). Respirations; regular, unlabored. Bilateral breath sounds diminished. Comfort; pain medication, repositioned - 7:44 pm - pain level = 6, no location documented. - 11:03 pm - order for tramadol (a pain medication) 50 mg tablet every 6 hours as needed for moderate pain and morphine sulfate 2 mg injection every 4 hours as needed for severe pain. - 11:10 pm - pain level = 7, no location documented. - 11:14 pm - HR = 124, respirations = 24, SpO2 = 57%. - 11:15 pm - HR = 131, respirations = 36, SpO2 = not documented. - 11:16 pm - HR = 142, respirations = 49. Patient moaning out since writer arrival on floor, Tylenol given without effect. HR reaching 150 with MD (physician) updated and new order for Lopressor (a medication to lower HR and BP), IV obtained, patient continues to moan out with large loose stool times 2 during this time frame. Positive results noted following Lopressor. HR low 100’s with patient napping for short interval only, patient then waking up and again thrashing in bed turning sideways so they are flat which writer explained is not safe due to continuous tube feeding (TF). Patient continues with moaning and yelling out. HR now in high 120’s low 130’s. MD again updated with new orders obtained. Writer administering Tramadol (a pain medication). If patient continues to present as though they are in pain, writer will give PRN (as needed) Morphine. -- Per MR review on 8/26/2024 the following vital signs and pain assessments were documented by nursing: - 12:02 am - SpO2 = 100%, several different areas with probes placed for accuracy, digits cold with cyanosis. - 12:04 am - BP 166/125, moved (BP cuff) from left arm to right arm for confirmation. BP remaining elevated arm without movement. - 12:11 am - pain level = 8, pain severe. No location of pain documented. - 12:26 am - HR = 137, respirations = 45, BP = 71/55, SpO2 = 77%. - 1:00 am - pain level = 7, no location documented. - 1:06 am - PRN medication given with patient still moaning out, TF held due to possible gastrointestinal discomfort. HR remains elevated up to 140 (medical aware). PRN Clonidine given for elevated BP with BP down to a systolic of 95. Questioning if patient with abdominal discomfort without residual when assessed, abdomen rounded and firm presenting as did with assessment on 8/24. Patient is reacting with palpation of abdomen, at this time will place Lopressor on hold as per conversation with charge nurse. At 1:30 patient with large BM with HR converting to high 110’s eyes closed sleeping quietly at this time. TF remains on hold will restart at 2:00 am. - 1:59 am - compressions initiated and ongoing. - 3:31 am - at 1:59 am writer walking into patient’s room to restart TF, alarm sounding at time of entering room, patient with oxygen off. Wall monitor showing HR of 0-36 back to 0 due to this writer feeling for carotid pulse, no palpable pulse therefore chest compressions started, and Code Blue initiated. Continuing compressions until relieved by responders to Code Blue. From 8/25/2024 at approximately 1:00 pm until the time of the Code Blue (8/26/2024 at 2:00 am) the MR revealed the patient’s HR was in the 120’s - 140’s, (normal is 60 -100 beats/minute), respirations were 20 - 60 (normal is 12 - 20 breaths/minute), and the patient was moaning in pain (location of pain not specified, possible gastrointestinal discomfort). Nursing documented provider notification with administration of medication interventions, however, there was no documentation that a provider physically assessed the patient from approximately 1:00 pm on 8/25/2024 until Code Blue was called 13 hours later. -- During interview of Staff A, on 11/20/2024 at 2:00 pm, they acknowledged the above findings.”

“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: 21072 Based on document review, medical record review, and interview, the Medical Staff failed to ensure resident physicians were privileged or signed off by their supervising physician to perform the procedures they were performing. These failure were identified in 4 of 4 credential files. Findings include: -- In 6 of 19 medical records reviewed, the resident physicians who performed procedures were not privileged to do so. Please see Tag A-0339.”

