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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 Patient Rights was out of compliance.

A-0144 Patient Rights: care in a safe setting. The patient has the right to receive care in a safe setting. Based on document review and interviews, the facility failed to keep patients who had been identified as high-risk safe. Specifically, the facility failed to ensure interventions were in place to prevent patients on an M1 hold (a 72-hour involuntary mental health treatment process used when a professional determined that someone was a danger to themselves or others, or was so disabled by mental illness that they could not care for themselves) from eloping in two of three patients reviewed.

Based on document review and interviews, the facility failed to keep patients who had been identified as high-risk safe. Specifically, the facility failed to ensure interventions were in place to prevent patients on an M1 hold (a 72-hour involuntary mental health treatment process used when a professional determined that someone was a danger to themselves or others, or was so disabled by mental illness that they could not care for themselves) from eloping in two of three patients reviewed. (Patients #2 and #3)

Findings include:

Policies:

The Patient Rights and Responsibilities policy read, patients have the right to expect reasonable safety insofar as the corporation practices and environment are concerned. Patients have the right to be placed in protective privacy when the patient and/or their physician believe it is necessary for the patient's personal safety.

The Mental Health Holds - Emergency Evaluations of Persons Incapacitated Due to Mental Illness policy read, its purpose was to provide safe, quality care for patients with a mental illness who are in need of 72-hour Mental Health (M1) Hold under provisions of C.R.S. 27-65, and who require emergency department medical clearance and psychiatric evaluation or acute inpatient medical/surgical nursing care beyond the capability of an inpatient psychiatric unit or who may be awaiting placement/bed availability on an inpatient psychiatric unit.

The Patient Elopement policy read, its purpose was to ensure the safety of patients at risk for elopement and to establish a systematic approach to searching for patients who are missing. Elopement is defined as a patient who presents to the facility for clinical evaluation, leaves without completing the visit or treatment, or hospitalization, and does not notify clinical staff before leaving. An at-risk patient is a person who is "susceptible to mistreatment, self-neglect, or exploitation because s/he is unable to perform or obtain services necessary for his or her health, safety, or welfare, or lacks sufficient understanding or capacity to make or communicate responsible decisions concerning his or her person or affairs." Patients who express a wish to leave the facility against medical advice (AMA) are not considered to be an elopement unless it is determined that the patient is at-risk. At-risk patients examples include involuntary hold patients, mental status changes, neurological disorders affecting judgment, and a physical condition that places the patient at-risk. The facility will provide a safe environment for patients, visitors, and staff. Staff will implement appropriate interventions as needed in order to prevent elopement by patients. However, in the event of a patient's elopement, an immediate response by staff will be initiated.

The AMA Policy read, a patient on a mental health (M1) or alcohol or drug hold may not sign out AMA and may be restrained in accordance with hospital restraint policies to prevent them from leaving.

The Suicide Risk Assessment policy read, its purpose was to provide guidance to assist with the identification of patients in non-Behavioral Health (BH) settings who are at risk for suicide, ensuring a safe environment for the provision of care. It is the policy of the facility to create an environment of care that will foster the assessment, identification, and management of patients who are at increased risk for suicide or self-harming behaviors. Patients who are at an increased risk for suicide or self-harming behaviors require intensive support, close observations, and frequent reassessment for their emotional and physical well-being. The scope of this plan begins with the patient's initial presentation to the hospital and continues until the patient is discharged.

The Occurrence Reporting policy read, its purpose was to identify, trend, and analyze occurrences in the aggregate that will lead to improvements in patient, staff, and visitor safety; to meet regulatory reporting requirements; to provide a system for follow-up, intensive analysis, and investigation of sentinel events and other adverse outcomes which lead to improvements in patient safety. The facility's list of "Reportable Events" included elopement after a search of the facility if the patient is at risk or greater than eight hours regardless of the risk to the patient.

