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Based on interview, record review, policy review and video review, the hospital failed to follow its policies and procedures when they did not provide an appropriate medical screening examination (MSE) to determine if an emergency medical condition (EMC) existed, within its capabilities and capacity, for five patients (#15, #11, #19, #28, and #29) and failed to stabilize one patient (#10) out of 31 Emergency Department (ED) sampled cases who sought care at St. Mary's Medical Center from 12/01/21 through 05/31/22. Patients #19, #28 and #29 all presented with documented psychiatric (related to mental illness) concerns and all made successful elopements (when a patient makes an intentional, unauthorized departure from a medical facility) before a MSE that included an MHE was completed to determine if an EMC existed. Patient #15 presented with increased anxiety and she requested an MHE but left against medical advice before an MHE was performed to determine if an EMC existed. Patient #11 presented to the ED with nausea and vomiting and requested intravenous (IV, in the vein) fluids, by way of a central line (long, thin, flexible tube placed in a large vein that allows multiple fluids to be given and blood to be drawn) due to her history of drug abuse and difficult IV access. Patient #11 was informed that a central line would not be placed and she became upset and was removed from the ED by security. Patient #10 presented to the ED by law enforcement with altered mental status, bizarre behavior, delusions (false ideas of what is taking place or who one is) and paranoid (excessive suspiciousness without adequate cause) thinking. He received an MSE that included an MHE and was awaiting transfer to Hospital B for inpatient admission. While he awaited transport to Hospital B he exhibited escalating behavior and increased agitation (a state of feeling irritated or restless). No stabilizing treatment was given to decrease his agitation and the patient eloped the ED.

Findings included:

Review of the hospital's policy titled, "EMTALA - compliance with the Emergency Medical Treatment and Active Labor Act," revised 03/2016, showed that any individual who "comes to the hospital emergency department" requesting examination or treatment shall be provided with an appropriate MSE. This MSE will determine whether an individual has an actual EMC. This exam should be done in a non-discriminatory way. EMTALA is applicable to anyone who presents in any area or department of the hospital for primary assessment and treatment, including emergency room, and psychiatric service. The hospital must use its available resources to provide ongoing evaluation and stabilizing treatment as required by law.

Review of the hospital's policy titled, "Elopement Risk Patient (Flight Patient, High Risk)," revised 05/2022 showed that the hospital shall provide a safe, secure, legal containment for patients who were at risk of leaving the hospital. Precautions will be initiated on all patients who are at high risk for leaving the hospital.

Review of the hospital's policy titled, "Observation Attendant (Sitter)," revised 03/2022 showed that continuous direct observation is indicated to prevent patients, who are uncooperative, unable or unwilling to follow instructions, from injuring themselves and/or others, and to promote healing. Initiation of one to one (1:1) observation in cases of suicidal/homicidal ideation is an immediate need. One-to-one (1:1) observation means one competent observer to one patient within line of sight and close proximity with no physical barriers and, in the same room/area. Close proximity requires that observation be close enough for the observer to react to the patient's behavior as it occurs, without delay.

1. Review of Patient #19's medical record showed that he was a 54 year old male who presented to the ED by ambulance on 04/08/22 at 1:52 AM with report from law enforcement that the patient had stated that he had a microchip in his head that was overheating, that he was Jesus Christ and that his schizophrenia (serious mental disorder that affects a person's ability to think, feel, and behave clearly) allowed him to communicate with dead people. ED Staff S, RN completed an affidavit (a written statement confirmed by oath, for use as evidence in court) due to verbalized homicidal ideations (HI, thoughts or attempts to cause another's death) by the patient. The patient did not receive an MHE to determine if an EMC existed and the patient eloped at 4:50 AM.

2. Review of Patient #28's medical record showed that he was a 36 year old male who presented to the ED on 01/25/22 at 7:24 PM with SI. The patient was triaged and placed in the waiting room. The patient did not receive an MSE to determine if an EMC existed. The patient was triaged at 7:30 PM and eloped at 7:35 PM.

3. Review of Patient #29's medical record showed he was a 38 year old male who presented to the ED by law enforcement on 02/03/22 at 2:55 PM for a stated complaint of psychiatric evaluation. The patient had informed law enforcement that there was someone in his car trying to kill him. When the patients car was searched there were no other occupants found within the vehicle. He also reported of hearing voices telling him they were going to harm him. The patient was triaged, 1:1 observation was implemented. The patient received an MSE that did not include a MHE to determine if an EMC existed. Patient #29 eloped from the ED at 5:50 AM.

4. Review of Patient #15's medical record showed she was a 22 year old female who presented to the ED on 05/18/22 and requested a MHE for her increasing anxiety. Documentation showed that she had just been discharged from a drug rehabilitation a few days earlier. The triage (process of determining the priority of a patient's treatment based on the severity of their condition) nurse and physician both informed the patient that she would need to give a blood and urine sample for testing in order for possible placement. Patient #15 refused and left AMA. The patient did not receive an MHE to determine if an EMC existed.

5. Review of Patient #11's medical record showed that she was a 26 year old female who presented to the Emergency Department (ED) on 05/02/22 at 11:13 AM, with nausea, vomiting and abdominal pain, after she missed a dose of methadone (a medication used to treat moderate to severe pain or to treat narcotic drug addiction). The patient was actively vomiting and IV access was attempted but unsuccessful. The patient advised ED staff that she previously had an IV placed in her neck when she had the same issues in the past due to difficult IV access related to her history of drug abuse.