“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: 21072 Based on document review, medical record review, and interview, the Medical Staff failed to ensure surgical resident physicians were privileged / signed off to perform the procedures they were performing. Specifically, 1) 5 of 16 surgical resident physicians, Staff A, Staff B, Staff C, Staff D, and Staff E, performing invasive procedures were not privileged to do so. 2) In 6 of 19 medical records reviewed, (Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, and Patient #6) of patients who had an invasive procedure performed, they were performed by a surgical resident physician that was not credentialed to do so. Findings include: -- Review of the Medical Staff bylaws dated 6/25/2020, under section titled Special Conditions for Residents or Fellows in Training, it states, “Residents or fellows in training in the Hospital shall not normally hold membership on the Medical Staff and shall not normally be granted specific clinical privileges. Rather, they shall be permitted to function clinically only in accordance with the written training protocols developed by the residency program directors in conjunction with the residency training program. The protocols must delineate the roles, responsibilities, and patient care activities of residents and fellows including which types of residents may write patient care orders, under what circumstances they may do so, and what entries a supervising physician must countersign. The protocol must also describe the mechanisms through which resident directors and supervisors make decisions about a resident’s progressive involvement and independence in delivering patient care and how these decisions will be communicated to appropriate Medical Staff and Hospital leaders.” -- Reivew of policy and procedure titled “Supervision for Residents,” last revised 8/30/2024, “The supervising physician may be an attending, faculty, chief, senior or junior resident. ... All residents must report to the charge nurse prior to starting any procedure to verify their credentialing status. The resident is considered credentialed for a procedure if credentialed is listed next to the procedure name in New Innovations. ... Urgent patient care issues should be discussed immediately with the attending/faculty. Consultation should be used frequently within the chain of command, as this is optimal for learning, teaching, and patient care.” --Review of email dated 6/6/2024, from Staff F, Graduate Medical Education Department Manager, “Resident Supervision / Procedure Privileging: ... Staff G, Physician Director Graduate Medical Education met with the residents to review elements of the programs updated Supervision Policy. .... The final policy will be released in Policy Stat once finalized: Procedure list and required numbers: To be credentialed for the following procedures every resident (regardless of post graduate year) must hand in 10 fully completed procedures cards with at least 3 with the competency level of Proficient. The following are bedside procedures: Central Venous Insertion, Arterial Cannulation, Chest Tube, Bronchoscopy, Repair of skin / soft tissue lacerations and surgical incisions, excision of lesions under the skin and subcutaneous tissue, and Tube Thoracostomy. MR Reviews -- Review of Patient #1’s medical record revealed, they presented to the emergency department (ED) on 12/29/2023 at 1:10 pm, with a chief complaint of rib injury following an recent assault. The patient had a chest x-ray performed 2 days later (at another location). The results, that had just become available, revealed a right sided pneumothorax (a collapsed lung). Patient #1 complained of right-sided chest pain worse with breathing. Denied any shortness of breath and did not appear to be in any acute distress. They were hemodynamically stable. Case was discussed with general surgery resident. Patient #1 was admitted to their service. Treatment plan included the placement of a chest tube. The consent was obtained by Staff A, Surgical Resident Physician on 12/29/2023 at 6:35 pm for insertion of a ride sided pigtail catheter (type of chest tube). Staff A inserted the chest tube at 9:26 pm. Minimal amount of serosanguineous fluid was evacuated. Post procedure chest x-ray was pending. The patient tolerated the procedure well without any complication. The chest tube came out during the night. Documentation by the attending physician on 12/30/2023 at 2:04 pm indicated, they were available. (Not directly supervising the resident physician.) Review of Staff A’s personnel file revealed that they were not credentialed to perform the chest tube placement procedure. -- Review of Patient #2’s medical record revealed, they presented to ED on 5/20/2024 at 9:36 am from a facility after being found confused with altered mental status. There was a concern of seizures. Patient with a history of tobacco abuse and drug abuse. In the ED Patient #2 was very agitated and was having difficulty breathing. Patient #2 was tachycardic (rapid heart rate) and tachypneic (rapid respirations). Patient was intubated for airway protection and sedated. Chest x-ray showed signs of aspiration pneumonitis. Intravenous antibiotics were initiated. Urine drug screen test was negative. It was suspected that patient could have consumed synthetic drug. 5/22/2024 Patient #2 continued to decline and developed multisystem failure. Hemodialysis (HD) was ordered by nephrology. At 3:25 am, Staff B, Surgical Resident Physician documented the insertion of a right femoral HD catheter via ultrasound. Dialysis was initiated at 7:30 am and stopped at 8:00 am due to the catheter not functioning. Surgery was notified of need for new catheter. At 10:26 am, Staff A documented the insertion a hemodialysis catheter in right internal jugular via ultrasound. The patient tolerated the procedure well and there were no complications. Chest x-ray was performed post procedure, resident informed dialysis nurse of correct placement. Dialysis was resumed. At 11:05 am, X-ray notified nurse of critical result of chest x-ray, regarding new HD catheter placement, possibly in aorta rather than the superior vena cava. General surgery notified dialysis stopped. At 11:30 am, providers at bedside, updated. At 1:05 pm, nursing documented, Patient #2 received 1 hour of HD, no fluid removal. blood pressure remained stable. During treatment, Staff H, Physician entered the room and determined the right jugular catheter placed this morning for HD was not appropriate for use at this time. Patient to go to OR (operating room) or IR (interventional radiology) to receive new catheter. At 2:11 pm, computed tomography (CT) of the chest confirmed catheter on the right inserted into the right brachiocephalic artery with its tip in the ascending aorta. At 4:20 pm, insertion of right groin hemodialysis catheter (revision of surgically placed temporary HD catheter) by interventional radiology. 5/23/2024 At 8:28 am, Staff H, Physician documented, they were “notified after the placement of this line that there was a complication with the placement. The resident is credentialed to perform central line/temporary HD catheter placement, and I was immediately available if needed and was here for indirect supervision of the resident. I was however not aware that this procedure was taking place or officially consulted for this malfunctioning catheter / catheter placement. I was made aware after the fact that confirmation X-ray for line placement indicated catheter in artery and computed tomography angiography (CTA) indicated location at junction of right innominate/subclavian artery. I discussed this with Staff I, Vascular Surgeon and I have arranged for transfer to another medical center after discussing with cardiothoracic (CT) surgeon at that facility via transfer center, as CT surgery is not available at Wynn hospital and will be needed for catheter removal and likely artery repair.” -- Review of Staff A’s personnel file revealed that they were not credentialed to perform the central line/hemodialysis catheter placement procedure. -- Review of Patient #3’s medical record revealed, they presented to the ED from another facility on 10/28/2023 at 2:35 pm with diagnosis of an unwitnessed fall. Patient sustained a laceration to the forehead. The CT of the head was abnormal and therefore further studies were requested. No acute infarct was noted, unfortunately suboptimal study. Patient noted to have a leukocytosis (high white blood cell count). Patient did just finish course of antibiotics for a urinary tract infection and vancomycin for Clostridium difficile. They complained of a headache and generalized weakness. Staff C, Surgical Resident Physician inserted an arterial line in the right femoral artery on 10/30/2023 at 11:30 pm for hemodynamic monitoring. Staff H, Physician documented on 10/31/2023 at 5:11 pm (under procedure note), they were available.(not directly supervising). -- Review of Staff C’s personnel file revealed that they were not credentialed to perform the arterial line catheter placement procedure. -- Review of Patient #4’s medical record revealed, they presented to ED on 11/11/2023 at 11:08 pm after an urgent care visit where he was found to have a spontaneous pneumothorax. Pneumothorax was confirmed by imaging in the ED. It was discussed with the patient that due to the size of his pneumothorax he would need a pigtail chest tube placed and to be admitted for monitoring. At 5:02 am, Staff D, Surgical Resident Physician placed a pigtail chest tube into the right chest. Post procedure chest x-ray confirmed placement. Staff A, was present during entire procedure. On 11/12/2023 at 9:23 am, Staff H, Physician documented “I was not present for the entirety of the procedure(s), but I was readily available for direct supervision.” -- Review of Staff D’s personnel file revealed that they were not credentialed to perform the chest tube placement procedure. -- Review of Staff A’s personnel file revealed that they were not credentialed to perform the chest tube placement procedure. -- Review of Patient #5’s medical record revealed, they presented to the ED on 11/23/2023 at 8:23 pm via ambulance after being hit by a car. The patient had multiple contusions and laceration to the scalp. X-rays were completed and revealed the following: closed nondisplaced fracture of proximal end of left humerus, fracture of sacrum, closed fracture of left inferior pubic ramus, closed fracture of superior ramus of left pubis. Staff E, Surgical Resident Physician, documented on 11/24/2023 at 1:29 am the repair of a right upper frontal bone laceration. -- Review of Staff E’s personnel file revealed that they were not credentialed to perform the repair of skin laceration procedure. -- Review of Patient #6’s medical record revealed, they presented to the ED on 11/3/2023 at 8:02 pm, via ambulance from a nursing home after being found on the floor. When emergency medical services arrived the patient was receiving cardio pulmonary resuscitation (CPR) by staff. Patient was intubated on arrival, required a chest tube for right sided pneumothorax. On 11/4/2023 at 2:04 am - Staff A placed a 36 french chest tube into the right 4th rib. -- Review of Staff A’s personnel file revealed that they were not credentialed to perform the chest tube placement procedure. Staff Interviews -- Per interview of Staff J, Senior Director of Quality Management Systems & Regulatory Affairs and Staff K, Manager, Quality Management, on 10/21/2024 at 12:00 pm, they have heard of issues regarding the residency programs, including surgical residents. There have been quality concerns and concerns regarding the oversight of residents brought to Staff J and Staff K’s by various staff members. There have been MIDAS (online occurrence reporting system) reports generated about surgical residents and adverse events involving surgical residents. If there was an issue with a residents case, the quality department would look at the case and decide what needs to be written up for a report and then send it over to the resident program. If there are issues with a particular resident, those concerns would be brought to the supervising physician. The quality department does not get any follow up to resident concerns. -- Per interview of Staff G, Physician Director Graduate Medical Education, on 10/21/2024 at 2:00 pm, residents are required to have 10 procedure cards turned in for invasive procedures, with 3 indicating they are proficient at performing the procedure before being able to perform the procedure on their own. A senior resident can oversee a junior resident as long as the senior resident is credentialed to perform the procedure. This does not require the attending to be present during the procedure. In an emergency, an uncredentialed resident can perform a bedside procedure. In non-emergent cases, uncredentialed residents that perform bedside procedures without a supervising provider, would require a root cause analysis. The charge nurse has access to the online list of credentialed residents. The nurse has a right to say no to the resident if they are not credentialed -- Per interview of Staff L on 10/22/2024 at 2:22 pm, attending physicians are not around during the day and residents are not supervised. The attending will say there is a senior resident around who can watch patients. There is a weekly Morbidity & Mortality Meeting to discuss complications with residents. Chest tubes are an issue, they have had difficulty inserting. One resident inserted a chest tube and left a foreign body but there were no repercussions. In the intensive care unit (ICU), a resident placed a chest tube and left and it was not working. The resident then returned to put in a second chest tube. Because there is no supervision, they do what they want to. That incident was reported through the Midas system. The bedside nurses in ICU complain about the residents and the lack of supervision. Some providers are immediately available and others are not. Residents are not honest with their concerns for fear of backlash. -- Per interview of Staff H on 10/22/2024 at 2:35 pm, once residents are signed off on a procedure they can perform them independently. There have been discussions about what they are doing. Sometimes the paperwork doesn’t get submitted for credentialing. There are not a lot of senior residents in the program for support. There has been discussion about chest tubes and the program has had a significant overhaul. -- Per interview of Staff M on 10/22/24 at 3:55 pm, there is not a lot of supervision of the residents and the procedures they are performing. If they (residents) get into trouble they will call Staff N, Physician or Staff H equally, they do not call before they do procedures. If nursing staff reach out to the attending they just say “oh, ok.” If nursing staff says something to a resident they respond “they are just going to Midas us anyway.” “One resident when drawing blood gases had multiple missed attempts, using the patient as a pin cushion.” Staff M puts in a Midas report for more than 2 attempts. Another patient had to be transferred due to issues with a hemodialysis catheter placement by a resident. Staff N will have residents change ventilator settings after a blood gas is resulted. The residents will ask Staff M, what they should do? Staff M indicated that it is not nursing’s role to make that decision. -- Per interview of Staff O on 10/23/2024 at 10:05 am, there have been issues identified with chest tube insertions. One resident placed an central line into the aorta. There was also an issue with a first year resident, they were not able to reach an attending and proceeded to put chest tube in themselves. Recently, Staff O was consulted to go to the ED for a trauma case. The chest tube was already placed however, it was not in the lung it was exterior to the ribcage A thoracic surgeon was called and then they placed the chest tube. During this same case, 2 residents were not able to place a femoral line and the senior resident had to be notified. The residents procedure notes do not reflect any complications that occur during procedures. -- Per interview of Staff P on 10/28/24 at 2:35 pm, residents do not always let the nurse know when they are doing a procedure, so nursing is unable to check if they are credentialed to perform a procedure.. -- During interview of Staff K on 10/28/2024 at 12:15 pm, they acknowledged the above findings.”

“INFORMED CONSENT CFR(s): 482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. This Standard is not met as evidenced by: 36617 Based on document review, medical record review, and interview in 4 of 31 medical records reviewed, Patient #2, Patient #4, Patient #7, and Patient #8, the facilty failed to ensure properly executed informed consent forms were completed. Specifically, surgical consents for procedures performed by surgical resident physicians were incomplete and/or incorrect. This could cause patients to be unaware of the procedure to be performed on them. Findings include: -- Review of the facility’s policy and procedure titled, “Advance Directives, Consents and Medical Decisions Management Plan,” revised 2/2024, indicated “an informed consent must contain the following ... name and description of the surgery in terms understandable by the patient. ... Name, signature, and date of the provider(s) performing the procedure ... Every blank should be filled in before the patient or responsible person signs and it is witnessed.” -- Review of Patient #2’s medical record revealed the document titled, “Consent for Operative and/or Diagnostic Procedures and/or Treatment,” dated 5/20/2024 at 5:23 pm, indicated it was for placement of an arterial line. The space for the provider name was left blank. Staff B, Surgical Resident Physician signed the consent electronically on 5/29/2024 (9 days after the procedure was performed). A consent form dated 5/22/2024 at 1:43 am for placement of a hemodialysis catheter, the name of the procedure being performed was left blank. A consent form dated 5/22/2024 at 9:10 am for placement of a hemodialysis catheter, the space for provider name was left blank. Staff A, Surgical Resident Physician electronically signed the consent on 5/29/2024 (7 days after the procedure was performed). -- Review of Patient #4’s medical record revealed the informed consent form was dated 11/23/2023 at 3:47 am, for the placement of a chest tube was signed by the emergency department (ED) physician. However a surgical resident physician inserted the chest tube. The residents name was not on the consent form. -- Review of Patient #7’s medical record revealed the informed consent form dated 8/3/2024 at 12:13 pm, lacked the name and signature of the provider performing the procedure. -- Review of Patient #8’s medical record revealed the informed consent dated 12/12/2023 at 3:20 pm, lacked the name and signature of the provider performing the procedure. -- Per interview of Staff G, Physician Director Graduate Medical Education on 10/21/2024 at 2:00 pm, informed consent forms should contain the name of the resident performing the procedure.”

