Saint Anne’s Hospital

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 37556 The Hospital was out of compliance for the Condition of Participation for Patient Rights. Based on a review of medical records and relevant policies and procedures, and staff interviews, for one (Patient #1) of 17 sampled patients, the Hospital failed to ensure staff compliance with established policies and procedures to enhance patient safety. In September 2025, Patient #1 was brought to the Emergency Department (ED) by Emergency Medical Services (EMS) after making suicidal statements and intoxication. Patient #1 did not receive adequate safety supervision and was subsequently found unresponsive on the floor next to his/her bed, with a bra reportedly wrapped around his/her neck and affixed to the stretcher. Despite resuscitation efforts, Patient #1 was pronounced deceased. Cross Reference: Patient Rights: Care in a Safe Setting (Tag 144).”

“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: 37556 The Hospital was out of compliance for the Condition of Participation for Quality Assessment and Performance Improvement (QAPI). Based on records reviewed and interview the Hospital failed for one (Patient #1) out of a total sample of 15 patients, to ensure the Quality Assessment and Performance Improvement (QAPI) Program identified policy non-compliance and implemented actions identified for the Hospital’s performance improvement following a suicide event on 9/4/25. Additionally, the Hospital failed to ensure policies and procedures were reviewed within the next review date period to ensure accurate and updated procedures were developed and implemented within the Hospital. Cross Reference: - QAPI: Patient Safety (Tag 286). - QAPI: System QAPI Policies and Procedures (Tag 322). - Patient Rights: Care in a Safe Setting (144).”

“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: 37556 Based on a review of medical records and relevant policies and procedures, and staff interviews, for one (Patient #1) of 17 sampled patients, the Hospital failed to ensure staff compliance with established policies and procedures to enhance patient safety. On 9/3/25, Patient #1 was brought to the Emergency Department (ED) by Emergency Medical Services (EMS) after making suicidal statements and intoxication. Patient #1 did not receive adequate safety supervision and was subsequently found unresponsive on the floor next to his/her bed, with a bra reportedly wrapped around his/her neck and affixed to the stretcher. Despite resuscitation efforts, Patient #1 was pronounced deceased. Findings include: Review of the Hospital’s policy titled, Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID: 17085285), dated November 2024, indicated the purpose was to prevent patient injury and to provide a safe and secure environment for patients who are assessed to be at risk for suicide and/or self-injury. Screening for suicidal risk would be completed using the Columbia Suicide Severity Rating Scale (C-SSRS) and directed specific observation levels (E.G., Safety Watch or Constant Observation) based on suicide risk score following the C-SSRS assessment. Suicide screening maybe repeated if there was a change in patient status. Review of the Hospital’s policy titled, Observation Levels (Policystat ID: 14589625), dated December 2023, indicated the the purpose was to define different observation levels and types of observation and to specify requirements and interventions associated with each level and type of observation. Frequent checks were used when a patient required visual monitoring for behavioral health needs at prescribed intervals, limited to use in adult and pediatric behavioral health units. Safety watch observation was used to enhance patient safety when a patient, based on assessment, required observation to prevent harm when other alternatives such as remote monitoring are not adequate. This level of observation was indicated for patients at mild to moderate risk for suicide. The Nurse would assess the patient every four hours and document on safety watch flow sheets. The safety observer may watch up to four patients at a time with direct observation, and document patient observations in the medical record and/or report to findings to the nurse to document. There was no documentation at the time of Survey to support Hospital staff received education for the following policies and procedures: Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID: 17085285) and Observation Levels (Policystat ID: 14589625). Review of the Hospital’s policy titled, Patient Observation for Prevention of Harm (POC 69), dated September 2025, indicated that patient observation would be utilized for patients who are assessed and determined to be at risk for safety and/or harm to self/others. The Policy applied to all patients assessed to be a safety risk on the inpatient units and ED setting. Frequent observation was defined as an assignment of a patient observer to monitor the patient regularly, no less frequently that every 30 minutes or more frequently if indicated, to prevent harm to patients. The policy indicated the following: - For suicide risk assessment guidance, refer to the policy, Suicide Risk Assessment and Management (POC 22). - The Patient Observer would document the indicated patient safety observations on the Frequent/Continuous Observation Monitoring tool. - The Registered Nurse would provide support to the observer, including patient’s diagnosis, reason for observation, frequency of observation, and patient care needs. The nurse would complete the Continuous/Frequent Observation Handoff Checklist which included a section to remove any unnecessary medical equipment such as IV pole. In collaboration with the Nurse Manager/Supervisor, reassessment would occur at least every four hours and use clinical judgement on safety observation levels, and report findings and changes to the provider. - The Nurse Manager would evaluate and