Christus St Michael Health System

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 40989 Based on the document review and interview, the hospital failed to: 1. protect, intervene, and report immediately the physical harm and abuse inflicted on Patient #8 by non-hospital personnel. 2. have a policy or process to administer Midazolam (Versed-a benzodiazepine medication commonly used for sedation and anesthesia) and Droperidol (an antiemitic and amnesia medication with a black box warning for cardiac risks) off label (using a drug for a purpose not specifically approved by the FDA) for the use of a psychiatric behavioral medication emergency in in 2 (Patient #8, #6) of 2 patient medical records reviewed. The deficient practices were identified under the following Conditions of Participation and were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death. Refer to Tag A0144 3. ensure nursing de-escalated, assessed, and reassessed 2 (Patient #4 and #5) of 2 patients after the administration of a chemical restraint. 4. ensure that only a physician ordered a chemical restraint/emergency behavioral medication as required by the Texas Administration Code, Title 26 Rule 320.119(b), and follow the hospital policy titled, “Standardized Use of Restraint and/or Seclusion” in 2 (Patient #4 and #5) of 2 medical records reviewed. 5. ensure a physician or trained Registered Nurse (RN) performed a face-to-face evaluation within 1 hour of the administration of the chemical restraint/emergency behavioral medication in 2 (Patient #4 and #5) of 2 patient medical records reviewed. Refer to Tag A0160”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 32143 Based on review and interviews, the governing body (GB) failed to ensure that an adverse patient safety event was fully investigated, and preventive actions recommended were measured, analyzed, and tracked in 1 (Patient #8) of 1 patient reviewed. Refer to Tag A0286”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 40989 Based on the document review and staff interview, the hospital failed to: 1. ensure Patient #8’s right to receive care in a safe setting. The hospital failed to protect Patient #8 from physical harm and abuse by non-hospital personnel, failed to intervene during the incident, and failed to report the abuse immediately. 2. have a policy or process to administer Midazolam (Versed-a benzodiazepine medication commonly used for sedation and anesthesia) and Droperidol (an antiemetic and amnesia medication with a black box warning for cardiac risks) off label (using a drug for a purpose not specifically approved by the FDA) for the use of a psychiatric behavioral emergency in 2 (Patient #8, #6) of 2 patient charts reviewed. The deficient practices were identified under the following Conditions of Participation and were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death. Findings: Patient #8 was transported to the hospital by EMS and escorted by Bowie County Sheriff Officers (BCSO) for medical care on 5/16/2025 after a suicide attempt. A review of the hospital’s self-reported incident revealed that Patient #8 was physically abused by the BCSO and Emergency Medical Services (EMS) Personnel while in the care of the hospital. Patient #8 A review of the medical record for Patient #8 was completed in the administrative conference room on 7/21/2025-7/23/2025 with Risk Manager (RM) Staff #9 and Staff #11 Registered Nurse (RN) navigator. The navigator assists the surveyor in navigating through the medical record. Patient #8 was a 21-year-old male who presented to the Emergency Room (ER) on May 16, 2025. He was transported to the hospital by EMS after an alleged suicide attempt. He was escorted by 2 Bowie County Sheriff Officers (BCSO). Upon arrival, Patient #8 was noted to be handcuffed with his arms behind his back due to aggressive behavior. A review of the Triage Nurse note documented by RN Staff #5 dated 5/16/2025 at 10:10 PM revealed that Patient #8 was, “Pt BIBA (brought in by ambulance) with BCSO at the side. C/O (complains of) ingestion of approximately 100 ibuprofen (per pt), suicidal, delirium, and aggressive behavior. Pt is handcuffed behind the back and on an EMS cot upon ED arrival. Pt is continuously yelling/screaming profanities and threatening EMS personnel and BCSO. Unable to obtain much information from pt due to aggression and belligerent outbursts. EMS reports pt has been spitting, kicking, biting, and cursing continuously, all in route and upon ED arrival. EMS reports they were called by pt mother due to pt acting delirious and threatening suicide; pt has a small abrasion to the left FA, no bleeding noted, wound is open to air. Unable to obtain full orientation status because the patient will not calm down enough to answer questions. Pt appears to be oriented to self, but unsure about other orientation status due to not being able to get answers from pt. EMS personnel and BCSO at side until pt is more calm. Physician #16 aware of pt upon ED arrival” Patient #8 was taken to ER Room #1 by EMS and BCSO upon arrival at 10:10 PM. A review of Physician #16’s orders dated 5/16/2025 at 10:13 PM revealed Patient #8 was ordered the following medication. Versed 5mg injection STAT (a sedative primarily used as a moderate sedation before surgery or during a procedure. This drug may cause amnesia and requires monitoring. Adverse effects: variations in blood pressure and heart rate, impaired balance and gait, sedation, respiratory depression, and retrograde amnesia. Adverse effects may be potentiated by other medications, like analgesics.) There was no indication for use. The medication administration record (MAR) stated RN Staff #5 administered the medication intramuscularly to the left anterior thigh at 10:17 PM. Droperidol 5mg Injection STAT (an antiemetic medication used to reduce nausea and vomiting and as an amnesia agent before surgery or diagnostic procedures. It does have a black box warning for cardiac risks). There was no justification for use documented on the medication order. The MAR stated the nurse administered the medication IM to the right anterior thigh at 10:20 PM. A review of Physician #16’s note dated 5/16/2025 at 10:22 PM was as follows: “21-year-old male (Patient #8) presents to the Emergency Department with a suicide attempt, taking 100 pills of Ibuprofen. He is escorted by EMS and police department and has been combative with first responders and arrives handcuffed, screaming at staff. The police department did not report any obvious evidence of an overdose. Additionally, EMS reports they did not note any significant trauma. The initial call was made by the family in relation to the suicide attempt. Patient was able to be verbally de-escalated during transport, but became combative upon arriving at the ER ...He is in acute distress ...Bruising to the left face with 1 1-centimeter laceration to the left upper lip ...Tachycardia (fast heart rate) ...agitated, aggressive, hyperactive, combative ...” Medical Decision Making Differential diagnosis includes agitated delirium, sympathomimetic abuse, metabolic acidosis secondary to NSAID overdose, and intracranial hemorrhage. This is a 21-year-old male who arrives combative with staff and PD. In order to facilitate care after verbal de-escalation had failed medications for acute agitation were administered, including 5 mg of Versed and 5 mg of Droperidol. After this had been given but before it had taken effect patient bit his lip, which began to bleed rather profusely, compromising his airway with frequent coughing and gagging. At this time, a decision was made to intubate the patient to protect his airway and for further behavioral control. While the equipment is being prepared the medications did take effect and patient became very somnolent as expected. For this reason, sedation was avoided for RSI and simply used additional paralytics. Patient’s ingestion was greater than 1 hour prior to arrival per report, no indication for activated charcoal or gastric lavage, and none was recommended by poison control, see discussion in ED workup tab. The ED workup documented on 5/16/2025 at 10:15 PM revealed Physician #16 spoke to poison control, and it was recommended to administer IV fluids and monitor for GI upset. Stated that in very high overdoses can lead to metabolic acidosis. Benzodiazepines to be administered for seizures, if any occur. Recommended 4-6 hours of observation. Case #76020695. After intubation patient has had some hypotension, which presumably will correct with sufficient IV hydration given the amount of his base deficit. He was given 2 Amps of bicarb for the short-term in the ER. Midazolam and fentanyl were preferred for PO sedation medications, anticipating that the patient will be positive for methamphetamines and unable to rule out methamphetamine overdose as the true origin of the patient’s symptoms given his agitation on arrival ...” There were no documented indications that patient #8 would be positive for Methamphetamines. A review of the documentation by RN Staff #5 on 5/16/2025 was as follows: “10:15 PM revealed Patient #8 was handcuffed due to physical/violent aggression towards EMS and BCSO. Patient is also having to be physically held down by EMS personnel and BCSO due to kicking even while being restrained in handcuffs. Respirations 23. Physically and verbally aggressive, exaggerated, and overly dramatic. Impaired judgement with moderate confusion. Violent restraint and physical hold by BCSO and EMS personnel. 10:17 PM Patient is verbally and physically aggressive. Expressing feelings of threats. Versed 5mg IM administered to the left anterior thigh. Patient is no longer restrained due to the discontinuation of physical hold. Respirations 22. Impaired judgement with moderate confusion. 10:22 PM Behavioral Health Emergency. Physically and verbally aggressive. Droperidol 5mg IM was administered to the right anterior thigh. Patient is no longer being restrained due to discontinuation of physical hold. Respirations 21. 10:27 PM Behavioral Health Emergency. Pt is verbally and physically aggressive. Expressing feelings of threats. Physical hold discontinued-no longer meets criteria. 10:32 PM Behavioral Health Emergency. Pt is verbally and physically aggressive. Expressing feelings of threats. Pt is no longer being physically restrained due to discontinuation of the order. 10:40 PM Due to patient’s extremely aggressive behavior, unable to obtain a full set of vital signs at this time. Vital signs-Temperature 98 F, Pulse 134 (normal rate 60-100), Respirations 22 (normal rate 16-20), Oxygen level 98%, Blood Pressure 157/61 (normal level 120/80) ...” An interview was conducted with RN Staff #11 on 7/22/2025 after 11:30 AM. RN Staff #11 was asked what time the handcuffs were removed from Patient #8. RN Staff #11 stated, “On the restraint monitoring record, it shows that the restraint was released at 10:17 PM.” RN Staff #11 was asked if that release was for the handcuffs or the physical hold. RN Staff #11 stated, “It must be for the hold because there is no documentation when the cuffs were released”. RN Staff #11 was asked if there was any documentation that Patient #8 reportedly “bit his lip” other than the physician note. RN Staff #11 confirmed that Physician #16 was the only caregiver who documented that the patient bit his lip. There was no documentation by the nursing staff on when or if patient #8 had bitten his lip. RN Staff #11 was asked if the BCSO or the EMS personnel had hit the patient in the face and caused the 1-centimeter laceration. Staff #11 confirmed the nursing staff failed to document how or when the laceration to the cheek occurred and did not document that the patient was assaulted by EMS personnel and BCSO. An interview with RN Staff #5 was conducted on 7/23/25 at 8:15PM. the nurse stated that when the decision was made to intubate, the physician and NP came into the patient’s room and asked “what happened here? _____ (Staff #4) stated I don’t know.” Staff #5 did not report the incident to the physician. Staff #5 reported MD was focused on trying to protect the airway due to patient being held down and medications impairing the patient’s airway. RN Staff #5 confirmed that the BCSO and EMS were holding patient #8’s legs and shoulders down to the bed while he was handcuffed. Staff #5 stated the patient was held when he came in, while he was receiving medications and afterwards until the patient was intubated. However, on 5/16/25 at 10:17pm staff #5 documented, “Patient is no longer restrained due to the discontinuation of physical hold.” Staff #5 was asked why the nurses and ER staff did not apply physical restraints for the safety of the patient? Staff #5 stated “like what? Soft restraints? The surveyor stated, “any type you have in the ER to ensure the patient was safely restrained to prevent harm, soft restraints, leathers. Whatever you had.” Staff #5 stated, “no. we didn’t.” Staff #5 confirmed the EMS personnel tried to put a mask on the patient because he was spitting but it kept coming off.” Further review of the medical record revealed RN Staff #4 started an intravenous line, and blood was collected to send to the lab for further testing. On 5/16/2025 at 10:40 PM, Patient #8 was intubated (an endotracheal tube was placed into the patient’s airway to assist with breathing) with a Glidescope (a video camera used to assist with placing the endotracheal tube) by Physician #16 placed on a ventilator. A review of the Intubation note dated 5/16/2025 at 11:58 PM by Physician #16 revealed the procedure was performed in an emergent situation. Rocuronium (a fast acting paralytic medication used to intubate a patient) was administered at 10:39 PM for the intubation. A review of the procedure note documented 5/17/2025 at 12:15 AM by Nurse Practitioner (NP) #19 revealed that a 2-centimeter laceration to the left cheek was repaired with sutures, and no complications were noted. The NP did not document on the cause of the laceration. A review of the ER course documented by Physician #16 on 5/16/2025 at 11:32 PM revealed Patient #8 was in Metabolic Acidosis, secondary to the Ibuprofen overdose. Metabolic Acidosis is when there is too much acid in the blood, and this can be caused by an overdose of non-steroidal anti-inflammatory drugs (NSAID). Ibuprofen is an NSAID. According to the National Center for Biotechnology Information (NCBI), Ibuprofen toxicity can result in tachycardia (fast heart rate) and hypotension (low blood pressure). Symptoms include confusion, agitation, and nausea/vomiting. Patient #8’s lab results revealed there was no Methamphetamines present. Review of Patient #8’s vital signs revealed that at 10:48 PM his heart rate was 139 and his blood pressure was 109/37, at 11:03 PM his heart rate was 137 and his blood pressure was 110/31, at 11:18 PM his heart rate was 145 and blood pressure was 119/33, at 11:30 PM his heart rate was 117 and blood pressure was 108/34. The patient was administered multiple doses of sodium bicarbonate (a medication used to treat metabolic acidosis) and placed on a Levophed (a medication to treat life-threatening low blood pressure) drip to control his hypotension. A review of the NP’s history and physical documented on 5/17/2025 at 12:45 AM revealed Patient #8 was admitted to the Intensive Care Unit on 5/17/2025 with profound Metabolic Acidosis, intentional ibuprofen overdose, Altered Mental Status, Acute Respiratory failure, intubated and sedated. The physical exam revealed the patient had swelling to his left jaw, laceration to the left forearm, laceration to the right hand, lacerations x 3 to the left hand, and scratches tracking down the right arm. On 5/17/2025 at 11:57 AM, the Nurse Practitioner in the ICU ordered a CT scan of the Head/Brain for an Altered Mental Status that resulted in no acute intracranial hemorrhage or skull fractures. And a non-specific finding of left periorbital soft tissue swelling. A CT Maxillofacial for facial bruising was ordered on 5/17/2025 at 12:00 PM by the NP in the ICU. The CT resulted in Nasal, left periorbital, and left facial soft tissue swelling. No acute facial fractures, globe rupture, lens dislocation, or retrobulbar hemorrhage. During an interview on 7/23/2025, after 2:30 PM with RN Staff #11, it was confirmed that the only injuries documented by the ER nurses were the left forearm when he arrived in the ER. A review of the hospital’s Event Record #14201 was completed on 7/21/2025 with RM Staff #9 after 10:00 AM. The event record included two written statements by RN Staff #4 and RN Staff #5. The statements were as follows: Reported by RN Staff #4 on 5/17/2025 6:47 AM: “Upon entering the room, EMS and Law Enforcement personnel were physically restraining the patient. His behavior was violent. He was making verbal threats to rape, kill, and haunt staff. During this time, the patient was handcuffed behind the back and being physically restrained to the bed. He attempted to kick the medic that was holding down his left arm. After this attempt, the medic punched him several times on the left side of his face. While this nurse was attempting to secure an IV for sedation, the patient continued to fight EMS and Law Enforcement. The same medic asked me twice if there were cameras in the room. He asked the officer across from him who was holding down the patients left leg if his body camera was on, and if so, would he turn it off. The officer complied and turned off his body camera. The medic began again punching the patient on the left side of his face and grabbing him forcefully by the jaw. I secured the IV and walked out of the room. I returned to the room shortly after when BLS crew informed me they were suctioning blood from his mouth as he was coughing and gagging. I notified the provider who determined at that point we would need to secure the patients airway with intubation.” Reported by RN Staff #5 on 5/17/2025 6:47 AM. “Entering the ED room 1 with (RN Staff #4); I observed the patient on EMS cot. Medic, EMT, BLS crew, and 2 BCSO officers are surrounding patient on cot, speaking with him. Patient is handcuffed behind the back due to physical aggression (assaulting first responder staff) and threats towards EMS personnel and BCSO officers. Patient is moved from EMS cot to ED stretcher, still handcuffed behind his back. Patient continues to yell/curse/scream/threaten EMS personnel as well as BCSO officers, saying things like, “I’m going to f****** kill you! I’m going to haunt you in your mother f****** dreams! You’re all sad!” Even after multiple attempts at verbal redirection from EMS personnel, BCSO officers, and hospital staff, patient is still extremely aggressive verbally and physically which he is a threat to his own safety and everyone around him. As I am trying to get report from the medic, I am at the top of the bed near the patient’s head. While the medic is attempting to give me report, the patient continues to say profanity and curse at the medic. I informed the medic, “hey, I’m not really able to hear you, can we step over there (talking about away from the patient) so I can maybe hear you better?” Patient continues to shout profanity at medic, medic then pushes his hand onto patient left side of face, pushing his head into the ED stretcher; patient is still handcuffed behind his back. Other staff (EMS personnel and BCSO) are still physically restraining patient due to severity of aggression at this time. Patient continues to say profanity and curse which at this time the medic started to hit patient on left side of his face; unknown amount of times patient was hit, but at least 2-3 times if not more. Patient was continuing to shout profanity and continuing to be physically aggressive (kicking, spitting, biting) and still being physically restrained. I was able to administer IM droperidol to patient’s right thigh. At some point after administering the medication, maybe 1-2min after, the patient was trying to continue to move around out of bed, the shorter BCSO hit the patient at least 2-3 times in the left side rib area. At this point in time, myself and (RN Staff #4), left out of ED room to notify (Physician #16) of medications being administered and what is our next step, to which he informs me, “let’s give the meds approx. 10-15min and then if he is still very agitated, we will intubate him for his safety and ours.” I went to go inform EMS personnel and BCSO of this information given by (Physician #16). Upon entering the room again, one of the EMS people are suctioning blood out of the patients mouth as well as small amount of blood on ED stretcher next to patient’s mouth. I then went to inform (Physician #16) of this information, and he determined it was time to intubate.” An interview was conducted with RN Staff # 5 on 7/23/25 at 8:15 PM. Staff #5 stated that she came back into the patient room and saw the EMT suctioning the patient’s mouth, but it was a little bit of saliva that was blood-tinged.” There was no found documentation in the patient’s chart of coughing or gagging. The document revealed that the Administrator on call, Staff #3, was notified on 5/17/2025 at approximately 7:00 AM. Staff #3 notified the Chief Executive Officer (CEO) and CNO approximately 9:45 AM on 5/17/2025 and advised the staff that an investigation was in process. Staff #3 notified the RM, Staff #9, at approximately 9:45 AM on 5/17/2025. An interview was conducted with Chief Nursing Officer (CNO) Staff #2 and Risk Manager (RM) Staff #9 on 7/22/2025 at 10:35 AM. Staff #9 confirmed that an incident report was completed by RN Staff #4 and RN Staff #5 on 5/17/2025 at 6:47 AM. Staff #2 stated that he contacted the BCSO and the LifeNet EMS as soon as he was made aware of the incident. Staff #2 stated that the EMS personnel were placed on administrative leave, and the BCSO contacted the Texas Rangers, who were conducting an internal investigation into the incident. Staff #2 confirmed that there was no documentation of the date and time of the conversations or who he spoke with. Staff #2 was asked if the nurses who cared for Patient #8 reported the incident to anyone. Staff #2 replied, “The charge nurse, RN Staff #10, was notified, and the incident was reported to the house supervisor at that time, who reported the incident to the administrative team”. A review of the House Supervisor reports dated 5/16/2025 and 5/17/2025 did not reveal any information regarding the incident that occurred with Patient #8 during the 7:00 PM-7:00 AM shift on 5/16/2025. Staff #2 and RM Staff #9 were asked if Physician #16 was aware that Patient #8 had been physically abused by BCSO and EMS Personnel. Staff #2 could not confirm nor deny whether Physician #16 was aware of the physical abuse. An interview was conducted with RN Staff #11 on 7/23/2025 after 11:00 AM. RN Staff #11 was asked if Patient #8 had a laceration to his face when he arrived with EMS. RN Staff #11 confirmed that the only wound that was documented on arrival was the one on his left forearm. RN Staff #11 was asked if talked with RN Staff #4 and #5 after the incident occurred. Staff #11 confirmed she had a conversation with the two RN’s. RN Staff #11 was asked if the nursing staff had notified the physician that the BCSO and the EMS had physically abused the patient. RN Staff #11 confirmed there was no documentation in the medical record that the physician was notified. RN Staff #11 stated that during the time of the restraint that the nursing staff felt uncomfortable about being next to the BCSO and the EMS personnel, so they documented the restraint on paper and stayed at the foot of the bed. Staff #11 was asked if RN Staff #4 or #5 called anyone for help at the time of the incident. Staff #11 confirmed Patient #8 was not under arrest but remained handcuffed for restraint purposes due to his aggression after care was turned over to hospital staff. Staff #11 confirmed that security was not notified of the aggressive patient, and a code BERT (Behavioral Emergency Response Team) was not called. Code BERT is a team that is available 24/7 to respond to behavioral emergencies in which patients, families, or visitors require a coordinated response to diffuse a crisis situation. Staff #11 stated that the ER Department provided training on 5/29/2025 at the ER monthly staff meeting on what to do if staff were to witness a patient being abused by EMS or law enforcement. Staff #11 confirmed that staff were instructed to call 911 and give detailed information to the dispatcher. Staff #11 also stated that the same topic was discussed in the ER Huddle meeting dated 5/18/2025. RM Staff #9 confirmed that Quality Director, Staff #12, completed a self-report to the Texas Health and Human Services on 5/23/2025. This was 7 days after the incident occurred. Staff #12 reported the incident to DSHS regarding the patient abuse by EMS personnel on 5/26/2025. This was 10 days after the incident occurred. An interview was conducted with Assistant Chief Nursing Officer (ACNO) Staff #8 on July 23, 2025, after 2:00 PM. Staff #8 confirmed Patient#8 was not on the restraint log for the chemical restraint dated 5/16/2025. An interview was conducted with RN Staff # 5 on 7/23/25 at 8:15 PM. Staff #5 had stated that she observed the EMT push the patient’s face “hard” to the side when the patient was cursing and spitting. Staff # 5 reported that she observed the BCSO take his elbow and hit the patient 3 times in the left side. “I put my arms and hands up like whoa... wait” and decided to go get some meds. Staff #5 stated that she did not see the EMS personnel hit the patient in the face because she was out of the room getting medications but in her written statement she stated, “Patient continues to say profanity and curse which at this time the medic started to hit patient on left side of his face; unknown amount of times patient was hit, but at least 2-3 times if not more.” RN Staff #5 was asked why both nurses left the patient unattended with their abusers. Staff #5 stated, “I left to go get medications, and ____(RN Staff #4) was still in the room with the patient.” In staff #5’s written statement, she stated “both,” meaning herself and RN Staff #4 left the patient alone with the EMT and officers after they had physically abused the patient. RN Staff # 5 was asked why she or RN Staff #4 did not try to get help or ask the officer and EMT to leave the room. Staff #5 reported the ER was really busy, and so much was going on. She stated they did not have enough staff that night with all the “fires” going on, and she had to go intubate another patient right after intubating patient #8. The surveyor requested an interview with RN Staff #4 on the morning of 7/23/25. CMO Staff #17 stated that she would get in touch with RN Staff #4 and #5 and let the surveyor know. In the afternoon hours, CMO Staff #17 stated that both nurses had refused to interview with the surveyor. At approximately 7:30 PM, CMO Staff #17 arrived at the lobby of the hotel where the surveyors were staying. Staff #17 stated that RN Staff #5 was working at the ER tonight