“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: 21072 Based on document review, medical record review and interview, the facility failed to ensure compliance with the Condition of Participation of Emergency Services. Specifically, the facility failed to address Patient #1’s presenting symptoms of 10/10 headache, screaming in pain, slurred speech, and altered mental status. This could lead to a patient not being provided with appropriate treatment. Findings include: -- Hospital staff failed to monitor a patient (Patient #1) who presented to the emergency department with a 10/10 headache, screaming in pain, slurred speech and altered mental status. See Tag A1104.”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 21072 Based on document review, medical record review, and interview, in 1 of 20 medical records reviewed, the hospital failed to provide appropriate care to Patient #1. Specifically, the facility failed to address Patient #1’s presenting symptoms of 10/10 headache, screaming in pain, slurred speech, and altered mental status. This could lead to a patient not being provided with appropriate treatment. Findings include: -- Per review of facility’s policy and procedure (P&P) titled, EMTALA - Screening, Stabilization, Management of Transfers and Recordkeeping; Reporting Suspected EMTALA Violations, last revised 1/3/2023, “A Medical Screening Examination is an ongoing process, not an isolated event. As screening and treatment progress the record must reflect continued monitoring according to the individual’s needs and must continue until it is determined that the individual does not have an Emergency Medical Condition or is Stabilized or Appropriately Transferred. ... Scope of Examination - A Medical Screening Examination is the process required to reach, within reasonable clinical confidence, the point at which it can be determined whether an Emergency Medical Condition exists or not. The scope of the examination must be tailored to the presenting complaint, signs and symptoms, and the medical history of the individual. The process may range from a simple examination (such as a brief history and physical) to a complex examination that may include laboratory tests, MRI or diagnostic imaging, lumbar punctures, other diagnostic tests and procedures, information from other sources (e.g. pre-hospital care providers, law enforcement, family or friends as applicable), and the use of on-call Physician specialists. A medical record documenting the history and physical examination, and any special reports such as consultations, clinical laboratory, x-ray, etc., will be created to document the Medical Screening Examination. ... A Medical Screening Examination is an ongoing process, not an isolated event. As screening and treatment progress, the record will reflect continued monitoring according to the individual’s needs and continue until it is determined that the person does not have an Emergency Medical Condition or the person is Stabilized or Appropriately Transferred.” -- Per review of facility’s policy and procedure (P&P) titled, “Emergency Department Triage Policy,” last revised 2/26/2024, ESI Level 2 is a condition that has the potential to threaten life and limb and requires rapid medical interventions.” -- Per medical record review, Patient #1, presented to emergency department on 3/21/2024 at 10:51 am. Patient #1 triaged as a level 2 on Emergency Severity Index (1 is critical - 5 least urgent) at 11:13 am. At 11:20 am, Patient #1 seen by provider. Note stated “Patient is a [age and gender] with no significant PMH (past medical history) who was brought to emergency department from school due to not being themselves at school. This morning, school called mom and when she went to pick up, he was weak and on wheelchair. Patient reports having 10/10 headache, over forehead, associated with right ear pain, nausea and vomiting. Was recently diagnosed with streptococcal pharyngitis (strep throat) and is currently treated with amoxicillin at home. Today is day 7 of amoxicillin. Denies fever, chills, skin rash, chest pain, shortness of breath, abdominal pain.” Review of systems revealed Patient #1 positive for nausea and vomiting and headaches. Physical exam revealed Patient #1 was in acute distress, screaming in pain, and vomiting at the bedside. Right ear tympanic membrane is erythematous (red). Point of care testing glucose fingerstick showed 297 (normal 70-110. Hyperglycemia is elevated glucose level). Complete blood count, complete metabolic panel, urine analysis, and urine toxicology pending. Chest x-ray also ordered. Medical decision making included Patient #1 vomited twice at the bedside. Differential diagnosis at this time included but not limited to diabetic ketoacidosis (a serious complication of diabetes. signs and symptoms include thirst, frequent urination, feeling a need to throw up and throwing up, stomach pain. weakness, tiredness, shortness of breath, confusion), substance use, acute otitis media, and meningococcal infection. (Meningitis is a serious infection and inflammation of the fluid and membranes surrounding the brain and spinal cord. The inflammation from meningitis typically triggers symptoms such as headache, fever, and a stiff neck.) Complete metabolic panel resulted at 12:43 pm indicated glucose level was 274. Patient #1’s neurological exam at 1:00 pm revealed Patient #1’s speech was garbled. Tylenol (pain medication) was administered at 1:48 pm, (3 hours after presented with 10/10 headache). At 3:02 pm Patient #1’s first temperature (98.5 degrees Fahrenheit) was obtained by staff (more than 4 hours after presenting to the hospital). No further temperatures were documented. Urine resulted at 4:46 pm showed urine glucose 4+ (abnormal), urine protein 1+ (abnormal), urine ketones 1+ (abnormal). Urine toxicology screen results were all negative. At 6:42 pm patient’s transfer disposition set - to transfer to another hospital. At 7:11 pm a pediatric attending consultant assessed the child. The pediatrician’s assessment and plan stated “... based on clinical findings and laboratory results, is unclear what is the etiology of presentation. Patient will benefit for transfer to higher level of care facility for further evaluation and management. At 11:37 pm, Patient #1 was transferred to another hospital via ambulance. Condition was stable. Vital signs were heart rate - 89, respirations - 20, blood pressure - 118/81, and oxygen saturation: 99 %. Denied pain. -- Per interview of Staff A, Physician on 5/24/2024 at 11:50 am, he/she/they recalled the patient was just screaming. His mother stated he was “normal” prior to this event. There were a number differential diagnoses, including substance abuse and diabetic ketoacidosis which can present with altered mental status. -- Per interview of Staff B, Physician, on 5/24/2024 at 12:05 pm, he/she/they said diabetic ketoacidosis can cause altered mental status. Staff B was concerned about possible substance induced problem. Patient had a recent strep infection, so possibly an infectious process. He had no signs of head trauma, he had not fallen or been in a fight, so a head computed tomography was not indicated at the time. -- During interview of Staff C, Manager of Quality Management on 5/24/2024 at 3:00 pm, he/she/they acknowledged these findings.”

“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: 21072 Based on document review and interview, the hospital’s Governing Body did not ensure that the quality of patient care provided by medical staff was appropriately monitored. Though aware of concerns identified in the cardiothoracic surgery program, action was not take to address these concerns. In 9 of 9 mortality and morbidity reviews completed for the facility’s cardiothoracic surgery program cases were not thorough and complete. The reviews failed to describe actions to address opportunities for improvement identified, failed to address patients preoperative health issues, failed to address technical issues identified within cases and failed to bring back a case that was postponed for review at a future meeting. These failures placed all patients at risk for serious harm, serious injury or death. Findings include: -- The facility failed to address issues identified within the cardiothoracic surgery program. (Please see Tag A-0049)”

“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: 36617 Based on medical record review, document review, and interview, the facility failed to ensure midlevel providers were appropriately privileged to perform procedures. These failures were identified in 3 of 7 credential files. This could lead to untoward patient outcomes. Findings include: -- The facility failed to ensure midlevel’s were appropriately privileged to perform procedures. In 1 of 15 medical records reviewed a patient suffered a serious adverse outcome. Please see Tag A-0339.”

“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: 21072 Based on observation, interview, and document review, the hospital’s contracted food service did not consistently implement recognized food safety standards, for example, Hazard Analysis Critical Control Points as adopted by the Food and Drug Administration (FDA) for documenting food temperatures throughout the cooling process. Specifically: (1) 9 large turkey breasts were cooked and cooled without documentation of the critical time and temperatures required for the cooling process, (2) a 4-gallon container with chicken noodle soup and 4-gallon container with cheese sauce were cooled without documentation of the complete cooling times and temperatures, and (3) documented cooling logs to track proper cooling of hazardous foods were not consistently maintained. Additionally, this lack of compliance was also not resolved after being identified in several monthly safety meeting minutes. Failure to monitor temperatures and cooling of foods can result in untoward outcomes for patients and staff. Regarding finding (1) include: -- Per observation and tour of the kitchen on 5/23/24 at 10:00 am, the walk-in meat cooler had 9 approximately 12 pound turkey breasts wrapped in foil on carts, with stickers dated 5/23/2024 indicating they were cooked and cooling. -- Per interview of Staff SS, Production Manager, on 5/23/2024 at 10:00 am, the 9 turkey breasts were rapidly cooled in the blast chiller. -- Review of policy and procedure titled “Guidance on Cooling of Time/Temperature Controlled for Food Safety,” last revised 1/29/2021, indicated turkey breasts should be cooled from 140 to 40 degrees Fahrenheit under Hazard Analysis Critical Control Points timed protocols and documented in cooling logs to verify compliance. -- Per interview of Staff TT, Director of Food & Dietary Services, on 5/23/2024 at 4:10 pm, they indicated that the cooling logs documentation for the turkey breasts were not completed. He/she/they was unable to determine if the turkey breasts were properly cooled. (The 9 turkey breasts were discarded by facility staff.) Regarding finding (2) above: -- Per observation on 5/24/2024 at 10:45 am, there were 2 - 4 - gallon plastic containers stored in the walk-in meat cooler. One container was being used to cool chicken noodle soup (approximately 1 gallon of soup at an 8-inch depth) and the other container was being used to cool cheese sauce (approximately 2 gallons of sauce at a 10-inch depth). -- Review of policy and procedure titled “Guidance on Cooling of Time/Temperature Controlled for Food Safety,” last revised 1/29/2021,” indicted soup and cheese sauce should be cooled from 140 to 40 degrees Fahrenheit under Hazard Analysis Critical Control Points timed protocols and documented in cooling logs to verify compliance. Also, to expedite rapid cooling, food should be in shallow pans, less than 2 inches deep, and in stainless steel containers to conduct cooling transfer. -- During interview of Staff TT and Staff UU, on 5/24/2024 at 10:45 am, they did not have completed cooling logs for the soup or cheese sauce. Staff UU indicated the cheese sauce had partial log temperatures started but the cooling process was not finished at the end of the staff shift (log documentation only reached 68 degrees Fahrenheit vs 40 degrees Fahrenheit or below as required), and the missing final temperatures were not monitored by any staff next shift. (The soup and cheese sauce were discarded by facility staff.) Regarding finding (3) above: -- Review of food cooling logs for the period of 11/1/2023 - 5/23/2024 revealed that logs were not consistent or complete, for example: - On 11/7/2023, a roast turkey breast was documented to have started the Hazard Analysis Critical Control Points chilling process at 3:00 pm, but without any temperatures recorded for the start and completion of cooling. - On 1/15/2024, 4 containers of chicken and dumplings were documented to have started the Hazard Analysis Critical Control Points chilling process at 1:20 pm, with an initial temperature recorded at 190 degrees Fahrenheit, but no other cooling temperatures recorded for the completion of cooling. - On 4/10/2024, chicken was documented to have started the Hazard Analysis Critical Control Points chilling process at 8:44 am, with an initial temperature recorded at 182 degrees Fahrenheit, but no other cooling temperatures recorded to show completion of cooling. -- Review of Safety Committee Meeting Minutes from meetings conducted on 11/28/2023, 12/13/2023, 1/10/2024, and 2/21/2024 revealed that Staff VV, Food Safety Manager, had documented that Hazard Analysis Critical Control Points food temperature logs were incomplete or not being done consistently. Though additional training was listed as the corrective action for each of these months, there was no documentation provided to ensure that the ongoing issues were resolved. -- Per interview of Staff TT on 5/24/2024 at 11:10 am, they confirmed no other cooling logs or documents were available.”