The Serious Safety Event Identification, Notification, and Management policy read, its purpose was to provide direction to the facility on identification, notification, and management of patient serious safety events (SSE). Improve the facility's culture, systems, and processes with the intent to prevent recurrence and improve safety systems. An event may be considered an SSE regardless of the severity of harm caused to the patient, the event is indicative of a serious gap in safety systems, policies, or processes that directly increases risk of future occurrence of an SSE. Any elopement (that is, unauthorized departure) of a patient from a staffed around-the-clock care setting (including the ED), leading to death, permanent harm, or severe harm to the patient.

Reference:

The Performance Improvement Risk Management Patient Safety Plan 2024 read, the facility has a comprehensive ongoing Performance Improvement (PI), Risk Management (RM), and Patient Safety (PS) Plan that supports the mission, vision, and values developed by the facility board of trustees. Leadership will set priorities that ensure the safety and quality of care and treatment. Facility leadership responsibilities include but are not limited to upholding the values and principles of the facility's mission; fostering communication, coordination, safety, and timeliness of care among individuals and departments to coordinate patient care and improve patient safety; and implementing an effective program to continuously measure, assess, and improve performance, reduce risks, and improve patient safety.

1. The facility failed to prevent high-risk patients placed on M1 holds from eloping.

A. Document review

i. Patient #2's medical record was reviewed and revealed Patient #2 was brought into the Emergency Department (ED) by ambulance on 9/29/24 at 4:40 p.m. Patient #2 had been assaulted and sustained a head injury. Patient #2 also reported daily alcohol use and withdrawal symptoms. The medical record revealed Patient #2 had been treated with intravenous (IV) fluids, medication for alcohol withdrawal symptoms, lab work, and imaging. At 5:16 p.m., Patient #2's blood alcohol level was 267. Further medical record review revealed Patient #2 left the ED at 6:41 p.m. before being reassessed by the provider and before they had received discharge instructions. Patient #2 was escorted by security to a nearby bus stop. The police department arrived to assist and witnessed Patient #2 fall to the ground and hit their head so the police called emergency medical services (EMS) to transport Patient #2 back to the ED.

ii. Patient #2 returned to the ED by ambulance at 6:52 p.m. Medical record review revealed Patient #2 was evaluated by an ED provider who documented Patient #2 was a 30-year-old male who presented with acute psychosis (symptoms that indicated a person had lost touch with reality or was having difficulty relating to others), auditory hallucinations, and thoughts of harming others, which posed a threat to life or bodily function. Additionally, the record revealed Patient #2 had a history of schizophrenia (a chronic mental illness that affects a person's thoughts, feelings, and behaviors) and had experienced a fall, which necessitated head imaging to rule out serious injury. Additionally, the provider documentation read, Patient #2 was placed on an M1 hold at 6:52 p.m. immediately after evaluation for endorsing auditory hallucinations and thoughts of wanting to harm people. Further, the provider's documentation read, the nurse had notified them that although the patient was initially calm and cooperative during evaluation, when security went to the bedside Patient #2 got agitated, leaped out of bed, and eloped from the ED at 7:00 p.m. The medical record read, Patient #2 was being aggressive and threatening toward staff as he was leaving the ED and was unable to be safely detained. Documentation revealed the police department had been called to search for Patient #2 because the patient still had an IV in place and was on an M1 psychiatric hold. Further review of Patient #2's medical record revealed there was no evidence of safety interventions such as a sitter at the bedside, fifteen-minute checks, or that a safe environment checklist was implemented for Patient #2 on this ED visit.

This was in contrast to the Suicide Risk Assessment policy which read, patients who were at an increased risk for suicide or self-harming behaviors required intensive support, close observations, and frequent reassessment for their emotional and physical well-being. The scope of this plan should have begun with the patient's initial presentation to the hospital and continued until the patient was discharged.

a. A security report on 9/29/24 read, Patient #2 was picked up by the police after falling and brought back to the ED by ambulance at 6:52 p.m. The security report read, at 6:57 p.m. Patient #2 eloped after the doctor had put them on an M1 hold. The security report read, the police department was called immediately and the patient was followed off the grounds until they were no longer in sight.

b. On 11/25/24, a review of the facility's incident log revealed no incident report was filed for Patient #2's elopement.