6. Review of Patient #10's medical record showed he was a 29 year old male who presented to the ED with law enforcement on 03/12/22 for altered mental status, bizarre behavior with delusions and paranoid thinking. He was given an MSE with an MHE that recommended admission to a psychiatric hospital for inpatient treatment. On 03/14/22 Hospital B accepted the patient but transportation was not available until 9:00 AM on 03/15/22. During the evening of 03/14/22 documentation showed that the patient had walked in and out of his room multiple times to the nursing station with signs of escalating behaviors. At approximately 10:30 PM Patient #10 walked to the nurse's station and talked with staff. A Public Safety Officer (PSO) and the patient's 1:1 sitter stood next to the patient when he suddenly ran toward the ambulance exit doors. The PSO ran after him into the hospital parking lot. Patient #10 ran out of the parking lot and off hospital property. Law enforcement was called but was not able to locate the patient.

See A-2406 and A-2407 for additional information.

Based on interview, record review and policy review, the hospital failed to provide, within its capability and capacity, an appropriate and complete medical screening exam (MSE) to rule out an emergency medical condition (EMC, an illness, injury, symptom or condition so serious one should seek care right away to avoid severe harm or serious impairment) for five patients (#15, #11, #19, #28 and #29) out of 31 Emergency Department (ED) records reviewed from December 2021 through June 2022. This failed practice had the potential to cause harm to all patients who presented to St. Mary's Medical Center ED seeking care for an EMC. The hospital's average monthly ED census over the past six months was 1,701.

Findings included:

Review of the hospital's policy titled, "EMTALA - Compliance with the Emergency Medical Treatment and Active Labor Act (EMTALA)," revised 03/2016, showed that EMTALA was applicable to all licensed independent practitioners (LIP) who provided an examination, treatment or transfer of any individual presenting to the hospital or within 250 yards of the hospital seeking primary assessment and treatment for a medical, psychiatric (relating to mental illness) or obstetric (the branch of medical science concerned with childbirth and caring for and treating women in or in connection with childbirth) condition. The policy showed that the hospital would provide ongoing evaluation and stabilizing treatment utilizing available resources. The policy also showed that an MSE was considered a continuous process which required ongoing monitoring according to each individual patient's needs. The policy showed that patients who Left Without Being Seen (logged as a disposition of LWBS) received a full explanation as to the risks and benefits of leaving and documentation should prove that all steps were taken to discourage the individual from leaving the hospital before a completed MSE. The policy showed that when a patient left Against Medical Advice (AMA), an AMA form was completed, signed by the patient and witnessed. If the patient refused to sign the form, the form was annotated with "Patient refuses to sign". The policy also showed incident reports (referred to as Verge) were completed when a patient left before their MSE was completed either as a LWBS or AMA.

Review of the hospital's policy titled, "Suicidal Ideation (SI, thoughts of causing one's own death) Risk Assessment," Revised 03/21, showed that the Columbia Suicide Severity Rating Scale (C-SSRS, scale to evaluate a person's risk to self-inflicted harm and desire to end one's life) was conducted on every patient who presented to the ED. The policy showed that patients who screened positive for suicide risk were placed on a level of observation appropriate to the degree of risk assessed. The policy showed patients with a positive screening on the C-SSRS received further assessment by a LIP and that patients determined at risk for suicide maintained determined levels of observation and interventions until changed by the licensed independent mental health practitioner. The policy showed that an order from the licensed mental health practitioner was required to remove or change any suicide levels of observation. Appendix A of the policy showed that the primary physician or mental health social worker was able to screen, assess and place a patient on a legal hold, if indicated. Appendix A also showed that patients remained on safety precautions until all appropriate consultations were completed and a plan of care was determined and finalized. Appendix D of the policy showed that a competent one to one (1:1, continuous visual contact with close physical proximity) observer stayed with the patient unless relieved by another observer, watched for specific symptoms or behaviors outlined in the observer training module and notified the nurse if the patient exhibited any symptoms or behaviors of concern.

Review of the hospital's policy titled, "Elopement (when a patient makes an intentional, unauthorized departure from a medical facility) Risk Patient (Flight Patient, High Risk)," Revised 05/22, showed that precautions were initiated on all patients at high risk for leaving the hospital. The policy showed that elopement precautions (EP, interventions to prevent someone from leaving who may be at risk for self-harm or injury) could be initiated by nursing without a physician's order and the charge nurse would notify the House Supervisor and security of any patient at high risk for elopement. The policy showed High Risk Precautions could include assigning patients a room near the nursing station, assigning the patient a "sitter" (person assigned to continuously observe a patient within close proximity, to ensure their safety), and securing the patients' personal belongings. The policy showed that staff should implement the Continuum of De-escalation Policy up to and including level three to prevent a patient elopement. The policy showed that if a patient eloped, nursing staff called the local police department immediately and provided a description of the patient and last known direction of travel. The policy showed that when a patient left before formally discharged; staff also searched hospital grounds with the assistance of security personnel, insured that the physician and administration were notified, notified the patients' family members/care providers, notified hospital administration, and completed a Verge report.

Review of the hospital provided document titled, "Behavioral Health Services Agreement," signed on 07/21/21 showed that the agreement between Facility C and the hospital was effective 09/02/21. The agreement showed that Facility C provided information and collaborated with the ED healthcare team members to gather information and coordinate care for the patients with behavioral health problems who presented for services. Facility C conducted the mental health assessment including referral, as appropriate. Facility C was responsible for 24-hour coverage.