“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: 21072 Based on document review and interview, the hospital’s Governing Body did not ensure that the quality of patient care provided by medical staff was appropriately monitored. Though aware of concerns identified in the cardiothoracic surgery program, action was not take to address these concerns. In 9 of 9 mortality and morbidity reviews completed for the facility’s cardiothoracic surgery program, the reviews were not thorough and complete. The reviews failed to describe actions to address opportunities for improvement identified, failed to address patients preoperative health issues, failed to address technical issues identified within cases and failed to bring back a case that was postponed for review at a future meeting. These failures could lead to poor patient outcomes. Findings include: -- Per review of document titled “Cardiothoracic Surgical Case Review,” in 5 of 9 reviews completed, the facility failed to take action on opportunities for improvement that were identified. -- Per review of document titled “Cardiothoracic Surgical Case Review,” in 1 of 9 reviews completed, the facility indicated there were opportunities for improvement, the facility failed to identify what they were. -- Per review of document titled “Cardiothoracic Surgical Case Review,” in 2 of 9 reviews completed, the facility failed to address patients’ preoperative comorbidities. -- Per review of document titled “Cardiothoracic Surgical Case Review,” in 1 of 9 reviews completed, a case was requested to be brought back to next review meeting. The facility failed to bring back this case for discussion. -- Per review of document titled “Cardiothoracic Surgical Case Review,” in 1 of 9 reviews completed the facility failed to address complications that occurred during a case and failed to address technical issues that were identified within the case review. -- Per interview of Staff I, Chief Quality Officer, and Staff J, Quality Management Supervisor and Staff F, Quality Professional, on 3/21/2024 at 9:20 am and other dates and times throughout the survey, mortality reviews are sent to the office of the surgeons. Cases are sent the week prior to the meeting for the surgeons to review. The cardiothoracic surgery case reviews are interdisciplinary, which include nursing and anesthesia concerns. The surgeons round on each other’s patients together and are aware of all the cardiac surgery patients. The reviews are completed by the surgeon that was not involved in the surgery. Staff I indicated they are aware that the cardiothoracic surgery program has elevated mortality rate and that there are concerns within the cardiothoracic surgery program. -- Per interview of Staff I and Staff BC, Director Quality Management and Regulatory Affairs on 5/2/2024 at 8:53 am and 10:34 am, cardiothoracic surgery case reviews have identified concerns in the cardiothoracic surgery program. Reviews are not addressing the appropriateness of cases being taken. Nursing concerns have been identified. They are aware there needs to be changes within the cardiothoracic surgery program. -- Per interview of Staff BD, Assistant Vice President of Cardiac Services, on 5/2/2024 at 8:55 am, during a recent meeting regarding cardiothoracic surgery it was identified that there are risks being taken that shouldn’t be. There have been conversations started surrounding referring out cardiac surgery patients. -- Per interview of Staff BE, Chief Medical Officer on 5/6/2024 at 9:00 am, they are aware of problems within the cardiothoracic surgery program. -- Per interview of Staff BF, Sr. Director of Critical Care on 5/2/2024 at 11:40 am, they are aware of issues with mortalities in the cardiothoracic surgery program. Staff BF is also aware of issue with nursing staff and medical staff. -- Per interview of Staff AE, Physician on 5/2/2024 at 2:22 pm, various factors can come in to play with patient mortalities. Staff AE indicated there are issue in the ICU. “There is no cardio thoracic intensivist overnight, just a bedside nurse.” -- Per interview of Staff J on 5/3/2024 at 8:52 am, cardiothoracic surgery mortalities are a known area of concern. High level meetings to talk about increased mortality rate have occurred. -- Per interview of Staff I on 5/3/2024 at 4:46 pm, the chair of surgery, human resources and quality are aware of the issues in the cardiothoracic surgery program. There are a variety of problems in the program. The Hospital Chief Executive Officer has discussed having someone come it to help to ensure the program can go forward. The whole program needs to be revamped. -- Per interview of Staff AI, Acting Director of Nursing Administration on 5/6/2024 at 1:00 pm, there have been some issues with the cardiothoracic surgery program pertaining to mortality, quality, and physician issues. -- Per review of Medical Executive Meeting Minutes, dated 3/12/2024, two governing body members were in attendance as well as the Hospital Chief Executive Officer, Chief Medical Officer, and Chief Quality Officer. The minutes revealed “There will be new upcoming initiatives on mortality reviews.” -- Per review of Medical Executive Meeting Minutes, dated 4/11/2024, two governing body members were in attendance as well as the Hospital Chief Executive Officer, Chief Medical Officer, and Chief Quality Officer. The minutes revealed “ ... report on issues with peer reviews outstanding since years. ... The Department of Health (DOH) was looking at one cardiothoracic surgery case. They asked for mortality rate.” -- Per review of Medical Executive Meeting Minutes, dated 5/9/2024, two governing body members were in attendance as well as the Hospital Chief Medical Officer. The minutes revealed “We are in transition right now, we don’t have cardiothoracic surgery as we are being evaluated by the DOH ... DOH issuing an Immediate Jeopardy and they want an immediate plan to demonstrate safety and high quality care for the patients and part of that plan was to pause the program. ... There was extensive discussion about this being a structural and cultural issue in the organization and how things like this happen ...””

“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: 48296 Based on document review, medical record review and interview, 1) in 1 of 1 medical records, Patient #7, the facility failed to follow a patient’s wishes concerning their plan of care. 2) In 5 of 10 medical records of patients receiving anesthesia, the facility failed to ensure a properly executed anesthesia consent form was completed. Specifically, the surgical procedures were abbreviated on the anesthesia consent form. This could lead to the facility providing treatment that does not align with the patient’s plan of care and patients to be unaware of the procedure to be performed on them. Findings regarding 1) include: -- Per medical record review, Patient #7 presented to the facility on 12/21/2023 for a planned transcatheter aortic valve replacement (minimally invasive valve replacement). During the procedure, the valve migrated into the left ventricle after deployment and was unable to be retrieved. Patient #7 went urgently to the operating room for open heart surgery to retrieve the valve. Open heart surgery was successful and Patient #7 was sent to the intensive care unit. Patient #7 had a long hospital course complicated by renal dysfunction and respiratory failure. Patient #7 was refusing treatments and testing and requesting to die. A palliative care meeting was held with Patient #7, Patient #7’s nurse, and social work on 1/11/2024. Patient #7 was “awake, alert, and oriented X 4 and able to provide a good understanding of her medical condition.” Patient #7 verbalized wishes regarding plan of care and wanted to become a do not resuscitate (DNR) and do not intubate (DNI) (place an artificial airway for breathing). Patient #7 had a health care proxy who did not agree with Patient #7’s wishes. During the palliative care meeting on 1/11/2024, Patient #7 rescinded the previous health care proxy in fear their wishes would not be followed. The discussion was deferred and an ethics consult was placed. Patient #7 remained a full code. On 1/13/2024 Patient #7 was changed to a do not resuscitate (DNR) and do not intubate (DNI), two days after they expressed their wishes. -- Per interview of Staff FF, Registered Nurse, on 5/24/2024 at 10:35 am, Patient #7 made their wishes known about wanting to be comfort care. Patient #7’s family did not want to let go. Following the palliative care meeting, a decision was made to wait for family to come in for further discussion. -- Per interview of Staff GG, Nurse Practitioner, on 5/24/2024 at 11:25 am, there was a goals of care meeting with the multidisciplinary team (physicians, nurses, and social work) where Patient #7’s decision making capacity was determined. Patient #7 was able to make her own decisions regarding her care. Patient #7 was a full code but expressed wanting to be comfort measures. Patient #7 understood the outcomes of her decision and again expressed the desire to be comfort care. Patient #7’s health care proxy did not want her to be comfort measures. Patient #7 rescinded her health care proxy. Staff GG ordered an ethics consult due to the disagreement between the patient and the family. -- Per interview of Staff HH, Physician, on 5/24/2024 at 2:25 pm “when patients have capacity, they can make their own plan of care decisions.” Staff HH opined that Patient #7 “probably” should have been made a do not resuscitate (DNR) and do not intubate (DNI) following the palliative care meeting (on 1/11/2024). -- During interview of Staff E, Manager Quality Management on 5/28/2024 at 12:45 pm, they acknowledged these findings. Findings regarding (2) include: -- Review of the facility’s policy and procedure titled, “ Advance Directives, Consents and Medical Decisions Management Plan,” revised 2/2024, indicated an informed consent form should have no abbreviations or acronyms. -- Review of the facility’s policy and procedure titled, “Pre-operative/Pre-procedure Management,” revised 4/2024, indicated the anesthesia department should complete the informed consent for anesthesia. The policy did not address the use of abbreviations on the informed consent. -- Review of Patient #27’s medical record revealed, the document titled, “Consent for Anesthesia Services,” dated 1/2/2024, noted the surgical procedure being performed was “CABG.” (CABG - coronary artery bypass graft) -- Review of Patient #28’s medical record revealed, the document titled, “Consent for Anesthesia Services,” dated 12/3/2023, noted the surgical procedure being performed was “ORIF, Fracture, Vertebra, Lumbar.” (ORIF - open reduction and internal fixation) -- Review of Patient #29’s medical record revealed, the document titled, “Consent for Anesthesia Services,” dated 1/2/2024, noted the surgical procedure being performed was C/S. (C/S - Caesarean Section) -- Review of Patient #30’s medical record revealed, the document titled, “Consent for Anesthesia Services,” dated 12/31/2023, noted the surgical procedure being performed was C/S. (C/S - Caesarean Section) -- Review of Patient #31’s medical record revealed, the document titled, “Consent for Anesthesia Services,” dated 11/9/2023, noted the surgical procedure being performed was C-section. (C/S - Caesarean Section) -- During interview of Staff XX, Educator on 5/8/2024 at 3:10 pm, /they acknowledged the above findings and indicated there should be no abbreviations on an informed consent form.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: 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 ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, 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: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 48296 Based on document review and interview, in 2 of 2 adverse events reviewed, the hospital failed to educate appropriate staff to prevent a recurrence of the events. These failures could lead to poor patient outcomes. Findings include: -- Review of the hospital’s investigation report of an event, involving a patient, dated 10/23/2023, revealed that all registered nursing staff and patient care technician staff were to be provided education. -- Per interview with Staff B, Patient Care Technician on 3/19/2024 at 3:15 pm, Staff B indicated that they have not received any education on feeding patients that are on oxygen masks -- Per interview of Staff A, Clinical Nurse Coordinator for Cardiothoracic, on 3/20/2024 at 12:25 pm, they indicated that after this event all patient care technicians and registered nurses were educated via Net Learning (an electronic online learning system) and during staff huddles on feeding patients who are currently wearing bilevel positive airway pressure and continuous positive airway pressure devices. The facility was unable to provide evidence that registered nursing staff completed this education. -- Review of hospitals investigation report of an event, involving a patient, dated 2/16/2024, revealed “the event has caused us to look at our .... process. ... We will have them go to pre-op ...” There was no documention that staff was educated about the process change. -- Per interview of Staff BG, Registered Nurse (RN) on 3/20/2024 at 9:38 am, they were not aware the preoperative endoscopy inpatients would be coming to to pre-op area prior to their procedure. -- Per interview of Staff BH, RN on 3/202024 at 9:43 am, they were not aware the preoperative endoscopy inpatients would be coming to to pre-op area prior to their procedure. -- Per interview of Staff BI, RN on 3/20/2024 at 9:57 am, they were not aware the preoperative endoscopy inpatients would be coming to to pre-op area prior to their procedure. -- Per interview of Staff D, Director of Perioperative Services, on 3/19/2024 at 11:24 am and on 3/20/2024 at 10:35 am, Staff D acknowledged they did not have documentation that staff had received education to prevent a similar type event.”