and had changed her mind and wanted to speak with the surveyors. Staff #17 stated RN Staff #4 continues to refuse to talk with the surveyors. An interview was conducted with CNO Staff #2 and RM Staff #9 on 7/23/2025 after 10:00 AM. CNO Staff #2 confirmed that the nurses acted appropriately, and RM Staff #9 stated the nurses did a great job. CNO Staff #2 confirmed there was further education in the ER on how to respond when they witness police officers or EMS personnel abusing patients. A telephone interview was conducted with Physician #16 and CMO #17 on 8/7/2025 at 10:10 AM. Physician #16 was asked what he remembered about Patient #8. Physician #16 stated, “I remember EMS rolled the patient in on a stretcher in the hallway, and he was screaming and yelling, and EMS was having to tighten the straps on the cot. I did a quick exam at the foot of the bed and realized I was going to have to order some medications to calm him down before I could do a full exam, so I went to the desk to get the orders put in. At that time, they moved the patient into Room #1, which is one of our larger rooms. Then the nurse came and got me, telling me that the patient was bleeding, and she was worried about his airway. I went into the room and noticed that the police department was having trouble restraining him, and he had some swelling on his face, and he was bleeding and gagging on the blood, so I decided to intubate him to protect his airway”. Physician #16 was asked if he knew why the patient was bleeding. He confirmed that none of the staff informed him of what happened to the patient’s lip. He was asked if he was told that the patient was hit in the face by EMS and BCSO? Physician #16 stated that no staff witnessed the patient being hit by the EMS or BCSO. Physician #16 was asked why he thought that the patient was using methamphetamines. He confirmed there was no reported drug abuse, but the patient’s actions and behaviors would make you think that. Physician #16 was asked if anyone from the Risk Department or anyone investigating these allegations of abuse ever talked to him regarding this patient. Physician #16 said, “This is probably the most formal discussion that I have had regarding this patient.” Physician #16 stated there was enough staff, but we used the police department and EMS to help restrain the patient. Patient #6 Patient #6 was a 75-year-old male who was transported to the ER on 6/23/2025 at 7:35 AM due to an altered mental status. A review of the triage notes by the RN revealed that the patient assaulted several staff members at his long-term care facility, including the ambulance crew. A review of Physician #21’s Physical Exam revealed Patient #6 had edema with chronic skin changes on bilateral lower extremities, was uncooperative, and agitated. Medical Decision-Making Note dated revealed the patient was brought to the hospital by the police department after he was located a block away from the nursing home in his motorized wheelchair. He was uncooperative and refused to answer any questions. The patient believed we were asking questions to get money from him, and also believes the year is 2005. He refused ECG monitoring and medical workup despite being altered. He complied with the pulse oximetry and was found to be hypoxic (low oxygen level) and would not keep his nasal cannula on. He was given Droperidol and Versed so that he could be medically evaluated and treated, as he has had this type of behavior before. He removed his IV catheter and attempted to get out of bed to leave, even though he is non-ambulatory at baseline and refused a replacement IV. A review of Physician #16’s orders was as follows: “6/23/2025 at 10:11 AM: Droperidol 5mg IM Once. The MAR revealed the medication was administered by RN #28 on 6/23/2025 at 10:54 AM. 6/23/2025 at 10:11 AM: Midazolam (Versed) 5mg IM Once. The MAR revealed the medication was administered by RN #28 on 6/23/2025 at 10:54 AM.” Physician #27 wrote an order on 6/23/2025 at 10:47 AM that read, “Patient may be physically constrained to facilitate medication administration for his safety.” A review of RN Staff #28’s note dated 6/23/2025 at 10:20 AM was as follows: “Medications ordered to be given due to patient experiencing delirium and potential encephalopathy”. An interview was conducted with RM Staff #9 on 7/23/2025 after 9:00 AM. RM Staff #9 was asked if physicians were required to document the justification for use when a restraint was ordered. RM Staff #9 confirmed there was no documentation for the justification of the Versed or Droperidol. RM Staff #9 was asked why these medications were administered to Patient #6. RM Staff #9 confirmed that the medications were administered as a behavior modification so that the patient could be treated medically. RM Staff #9 was asked if the Versed and Droperidol were administered as a restraint. RM Staff #9 confirmed there was no restraint documentation in the medical record, but the medications were administered for a behavioral emergency. A review of the discharge data documented on 6/23/2025 at 3:04 PM was as follows: “Patient #6 is a 75-year-old male admitted on 6/23/2025 with a past medical history of Chronic Obstructive Pulmonary Disorder, venous insufficiency, depression, heavy alcohol use, who presented with altered mental status, aggressive behavior, and hypoxia. CT of the head showed chronic changes without acute findings. Workup revealed a Urinary Tract Infection with pyuria. Required chemical sedation (droperidol, midazolam) for agitation ...” An interview was conducted with Pharmacy Manager, Staff #13, on 7/23/2025 after 3:00 PM. Staff #13 was asked if the pharmacy was aware that Droperidol and Versed were being used for chemical restraints/emergency behavioral medications. Staff #13 confirmed the pharmacy was not aware that the medications were being used for chemical restraints. An interview was conducted with the Chief Medical Officer (CMO), Staff #17, on 7/23/2025 after 3:00 PM. Staff #17 confirmed the hospital did not have a policy or process Droperidol and Versed to be administered to patients during a behavioral health emergency. A review of the hospital policy titled, “Standardized Use of Restraint and/or Seclusion” Number: 3.080 with a revised date of 2/25 was as follows: “ ...Ill. OBJECTIVE: This policy standardizes the indications and methods for restraint and/or seclusion. IV. POLICY STATEMENT: CHRISTUS Health, in compliance with ethical, regulatory, and patient-focused considerations, supports the right of a patient to be free from restraints and seclusion through the promotion of safety, dignity and alternatives to the use of restraint and/or seclusion whenever possible, with the goal of being restraint/ seclusion-free. B. Restraint Orders: Elements of ALL Restraint/Seclusion Orders *Orders for restraints and/or seclusion are not written as standing or PRN orders *The restraint order includes the justification for the use of restraint and/or seclusion, the type of restraint, time limit of restraint, and specifies the limb(s) where the restraints are to be applied. *The LP* responsible for the care of the patient, places the order for the restraint or seclusion immediately prior to the application of the device. *TX - Physician member of medical staff may order restraint or seclusion. Restraint orders must be authenticated by the physician within 48 hours 1. Physical Hold for Forced Medication a. A physical hold to administer medications is used only in emergency situations. This method is only utilized if less restrictive interventions have been found to be ineffective to protect the patient or others from harm. i. Physical hold and medication are not intended to be repetitive; they are used to support the safety of the patient and Associates in emergency situations. ii. The objective of the physical hold to administer mediations is to stabilize the patient to restraints. iii. Physical hold for forced medication is a physical restraint and requires a face-to-face evaluation and restraint monitoring for medication effectiveness and monitoring. 2. The decision to administer medication in response to a behavioral health emergency is driven by a comprehensive, individual patient assessment, including a physical assessment to identify medical problems that may be causing behavior changes in the patient. a. Medication administered in response to a behavioral health emergency is not intended to be repetitive and is not ordered PRN. i. In Texas, only the physician may order a single, immediate administration of a psychoactive medication(s) for a psychiatric emergency. b. Medication administered in response to a behavioral health emergency requires a face-to-face evaluation, restraint monitoring and evaluation of medication effectiveness. c. Medication is not used as a means of coercion, discipline, or staff convenience or retaliation. 3 ... c. Appropriate medication selection criteria for the standard treatment or dosage for the patient’s condition includes all of the following: i. The drug or medication is used within the pharmaceutical parameters approved by the Food and Drug Administration (FDA) and the manufacturer; ii. The use of the drug or medication follows national practice standards; and iii. The use of the drug or medication to treat a specific patient’s clinical condition is based on that patient’s symptoms, overall clinical situation, and on the physician’s or other LP’s knowledge of that patient’s expected and actual response to the medication. C. Notification of Attending Physician: The attending physician responsible of the management and care of the patient shall be notified about the use of restraint as soon as possible if he/she is not the ordering physician. l. If the face-to-face evaluation of a violent/psychiatric restrained or secluded patient is completed by a trained registered nurse or physician assistant, he/she must consult the attending physician or other LP who is responsible for the care of the patient as soon as possible after, within one hour, the completion of the 1-hour face-to-face examination ... F. Patient Monitoring and Evaluation: 1. A physician or other LP responsible for the care of the patient must evaluate the patient in-person within one hour of the initiation of Violent/Self-Destructive restraints. This assessment includes the following: a. An evaluation of the patient’s immediate situation b. The patient’s reaction to the intervention c. The patient’s medical and behavioral condition d. The need to continue or terminate the restraint or seclusion e. Guidance in identifying ways to help patient regain control f. Revise the patient’s plan of care, treatment and service as needed g. The original order for Violent/Self-Destructive restraint or seclusion may only be renewed within the required time limits for up to a total of 24 hours. After the original order expires, a physician or other LP must see and assess the patient before issuing a new order ...” 2. The patient who is simultaneously restrained and secluded is continually monitored by trained staff either in-person or through the use of both video and audio equipment that is in close proximity to the patient ... Assessment and Monitoring Violent/Self-Destructive Behavior *ALL Restraints/Seclusion every 2 hours; *Additionally charted every 15 minutes *Signs of injury associated with the application of restraint/skin integrity *Circulation/pulse (cardiac status) and range of motion in the extremities *Respiratory status *If medication is given in response to a behavioral health emergency, the patient is assessed every 5 minutes for the first 15 minutes, then as described above, until discontinued after one hour face to face evaluation. If physical restraints are in place, monitoring continues as described above.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(1)(i)(B) [A restraint is-] (B) A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition. This Standard is not met as evidenced by: 40989 Based on document review and interview, the hospital failed to: 1. ensure nursing de-escalated, assessed, and reassessed 2 (Patient #4 and #5) of 2 patients after the administration of a chemical restraint. 2. ensure that only a physician ordered a chemical restraint/emergency behavioral medication as required by the Texas Administration Code, Title 26 Rule 320.119(b) that states (b) only a physician member of the facility’s medical staff may order restraint or seclusion. Also, the hospital failed to follow the hospital policy titled, “Standardized Use of Restraint and/or Seclusion” in 2 (Patient #4 and #5) of 2 medical records reviewed. 3. ensure a physician or trained Registered Nurse (RN) performed a face-to-face evaluation within 1 hour of the administration of the chemical restraint/emergency behavioral medication in 2 (Patient #4and #5) of 2 patient medical records reviewed. Findings: Patient #4 A review of the medical record was completed with Risk Manager (RM) Staff #9 on 7/23/2025 after 10:00 AM. Patient #4 was a 64-year-old male who was brought to the Emergency Room (ER) by the police department on 7/16/2025 at 10:14 AM. Patient #4 had an order from the county judge for emergency apprehension and detention dated 7/15/2025. Patient #4 had a history of Schizophrenia and was taken into custody for erratic behavior in public. Patient #4 was on every (q) 15-minute checks with a sitter. A review of the medication orders revealed that Physician #27 wrote an order on 7/16/2025 at 1:32 PM for Geodon (an antipsychotic) 20 mg intramuscular (IM) and Ativan (an antianxiety medication that can cause sedation) for Psychosis. The Registered Nurse (RN) administered the medication on 7/16/2025 at 1:56 PM. A review of the nurse’s note dated 7/16/2025 at 2:00 PM was as follows: “Received medication orders for patients’ restlessness. Prepared medications. Called security. Once one security officer arrived, I asked the patient if he would be willing to take the medications by injection. Pt got upset and kept repeating “no!” Security called more officers to the room. I asked Physician #27 for permission for a pt hold to administer the medications, got approval. Once more officers arrived, and I asked the patient again if he would take the injections. Security was able to get the patient to get onto a stretcher, and the patient took medications without incident”. RM Staff #9 confirmed there was no documentation that the nurse made other attempts to de-escalate the patient before administering a chemical restraint. A review of the medication orders revealed that Physician #29 wrote an order on 7/17/2025 at 6:04 AM for Geodon 20mg IM for Psychosis. The RN administered the medication on 7/17/2025 at 6:22 PM. In an interview on 7/24/2025 after 9:00 AM, RN Staff #11 confirmed there was no documentation in the medical record regarding a behavioral emergency or why Patient #4 received the IM antipsychotic medication. A review of the nurse’s note dated 7/17/2025 at 11:58 AM was as follows: “Patient is currently being verbally loud. Went into the patient’s room to introduce myself & the patient yelled, get me out of here now. Notified (unknown staff’s name) to order something for the patient to calm him down. On 7/17/2025 at 1:20 PM, Security called to bedside. Attempted to give pt’s Droperidol IM & pt yelled “No, get away from me. I don’t want to be poked with another needle. Will continue to monitor the patient & let him calm down. Further review of the medical record revealed that Physician #29 ordered Droperidol 5mg IM and Versed 5mg IM on 7/17/2025 at 12:31 PM for agitation per hospital policy. The RN administered Versed 2mg IM on 7/17/2025 at 12:40 PM. This was 3mg less than what Physician #29 ordered. The nurse administered Droperidol 5mg IM on 7/17/2025 at 2:44 PM. This was greater than 2 hours after the order was written for a behavioral emergency. During an interview on 7/24/2025, after 9:00 AM, RN Staff #11 confirmed the RN did not administer the correct dose of Versed. Staff #11 confirmed there was no documentation in the medical record that the order was cancelled, changed, or a new order was written for the 2mg Versed administered. A review of the nurse’s note dated 7/18/2025 was as follows: “1:53 AM-Pt has started to stand in the doorway, screaming and yelling. Unable to understand what the patient is yelling. Pt is pointing at the nurses and security while yelling. Charge nurse, NP #19, and House supervisor notified. House Supervisor in ER during scene. 1:59 AM-TTPD (Police Department) at doorway talking to pt. Pt in bed at this time”. 2:05 AM-Pt willing to let me give him a shot”. A review of the medication orders revealed Nurse Practitioner (NP) #19 ordered Geodon 20 mg injection on 7/18/2025 at 1:43 AM as a 1-time STAT dose for psychosis. A review of the Medication Administration Record revealed the nurse administered the medication on 7/18/2025 at 2:06 AM. An interview was conducted with RN Staff #11 on 7/24/2025, after 9:00 AM. RN Staff #11 confirmed that Patient #4 received multiple chemical restraints/EBM’s during his ER visit dated 7/16/2025-7/18/2025. RN Staff #11 confirmed there was no restraint documentation, to include monitoring, of Patient #4 after the administration of a chemical restraint/EBM. RN Staff #11 confirmed that Patient #4 was placed on psychiatric precautions with a sitter, but there was no restraint monitoring on the patient for any of the medications administered. Behavioral monitoring was completed every 2 hours, and the documentation included the patient’s location, activity, behaviors/mood, interventions, and safety room checks of patients on psychiatric precautions. RN Staff #11 confirmed that behavioral monitoring was not the same as restraint monitoring. RN Staff #11 confirmed there was no restraint documentation or 1-hour face-to-face with any of the chemical restraints administered to Patient #4 during the ER visit dated 7/16/2025-7/18/2025. On 7/18/2025, Patient #4 was transferred to an Inpatient Psychiatric Hospital. Patient #5 Patient #5 was an 81-year-old male who was transferred to the ER by EMS on 7/02/2025 at 8:25 PM with confusion and combativeness. Reportedly, he went after his wife with a knife. He has a known diagnosis of Dementia. Patient #5 was on every (q) 15-minute checks with a sitter. A review of the nurse’s note dated 7/03/2025 was as follows: “7:25 AM stated the patient was in the hall, very upset that it was past time for him to leave. Case Management (CM) was able to talk him down. He is yelling insults at the staff and yelling that security better stay close by, cause he may jump on someone. 10:25 AM stated that it appeared the patient had been hallucinating and was given Geodon IM. Shortly after the medication was administered, the patient suddenly stood up and attempted to bite my right arm. I lightly pushed the patient away, where he was now in a sitting position on the edge of the stretcher to prevent from being bitten. The patient was close to the edge of the stretcher and then fell to the floor, landing on his right side. Patient did not hit his head, no LOC. The patient does complain of right shoulder and right hip pain. NP #20 was made aware, and X-rays have been ordered. No other injuries noted”. A review of the medication orders revealed NP #20 ordered Geodon 10mg Injection STAT Once for Psychosis on 7/03/2025 at 10:40 AM. Review of the MAR revealed the medication was administered to Patient #5 on 7/03/2025 at 10:18 AM. An interview was conducted with Risk Manager (RM) Staff #9 on 7/24/2025 after 9:00 AM. RM Staff #9 was asked if the nurses could administer a chemical restraint without a physician’s order. RM Staff #9 confirmed that there must be an order from a physician to administer a chemical restraint/EBM. Staff #9 confirmed the Geodon 10mg was administered to Patient #5 as a chemical restraint/EBM without a physician’s order. A review of the nurse note dated 7/03/2025 at 9:34 PM revealed the patient was attempting to get out of bed. The nurse and the sitter attempted to de-escalate the patient. The patient started yelling and the patient “swing” (sic) at the nurse and security at the bedside. A review of the medication order dated 7/03/2025 at 9:50 PM revealed NP #19 wrote an order for Geodon 10 mg injection STAT once for Psychosis. The MAR revealed the medication was administered by the nurse at 9:59 PM. A review of the nurse note dated 7/04/2025 at 5:40 AM stated the patient became angry, walking in the halls, and screaming at staff. Security attempted to de-escalate the patient, and the patient did not cooperate. A review of the medication order dated 7/04/2025 at 5:50 AM revealed NP #20 wrote an order for Geodon 10 mg injection STAT once for Psychosis. The MAR revealed the medication was administered by the nurse on 7/04/2025 at 5:53 AM. An interview was conducted with RN Staff #11 on 7/24/2025 after 9:00 AM. RN Staff #11 confirmed the nursing staff failed to assess and reassess 2 (Patient #4 and #5) of 2 patients who received chemical restraints/EBMs. Also, Staff #11 confirmed a 1-hour face-to-face evaluation was not completed on 2 (Patient #4 and #5) of 2 patients who received a chemical restraint/EBM. An interview was conducted with Chief Medical Officer (CMO) Staff #17 on 7/23/2025 at 2:45 PM. Chief Medical Officer (CMO) Staff #25 was asked if NPs can order chemical restraints/Emergency Behavioral Medications. CMO Staff #17 confirmed that only physicians are allowed to order those medications for behaviors, and it states it very clearly in our policy. A review of the hospital policy titled, “Standardized Use of Restraint and/or Seclusion” Number: 3.080 with a revised date of 2/25 was as follows: “ ...Ill. OBJECTIVE: This policy standardizes the indications and methods for restraint and/or seclusion. IV. POLICY STATEMENT: CHRISTUS Health, in compliance with ethical, regulatory, and patient-focused considerations, supports the right of a patient to be free from restraints and seclusion through the promotion of safety, dignity, and alternatives to the use of restraint and/or seclusion whenever possible, with the goal of being restraint/ seclusion-free. B. Restraint Orders: Elements of ALL Restraint/Seclusion Orders *Orders for restraints and/or seclusion are not written as standing or PRN orders *The restraint order includes the justification for the use of restraint and/or seclusion, the type of restraint, time limit of restraint, and specifies the limb(s) where the restraints are to be applied. *The LP* responsible for the care of the patient, places the order for the restraint or seclusion immediately prior to the application of the device. 1. Physical Hold for Forced Medication a. A physical hold to administer medications is used only in emergency situations. This method is only utilized if less restrictive interventions have been found to be ineffective to protect the patient or others from harm. i. Physical hold and medication are not intended to be repetitive; they are used to support the safety of the patient and associates in emergency situations. ii. The objective of the physical hold to administer mediations is to stabilize the patient to restraints. iii. Physical hold for forced medication is a physical restraint and requires a face-to-face evaluation and restraint monitoring for medication effectiveness and monitoring. 2. The decision to administer medication in response to a behavioral health emergency is driven by a comprehensive, individual patient assessment, including a physical assessment to identify medical problems that may be causing behavior changes in the patient. a. Medication administered in response to a behavioral health emergency is not intended to be repetitive and is not ordered PRN. i. In Texas, only the physician may order a single, immediate administration of a psychoactive medication(s) for a psychiatric emergency. b. Medication administered in response to a behavioral health emergency requires a face-to-face evaluation, restraint monitoring, and evaluation of medication effectiveness. c. Medication is not used as a means of coercion, discipline, or staff convenience or retaliation. 3 ... c. Appropriate medication selection criteria for the standard treatment or dosage for the patient’s condition includes all of the following: i. The drug or medication is used within the pharmaceutical parameters approved by the Food and Drug Administration (FDA) and the manufacturer; ii. The use of the drug or medication follows national practice standards; and iii. The use of the drug or medication to treat a specific patient’s clinical condition is based on that patient’s symptoms, overall clinical situation, and on the physician’s or other LP’s knowledge of that patient’s expected and actual response to the medication. C. Notification of Attending Physician: The attending physician responsible of the management and care of the patient shall be notified about the use of restraint as soon as possible if he/she is not the ordering physician. l. If the face-to-face evaluation of a violent/psychiatric restrained or secluded patient is completed by a trained registered nurse or physician assistant, he/she must consult the attending physician or other LP who is responsible for the care of the patient as soon as possible after, within one hour, the completion of the 1-hour face-to-face examination ... F. Patient Monitoring and Evaluation: 1. A physician or other LP responsible for the care of the patient must evaluate the patient in-person within one hour of the initiation of Violent/Self-Destructive restraints. This assessment includes the following: a. An evaluation of the patient’s immediate situation b. The patient’s reaction to the intervention c. The patient’s medical and behavioral condition d. The need to continue or terminate the restraint or seclusion e. Guidance in identifying ways to help patient regain control f. Revise the patient’s plan of care, treatment and service as needed g. The original order for Violent/Self-Destructive restraint or seclusion may only be renewed within the required time limits for up to a total of 24 hours. After the original order expires, a physician or other LP must see and assess the patient before issuing a new order ...” 2. The patient who is simultaneously restrained and secluded is continually monitored by trained staff either in-person or through the use of both video and audio equipment that is in close proximity to the patient ... Assessment and Monitoring Violent/Self-Destructive Behavior *ALL Restraints/Seclusion every 2 hours; *Additionally, charted every 15 minutes *Signs of injury associated with the application of restraint/skin integrity *Circulation/pulse (cardiac status) and range of motion in the extremities *Respiratory status *If medication is given in response to a behavioral health emergency, the patient is assessed every 5 minutes for the first 15 minutes, then as described above, until discontinued after one hour face to face evaluation. If physical restraints are in place, monitoring continues as described above ...””