1. Review of Patient #19's medical record showed that the patient was a 54-year-old male who was presented to the ED by ambulance on 04/08/22 at 1:42 AM after a crisis intervention team (CIT) report was submitted by the patient's local police department. The medical record included the CIT report with documentation which included that Patient #19 reported to police that he had a microchip in his head which was overheating, he was Jesus Christ, and that his schizophrenia (serious mental disorder that affects a person's ability to think, feel, and behave clearly) allowed him to communicate with dead people. The medical record showed that Staff S, Registered Nurse, (RN), completed Patient #19's vital signs at 1:52 AM and the vital signs were normal other than a slightly elevated blood pressure (BP, a measurement of the pressure of blood flow in two different parts of the heart, normal is approximately 90/60 to 120/80) of 145/82. Staff S also documented a note at 2:12 AM which showed that the patient verbalized to her that there were individuals that he wanted to "kill with a gun", as well as the patient's concerns of the microchip implanted in his brain and that he could be pregnant. The medical record contained a notarized affidavit (a written statement confirmed by oath, for use as evidence in court) completed by Staff S due to Patient #19's homicidal ideation (HI, thoughts or attempts to cause another's death) comments and hallucinations of the television telling him that people had raped his daughter. Staff S also documented that the C-SSRS showed that he intended to harm against another person and potential for harm to others and that the patient was placed on line-of-site observation. The medical record did not contain any documentation of 1:1, line-of-site or constant observation by any staff member. The nursing assessment showed affect as inconsistent with thought content and behaviors as delusional with flight of ideas and paranoia. ED provider notes completed by Staff T, ED physician, on 04/08/22 at 3:40 AM showed that Patient #19 was brought in by EMS for further evaluation of agitation (a state of feeling irritated or restless) and unusual thought pattern, history of schizophrenia for which the patient was followed by outpatient provider, and daily methamphetamine (a drug with more rapid and lasting effects than amphetamine, used illegally as a stimulant) use. Staff T's ED provider note Review of Systems documented that Patient #19 had psychiatric symptoms of agitation and hallucinations (seeing or hearing things which are not there); and that the patient reported feeling he could rip somebody's head off but had no specific plan for homicide. The physical examination had entries in the psychiatric documentation of abnormal thinking pattern. Staff T documented Patient #19's diagnoses as acute psychosis (mental disorder characterized by a disconnection from reality where a person experiences delusions, hallucinations, talking incoherently, and agitation) and methamphetamine abuse. Patient #19's medical record showed that Staff T documented that diagnosis management included that the patient admitted to having been prescribed medications for psychosis, but only methamphetamine use controlled his hallucinations. Staff T documented that a mental health evaluator with Facility C had been contacted and would provide further evaluation of the patient. Staff T ordered a urinalysis and urine drug screen which resulted positive for methamphetamines and a COVID-19 (highly contagious, and sometimes fatal, virus) antigen test which resulted negative. The medical record contained no orders for other laboratory tests or any medication administration. Documentation entered by Staff T showed that at 4:40 AM the patient attempted to elope the ED and that she was able to convince the patient to return to his room. Staff T documented that the patient was not suicidal; and although she was aware of the affidavit completed by Staff S, she did not believe the patient to be homicidal. Staff T stated that the CIT submitted by the local police department did not contain identification of the officer or badge number whom completed it. Staff T documented that the patient then exhibited increased agitation and unstable behavior and again attempted to leave the ED. Staff T's documentation in Patient #19's medical record stated "for the safety of staff and other patients he has eloped the ED." Staff T documented that the local police department, nursing supervision and hospital administration were notified of the patient's elopement. The medical record also contained documentation at 5:00 AM by Staff BB, RN, former ED charge nurse, which stated that the patient became more agitated while waiting for a psychiatric assessment, stated he was going to his mother's house, and eloped the ED. Staff T, ED physician, documented that the local police department notified the hospital that they had recovered Patient #19 approximately forty-five minutes after his elopement. She documented that the notifying officer stated the patient was not suicidal or homicidal and that the officer decided to take the patient home.

When local law enforcement contacted the hospital that Patient #19 had been located; they were not directed to return the patient to the ED for further evaluation to determine if he had an EMC.

Review of the police report for Patient #19 after his elopement from the ED on 04/08/22 showed a timeline as follows:
- At 5:13 AM a call was received to the local police department dispatch by Patient #19 where he reported he was outside a gas station approximately five blocks from the hospital and was cold.
- At 5:14 AM communication was relayed to responding officers that Patient #19 was previously listed as "Be On Look Out" (BOLO) (following his elopement from the hospital).
- Between 5:17 AM and 5:33 AM Law Enforcement Officer DD made contact with Patient #19 and drove from the gas station to the hospital with Patient #19 in the police car.
- At 5:34 AM Law Enforcement Officer DD arrived at the hospital (with Patient #19 in the police car).
- At 5:34 AM Law Enforcement Officer EE arrived at the hospital.
- At 5:38 AM Law Enforcement Officer DD left the hospital (with Patient #19 in the police car).
- At 5:55 AM Law Enforcement Officer DD arrived at Patient #19's home.
- At 5:57 AM Law Enforcement Officer DD left Patient #19's home.

During an interview on 06/13/22 at 3:25 PM, Staff S, Registered Nurse, RN, stated that she performed the triage (process of determining the priority of a patient's treatment based on the severity of their condition) and assessment for Patient #19 on 04/08/22. She stated that she completed an affidavit because the patient had made statements of homicidal intentions. Staff S stated that she understood that an affidavit was completed to outline how the patient expressed behaviors that were deemed as harmful to themselves or others and that it helped if the patient required a hold or inpatient placement. Staff S stated that the providers were notified that an affidavit was present by the primary nurse or the person who completed the affidavit. She stated that occasionally the provider requested that staff members completed an affidavit. Staff S stated that she expected that a patient who presented with psychiatric-related concerns stayed in the ED until a MHE had been completed. She stated that patients with psychiatric issues regularly eloped from the ED. Staff S stated that within the last two months expectations were relayed to ED staff to help prevent elopements. She stated the new expectations included that sitters were not allowed to observe more than one patient at the same time.