approve all requests for patient observation (refer to the Safety Observer Request Form). Re-evaluates patients requiring observation monitoring every 4 hours to assess the continued need for observation. There was no documentation at the time of Survey to support the policy titled, Suicide Risk Assessment and Management (POC 22), was active and/or available for staff access, to reference for further suicide risk assessment and management guidance during Patient #1’s stay in the ED or at the time of the Survey. There was no documentation to support a Continuous/Frequent Observation Handoff Checklist was completed for Patient #1. Review of the policy titled, Incident Reports: General Overview (RI 30), dated February 2024, indicated that following an incident, the Hospital respond in a timely, consistent, and effective manner. The Hospital would take immediate steps to ensure patient and staff safety, included assessment of risk to original patient or other patients or staff, immediate corrective action(s) to prevent further harm, pending the larger investigation, and preservation of evidence for analysis. Review of the policy titled, Incident Reports: Sentinel Events (RI 53), dated June 2022, defined a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results included but not limited to death. The preliminary review of a sentinel event would generally be initiated within 24 hours. The review process by Risk Management would generally be initiated within 72 hours. Review of the incident report and medical records, if applicable and coordinate immediate corrective actions to obvious and immediate proceed issues identified and attributed to the event under review. The Department of Public Health received a complaint letter alleging that on 9/3/25, Patient #1 was brought to the Emergency Department (ED) by Emergency Medical Services (EMS) after making suicidal statements and alcohol intoxication. It was alleged that Patient #1 did not receive adequate safety supervision for Patient #1, who made repeated suicidal statements at the Hospital to nursing staff, the ED physician, and family; however, Patient #1 was placed on five-minute checks without having a psychiatric evaluation. Patient #1’s bra and stretcher were ligature risks for a patient with active suicide ideation. Patient #1’s room lights were dimmed, the door was closed and blinds drawn, limiting the visibility and observation by staff. Patient #1’s family left the ED around 10:30 P.M. and notified the assigned nurse . Patient #1 was subsequently found unresponsive on the floor next to her bed, with a bra reportedly wrapped around her neck and affixed to the stretcher. Despite resuscitation efforts, Patient #1 was pronounced deceased. Review of Patient #1’s medical record indicated that on 9/3/25, around 4:32 P.M., Patient #1 was transported to the Emergency Department (ED) by emergency medical services (EMS) after making suicidal statements and being found intoxicated. Nurse #1’s triage note at 4:38 P.M., indicated Patient #1 was tearful throughout triage and reported a history of two suicide attempts and said, “I’ve tried to kill myself twice and I think the third time will do the charm.” Despite this, the Nurse #1 completed the Columbia Suicide Severity Rating Scale (a suicide risk assessment) at 4:49 P.M. and noted question number six, “Have you ever done anything, started to do anything, or prepared to do anything to end your life?” answered as “No”. Nurse #1 then scored Patient #1 as a low risk (for self-harm). Patient #1 was allowed to have a bra and was placed in a room with at least one ligature risk (IV Pole attached to stretcher). At 5:36 P.M., The ED Physician assessed Patient #1 and documented “Though the patient admits to suicidal ideation, Patient #1 believes he/she can remain safe while in the ED” and Patient #1 was appropriate for frequent observation (safety checks every 5 minutes). At 12:08 P.M., staff found Patient #1 unresponsive on the floor with a bra wrapped around his/neck and affixed to the stretcher (specifically the IV pole that was in the horizontal position at the head of the stretcher). Patient #1 was found pulseless and apneic, and resuscitation efforts began but Patient #1 was pronounced deceased at 12:26 P.M. Review of the Department of Public Health’s (DPH) Health Care Facility Reporting System, included serious reportable event from the Hospital, dated 9/5/25, indicating that on 9/4/25, Patient #1 presented to the Emergency Department (ED) around 4:42 P.M., via emergency medical services (EMS) after being found intoxicated on a boat and making suicidal statements. Patient #1 had a physician evaluation, changed into safety clothing, placed under safety observation, and had a blood alcohol level of 257. Patient #1’s curtain and door were left open and Patient #1 remained on 5 minute checks until he/she was found on the floor next to the stretcher with a bra wrapped around his/neck and attached to the stretcher (specifically the IV pole that was in the horizontal position at the head of the stretcher). Patient #1 was found pulseless and apneic, and resuscitation efforts began but Patient #1 was pronounced deceased at 12:26 P.M. Review of the Hospital’s Internal Investigation of Patient #1’s suicide event on 9/4/25, included a Critical Event Huddle, dated 9/5/25, indicated Patient #1 had a C-SSRS completed by a nurse and scored as a low risk and placed on 5-minute safety watch intervals. Family remained with Patient #1 until about 11:00 P.M. A safety check was performed at 11:55 P.M., and again at 12:08 A.M., when a safety sitter called a nurse to the room because Patient #1 was found with a bra wrapped around his/her neck. During an interview on 9/9/25, at 12:30 P.M., The Corporate Director of Risk Management and Risk Manager, said the Hospital’s investigation of Patient #1’s suicide event on 9/4/25 was ongoing; however, they said the Hospital did not identify any staff non-compliance