“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: 32143 Based on review and interviews, the governing body (GB) failed to ensure that an adverse patient safety event was fully investigated, and preventive actions recommended were measured, analyzed, and tracked in 1 (Patient #8) of 1 patient reviewed. Findings: Patient #8 was transported to the hospital by EMS and escorted by BCSO for medical care on 5/16/2025 after a suicide attempt. A review of the hospital’s self-reported incident revealed that Patient #8 was physically abused by the Bowie County Sheriff Officers (BCSO) and Emergency Medical Services (EMS) Personnel while in the care of the hospital. Patient #8 A review of the medical record for Patient #8 was completed in the administrative conference room on 7/21/2025-7/23/2025 with Risk Manager (RM) Staff #9 and Staff #11 Registered Nurse (RN) navigator. The navigator assists the surveyor in navigating through the medical record. Patient #8 was a 21-year-old male who presented to the Emergency Room (ER) on May 16, 2025. He was transported to the hospital by EMS after an alleged suicide attempt. He was escorted by 2 Bowie County Sheriff Officers (BCSO). Upon arrival, Patient #8 was noted to be handcuffed with his arms behind his back due to aggressive behavior. A review of the Triage Nurse note documented by RN Staff #5 dated 5/16/2025 at 10:10 PM revealed that Patient #8 was, “Pt BIBA (brought in by ambulance) with BCSO at the side. C/O (complains of) ingestion of approximately 100 ibuprofen (per pt), suicidal, delirium, and aggressive behavior. Pt is handcuffed behind the back and on an EMS cot upon ED arrival. Pt is continuously yelling/screaming profanities and threatening EMS personnel and BCSO. Unable to obtain much information from pt due to aggression and belligerent outbursts. EMS reports pt has been spitting, kicking, biting, and cursing continuously, all in route and upon ED arrival. EMS reports they were called by pt mother due to pt acting delirious and threatening suicide; pt has a small abrasion to the left FA, no bleeding noted, wound is open to air. Unable to obtain full orientation status because the patient will not calm down enough to answer questions. Pt appears to be oriented to self, but unsure about other orientation status due to not being able to get answers from pt. EMS personnel and BCSO at side until pt is more calm. Physician #16 aware of pt upon ED arrival” Patient #8 was taken to ER Room #1 by EMS and BCSO upon arrival at 10:10 PM. A review of Physician #16’s orders dated 5/16/2025 at 10:13 PM revealed Patient #8 was ordered the following medication. Versed 5mg injection STAT (a sedative primarily used as a moderate sedation before surgery or during a procedure. This drug may cause amnesia and requires monitoring. Adverse effects: variations in blood pressure and heart rate, impaired balance and gait, sedation, respiratory depression, and retrograde amnesia. Adverse effects may be potentiated by other medications, like analgesics.) There was no indication for use. The medication administration record (MAR) stated RN Staff #5 administered the medication intramuscularly to the left anterior thigh at 10:17 PM. Droperidol 5mg Injection STAT (an antiemetic medication used to reduce nausea and vomiting and as an amnesia agent before surgery or diagnostic procedures. It does have a black box warning for cardiac risks). There was no justification for use documented on the medication order. The MAR stated the nurse administered the medication IM to the right anterior thigh at 10:20 PM. A review of Physician #16’s note dated 5/16/2025 at 10:22 PM was as follows: “21-year-old male (Patient #8) presents to the Emergency Department with a suicide attempt, taking 100 pills of Ibuprofen. He is escorted by EMS and police department and has been combative with first responders and arrives handcuffed, screaming at staff. The police department did not report any obvious evidence of an overdose. Additionally, EMS reports they did not note any significant trauma. The initial call was made by the family in relation to the suicide attempt. Patient was able to be verbally de-escalated during transport, but became combative upon arriving at the ER ...He is in acute distress ...Bruising to the left face with 1 1-centimeter laceration to the left upper lip ...Tachycardia (fast heart rate) ...agitated, aggressive, hyperactive, combative ...” Medical Decision Making Differential diagnosis includes agitated delirium, sympathomimetic abuse, metabolic acidosis secondary to NSAID overdose, and intracranial hemorrhage. This is a 21-year-old male who arrives combative with staff and PD. In order to facilitate care after verbal de-escalation had failed medications for acute agitation were administered, including 5 mg of Versed and 5 mg of Droperidol. After this had been given but before it had taken effect patient bit his lip, which began to bleed rather profusely, compromising his airway with frequent coughing and gagging. At this time, a decision was made to intubate the patient to protect his airway and for further behavioral control. While the equipment is being prepared the medications did take effect and patient became very somnolent as expected. For this reason, sedation was avoided for RSI and simply used additional paralytics. Patient’s ingestion was greater than 1 hour prior to arrival per report, no indication for activated charcoal or gastric lavage, and none was recommended by poison control, see discussion in ED workup tab. The ED workup documented on 5/16/2025 at 10:15 PM revealed Physician #16 spoke to poison control, and it was recommended to administer IV fluids and monitor for GI upset. Stated that in very high overdoses can lead to metabolic acidosis. Benzodiazepines to be administered for seizures, if any occur. Recommended 4-6 hours of observation. Case #76020695. After intubation patient has had some hypotension, which presumably will correct with sufficient IV hydration given the amount of his base deficit. He was given 2 Amps of bicarb for the short-term in the ER. Midazolam and fentanyl were preferred for PO sedation medications, anticipating that the patient will be positive for methamphetamines and unable to rule out methamphetamine overdose as the true origin of the patient’s symptoms given his agitation on arrival ...” There were no documented indications that patient #8 would be positive for Methamphetamines. A review of the documentation by RN Staff #5 on 5/16/2025 was as follows: “10:15 PM revealed Patient #8 was handcuffed due to physical/violent aggression towards EMS and BCSO. Patient is also having to be physically held down by EMS personnel and BCSO due to kicking even while being restrained in handcuffs. Respirations 23. Physically and verbally aggressive, exaggerated, and overly dramatic. Impaired judgement with moderate confusion. Violent restraint and physical hold by BCSO and EMS personnel. 10:17 PM Patient is verbally and physically aggressive. Expressing feelings of threats. Versed 5mg IM administered to the left anterior thigh. Patient is no longer restrained due to the discontinuation of physical hold. Respirations 22. Impaired judgement with moderate confusion. 10:22 PM Behavioral Health Emergency. Physically and verbally aggressive. Droperidol 5mg IM was administered to the right anterior thigh. Patient is no longer being restrained due to discontinuation of physical hold. Respirations 21. 10:27 PM Behavioral Health Emergency. Pt is verbally and physically aggressive. Expressing feelings of threats. Physical hold discontinued-no longer meets criteria. 10:32 PM Behavioral Health Emergency. Pt is verbally and physically aggressive. Expressing feelings of threats. Pt is no longer being physically restrained due to discontinuation of the order. 10:40 PM Due to patient’s extremely aggressive behavior, unable to obtain a full set of vital signs at this time. Vital signs-Temperature 98 F, Pulse 134 (normal rate 60-100), Respirations 22 (normal rate 16-20), Oxygen level 98%, Blood Pressure 157/61 (normal level 120/80) ...” An interview was conducted with RN Staff #11 on 7/22/2025 after 11:30 AM. RN Staff #11 was asked what time the handcuffs were removed from Patient #8. RN Staff #11 stated, “On the restraint monitoring record, it shows that the restraint was released at 10:17 PM.” RN Staff #11 was asked if that release was for the handcuffs or the physical hold. RN Staff #11 stated, “It must be for the hold because there is no documentation when the cuffs were released”. RN Staff #11 was asked if there was any documentation that Patient #8 reportedly “bit his lip” other than the physician note. RN Staff #11 confirmed that Physician #16 was the only caregiver who documented that the patient bit his lip. There was no documentation by the nursing staff on when or if patient #8 had bitten his lip. RN Staff #11 was asked if the BCSO or the EMS personnel had hit the patient in the face and caused the 1-centimeter laceration. Staff #11 confirmed the nursing staff failed to document how or when the laceration to the cheek occurred nor that the patient was assaulted by EMS personnel and BCSO. An interview with RN Staff #5 was conducted on 7/23/25 at 8:15PM. the nurse stated that when the decision was made to intubate, the physician and NP came into the patient’s room and asked “what happened here? _____ (Staff #4) stated I don’t know.” Staff #5 did not report the incident to the physician. Staff #5 reported MD was focused on trying to protect the airway due to patient being held down and medications impairing the patient’s airway. RN Staff #5 confirmed that the BCSO and EMS were holding patient #8’s legs and shoulders down to the bed while he was handcuffed. Staff #5 stated the patient was held when he came in, while he was receiving medications and afterwards until the patient was intubated. However, on 5/16/25 at 10:17pm staff #5 documented, “Patient is no longer restrained due to the discontinuation of physical hold.” Staff #5 was asked why the nurses and ER staff did not apply physical restraints for the safety of the patient? Staff #5 stated “like what? Soft restraints? The surveyor stated, “any type you have in the ER to ensure the patient was safely restrained to prevent harm, soft restraints, leathers. Whatever you had.” Staff #5 stated, “no. we didn’t.” Staff #5 confirmed the EMS personnel tried to put a mask on the patient because he was spitting but it kept coming off.” Further review of the medical record revealed RN Staff #4 started an intravenous line, and blood was collected to send to the lab for further testing. On 5/16/2025 at 10:40 PM, Patient #8 was intubated (an endotracheal tube was placed into the patient’s airway to assist with breathing) with a Glide scope (a video camera used to assist with placing the endotracheal tube) by Physician #16 placed on a ventilator. A review of the Intubation note dated 5/16/2025 at 11:58 PM by Physician #16 revealed the procedure was performed in an emergent situation. Rocuronium (a fast-acting paralytic medication used to intubate a patient) was administered at 10:39 PM for the intubation. A review of the procedure note documented 5/17/2025 at 12:15 AM by Nurse Practitioner (NP) #19 revealed that a 2-centimeter laceration to the left cheek was repaired with sutures, and no complications were noted. The NP did not document on the cause of the laceration. A review of the ER course documented by Physician #16 on 5/16/2025 at 11:32 PM revealed Patient #8 was in Metabolic Acidosis, secondary to the Ibuprofen overdose. Metabolic Acidosis is when there is too much acid in the blood, and this can be caused by an overdose of non-steroidal anti-inflammatory drugs (NSAID). Ibuprofen is an NSAID. According to NCBI, Ibuprofen toxicity can result in tachycardia (fast heart rate) and hypotension (low blood pressure). Symptoms include confusion, agitation, and nausea/vomiting. Patient #8’s lab results revealed there was no Methamphetamines present. Review of Patient #8’s vital signs revealed that at 10:48 PM his heart rate was 139 and his blood pressure was 109/37, at 11:03 PM his heart rate was 137 and his blood pressure was 110/31, at 11:18 PM his heart rate was 145 and blood pressure was 119/33, at 11:30 PM his heart rate was 117 and blood pressure was 108/34. The patient was administered multiple doses of sodium bicarbonate (a medication used to treat metabolic acidosis) and placed on a Levophed (a medication to treat life-threatening low blood pressure) drip to control his hypotension. A review of the NP’s history and physical documented on 5/17/2025 at 12:45 AM revealed Patient #8 was admitted to the Intensive Care Unit on 5/17/2025 with profound Metabolic Acidosis, intentional ibuprofen overdose, Altered Mental Status, Acute Respiratory failure, intubated and sedated. The physical exam revealed the patient had swelling to his left jaw, laceration to the left forearm, laceration to the right hand, lacerations x 3 to the left hand, and scratches tracking down the right arm. On 5/17/2025 at 11:57 AM, the Nurse Practitioner in the ICU ordered a CT scan of the Head/Brain for an Altered Mental Status that resulted in no acute intracranial hemorrhage or skull fractures. And a non-specific finding of left periorbital soft tissue swelling. A CT Maxillofacial for facial bruising was ordered on 5/17/2025 at 12:00 PM by the NP in the ICU. The CT resulted in Nasal, left periorbital, and left facial soft tissue swelling. No acute facial fractures, globe rupture, lens dislocation, or retrobulbar hemorrhage. During an interview on 7/23/2025, after 2:30 PM with RN Staff #11, it was confirmed that the only injuries documented by the ER nurses were the left forearm when he arrived in the ER. A review of the hospital’s Event Record #14201 was completed on 7/21/2025 with RM Staff #9 after 10:00 AM. The event record included two written statements by RN Staff #4 and RN Staff #5. The statements were as follows: Reported by RN Staff #4 on 5/17/2025 6:47 AM: “Upon entering the room, EMS and Law Enforcement personnel were physically restraining the patient. His behavior was violent. He was making verbal threats to rape, kill, and haunt staff. During this time, the patient was handcuffed behind the back and being physically restrained to the bed. He attempted to kick the medic that was holding down his left arm. After this attempt, the medic punched him several times on the left side of his face. While this nurse was attempting to secure an IV for sedation, the patient continued to fight EMS and Law Enforcement. The same medic asked me twice if there were cameras in the room. He asked the officer across from him who was holding down the patients left leg if his body camera was on, and if so, would he turn it off. The officer complied and turned off his body camera. The medic began again punching the patient on the left side of his face and grabbing him forcefully by the jaw. I secured the IV and walked out of the room. I returned to the room shortly after when BLS crew informed me they were suctioning blood from his mouth as he was coughing and gagging. I notified the provider who determined at that point we would need to secure the patients airway with intubation.” Reported by RN Staff #5 on 5/17/2025 6:47 AM. “Entering the ED room 1 with (RN Staff #4); I observed the patient on EMS cot. Medic, EMT, BLS crew, and 2 BCSO officers are surrounding patient on cot, speaking with him. Patient is handcuffed behind the back due to physical aggression (assaulting first responder staff) and threats towards EMS personnel and BCSO officers. Patient is moved from EMS cot to ED stretcher, still handcuffed behind his back. Patient continues to yell/curse/scream/threaten EMS personnel as well as BCSO officers, saying things like, “I’m going to f****** kill you! I’m going to haunt you in your mother f****** dreams! You’re all sad!” Even after multiple attempts at verbal redirection from EMS personnel, BCSO officers, and hospital staff, patient is still extremely aggressive verbally and physically which he is a threat to his own safety and everyone around him. As I am trying to get report from the medic, I am at the top of the bed near the patient’s head. While the medic is attempting to give me report, the patient continues to say profanity and curse at the medic. I informed the medic, “hey, I’m not really able to hear you, can we step over there (talking about away from the patient) so I can maybe hear you better?” Patient continues to shout profanity at medic, medic then pushes his hand onto patient left side of face, pushing his head into the ED stretcher; patient is still handcuffed behind his back. Other staff (EMS personnel and BCSO) are still physically restraining patient due to severity of aggression at this time. Patient continues to say profanity and curse which at this time the medic started to hit patient on left side of his face; unknown amount of times patient was hit, but at least 2-3 times if not more. Patient was continuing to shout profanity and continuing to be physically aggressive (kicking, spitting, biting) and still being physically restrained. I was able to administer IM droperidol to patient’s right thigh. At some point after administering the medication, maybe 1-2min after, the patient was trying to continue to move around out of bed, the shorter BCSO hit the patient at least 2-3 times in the left side rib area. At this point in time, myself and (RN Staff #4), left out of ED room to notify (Physician #16) of medications being administered and what is our next step, to which he informs me, “let’s give the meds approx. 10-15min and then if he is still very agitated, we will intubate him for his safety and ours.” I went to go inform EMS personnel and BCSO of this information given by (Physician #16). Upon entering the room again, one of the EMS people are suctioning blood out of the patients mouth as well as small amount of blood on ED stretcher next to patient’s mouth. I then went to inform (Physician #16) of this information, and he determined it was time to intubate.” An interview was conducted with RN Staff # 5 on 7/23/25 at 8:15 PM. Staff #5 stated that she came back into the patient room and saw the EMT suctioning the patient’s mouth, but it was a little bit of saliva that was blood-tinged.” There was no found documentation in the patient’s chart of coughing or gagging. The document revealed that the Administrator on call, Staff #3, was notified on 5/17/2025 at approximately 7:00 AM. Staff #3 notified the Chief Executive Officer (CEO) and CNO approximately 9:45 AM on 5/17/2025 and advised the staff that an investigation was in process. Staff #3 notified the RM, Staff #9, at approximately 9:45 AM on 5/17/2025. An interview was conducted with Chief Nursing Officer (CNO) Staff #2 and Risk Manager (RM) Staff #9 on 7/22/2025 at 10:35 AM. Staff #9 confirmed that an incident report was completed by RN Staff #4 and RN Staff #5 on 5/17/2025 at 6:47 AM. Staff #2 stated that he contacted the BCSO and the LifeNet EMS as soon as he was made aware of the incident. Staff #2 stated that the EMS personnel were placed on administrative leave, and the BCSO contacted the Texas Rangers, who were conducting an internal investigation into the incident. Staff #2 confirmed that there was no documentation of the date and time of the conversations or who he spoke with. Staff #2 was asked if the nurses who cared for Patient #8 reported the incident to anyone. Staff #2 replied, “The charge nurse, RN Staff #10, was notified, and the incident was reported to the house supervisor at that time, who reported the incident to the administrative team”. A review of the House Supervisor reports dated 5/16/2025 and 5/17/2025 did not reveal any information regarding the incident that occurred with Patient #8 during the 7:00 PM-7:00 AM shift on 5/16/2025. Staff #2 and RM Staff #9 were asked if Physician #16 was aware that Patient #8 had been physically abused by BCSO and EMS Personnel. Staff #2 could not confirm nor deny whether Physician #16 was aware of the physical abuse. An interview was conducted with RN Staff #11 ER Clinical Director on 7/23/2025 after 11:00 AM. RN Staff #11 was asked if Patient #8 had a laceration to his face when he arrived with EMS. RN Staff #11 confirmed that the only wound that was documented on arrival was the one on his left forearm. RN Staff #11 was asked if talked with RN Staff #4 and #5 after the incident occurred. Staff #11 confirmed she had a conversation with the two RN’s. RN Staff #11 was asked if the nursing staff had notified the physician that the BCSO and the EMS had physically abused the patient. RN Staff #11 confirmed there was no documentation in the medical record that the physician was notified. RN Staff #11 stated that during the time of the restraint that the nursing staff felt uncomfortable about being next to the BCSO and the EMS personnel, so they documented the restraint on paper and stayed at the foot of the bed. Staff #11 was asked if RN Staff #4 or #5 called anyone for help at the time of the incident. Staff #11 confirmed Patient #8 was not under arrest but remained handcuffed for restraint purposes due to his aggression after care was turned over to hospital staff. Staff #11 confirmed that security was not notified of the aggressive patient, and a code BERT (Behavioral Emergency Response Team) was not called. Code BERT is a team that is available 24/7 to respond to behavioral emergencies in which patients, families, or visitors require a coordinated response to diffuse a crisis situation. Staff #11 stated that the ER Department provided training on 5/29/2025 at the ER monthly staff meeting on what to do if staff were to witness a patient being abused by EMS or law enforcement. Staff #11 confirmed that staff were instructed to call 911 and give detailed information to the dispatcher. Staff #11 also stated that the same topic was discussed in the ER Huddle meeting dated 5/18/2025. RM Staff #9 confirmed that Quality Director, Staff #12, completed a self-report to the Texas Health and Human Services on 5/23/2025. This was 7 days after the incident occurred. Staff #12 reported the incident to DSHS regarding the patient abuse by EMS personnel on 5/26/2025. This was 10 days after the incident occurred. An interview was conducted with Assistant Chief Nursing Officer (ACNO) Staff #8 on July 23, 2025, after 2:00 PM. Staff #8 confirmed Patient#8 was not on the restraint log for the chemical restraint dated 5/16/2025. An interview was conducted with RN Staff # 5 on 7/23/25 at 8:15 PM. Staff #5 had stated that she observed the EMT push the patient’s face “hard” to the side when the patient was cursing and spitting. Staff # 5 reported that she observed the BCSO take his elbow and hit the patient 3 times in the left side. “I put my arms and hands up like whoa... wait” and decided to go get some meds. Staff #5 stated that she did not see the EMS personnel hit the patient in the face because she was out of the room getting medications but in her written statement she stated, “Patient continues to say profanity and curse which at this time the medic started to hit patient on left side of his face; unknown amount of times patient was hit, but at least 2-3 times if not more.” RN Staff #5 was asked why both nurses left the patient unattended with their abusers. Staff #5 stated, “I left to go get medications, and ____(RN Staff #4) was still in the room with the patient.” In staff #5’s written statement, she stated “both,” meaning herself and RN Staff #4 left the patient alone with the EMT and officers after they had physically abused the patient. RN Staff # 5 was asked why she or RN Staff #4 did not try to get help or ask the officer and EMT to leave the room. Staff #5 reported the ER was really busy, and so much was going on. She stated they did not have enough staff that night with all the “fires” going on, and she had to go intubate another patient right after intubating patient #8. The surveyor requested an interview with RN Staff #4 on the morning of 7/23/25. CMO Staff #17 stated that she would get in touch with RN Staff #4 and #5 and let the surveyor know. In the afternoon hours, CMO Staff #17 stated that both nurses had refused to interview with the surveyor. At approximately 7:30 PM, CMO Staff #17 arrived at the lobby of the hotel where the surveyors were staying. Staff #17 stated that RN Staff #5 was working at the ER tonight and had changed her mind and wanted to speak with the surveyors. Staff #17 stated RN Staff #4 continues to refuse to talk with the surveyors. An interview was conducted with CNO Staff #2 and RM Staff #9 on 7/23/2025 after 10:00 AM. CNO Staff #2 confirmed that the nurses acted appropriately, and RM Staff #9 stated the nurses did a great job. CNO Staff #2 confirmed there was further education in the ER on how to respond when they witness police officers or EMS personnel abusing patients. A telephone interview was conducted with Physician #16 and CMO #17 on 8/7/2025 at 10:10 AM. Physician #16 was asked what he remembered about Patient #8. Physician #16 stated, “I remember EMS rolled the patient in on a stretcher in the hallway, and he was screaming and yelling, and EMS was having to tighten the straps on the cot. I did a quick exam at the foot of the bed and realized I was going to have to order some medications to calm him down before I could do a full exam, so I went to the desk to get the orders put in. At that time, they moved the patient into Room #1, which is one of our larger rooms. Then the nurse came and got me, telling me that the patient was bleeding, and she was worried about his airway. I went into the room and noticed that the police department was having trouble restraining him, and he had some swelling on his face, and he was bleeding and gagging on the blood, so I decided to intubate him to protect his airway”. Physician #16 was asked if he knew why the patient was bleeding. He confirmed that none of the staff informed him of what happened to the patient’s lip. He was asked if he was told that the patient was hit in the face by EMS and BCSO? Physician #16 stated that no staff witnessed the patient being hit by the EMS or BCSO. Physician #16 was asked why he thought that the patient was using methamphetamines. He confirmed there was no reported drug abuse, but the patient’s actions and behaviors would make you think that. Physician #16 was asked if anyone from the Risk Department or anyone investigating these allegations of abuse ever talked to him regarding this patient. Physician #16 said, “This is probably the most formal discussion that I have had regarding this patient.” Physician #16 stated there was enough staff, but we used the police department and EMS to help restrain the patient. An interview was conducted on 7/23/25 at 2:46 pm with Staff #9. Staff #9 was asked if she had completed an RCA (Root Cause Analysis) for the adverse patient event. Staff #9 reported that she and the administrative staff had conversations about the incident, but Staff #9 confirmed there were no meeting minutes or a sign-in sheet for a meeting. Staff #9 showed the surveyors a fishbone diagram to show the problems identified. There was no additional information on how the findings were determined to affect patient safety, analysis of the event and failures that contributed to the event, or preventive actions taken to ensure this patient abuse would not recur, or how any implementations were being measured, analyzed, and tracked. Staff #9 was asked if she had interviewed the nursing staff involved, and she reported that she had met with the nurses but did not ask for any other information because the nurses had filed an incident report. Staff #9 was not able to provide a written statement, or any meeting minutes held with the nursing staff involved. There was no written evidence that Staff #9 had met and interviewed the treating physician or Nurse Practitioner. Staff #9 stated that she felt the nurses had done a good job, and the outcome of the sentinel event was for the staff to call 911 next time they have this type of incident. There was no other monitoring information available. According to the facility policy and procedure “Root cause analysis-Sentinel Events and Serious Safety Events” stated, “ II. SCOPE: This Policy applies to CHRISTUS St. Michael Health System and CHRISTUS St. Michael Hospital -Atlanta. Ill. OBJECTIVE Describes a standardized system for conducting Root Cause Analysis investigation of patient safety events to assist in identification of health system failures that may not be immediately apparent at initial review. IV. POLICY STATEMENT: CHRISTUS Health is committed to build a safety culture through engagement of all Associates by sharing safety knowledge and actions to mitigate the risk of safety events. Pursuant to quality and patient safety committee (regardless of name of the committee) direction, as well as the direction of the Board, certain committees of the facility will engage in quality and patient safety review of certain events via various methods designed to investigate quality and patient safety with the intent of improving quality and patient safety. All investigation carried out is done at the request of and for the benefit of the quality and patient safety committees (regardless of the name of the committee) as requested by the facility Board and the system Board. This policy addresses one type of systematized approach. However, the existence of a policy to delineate this process does not remove or lessen the privileges that attach to this type of investigation or create waiver. Within this broader context, the Root Cause Analysis Policy describes a standardized system for conducting Root Cause Analysis investigation of patient safety events to assist in identification of health system. Identifying root causes of patient safety events reveals underlying reasons leading to preventable errors. V. DEFINITIONS: A. Root Cause Analysis - a systematic technique to prevent reoccurrence, as a process of continuous improvement, to find underlying physical and procedural problems, to guide organizational change and to promote a safety culture. B. Sentinel Event - a patient safety event (not primarily related to the natural course of the patient’s illness or underlying conditions) that reaches a patient and causes serious harm. See Appendix A: Joint Commission List of Sentinel Events C. Plan-Do-Study-Act method - a way to test a change that is implemented via a corrective action plan. The PDSA cycle is preferred quality management method for testing a change by developing a plan to test the change (Plan), carrying out the test (Do), observing and learning from the consequences (Study), and determining what modifications should be made to the test (Act). VI. PROCESS OR PROCEDURES: A. Identification and Assessment of Events CHRISTUS Health promotes patient safety management analysis based on a severity assessment code as indicated in the Patient Safety Event Management Analysis Guidelines. All sentinel events and high-risk serious safety events will undergo a rigorous root cause analysis methodology. B. Root Cause Analysis Methodology CHRISTUS Health Quality Team has adopted Root Cause Analysis Guidelines based on evidence-based practice. The guidelines serve as a framework for the RCA. C. Reporting 1. The facility risk manager/appropriate designee will, upon learning of events requiring RCA, shall notify the facility leadership, and system quality leadership using the available Internal Reporting of Serious Patient Safety Event (IRSPSE) Process/Form. 2. The Facility’s Quality Committee will approve the completed Root Cause Analysis and monitor the plan. D. Action Plan Action Plans will follow the Plan-Do-Study-Act (PDSA) Methodology. VII. REGULATIONS/REQUIREMENTS: The Joint Commission, https ://www. iointcommission .org/-/media/tjc/ documents/ resources/patientsafety-topics/sentinelevent/ rca framework 101017 .pdf?db=web&hash=B2B439317 A20C3D1982F9FBB94E1724B.” According to the Joint Commission’s requirements regarding Root Cause Analysis (RCA) following a Sentinel Event. These expectations are outlined in their Sentinel Event Policy and Patient Safety Systems standards and are mandatory for accredited healthcare organizations. When is an RCA Required? - Must be conducted within 45 days of the organization becoming aware of a sentinel event. - A sentinel event is an unexpected occurrence involving death, serious physical or psychological injury, or the risk thereof. RCA Requirements The RCA must: Identify Root Causes - Focus on system-level issues, not just individual error. Be Thorough - Include interviews, chart reviews, process mapping, and timeline reconstruction. Involve Leadership - Demonstrate leadership’s role in accountability and safety culture. Focus on Prevention - Include a Corrective Action Plan (CAP) that addresses risks, assigns responsibility, sets deadlines, and outlines follow-up. Corrective Action Plan Expectations - Be Specific, Measurable, Achievable, Realistic, and Time-bound (SMART) - Be implemented and monitored - Include follow-up to measure effectiveness Confidentiality - The RCA is a confidential internal document but must be available to The Joint Commission during reviews or audits. Tools & Methods (Recommended) The Joint Commission encourages the use of tools such as: - Five Whys - Fishbone Diagrams - FMEA (Failure Mode and Effects Analysis) - National Patient Safety Foundation RCA Framework.” Reference The Joint Commission Sentinel Event Policy: https://www.jointcommission.org/resources/patient-safety-topics/sentinel-event/“”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 36827 Based on review of patient records, policies and procedures, interview, and Texas state law, the facility failed to: A) ensure that 20 patients (Patient #11 through Patient #30) of 20 patients who presented to the emergency department after a sexual assault were provided with all the patient rights required by state law in the Texas Health and Safety Code, Chapter 323, Subchapter A. Emergency Services for Survivors of Sexual Assault. Without these patient rights resources required by Texas state law, patients may not have access to the information necessary to make the best medical decision for their situation. This has the potential to lead to lifelong physical and mental health complications. If a patient did not know their rights to receive prophylactic treatment for sexually transmitted infections, it could potentially result in death. Refer to Tag A0117 B) ensure patients were properly protected from abuse. The facility failed to ensure the state required mandatory report of suspected abuse to the Texas Department of Family Protective Services (DFPS), Child Protective Services (CPS) was made for 4 minor patients (Patient #14, Patient #21, Patient #26 and Patient #29) of 10 minor patients when there was a reasonable suspicion that abuse was involved. Refer to Tag A0145”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 36827 Based on review of patient records, policies and procedures, interview, and Texas state law, the facility failed to ensure that 20 patients (Patient #11 through Patient #30) of 20 patients who presented to the emergency department after a sexual assault were provided with all the patient rights required by state law in the Texas Health and Safety Code, Chapter 323, Subchapter A. Emergency Services for Survivors of Sexual Assault. Sec. 323.004. MINIMUM STANDARDS FOR EMERGENCY SERVICES, Subsection (b) requires: (b) A health care facility providing care to a sexual assault survivor shall provide the survivor with: ... (3) access to a sexual assault program advocate, if available, as provided by Subchapter H, Chapter 56A, Code of Criminal Procedure; (4) the information form required by Section 323.005; (Sec. 323.005. INFORMATION FORM. (a) The commission shall develop a standard information form for sexual assault survivors ...) ... (7) the name and telephone number of the nearest sexual assault crisis center; and ... Without these patient rights resources required by Texas state law, patients may not have access to the information necessary to make the best medical decision for their situation. This has the potential to lead to lifelong physical and mental health complications. If a patient did not know their rights to receive prophylactic treatment for sexually transmitted infections, it could potentially result in death. Findings included the following: The facility provided three policies for review: Policy Subject: Medical / Forensic Examination of the Patient with Suspected or Reported Sexual Assault; Policy # NS/SANE-PP-01; Date Reviewed: 01/24 Review of this policy showed it did not contain information about providing patients with the required rights listed above. Policy Subject: Management of Patient of Suspected Sexual Assault / Abuse Plan; Policy #: NS/SANE-PP-02; Date Reviewed: 11/03 Review of this policy showed it did not contain information about providing patients with the required rights listed above. Policy Subject: Management of the Patient of Suspected Sexual Assault / Abuse When No Certified Sexual Assault Nurse Examiner is Available; Policy #: NS/SANE-PP-03; Date Reviewed: 01/24 Review of this policy showed it contained one statement on page 2 of 2 about a patient advocate as follows: “6. A patient advocate may be contacted to provide support to the patient. The patient may chose (sic) a family member or friend for that role.” While it is a patient’s right to have a family member or friend in the room to support them, this policy statement did not fulfill the requirement listed as “(3) access to a sexual assault program advocate, if available, as provided by Subchapter H, Chapter 56A, Code of Criminal Procedure;”. A patient would be allowed to refuse the offer of a sexual assault program advocate; but access, if available, must be offered. The patient rights to be provided with the standard information form for sexual assault survivors and the name and telephone number of the nearest sexual assault crisis center were not addressed. An interview was conducted with Staff #17 on the afternoon of 7-24-25. Staff #17 provided a copy of the Sexual Assault Forensic Exam Process. It was listed at the bottom of the page as being updated on 7-2-25. Staff #17 stated she took the old process form and updated it after the facility had received a patient complaint. Staff #17 confirmed that this form had not gone through any committees and had not received approval from the medical staff or governing body. Review of the process form showed item 2. b. referred to the old “DSHS” (Department of State Health Services) non-safe ready information handout. The current program and handout were managed by the Texas Health and Human Services and not DSHS. Item 9, pertaining to pediatrics, instructed staff to perform a medical clearance on pediatric patients whose assault was over 120 hours old and refer them to the Children’s Advocacy Center. This information was incorrect. Review of the Texas Health and Human Services state approved information handout explained the following: “For parents, or guardians of a minor child, your child has the right to receive the forensic medical examination at any time, regardless of when the assault occurred. ... Texas law requires all emergency rooms to have staff who are able to conduct a forensic exam for sexual assault and are trained in forensic evidence collection techniques. ... Texas law requires health care facilities that are not SAFE-ready to give survivors of sexual assault this informational handout and notify you of your right to choose to have an exam conducted at this facility or to be transferred to another facility. It is your decision about whether you want to be transferred to another facility.” The Safe-ready designation was a designation that a facility could assign to itself. A SAFE-ready facility employs SANE (sexual assault nurse examiner) Nurses. The facility had not designated itself as a SAFE (sexual assault forensic examination)-ready facility. Patient medical records were reviewed on 7-22-25 in the conference room. Patient #11 Patient #11 was a 3-year-old brought in by her mother on 5-12-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence the patient’s mother was provided with the state required information sheet. Patient #12 Patient #12 was a 33-year-old who presented to the emergency department on 5-21-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient. Review of the patient medical record showed the record did not contain evidence that the patient had been given the name and phone number of the local sexual assault crisis center. Patient #13 Patient #13 was a 20-year-old who presented to the emergency department on 5-1-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient. Review of the patient medical record showed the record did not contain evidence that the patient had been given the name and phone number of the local sexual assault crisis center. Patient #14 Patient #14 was a 5-year-old who was brought in by her mother on 6-24-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the patient was provided access to a patient advocate. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient’s mother. Review of the patient medical record showed the record did not contain evidence that the patient’s mother had been given the name and phone number of the local sexual assault crisis center. Patient #15 Patient #15 was a 3-year-old who was brought in by her father on 5-15-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the patient was provided access to a patient advocate. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient’s father. Review of the patient medical record showed the record did not contain evidence that the patient’s father had been given the name and phone number of the local sexual assault crisis center. Patient #16 Patient #16 was a 22-year-old who presented to the emergency department on 6-25-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the patient was provided access to a patient advocate. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient. Review of the patient medical record showed the record did not contain evidence that the patient had been given the name and phone number of the local sexual assault crisis center. Patient #17 Patient #17 was a 49-year-old who presented to the emergency department on 5-5-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the patient was provided access to a patient advocate. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient. Review of the patient medical record showed the record did not contain evidence that the patient had been given the name and phone number of the local sexual assault crisis center. Patient #18 Patient #18 was a 42-year-old who presented to the emergency department on 5-1-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the patient was provided access to a patient advocate. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient. Review of the patient medical record showed the record did not contain evidence that the patient had been given the name and phone number of the local sexual assault crisis center. Patient #19 Patient #19 was a 19-year-old who presented to the emergency department on 6-7-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient. Review of the patient medical record showed the record did not contain evidence that the patient had been given the name and phone number of the local sexual assault crisis center. Patient #20 Patient #20 was a 21-year-old who presented to the emergency department on 6-8-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient. Review of the patient medical record showed the record did not contain evidence that the patient had been given the name and phone number of the local sexual assault crisis center. Patient #21 Patient #21 was a 5-year-old brought in by her mother on 4-19-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient’s mother. Review of the patient medical record showed the record did not contain evidence that the patient’s mother had been given the name and phone number of the local sexual assault crisis center. Patient #22 Patient #22 was a 12-year-old brought in by a family friend on 6-7-25 with a Chief Complaint of SANE (sexual assault nurse examination). Review of the patient medical record showed the record did not contain evidence that the patient was provided access to a patient advocate. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient. Review of the patient medical record showed the record did not contain evidence that the patient had been given the name and phone number of the local sexual assault crisis center. Patient #23 Patient #23 was a 16-year-old brought in by the father on 7-2-25 with a Chief Complaint of SANE (sexual assault nurse examination). Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient’s father. Review of the patient medical record showed the record did not contain evidence that the patient’s father had been given the name and phone number of the local sexual assault crisis center. Patient #24 Patient #24 was a 14-year-old brought in by the mother on 5-31-25 to the off-site Emergency Department with an Arrival Complaint of SANE (sexual assault nurse examination). A SANE nurse was not available, so the mother took the patient to the main campus Emergency Department on 6-1-25. Both records were reviewed with the same findings. Review of the patient medical record showed the record did not contain evidence that the patient was provided access to a patient advocate. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient’s mother. Review of the patient medical record showed the record did not contain evidence that the patient’s mother had been given the name and phone number of the local sexual assault crisis center. Patient #25 Patient #25 was a 20-year-old who presented to the emergency department on 6-8-25 with a Chief Complaint of SANE (sexual assault nurse examination). Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient. Review of the patient medical record showed the record did not contain evidence that the patient had been given the name and phone number of the local sexual assault crisis center. Patient #26 Patient #26 was a 6-year-old brought in by her mother on 6-23-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient’s mother. Review of the patient medical record showed the record did not contain evidence that the patient’s mother had been given the name and phone number of the local sexual assault crisis center. Patient #27 Patient #27 was a 47-year-old who presented to the emergency department on 7-21-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the patient was provided access to a patient advocate. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient. Review of the patient medical record showed the record did not contain evidence that the patient had been given the name and phone number of the local sexual assault crisis center. Patient #28 Patient #28 was a 24-year-old who presented to the emergency department on 7-12-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient. Review of the patient medical record showed the record did not contain evidence that the patient had been given the name and phone number of the local sexual assault crisis center. Patient #29 Patient #29 was a 10-year-old brought in by her mother on 5-29-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient’s mother. Review of the patient medical record showed the record did not contain evidence that the patient’s mother had been given the name and phone number of the local sexual assault crisis center. Patient #30 Patient #30 was a 12-year-old brought in by her grandmother on 7-19-25 with a Chief Complaint of SANE (Sexual Assault Nurse Examination). Review of the patient medical record showed the record did not contain evidence that the patient was provided access to a patient advocate. Review of the patient medical record showed the record did not contain evidence that the state required information sheet had been given to the patient’s grandmother. Review of the patient medical record showed the record did not contain evidence that the patient’s grandmother had been given the name and phone number of the local sexual assault crisis center.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 36827 Based on review of records and interview, the facility failed to ensure patients were properly protected from abuse. The facility failed to ensure the state required mandatory report of suspected abuse to the Texas Department of Family Protective Services (DFPS), Child Protective Services (CPS) was made for 4 minor patients (Patient #14, Patient #21, Patient #26 and Patient #29) of 10 minor patients when there was a reasonable suspicion that abuse was involved. Findings included: A review of hospital policy was made. Policy Subject: Management of the Patient of Suspected Sexual Assault / Abuse When No Certified Sexual Assault Nurse Examiner is Available; Policy #: NS/SANE-PP-03; Date Reviewed: 01/24 contained the following on page 1 of 2: “INTERVENTIONS: ... 4. If the victim is a child, elderly or a disabled person, Texas law requires suspected sexual assault to be reported to the Child or Adult Protective Services.” Policy Subject: Management of Patient of Suspected Sexual Assault / Abuse Plan; Policy #: NS/SANE-PP-02; Date Reviewed: 11/03 contained the following on page 3 of 5: “DOCUMENTATION ED Record: 1. ED (emergency department) personnel and the SANE (sexual assault nurse examiner) will make all usual and customary entries, including notification of police, CPS, private physicians or referral agencies.” Medical records for patients who presented to the Emergency Department after a sexual assault were reviewed on 7-22-25 in the conference room. Ten of the 21 records selected for review were minors. Review results were as follows: Patient #14 Patient #14 was a 5-year-old who was brought in by her mother on 6-24-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the patient had accused a family member of the assault. No evidence was found in the record that a report to Child Protective Services was made. Patient #21 Patient #21 was a 5-year-old brought in by her mother on 4-19-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the patient had accused a family friend she had been left with of the assault. No evidence was found in the record that a report to Child Protective Services was made. Patient #26 Patient #26 was a 6-year-old brought in by her mother on 6-23-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the patient had accused a family member of physical and sexual assault. No evidence was found in the record that a report to Child Protective Services was made. Patient #29 Patient #29 was a 10-year-old brought in by her mother on 5-29-25 with a Chief Complaint of Sexual Assault. Review of the patient medical record showed the patient had accused a family member of sexual assault. No evidence was found in the record that a report to Child Protective Services was made. Interview was conducted with Staff #2. Staff #2 stated that the hospital staff report all suspected child abuse and neglect to CPS and should have documented the call information along with the intake number for tracking. Staff #2 stated this was most likely a documentation error where the staff failed to document the CPS call and intake number. Staff #2 had hospital staff call CPS that afternoon and provided the new intake numbers to ensure if it wasn’t just a documentation error, CPS had a report on file.”