During a telephone interview on 06/13/22 at 4:00 PM, Staff T, ED Physician, stated a request for a MHE was not entered as a patient order. The unit secretary was notified of the need for a MHE and the unit secretary contacted Facility C with the consult request. Staff T stated that it was the role of the sitter to ensure that a patient was compliant with staying in their room. The sitter was expected to employ verbal de-escalation of the patient. Staff T stated that if a patient eloped the ED, the local police department was notified and a Verge report was completed. After completion of the Verge report, it was the responsibility of the Quality Office to address the issue and made determinations of needed actions. Staff T stated that a patient who eloped with an affidavit in place would be of concern and that was why the police were notified. Staff T stated she would not comment on the return of Patient #19 to the hospital after his elopement and why police were told re-evaluation or continued attempts for a MHE were not needed because she wasn't able to access the patient's medical record during the interview.

Staff F, Regional CNO was present during the telephone interview with Staff T, ED Physician and stated that Staff T had the ability to access the medical records during the interview.

During a telephone interview on 06/09/22 at 3:40 PM, Law Enforcement Officer DD stated that he was on-duty the early morning of 04/08/22 and responded to the initial call from the hospital regarding the elopement of Patient #19. He stated he performed the initial canvas of the area to try to locate Patient #19, but was unsuccessful in locating him. Law Enforcement Officer DD also responded to a call to the police department by Patient #19 requesting assistance from cold temperatures. He stated that Patient #19 was recovered and taken back to the hospital via police car. Law Enforcement Officer DD stated that he stayed with the patient in the police car while Law Enforcement Officer EE went into the ED to confirm with the hospital if the patient needed to be returned to the ED or taken home. He stated Officer EE reported to him that there was not a 96-hour hold on the patient and it was reported to him that there was not an affidavit or reason for him to be returned to the ED. Law Enforcement Officer DD then returned Patient #19 to his home in a nearby town.

During a telephone interview on 06/09/22 at 4:05 PM, Law Enforcement Officer EE stated that he accompanied Law Enforcement Officer DD back to the hospital on 04/08/22 after Patient #19 was recovered at a nearby gas station. Law Enforcement Officer EE stated he went inside the hospital ED to determine if the patient needed to be returned. He stated that an ED staff member told him that there were no affidavits for the patient and the patient could not be held in the ED. He was informed of a CIT from the patient's local police department which precipitated his transport to the ED; but that the CIT did not include a narrative of SI or HI and that the CIT did not identify an officer by name or badge number. Law Enforcement Officer EE stated he did not recall the name of the ED staff who told him there were no affidavits and that Patient #19 did not need to be re-evaluated in the ED. Law Enforcement Officer EE stated that the local police department responded to several calls each month to the hospital where a patient left before discharge. He stated that it had been his experience that this hospital accepted a CIT as an affidavit, but understood that the form must contain a signature of the officer making the sworn statement. Law Enforcement Officer EE stated that on occasions when he had escorted a patient to the ED for evaluation, the ED staff did not take a "hands on" approach and did not always appear equipped to handle actively psychotic patients.

During a telephone interview on 06/13/22 at 9:30 AM, Staff N, Regional ED Medical Director and ED physician, stated that ED physicians at the hospital were a contracted group and were not employed by the hospital. Staff N stated that elopements were a concern and were challenging when alcohol, drugs and combative psychiatric patients were involved. He stated that it was the policy of the company that provided ED physician services to the hospital that a physician "can't restraint patients" and patients who presented aggressive or psychotic behaviors were "out of their hands". Staff N stated that as an independent contractor to the hospital the physicians followed their own company policies not the hospitals' policies. Staff N stated that orders for chemical restraints, physical restraints and seclusion were an option in managing the safety of a combative patient. Staff N also stated that physicians were not involved in any "hands-on" interaction other than to perform a MSE to determine if an EMC exists or to provide treatment. He stated the ED staff must abide by the rules set forth by the hospital's ED department and does this by restricted access to a specific area for psychiatric patients who require 1:1 observation and monitoring. Staff N stated that he was not aware of a specific policy regarding a physician's decision to invoke a psychiatric hold. He stated that a CIT would be treated as an affidavit but because rules and regulations vary from state-to-state and their company provided ED physician services in multiple states, options were not always clear. Staff N stated that when a patient eloped the local police were notified.

During an interview on 06/13/22 at 11:25 AM, Staff O, Hospital ED Medical Director and ED physician, stated that patient presentation would be considered when a CIT or affidavit accompanied a patient before determining a mandatory hold was needed. He stated that if a psychiatric patient eloped and re-presented to the ED, the need for reassessment of a patient awaiting an MHE was determined by the "imminent threat" presented by the patient to harm themselves or others. Otherwise, one made sure of "dotting i's and crossing t's" to ensure there was no reason to hold a patient before the patient eloped. Staff O stated that a MHE was part of determining if an EMC existed in a psychiatric patient and necessary for completion of the MSE. He stated an obligation existed to insure that a complete MSE was performed on all patients presenting to the ED. Staff O stated that use of verbal de-escalation and medications were some methods used in preventing the elopement of a patient with psychiatric concerns.

During an interview on 06/06/22 at 1:20 PM, Staff E, RN, former Manager ED/ICU, stated that patients with psychiatric issues were evaluated in the ED by a contracted company. He stated that Facility C staff accomplished MHEs on site, but the evaluations could be conducted via telehealth, if needed. Staff E also stated that the ED utilized the C-SSRS that determined if a patient with psychiatric concerns required 1:1 or line of site (LOS, continuous visual contact with the patient) monitoring.

During a telephone interview on 06/14/22 at 9:15 AM, Facility C President GG and contracted provider HH, Licensed Clinical Social Worker (LCSW), stated once an ED physician determined the need for a MHE, the hospital paged an evaluator, and an evaluator responded via phone within fifteen minutes. The MHE took place face-to-face unless weather or other circumstances prevented travel, at which time the evaluation could take place via telehealth. Response time for the face-to-face evaluation varied due to an evaluator's workload and geographic location at the time of the request.