with policies and procedures or standards of care issues identified while reviewing Patient #1’s stay in the ED. They reinforced the information listed in the report submitted to DPH on 9/5/25 was accurate and up to date. They said the Hospital had begun re-educating nursing staff regarding completing and documenting a C-SSRS assessment and safety supervision to reinforce the Hospital’s policies and procedures should any concerns arise during the investigation. They said the suicide policy titled, Assessment and Management of Suicide Risk and Self-injurious Behavior (POC 22), dated 4/30/24, was in place at the time of Patient #1’s suicide event, continuously referenced during the Hospital’s internal investigation, and still active at the time of the Survey. During an interview on 9/9/25, at 1:50 P.M., The Corporate Director of Risk Management, Risk Manager, and Interim President/Chief Nursing Officer said that upon requesting Safety Sitter #1’s personnel file for DPH’s review during the Survey, they learned that Safety Sitter #1 was suspended on 9/8/25 after an interview with Human Resources and the Director of the ED. They said Safety Sitter #1 was suspended pending further investigation due to concerns about the safety checks performed for Patient #1; however, they do not know further details about the concerns and does not require Hospital corrective actions at this time as the investigation was going. During an interview on 9/9/25 at 3:03 P.M., Safety Sitter #1 said that during the overnight shift on 9/3/25, he was completing frequent (5-minute) safety checks for five patients, including Patient #1. Safety Sitter #1 said that he was unaware that Patient #1 had suicidal ideation or alcohol intoxication, as those details were not provided during a change of shift report. Safety Sitter #1 said that during shift report, he learned Patient #1 had family members visiting him/her and the room door was closed, the curtain was closed, and the lights were off. Safety Sitter #1 said he did not complete the required safety checks for Patient #1 as he thought Patient #1 was sleeping and did not want to disturb the patient/family. Safety Sitter #1 said he was unaware that Patient #1’s family had left until CNA #1 saw Patient #1 and called for help because Patient #1 had a bra wrapped around his/her neck. During an interview on 9/10/25 at 8:15 A.M., The Director of the ED said that on 9/8/25, she spoke with Safety Sitter #1 who said words to the effect of, he falsely documented the “Change to Continuous Observation” form during times that he did not complete safety checks for Patient #1 as he watched to catch up on completing the documentation and he thought Patient #1 was okay because family members were visiting. The Director of the ED said staff completing safety checks are required to visualize patients, even if family members are visiting, and reporting any changes to the assigned nurse. During an interview on 9/10/25, at 2:37 P.M., the ED Physician said he was assigned to care for Patient #1 while in the ED during the overnight shift beginning on 9/3/25. The ED Physician said Patient #1 had expressed active suicidal thoughts while in the ED but denied having a suicide plan. The ED Physician said Patient #1’s blood work indicated alcohol intoxication but based on his evaluations, Patient #1 appeared clinically sober and able to consent to safety while in the ED. The ED Physician said he ordered 5-minute safety checks for Patient #1 due to his/her reports of suicidal ideation. The ED Physician said he responded to the code blue when Patient #1 was found after he/she used his/her bra to hang him/herself. During an interview on 9/10/25 at 12:55 P.M., the Surveyor asked ED Nurse Manager to access the Hospital’s active suicide policy via Policystat (intranet database), which was titled, Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID 17085285), dated November 2024. The ED Nurse Manager said ED nursing staff had not been educated on the Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID 17085285) policy. The ED Nurse Manager said the Assessment and Management of Suicide Risk and Self-injurious Behavior (POC 22) was the Hospital’s prior policy but not available for access at the time of the interview. During an interview on 9/10/25 at 3:40 P.M., The Clinical Educator said the policy titled, Assessment and Management of Suicide Risk and Self-injurious Behavior (POC 22) was an older policy that had been retied. The Clinical Educator said policy titled, Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID 17085285) was still being reviewed and tailored to that specific Hospital; therefore, nursing staff had not been educated on the active policy. During an interview on 9/11/25 at 8:00 A.M., The Interim President/Chief Nursing Officer said that following the review of Patient #1’s suicide event on 9/4/25, the Hospital discovered the policy titled, Assessment and Management of Suicide Risk and Self-injurious Behavior (POC 22) had been retired and removed from the intranet on an unknown date. As a result, it was not accessible to staff during Patient #1’s stay in the ED. She said the Hospital was currently reviewing the corporate policy titled, Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID 17085285), which is under revision to be adapted specifically for that specific Hospital. The Hospital failed to ensure staff received education necessary support compliance with established policies and procedures intended to enhance patient safety. On the overnight shift beginning on 9/3/25, staff failed to implement policies and did not perform physician ordered safety checks every 5-minutes for Patient #1. Patient #1 was left unsupervised by staff for approximately 28 minutes and later found unresponsive on the floor next to his/her bed, with a bra reportedly wrapped around his/her neck and affixed to the stretcher. Despite resuscitation efforts, Patient #1 was pronounced deceased.”