This was in contrast to the Occurrence Reporting policy which read, the facility's list of reportable events included elopement after a search of the facility if the patient was at risk.

c. A review of the AMA policy revealed patients on an M1 hold could be physically restrained if they tried to sign out AMA. However, upon request, the facility was unable to provide a policy or guidance staff were to follow when a patient on an M1 hold tried to elope from the facility.

ii. Patient #3's medical record was reviewed and revealed Patient #3 came to the ED on 10/27/24 at 2:40 p.m. with the chief complaint of abdominal pain. The record revealed the ED provider assessed the patient at 2:42 p.m. and documented Patient #3 had stabbed themselves in the abdomen with an object and had concerns about worsening abdominal pain. The medical record also read, Patient #3 was an 18-year-old female with a history of morbid obesity, borderline personality disorder, and recurrent self-harm behavior. Further, the record revealed Patient #3's case had been immediately discussed with the attending physician who had recommended an M1 medical hold for self-harm. The medical record read, orders were placed, the M1 form was filled out, and the staff were notified of Patient #3's high-risk status. Further, the medical record read, at 3:41 p.m. Patient #3 ran out of the ED front door and nursing staff and security were unable to stop the patient. Nursing documentation read, security notified the police department of the patient's elopement while on a high-risk M1 hold.

a. A security report placed on 10/27/24 read, Patient #3 ran out the front door followed by security and medical staff who stated the patient was not free to leave and had an IV in place. The report read, Patient #3 got in their car, ripped their IV out, and blood started shooting out of the IV site. Patient #3 then drove off. The report further read that the police department did not respond when facility security called to notify them of Patient #3's elopement. The security response ended at 5:03 p.m. with no further information to report.

b. A review of the facility's incident log revealed on 10/27/24 an incident report had been filed that read, Patient #3 had eloped and the police department was called but did not find the patient. Additionally, the facility completed an SSE analysis of this event on 10/30/24.

c. A review of the AMA policy revealed patients on an M1 hold could be physically restrained if they tried to sign out AMA. However, upon request, the facility was unable to provide a policy or guidance staff were to follow when a patient on an M1 hold tried to elope from the facility.

B. Interviews

i. On 11/26/24 at 3:17 p.m., an interview and live record review was conducted with registered nurse (RN) #2. RN #2 verified Patient #2 had been brought in by ambulance, was evaluated by the ED provider, and was placed on an M1 hold immediately after evaluation. RN #2 stated M1 hold paperwork had been initiated at 6:52 p.m. and was in the record. Also, RN #2 stated there was no nursing documentation in the record. RN #2 stated they were not sure why there was no nursing documentation in the record and there should have been a nursing note. Additionally, RN #2 stated there should have been an incident report placed for Patient #2's elopement so the facility could find areas for improvement and address any gaps in care.

ii. On 12/2/2024 at 9:40 a.m., an interview was conducted with ED manager (Manager) #3. Manager #3 stated patients placed on an M1 hold should have had a behavioral health (BH) huddle (a brief meeting to discuss the patient's risk level) at the bedside which included the provider, the charge nurse, and the primary nurse. Manager #3 stated if the patient was high-risk no one should have left the patient's room and the ED charge nurse would have assigned someone to stay in the room with the patient. Manager #3 stated high-risk patients could not be left alone because they could harm themselves and it was the ED staff's job to keep them safe.