During an interview on 06/14/22 at 10:00 AM, Staff C, Chief Executive Officer stated he had been in the position at the hospital for three months and was aware of elopements from the hospital's ED. He stated that a root cause analysis (RCA) completed in April 2022 revealed not only concerns with elopement; but with the overall culture of the ED physicians, ED nurses, security, hospital policies and hospital administration with regard to psychiatric patients in the ED.

During an interview on 06/13/22 at 1:40 PM, Staff P, RN, stated that an ED staff meeting was held sometime in late January 2022 when, Staff E, former ED Director, informed ED charge nurses that they were not to attempt to stop an elopement patient. Staff P stated that he was working as the nursing house supervisor on the early morning of 04/08/22. He stated that he was a notary public and notarized the affidavit completed by Staff S regarding Patient #19 and homicidal comments. Staff P stated that a CIT could be utilized as an affidavit, but that the completing officer would be required to sign the CIT for it to be a valid form. Staff P stated that Facility C staff performed the MHEs for the ED. He stated that it can take a few hours for Heartland to present to the ED and the MHEs were almost always accomplished face-to-face. He stated that the ability to perform the MHE via telehealth existed in the ED, but the MHE was rarely completed via this media.

During an interview on 06/13/22 at 1:20 PM, Staff R, RN, ED, stated that she believed all psychiatric patients were a risk for elopement and would require elopement precautions.

During a telephone interview on 06/15/22 at 4:00 PM, Law Enforcement Officer FF stated that he was sent to Patient
#19's home on 04/08/22 at approximately 00:39 AM to do a wellness check. He reported that the patient was talking erratically, admitted to hallucinations of voices from the television telling him that neighbors had violated his daughter, admitted he was schizophrenic but had not taken prescribed medications, and admitted to use of methamphetamines recently. Law Enforcement Officer FF stated that he and his partner had concerns for Patient #19's mental welfare and his partner completed the CIT form to relay concerns regarding the patient's behavior and to assist Patient #19 in obtaining a medical and mental health evaluation at the hospital. Law Enforcement Officer FF stated that the CIT form their local police department utilized did not contain a signature line and did not undergo notary processes. Law Enforcement Officer FF stated that Patient #19 agreed to be transported to the hospital via ambulance and that neither he nor his partner accompanied the patient to the hospital.

The patient presented to the hospital at 1:52 AM via ambulance and eloped at approximately 4:50 AM. The patient had a diagnosis of acute psychosis and an affidavit completed by ED staff that showed the patient had verbalized homicidal statements. The patient did not receive an MHE during the course of his ED visit, exhibited increased agitation, and ultimately eloped the ED. Subsequent to his recovery by police, an opportunity to reassess and/or obtain an MHE existed and was deferred by the hospital.

2. Review of Patient #28's medical record showed that he was a 36-year-old male who presented to the hospital on 1/25/22 at 7:24 PM with SI. The record showed Staff J, RN, completed a triage assessment at 7:30 PM and a general ED nursing assessment at 7:32 PM. Patient #28's medical record included the C-SSRS which had affirmative answers to the questions regarding wishing to be dead or not alive anymore and to having had actual thoughts and intention within the last month of killing himself. The record also showed a note documented by Staff J at 7:38 PM which showed that Patient #28 was brought to the ED by his girlfriend, paced the room, made statements about not wanting to take his current medications and that the patient stated "I want to kill myself". Staff J documented in Patient #28's medical record that she then asked the patient to step out of the room; that the patient sat down in the waiting room and then walked out of the hospital. The medical record showed that Staff J documented she went outside to look for the patient and she did not see him. Staff J documented that she notified the charge nurse. The medical record showed a nursing Discharge Summary note documented by Staff BB, RN, former ED charge nurse, on 1/25/22 at 7:35 PM which showed the reason for the patient's incomplete ED visit was "Eloped without notifying Staff."

Patient #28's medical record showed that the patient's disposition was logged as LWBS on 01/25/22 at 7:35 PM. The medical record did not contain documentation that law enforcement, hospital administration or the patient's family were notified. Although requested, the hospital could not present a Verge report associated with Patient #28's ED visit.

During an interview on 06/08/22 at 2:30 PM, Staff J, RN, stated that she remembered that after she triaged and assessed Patient #28, she felt uncomfortable with leaving the patient in the triage room because he had stated that he wanted to harm himself and there were things in the triage room that he could have used to cause self-harm. Staff J stated that when the ED had available rooms, the patients were taken directly back to a room, triaged and assessed; but if there were not available rooms, patients were triaged and asked to return to the waiting area until a room became available. Staff J stated that after triage, she asked Patient #28 to wait in the ED waiting room. When she returned to place him in an ED room, he had left the hospital. Staff J stated she informed the ED charge nurse and was told to go outside and see if she could see the patient in the immediate vicinity of the ED. She stated she then went outside and did not see Patient #28. Staff J stated that she did not complete a hospital Verge report because she had made a note in the medical record regarding the patient leaving and had notified the ED charge nurse of the event. Staff J stated that she did not consider Patient #28's exit as an elopement. She stated that patients did not receive a level of precaution for observation until the ED provider evaluated them and made that determination.

During an interview on 06/13/22 at 3:25 PM, Staff S, RN, stated that once a patient was identified as SI or HI, they were to be placed on 1:1 observation and precautions. Staff S stated that an SI or HI patient was to have their belongings collected and the patient immediately placed in an ED treatment room. Staff S stated that once a patient expressed SI, they would not be released to the ED waiting area.