“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: 36827 Based on observation, review of policy, and interview, the facility failed to have the required signage conspicuously placed in 2 of 2 Obstetric (OB) Triage and Treatment Emergency Rooms (N252A andN252B) on the Obstetric (OB) Unit. Findings included: On 7-21-25 at 3:00 PM, a tour of the OB Unit was made. Two rooms (N252A andN252B) had been designated as OB Emergency Rooms. Interview with Staff #23 and Staff #24 was conducted at the time of the tour. Staff #24 explained that OB patients who were greater than 20 weeks of gestation would be brought to the OB Unit Emergency Rooms to be evaluated and treated per hospital policy. Policy #LDR-PP-54, Subject: Obstetric Triage, was reviewed and confirmed this to be hospital policy. Observation of the OB Unit showed that patients would arrive to the front desk to register. The required signage (commonly referred to as “It’s the Law” sign) was noted to be displayed on the wall in hallway to the patient’s back as they registered. The patient would then be escorted to one of two OB Unit Emergency Rooms. The OB Unit Emergency Rooms did not have the required signage displayed in the rooms as required. Staff #23 and Staff #24 confirmed these findings.”

“A life safety code (LSC) full survey was conducted on site from 03/05/24-03/07/24 for the Christus Saint Michael Health System (Texarkana, TX), Christus Saint Michael Rehabilitation Hospital (Texarkana, TX), and Christus Saint Michael Hospital (Atlanta, TX). An entrance conference was conducted on 03/05/24 at 4:30 pm with facility leadership in the administrative conference room to discuss the purpose of the LSC survey, and the survey process was explained. Instructions were provided on writing plans of correction. An opportunity was provided for questions and discussion. An LSC exit conference was conducted on 03/07/24 at 12:45 pm in the administration conference room with facility leadership present. The preliminary findings of the survey and the next steps in the survey process were explained. An opportunity was provided for questions and discussion. The LSC resurvey survey was conducted under the authority of Chapter 2 of the State Operations Manual, Appendix A, Acute Care Hospitals, 42CFR482 to determine the Hospital’s compliance. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the plan of correction, correction dates, and the signature space. Any discrepancy in the original deficiency citation(s) will be reported to the Dallas Regional Office (RO) for referral to the Office of the Inspector General (OIG) for possible fraud. If information is inadvertently changed by the provider/supplier, the State Survey Agency (SA) should be notified immediately.”

“Multiple Occupancies - Construction Type CFR(s): NFPA 101 Multiple Occupancies - Construction Type Where separated occupancies are in accordance with 18/19.1.3.2 or 18/19.1.3.4, the most stringent construction type is provided throughout the building, unless a 2-hour separation is provided in accordance with 8.2.1.3, in which case the construction type is determined as follows: * The construction type and supporting construction of the health care occupancy is based on the story in which it is located in the building in accordance with 18/19.1.6 and Tables 18/19.1.6.1 * The construction type of the areas of the building enclosing the other occupancies shall be based on the applicable occupancy chapters. 18.1.3.5, 19.1.3.5, 8.2.1.3 This Standard is not met as evidenced by: 35321 Findings: applicable to all locations The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Observed at Christus Saint Michael Health System (Texarkana, TX), level 1, 2-hour separation from clinic, there was gap at the deck which was filled with mineral wool. Verify approved construction type and method of achieving 2-hour separation.”

“Hazardous Areas - Enclosure CFR(s): NFPA 101 Hazardous Areas - Enclosure Hazardous areas are protected by a fire barrier having 1-hour fire resistance rating (with 3/4 hour fire rated doors) or an automatic fire extinguishing system in accordance with 8.7.1 or 19.3.5.9. When the approved automatic fire extinguishing system option is used, the areas shall be separated from other spaces by smoke resisting partitions and doors in accordance with 8.4. Doors shall be self-closing or automatic-closing and permitted to have nonrated or field-applied protective plates that do not exceed 48 inches from the bottom of the door. Describe the floor and zone locations of hazardous areas that are deficient in REMARKS. 19.3.2.1, 19.3.5.9 Area Automatic Sprinkler Separation N/A a. Boiler and Fuel-Fired Heater Rooms b. Laundries (larger than 100 square feet) c. Repair, Maintenance, and Paint Shops d. Soiled Linen Rooms (exceeding 64 gallons) e. Trash Collection Rooms (exceeding 64 gallons) f. Combustible Storage Rooms/Spaces (over 50 square feet) g. Laboratories (if classified as Severe Hazard - see K322) This Standard is not met as evidenced by: 35321 Findings: The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Observed at Christus Saint Michael Health System (Texarkana, TX), level 6, electrical room (S659) - the required wall stenciling was painted over.”

“Cooking Facilities CFR(s): NFPA 101 Cooking Facilities Cooking equipment is protected in accordance with NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, unless: * residential cooking equipment (i.e., small appliances such as microwaves, hot plates, toasters) are used for food warming or limited cooking in accordance with 18.3.2.5.2, 19.3.2.5.2 * cooking facilities open to the corridor in smoke compartments with 30 or fewer patients comply with the conditions under 18.3.2.5.3, 19.3.2.5.3, or * cooking facilities in smoke compartments with 30 or fewer patients comply with conditions under 18.3.2.5.4, 19.3.2.5.4. Cooking facilities protected according to NFPA 96 per 9.2.3 are not required to be enclosed as hazardous areas, but shall not be open to the corridor. 18.3.2.5.1 through 18.3.2.5.4, 19.3.2.5.1 through 19.3.2.5.5, 9.2.3, TIA 12-2 This Standard is not met as evidenced by: 35321 Findings: The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Observed at Christus Saint Michael Hospital (Atlanta, TX): (a) there was no emergency gas shutoff system for cooking appliances. (b) The Ansul nozzle aiming device was not pointed over the tabletop grill. 2) Observed at Christus Saint Michael Health System (Texarkana, TX), level 1 dietary - remove redundant “Emergency shut-off” signage.”

“Subdivision of Building Spaces - Smoke Compar CFR(s): NFPA 101 Subdivision of Building Spaces - Smoke Compartments 2012 EXISTING Smoke barriers shall be provided to form at least two smoke compartments on every sleeping floor with a 30 or more patient bed capacity. Size of compartments cannot exceed 22,500 square feet or a 200-foot travel distance from any point in the compartment to a door in the smoke barrier. 19.3.7.1, 19.3.7.2 Detail in REMARKS zone dimensions including length of zones and dead-end corridors. This Standard is not met as evidenced by: 35321 Findings: The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Observed at Christus Saint Michael Rehabilitation Hospital (Texarkana, TX), there was an unsealed penetration above ceiling at the cross-corridor doors along the smoke compartment wall.”

“Building Services - Other CFR(s): NFPA 101 Building Services - Other List in the REMARKS section any LSC Section 18.5 and 19.5 Building Services requirements that are not addressed by the provided K-tags, but are deficient. This information, along with the applicable Life Safety Code or NFPA standard citation, should be included on Form CMS-2567. This Standard is not met as evidenced by: 35321 Findings: The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Based on review of the records, the temperature for the operating rooms at Christus Saint Michael Health System (Texarkana, TX) were out of range for the sampling years 2022, 2023, and persisted into January 2024 even though the acceptable temperature range per ASHRAE 170 was noted on the temperature/humidity logging sheet. Facility failed to take proactive action to bring temperature in operating rooms into compliance.”

“HVAC CFR(s): NFPA 101 HVAC Heating, ventilation, and air conditioning shall comply with 9.2 and shall be installed in accordance with the manufacturer’s specifications. 18.5.2.1, 19.5.2.1, 9.2 This Standard is not met as evidenced by: 35321 Findings: The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Observed at Christus Saint Michael Health System (Texarkana, TX), level 1, medical gas room - the vaneometer was showing this room as overly positive. This space requires negative ventilation. 2) Observed at Christus Saint Michael Health System (Texarkana, TX), level 6, mechanical room - there was leakage from the chiller pipe. 3) Observed at Christus Saint Michael Health System (Texarkana, TX), level 4, mechanical room - AHU No. 7 serving the pharmacy was not running and there was no notification to staff or out of service notice. 4) Observed at Christus Saint Michael Health System (Texarkana, TX), AHU No. 8 which served “Biomed / Food Services” had a leak and stopped running. Facility was surprised unit was down and did not receive any alarm notification. 5) Observed at Christus Saint Michael Health System (Texarkana, TX) rooftop, AHU-19 outdoor unit - the mesh screen was very dirty and needed replacement. 6) Observed at Christus Saint Michael Rehabilitation Hospital (Texarkana, TX): (a) the exhaust for the ware wash room in dietary should be located more toward the dirty side of the dish washing machine. (b) Soiled Utility (H152) had barely noticeable exhaust. 7) General Comment - provide label in large font for all the air handling units so it is easily identifiable.”

“Evacuation and Relocation Plan CFR(s): NFPA 101 Evacuation and Relocation Plan There is a written plan for the protection of all patients and for their evacuation in the event of an emergency. Employees are periodically instructed and kept informed with their duties under the plan, and a copy of the plan is readily available with telephone operator or with security. The plan addresses the basic response required of staff per 18/19.7.2.1.2 and provides for all of the fire safety plan components per 18/19.2.2. 18.7.1.1 through 18.7.1.3, 18.7.2.1.2, 18.7.2.2, 18.7.2.3, 19.7.1.1 through 19.7.1.3, 19.7.2.1.2, 19.7.2.2, 19.7.2.3 This Standard is not met as evidenced by: 35321 Findings: applicable to all locations The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Based on review of the records, facility failed to update the EOP call list to include active employees and remove no longer employed personnel from list.”

“Gas and Vacuum Piped Systems - Other CFR(s): NFPA 101 Gas and Vacuum Piped Systems - Other List in the REMARKS section any NFPA 99 Chapter 5 Gas and Vacuum Systems requirements that are not addressed by the provided K-Tags, but are deficient. This information, along with the applicable Life Safety Code or NFPA standard citation, should be included on Form CMS-2567. Chapter 5 (NFPA 99) This Standard is not met as evidenced by: 35321 Findings: The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Observed at Christus Saint Michael Hospital (Atlanta, TX), there were dissimilar metal contacts in the mechanical room. Also, the hanger strap supporting the medical gas piping shifted off-center off the isolator tape.”

“Gas and Vacuum Piped Systems - Central Supply CFR(s): NFPA 101 Gas and Vacuum Piped Systems - Central Supply System Operations Adaptors or conversion fittings are prohibited. Cylinders are handled in accordance with 11.6.2. Only cylinders, reusable shipping containers, and their accessories are stored in rooms containing central supply systems or cylinders. No flammable materials are stored with cylinders. Cryogenic liquid storage units intended to supply the facility are not used to transfill. Cylinders are kept away from sources of heat. Valve protection caps are secured in place, if supplied, unless cylinder is in use. Cylinders are not stored in tightly closed spaces. Cylinders in use and storage are prevented from exceeding 130 degrees Fahrenheit, and nitrous oxide and carbon dioxide cylinders are prevented from reaching temperatures lower than manufacture recommendations or 20 degrees Fahrenheit. Full or empty cylinders, when not connected, are stored in locations complying with 5.1.3.3.2 through 5.1.3.3.3, and are not stored in enclosures containing motor-driven machinery, unless for instrument air reserve headers. 5.1.3.2, 5.1.3.3.17, 5.1.3.3.1.8, 5.1.3.3.4, 5.2.3.2, 5.2.3.3, 5.3.6.20.4, 5.6.20.5, 5.3.6.20.7, 5.3.6.20.8, 5.3.6.20.9 (NFPA 99) This Standard is not met as evidenced by: 35321 Findings: The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Observed at Christus Saint Michael Hospital (Atlanta, TX), there were storage of medical gas bottles in the electrical room by the boiler area.”

“Electrical Systems - Other CFR(s): NFPA 101 Electrical Systems - Other List in the REMARKS section any NFPA 99 Chapter 6 Electrical Systems requirements that are not addressed by the provided K-Tags, but are deficient. This information, along with the applicable Life Safety Code or NFPA standard citation, should be included on Form CMS-2567. Chapter 6 (NFPA 99) This Standard is not met as evidenced by: 35321 Findings: The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Observed at Christus Saint Michael Rehabilitation Hospital (Texarkana, TX), electrical room - the two automatic transfer switches were missing phenolic label.”

“Electrical Systems - Maintenance and Testing CFR(s): NFPA 101 Electrical Systems - Maintenance and Testing Hospital-grade receptacles at patient bed locations and where deep sedation or general anesthesia is administered, are tested after initial installation, replacement or servicing. Additional testing is performed at intervals defined by documented performance data. Receptacles not listed as hospital-grade at these locations are tested at intervals not exceeding 12 months. Line isolation monitors (LIM), if installed, are tested at intervals of less than or equal to 1 month by actuating the LIM test switch per 6.3.2.6.3.6, which activates both visual and audible alarm. For LIM circuits with automated self-testing, this manual test is performed at intervals less than or equal to 12 months. LIM circuits are tested per 6.3.3.3.2 after any repair or renovation to the electric distribution system. Records are maintained of required tests and associated repairs or modifications, containing date, room or area tested, and results. 6.3.4 (NFPA 99) This Standard is not met as evidenced by: 35321 Findings: The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Applicable for all locations - Based on review of the records, facility did not perform any receptacle maintenance and testing at all in patient care areas. NFPA 99-2012, section 6.3.3.2 lists the minimum requirements for receptacle testing regardless of hospital-grade or not. Describe the facility justification of testing frequency (e.g. appropriate testing intervals) based on documented performance data. For example, experiential data shows that retention force of the grounding blade of each electrical receptacle decreases over time due to repeated usage. Thus, the failure rate has a direct correlation to time and usage. What data does the facility collect or will implement that could provide the kind of indication of pending failures or reveal non-conformance receptacles such that it could take pre-emptive action before the onset of failure?”

“Electrical Systems - Essential Electric Syste CFR(s): NFPA 101 Electrical Systems - Essential Electric System Receptacles Electrical receptacles or cover plates supplied from the life safety and critical branches have a distinctive color or marking. 6.4.2.2.6, 6.5.2.2.4.2, 6.6.2.2.3.2 (NFPA 99) This Standard is not met as evidenced by: 35321 Findings: The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Observed at Christus Saint Michael Rehabilitation Hospital (Texarkana, TX) in bath tub room - the label on the electrical cover plate was fading and thus no longer legible. This is one example of many similar findings. 2) Observed at Christus Saint Michael Health System (Texarkana, TX), level 6 of south tower, pod 4 nurse station - red receptacle exhibited low retention force. 3) Observed at Christus Saint Michael Health System (Texarkana, TX), level 2 endoscopy rooms - none of the electrical receptacles were labeled. 4) Observed at Christus Saint Michael Rehabilitation Hospital (Texarkana, TX), there was no red receptacle for crash cart charging in the corridor.”