“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: 36617 Based on document review, medical record review and interview, the Medical Staff failed to ensure that mid-level providers were privileged or signed off to perform the procedures they were performing. Specifically, 1) 3 of 7 physician assistants, Staff II, Physician Assistant, Staff JJ, Physician Assistant, Staff KK, Physician Assistant, performing or assisting with invasive procedures were not privileged to do so. 2) In 1 of 15 medical records reviewed, (Patient # 15) of patients who had an invasive procedure performed or assisted by a mid-level provider resulted in a serious adverse outcome. This failure to appropriately privilege mid-level providers could place patients at risk for serious harm. Findings regarding 1) include: -- Review of the facility’s document titled, “Bylaws of Mohawk Valley Health System, Part III Credentials Procedure,” dated 6/25/2020, stated “every practitioner practicing at the hospital by virtue of medical staff membership or otherwise, shall, in connection with such practice, be entitled to exercise only those clinical privileges specifically granted to him by the Governing Body. Applications for additional clinical privileges must be in writing. Such requests should specify the type of clinical privileges desired and the applicant’s relevant training and/or experience which would substantiate the granting of such privileges. The applicant must provide additional material documenting this training and/or experience if so requested. Such application shall be reviewed by the chairman of the department or other individual so designated, who will make the appropriate recommendations regarding such clinical privileges to the Credentials Committee.” -- Review of the facility’s document titled, “Rules and Regulations of Mohawk Valley Health System,” dated 6/25/2020, stated “advanced practice practitioners are clinical practitioners who are not authorized to exercise clinical privileges independently. They may provide patient care only under the supervision of a physician with appropriate clinical privileges. Advanced practice practitioners include advanced practice registered nurses (registered nurse practitioner, certified registered nurse anesthetist, certified nurse midwife) and physician assistants.” -- Review of the document titled “Supervising Member Agreement Advance Practice Provider,” dated 6/9/2023, indicated Staff II was supervised by Staff LL, Director of Interventional Radiology who accepted full legal and ethical responsibility for the performance of duties and acts under their supervision. Additionally, the supervising physician accepted responsibility for proper conduct of the advanced practice practitioner in the hospital and to abide by all bylaws, policies, and rules governing the use of advance practice provider. This document was signed by Staff LL. -- Per interview of Staff LL, Physician, Director Interventional Radiology and Supervising Physician for Staff II on 5/30/2024 at 2:00 pm, Staff LL indicated being contracted by the facility. The Physician Assistant, Staff II had been doing thoracenteses in the department. Staff II was instructed how to perform the procedure, watched a number of times, and performed five to ten procedures. The credentialing is performed by the medical director. Staff LL is not involved with credentialing due to being in a private practice. The Physician Assistant (Staff II) was a hospital employee therefore the credentialing and privileging would be their responsibility. Staff LL indicated there were no competencies or skills checklist for the Physician Assistant, Staff II. Staff LL stated they have no documentation of how many thoracenteses the Physician Assistant (Staff II) had performed and was unsure if they were the collaborating physician for oversight of Staff II. -- Per interview of Staff BA, Medical Staff Coordinator on 6/5/2024 at 9:40 am, they discussed the physician assistant hiring process. The medical staffing office determines who will be the supervising physician for the physician assistant once on the job, and they must sign all required paperwork. Additional privileges are obtained by sending a link to the virtual committee and supervising physicians. Each physician assistant must provide 10 proctor cases that go back to Staff BA and then onto the virtual committee. Physician assistants are told they must let Staff BA know that they are requesting additional privileges. -- Per interview of Staff II, Physician Assistant on 6/4/2024 at 4:30 pm, Staff II discussed that this was their first job as a physician assistant and all training had been provided through this facility. Staff II discussed that they were observed performing “a handful” of thoracenteses and then allowed to perform on own without supervision. Staff II discussed that they did not feel supported and did not feel adequately trained. Staff II also discussed that physicians were not always available for consultation. Staff II discussed that they had gone to their supervisor and discussed not feeling supported and receiving inadequate training as a new physician assistant in the organization. -- Per review of Staff II’s credential file, it contained the form titled, “Delineation of Privileges, Appointment Provisional 9/1/2023 - 5/1/2024”. This form listed multiple privileges that were granted to Staff II, including inpatient, outpatient, patient evaluation/assessment, history and physical, instrumental control of vessel bleeding, repair of minor lacerations, minor surgery, major joint injection/aspiration, etc. There was no documentation in Staff II’s credential file indicating Staff II was privileged or signed off on by their supervising physician to perform thoracenteses. Additionally, there was no documentation of training or competency of this procedure indicating 10 procedures were performed and the request for the privilege approved. -- Review of six medical records (Patient’s #16 - #21, dated 9/25/2023 - 2/27/2024), revealed Staff II was performing ultrasound guided thoracenteses in the interventional radiology unit and at patient’s bedside. -- Review of Staff MM’s, Physician Assistant credential file revealed, the form titled, “Delineation of Privileges, Appointment Provisional 12/4/2023- 8/1/2024,” had additional privileges granted for fluoroscopy paracentesis, thoracentesis, spinal puncture diagnostics, etc. -- Review of two medical records (Patient #22 and Patient #23), dated 5/13/2024 and 6/3/2024, revealed Staff JJ, Physician Assistant assisted with surgeries in the operating room. -- Per review of Staff JJ’s credential file, it contained the form titled, “Delineation of Privileges, Appointment 2/1/2023 - 2/1/2025.” This form listed multiple privileges that were granted to Staff JJ, including inpatient, outpatient, patient evaluation/assessment, history and physical, instrumental control of vessel bleeding, repair of minor lacerations, minor surgery, major joint injection/aspiration, cryosurgery, emergency stabilization, etc. There was no documentation that Staff JJ had been privileged to assist with surgeries. -- Review of 2 medical records, Patient #24 and Patient #25, dated 4/16/2024 and 4/30/2024, revealed Staff KK, Physician Assistant assisted with surgeries and robotic surgeries in the operating room. -- Per interview of Staff KK on 6/5/2024 at 12:00 pm, they assist providers with surgery and robotics. Staff KK switches instruments out, puts in ports and sometimes closes skin after procedure. Staff KK assists in surgeries done by the thoracic surgeon and also with obstetrical cases. -- Per review of Staff KK’s credential file, it contained the form titled, “Delineation of Privileges, Appointment 10/1/2023 - 10/1/2025.” This form listed multiple privileges that were granted to Staff KK, including inpatient, outpatient, patient evaluation/assessment, history and physical, instrumental control of vessel bleeding, repair of minor lacerations, minor surgery, etc. There was no documentation that Staff KK was privileged to assist with surgery or robotic surgery. -- During interview of Staff E, Manager of Quality Management on 6/5/2024 at 3:00 pm, they acknowledged the above findings. Findings regarding 2) include: -- Review of Patient #15’s medical record revealed, they presented to the hospital’s ambulatory surgery unit on 12/20/2023 at 9:22 am for evacuation of a hematoma (an abnormal collection of blood outside of a blood vessel) of the left antecubital fossa brachiocephalic AV (arteriovenous) fistula creation site (an access point for dialysis). (Patient #15 had been doing peritoneal dialysis at home) The surgery was cancelled due to the patient’s complaint of abdominal distention, nausea and lower extremity swelling. Patient #15 reported no bowel movement for unknown number of days, tried a laxative, but vomited it all up. The provider requested the patient be admitted to the hospital and worked up for a small bowel obstruction. On 12/21/2023 at 8:57 am a computed tomography of the abdomen indicated there was trace left pleural effusion (accumulation of fluid around the lung), moderate size right pleural effusion, and a small pericardial effusion (accumulation of fluid around the heart). The right pleural effusion and pericardial effusion were larger than prior examination. On 12/22/2023 Patient #15 had a colonoscopy and was found to have massive diverticulosis in the left colon which likely accounted for their constipation. No evidence of colitis. Peritoneal cultures were drawn which did have gram positive cocci (likely staphylococci) growing, for which the patient was started on antibiotics by the infectious disease team. Patient #15 was being treated for a urinary tract infection prior to admission, urine cultures remained positive for gram-negative rods, and treatment with ceftriaxone (antibiotic) continued. Peritoneal dialysis was initiated per nephrology recommendations. On 12/23/2023 at 12:23 pm internal medicine provider documented, patient was assessed and evaluated at bedside. “ ... was sitting up in the chair. Overnight, ... had a rapid response called due to hypotension. ... was given intravenous fluids, started on hydrocortisone injection, and Levophed (medication that increases blood pressure). “Continues to experience LLQ (left lower quadrant) pain especially when coughing or with movement. ... is hypothermic. ... endorses a cough as well. Denied fever chills, sweats, chest pain, shortness of breath, diarrhea, and constipation.” At 5:48 pm a computed tomography scan of the chest revealed, bilateral pleural effusions, right larger than left. These were seen previously as well. There is a small pericardial effusion. Patency of the vessels cannot be determined in the absence of intravenous contrast. There is some areas of atelectasis and patchy infiltrates (parts of lung collapse) at the lung bases, right greater than left. There is no adrenal mass. There are atherosclerotic changes of aorta. There is some fluid in the left upper quadrant suspect for some possible significant ascites (fluid in the abdominal cavity). On 12/25/2023 at 7:08 am, a repeat chest x-ray revealed impression: cardiomegaly (enlarged heart), pleural effusion on the right with loculated (inflammation of the pleura causes scarring and the tissue creates pockets of fluid that prevent the fluid from draining properly) component as before. Improved aeration at the left base. At 3:13 pm, internal medicine provider documented, “Persistent loculated right pleural effusion. Discussed with pulmonology. Obtain computed tomography-guided thoracentesis for further analysis of pleural fluid, cytology and culture. Pulmonology on board.” On 12/26/2023 at 11:29 am, documentation of the interventional radiology thoracentesis procedure indicated, consent was obtained and the patient was educated on the “risks and benefits including but not limited to bleeding, infection, pneumothorax, and trapped (lung can’t fully expand) were discussed. Alternative therapies were reviewed as well. All questions were answered. Consent was given.” He underwent an ultrasound guided thoracentesis performed by Staff II. At 4:56 pm internal medicine provider documented, patient started to experience bright red hemoptysis (bloody sputum) and had rhonchi (abnormal breath sound) post thoracentesis which was new and were not present during the morning assessment. During thoracentesis, 450 cubic centimeters of serosanguinous (bloody) fluid was removed. Post thoracentesis chest x-ray showed 25 percent pneumothorax as a complication. Patient did not receive morning dose of deep vein thrombosis prophylaxis and international normalized ratio (a blood test that measures how long it takes for blood to clot) in the morning was 1.2. Repeat stat chest x-ray showed right sided hydropneumothorax (air and fluid are around the lung) with progressive collapse of right lung. Concern for hemothorax. Call was placed to interventional radiology. Plan for patient to undergo immediate right-sided chest tube placement. Patient #15 continued to decline and on 12/28/2023 at 1:00 pm was taken for a video assisted thoracoscopic surgery (VATS - surgery for diagnosing and treating many conditions affecting the chest area), which was converted to open thoracotomy (opening chest), right lung decortication (removal of the surface layer, membrane, or fibrous cover of an organ, usually the lung to restore normal organ function by removing the tissue that restricts expansion), mechanical pleurodesis (a procedure performed to obliterate the pleural space to prevent recurrent pleural effusions, pneumothorax, or to treat a persistent pneumothorax), and evacuation of 2 liters of clotted blood. Post-operatively he remained intubated and sedated, with two chest tubes in place, and was transferred to the intensive care unit. The patient died on 12/30/2023 at 1:34 am. -- Review of Staff II’s credential file revealed, they were not privileged to perform the thoracentesis procedure. -- Per interview of Staff NN, Physician on 5/29/2023 at 1:40 pm, Staff II had done a number of thoracenteses before the complication with Patient #15. After the thoracentesis was completed a chest x-ray was done a few hours later that indicated there was air in the pleural space. The first chest x-ray looked like a pneumothorax but the follow-up x-ray revealed a larger amount of fluid in the parenchymal (lung) space. There was clearly an air leak and after being made aware Staff NN place a chest tube in the patient. There was blood in the space due to injury to the lung. Staff NN spoke with the patient’s primary physician and the surgical team became involved. Thoracic surgery was not available so the trauma team became involved. Hemothorax is a potential complication of a thoracentesis. There is always potential for lung injury. When you enter the lung and apply suction it could cause a tear in the lung. Typically, when you enter the pleural space you back off a little. Staff II was credentialed to perform the procedure and had been there 4 months. Staff NN was unsure how the staff was credentialed, they had a different provider as a preceptor. Staff II performed the procedure without supervision, but Staff NN was available if needed. After the incident Staff NN indicated sitting down with Staff II and reviewing what to do and what not to do. This was an unusual event, no formal changes were made in the department following this. -- During interview of Staff E, Manager of Quality Management on 5/31/2024 at 12:15 pm, they acknowledged 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: 49168 Based on medical record review, interview and document review, the facility did not ensure a registered nurse adequately supervised and evaluated the treatment of Patient #2’s abnormal critical blood glucose levels. This could increase the risk of adverse outcomes. Findings include: -- Per medical record review, Patient #2 was an elderly patient admitted on 1/5/2024 with shortness of breath and decreased oxygenation. Past medical history included lung disease, cardiac disease, prostate cancer, kidney disease and diabetes. He continued to have decreased oxygenation and shortness of breath. A computed tomography scan revealed multiple masses in both lungs. Patient #2’s orders included point-of-care-testing glucose monitoring before meals and at bedtime. On 1/5/2024 at 3:38 pm Patient #2’s point-of-care-testing glucose fingerstick was 36 (normal range 70 - 110). (Medical record does not provide name of staff member performing point-of-care-testing glucose fingerstick.) At 4:01 pm, 23 minutes after initial fingerstick, point-of-care-testing glucose fingerstick was 91. (Medical record does not provide name of staff member performing point-of-care-testing glucose fingerstick.) -- Per interview of Staff K, Senior Director of Nursing: Medical Surgical and Nursing Quality Staff, on 3/20/2024 at 10:00 am, they stated the staff that performed the point of car glucose testing on 1/5/2024 at 3:38 pm and 4:01 pm on Patient #2 was Staff L, Patient Care Technician. -- Per medical record review, Staff M’s, Registered Nurse end of shift summary documented on 1/5/2024 at 6:24 pm revealed “Assessment per flowsheet. Denies nausea/vomiting. Medicated x 1 for c/o pain with little relief; see eMAR. Napped in long intervals throughout shift. Pills crushed in applesauce per patient request. Turned and repositioned as per flowsheet. All questions answered within scope of practice. Contact precautions maintained. Bed alarm active; call bell in reach; comfort and safety maintained.” -- Review of the facility’s policy and procedure titled “Adult Diabetes Management Policy,” dated 7/2023, indicated the nurse shall be aware of clinical situations that increase the risk of hypoglycemia and observe for signs and symptoms. Refers to provider orders for the treatment of hypoglycemic (low blood sugar) as outlined in “Appendix A: Hypoglycemic Treatment Protocol,” dated 9/2022. Protocol outlines a blood glucose less than 40 requires a STAT (immediately without delay) venous (blood is drawn from a vein) glucose level. Outlines providing immediate treatment to the patient with either specific quantities of glucose gel, juice, soda, or milk. Blood glucose is to be rechecked in 15 minutes. Nursing documentation in the medical record is to include blood glucose results, registered nurse assessment including patient’s response to interventions, vital signs and assessments, notification of provider for any change in condition, and education completed with the patient. The medical record lacked documention by a registered nurse of interventions to address critically low blood sugar, a venous glucose level, an assessment including patient’s response to interventions, vital signs and assessments done when the patient experienced critically low blood glucose level. -- Per interview of Staff N, Senior Nurse Manager, on 3/20/2024 at 2:30 pm, they explained registered nurses and patient care technicians receive blood glucose monitoring education at hire and through eLearning any time there is a policy change. Staff N reviewed the care provided by staff to Patient #2 and felt that staff should have been more closely monitoring Patient #2’s glucose level. Staff N engaged in education with staff involved with Patient #2’s care and communicated care needs to other staff at their nursing huddles. -- Per interview of Staff K, Senior Director of Nursing: Medical Surgical Nursing and Nursing Quality on 3/21/2024 at 1:00 pm, diabetic education went out to all nursing staff and patient care technicians through eLearning on 1/9/2024. Reviewed the list of staff that have completed and have not completed the mandatory diabetic education through eLearning. Staff K acknowledged Staff L had not completed the required diabetic education. Staff K verified Staff M was not on either the completed or incomplete diabetic education lists due to a technical error with his/her/their eLearning account. This error prevented Staff M, along with other staff, from accessing required education for completion.”