During an interview on 06/08/22 at 8:15 AM, Staff A, RN, Director of Performance Improvement, stated that a patient elopement involved an event report and investigation; and could evolve into an RCA investigation.

During a telephone interview on 06/09/22 at 12:30 PM, Patient #28 stated "I'm ok" and then disconnected the call.

The patient presented to the hospital ED making active statements of SI, was triaged and assessed by nursing. The nursing assessment included a C-SSRS with affirmative answers to SI and no level of precautions or safety observations were implemented. The patient did not receive an MSE or a MHE to rule-out the presence of an EMC. The patient was triaged at 7:30 PM, was inappropriately placed in the waiting room, and eloped from the hospital at 7:35 PM.

3. Review of Patient #29's medical record showed that he was a 38-year-old male who presented to the ED by law enforcement on 02/03/22 at 2:55 AM for a stated complaint of psychiatric evaluation. Patient #29's medical record showed a consent for treatment documented by Staff II, patient registration clerk, on 2/3/22 at 2:55 AM of "patient unable to answer or sign forms due to mental state." The record contained a triage assessment note documented by Staff P, RN at 3:30 AM which showed that the patient had presented himself to the police with the complaint of a person in his car threatening to kill him. Police searched the vehicle and no occupants were found within the vehicle. Patient #29 continued to report to the police that there were people in the car and he could hear them telling him they were going to do him harm. Staff P documented vital signs at 3:30 AM for Patient #29 with normal values except for an elevated blood pressure recording of 174/117. The C-SSRS was attempted and the patient did not report suicidal thoughts or plan. Staff P documented at 3:35 AM that the patient exhibited paranoid thought patterns; but was calm and cooperative with law enforcement and ED staff. The record contained a document titled "Special Precautions/Observation Record" with hand-written observations on 02/03/22 every 15 minutes from 3:30 AM until 5:00 AM. Documentation by Staff T, ED Physician, at 3:28 AM which restated the patient's presentation via law enforcement and insistence that there were people in his car threatening harm, even after police had verified that there was no one in the vehicle. Staff T's documentation showed that Patient #29 was brought to the ED for a psychological evaluation and that the patient was "seeing things". Staff T also documented that the patient had reported to her that he had recently sought help at another ED, was evaluated by a psychiatric assessor and was turned away because they didn't believe him. Staff T's evaluation included a chief complaint of Psychological Evaluation, past medical history of seizures (excessive activity in the brain which causes uncontrolled jerking movements) and reported home medications of Keppra and Depakote (both medications used to treat seizures). No other abnormal findings were documented with Patient #29's physical examination except for poor eye contact and flat affect. The patient allowed blood drawn and laboratory results were within normal limits except for an elevated blood urea nitrogen (BUN, blood test that specifies kidney function) of 27 mg/dL (normal range 7-18), creatinine (blood test that shows how the kidney is functioning) of 2.0 mg/dL (normal range 0.6-1.3), glucose (sugar) 139 mg/dL (normal range 70-99); and decreased aspartate aminotransferase (AST, an enzyme that is found mostly in the liver) of 14 U/L (normal range 15-37) and albumin level (a measurement of protein in the blood that can indicate malnutrition) level of 3.0 g/dL (normal range 3.4-5.0). Patient #29's toxicology results revealed decreased acetaminophen <2 ug/mL (normal range 10-30); otherwise no abnormalities in toxicology were documented. Staff T documented in her evaluation note that the patient become agitated and eloped the ED. The note showed that the patient was seen leaving the building and then returned to the ED waiting room. Staff T documented that she talked with Patient #29 in the waiting room after he left and requested that he return for continued evaluation and to speak with the mental health evaluator. Staff T documented that Patient #29 did begin to walk back to the ED treatment rooms, but then turned and walked out of the hospital. Staff T's documentation stated "I have no cause to hold him against his will" and that Patient #29 decided to elope again. Staff T's documentation included the s

Based on observation, interview, record review, policy review and video review, the hospital failed to ensure an emergency medical condition (EMC, an illness, injury, symptom or condition so serious one should seek care right away to avoid severe harm or serious impairment) was stabilized when one patient (#10), out of 31 sampled cases from December 2021 through May 2022, showed signs of escalating behavior with increased agitation (a state of feeling irritated or restless) and was able to make a successful elopement (when a patient makes an intentional, unauthorized departure from a medical facility) while he awaited transfer from St. Mary's Medical Center Emergency Department (ED) to Hospital B for inpatient psychiatric (relating to mental illness) treatment. The hospital's average monthly ED census over the past six months was 1,701.

Findings included:

Review of the hospital's policy titled, "EMTALA - Compliance with the Emergency Medical Treatment and Active Labor Act," revised 03/2016 showed that the hospital was to provide ongoing evaluation and stabilizing treatment as required by law.

Review of the hospital's policy titled, "Elopement Risk Patient (Flight Patient, High Risk)," revised 05/2022 showed that the hospital shall provide a safe, secure, legal containment for patients who are not alert and oriented and are a high risk for leaving the hospital. Precautions will be initiated on all patients who are at high risk for leaving the hospital.

Review of the hospital's policy titled, "Observation Attendant (Sitter) [person assigned to continuously observe a patient within close proximity, to ensure their safety]," revised 03/2022 showed that continuous direct observation is indicated to prevent patients, who are uncooperative, unable or unwilling to follow instructions, from injuring themselves and/or others, and to promote healing. In cases of suicidal (SI, thoughts of causing one's own death) or homicidal (HI, thoughts or attempts to cause another's death) one-to-one (1:1 continuous visual contact with close physical proximity) observation becomes an immediate need.

1. Observation on 06/07/22 of the hospital ED showed ED room #19 (psychiatric safe room for behavioral health patients) located approximately 11' from an unlocked ED exit door that led out into the patient waiting area and approximately 22' from unlocked ED ambulance entry doors.