“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: 37556 Based on records reviewed and interview the Hospital failed for one (Patient #1) out of a total sample of 15 patients, to ensure the Quality Assessment and Performance Improvement (QAPI) Program functioned effectively to identify, investigate, and respond to critical system failures following a suicide event on the Emergency Department on 9/4/25. The Hospital failed to maintain an up-to-date Quality and Safety Plan; ensure staff were educated on established policies and procedures related suicide risk assessment and safety observation; and develop and implemented corrective actions following a sentinel event for Patient #1 while under Hospital care. Findings include: Review of the Hospital’s policy titled, Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID: 17085285), dated November 2024, indicated the purpose was to prevent patient injury and to provide a safe and secure environment for patients who are assessed to be at risk for suicide and/or self-injury. Screening for suicidal ideation would be completed using the Columbia Suicide Severity Rating Scale (C-SSRS) by the Registered Nurse, social worker, or provider. Review of the Hospital’s policy titled, Observation Levels (Policystat ID: 14589625), dated December 2023, indicated the purpose was to define the different levels and types of observation and to specify requirements and interventions associated with each level and type of observation. There was no documentation at the time of Survey to support Hospital staff received education for the following policies and procedures: Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID: 17085285) and Observation Levels (Policystat ID: 14589625). Review of the Hospital’s policy titled, Patient Observation for Prevention of Harm (POC 69), dated September 2025, indicated that patient observation would be utilized for patients who are assessed and determined to be at risk for safety and/or harm to self/others. For suicide risk assessment guidance, refer to the policy, Suicide Risk Assessment and Management (POC 22). There was no documentation at the time of Survey to support the policy titled, Suicide Risk Assessment and Management (POC 22), was active and/or available for staff access, to reference for further suicide risk assessment and management guidance during Patient #1’s stay in the ED or at the time of the Survey Review of the policy titled, Patient Safety Evaluation System (LD 07), dated March 2023, included the Quality and Safety Plan, dated 1/1/23 to 12/31/24. There was no documentation at the time of Survey to support the Hospital maintained an up-to-date Quality and Safety Plan for 2024 to 2025. Review of the policy titled, Incident Reports: General Overview (RI 30), dated February 2024, indicated that following an incident, the Hospital respond in a timely, consistent, and effective manner. The Hospital would take immediate steps to ensure patient and staff safety, included assessment of risk to original patient or other patients or staff, immediate corrective action(s) to prevent further harm, pending the larger investigation, and preservation of evidence for analysis. Review of the policy titled, Incident Reports: Sentinel Events (RI 53), dated June 2022, defined a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results included but not limited to death. The preliminary review of a sentinel event would generally be initiated within 24 hours. The review process by Risk Management would generally be initiated within 72 hours. Review of the incident report and medical records, if applicable and coordinate immediate corrective actions to obvious and immediate proceed issues identified and attributed to the event under review. Review of the Department of Public Health’s (DPH) Health Care Facility Reporting System, included serious reportable event from the Hospital, dated 9/5/25, indicating that on 9/4/25, Patient #1 presented to the Emergency Department (ED) around 4:42 P.M., via emergency medical services (EMS) after being found intoxicated on a boat and making suicidal statements. Patient #1 had a physician evaluation, changed into safety clothing, placed under safety observation, and had a blood alcohol level of 257. Patient #1’s curtain and door were left open and Patient #1 remained on 5 minute checks until he/she was found on the floor next to the stretcher with a bra wrapped around his/neck and attached to the stretcher (specifically the IV pole that was in the horizontal position at the head of the stretcher). Patient #1 was found pulseless and apneic, and resuscitation efforts began but Patient #1 was pronounced deceased at 12:26 P.M. Review of the Hospital’s Internal Investigation of Patient #3’s suicide event on 9/4/25, included a Critical Event Huddle, dated 9/5/25, indicated Patient #1 had a C-SSRS completed by a nurse and scored as a low risk and placed on 5-minute safety watch intervals. Family remained with Patient #1 until about 11:00 P.M. A safety check was performed at 11:55 P.M., and again at 12:08 A.M., when a safety sitter called a nurse to the room because Patient #1 was found with a bra wrapped around his/her neck. Review of Patient #1’s medical record indicated that on 9/3/25, around 4:32 P.M., Patient #1 was transported to the Emergency Department (ED) by emergency medical services (EMS) after