“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: 21072 Based on observation, interview and document review, the facility did not provide basic safe practices for medication administration by confirming a patient’s, Patient #12, identity with their arm band prior to administration of medication. This could increase the risk of medication errors. Findings include: -- Per observation on 3/20/2024 at 9:45 am of Patient #12 on 8 West Medical Surgical Unit, a medication vial and patient bar-coded armband were on the countertop inside the room. -- Per interview with Staff O, Registered Nurse on 3/20/2024 at 9:45 am, they acknowledged the above findings. Staff O indicated being assigned to care for the above patient and the bar-coded armband was on the counter at the start of the shift instead of being worn by the patient. They indicated the patient bar-coded armband was used to scan for medication administration. -- During interview with Staff N, Senior Nurse Manager on 3/20/2024 at 10:00 am, they acknowledged the above finding. -- Review of facility policy and procedure titled “Medication Administration and Documentation Policy,” revised 1/2023 indicated all patients are to have a bar-coded armband, if the armband has been removed a new armband must be requested prior to administering medications, even if the patient is known to the clinician. It further stated that “medications may not be administered to a patient without a bar-coded armband in place except during emergency situations and registration downtime.” -- During interview of Staff K, Senior Director of Nursing: Medical Surgical Nursing and Nursing Quality on 3/20/2024 at 1:00 pm, they acknowledged Patient #12 did not have an approved reason to not wear the required bar-coded armband.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 21072 Based on document review, medical record review, interview, and observation (1) in 2 of 10 medical records reviewed, Patient #27 and Patient #28, the facility failed to ensure the pre-procedural documentation was completed before the patient arrived in the operating room. (2) Staff were not following generally accepted standards of practice and facility policies and procedures related to hand hygiene and personal protective equipment. (3) Staff failed to use alcohol based skin preparation/antiseptics properly. This could increase the risk for adverse outcomes in the perioperative services departments. Findings related to (1) include: -- Review of the facility’s policy and procedure titled “Pre-Operative/Pre-Procedure Management,” revised 4/2024 indicated nursing should provide proper preparation of the patient. Ensure the pre-operative checklist is completed in the medical record. -- Review of Patient #27’s medical record indicated they were admitted to the facility on 12/25/2023 with chest pain and was scheduled for coronary artery bypass graft surgery on 1/3/2024. The nursing pre-operative checklist documentation was not completed. -- Review of Patient #28’s medical record indicated they were admitted to the facility on 12/2/2023 after a fall and was scheduled for an open reduction and internal fixation of fractured vertebra, lumbar L3-S1 on 12/3/2024. The nursing pre-operative checklist documentation was not completed. -- Per interview of Staff WW, Interim Director Operating Room on 5/9/2024 at 10:35 am, the pre-operative checklist should be completed by the inpatient unit nurse prior to the patient going to surgery. -- Per interview of Staff XX, Educator on 5/9/2024 at 11:50 am, completion of pre-operative nursing duties has been an ongoing struggle. Staff XX has met with other educators on the nursing units to reinforce the need for floor staff to perform pre-procedure documentation. Staff have been assigned net learning education as well. Education is also provided during hospital orientation. Tip sheets have been posted on units to ensure patients are getting their chlorhexidine gluconate (a special antiseptic cleanser to clean your skin, especially the area on your body where surgery will be performed) baths prior to surgery. -- During interview of Staff E, Manager of Quality Management, on 5/8/2024 at 3:00 pm, they acknowledged the above findings. Findings related to (2) include: -- Review of the facility’s policy and procedure titled “Hand Hygiene,” revised 10/2023 indicated handwashing or hand antisepsis is to be done immediately after glove removal. -- Per observation on 5/10/2024 at 11:40 am, Staff AB, Registered Nurse entered the operating room charge nurse area from the operating room corridor wearing their surgical mask and gloves. Staff AB removed and discarded their surgical mask and gloves. Staff AB did not perform handwashing/hand antisepsis after removing their surgical mask and gloves. -- During interview of Staff WW on 5/10/2024 at 11:45 am, he/she/they acknowledged the above finding. -- Review of the facility’s policy and procedure titled “Surgical Attire,” revised 1/2024 indicated masks will not be worn hanging down from the neck. A fresh, clean surgical mask will be worn for every procedure. The mask will be replaced and discarded whenever it becomes wet or soiled. -- Per interview on 5/13/2024 at 12:50 pm, Staff AC, Surgical Technician, stated they change their mask after lunch but not between operating room cases. -- Per interview of Staff WW on 5/9/2024 at 10:35 am and 5/10/2024 at 9:45 am stated they submitted a Midas (occurrence) report regarding Staff P, (Physician) for ripping off their mask in the operating room after a procedure. Masks should not be taken off until the patient is extubated, there are no patient complications, and the patient is ready to go to the post anesthesia care unit. A new mask should be worn with every case. Staff WW has seen staff with masks around their necks and instructs them to remove them. As soon as a mask comes down it is to be discarded and a new mask worn with every case. -- Per interview of Staff XX, Educator on 5/9/2024 at 11:50 am and 5/10/2024 at 12:30 pm revealed some operating room staff walk around the department with masks hanging around their neck. Masks are to be on or off, not hanging around a person’s neck. Findings related to (3) include: -- Review of the facility’s document titled “Surgical Fire Safety 2024,” (with references to Fire Prevention and Management, Operating Room, Lippincott Procedures, revised 5/2023) indicated to prevent flammable skin prep solutions from pooling or soaking into the linens or patient’s hair, remove materials saturated with the skin prep solution and wick excess solution with a sterile towel to help dry the prep area. Ensure skin prep solutions, especially those that contain alcohol, are allowed to dry thoroughly and fumes are allowed to dissipate before applying surgical drapes or using a potential ignition source. ChloraPrep (contains 2% Chlorhexidine gluconate and 70% isopropyl alcohol) instructions state “avoid getting solution into hairy areas. Hair may take up to one hour to dry. Wet hair is flammable. Do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of three minutes on hairless skin; up to 1 hour in hair”. -- Per interview of Staff QQ, Registered Nurse on 5/6/2024 at 11:05 am stated regarding skin preps, Staff P, Physician uses 70% alcohol in a sterile basin with four 4X4 sponge sticks and uses it from the patient’s neck to ankle bilaterally. The sternum is prepped with the alcohol first away from the incision area. ChloraPrep is then used. Staff QQ has seen Staff P pour the last bit of alcohol left over on the patient. Staff AE, Physician uses ChloraPrep. There is a three minute drying time when ChloraPrep is used, and he/she/they adds another one - two minutes. Per the Association of periOperative Registered Nurses (AORN) you wait one hour with hair and alcohol involved. -- Per interview of Staff AE, Registered Nurse on 5/6/2024 at 11:35 am stated both cardiothoracic surgeons use different skin preps. Staff P takes 70% alcohol and cleanses a patient’s skin from chin to toes and doesn’t wait for it to dry. You’re supposed to wait one hour for the areas to dry. -- Per interview of Staff WW on 5/9/2024 at 10:35 am and 5/10/2024 at 9:45 am, staff brought concerns to him/her/them about Staff P use of alcohol skin preps. There is annual net learning on fire safety in the operating room. Patient safety is the #1 priority.”