Also, Manager #3 stated if a patient on an M1 hold tried to leave, the M1 policy directed the staff not to physically restrain the patient. Manager #3 stated ED staff were to call security for assistance. Manager #3 stated some patients got violent and angry and that would have been when staff relied on security and the police department to assist. Manager #3 explained that if a patient started to run, staff would have been able to verbally try to persuade them to stay but the policy stated they could not physically restrain the patient. Manager #3 said security or the police would have been able to restrain the patient.

This was in contrast to the AMA policy which revealed patients on an M1 hold could be physically restrained if they tried to sign out AMA. However, upon request, the facility was unable to provide a policy or guidance staff were to follow when a patient on an M1 hold tried to elope from the facility.

Additionally, Manager #3 stated Patient #2's medical record revealed that an M1 hold had been placed. Manager #3 stated interventions to ensure Patient #2's safety should have included a sitter at the bedside, documentation on the sitter checklist, and documentation of a safe environment. Manager #3 stated they had no idea why none of these safety interventions had been implemented.

Further, Manager #3 stated Patient #2 had eloped. Manager #3 stated the nurse caring for Patient #2 should have completed an incident report. Manager #3 stated they could not answer why no incident report had been filed. Manager #3 stated incident reports were important to educate staff, to trigger a review of the medical record, and to identify processes that could have been done differently to prevent a similar situation from occurring again.

iii. On 12/2/24 at 11:30 a.m., an interview was conducted with ED director (Director) #4. Director #4 stated interventions implemented to keep M1 patients safe included conducting a BH huddle at the patient's bedside, implementing an in-person or virtual sitter, and that the primary nurse would have done the safety checklist and implemented interventions that would have created a safe environment. Director #4 stated the safety interventions were important to protect patients and staff. Director #4 stated if an M1 patient wanted to leave, staff would have tried to verbally persuade the patient to stay, and then notified security and the police if necessary. Director #4 explained staff would not have gone hands-on with a patient unless there had been a threat to themselves or staff, and in that case, would have restrained the patient. Director #4 stated if an M1 patient eloped and made it out of the building, the staff should have called the police department. Director #4 stated the ED staff would have done all within their power to keep the patient safe, but if the patient darted out the door, it would have been the police department's responsibility at that point.

Also, Director #4 stated ED nursing staff should have documented a nurse's note about the event if a patient had eloped. Director #4 stated the nurse should have notified the provider, documented the events and that the provider had been notified, documented that security and the police had been notified, and discharged the patient from the system.

Additionally, Director #4 stated an incident report should have been placed after a patient elopement. Director #4 stated anyone would have been able to place an incident report, but the primary nurse would have been ultimately responsible.

Finally, Director #4 stated they did not know why there had been no nursing notes about Patient #2's care, safety interventions, and elopement. Director #4 stated even though there had been no nursing assessment documented there still should have been a note with Patient #2's disposition. Director #4 stated the disposition note would have been important to document that Patient #2 had been in the ED, what the staff had done to keep them safe, where the patient had gone after discharge, and what condition they had been in when they left. Director #4 stated they had no idea why an incident report had not been filed about Patient #2's elopement.

iv. On 12/2/24 at 1:17 p.m., an interview was conducted with the vice president of quality, risk, and infection control (VP) #1. VP #1 stated they did not know why an incident report had not been completed about Patient #2's elopement. VP #1 stated because an incident report had been filed for Patient #3's elopement, the facility completed an SSE analysis to investigate what processes had failed and what the facility could have done to improve patient safety. VP #1 stated incident reporting was important to improve patient safety and so that the facility would have been able to fix processes that might have been failing. VP #1 stated if they had been aware of Patient #2's incident, it could have been investigated and actions could have been taken to prevent future patient elopements from the ED such as Patient #3's incident.

These interviews were in contrast to The Patient Rights and Responsibilities policy which read, patients had the right to expect reasonable safety as far as the facility's practices and environment were concerned. Patients had the right to be placed in protective privacy when the patient and/or their physician believed it was necessary for the patient's safety.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.24 Medical Record Services was out of compliance.