making suicidal statements and being found intoxicated. Nurse #1’s triage note at 4:38 P.M., indicated Patient #1 was tearful throughout triage and reported a history of two suicide attempts and said, “I’ve tried to kill myself twice and I think the third time will do the charm.” Despite this, the Nurse #1 completed the Columbia Suicide Severity Rating Scale (a suicide risk assessment) at 4:49 P.M. and noted question number six, “Have you ever done anything, started to do anything, or prepared to do anything to end your life?” answered as “No”. Nurse #1 then scored Patient #1 as a low risk (for self-harm). Patient #1 was allowed to have a bra and was placed in a room with at least one ligature risk (IV Pole attached to stretcher). At 5:36 P.M., The ED Physician assessed Patient #1 and documented “Though the patient admits to suicidal ideation, Patient #1 believes he/she can remain safe while in the ED” and Patient #1 was appropriate for frequent observation (safety checks every 5 minutes). At 12:08 P.M., staff found Patient #1 unresponsive on the floor with a bra wrapped around his/neck and affixed to the stretcher (specifically the IV pole that was in the horizontal position at the head of the stretcher). Patient #1 was found pulseless and apneic, and resuscitation efforts began but Patient #1 was pronounced deceased at 12:26 P.M. During an interview with Nurse #2 on 9/10/25, he said that he was assigned to care for Patient #1 during the overnight shift beginning 9/3/25 in the ED. Nurse #2 said Patient #1 was expressing suicidal ideation in the ED but denied having a suicide plan. Nurse #2 said he asked Patient #1 if she had any prior suicide attempts and she said “no.” Nurse #2 said he was aware Patient #1’s C-SSRS assessment scored him/her at a low risk for suicide and he/she had several ligature risks in his/her room. Nurse #2 said he was not aware that Patient #1 had prior suicide attempts as he did not read Patient #1’s triage note. Nurse #1 said that within an hour after Patient #1’s suicide event, he heard from a staff member that Safety Sitter #1 did not complete the safety checks for Patient #1. During an interview on 9/9/25, at 12:30 P.M., The Corporate Director of Risk Management and Risk Manager, said the Hospital’s investigation of Patient #1’s suicide event on 9/4/25 was ongoing; however, they said the Hospital did not identify any staff non-compliance with policies and procedures or standards of care issues identified while reviewing Patient #1’s stay in the ED. They reinforced the information listed in the report submitted to DPH on 9/5/25 was accurate and up to date. They said the Hospital had begun re-educating nursing staff regarding completing and documenting a C-SSRS assessment and safety supervision to reinforce the Hospital’s policies and procedures should any concerns arise during the investigation. They said the suicide policy in place at the time of Patient #1’s suicide event and continuously referenced during the Hospital’s internal investigation, and at the time of the Survey was the policy titled, Assessment and Management of Suicide Risk and Self-injurious Behavior (POC 22), dated 4/30/34. During an interview on 9/9/25, at 1:50 P.M., The Corporate Director of Risk Management, Risk Manager, and Interim President/Chief Nursing Officer said that upon requesting Safety Sitter #1’s personnel file for DPH’s review during the Survey, they learned that Safety Sitter #1 was suspended on 9/8/25 after an interview with Human Resources and the Director of the ED. They said Safety Sitter #1 was suspended pending further investigation due to concerns about the safety checks performed for Patient #1; however, they do not know further details about the concerns and does not require Hospital corrective actions at this time as the investigation was going. There was no documentation to support the Hospital followed the policy titled, Incident Reports: Sentinel Events (RI 53), which required a timely review of incident reports and medical records to coordinate immediate corrective actions; additionally, the Hospital failed to identified or address inaccurate suicide risk scoring and did not not acknowledge or mitigate identified environmental hazards, including ligature risks on stretchers. During an interview on 9/9/25 at 3:24 P.M., Nurse #1 said she completed the nursing triage assessment, and the C-SSRS for Patient #3 in the ED. Nurse #1 said Patient #1 was tearful throughout the assessment. Nurse #1 said Patient #1 reported words to the effect of, making two suicide attempts in the past and the third time would do the trick, but denied having an active suicide plan. Nurse #1 said Patient #1 reported feeling this way for the past six months. Nurse #1 said Patient #1 appeared intoxicated but that did not interfere with gathering information for the assessment. During an interview on 9/10/25, at 2:37 P.M., the ED Physician said he was assigned to care for Patient #1 while in the ED during the overnight shift beginning on 9/3/25. The ED Physician said he ordered 5-minute safety checks for Patient #1 due to his/her reports of suicidal ideation without an active suicide plan. The ED Physician said that if patient scores moderate to high risk of suicide on the C-SSRS assessment then the physician would speak with nursing staff about any safety concerns. The ED Physician said the clinical