Review of Patient #10's medical record showed that he was a 29 year old male who presented to the ED on 03/12/22 at 10:45 PM by law enforcement with altered mental status (any change in a person's mood, behavior, psychomotor skills, and/or cognition) with bizarre behavior with delusions (false ideas of what is taking place or who one is) and paranoid (excessive suspiciousness without adequate cause) thinking. The patient received a medical screening examination (MSE) with a mental health evaluation (MHE) with recommendation of inpatient psychiatric treatment. Documentation by Staff T, ED Physician on 03/12/22 at 11:58 PM showed that Patient #10 would not be agreeable with this plan and a request was made for affidavits (a written statement confirmed by oath, for use as evidence in court) to hold the patient. The patient was deemed high risk for elopement. Staff T documented that she and the patient's girlfriend completed affidavits. Staff T documented that the patient had rested quietly through her shift, the patient's girlfriend had remained at his bedside and awaiting bed availability at that time. Documentation by Staff R, Registered Nurse, (RN), showed that on 03/13/22 at 10:00 AM the patient was evaluated by the mental health assessor, the patient had been calm and cooperative and was a line of sight observation. Staff R, RN documented at 12:25 PM that the patient refused to cooperate with hospital process to change into a hospital gown and take an oral medication that was ordered and became combative with security that resulted in a medication injection with 1:1 observation. Staff R, RN documented that patient was awaiting involuntary placement for his homicidal ideations (HI, thoughts of causing another's death). Documentation by Staff T, ED Physician showed that she had resumed care of Patient #10 on 03/13/22 at 7:00 PM. Staff T documented that patient continued to await placement inpatient admission and that the patient had experienced an episode of combativeness and agitation earlier in the day that required law enforcement involvement and placement of both chemical and physical restraints. During her shift the patient had again became agitated and would not stay in his room and was argumentative with staff. Staff T documented that the patient was requested on multiple occasions to stay in his room and he continued to become increasingly agitated, security was called and law enforcement were called for backup. The patient became combative with security that resulted in a physical take down and was then placed in ED room #19 and required both chemical and physical restraints. Staff T documented a concern for combativeness and continued agitation. Staff O, ED Physician documented that he assumed care of Patient #10 at change of shift on 03/14/22 at 7:00 AM from Staff T, ED Physician. Staff O documented at the end of his shift that the patient had had no major behavioral events during his shift and that the patient continued to await placement and was resting comfortably. Staff O signed out care of the patient to Staff T at change of shift at 7:00 PM on 03/14/22. Staff Z, RN documented on 03/14/22 at 9:19 PM that transportation was being arranged for the patient to be transferred to Hospital B for inpatient admission and that transportation would take place at 9:00 AM on 03/15/22. Staff T, Physician documented on 03/14/22 at 11:00 PM that she had assumed care of Patient #10 at 7:00 PM and that later in the shift she had been informed that the patient had been accepted at Hospital B for ongoing psychiatric care and that transportation was being arranged but would not occur until 9:00 AM the following morning. Staff T documented that the patient had been in and out of his room on multiple occasions throughout the evening, agitated and continually asked for his clothing and his phone. The patient had been redirected on three occasions. Staff T documented that on one of the occasions the patient came out of his room, to the nursing station, with increased agitation, security was present and they attempted to redirect the patient when he suddenly made a dash for the ED exit and was able to run out of the ambulance entrance. Staff T documented that law enforcement was notified and that the patient was without clothing or shoes and was in a hospital gown.

Although requested the two affidavits that were documented to have been completed for Patient #10 were not located within the electronic medical record.

Record review of the Special Precautions/Observation record for Patient #10 dated 03/14/22 showed constant 1:1 observation with every fifteen minute documentation that included the sitters initials, patient location and the patients behavior from 7:00 AM through 10:30 PM. Staff CC, former Certified Nurse Assistant (CNA) was the patient sitter for Patient #10 at the time of his elopement.

Review of video recording titled, "03-2022 18-28-033," dated 03/14/22, showed the camera view of the ED nurse's station with Staff, JJ, ED Unit Secretary; Staff Z, RN, Charge Nurse; Staff BB, former ED RN; and Staff T, ED Physician seated behind the nursing station. The review showed:
- At 1:19 (time stamped, not actual time) Staff T, ED Physician entered camera view and walked into the nursing station and sat down at a computer along the back wall with her back to the camera.
- At 1:27 Patient #10 walked into camera view, approached the nurses station with a blanket wrapped around him and was accompanied by Staff V, PSO and Staff CC, former CNA, patient sitter.
- At 2:28 Patient #10 turned to his right and began to walk towards the camera when he suddenly turned to his left and ran. The blanket fell to the floor and Staff V, PSO picked it up and walked in the direction the patient ran. The patient appeared to only have paper scrubs that were tied around his waist that covered his genital area. Staff Z, RN and Staff BB, former ED RN remained at the desk. Staff BB extended his right arm and appeared to have held his hand with fingers toward the floor then waved his hand in a forward motion in what appeared to be a sign of "go away" in the direction the patient exited. Staff T, ED Physician remained seated at the computer with her back to the camera.
- At 2:35 Staff V, PSO turned back towards the camera with blanket in hand and walked toward the camera and placed the blanket on a cart and turned and walked back in the direction that the patient had exited. Staff Z, RN was on the phone and Staff BB, former ED RN extended his right arm again with his right hand fingers toward the floor and motioned in a way that appeared as if he was indicating "go away".