“INFORMED CONSENT CFR(s): 482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. This Standard is not met as evidenced by: 36617 Based on document review, medical record review, and interview, in 1 of 10 medical records reviewed, Patient #28, the facility failed to ensure a properly executed informed consent form was completed. Specifically, the surgical procedures were abbreviated on the surgical consent form. This could cause patients to be unaware of the procedure to be performed on them. Findings include: -- Review of the facility’s policy and procedure titled, “ Advance Directives, Consents and Medical Decisions Management Plan,” revised 2/2024, indicated an informed consent form should have no abbreviations or acronyms. -- Review of Patient #28’s medical record revealed, the document titled, “Consent for Operative and/or Diagnostic Procedures and/or Treatment,” dated 12/3/2023, noted the surgical procedure being performed was “ORIF, Fracture, Vertebra, Lumbar L3-S1.” -- During interview of Staff XX, Educator on 5/8/2024 at 3:10 pm, they acknowledged the above finding and indicated there should be no abbreviations on an informed consent form.”

“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: 36617 Based on medical record (MR) review, interview and document review, in 7 of 11 medical records reviewed (Patients #2, #3, #4, #5, #6, #7, #8) the facility did not provide an appropriate medical screening exam to determine if an emergency medical condition existed. Specifically, Patients #2, #3, #4, #5, #6, #7, #8 presented to the emergency department with a chief complaint of a sexual assault and did not have a genitourinary exam performed to determine the extent or presence of any injuries.”

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 48296 Based on observation and interview, the hospital failed to post EMTALA (Emergency Medical Treatment and Labor Act) signage in all areas likely to be noticed by all patients arriving to the emergency department. Specifically, EMTALA signs were not posted in the ambulance entrance area of the ED. This lack of notification could affect patient’s rights. Findings include: -- During a tour of the emergency department on 3/12/2024 at 9:30 am, there was no EMTALA signage posted in the entrance to the emergency department where patients arrive via ambulance. Staff A, Emergency Department Manager, acknowledged this finding at the time of observation.”