team can make determinations for safety interventions aside from the suicide risk score. During an interview on 9/11/25 at 8:46 A.M., Safety Sitter #2 said she began the 5-minute safety checks for Patient #1 while in the ED. Safety Sitter #2 said that throughout her assignment, Patient #1 was screaming that he/she wanted to die and staff could hear that from the nursing station. Safety Sitter #2 said she thought Patient #1 should have been on a 1:1 for safety supervision and reported that to a nurse who said the physician ordered Patient #1 to be on frequent (5-minute checks). Safety Sitter #2 said she provided a detailed change of shift report to Safety Sitter #1. During an interview on 9/9/25 at 3:03 P.M., Safety Sitter #1 said that during the overnight shift on 9/3/25, he was completing frequent (5 minute) safety checks for five patients, including Patient #1. Safety Sitter #1 said that he was unaware that Patient #1 had suicidal ideation or alcohol intoxication, as those details were not provided during a change of shift report. Safety Sitter #1 said that during shift report, he learned Patient #1 had family members visiting him/her and the room door was closed, the curtain was closed, and the lights were off. Safety Sitter #1 said he did not complete the required safety checks for Patient #1 as he thought Patient #1 was sleeping and did not want to disturb the patient/family. Safety Sitter #1 said he was unaware that Patient #1’s family had left until CNA #1 saw Patient #1 and called for help because Patient #1 had a bra wrapped around his/her neck. During an interview on 9/10/25 at 8:15 A.M., The Director of the ED said that on 9/8/25, she spoke with Safety Sitter #1 who said words to the effect of, he falsely documented the “Change to Continuous Observation” form during times that he did not complete safety checks for Patient #1 as he watched to catch up on completing the documentation and he thought Patient #1 was okay because family members were visiting. The Director of the ED said staff completing safety checks are required to visualize patients, even if family members are visiting, and reporting any changes to the assigned nurse. The ED Director said that on 9/6/25, the Hospital began ED staff re-education related to suicide assessment screening (C-SSRS) and continuous safety supervision for any potential immediate gaps related to Patient #1’s suicide event on 9/4/25. The ED Director said she was unsure if there were any identified concerns that initiated the education on 9/6/25. During an interview on 9/10/25 at 12:55 P.M., the Surveyor asked ED Nurse Manager to access the Hospital’s active suicide policy via Policystat (intranet database), which was titled, Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID 17085285), dated November 2024. The ED Nurse Manager said ED nursing staff had not been educated on the Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID 17085285) policy. The ED Nurse Manager said the Assessment and Management of Suicide Risk and Self-injurious Behavior (POC 22) was the Hospital ’ s prior policy but was not available for access at the time of the interview. During an interview on 9/10/25 at 1:00 P.M., ED Charge Nurse #1 said that if a patient came into the ED and scored moderate to high risk of suicide on the C-SSRS, they would require frequent (5-minute checks). She said that a patient would require 1:1 safety supervision if a patient came into the ED with a history of suicide attempts and suicidal ideation as the chief complaint. During an interview on 9/11/25 at 11:20 A.M., ED Charge Nurse #2 said that if a patient came into the ED and had suicidal ideation, they would require a 1:1 safety supervision until a physician completed an evaluation and orders. During an interview on 9/10/25 at 3:40 P.M., The Clinical Educator said the policy titled, Assessment and Management of Suicide Risk and Self-injurious Behavior (POC 22) was an older policy that had been retied. The Clinical Educator said policy titled, Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID 17085285) was still being reviewed and tailored to that specific Hospital. The Clinical Nurse Educator said she has education content prepared for the policy titled, Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID 17085285) but she is waiting for leadership to complete the policy and approve the roll out of education. The Clinical Educator said she was unsure if the Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID 17085285) was active and available for staff access and use. During an interview on 9/11/25 at 8:00 A.M., The Interim President/Chief Nursing Officer said that upon review of Patient #1’s suicide event on 9/4/25, the Hospital had identified the policy titled, Assessment and Management of Suicide Risk and Self-injurious Behavior (POC 22) had been retired and removed from the intranet on an unknown date and was not available for staff to access during Patient #1’s stay in the ED. She said the Hospital was currently reviewing the policy titled, Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policystat ID 17085285), as this was a corporate policy that was being reviewed and edited to that specific Hospital. The Hospital failed to develop and/or implement any sustainable corrective actions regarding appropriate suicide assessment or adequate patient safety supervision.”