“Electrical Systems - Essential Electric Syste CFR(s): NFPA 101 Electrical Systems - Essential Electric System Maintenance and Testing The generator or other alternate power source and associated equipment is capable of supplying service within 10 seconds. If the 10-second criterion is not met during the monthly test, a process shall be provided to annually confirm this capability for the life safety and critical branches. Maintenance and testing of the generator and transfer switches are performed in accordance with NFPA 110. Generator sets are inspected weekly, exercised under load 30 minutes 12 times a year in 20-40 day intervals, and exercised once every 36 months for 4 continuous hours. Scheduled test under load conditions include a complete simulated cold start and automatic or manual transfer of all EES loads, and are conducted by competent personnel. Maintenance and testing of stored energy power sources (Type 3 EES) are in accordance with NFPA 111. Main and feeder circuit breakers are inspected annually, and a program for periodically exercising the components is established according to manufacturer requirements. Written records of maintenance and testing are maintained and readily available. EES electrical panels and circuits are marked, readily identifiable, and separate from normal power circuits. Minimizing the possibility of damage of the emergency power source is a design consideration for new installations. 6.4.4, 6.5.4, 6.6.4 (NFPA 99), NFPA 110, NFPA 111, 700.10 (NFPA 70) This Standard is not met as evidenced by: 35321 Findings: The surveyor observed, while accompanied by the facility team, during the hours of the survey from 4:30 pm - 8 pm on 3/05/24, 8:45 am - 9:15 pm on 03/06/24, and 7:30 am - 1:15 pm on 03/07/24 that there were the following issues: 1) Observed at Christus Saint Michael Hospital (Atlanta, TX), the required task light with battery backup at the generator set location was not working. It produced smoke when energized. 2) Observed at Christus Saint Michael Hospital (Atlanta, TX), there was no red receptacle connected to the Life Safety branch of the EES at the generator set location. 3) Observed at Christus Saint Michael Health System (Texarkana, TX), level 2 - electrical room next to generator had storage of rubbish. 4) Observed at Christus Saint Michael Rehabilitation Hospital (Texarkana, TX): (a) the generator was leaking coolant. (b) The light inside the generator was loose from its socket. (c) Staff did not know the purpose of circuit break no. 7 at the genset location. (d) the generator EPO was missing the tool to break glass in case of emergency.”

“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: 40989 Based on document review and interview the Governing Body failed to: 1. adopt and implement 3 of 4 policies reviewed for Hospital #1 and Hospital #2. Also, the Governing Body failed to ensure the policies were reviewed every 3 years. The hospital was unable to provide additional hospital policies that had been adopted and implemented for Hospital #1 and Hospital #2. Findings: A review of the policy titled, “Verbal/Telephone Orders”, Policy Number: 3.140, Approved by the Chief Clinical Officer with a reviewed date of 3/2018 was a hospital systems policy and had not been adopted by the quality council committee and/or the governing board for Hospital #1 and/or Hospital #2. The policy had not been reviewed since 2018. This was 3 years over the required every 3-year review process. Further review of the policy revealed the system policy referred to different states with different rules. The policy was as follows: “ ...D. Authentication 1. The provider must authenticate all verbal and/or telephone orders within the statutory guidelines (Texas:96 hours, New Mexico: 72 hours, and Louisiana: within 10 days) ...” A review of the policy titled, “Moderate Sedation,” Policy Number: 3.400, created 3/2017 with no review or revision date, and approved by the Chief Clinical Officer was a hospital systems policy and had not been adopted by the quality council committee and/or the governing board for Hospital #1 and/or Hospital #2. Further review of the policy revealed the system policy referred to different states with different rules. The policy was as follows and had attached addendums from multiple states: “ ...B ...The following are position statements from each State Board of Nursing for a Registered Nurse. a. Appendix A: Texas Board of Nursing b. Appendix B: Louisiana State Board of Nursing c. Appendix C: Arkansas State Board of Nursing d. New Mexico State Board of Nursing ...” An interview was conducted with RN Staff #2 on 1/24/2024 after 1:00 PM. RN Staff #2 confirmed the Moderate Sedation Policy referred to several different states and placed the staff and patients at risk for medication errors that could cause irreversible damage to a patient because some states are more restrictive, and some states are less restrictive on what medications a nurse may give for moderate sedation.” RN Staff #2 confirmed the policy had not been reviewed since 2017. This was 3 years over the required every 3-year review process. A review of the hospital policy title, “Informed Consent for Invasive/Surgical Procedure” Number 7.003, Approved by the Chief Clinical Officer with a Reviewed/Revised date of 9/23 was a hospital systems policy and had and had not been adopted by the quality council committee and/or the governing board for Hospital #1 and/or Hospital #2. Further review of the policy revealed the system policy referred to different states with different rules. The policy was as follows and had attached addendums from multiple states: “ ...VI. REGULATIONS/REQUIREMENTS The Joint Commission ... CMS CoP ... Texas Admin Code ... Remedies Code ... Louisiana Admin Code ... See Appendix ... Risks and Hazards 1. Texas Admin Code ... 2. Louisiana Administrative Code ... Adult and Surrogate Decision Maker ... Tx ... LA Louisiana State Legislature Revised Statute ... NM New Mexico NMSA 1978 Relating to Healthcare ...” During an interview on the morning of 1/25/2024 with Physician #89 and Staff #126 it was confirmed the policies had not been adopted by the governing body for the facility and they were the current policies being followed. No further policies were provided for review. Staff #126 was asked how the governing body adopted policies that referred to other state requirements and laws. CEO stated, “They can’t. It has to be for this state.” 2. A. ensure a properly executed informed consent was completed in 5 (Patient #41, #44, #46, #62, and #3) of 11 patient medical records reviewed. Also, the facility failed to follow the hospital’s Informed Consent Policy and the Moderate Sedation Policy. Refer to Tag A0131 B. ensure 3 (# 29, # 30, # 31) of 7 staff members working in high-risk areas (hemodialysis and surgery) were vaccinated and/or had positive immunity against the Hepatitis B virus. C. identify 1 of 6 IV (intravenous) pumps in the dialysis treatment room with overdue preventative maintenance (PM). D. verify dialysate conductivity and pH with an independent device before treatment initiation on 1 (#5) of 6 patient treatments observed. Also, the hospital staff failed to follow the facility policy, “Water Treatment and Monitoring” and “Hemodialysis: Plan of Care”. E. implement a schedule to ensure each hemodialysis machine was tested quarterly for bacterial growth and the presence of endotoxins. The hospital staff failed to test 7 (#3300/500, #3305/505, #3306/306, #3307/307, #3308/308, # 3309/309, #3310/310) of 11 dialysis machines one or more quarters of 2023. F. ensure that 2 (# 76 and # 77) of 2 patients undergoing hemodialysis treatment with an unknown Hepatitis B status were treated in a location that prevented the transmission of Hepatitis B to other patients and staff members. Also, the hospital staff failed to follow the hospital policy, “Hepatitis B”. G. ensure the patient’s dialysis access was visible throughout the patient’s entire treatment in 4 (# 64, # 65, # 66, # 67) of 6 patient observations. H. ensure the acid and bicarb pick-up wands fit securely on the acid and bicarb concentrate jugs in the dialysis treatment room. I. follow its policy and procedure and ensured when staff called a code that all employees responded to a possible infant abduction. Also, the facility failed to ensure the infant alarm system was working properly, and that all infants including NICU (Neonatal Intensive Care Unit) infants were protected in 3 of 3 (Women services, Nursery, NICU) units. Refer to Tag A0144 3. A. have an acuity tool for the Intensive care units and 4 North patient care unit. Nursing failed to accurately staff up in numbers or down to the acuity of patients according to the minimal staffing matrix provided in 2 (CIVCU and surgical ICU) of 4 (CVICU, Surgical ICU, 4 North, and Emergency Room) units reviewed. Refer to Tag A0392 B. ensure physician orders were obtained to change ventilator settings for 1 (patient # 22) out of 1 Neonatal Intensive Care Unit (NICU) patient. Refer to Tag A0395 C. ensure Nursing Services documented verbal orders from physicians for moderate sedation medications in the Radiology Department in 4 (Patient #6, #41, #42, and #43) of 4 medical records reviewed. Also, the hospital failed to ensure physicians signed verbal orders for sedation medications according to the facility’s Verbal Order Policy. Refer to Tag A0409 4. A. Maintain the condition of the dietary area to ensure the safety and well-being of patients and staff. Refer to tag 701 B. Promptly dispose of, or properly store decommissioned office chairs, tables, hospital beds, rails, and miscellaneous metal Refer to tag 713 C. Ensure the emergency generator started for testing Refer to tag 724 D. Designate or determine who would monitor the “day-to-day” maintenance of the negative pressure rooms. Also, the facility staff failed to monitor and document the negative pressure room that showed 12 air exchanges each hour and verified an air filtration rate of at least 95% per policy, “Tuberculosis Control Plan”. In addition, the facility staff failed to provide negative pressure room settings data to the Infection Control Committee to support that they were monitoring and maintaining negative pressure rooms. Refer to tag 726 5. ensure the infection prevention and control program maintained a clean and sanitary environment to avoid sources and transmission of infection in the following departments Hospital #1, Dietary, Labor and delivery, Post- Partum, Main Warehouse, Medical, surgical, cardiovascular ICU’s, Central supply Cath Lab, Out Patient Cancer Treatment Area, Out Patient Oncology, Out patient Imaging. Hospital #2- Dietary, Medical Surgical Floor, Laboratory. Refer to Tag A0750 6. A. ensure the immediate use of steam sterilization for autoclaves #8 and #9 in the sub-sterile rooms were being used only for carefully selected clinical situations, such as a dropped instrument or no replacement instrument available. Also, the facility failed to complete and record the “Flash Sterilization Log” record per the facility policy. It was determined that this deficient practice posed an Immediate Jeopardy to patient health and safety and placed all patients having a Surgical procedure in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death. B. address the temperature and humidity in the twelve surgical operating rooms and the two surgical instrument room areas that were out of range for November 2023 through January 25, 2024. C. ensure sterility of transesophageal echocardiography (TEE) scope, which is a scope that is used for echocardiography to assess the structure and function of the heart, and to ensure the HEPA filter was changed every six months in the GUS System (this system is a manual high-level disinfection for endoscopes). Refer to Tag A0940”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 40989 Based on document review and interview the hospital failed to: A. ensure a properly executed informed consent was completed in 5 (Patient #41, #44, #46, #62, and #3) of 11 patient medical records reviewed. Also, the facility failed to follow the hospital’s Informed Consent Policy and the Moderate Sedation Policy. Refer to Tag A0131 B. ensure 3 (# 29, # 30, # 31) of 7 staff members working in high-risk areas (hemodialysis and surgery) were vaccinated and/or had positive immunity against the Hepatitis B virus. C. identify 1 of 6 IV (intravenous) pumps in the dialysis treatment room with overdue preventative maintenance (PM). D. verify dialysate conductivity and pH with an independent device before treatment initiation on 1 (#5) of 6 patient treatments observed. Also, the hospital staff failed to follow the facility policy, “Water Treatment and Monitoring” and “Hemodialysis: Plan of Care”. E. implement a schedule to ensure each hemodialysis machine was tested quarterly for bacterial growth and the presence of endotoxins. The hospital staff failed to test 7 (#3300/500, #3305/505, #3306/306, #3307/307, #3308/308, # 3309/309, #3310/310) of 11 dialysis machines one or more quarters of 2023. F. ensure that 2 (# 76 and # 77) of 2 patients undergoing hemodialysis treatment with an unknown Hepatitis B status were treated in a location that prevented the transmission of Hepatitis B to other patients and staff members. Also, the hospital staff failed to follow the hospital policy, “Hepatitis B”. G. ensure the patient’s dialysis access was visible throughout the patient’s entire treatment in 4 (# 64, # 65, # 66, # 67) of 6 patient observations. H. ensure the acid and bicarb pick-up wands fit securely on the acid and bicarb concentrate jugs in the dialysis treatment room. I. follow its policy and procedure and ensured when staff called a code that all employees responded to a possible infant abduction. Also, the facility failed to ensure the infant alarm system was working properly, and that all infants including NICU (Neonatal Intensive Care Unit) infants were protected in 3 of 3 (Women services, Nursery, NICU) units. Refer to Tag A0144”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 32143 Based on review and interview nursing failed to: A. have an acuity tool for the Intensive care units and 4 North patient care unit. Nursing failed to accurately staff up in numbers or down to the acuity of patients according to the minimal staffing matrix provided in 2 (CIVCU and surgical ICU) of 4 (CVICU, Surgical ICU, 4 North, and Emergency Room) units reviewed. Refer to Tag A0392 B. ensure physician orders were obtained to change ventilator settings for 1 (patient # 22) out of 1 Neonatal Intensive Care Unit (NICU) patient. Refer to Tag A0395 C. ensure Nursing Services documented verbal orders from physicians for moderate sedation medications in the Radiology Department in 4 (Patient #6, #41, #42, and #43) of 4 medical records reviewed. Also, the hospital failed to ensure physicians signed verbal orders for sedation medications according to the facility’s Verbal Order Policy. Refer to Tag A0409”

“PHYSICAL ENVIRONMENT CFR(s): 482.41 The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. This Condition is not met as evidenced by: 49344 Based on observation, interview, and record review the facility failed to: A. Maintain the condition of the dietary area to ensure the safety and well-being of patients and staff. Refer to tag 701 B. Promptly dispose of, or properly store decommissioned office chairs, tables, hospital beds, rails, and miscellaneous metal Refer to tag 713 C. Ensure the emergency generator started for testing Refer to tag 724 D. Designate or determine who would monitor the “day-to-day” maintenance of the negative pressure rooms. Also, the facility staff failed to monitor and document the negative pressure room that showed 12 air exchanges each hour and verified an air filtration rate of at least 95% per policy, “Tuberculosis Control Plan”. In addition, the facility staff failed to provide negative pressure room settings data to the Infection Control Committee to support that they were monitoring and maintaining negative pressure rooms. Refer to tag 726”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 30250 Based on observations, interviews, and review of documentation the facility failed to ensure the infection prevention and control program maintained a clean and sanitary environment to avoid sources and transmission of infection in the following departments Hospital #1, Dietary, Labor and delivery, Post- Partum, Main Warehouse, Medical, surgical, cardiovascular ICU’s, Central supply Cath Lab, Out Patient Cancer Treatment Area, Out Patient Oncology, Out patient Imaging. Hospital #2- Dietary, Medical Surgical Floor, Laboratory. Refer to Tag A0750”

“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: 47892 Based on observation, record review, and interview, the facility’s surgical staff failed to: A. ensure the immediate use of steam sterilization for autoclaves #8 and #9 in the sub-sterile rooms was being used only for carefully selected clinical situations, such as a dropped instrument or no replacement instrument available. Also, the facility failed to complete and record the “Flash Sterilization Log” record per the facility policy. It was determined that this deficient practice posed an Immediate Jeopardy to patient health and safety and placed all patients having a Surgical procedure in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death. B. address the temperature and humidity in the twelve surgical operating rooms and the two surgical instrument room areas that were out of range for November 2023 through January 25, 2024. C. ensure sterility of transesophageal echocardiography (TEE) scope, which is a scope that is used for echocardiography to assess the structure and function of the heart, and to ensure the HEPA filter was changed every six months in the GUS System (This system is a manual high-level disinfection for endoscopes). Findings Included: A. A review of the record titled, “Flash Sterilization Log” for autoclaves #8 and #9 revealed that complete instrument sets were being sterilized in the immediate use steam sterilization (IUSS) autoclaves which are 4-minute steam and 1-minute dry time. A full set of instruments should be run on a 4-minute steam and a 20-minute dry time. During a tour on 1/23/24 at 1:30 PM it was observed on the IUSS log that a Neck Pan with 8 instruments was run on the IUSS cycle, which was 4-minute steam and 1-minute dry time. During a tour on 1/23/24 at 1:30 PM, sterilizer #8 was open with a curette inside that had been sterilized on the IUSS setting. Staff member #12 had not placed a patient identification sticker on the log. The staff members were filling the log out inconsistently. There was no information on the load record for the curette instrument. A review of the Facility’s policy titled; “Sterile Processing Department” dated effective 6/2020 revealed the following: “...Objective: To ensure cleanliness and sterility of instrumentation, supplies, and equipment processed in steam or Ethylene oxide (ETO) sterilizer, along with VPROMAX system. Policy: It is the goal of CHRISTUS St. Michael (CMS) to prevent infection and to protect employees from infectious material by practicing proper decontamination cleaning and sterilization procedures in caring for instruments and equipment. Assurance of sterilization in steam and ETO autoclaves is confirmed through the use of Integrators next to each item sterilized. The Integrator is documented to be equivalent to and to parallel the same thermal death curve as a biological, with an immediate readout. Other sterilization monitoring devices such as Biologicals will act only as a secondary source to support overall sterilizer performance. Assurance of sterilization in Steris units is confirmed through use of biological and Chemical indicators. These procedures are to be performed only by persons specifically trained to do them. The same system of testing and documentation will be used housewide, as approved by the Infection Control Committee. Procedure: IV. IMMEDIATE USE STEAM STERILIZATION (IUSS) A. Immediate Use Steam Sterilization Immediate use steam sterilization will not be the primary means to sterilize sets or single items. The only acceptable reasons to use immediate use steam sterilization are: 1. In an emergency situation. 2. Dropped items. 3. Items that have had the packaging compromised. Any items that receive immediate use steam sterilization and do not meet these criteria must have the reason(s) why the item had immediate use sterilization cycle used documented on the Daily Flashing documentation Record...” A review of this policy revealed that the facility’s surgical staff was not following its policy. Upon a review of the 2017 “Association for the Advancement of Medical Instrumentation” ANSI/AAMI ST79:2017, the guidelines revealed the following: “...ANSI/AAMI ST79:2017 -- Comprehensive guide to steam sterilization and sterility assurance in health care facilities. 13 Process monitoring, testing, and quality control 13.3 Product identification and traceability 13.3.1 General considerations Each item or package intended for use as a sterile product should be labeled with a lot control identifier to allow full traceability of that item to the patient; alternately, an instrument tracking system may be used. Each load should have a load control record that includes a detailed content list, including specific identification of sets and the contents of sealable pouches. 13.3.2 Package labeling and expiration dating, if applicable Each item or package intended for use as a sterile product should be labeled with a lot control Identifier prior to sterilization. The lot control identifier should identify: a) the sterilizer identification number or code. b) a detailed list of the contents (e.g., identification of multiple sets and the contents of paper-plastic pouches). c) the person who assembled the package. d) the date of sterilization. e) the cycle number (cycle run of the sterilizer); and f) the patient, if applicable, Items processed for immediate use should include a patient identifier...” An interview was conducted with Staff #12 on 1/23/24 at 2:30 PM. Staff # 12 was asked if they should be running 9 instruments on an IUSS setting. Staff #12 stated, “This is the setting they told me to use for this set of instruments.” When asked where the documentation was for the curette that had been flashed on IUSS, Staff #12 stated “I just haven’t had time to put the information on the log”. An interview was conducted with Staff #17 and #18 on 1/23/24 at 2:50 PM. They were asked why operating room staff would run 9 instruments on an IUSS setting of 4-minute steam and 1-minute dry time. Staff #17 stated, “There is a to-follow case for the same surgeon doing the same procedure. Those are the surgeon’s special instruments that the surgeon uses on both cases he is doing today”. An interview was conducted with Staff #91 on 1/23/24 at 2:55 PM. Staff #91 was asked if operating room staff should be processing 9 instruments on an IUSS cycle. Staff #91 stated, “They should not be flashing (using IUSS) at all”. B. A review of the daily temperature and humidity records were as follows: November 2023 Daily Temperature and Humidity: 1. Operating Room 1: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 2. Operating Room 2: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 3. Operating Room 3: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 4. Operating Room 4: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 5. Operating Room 5: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 6. Operating Room 6: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 7. Operating Room 7: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 8. Operating Room 8: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 9. Operating Room 9: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 10. Operating Room 10: there were 18 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 11. Operating Room 11: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 12. Operating Room 12: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 13. Instrument Room 1: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 14. Instrument Room 2: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. There were no notations that the staff had reported the out-range temperature and Humidity. December 2023 Daily Temperature and Humidity Record: 1. Operating Room 1: there were 26 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 2. Operating Room 2: there were 25 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 3. Operating Room 3: there were 26 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 4. Operating Room 4: there were 27 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 5. Operating Room 5: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 6. Operating Room 6: there were 18 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 7. Operating Room 7: there were 14 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 8. Operating Room 8: there were 28 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 9. Operating Room 9: there were 15 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 10. Operating Room 10: there were 11 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 11. Operating Room 11: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 12. Operating Room 12: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 13. Instrument Room 1: there were 22 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 14. Instrument Room 2: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. There were only 6 of 330 notations made by the staff who had reported the out-range temperature and Humidity. January 2024 Daily Temperature and Humidity Record: 1. Operating Room 1: there were 15 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 2. Operating Room 2: there were 16 of 25 days where the temperature was out of range and 3 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 3. Operating Room 3: there were 17 of 25 days where the temperature was out of range and 2 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 4. Operating Room 4: there were 18 of 25 days where the temperature was out of range and 3 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 5. Operating Room 5: there were 23 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 6. Operating Room 6: there were 18 of 25 days where the temperature was out of range and 2 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 7. Operating Room 7: there were 11 of 25 days where the temperature was out of range and 2 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 8. Operating Room 8: there were 23 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 9. Operating Room 9: there were 6 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 10. Operating Room 10: there were 6 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 11. Operating Room 11: there were 25 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 12. Operating Room 12: there were 25 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 13. Instrument Room 1: there were 24 of 25 days where the temperature was out of range and 1 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. 14. Instrument Room 2: there were 25 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines. There were only 35 of 252 notations made by the staff who had reported the out-of-range temperature and humidity for the sterile processing and decontamination area. Review of the AORN Perioperative Standards and Recommended Practices, “Temperature should be maintained between 68 degrees F to 75 degrees Fahrenheit (20 degrees to 23 C) within the operating room suite. General work areas in sterile processing should be maintained between 68 degrees to 73 degrees F. Relative humidity should be maintained between 20% and 60% within the perioperative suite, including operating rooms, recovery areas, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas, and should be maintained below 60% in sterile storage areas. Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use, and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored, or procedures are performed. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system. Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system.” A review of the Facility’s policy titled; “Environment of Care: OR Temperature and Humidity” effective date 9/2023 revealed the following: “...Objective: To establish guidelines for the recommended room temperature and humidity in the Operating Room (OR). Temperature: The Temperature range in a restricted are (Operating Room) should be 68* F to 75* F but the range may be intentionally adjusted for a limited time based on the individual needs of the patient, such as pediatric surgical patients of patients undergoing procedures that require intentional hypothermia, may require that the room temperature be adjusted outside of the recommended range. Humidity: The recommended range for Humidity in the operating room is 20% to 60%. The thermostat in the room can be regulated to maintain humidity in this range. Procedure: Temperature and Humidity will be monitored daily in each Operating Room and documented on the Temperature/Humidity log in each room. When humidity is out of the recommended 20% to 60% range, adjustments will be made to the room thermostat. Increasing the temperature on the thermostat should lower the humidity. If temperature or humidity does not adjust within 30 minutes notify Plant Operations by calling 2800 and request a P-1 Work Order. If temperature or humidity continues to be out of range despite intervention by Plant Operations subsequent cases in the Operating Room should be moved to another room with the correct temperature and humidity level...” The facility’s surgical staff did not follow their policy. In an interview Staff #17 and #18 agreed that The Daily Temperature and Humidity Records were out of range. C. While observing the process for cleaning and disinfection of the TEE scope on 1/22/2024 at 2:30 PM, Staff #20 drooped the processor adaptor of the scope on the floor of the scope cleaning room. Staff #20 picked the adaptor up off the floor continued to coil the scope and placed it in a plastic tub for transfer to the drying cabinet. Dropping the connection on the floor and then picking it up from the floor contaminated the TEE scope. In effect, the scope needed to be reprocessed. Also, the bin that was to be used for transporting the scope to the drying cabinets was not labeled that it had been cleaned and was ready for use to transport a clean TEE scope. There was no way of knowing if the transport bin was clean and disinfected. An interview with Staff #20 on 1/22/2024 at 2:30 PM revealed that Staff #20 was unsure if the transport bin was clean. When Staff #20 was asked if the scope was considered clean after picking the adaptor up from the floor with sterile gloves and continuing to coil the disinfected scope. Staff #20 confirmed the TEE scope was contaminated and needed to be reprocessed. The GUS system is used to disinfect the TEE scope. This system is a manual high-level disinfection for endoscopes. This system contains a HEPA filter to protect staff from the toxic fumes of the Metracide OPA used to disinfect the scope. The HEPA filters need to be changed every six months according to manufacturer guidelines. Staff #17 was unable to produce documentation showing that the HEPA filter had ever been changed in the GUS system that was used in the scope cleaning and processing room. In an interview on 1/25/2024 at 2:30 PM Staff #85 stated, “We cannot get documentation on the GUS System filter change.” Staff #2 and #17 confirmed that the filter had not been changed and that there was no evidence found of when the HEPA filter had been changed.”