A0438- FORM AND RETENTION OF RECORDS. The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries. Based on document reviews and interviews, the facility failed to ensure medical records were accurately documented in four of eight emergency department (ED) patients' records reviewed.

Based on document reviews and interviews, the facility failed to ensure medical records were accurately documented in four of eight emergency department (ED) patients' records reviewed. (Patients #2 and #3)

Findings include:

Facility policies:

The Patient Elopement: Prevention and Search Guidelines policy read, elopement is defined as a patient who presents to the facility for clinical evaluation, leaves without completing the visit or treatment, or hospitalization, and does not notify clinical staff before leaving. Patients who express a wish to leave the facility against medical advice (AMA) are not considered to be an elopement unless it is determined that the patient is at-risk. At-risk patients include involuntary hold (M1 hold) patients.

The AMA policy read, a patient can sign out of the hospital against medical advice. At any time, a patient may choose to be discharged or leave the facility. If, despite every effort to dissuade them, a patient insists on leaving the facility without the written order or consent of their provider, efforts will be made to inform the patient of the risks involved that may result from this action. Patients on an M1 hold may not leave AMA. When a patient expresses the desire to leave the facility AMA, staff will contact the patient's provider and advise them about the patient's decision to leave. Prior to contacting the provider, staff will attempt to explore the patient's anxieties, conflicts, expectations, and disappointments in regard to the treatment they are receiving. If a provider refuses to discharge the patient, the provider or designee shall discuss the possible effects/consequences of leaving AMA with the patient and also offer alternatives to leaving AMA. Any patient who makes the decision to leave AMA will be asked to sign the Informed Consent to Refuse form. If the patient refuses to sign the form, document the reason/refusal on the form and place it in the medical record. Providers/staff will document all pertinent information and the patient's rationale for leaving AMA in the patient's medical record.

1. The facility failed to ensure patient dispositions were accurately documented in the medical records.

A. Document Review

i. Review of the facility's ED patients list revealed Patient #2 left the facility AMA on 8/10/24.

a. A medical record review was conducted for Patient #2. The coding summary revealed Patient #2 left the facility AMA on 8/10/24 at 9:49 p.m. Nursing documentation revealed Patient #2's disposition was AMA and they had refused treatment. This was in contrast to the Provider's documentation which revealed a plan was discussed with Patient #2 who understood their return precautions and follow-up. The provider further documented Patient #2 agreed with the plan and was discharged home.

b. On 11/25/24 at 4:49 p.m., email correspondence from the infection prevention manager to the surveyors revealed the ED manager had reviewed Patient #2's medical record and did not know why the nurse documented Patient #2 had left AMA.

ii. Review of the facility's ED patients list revealed Patient #2 had been discharged home on 9/29/24.

a. A medical record review was conducted for Patient #2. The coding summary revealed Patient #2 was discharged home on 9/29/24 at 6:43 p.m. Nursing documentation revealed Patient #2's disposition was AMA and they had refused treatment. This was in contrast to the Provider's documentation which revealed Patient #2 had eloped before they were reassessed for discharge and the police department had been called to bring them back to the facility.

iii. Review of the facility's ED patients list revealed Patient #2 had left the facility AMA on 9/29/24.

a. A medical record review was conducted for Patient #2. The coding summary revealed Patient #2 left the facility AMA on 9/29/24 at 7:00 p.m. This was in contrast to the Provider's documentation which revealed Patient #2 eloped from the ED and the police department had been called to search for them because they were on an M1 hold. There was no nursing documentation located in Patient #2's record.

Patient #2's disposition documented on the ED patients list and coding summary were in contrast to the AMA policy which read, patients on an M1 hold could not leave AMA.

iv. Review of the facility's ED patients list revealed Patient #3 had left the facility AMA on 10/27/24.

a. A medical record review was conducted for Patient #3. The coding summary revealed Patient #3 left the facility AMA on 10/27/24 at 3:41 p.m. Nursing documentation revealed Patient #2's disposition was AMA and they had refused treatment. This was in contrast to a nursing note and the Provider's documentation which revealed Patient #2 was on an M1 hold and had eloped from the ED.