“SYSTEM QAPI POLICIES AND PROCEDURES CFR(s): The unified and integrated QAPI program establishes and implements policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated QAPI program has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed. This Standard is not met as evidenced by: 41143 Based on record review and interview, the Hospital failed to ensure the unified and integrated QAPI plan of the Hospital’s Organization addressed the needs and concerns of the Hospital in establishment of its policies and procedures for one Patient (#1) out of a total sample of 17 patients. Patient #1 was admitted to the Hospital Emergency Department (ED) for observation with suicidal ideation and was found without pulse following a suicide event in the ED without clear and established suicide prevention and observation policies and procedures in place. Findings include: Patient Safety Evaluation System (LD 07), included Appendix C: Quality and Safety Plan, dated 1/1/23 to 12/31/24, indicated the following: - The Patient Safety Plan ensures the Hospital will implement/maintain strategies endorsed by regulating and professional health care organizations to demonstrate the organizations accountability for delivering care safely, effectively, patient-centered, efficiently, timely, and equitably to both reduce risk from avoidable harm while insuring evidence based care delivery while cared for in the hospital setting. - Ensure adoption of all best practice strategies endorsed by regulating and quality improvement organizations to mitigate risk from harm and to ensure maintaining those strategies for continuous reliability in preventing harm. Review of the Hospital’s policy titled, Screening and Assessment of Suicide/Self-Injury Risk or Behavior Outside of Behavioral Health Units (Policy stat ID 17085285), dated November 2024, indicated the purpose was to prevent patient injury and to provide a safe and secure environment for patients who are assessed to be at risk for suicide and/or self-injury. All patients on Suicide/self-injury precautions would have additional measures to the environmental screening and safety section below. Screening for suicidal ideation would be completed using the Columbia Suicide Severity Rating Scale (C-SSRS) by the Registered Nurse, social worker, or provider. The policy indicated the following: - The C-SSRS screening score for low risk was 0.5-1.5 (observations above standard level of care are not required. Providers would be alerted to consider a consult to behavioral health on discharge. The C-SSRS score for moderate was 2.0-4.5 (consider placing an order for and initiating either Safety Watch or Remote Monitoring, based on clinical judgement and notify the provider of the level.) The C-SSRS score for high was 5+ (Place an order for both Constant Observation and Suicide/self-injury Precautions. Notify the provider of the level, the provider would sign and acknowledge the constant observation and suicide/self-injury precautions orders). Suicide screening maybe repeated if there is a change in patient status. - All patients who score moderate risk or high risk on the C-SSRS would have a suicide risk assessment conducted by a licensed clinical social worker or ordering provider using an evidence-based process. An overall risk level would be determined, and interventions would be implemented based on risk level and clinical judgement on an individual patient basis. Patients who are assessed to be at high risk for suicide/self-injurious must be continued or placed immediately on constant observation and suicide/self injury precautions. Assessment is an ongoing process and changes would be documented by the provider in follow-up progress notes. - Environmental safety checks must be done upon the patient’s arrival to the unit and at every hand-off which included objects with high potential for harm removed from room or reviewed with the 1:1 observer during hand-off when unable to be removed. Review of the Hospital’s policy titled, Patient Observation for Prevention of Harm (POC 69), dated September 2025, indicated that patient observation would be utilized for patients who are assessed and determined to be at risk for safety and/or harm to self and others. The policy applied to all patients assessed to be a safety risk on the inpatient and in the ED. The policy defined frequent observation as an assignment of a patient observer to monitor the patient regularly, no less frequently that every 30 minutes or more frequently if indicated, to prevent harm to patients. The policy indicated the following: - For suicide risk assessment guidance, refer to the policy, Suicide Risk Assessment and Management (POC 22). - The Patient Observer would document patient safety observations every 30 minutes on the Frequent/Continuous Observation Monitoring tool. - The Registered Nurse would provide support to the observer, including patient’s diagnosis, reason for observation, frequency of observation, and patient care needs. Completes the Continuous/Frequent Observation Handoff Checklist which included a section to remove any unnecessary medical equipment such as IV pole. In collaboration with the Nurse Manager/Supervisor, assess and reassessment at least every four hours and use clinical judgement on safety observation levels and report findings and changes to the provider. - The Nurse Manager would evaluate and approve all requests for patient observation (refer to the Safety Observer Request Form). Re-evaluates patients requiring observation monitoring every 4 hours to assess the continued need for observation. There was no documentation at the time of Survey to support the policy titled, Suicide Risk Assessment and Management (POC 22), was active and/or available for staff access on 9/3/25 - 9/4/25 (when Patient #1 was in the ED) or at the time or Survey, to reference for further suicide risk assessment guidance. Review of the Hospital’s policy titled, Observation Levels, dated December 2023, indicated the purpose was to define the different levels and types of observation and to specify requirements and interventions associated with each level and type of observation. Frequent checks were used when a patient required visual monitoring for behavioral health needs at prescribed intervals, limited to use in adult and pediatric behavioral health units. Safety watch