“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: 40989 Based on document review and interview the facility failed to ensure a properly executed informed consent was completed in 5 (Patient #41, #44, #46, #62, and #3) of 11 patient medical records reviewed. Also, the facility failed to follow the hospital’s Informed Consent Policy and the Moderate Sedation Policy. A review of medical records was completed on 1/23-1/24/24 with RN Staff #75, RN Staff #80, RN Staff #81, and Staff #76. Findings: Patient #41 Patient #41 was a 57-year-old male scheduled for a Tunneled Hemodialysis Catheter (a catheter used for a patient to receive Dialysis) on 1/12/2024 by Physician #78. A review of the document titled, “Disclosure and Consent Medical Care and Surgical Procedures” revealed RN Staff #75 signed as a witness to the patient signature 4 minutes before the patient signed the informed consent. RN Staff #75 and RN Staff #80 confirmed the witness’s signature should be signed at the time of the patient’s signature but never before the patient has signed. Patient #44 Patient #44 was a 54-year-old female admitted to the ED on 1/15/2024 with Right Ankle Pain. A review of the Informed Consent titled, “Description of Medical Care and Surgical Procedure(s)” was as follows: “ ...I voluntarily request my physician/healthcare provider (Physician #83) and such other assistants, as he/she deems appropriate to treat my condition which is: Bone Fracture or Deformity. Laterality: Right Site Specific: (blank) I understand that the following care/procedure(s) are planned for me: Closed Reduction of Fracture ...” RN Staff #80 confirmed the informed consent did not identify the location of the fractured bone and/or deformity. Also, it did not identify the fracture and/or deformity for the closed reduction procedure. A review of the Informed Consent titled, “Anesthesia and/or Perioperative Pain Management (Analgesia)” revealed the patient consented to Moderate Sedation on 1/15/2024. A review of the medical record confirmed the patient received 100mg of Ketamine (a dissociative anesthetic) IV (intravenous) and 50 mg of Propofol (a general anesthetic drug) IV for procedural sedation. During an interview on 1/24/2024 after 11:00 AM with RN Staff #80 and Physician #89, it was confirmed the patient should have consented to Deep Sedation. Physician #80 stated, “Administering Propofol should always be considered as a deep sedation and all of our ED Physicians have documented training and privileges to administer Deep Sedation.” An interview was conducted with RN Staff #102 on 1/25/2024 at 11:00 AM. RN Staff #102 was asked what types of sedation were given in the ED. RN Staff #102 stated, “We only consent for Moderate Sedation in the ED.” She was asked what medications were given for moderate sedation. RN Staff #102 confirmed Propofol, Ketamine, Versed (A sedative/hypnotic drug), and Fentanyl (an opioid drug used to treat severe pain) were given for moderate sedation in the ED. RN Staff #102 was asked if the physician remained with the patient until the patient returned to baseline from the deep sedation. RN Staff #102 stated, “No, they do not, the nurses monitor them.” Patient #46 Patient #46 was a 22-year-old male admitted to the ED on 1/12/2024 with a Left Ankle fracture. A review of the Informed Consent titled, “Anesthesia and/or Perioperative Pain Management (Analgesia)” revealed the patient consented to Moderate Sedation on 1/12/2024. A review of the medical record confirmed the patient received 50 mg of Ketamine IV and 100 mg of Propofol IV for procedural sedation. During an interview on 1/24/2024 after 11:00 AM with RN Staff #80 and Physician #89, it was confirmed the patient should have consented to Deep Sedation. Physician #80 stated, “Administering Propofol should always be considered as a deep sedation and all of our ED Physicians have documented training and privileges to administer Deep Sedation.” Patient #62 Patient #62 was a 68-year-old female admitted to the ED on 1/7/2024 with a left wrist dislocation. A review of the informed consent for a Closed Reduction of the Left Wrist (a procedure to reset the dislocated bone) revealed Physician #83 failed to date and time his signature on the procedure consent. Further review revealed Physician #83 failed to date and time his signature on the informed consent for Moderate Sedation. Without a date and time of the physician’s signature, this surveyor was unable to determine if the physician discussed the risks and benefits of the procedure before the patient signed the informed consent. RN Staff #81 confirmed the physician was to date and time the informed consent. A review of the hospital policy title, “Informed Consent for Invasive/Surgical Procedure” Number 7.003 with a Reviewed/Revised date of 9/23 was as follows: “ ...IV. PROCESS OR PROCEDURES A. Informed Consent for Invasive Procedures Responsibility The law places the duty to obtain informed consent upon the physician/licensed practitioner and it is nondelegable. The physician or licensed practitioner ordering or performing the medical treatment, procedure, or administration of anesthesia has a duty to the patient to disclose the nature of treatment(s), procedure(s), or surgery(s) to be performed and/or administration of anesthesia including possible alternatives and risks of non-treatment. The informed consent process is not delegated ... 3. Documentation of the informed consent communication with the patient regarding benefits, risks, and hazards, of the procedure(s) including possible alternatives and risks of non-treatment will be documented by the physician/practitioner signing the appropriate section of the consent form. 4. The consent form must include: a. The name(s) of the practitioner(s) performing the treatment or procedure b. Patient identity; c. Date when patient informed and date when patient signed the form, if different; ... 12. No elective surgery or procedure requiring shall be performed without a properly executed informed consent (sic). Non-valid incomplete consent forms shall be grounds for cancellation of the procedure or surgery. VI. REGULATIONS/REQUIREMENTS The Joint Commission ... CMS CoP ... Texas Admin Code ... Remedies Code ... Louisiana Admin Code ... See Appendix ... Risks and Hazards 1. Texas Admin Code ... 2. Louisiana Administrative Code ... Adult and Surrogate Decision Maker ... Tx ... LA Louisiana State Legislature Revised Statute ... NM New Mexico NMSA 1978 Relating to Healthcare ...” An interview was conducted with RN Staff #81 on 1/25/2024 at 9:30 AM. She was asked if the informed consent policy was current. RN Staff #81 confirmed the policy was the current policy. During an interview on 1/24/2024 after 10:00 AM Physician #89 confirmed the Informed Consent Policy was a systems policy that had not been adopted for the hospital through the local Quality Council or Governing Board and covered multiple states in the policy. A review of the policy titled, “Moderate Sedation,” Policy Number: 3.400 created 3/2017 with no review or revision date, and approved by the Chief Clinical Officer was as follows: “..II. OBJECTIVE/S: To provide for safe effective administration of medication for the purpose of moderate sedation during interventional procedures ... III. POLICY STATEMENT: A. Sedation practices throughout an institution are to be monitored and approved by the department of Anesthesia ... VIII. GENERAL RESPONSIBILITIES A. Physicians: Physicians are granted the privilege to administer moderate sedation through the Medical Staff Office. The medication used to achieve moderate sedation is selected and ordered by the physician in conjunction with the procedure and is used to increase the patient’s tolerance to the procedure. Medication used for Moderate Sedation is titrated to effect, not a predetermined dose. Although some rapid-acting anesthetic induction agents are administered by physicians for quick procedures they are not considered appropriate medications for an RN moderate sedation in which the physician will be involved in the procedure for a significant period of time. B ...The following are position statements from each State Board of Nursing for a Registered Nurse. a. Appendix A: Texas Board of Nursing b. Appendix B: Louisiana State Board of Nursing c. Appendix C: Arkansas State Board of Nursing d. New Mexico State Board of Nursing ...” During an interview on 1/24/2024 after 10:00 AM Physician #89 confirmed the Moderate Sedation Policy was a systems policy that had not been adopted by the hospital through the local Quality Council or Governing Board. It was also confirmed the policy referenced multiple states in the policy. Physician #89 was asked what medications the nurses were allowed to administer for moderate sedation. Physician #89 confirmed the current policy in use did not define which medications were to be used for moderate sedation. An interview was conducted with RN Staff #2 on 1/24/2024 after 1:00 PM. RN Staff #2 confirmed the Moderate Sedation Policy referred to several different states and placed the staff and patients at risk for medication errors that could cause irreversible damage to a patient because some states are more restrictive, and some states are less restrictive on what medications a nurse may give for moderate sedation. RN Staff #2 was asked if the nurses were allowed to administer Propofol IV Push for moderate sedation. RN Staff #2 confirmed the nurses were not allowed to administer Propofol for moderate sedation. 48653 Patient # 3 A review of medical records was completed with Staff # 3 on 1/22/2024 at 11:00 AM. A review of patient # 3’s medical records with Staff # 3 (Clinical Director) revealed the patient had a new diagnosis of advanced chronic kidney disease, requiring hemodialysis treatment. The patient’s first hemodialysis treatment initiation occurred on January 19th, 2024. Upon further review of the patient’s medical record, it was determined there was no informed consent provided to the patient prior to the initiation of hemodialysis treatment on January 19th, 2024. There was no hemodialysis consent present in the patient’s medical record. A review of the hospital’s policy titled, “Informed Consent for Invasive/Surgical Procedure” with a revision date of 9/23 revealed the following, “OBJECTIVE/S: To ensure patients are apprised of their rights and afforded the opportunity to make voluntary and informed decisions about medical care and treatment. POLICY STATEMENT: A competent adult patient or a surrogate decision-maker acting on the patient’s behalf has the right to receive from the patient’s physician/practitioner information necessary to make informed choices and decisions regarding the patient’s medical care and treatment. The primary purpose of the informed consent process is to ensure that the patient or his/her surrogate decision-maker is provided information in a manner that the patient and/or the patient’s surrogate decision-maker to effectively exercise the right to make informed decisions. PROCESS OR PROCEDURES: A. Informed Consent for Invasive Procedures ... The law places the duty to obtain informed consent upon the physician/licensed practitioner and it is nondelegable. The physician or licensed practitioner ordering or performing medical treatment, procedure, surgery, or administration of anesthesia has a duty to the patient to disclose the nature of treatment(s), procedure(s), or surgery(s) to be performed as well as the risks, hazards, and benefits of the treatment(s), procedure(s), surgery(s) and/or administration of anesthesia including possible alternatives and risks of non-treatment. The informed consent process is not delegated. 1. For all medical and surgical invasive procedures informed consent will be obtained.” In an interview with Staff # 3 on 01/22/2023 at 11:00 AM, Staff # 3 stated, “We were unable to locate a signed informed consent for hemodialysis for this patient. The RN who initiated dialysis treatment said she remembered printing it, but we are unable to locate it.””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 48653 Based on observation, record review, and interview the: A. “Associate Health Department” failed to ensure that 3 (# 29, # 30, # 31) of 7 staff members working in high-risk areas (hemodialysis and surgery) were vaccinated and/or had positive immunity against the Hepatitis B virus. B. staff failed to identify 1 of 6 IV (intravenous) pumps in the dialysis treatment room with overdue preventative maintenance (PM). C. staff failed to verify dialysate conductivity and pH with an independent device prior to treatment initiation on 1 (#5) of 6 patient treatments observed. Also, the hospital staff failed to follow the facility policy, “Water Treatment and Monitoring” and “Hemodialysis: Plan of Care”. D. staff failed to implement a schedule to ensure each hemodialysis machine was tested quarterly for bacterial growth and the presence of endotoxins. The hospital staff failed to test 7 (#3300/500, #3305/505, #3306/306, #3307/307, #3308/308, # 3309/309, #3310/310) of 11 dialysis machines one or more quarters of 2023. E. staff failed to ensure that 2 (# 76 and # 77) of 2 patients undergoing hemodialysis treatment with an unknown Hepatitis B status were treated in a location that prevented the transmission of Hepatitis B to other patients and staff members. Also, the hospital staff failed to follow facility policy, “Hepatitis B”. F. staff failed to ensure the patient’s dialysis access was visible throughout the patient’s entire treatment in 4 (# 64, # 65, # 66, # 67) of 6 patient observations. G. staff failed to ensure the acid and bicarb pick-up wands fit securely on the acid and bicarb concentrate jugs in the dialysis treatment room. A. This deficient practice had the likelihood to result in harm to staff members working in high-risk areas in the hospital due to failure to monitor hepatitis B immunity and vaccination status. The unknown immunity status of staff members could result in the transmission of the hepatitis B virus between patients and staff members. Staff # 29 A review of Staff # 29’s personnel file revealed Staff # 29 had a nonreactive HBV surface Antibody result on 08/22/22. Staff # 29 received dose # 1 of the vaccine series on 01/05/2023 at Associate Health. Staff # 29 did not receive dose # 2 or # 3 of the series. There was no evidence of a complete vaccine series or positive immunity for Staff # 29. Staff # 29 did not sign a Declination Form verifying refusal of vaccine and understanding of occupational risk and exposure to the hepatitis B virus. Staff # 30 A review of Staff # 30’s personnel file revealed Staff # 30 received a complete Hepatitis B vaccine series in 1999. There was no evidence of positive immunity for Staff # 30. Staff # 31 A review of Staff # 31’s personnel file revealed Staff # 31 declined the Hepatitis B vaccine on 3/15/2016. There was no evidence of a complete vaccine series or positive immunity for Staff # 31. Staff # 31 did not sign a Declination Form verifying refusal of vaccine and understanding of occupational risk and exposure to the hepatitis B virus. A review of the facility policy titled, “Vaccine Preventable Diseases and Immunization Policy” with a revision date of 05/08/2023 revealed the following, “PURPOSE: The purpose of this policy is to protect the health and safety of patients, associates, patient and associate family members, and the community as a whole from vaccine-preventable diseases and to comply with state and federal laws and regulations. POLICY STATEMENT: Christus requires, in accordance with the State Safety Code (where applicable) and Centers for Disease Control (CDC), that Covered Individuals working in a CHRISTUS Entity receive vaccines or provide serologic proof of immunity for the following vaccine-preventable diseases based on the level of risk the individual presents to patients by the individuals routine direct or indirect exposure to patients: Diphtheria, Pertussis, Hepatitis B, Tetanus, Influenza, Rubella, Measles, Varicella, Mumps, Meningococcal. Other preventable disease immunizations may be required should circumstances, public health or infection control conditions warrant. PROCESS OR PROCEDURES: 1. Christus will adhere to CDC document and the Immunization Action Coalition Health-Care Personnel Vaccination Recommendations; see attachment A ... RESPONSIBILITIES: A. Associate Health Department 1. Associate Health will maintain a record of immune status for Covered Individuals as received. Physicians and other LIP, vendors, students, and Allied Health Professionals are responsible for providing approved documentation of immunity to their sponsoring CHRISTUS department or their sponsoring agency where it will be maintained. Associate Health will maintain proof of vaccination as received. 2. CHRISTUS will evaluate whether a Covered Individual has complied with this policy. 3 ... Covered Individuals and their supervisors will be notified of immunization compliance, failure to meet the requirements may result in the withdrawal of a contingent offer letter or disciplinary actions.” A review of Attachment A titled “Healthcare Personnel Vaccination Recommendations” referenced in the facility policy, “Vaccine Preventable Disease and Immunization Policy” states the following, “Hepatitis B: Unvaccinated healthcare personnel (HCP) and/or those who cannot document previous vaccination should receive either a 2-dose series of Heplisav-B at 0 and 1 month or a 3-dose series of either Energix-B or Recombivax HB at 0, 1, and 6 months. HCP who perform tasks that may involve exposure to blood or body fluids should be tested for hepatitis B surface antibody 1-2 months after dose # 2 of Heplisav-B or dose # 3 of Energix-B or Recombivax HB to document immunity. If antibody is at least 10 mIU/ml (positive), the vaccinee is immune. No further serologic testing or vaccination is recommended. If antibody is less than 10 mIU/ml (negative), the vaccinee is not protected from hepatitis B virus infection and should receive another 2-dose or 3-dose series of Hep B vaccine on the routine schedule followed by anti-body testing 1-2 months later ... For HCP with documentation of a complete 2-dose or 3-dose vaccine series but no documentation of anti-body of at least 10 mIU/ml: HCP who are at risk of occupational blood or body fluid exposure might undergo antibody testing upon hire or matriculation.” An interview with Staff # 103 (Associate Health RN) on 01/24/2024 at 9:30 AM confirmed the immunity status against the hepatitis B virus was unknown in staff members working in high-risk and high-exposure areas in the hospital. Staff # 103 also verified the non-compliance with Attachment A which is referenced in the facility policy “Vaccine Preventable Diseases and Immunization Policy”. B. During a tour of the dialysis treatment room with Staff # 3 on 1/23/24 at 8:32 AM, the surveyor observed 1 of 6 IV pumps with an overdue PM. The IV pump was labeled with a PM due date of “07/2023”. An interview with Staff # 3 confirmed the IV pump was overdue for preventative maintenance. Staff # 3 removed the IV pump from service until the PM could be completed by the appropriate staff. C. This deficient practice had the likelihood to result in harm to all patients undergoing dialysis treatment at the facility by introducing improper water and dialysate concentrations to the patients. During a tour of the dialysis treatment room on the 5th floor with Staff # 3 (Clinical Director) on 1/22/24 at 1:05 PM, the surveyor observed Staff # 31 and # 54 preparing the dialysis machine in Bay 2 for patient # 5’s dialysis treatment. Staff # 54 was responsible for running the machine tests and verification checks. Staff # 31 did not verify that conductivity had been completed by Staff # 54 prior to initiating treatment on Patient # 5. Neither Staff # 31 nor # 54 completed an independent conductivity check prior to treatment initiation. Also, the RO (reverse osmosis) and bleach water located at the tri-station were not labeled with the date they were made. A review of the facility policy titled, “Water Treatment and Monitoring” with a revision date of 07/17 revealed the following, “PURPOSE: Water used to prepare dialysis fluid for acute hemodialysis should meet the quality requirements set forth by AAMI. Monitoring to demonstrate ongoing compliance with the chemical quality requirements and microbiological quality requirements will be performed as per AAMI guidelines. POLICY: Prior to initiation of dialysis, dialysate pH and conductivity will be verified with an independent meter. The dialysate sample will be taken from the machine’s sample port after the machine is in dialysis mode and the conductivity is in working range. If the pH is below 6.9 or above 8, dialysis should not be started, Biomed and unit manager will be notified.” A review of the facility policy titled, “Hemodialysis: Plan of Care” with a revision date of 01/2018 revealed the following, “OBJECTIVE: For any critical event to be recognized immediately and have appropriate measures implemented. POLICY: The team member will provide an environment conducive to safety and security for patients, families, visitors, and team members ... OBJECTIVE II: 1. Patency and integrity of dialyzer membrane and tubing. Accuracy of dialysate components and testing of its physiologic compatibility with blood. a. Dialysate is checked with a phoenix meter for pH and conductivity verification prior to initiation of therapy.” In an interview with Staff # 31 and # 54 on 01/22/2024 at 1:15 PM, Staff # 31 and # 54 confirmed they had not conducted an independent conductivity check prior to the initiation of hemodialysis treatment on Patient # 5 as required by the hospital’s policy. Staff # 3 was present for the interview. D. This deficient practice had the likelihood of harming all patients receiving hemodialysis treatment at the hospital due to the improper testing of the hemodialysis machines. An improper testing schedule could result in failure to identify a positive culture and/or endotoxin result thus placing the patient at risk of bacterial and/or endotoxin transmission. A review of the “Hemodialysis Infection Report” for 2023 revealed the following: Machine # 3300/500 Machine # 3300/500 underwent culture and endotoxin testing on April 10, 2023, July 24, 2023, and November 13, 2023. There was no documentation of culture and/or endotoxin testing for machine # 3300/500 for the first quarter of 2023. Machine # 3305/505 Machine # 3305/505 underwent culture and endotoxin testing on January 27, 2023, February 7, 2023, May 2, 2023, and September 5, 2023. There was no documentation of culture and/or endotoxin testing for machine # 3305/505 for the fourth quarter of 2023. Machine # 3306/506 Machine # 3306/506 underwent culture and endotoxin testing on February 7, 2023, June 6, 2023, and September 5, 2023. There was no documentation of culture and/or endotoxin testing for machine # 3306/506 for the fourth quarter of 2023. Machine # 3307/507 Machine # 3307/507 underwent culture and endotoxin testing on February 7, 2023, June 6, 2023, and October 3, 2023. There was no documentation of culture and/or endotoxin testing for machine # 3307/507 for the third quarter of 2023. Machine # 3308/508 Machine # 3308/508 underwent culture and endotoxin testing on March 7, 2023, June 6, 2023, and October 3, 2023. There was no documentation of culture and/or endotoxin testing for machine # 3308/508 for the third quarter of 2023. Machine # 3309/509 Machine # 3309/509 underwent culture and endotoxin testing on March 7, 2023, July 11, 2023, and October 3, 2023. There was no documentation of culture and/or endotoxin testing for machine # 3309/509 for the second quarter of 2023. Machine # 3310/510 Machine # 3310/510 underwent culture and endotoxin testing on March 7, 2023, July 11, 2023, and November 7, 2023. There was no documentation of culture and/or endotoxin testing for machine # 3310/510 for the second quarter of 2023. A review of the facility policy titled, “Monthly Cultures, Endotoxin Assay of Dialysis Machines and Dialysis Water” with a revision date of 07/14/2017 revealed the following, “OBJECTIVE: To assure quality water during each hemodialysis treatment by monitoring cultures of dialysate and endotoxin levels from dialysis machines and dialysis water. POLICY: Cultures and endotoxin testing on dialysate will be done each month on a rotating schedule so at least 1/3 machines and 3 dialysis stations are cultured monthly. The Aquaboss R/O system in the dialysis unit on the 5th floor and all portable reverse osmosis equipment will be cultured and endotoxin testing done monthly.” An interview with Staff # 3 and # 33 on 01/23/2024 at 12:30 PM confirmed the schedule for endotoxin and bacterial growth testing of the dialysis machines was not adequate for ensuring all dialysis machines were tested quarterly for the presence of endotoxins and bacteria. E. This deficient practice had the likelihood to result in the transmission of Hepatitis B between patients and staff members due to the treatment location and staffing assignments which were determined before the patient’s hepatitis status was known. A review of medical records for patient # 76 and patient # 77 revealed the facility staff were not treating unknown Hepatitis B status patients as if they were positive when determining treatment location and staffing assignments. A review of medical records for Patient # 76 revealed the following, Patient # 76 was admitted to the hospital on 01/20/2024 with an unknown Hepatitis B status. The patient required hemodialysis treatment on 01/20/2024 at 10:20 AM and was placed in Bay 2 (Bay 2 is located at the beginning of the loop and close to the main doors in and out of the dialysis treatment room). The patient’s Hepatitis B surface antigen was sent to the laboratory on 01/20/2024 at 10:22 AM and resulted as non-reactive at 11:58 AM. Patient # 76 was not treated in a location that was located outside of normal traffic patterns in the dialysis treatment room. A review of medical records for Patient # 77 revealed the following, Patient # 77 was admitted to the hospital on 01/04/2024 with an unknown Hepatitis B status. The patient required hemodialysis treatment on 01/05/2024 at 5:45 PM and was placed in Bay 3 (Bay 3 is in the middle of the loop and the center of the hemodialysis treatment room, just across from the nurses’ station). The patient’s Hepatitis B surface antigen was sent to the laboratory on 01/05/2024 at 5:34 PM and resulted as non-reactive at 7:37 PM. Patient # 77 was not treated in a location that was located outside of normal traffic patterns in the dialysis treatment room. A review of the facility policy titled, “Hepatitis B” with a review date of 04/14/2021 revealed the following, “OBJECTIVE: To minimize the spread of hepatitis infections in the dialysis setting. POLICY: Hepatitis B Testing: 1. In order to prevent transmission of Hepatitis B among dialysis patients, all new patients will be tested and their HBV serologic status (Hepatitis B surface antigen, Hepatitis B surface antibody, and total Hepatitis B core antibody) results will be obtained prior to completion of first hemodialysis treatment unless otherwise required by applicable state law. 2. If the Hepatitis B surface antigen status is unknown, the Nephrologist and Medical Director will be notified, and the patient treated as a suspect patient for Hepatitis B infection.” In an interview with Staff # 33 (Lead Dialysis Nurse) on 01/24/2024 at 09:00 AM, Staff # 33 stated, “Each nurse picks their assignments, and we try to be flexible with one another when determining who gets which patients.” The surveyor asked Staff # 33 if the nurses had taken into consideration the hepatitis B status of the patient when determining the assignments. Staff # 33 stated, “No, we don’t consider the hepatitis status of the patient in staffing assignments unless they are hepatitis B positive. If they are unknown, we do not make assignments as if the unknown status patient is positive.” An interview with Staff # 3 (Clinical Director) on 01/24/2024 at 09:05 AM confirmed the facility staff were not treating hepatitis B unknown status patients as if they were positive when determining the patient’s treatment location and staffing assignments. F. This deficient practice had the likelihood of resulting in harm to all dialysis patients receiving hemodialysis at the hospital due to the increased risk of bleeding dialysis patients have during treatment. Ensuring visibility of the patient’s dialysis access is imperative in the early recognition of bleeding in dialysis patients. During a tour of the facility’s dialysis treatment room on the 5th floor with Staff # 3, the surveyor observed 4 out of 6 dialysis patient’s accesses covered and not visible from the nurse’s station. A review of facility policy titled, “Hemodialysis Plan of Care” with a revision date of 01/2018 revealed, “OBJECTIVE: For any critical event to be recognized immediately and have appropriate measures implemented. POLICY: The team member will provide an environment conducive to safety and security for patients, families, visitors, and team members .... PROCESS/PROCEDURE: II. The patient and the equipment are monitored throughout the dialysis to prevent complications ...” An interview with Staff # 3 on 01/22/24 at 11:30 AM confirmed Staff # 3 recognized that 4 out of 6 patients had accesses that were covered and not visible from the nurse’s station. Staff # 3 uncovered the patient’s dialysis access upon recognizing the issue. G. During a tour of the facility’s dialysis treatment room on the 5th floor with Staff # 3, the surveyor observed the acid and bicarb pick-up wands at bay 1, 2, 3, 4, 5, and 6 hanging out of the acid and bicarb concentrate jugs during the patient’s treatment. The wands did not fit securely onto the acid and bicarb concentrate jugs. There was a gap between the top of the jug and the wands which could allow other fluid and debris to enter the acid and bicarb concentrate jugs during the patient’s treatment. During an interview with Staff # 3 on 01/22/2024 at 11:45 AM, Staff # 3 stated “I was unaware there were wands that could fit securely into the concentrate jugs. I will reach out to our vendor to get them ordered.” 32143 H. the facility failed to follow its policy and procedure and ensure when the staff called a code that all employees responded to a possible infant abduction. Also, the facility failed to ensure the infant alarm system was working properly, and that all infants including NICU (Neonatal Intensive Care Unit) infants were protected in 3 of 3 (Women services, Nursery, NICU) units. Findings: A nursery and neonatal intensive care unit tour was conducted on 1-22-24 with staff # 2 RN, 104 RN, and 56 RN in the afternoon. A HUGS electronic alarm system was identified as the nursery’s infant alarm system used in the facility. According to https://safesis.pt/wp/wp-content/uploads/2016/10/hugs.pdf, the HUGS system pamphlet stated, “Our Hugs Infant Protection solution offers the most advanced and secure protection from a single department to the entire hospital. Every infant wears a Hugs tag that is attached to the ankle with a special tamper-detecting band. The tag activates as soon as attached and is automatically enrolled in the system. From that moment on, the infant is safeguarded throughout your campus.” An interview with staff #104 was conducted on 1-22-24. Staff # 104 confirmed the NICU babies were not protected with a HUGS tag due to the NICU being a locked unit. The nurse must open the door to allow visitors in and let them out. However, the unit allows housekeeping, maintenance, respiratory, laboratory, radiology, dietary, and visitors onto the unit. The same nurse does not always let the visitors in and out and would not be aware of what they came in with (such as a bag) or left out with. There was no monitor technician in the NICU and twice the surveyor observed no one watching the baby monitors. During a tour of the nursery, an interview with staff #106 (RN -Nursery) stated, that an upgrade for the HUGS unit had been purchased and they were waiting for an upgrade. The surveyor had the nursery RN activate a HUGS tag which was given to the surveyor. The surveyor walked with the activated HUG tag to the outside doors of the women’s care unit, next to the elevators at 1:30 PM. An alarm sounded within the unit but there was no code called overhead. The surveyor waited for two minutes, and a nurse called from the women’s care unit to the operator and asked them to call a code overhead. The doors to the unit never closed. There were no security guards that responded to the unit. An abductor would have had 2 minutes to leave the hospital before anyone knew within the hospital that a baby had been abducted. A review of the policy and procedure, “Response to Nursery Alarm Code Two-Two” Policy#: SEC-PP-41 stated, “General Information: The LDRP/Nursery Department is equipped with a Sekurmed Alarm System that when activated will secure the entrance/exit doors and set off an audible alarm. The alarm system is an electronic device with sensors on the exit doors that will activate the alarm if an infant wearing the coded Sekurmed bracelet is taken near a sensor. There are two centralized monitoring panels for the system, with one located at the nursing station and the other in the resource center communications center. Keypad Reset/Bypass Panels are located at the entrance and exit to each magnetically locked door and only authorized personnel have the access code to these doors. CCTV cameras are located throughout the facility and are monitored internally. Each camera is connected to the CCTV Monitor/Recorders and automatically locks the nursery when the alarm is activated. PROCEDURE: I. When the alarm is activated, it alerts the Nursing Staff and PBX. 2. The Nursing Staff immediately accounts for all infants in the unit. 3. The PBX Operator notifies the on-duty Security Officers via the overhead paging system and radio of the alarm and location, zone # 4. Security Two will immediately respond to the LDRP/Nursery Unit - 5. Contact will be made with the unit Charge Nurse by Security Two, who will investigate the cause of the alarm. 6. In the event of an actual or attempted infant abduction the Security Supervisor or senior officer at the scene will request the PBX Operators to contact the Texarkana, Texas Police Department for assistance. Security officers will take action to secure and search the area both inside and outside CHRISTUS St. Michael. Special care will be taken by security officers to obtain a full description of any suspect(s) in the areas. If the suspected abductor is located, security officers will attempt to detain the suspect taking special care not to cause harm to the infant or create a hostage or shooting situation. Upon arrival of the Texarkana, Texas police, full charge of the situation and investigation will be turned over to them, with full assistance of all security officers. 7. Security Six will report to the first level north tower stairway (located by the playground) and will take a position that will enable him/her to observe the north parking lot and any person exiting the north stairway. 8. Security Seven and Eight will patrol all CSM parking areas. 9. All alarms reported from this unit whether actual or false will be investigated and the finding recorded in the officer’s daily activity report. I 0. Security Two will be responsible for reviewing CCTV security footage.” An interview was conducted with staff # 2 and #104 on 1-22-24 at 1:40 PM. Staff #2 and #104 confirmed that the PBX operator did not call a code overhead and the unit doors to the women’s care unit and nursery did not close and lock when the alarm went off. Staff # 104 stated that the RN from the unit should have called the operator to have the code called overhead. Staff # 104 stated the new version of the alarm system should be upgraded soon. An interview with staff # 108 (bio-med) on 1-22-24 concerning the upgrade for the HUGS system. Staff #108 stated that there was a purchase for an upgrade on the system. Staff #108 provided a purchase order dated 11-11-22, 2 years ago. Staff #108 stated that they have been meeting about the issue and would have to perform some tasks before the upgrade could happen. Staff #108 was asked if there was a team project, a performance improvement project, or any type of meeting minutes to show why there was such a delay. Staff #108 stated they had not been keeping any minutes. Staff # 108 stated that he had an email from 1-11-24 from staff # 118 Project Manager, Clinical Strategies Information Services. The email stated, “Below are the scheduled times for the site walk. Cassandra Langley with Techsystems will meet you at the Lobby to conduct the walk for your area of responsibility. 9:00am to 11:00am - walk with Facilities, Electrician and Local IT - Identify IDF Closets where our PSs will be hung and work with Electrician** for hard-wiring PS’s. Local IT - are there enough ports on switch, are there dedicated network ports available for Hugs PCs, locate Hugs Equipment so TSI may retrieve MAC Addresses for IP Addresses for Hugs Devices 12:00pm - 1:00pm - Walk doors with AC Vendor/Facilities/Security and Jason to discuss cutting data on 1/E AC Readers, Identify doors w/o AC, determine who is supplying power to these maglocks. - 1:00pm to 2:00pm- Walk elevators with Vendor and Facilities/Security/ Nurse Mgmt to determine need for quote to be able to lock-down elevators during an Infant Exit or Band Tamper Hugs Alerts.” Staff # 108 was not able to provide any other information. An interview was conducted with staff # 113 operator and staff # 114 operator on 1/24/22 at 9:30 A.M. Staff # 114 stated that the facility has an alarm system for the HUGS and pointed to a screen above where they sat. Staff # 113 stated that she could hear and see when the alarms went off, but they were instructed to wait until they received a call from the women’s unit to call the code overhead. Staff #113 stated the alarms can go off often but it’s never an issue. Staff #113 and 114 stated that they should call the code overhead within one minute or sooner.”