Patient #3's disposition documented on the ED patients list, coding summary, and nursing documentation for disposition were in contrast to the AMA policy which read, patients on an M1 hold could not leave AMA.

v. On 12/3/24 at 9:30 a.m., email correspondence from the vice president of quality, risk, and infection control (VP) #1 to the surveyors revealed there were no AMA forms for Patient #2 or Patient #3 located in their medical records.

vi. The Ongoing Medical Record Quality Reviews policy read, the purpose was to ensure medical records were monitored regularly for completeness, timeliness, and accuracy. Resulting actions were taken to improve quality and timeliness of documentation and in rare instances, health information management (HIM) was responsible for facilitating. Medical records were reviewed on a monthly basis collaboratively by nursing, patient care staff, and occasionally HIM. A random sampling of all patient types, service lines, and payers would be utilized. The findings from the reviews were collectively reported to the specific hospital committee for actions related to any deficiencies identified, and escalated to the specific hospital committee as needed.

The review of medical records would be based on hospital-defined indicators that addressed the presence, timeliness, readability, quality, consistency, clarity, accuracy, completeness, and authentication of data and information contained within the record. The specific hospital committee determined the number, type, review criteria, and responsibility for the reviews. The specific committee was responsible for identification of deficiencies, pursuing opportunities for improvement, and assured improvement was attained for enhancement of patient care.

This was in contrast to the continental division 2024 reporting calendar to quality and patient safety council (QPSC)/clinical patient safety and quality committee (CPSQC) which revealed medical records were reviewed for timeliness/delinquency, completeness/legibility, and quality of history and physicals, not accuracy of documentation.

B. Interviews

i. On 11/26/24 at 3:16 p.m., an interview and live medical record review was conducted with registered nurse (RN) #2. RN #2 stated elopement meant a patient had fled the premises without having a conversation with staff to discuss the risks and benefits of leaving. RN #2 stated patients who left AMA were alert, oriented, and of sound mind and staff had explained the risks of leaving AMA. RN #2 reviewed Patient #2's medical records and confirmed Patient #2 was discharged home on 8/10/24. RN #2 also confirmed Patient #2 eloped during both ED visits on 9/29/24. Additionally, RN #2 reviewed Patient #3's medical record and confirmed they had eloped from the ED on 10/27/24. RN #2 stated it was in patients' best interests to ensure care was properly documented and medical records were accurate.

ii. On 12/2/24 at 9:40 a.m., an interview and live medical record review was conducted with ED manager (Manager) #3. Manager #3 stated they did not know why the medical record for Patient #2 on 8/10/24 indicated they left AMA when the Provider's note read Patient #2 had been discharged home. Manager #3 also confirmed Patient #2 had eloped during their first visit on 9/29/24 and did not know why the ED patient list read Patient #2 had been discharged home. Manager #3 stated AMA was documented in the same way as elopement in their electronic medical record (EMR) system. Manager #3 stated there was not an option in the EMR for staff to document elopements, which was why staff documented patients who eloped as leaving AMA. Manager #3 stated staff followed policy the best they could with what options were available to them in the EMR.

iii. On 12/2/24 at 11:30 a.m., an interview was conducted with ED director (Director) #4. Director #4 stated all changes to the facility's EMR system had to go through corporate. Director #4 stated there had never been a way for staff to document elopement dispositions in the EMR in the eight years they had worked at the facility.

iv. On 12/2/24 at 1:17 p.m., an interview was conducted with VP #1. VP #1 stated there was a difference between elopement and AMA. VP #1 stated the EMR did not give staff the option to document elopements in the medical record. VP #1 stated it was important for patients' dispositions to be accurately documented to ensure the facility was able to follow up with patients if needed.