Review of video recording titled, "1-2022-03-14 22-18-29-032," dated 03/14/22, showed the camera view of two sets of automatic exit doors. The review showed:
- At 2:32 (time stamped, not actual time) Patient #10 came into camera view. He reached out and placed his hands on the first set of double automatic doors and then immediately turned to his left then stopped when the doors opened and then ran through the first set of doors and then exited the second set of automatic doors to the outside.
- At 2:41 Patient #10 stopped just beyond the exit door and looked around then turned in circles and appeared confused as to what he was going to do or go.
- At 2:48 Patient #10 ran to the left and out of camera view.

Review of video recording titled, "0 2022-03-14-22-18-29-014," dated 03/14/22, showed a four screen view of the hospital ED parking lot. The review showed:
- At 2:53 (time stamped, not actual time) Patient #10 was in the parking lot running alongside the sidewalk.
- At 2:56 Patient #10 turned and ran back in the direction of the hospital and stopped at the passenger side of a parked car in front of the ED doors. The patient bent down and appeared to talk to the driver of the car when the car drove away and the patient ran after it.
- At 3:09 Staff V, PSO came into camera view on the sidewalk when Patient #10 ran away from the hospital then stopped and ran back towards the ED. Staff V, PSO walked towards the patient.
- At 3:23 Patient #10 turned and ran in front of Staff V in the direction away from the hospital. Patient #10 ran through the parking lot and eventually exited off hospital property.

During an interview on 06/13/22 at 4:50 PM, Staff V, Public Safety Officer (PSO) stated that he was called to the ED the night that Patient #10 eloped. He stated that the patient kept walking out of his room and wanted to use the phone. Staff V stated that he talked with the patient in an attempt to get the patient to go back into his room. He stated that the patient had a hospital gown on with a blanket wrapped around him when the patient started to run towards the door and he (Staff V) grabbed at the patient but the blanket came off of the patient and the patient ran out of the ED door. Staff V stated that at that time Staff T, ED Physician was behind the nursing station and she asked him if the patient had ran out of the hospital and when he replied yes, Staff T instructed him to call local law enforcement. Staff V went out into the parking lot and made verbal contact with the patient and informed him he didn't have his clothes on and to come back inside. He stated that the patient stopped momentarily then ran out of the parking lot and off of hospital property and did not return.

During a telephone interview on 06/14/22 at 6:01 PM, Staff Z, RN stated that she remembered Patient #10 and that she was the charge nurse the night that he successfully eloped from the ED. She stated that she was not able to remember if the physician had discussed giving him medication to calm him or not but generally when a patient exhibited increased agitation and restlessness they did administer medications to help calm them.

Review of the hospital document Verge report dated 03/14/22 at 10:30 PM showed the report was completed by Staff Y, RN, House Supervisor. The document showed Patient #10 as the patient involved and that the patient was being held since 03/12/22 awaiting psychiatric inpatient treatment when he came out of ED room #19 to talk to nursing staff about his father visiting. While at the desk the patient eloped through the ambulance bay doors with security in pursuit. Security was unable to catch the patient and local law enforcement were notified. Patient #10 was wearing a hospital gown at the time of his departure and he had been under 1:1 monitoring with a sitter for alleged HI.

During a telephone interview on 06/13/22 at 11:01 AM, Staff N, Regional ED Medical Director stated that the ED physicians were a contracted group and were not hospital employed. He stated that he was involved in the care of Patient #10 and that he had taken over care at 7:00 AM on one of the days during his time spent in the ED. Staff N stated that Patient #10 was cooperative with increased behaviors towards the end of his shift that required medication to calm him. He stated that the plan was for inpatient placement the following day. He stated if a patient was both intoxicated and psychotic then it was "out of their hands" as a physician they "can't" restrain as an independent contractor to the hospital and that they followed their own policies not the hospitals. Staff N stated that the prime reason the ED received any psychiatric patient was to do an MSE to rule out an EMC. He stated with Patient #10 he felt his issues were more of a psychosis. When Patient #10 became combative his behaviors required neuroleptics (antipsychotic medications) and sedatives (a drug taken for its calming or sleep-inducing effect).

During an interview on 06/13/22 at 11:26 AM, Staff O, ED Medical Director stated that they prefer for patients not to elope but if a patient had escalating behaviors they do all that they can do and if they do elope then they call the police and hope that they were located and returned. He stated that if a patient was at no imminent risk of harm to self or others then the hospital had no reason to hold them and a patient could possibly elope but if the staff "crossed their t's and dotted their i's" then patients wouldn't be able to elope.

During an interview on 06/14/22 at 10:00 AM, Staff C, Chief Executive Officer (CEO) stated that the Root Cause Analysis (RCA, a tool to help study events where patient harm or undesired outcomes occurred in order to find the root cause) for Patient #10's elopement showed concerns for the overall care that was being delivered in the ED.

Although requested an RCA for Patient #10 was not provided.

During a telephone interview on 06/13/22 at 4:00 PM, Staff T, ED Physician stated that generally speaking, if a patient showed escalating behavior of coming in and out of their room, the staff would try to take the patient back into their room and if they successfully got out of the hospital the staff would notify law enforcement but she did not allow the staff to chase after the patients. Staff T stated that if a patient had an affidavit then the concern for their safety increased and that was why law enforcement was called. Staff T would not specifically speak to Patient #10 as she stated that she did not have the patient record to refer to.

Staff F, Regional CNO was present during the telephone interview with Staff T and stated that Staff T had the ability to access the patient record during the interview.

Patient #10 had received a MSE that included an MHE. The MHE recommended inpatient treatment and the patient was made involuntary status (a legal process through which a person is hospitalized and treated for mental health disorders without their consent). While the patient awaited transportation to Hospital B for inpatient psychiatric admission he exhibited increasing agitation and escalating behaviors that were recognized by Staff T, ED Physician, per her documentation, but were not treated and/or stabilized. Patient
#10 successfully eloped from St. Mary's Medical Center and was not located and/or returned by local law enforcement.