“MEDICAL STAFF CREDENTIALING CFR(s): 482.22(a)(2) The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations. A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section. This Standard is not met as evidenced by: 40989 Based on document review and interview the Medical Staff failed to ensure 1 (Physician #79) of 2 Interventional radiologists had training and were granted moderate sedation privileges in the Radiology Department before ordering moderate sedation in 2 (Patient #43 and Patient #61) of 4 medical records reviewed. Findings: Patient #43 Patient #43 was scheduled for a Percutaneous Transhepatic Biliary drainage/cholangiogram procedure in Radiology under moderate sedation by Physician #79 on 1/18/2024. A review of the medication orders revealed Physician #79 ordered Versed (a sedative drug) Intra-op PRN (as needed) and Fentanyl (an opioid drug used for severe pain) 12.5 mcg (micrograms) Intra-op PRN. Further review of the medical record revealed RN Staff #75 administered Versed .5mg IV at 1:13 PM and Fentanyl 12.5mcg IV was administered at 1:40 PM. Patient # 61 Patient #61 was scheduled for a procedure in the Interventional Radiology Department on 12/15/2023 by Physician #79. A review of the medication orders revealed Physician #79 ordered Fentanyl Intra-op PRN. Further review revealed RN Staff #75 administered Fentanyl 25 mcg at 3:57 PM, Fentanyl 25 mcg at 4:07 PM, and Fentanyl 25 mcg at 4:11 PM for procedural sedation. RN Staff #75 and Staff #76 confirmed Physician #79 ordered moderate sedation for Patient #61 on 12/15/2023. A review of the credential file for Physician #79 was completed on 1/25/2024 at 9:47 AM. An interview was conducted with RN Staff #75 on 1/25/2024 after 9:30 AM. RN Staff #75 was asked if all the physicians were granted privileges to perform moderate sedation for their procedures. RN Staff #75 stated, “If they are doing interventional radiology, they should have been granted privileges.” She was then asked if she was aware that Physician #79 had not been granted privileges to order or administer moderate sedation. RN Staff #75 confirmed she did not and stated, “She very rarely gives sedation for any of her cases, and when she does it’s just a very small amount.” During an interview on 1/25/2024 after 9:30 AM with Physician #89 it was confirmed there were no requested or approved privileges or certificate of training for moderate sedation in the credential file for Physician #79.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 32143 Based on review and interview nursing failed to have an acuity tool for the Intensive care units and 4 North patient care unit. Nursing failed to accurately staff up in numbers or down to the acuity of patients according to the minimal staffing matrix provided in 2 (CIVCU and surgical ICU) of 4 (CVICU, Surgical ICU, 4 North, and Emergency Room) units reviewed. On 1-25-24 at 9:45 AM staff #2 RN, # 82 RN, and #94 RN reviewed the staffing schedules for the month of January and provided the minimal staffing grid required to staff the nursing units of the Intensive Care Unit (ICU), 4 North, and the Emergency Room. A review of the ICU staffing revealed that in the first 2 weeks of January 2024, the ICUs were short 1 nurse on the day shift. Staff # 94 stated that the unit did not have Cardiovascular Intensive Care Unit (CVICU) patients and was being filled with patients on telemetry or patients who did not require that much care. Staff #94 stated that due to the patient acuity level being lower he did not need that many nurses per shift. However, nursing did not have acuity levels approved to lower the minimum grid staffing level. Staff #94 stated he did not understand that until now and would be working with the nurse staffing committee to develop the acuity levels to staff up or down from the grid when needed.”

“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: 32143 Based on review and interview nursing failed to ensure physician orders were obtained to change ventilator settings for 1 (patient # 22) out of 1 Neonatal Intensive Care Unit (NICU) patient. A review of Baby B’s chart revealed she was born on 12-11-23 at 26 weeks and 2 days gestation. The patient chart revealed a physician order for a respiratory ventilator ordered on 12/11/23 at 8:33 PM. A review of baby B’s physician’s order on 12/11/23 at 8:33 PM revealed an order to intubate the baby and settings for the ventilator as follows; Titrate to keep SPO2 @ greater than 88% Inspiratory pressure- 18 I time percentage- 0.35 Peep-6 Rate- 40 Pressure support-6 A review of the ventilator flowsheet revealed on 12/12/23 at 6:00 AM the Peep was decreased from 6 to 5. There was no physician order to change the setting and no protocol to follow for setting changes. 9:25 AM the rate was decreased to 25 and the Inspiratory pressure decreased from 18 to 16. There was no physician order to change the setting and no protocol to follow for setting changes. 4:35 PM- the rate had changed from 25 to 20. There was no physician order to change the setting and no protocol to follow for setting changes. 12/13/23 at 7:34 AM the rate changed from 20-15. There was no physician order to change the setting and no protocol to follow for setting changes. An interview was conducted with staff # 104 RN and staff # 110 Respiratory Therapy (RT) Director on 1-22-24. Staff # 104 confirmed that the NICU physicians were changing the settings on the ventilators and not writing the orders for the changes. Staff #104 stated that the physicians were asked to put the orders in but didn’t. The nurses would put in verbal orders, but the physicians asked the nurses not to because they wanted to write their own orders. The nurses of the unit were frustrated because the orders were not written, and the physicians would not write the orders for the changes. Staff #104 stated that this had been going on for several months but was not sure how long. There was no evidence that this issue had been directed up to the CMO to address with the NICU physicians nor was there any variance reporting. Staff #110 stated that there were no protocols to follow and that the physicians were changing the settings without putting in orders.”

“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: 48749 Based on observation, policy review, and interview, the facility failed to follow its policy Telemetry Monitoring dated 03/23/2022 as observed in the Neonatal Intensive Care Unit (NICU). The facility failed to ensure all patients on telemetry were being monitored at all times. Findings include: During an observation tour conducted on 01/22/2024 at 3:45 PM of the NICU, there was not a telemetry technician observed at the nurse’s station, monitoring the patients’ telemetry readings. A review of the facility’s policy Telemetry Monitoring dated 03/23/2022 stated, “POLICY: All patients require a physician order to be placed on telemetry. There will be a trained RN, LVN, or monitor technician (MT) assigned to continually visualize the telemetry monitors. All patients receiving specialty drips will be on telemetry (See IV Drug Administration-Vasoactive and Anti arrhythmia Policy). PCU or 6 South may, in extreme cases, accept patients who require closer monitoring for hemodynamic instability providing that the staff is sufficient in number and has the educational preparation and experience to care for such patients. Such a decision will be made by the Director/Clinical Director/RN Lead/House Supervisor in collaboration with the Team Leader. If the patient requires further interventional treatment beyond the scope of the unit providing basic telemetry monitoring, the patient will be transferred to the ICU. The need to continue telemetry will be evaluated daily. A physician order is required to transfer a patient to a non-telemetry bed. A review of the facility’s Monitor Technician Job Description dated 02/25/2013 stated, “POSITION SUMMARY The Monitor Tech maintains efficient operation of the nursing unit by assessing and maintaining supplies, promoting effective communication, both external and internal, accurate transcription, and transmission of physician orders through order management system. Also responsible for the activities of cardiac monitoring. MAJOR RESPONSIBILITIES 1. Maintains consistency with Administrative and Departmental policies with appropriate behavior, dress, attitude, attendance, confidentiality, professionalism, and reliability. 2. Respect the patient’s right to privacy by protecting confidential information unless obligated to or allowed by law to disclose the information. * Follows policies and procedures for “No Information” patients. * Awareness of conversations held at nursing stations. * No participation in conversations outside the patient care environment. 3. Contribute to the fulfillment of departmental and organizational goals. * Participates in voluntary departmental/organizational activities. * Supports cost containment activities by the efficient use of equipment and supplies. * Actively participates in department meetings. 4. Supports patient care activities. * Greets visitors promptly and courteously. * Answers call lights promptly and notifies the appropriate caregiver. * Directs phone calls for patients promptly and courteously * Delivers patient specimens to the lab within 30 minutes of collection. 5. Accepts responsibility for the performance of clerical duties as assigned or needed in order to deliver quality service. * Orders, maintains, and accounts for all unit supplies to promote efficient delivery of patient care. * Transcribes physician orders and utilizes order management system effectively as it relates to nursing and places for nurses to check when signing off orders. * Maintains organized, up-to-date medical records with an adequate number of stamped physician order sheets, progress notes, and other records in patient charts. * Retrieves appropriate patient care forms from HBO as requested by nursing staff. * Runs daily lab reports and places lab/x-ray reports for RNs to review. Immediately notifies RN when lab results are out of range. * Prepares new charts and scans charts for completeness * Discharges patients out of HBO system in a timely manner for room availability. * Assists in controlling noise level at nurse’s station and keeps desk area clean and neat.” An interview was conducted on 01/23/2024 at 9:00 AM with Staff #93. This surveyor questioned Staff #93 about why there was not a Telemetry Technician watching the cardiac monitors. Staff #93 reported that the “NICU does not use Telemetry Technicians. The nurses are responsible for watching their patient’s cardiac monitors.” When questioned about the patient-to-staff ratio, Staff#93 reported “The NICU staff with two patients to one nurse”. Staff #93 was asked how the nurses watch the monitors continuously for each patient if that nurse may be dealing with an emergency or not available at the nurse’s station. Staff #93 stated “All of the nurses help each other and watch the monitors. The nurses can pull up the telemetry on their computer screen”. The nursing staff were unable to provide a process to ensure another nurse was available to monitor other NICU infants if an RN was occupied with another baby in crisis. The RN would not be able to effectively monitor any other patients during that time.”

“ORDERS FOR DRUGS AND BIOLOGICALS CFR(s): Orders for drugs and biologicals may be documented and signed by 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. This Standard is not met as evidenced by: 40989 Based on document review and interview Nursing Services failed to document verbal orders from physicians for moderate sedation medications in the Radiology Department in 4 (Patient #6, #41, #42, and #43) of 4 medical records reviewed. Also, the hospital failed to ensure physicians signed verbal orders for sedation medications according to the facility’s Verbal Order Policy. Findings: Patient #6 Patient #6 is a 77-year-old male scheduled for a Tunneled Hemodialysis Catheter Placement under moderate sedation on 1/22/2024 by Physician #123 in the Radiology department. A review of the medical record revealed medication orders that read: “Versed (a sedative medication) Intravenous (IV) Intra-op PRN (as needed)” on 1/22/2024 at 10:40 AM. RN Staff #75 documented the administration of Versed .5 mg (milligrams) IV at 10:40 AM and “Fentanyl (an opioid used for pain control) Intravenous (IV) Intra-op PRN (as needed)” on 1/22/2024 at 10:40 AM. RN Staff #75 documented the administration of Fentanyl 25 mcg (micrograms) IV at 10:40 AM. Patient #41 Patient #41 was a 58-year-old male scheduled for a Tunneled Hemodialysis Catheter Placement under moderate sedation on 1/12/2024 by Physician #78 in the Radiology department. A review of the medical record revealed medication orders that read: “Versed IV Intra-op PRN” on 1/12/2024 at 8:39 AM. RN Staff #75 documented the administration of Versed .5 mg IV at 8:39 AM and “Fentanyl IV Intra-op PRN” on 1/12/2024 at 8:39 AM. RN Staff #75 documented the administration of Fentanyl 25 mcg IV at 8:39 AM. Patient #42 Patient #42 was a 55-year-old male scheduled for a Tunneled Hemodialysis Catheter Placement under moderate sedation on 1/08/2024 by Physician #78 in the Radiology department. A review of the medical record revealed medication orders that read: “Versed IV Intra-op PRN” on 1/08/2024 at 9:20 AM. RN Staff #75 documented the administration of Versed .5 mg IV at 9:20 AM and “Fentanyl IV Intra-op PRN” on 1/08/2024 at 9:20 AM. RN Staff #75 documented the administration of Fentanyl 25 mcg IV at 9:20 AM. Patient #43 Patient #43 was an 88-year-old female scheduled for a Percutaneous Transhepatic Biliary drainage/cholangiogram procedure in Radiology under moderate sedation by Physician #79 on 1/18/2024. A review of the medical record revealed medication orders that read: “Versed IV Intra-op PRN” on 1/18/2024 at 1:17 PM. RN Staff #75 documented the administration of Versed .5 mg IV at 1:13 PM. This was 4 minutes before the medication was ordered. The next medication order read, “Fentanyl IV Intra-op PRN” on 1/18/2024 at 1:40 PM. RN Staff #75 documented the administration of Fentanyl 12.5 mcg IV at 1:40 PM. RN Staff #75 was asked If she administered the Versed before the order was given. RN Staff #75 stated, “No, I did not. This is how the computer puts it in there. There is no verbal order written so when I document the medication it puts an order there by the physician. If the administration time is different than the documentation time, then the order is documented at the same time as my documentation and not at the actual administration time.” An interview was conducted with RN Staff #75 and Staff #76 on 1/24/2024. RN Staff #75 was asked if the physician writes the orders for the sedation medications before the procedure starts. RN Staff #75 stated, “No he does not. He will tell me what medications and how much to give during the procedure. Then I document the time and dosage of the medication administration in the medical record.” RN Staff #75 was asked if she wrote verbal orders for the medications she was administering and she confirmed she did not write verbal orders for the sedation medications. Still, once she put them in the EMR as administered then the physician would sign off on them. An interview was conducted with RN Staff #75, Interventional Radiology Supervisor Staff #76, and Staff #120 on 1/25/2024 at 10:00 AM. Staff #120 was asked why there was not a verbal order in the medical records for the sedation medication. Staff #120 stated, “When the nurse administers the sedation medications and documents the time in the medical record it automatically creates a verbal order by that physician. That order goes into the physician queue for the physician to sign.” After further review and multiple medical records reviewed for the Interventional Radiology Department Staff #120 confirmed no verbal orders were documented by the nursing staff in the medical record. Therefore, no verbal orders have been countersigned by the physicians ordering moderate sedation. Physician #89 confirmed verbal orders were not being documented and the physician responsible for the patient care was not able to countersign for the moderate sedation medications used in the Interventional Radiology Department since July 1, 2023. A review of the facility policy titled, “Verbal/Telephone Orders”, Policy Number: 3.140 with a reviewed date of 3/2018 was as follows: “ ...II. OBJECTIVE/S: This policy delineates the Christus Health Associates that are qualified to receive verbal/telephone orders, the individuals from which verbal/telephone orders may be received, and the process for recording, transcribing, transmitting, and authenticating verbal/telephone orders with the goal-maximizing patient safety ... V. PROCESS: A. Verbal Orders ... 2. All verbal orders must be documented in the medical record. ... D. Authentication 1. The provider must authenticate all verbal and/or telephone orders within the statutory guidelines (Texas: 96 hours, New Mexico: 72 hours, and Louisiana: within 10 days) ...””

“MEDICAL RECORD SERVICES CFR(s): 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. This Standard is not met as evidenced by: 28422 Based on a review of facility documentation and an interview with staff, the facility failed to ensure that medical records were promptly completed, consistent with hospital policies and procedures. Findings were: A review of delinquent medical records on 1-24-24 revealed that 39 of 432 providers had medical records that had not been completed, with an overall delinquency rate of 19%. Facility policy HIM-PP-22 titled “Content and Timely Completion of the Medical Record” states, in part: “OBJECTIVE: To assure that medical records will be completed in a timely manner. POLICY: The Medical Record must contain information to justify admission and continued Hospitalization to support the diagnosis and describe the patient’s progress and response to medications and services. All entries must be legible and complete. They must be authenticated and dated promptly by the person (identified by name and discipline) who is responsible for ordering, providing, or evaluating the service furnished. The author of each entry must be identified and authenticate his or her entry. Authentication may include signatures and written initials. PROCEDURE: All records must document the following as appropriate: A. Discharge Summary a. Must be completed within 30 days of discharge. b. A discharge Summary is required on all inpatient and Observation stays with the exception of observations of 48 hours less. For an observation visit less than 48 hours, a final progress note will be accepted. B. History and Physical: 1. A History and Physical Examination must be performed within thirty (30) days before or twenty-four (24) hours after admission and always prior to an operative or high-risk procedure requiring anesthesia services. 2. For medical history and physical examinations completed within 30 days prior to admission or admission, an update documenting any changes in the patient’s condition is required within twenty-four (24) hours after admission or admission or prior to surgery or a procedure requiring anesthesia services. The update must state “no change” in the patient’s history and physical condition and must be documented, authenticated, dated and timed if no change in the patient’s history and physical is determined. 3. A History and Physical can be handwritten, computer generated or dictated and transcribed. All handwritten History and Physicals must be legible. 4. History and Physical must be authenticated, dated and timed by the dictating/responsible provider. 5. Concurrent History and Physical Review - If the History and Physical is not in the legal patient record within twenty-four (24) hours after admission, a dictation deficiency is automatically assigned to the admitting physician. C. Consultation Report: 1. A Consultation Report must be dictated, computer generated or handwritten ( if legible) when a consultant sees a patient. 2. Consultation report should contain concise summaries of examination of the patient and the record, impression or diagnosis and recommendation for subsequent management within the scope of the consultation request. 3. Consultation report must be authenticated, dated and timed by the consulting physician. D. Operative Report: 1. The surgeon should enter a brief description of the procedure and significant findings in the Postoperative Progress Note immediately after the surgery and before the patient is transferred to the next level of care when the Operative Report is not documented immediately following the surgery. If the practitioner performing the operation or high-risk procedure accompanies the patient from the operating room to the next unit of care, the report can be written, computer generated or dictated in the new unit or area of care. 2. The patient’s medical record documents all operative or high-risk procedures and/or the administration of moderate or deep sedation/anesthesia by the operating surgeon; dictation of the operative report should be completed within twenty-four (24) hours following the procedure.” The above was confirmed in an interview with staff #89 on 1-24-24.”