“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: 48296 Based on medical record review, interview and document review, in 7 of 11 medical records reviewed (Patients #2, t #3, #4, #5, #6, #7 and # 8) the facility did not provide an appropriate medical screening exam to determine if an emergency medical condition existed. Specifically, Patients #2, #3, #4, #5, #6, #7, #8 presented to the emergency department with a chief complaint of a sexual assault and did not have a genitourinary exam performed to determine the extent or presence of any injuries. Findings include: -- Review of Patient #2’s medical record revealed she, a minor (a person under the age of full legal responsibility), under the age of 16, presented to the emergency department on 11/10/2023 at 12:00 pm following a sexual assault. Patient #2, reported that her mother’s boyfriend had given her marijuana, touched her breasts and abdomen, and placed his mouth on her nipples. Patient #2 denied rectal or vaginal penetration. Patient #2 denied vaginal pain, bleeding, or discharge. An exam was not completed to ascertain the extent or presence of any genitourinary injuries. Patient #2 was instructed to follow up with the Child Advocacy Center and discharged. -- Review of Patient #3’s medical record revealed she, a minor under the age of 8, presented to the emergency department on 12/22/2023 at 11:05 pm for groin swelling and a potential sexual assault. The patient had reported pain in her private area previously, and her mother noted redness and inflammation to the vaginal area and marks on the patient’s back, a complete exam of these areas was not documented. -- Per interview on 3/13/2024 at 1:30 pm of Staff B, Physician, he/she/they were told by the Child Advocacy Center not to complete a sexual assault exam on Patient #3. The Child Advocacy Center also gave direction not to provide post exposure prophylaxis or labs to Patient #3. Staff B takes the direction of the Child Advocacy Center. -- Review of Patient #4’s medical record revealed she, a minor under the age of 18, presented to the emergency department on 12/29/2023 at 5:46 pm following a sexual assault. The patient reported vaginal discharge. There was no documentation of a genitourinary exam. -- Review of Patient #5’s medical record revealed she, a minor under the age of 16, presented to the emergency department on 12/29/2023 at 5:46 pm following a sexual assault. There was no documentation of a genitourinary exam. -- Review of Patient #6’s medical record revealed she, a minor under the age of 8, presented to the emergency department on 1/1/2024 at 5:49 pm following a sexual assault. Patient #6, reported being assaulted by a family friend earlier in the day. Patient #6 reported she was touched in her genitourinary area. The provider documented Patient #6’s genitourinary exam was deferred. Patient #6 was discharged with directions to be seen the following day at the local Child Advocacy Center. -- Review of Patient #7’s medical record revealed she, a minor under the age of 16, presented to the emergency department on 1/14/2024 at 11:23 pm with a chief complaint of a sexual assault. There was no documentation of a genitourinary exam provided. -- Review of Patient #8’s medical record revealed she, a minor under the age of 16, presented to the emergency department on 2/4/2024 at 10:17 pm with a sexual assault. There was no genitourinary exam documented. The patient was discharged with instructions to follow up with the Child Advocacy Center for a full exam. -- Review of facility’s policy and procedure “Sexual Assault: Care of the Pediatric Patient,” last revised 12/2022, indicated “a forensic examination should be completed if a patient presents within 72-hours post assault. If the patient presents more than 72 hours after the assault, he/she should receive a medical screening examination.” -- Per interview on 3/12/2024 at 10:50 pm of Staff I, Physician, providers are specially trained to perform examinations of sexual assault victims. Every provider and physician can perform an assessment/examination of a sexual assault victim. All providers perform examinations and give stabilizing treatment to patients. -- Per interview of Staff J, Emergency Department Medical Director, on 3/13/2024 at 8:30 am, he/she/they opined that the providers are not comfortable doing the pediatric sexual assault examinations. The providers would take care of the medical portion of the exam and ensure the patient is stable. A physical exam would be conducted if there was a concern for bleeding. There is no separate training for providers to learn to do sexual assault examinations, providers use what they have learned during residency. -- During interview on 3/13/2024 at 9:03 am, Staff A, Emergency Department Manager, he/she/they confirmed 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: 32908 Based on document review, medical record review and interview, 1 (Patient #1) of 10 medical records reviewed, of patient’s identified as being at risk for skin breakdown, developed 2 hospital acquired deep tissue injuries (damage to deeper underlying structures overlaid with either intact or non-intact skin, occurring due to prolonged pressure at the bone-muscle interface) to the coccyx/sacral (low back) area and left heel during his admission. Also, nursing staff did not obtain / perform a wound care consult timely. Findings include: -- Review of the facility’s document titled “Skin & Wound Treatment Protocols,” undated, indicated a “Stage 1 pressure injury is red non-blanchable intact skin that is localized and located over a bony prominence or under a device. Dark purple maroon or appearance of blood staining/pooling at center treat as suspected deep tissue injury. For a partial thickness loss wound or Stage 2 pressure injury is skin with a partial thickness loss shallow open wound red/pink wound bed without slough or an intact or open/ruptured serum filled blister.” Nursing interventions include to make provider aware and order wound team referral (consult). -- Review of the facility’s policy and procedure titled “Wound Management and Documentation Policy,” revised 4/2023, “the provider orders a Wound/Ostomy Nurse Evaluate & Treat Referral or nursing orders a Nursing Request for Wound Care Evaluation, this will provide proper record of the wound team notification and allow wound/ostomy care team opportunity to review information prior to performing consult and/or making recommendations.” -- Review of Patient #1’s medical record indicated he was admitted to the hospital on 4/25/2023 with a diagnosis of hemorrhagic cerebral vascular accident (stroke). Skin was documented as warm, dry and intact in the emergency department. - On 4/25/2023 - Care plan stated “Skin / Tissue - Integrity - Goal: Skin integrity remains intact” - On 4/28/2023 - (3 days after admission) nursing documented a Stage 1 or 2 pressure ulcer at coccyx/sacral region. - On 5/3/2023 (patient transferred to neurological intensive care unit) - nursing documented red/ruddy area to buttock/sacrum. - On 5/12/2023 - (15 days after a Stage 1 or 2 pressure ulcer in the coccyx/sacral region was documented) an initial wound care consult documented identified a newly hospital acquired deep tissue injury to sacrum and buttocks. - On 6/2/2023 - nursing documented a Wound Team Assessment: Unstageable pressure injury to coccyx/bilateral buttocks that extends down to perirectal skin. - On 6/8/2023 - preoperative surgical note: 11 centimeter x 5 centimeter debridement (removal) of dry eschar (dead skin) with underlying Stage 3 sacral decubitus (pressure ulcer). - On 6/10/2023 - nursing documented wound care reconsulted for left heel wound. (No wound care consult found.) - On 6/13/2023 - nursing (wound care) documented Stage 3 pressure injury coccyx/buttock/perirectal. - On 6/26/2023 - nursing (wound care) documented Stage 3 pressure injury coccyx/bilateral buttocks/perirectally improving with current treatment evidenced by increased healthy vibrant red granulation tissue and less slough perirectally and throughout wound. - On 7/12/2023- (one month after wound care consulted for heel) nursing (wound care) documented Spenco boots (provide relief of pressure for the feet, heels and ankles), in Envella bed (powered hospital support surface for use in the treatment and prevention of pressure ulcers), heels assessed and are intact no redness. - On 7/31/2023 - nursing documented wound consult placed for white discoloration of left heel, skin prep and Allevyn applied. - On 8/1/2023 - general surgery documented re-consulted for possible debridement of sacral decubitus ulcer and possible osteomyelitis (bone infection). Surgical debridement of the ulcer last done 6/8/2023. Magnetic Resonance Imaging of pelvis found edema (swelling) in the terminal cooccygeal segments raising the possibility of osteomyelitis. Nursing (wound care) documented left heel with small 0.5 centimeters x 0.5 centimeters area of skin discoloration, wound base purple discoloration, overlying skin is more white and macerated. periwound without redness, warmth or induration. Patient is on Envella bed, Spenco boots are in place while in bed, despite interventions appears that there is a small pressure injury to the left heel. Will monitor area for staging. - On 8/10/2023 - nursing (wound care) documented patient is seen for worsening left heel wound. Wound measures 4 centimeters x 4 centimeters. “Wound base with purple hue and white discoloration surrounding the purple hue. Patient is in Envella bed at this time, has protective Spenco boots on. The foot naturally wants to turn out to the left. Pressure does not seem to be coming from when he is in the bed. However, the area is larger than last assessment. Spoke with bedside registered nurse to see if patient is still getting up to the chair. Was informed that he still gets up every day into the chair. Pressure may be from heels resting on footrest when Patient #1 is up in the chair. Recommend betadine to area, cover with ABD (highly absorbent dressing that provides padding and protection for large wounds), Kerlix rolled bandage. When up in the chair patient should wear z-flex boots (fully offloads the heel and redistributes pressure over the Achilles) at all times.” Left heel deep tissue injury not present on admission. Also on this day, case management documented “team meeting held with patient’s wife, unit registered nurse manager, surgeon, surgical residents, bedside registered nurse, charge registered nurse, registered nurse case manager and this worker. Plan decided that patient will again have surgical intervention for wound and discussion of possible wound vacuum (a device that removes pressure over the area of the wound and can help it heal) and diverting colostomy (surgery that diverts stool away from the sacral/coccyx pressure ulcer to avoid contamination of the ulcer and allow for healing to occur)”. - On 8/11/2023 - sacral wound debridement, wound vac placed and diverting loop sigmoidostomy done. - On 8/17/2023 - nursing (wound care) documented seen for follow up of left heel deep tissue injury. Discharge plan to anticipate 6-8 weeks of systemic antibiotic therapy for confirmed osteomyelitis proximal coccyx - On 8/21/2023 - case management documented patient continues with wound vacuum and new colostomy. Per staff patient is doing much better feeding himself. Patient remains on intravenous antibiotics. - On 8/28/2023 - nursing (wound care) documented “patient was seen today for follow up left heel wound and left buttock from wound vacuum/rectal tube tubing. Wound Assessment: Left heel deep tissue injury 2.9 centimeters x 3.3 centimeters black intact discoloration, surrounding white tissue then purple discoloration, boggy but tissue intact. Recommend continue treatment. Continue left heel dressings and offloading interventions, heel stable blackened eschar.” - On 9/6/2023 - general surgery documented consulted for Stage 4 sacral decubitus ulcer managed with a wound vacuum. At this time the patient is not a good candidate for any reconstruction given his poor nutritional status. -- During interview of Staff A, Wound Ostomy and Continence Nurse on 11/29/2023 at 4:00 pm, he/she/they recalled Patient #1 had a skin (coccyx/sacral) area of concern when he was in the intensive care unit. He had a deep tissue injury that was initially treated with Santyl (ointment that removes dead tissue from wounds) and dry to moist dressings. The area was purple and then opened up. A surgical consult was ordered for debridement of the deep tissue injury. Staff A acknowledged the above findings regarding the coccyx/sacral pressure ulcer. -- Per medical record review on 8/10/2023 at 4:42 pm, Staff A documented the left heel deep tissue injury was not present on admission.”