“MAINTENANCE OF PHYSICAL PLANT CFR(s): 482.41(a) The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured. This Standard is not met as evidenced by: 49344 Based on observation, record review, and interview, the maintenance department failed to maintain the condition of the dietary area to ensure the safety and well-being of patients and staff. Findings Include: A tour with Staff #37, Staff #42, and Staff #43 of the dietary area at Hospital #1 was conducted on January 22, 2024, at 9:30 AM. Two floor drains in the preparation area near the sinks were not functioning properly. * The first drain was not level with the floor, resulting in standing water around it. Staff #43 reported that they had requested the repair of the first drain for seven years, but it had not been addressed due to old plumbing and pipes that needed fixing. * The second drain was obstructed and had been sealed with cement. A review of the work order log from July 1, 2023, through January 23, 2024, showed that staff in the dietary department had reported “clogged floor drains” 46 times in six months. The staff requested a shop vac to vacuum the continued drain problems. The work order requests revealed that the floor drain behind the server line had sewer water coming up, kitchen floor drains were clogged and backing up, the floor drain backing up into the baker’s area, and the kitchen sewer backed up. All work orders were closed and marked as completed. The dishwashing room had an electrical closet that was being used to store mops, buckets, and water hoses. An orange electrical cord was plugged in and wrapped around the door handle. The electrical cord was observed draped over the door leading outside the electrical room and was wrapped around storage shelves near the electrical closet. Also, staff members were using this room to charge their cell phones. Staff #43 reported that the electrical room was opened frequently because water would come out from the floor, requiring it to be shop vacuumed often. Also, the tiles in the ceiling at the back right corner were hanging and not secure which was a risk for rodents to enter the dietary area. Observed an eyewash station in the dietary area with a constant stream of water. Surveyor asked dietary staff to address the stream of water coming from the faucet and the staff reported it was broken. Surveyor observed in the grill area, a large 5-gallon bucket that was about ¾ full of brown discolored water found below the sink. The water had leaked from the sink into the bucket, and there were discolored towels and trash around the bucket. Maintenance staff notified Staff #37 that the leak would not be fixed until the other leaks in the hospital were resolved. Upon reviewing the work order log for the dates between July 1, 2023, and January 23, 2024, it was found that the dietary department staff had reported the “sink repairs” 11 times. All 11 work orders were closed and marked as completed. The coolers located in the grill area had gaskets around their doors which were shredded and torn. Furthermore, there were visible traces of grease and food particles on the inside of the doors. Hanging down from the cooler fan, there were electrical wires inside the food cooler. Behind the cooler, a wadded-up blue and white paper towel was wrapped around a wire near the heating coils, which could increase the risk of a fire hazard. Upon reviewing the work order log provided between July 1, 2023, and January 23, 2024, it was discovered that the dietary department staff had reported twice about the need to replace the seals around the coolers. The work order log indicates that the issue was resolved, with the work order being closed and marked as completed. The light bulb fixture in the daily use cooler located in the preparation area was hanging by its wires, which were duct taped to prevent the bulb from falling into the food. The light bulbs above the grill were not functioning. The surveyor observed a pipe on the exterior part of the meat cooler, which was meant for draining and defrosting. The pipe was found to be hanging above a preparation table and was not connected to anything. Dietary staff reported the reason for the defrost pipe being unhooked was that floor drain #2 was obstructed by concrete. While touring the dietary area, the dietary team was informed of all the findings that were discovered. Staff #37 and Staff #43 reported that multiple work orders had been submitted for cooler gaskets, an eyewash station faucet, and floor drains that were not draining. Emails would be sent from the maintenance department stating that the work orders had been completed. Staff #43 confirmed that the cooler gaskets, eyewash station, and floor drains have been not fixed. A tour with Staff #40, Staff #43, Staff #65, and Staff #86 of the dietary area at hospital #2 was conducted on January 24, 2024, at 9:00 AM. Observed in the preparation area there was a stand-alone freezer where the patient’s ice cream and popsicles were stored. The freezer had a heavy frost buildup. During the inspection, the surveyor observed that the baseboards appeared to have pulled away from the wall and the wall plaster was cracked and peeling. Also, the door frame had a rust-like appearance. An interview with Staff #40 on January 24, 2024, at 3:00 PM in the conference room confirmed that the maintenance department failed to complete work orders that had been submitted which addressed safety issues in the dietary department.”

“DISPOSAL OF TRASH CFR(s): 482.41(b)(6) (4) The hospital must have procedures for the proper routine storage and prompt disposal of trash. This Standard is not met as evidenced by: 28659 Based on observation and interview the facility failed to promptly dispose of, or properly store decommissioned office chairs, tables, hospital beds, rails, and miscellaneous metal on the afternoon of 01/23/2024. Findings Include On the afternoon of 01/23/2024, a tour of the back entrance service area of the hospital, which is the loading dock. The apron of the dock was being used to store decommissioned hospital furniture (chairs, coffee tables, over-bed tables, hospital beds, and rails). Other unidentified metal for disposal was observed in the concrete yard area. A front-end loader was being operated to place the unidentified metal onto a trailer. The volume of discarded furniture and equipment was more than could be counted. The surveyor stated, “This must have taken a while to accumulate?” Staff #100 stated, “Yes, daily, broken furniture and equipment are removed from the building”. The facility staff was unable to voice or demonstrate the process for prompt removal of decommissioned furniture and equipment.”

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 28659 Based on observation, and interview hospital facility #2 failed to ensure the emergency generator started for testing during the survey observation date 01/24/2023. On the morning of 01/24/2024 the survey team met with facility staff # 87, the maintenance staff. Staff #87 was asked to demonstrate the function of the emergency generator. Staff #87 opened the generator doors and pressed the start switch. The generator failed to start. Staff #87 attempted the switch several times without igniting the generator. Staff #87 left the generator and entered the building to ensure all breakers were functioning. He returned to the generator and pressed the ignition switch and again the generator failed to ignite. Staff #87 phoned the maintenance department of facility#1 and spoke with a maintenance co-worker who instructed him to manipulate the switch, as the switch fuse might be faulty. Staff #87 manipulated the switch and the generator ignited as desired. Staff # 87 confirmed the fuse was not making consistent contact. Staff #87 was asked by the surveyor, “You are going to have that fuse replaced, correct? Staff #87 stated Yes, ma’am”. Maintenance supervisor, staff #100, and VP of Operation staff #40 witnessed the initial test failure of the emergency generator for facility #2.”

“VENTILATION, LIGHT, TEMPERATURE CONTROLS CFR(s): 482.41(c)(4) There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas. This Standard is not met as evidenced by: 49344 Based on observation, record review, and interview the facility failed to designate or determine who would monitor the “day-to-day” maintenance of the negative pressure rooms. Also, the facility staff failed to monitor and document the negative pressure room that showed 12 air exchanges each hour and verified an air filtration rate of at least 95% per policy, “Tuberculosis Control Plan”. In addition, the facility staff failed to provide negative pressure room settings data to the Infection Control Committee to support that they were monitoring and maintaining negative pressure rooms. Findings Include: During a tour of Hospital #1 on January 24, 2024, at 2:00 PM with Staff #5, Staff #38, Staff #39, and Staff #40. During an interview with Staff #39 on January 24, 2024, at 1:00 PM, it was stated that the maintenance department checks negative pressure rooms with a vaneometer (portable test equipment that indicates airflow) twice a year. Additionally, nursing performs tissue tests (If air pressure is appropriately negative, the tissue will be pulled TOWARDS the room demonstrating an acceptable airflow) when isolated patients occupy these rooms. During the interview, Staff #39 demonstrated the use of the vaneometer. Surveyor asked about the parameters, Staff #39 replied, “I just make sure the needle swings towards the door, I don’t look at the number on the meter.” However, Staff #39 did not demonstrate or acknowledge the electronic room monitoring system used to ensure that there are 12 air exchanges per hour or that the pressure differentials are sufficient to prevent airborne particles from exposing other patients or staff members. A review of the CDC guidelines revealed the following: “C.I. Air-Handling Systems in Health-Care Facilities B. 2. Monitor areas with special ventilation requirements (e.g., AII or PE) for ACH, filtration, and pressure differentials.21, 120, 249, 250, 273-275, 277, 333-344 Category IB, IC (AIA: 7.2.C7, 7.2.D6) * Develop and implement a maintenance schedule for ACH, pressure differentials, and filtration efficiencies using facility-specific data as part of the multidisciplinary risk assessment. Take into account the age and reliability of the system. * Document these parameters, especially the pressure differentials.” An interview was conducted with Staff #38 and Staff #40 in a conference room on 1/24/2024 at 3:00 PM to discuss the findings from the tour and the interview with Staff #39. Staff #38 and Staff #40, both acknowledged that the policy for the Tuberculosis Control Plan was vague and needed to be clearer as to how often negative pressure rooms should be checked and whose responsibility it would be. During this interview, preventative maintenance reports were obtained. Preventative maintenance records revealed that negative pressure rooms were being done monthly by the maintenance department but did not show any specific parameters other than saying it was completed. There was no way to determine if this was hospital #1 or hospital #2 or which department in each hospital this preventative maintenance report was being conducted. A review of the facility’s policy titled, “Tuberculosis Control Plan #IC-PP-49”, revised date 8/08/2023 revealed the following: “Responsibility: Supervisory responsibility for the TB Control Program shall be assigned to the hospital Infection Control Committee. The Infection Preventionist shall act as a designee of the Committee to implement the Program on a day-to-day basis. The Infection Preventionist shall enlist the assistance of physicians, the Safety Officer, the Manager of Plant Operations, etc. as needed to implement and maintain the TB Control Program. ... Engineering/Environmental Controls: AIR should be negative pressure to adjacent areas, have at least 12 air changes per hour, directly exhausted to the outside, and are equipped with negative pressure monitors ...” Interviews with Staff #38 and Staff #40 confirmed that the Tuberculosis Control Plan Policy and process failed to show any details as to what department would oversee the monitoring of negative pressure rooms. Also, the preventative maintenance reports failed to include details of what hospital or department the testing was being done, what the pressure differentials were during the testing, or if there were any pressure failures during monitoring. 48749”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 30250 Based on observations, interviews, and review of documentation the facility failed to ensure the infection prevention and control program maintained a clean and sanitary environment to avoid sources and transmission of infection in the following departments Hospital #1, Dietary, Labor and delivery, Post- Partum, Main Warehouse, Medical, surgical, cardiovascular ICU’s, Central supply Cath Lab, Out Patient Cancer Treatment Area, Out Patient Oncology, Out patient Imaging. Hospital #2- Dietary, Medical Surgical Floor, Laboratory. Findings included: Tour of the facility and observation of patient care by surveyor staff revealed infection control issues and issues of maintaining a clean and sanitary environment:Tour of the laboratory area of the main campus on 01/22/24 identified the following issues: * Missing and chipped laminate was observed on several counters throughout this area, making thorough cleaning of the surface impossible. In interview on 01/23/24 the laboratory director verified that at the time of the tour on 01/2224, no work orders had been placed to address the missing and chipped laminate on the counters in the laboratory. Tour of the outpatient cancer treatment area on 01/23/24 identified the following issues: * The True beam room had a cabinet where IT had relocated wiring through cabinet. The wiring was through a hole (approximately 4 inches in circumference) that was open into the wall, creating a potential entry point for dust, dirt, and pests. At the time this was noted a work order had not been completed for this issue. A backboard was also observed stored on the floor in this room, presenting a risk of cross contamination. * Dust was observed on the light fixture in Exam room #3. This room also contained an exam table that had a sticker in place on the metal frame. Stickers and tape prevent surfaces from being cleaned effectively. Tour of the outpatient oncology area on 01/23/24 identified the following issues: * Room #1 had debris noted in the exam table drawer, indicating ineffective cleaning of this area. * Room #4 had dust noted inside a cabinet, indicating ineffective cleaning of this area. Tour of the outpatient endocrinology area on 01/23/24 identified the following issue: * Light fixtures in the area, contained what appeared to be multiple dead bug carcasses. Tour of the Outpatient Imaging Centers on 0/24/24 identified the following issues: * The hallway outside the MRI had a ceiling tile with a discolored water stain around it approximately 5” diameter in size. Ceiling tiles with water stains can harbor mold and may crumble, contaminating items below. * A patient nutrition refrigerator had debris visible on the shelves containing liquid nourishment for patients. Tour of the Atlanta Laboratory area on 0/24/24 identified the following issues: * There was missing and chipped laminate noted on several counters throughout this area, making thorough cleaning of the surface impossible. The above findings were verified on tours with staff members #6, 9, and 90. Facility based policy #13 for OPS-Environmental/Custodial Services entitled, “Office Areas/Ancillary Areas” stated in part, “General Cleaning & Disinfection Daily ... · Clean all visible ledges and surfaces 6’ (six feet) and under ... · HEALTHCARE: Clean all examination rooms or treatment rooms and tables, changing cleaning cloths after each room ... Weekly ... · Detail areas include high ledges (door closes, tops of shelf units, bookcases, etc.), ceiling corners and light fixtures, air vents, window blinds; carpet edges; and areas under and behind larger, harder-to-move equipment. · Carpet edges and all areas above 6’ (six feet) must be cleaned weekly with a high-dusting tool or a stiff brushing tool for carpeted edges.” Several surveyors note that the canisters used for the pneumatic tube system to send laboratory specimens appeared dirty at several locations throughout the facility, with visible dirt and debris present. In interview on 01/23/24, the lab director verified there was no cleaning schedule or process for ensuring the canisters are cleaned routinely. Facility based policy #LAB/LG-PP-13.6 entitled “Pneumatic Tube System” stated in part, “3. Emergency Procedures A. Reporting a leak or spill 1. If a user discovers a leak of body fluid or blood on the outside of the zip lock bags or the carrier, or inside the carrier bin, the user must immediately complete all the following steps ... d. Disinfect all carriers affected by wiping down with disinfectant wipes, let sit for 15 minutes then wash with hot water.” 32143 A tour was conducted in the central supply warehouse on 1-24-24 at 10:45 AM with staff #2 (RN), staff #59 (RN scribe), and staff # 97 (materials management supervisor). The following items were found. Loading Dock Multiple boxes (15-20) containing medical supplies were found sitting on the dock in the rain. The boxes were wet. 3 of the boxes contained sterile surgical supplies. Main Warehouse The main warehouse floors were littered with paper, dirt, dust, and general trash under the rolling carts holding the boxed supplies. 50 bottles of Similac baby formula were found unboxed in a plastic container with no lid. The container was sitting on the bottom shelf of a metal cart. Underneath the cart was a lot of dirt, dust, and debris. The bottles had fine dust and particles on them. Staff #97 confirmed that these bottles would go to the nursery and NICU. Boxes of needles, gowns, and electrodes were found open and exposed to dirt in the warehouse. Staff #97 confirmed there were no temperature or humidity checks done in the main warehouse. Staff #97 confirmed that the floors are swept with a dry broom and no mopping is done in the main warehouse. An interview with staff # 97 was conducted during the tour on 1-24-24 at 10:55 AM. Staff # 97 stated that the warehouse was not controlled for temperature or humidity. Staff #97 stated that there were surgical supplies that had temperature parameters in the warehouse but could not state how long they had been sitting in the warehouse before being unpacked. Unboxing Room for Medical Supplies (middle room between the warehouse and clean central supply) Unboxed sterile supplies were found sitting next to and against dirty boxes that had not been unboxed. Clean Central Supply Once the boxes are emptied from the middle room the supplies are brought into the clean central supply room. The room was very large and had multiple racks and shelves filled with supplies. On one end of the room was supplies and on the other end of the room was sterile processing. There was no wall or curtain to separate the central supply from sterile processing. Two rolling racks that held sterile medical supplies were rolled away from the wall. Dirt, a broken wheel, and medical supplies were found on the floor under the supply rack. Staff #17 (cs tech) stated on 1-24-24 @ 11:10 AM that housekeeping comes in and cleans the floor but never pulls any of the racks out to clean under them. An interview with staff #116 (material management) confirmed that they had not been checking for temperatures or humidity and were not aware that she should be until a survey told her earlier the day before. Staff #116 had a thermometer in the large room. She stated that she did not have a process but found a form on the website for the hospital system. The thermometer that was being used was not adequate to check the temperature of such a large area. Cardiovascular Intensive Care Unit- (CVICU) Supply Room Medical Intensive Care Unit Surgical Intensive Care Unit A small room was found on the units that were being used to store sterile and non-sterile medical supplies. The rooms were extremely hot. The rooms not only contained supplies but also a commercial ice and water machine that was putting off a large amount of heat with no air return found. Staff #2 stated there was no other place to put the ice machines. The rooms were not being monitored for temperature or humidity and the staff was not able to guarantee the integrity of the supplies in the rooms. The facility failed to ensure the clean and sterile supplies were being properly monitored for temperature and humidity. Staff #2 confirmed that the facility was not obtaining temperature or humidity checks. Staff #2 confirmed the facility deemed entity was Joint Commission. According to https://www.jointcommission.org/standards/standard-faqs/ambulatory/environment-of-care-ec/000001275/ the standards stated, “ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following: Positive air pressure relationship to adjacent areas Minimum outdoor air exchange 2 per hour Minimum total air exchange 4 per hour Maximum relative humidity 60% Temperature range 72 to 78 F or 22 to 26 C. “ 48749 During a tour of the facility’s Labor and Delivery Department on 01/22/2024 at 10:15 AM with Staff #2 and Staff #56, the following infection control issues were identified: Labor and Delivery: *Observed multiple holes on the fitted bed sheet of patient-ready room N250. *Observed blood on the handle of the stirrup and the footrest of a patient-ready bed in delivery room N250. *Observed black-colored stains on the mattress and side table of the Isolette (clear plastic enclosed crib that maintains a warm environment for a new baby and isolates from germs) in room N250. *Observed chipping and peeling of the laminate on the cabinets and table in patient room N250. *Observed brown-colored stains on the water jets of the bathtub and there was visible gray or black staining noted on the bottom of the bathtub in patient room N250. *Observed the laminate was chipped and peeling on several areas of the counter at the nurse’s workstation in labor and delivery. *Observed the patient nutritional freezer was iced over and not defrosted in labor and delivery. *Observed a pneumatic compression pump (a device that helps move fluid out of an area of the body with excess fluid) and a PC infusion pump (a monitoring system that delivers fluids in large or small amounts and may be used to deliver nutrients or medications) untagged as clean in the clean equipment room. *Observed a freezer located in the labor & delivery department medication room was iced over and not defrosted. *Observed the pyxis (an automated medication dispensing system) refrigerator located in the labor and delivery medication room was found to have dirt and debris built up on the bottom shelf. Postpartum: *Observed black-colored stains and scratches to the fiberglass on the floor of the shower located in room 278. *Observed there was an IV (intravenous) pole found with black-colored, sticky material on the base. The infusion pump was noted to not have a clean tag to indicate ready for use in room 278. * Observed visible black, sticky material on the pillowcase and there was hair-like material noted on the fitted bed sheet of patient-ready room 278. *Observed visible chipping and cracking of the drywall in room 278. *Observed a trash can filled with isolation material in the anti-chamber of an unoccupied negative air pressure room 274. *Observed a rip in the vinyl cushion of the chair in isolation room 274. *Observed two PC infusion pumps (a monitoring system that delivers fluids in large or small amounts and may be used to deliver nutrients or medications) were found untagged as clean in the clean equipment room. During a tour of the facility’s Cardiovascular Intensive Care Unit on 01/24/2024 at 09:30 AM with Staff #2 and Staff #56, the following infection control issues were identified: Cardiovascular Intensive Care Unit (CVICU): *Observed in the clean utility room where sterile supplies were stored, the temperature was very hot. There was an ice machine noted in the room and the room did not have temperature and humidity control. *Observed a hole in the wall and the drywall was cracked and broken in CVICU room 324. During a tour of the facility’s Central Supply on 01/24/2024 at 11:00 AM with Staff #2 and Staff #56, the following infection control issues were identified: Central Supply: *Observed a buildup of dust and debris on the floor under the bottom shelf holding supplies. *Observed a buildup of dirt and material on the floor between the shelves and around the border of the walls. *Observed a buildup of dust and debris on the shelves holding sterile supplies. *Observed open cardboard boxes stored on the shelf above sterile supplies. *Observed boxes of sterile supplies sitting on the loading dock exposed to the rain and temperature. During a tour of the facility on 01/23/2024 at 12:00 PM with Staff #2 and Staff #56, the following infection control issues were identified: Medical-Surgical Floor- Second Campus: *Observed a brown liquid dried to the side rail of a bed in a patient-ready room 504. *Observed chipping and peeling on the laminate of the cabinets in room 504. *Observed brown rust-like stains on the bottom of the shower chair in room 504. *Observed tears in the seat cushion and peeling laminate on the chair in the isolation room. *Observed two pre-made patient meals were found to be expired in the nutrition room. *Observed the laminate covering was stained, broken, and lifted away from the countertop in the nutrition room. 49344 On January 22, 2024, at 9:30 AM. a tour of the dietary area at Hospital #1 was conducted with Staff #37, Staff #42, and Staff #43. During the inspection of the meat cooler, the following items were observed: * The surveyor observed a large puddle of what appeared to be a bloody drainage on the floor. * Powdered gravy stored in a bowl was found to have an expiration date of January 6, 2024. * The French toast mix that was stored in a bowl had an expiration date of January 5, 2024. * An unlabeled container of “brown gravy” was observed and confirmed by Staff #37. During the inspection of the produce cooler, the following items were identified: * A container of mushrooms was found with dates marked on it. The dietary staff was unable to determine if the dates indicated the day of the produce’s arrival or if was it the expiration date. Staff #37 reported that dietary staff members have neglected to change the labels that indicate when the food arrived or expired. * Observed a container of bell peppers that had holes in the saran wrap, with no expiration date on the label. A review of records in the dietary area of Hospital #1 revealed no evidence that the soda fountain spigots in the retail area of the dietary department had been cleaned or maintained. Food cooler in the grill area, the surveyor observed bags of food that contained french fries, tater tots, and onion rings that were left unsealed. These food items were spilling onto the floor of the cooler. Also, the surveyor observed dark-colored fluid spillage beneath the food cooler. At 12:00 PM, during a dietary tray pass in Hospital #1, Staff #45 was observed passing trays to patient rooms while leaving the door of the tray cart open. The surveyor asked about the open door after the second tray was passed, Staff #45 acknowledged that it should be kept closed between dietary tray passes. An interview with Staff #40 and Staff #43 on January 22, 2024, at 3:00 PM in the conference room confirmed that the findings during the tour of the dietary area of Hospital #1 failed to maintain a clean and sanitary environment to avoid patients being served spoiled food. A tour with Staff #40, Staff #43, Staff #65, and Staff #86 of the dietary area in Hospital #2 was conducted on January 24, 2024, at 9:00 AM. During an inspection of the large freezer, it was discovered that an unpackaged piece of fish was found on the food rack. An interview with Staff #86 in the Kitchen of Hospital #2 on January 24, 2024, at 9:15 AM, stated that during the cleaning of the freezer, the “housekeeper found an unpackaged piece of fish under the rack on the floor. The housekeeper placed that fish on the frozen food rack and forgot to dispose of it.” Also, there were several containers and bags of unprepared food in the freezer that appeared to have freezer burn. The air conditioner vent cover was black in color, dusty, and dirty in appearance with a buildup of grease. Staff #86 reported that the vent does not receive regular maintenance or cleaning. A review of records in the dietary area of Hospital #2 revealed no evidence that the soda fountain spigots in the retail area of the dietary department had been cleaned or maintained. An interview with Staff #40 and Staff #43 on January 24, 2024, at 11:00 AM in the conference room confirmed that the findings during the tour of the dietary area of Hospital #2 failed to maintain a clean and sanitary environment. 47892 Findings; A tour was conducted on 1/22/2024 at 1:00 PM of the Cath Lab (catheterization laboratory is a procedure room where minimally invasive tests and procedures are performed to diagnose and treat cardiovascular disease) department, it was observed in Cath Lab #2 that there was a build-up of dust and debris on the bottom of each sterile supply cabinet. Also, a build-up of dust and debris was found in the small refrigerator in Cath lab #2. In an interview on 1/22/2024 at 1:25 PM, Staff #16 agreed that dust and debris were found at the bottom of each sterile supply cabinet and at the bottom of the small refrigerator.”

“Subsistence Needs for Staff and Patients CFR(s): §403.748(b)(1), §418.113(b)(6)(iii), §441.184(b)(1), §460.84(b)(1), §482.15(b)(1), §483.73(b)(1), §483.475(b)(1), §485.542(b)(1), §485.625(b)(1) [(b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following: (1) The provision of subsistence needs for staff and patients whether they evacuate or shelter in place, include, but are not limited to the following: (i) Food, water, medical and pharmaceutical supplies (ii) Alternate sources of energy to maintain the following: (A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (B) Emergency lighting. (C) Fire detection, extinguishing, and alarm systems. (D) Sewage and waste disposal. *[For Inpatient Hospice at §418.113(b)(6)(iii):] Policies and procedures. (6) The following are additional requirements for hospice-operated inpatient care facilities only. The policies and procedures must address the following: (iii) The provision of subsistence needs for hospice employees and patients, whether they evacuate or shelter in place, include, but are not limited to the following: (A) Food, water, medical, and pharmaceutical supplies. (B) Alternate sources of energy to maintain the following: (1) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (2) Emergency lighting. (3) Fire detection, extinguishing, and alarm systems. (C) Sewage and waste disposal. This Standard is not met as evidenced by: 28659 Based on observation and interview the facility failed to ensure the emergency generator for facility #2 was maintained in operational status on 01/24/2024. Findings include. On the morning of 01/24/2024 the survey team met with facility staff # 87, the maintenance staff. Staff #87 was asked to demonstrate the function of the emergency generator. Staff #87 opened the generator doors and pressed the start switch. The generator failed to start. Staff #87 attempted the switch several times without igniting the generator. Staff #87 left the generator and entered the building to ensure all breakers were functioning. He returned to the generator and pressed the ignition switch and again the generator failed to ignite. Staff #87 phoned the maintenance department of facility#1 and spoke with a maintenance co-worker who instructed him to manipulate the switch, as the switch fuse might be faulty. Staff #87 manipulated the switch and the generator ignited as desired. Staff # 87 confirmed the fuse was not making consistent contact. Staff #87 was asked by the surveyor, “You are going to have that fuse replaced, correct? Staff #87 stated Yes, ma’am”. Maintenance supervisor, staff #100, and VP of Operation staff #40 witnessed the initial test failure of the emergency generator for facility #2.”