observation was used to enhance patient safety when a patient, based on assessment, required observation to prevent harm when other alternatives such as remote monitoring are not adequate. This level of observation was indicated for patients at mild to moderate risk for suicide. The Nurse would assess the patient every four hours and document on safety watch flow sheets. The safety observer may watch up to 4 patients at a time with direct observation, and document patient observations in the medical record and/or report to findings to the nurse to document. Further review of the Hospital’s policies and procedures indicated the following: - Emergency Department Nursing Triage (ES 05), dated August 2022, with a next review date in July 2025. - Incident Reports: Sentinel Events (RI 53), dated June 2022, with a next review date in June 2025. - Incident Reports: Communication of Unanticipated Clinical Events (RI 18), dated June 2022, with a next review date in June 2025. - Patient Safety Evaluation System (LD 07), dated March 2023, included the Quality and Safety Plan, dated 1/1/23 to 12/31/24. There was no documentation at the time of the Survey to support the Hospital had reviewed the following policies within the next review date period to ensure accurate and updated procedures were developed and implemented within the Hospital: Emergency Department Nursing Triage (ES 05), Incident Reports: Sentinel Events (RI 53), Incident Reports: Communication of Unanticipated Clinical Events (RI 18), Incident Reports: Communication of Unanticipated Clinical Events (RI 18), and Patient Safety Evaluation System (LD 07). Review of Patient #1’s medical record indicated that on 9/3/25, around 4:32 P.M., Patient #1 presented to the Emergency Department (ED) with suicidal ideation (SI) and intoxication. Nurse #1’s Intake Evaluation indicated Patient #1 was tearful throughout triage and reported a history of two suicide attempts and said, “I’ve tried to kill myself twice and I think the third time will do the charm.” Further review of Patient #1’s medical record indicated on 9/4/25 at 12:08 P.M., an ED tech found Patient #1 on the floor next to the stretcher with a bra wrapped around his/her neck and attached to the stretcher (specifically the IV pole that was in the horizontal position at the head of the stretcher). Patient #1 was found pulseless and apneic, and resuscitation efforts began but Patient #1 was pronounced deceased at 12:26 P.M. Review of the Health Care Facility Reporting System, included a Hospital report, indicating that on 9/4/25, Patient #1 presented to the Hospital around 4:42 P.M., via emergency medical services (EMS) after being found intoxicated on a boat and making suicidal statements. Patient #1 had a physician evaluation, changed into safety clothing and placed under safety observation, and had a blood alcohol level of 257. Patient #1’s curtain and door were left open and Patient #1 remained on 5 minute checks until he/she was found on the floor next to the stretcher with a bra wrapped around his/neck and attached to the stretcher (specifically the IV pole that was in the horizontal position at the head of the stretcher). Patient #1 was found pulseless and apneic, and resuscitation efforts began but Patient #1 was pronounced deceased at 12:26 P.M. During an interview with the ED Nurse Manager on 9/10/25 at 11:30 A.M., she said Hospital policies POC 22 and 69 were from the previous Hospital organization were in place during the incident with Patient #1. She said the current posted policy for the observation and assessment of suicide or risk of self-harm from the current Hospital organization was posted on policy stat sometime around 9/3/25 or 9/4/25; the policy has since been taken down. She said there was no formalized education to staff regarding to the current Hospital’s organization suicide prevention and leadership was currently working on updates to the policy. She said the Hospital has been utilizing prior practices while the suicide prevention policy is being updated; Hospital staff are unsure of which policies are live. During an interview with the Corporate Director of Risk Management on 9/10/25 at 12:40 P.M. she said the current suicide assessment used by clinical staff at the Hospital was POC 22. She said Hospital leadership was using this policy to investigate and implement corrective actions and re-education to the Hospital staff following the incident with Patient #1. During an interview with Registered Nurse #2 on 9/10/25 at 3:03 P.M., he said he thought it was unusual that Patient #1 came into the Hospital with suicidal ideation and not placed on a 1:1 observation. During an interview with the Clinical Educator on 9/10/25 at 3:40 P.M., she said the Hospital suicide prevention policy, POC 22, was from the previous Hospital organization and was retired; staff were no longer using POC 22. She said the education department is responsible for updated orientation training and content; the most current Hospital policy staff were being trained on was the previous Hospital Organization’s suicide policy. She said she was unsure if the current Hospital Organization’s policy was placed on the intranet for staff to access. She said if a new policy is implemented by the Hospital, all staff would be required to complete an attestation or an online learning module on the new policy. She said this has not been completed for the current Hospital Organization’s suicide prevention policy. She said the education to be provided to Hospital staff for the new policy has been completed and ready to initiate once the Hospital leadership has verified the policies are finalized and ready to implement. She said the Hospital has been using other policies from the previous organization, and changes to the current organization’s policies are still ongoing. During an interview with the Interim President/CNO on 9/11/25 at 8:00 A.M., she said the Hospital’s Organization governing board is reported to by the individual hospital community boards. She said the Hospital currently practices the previous organization’s policy, POC 22, for suicide risk/prevention. She said the current observation/safety sitter policy referenced in POC 22 is not currently available to staff in the Hospital’s policy stat/the intranet; this was discovered upon review of Patient #1’s suicide event on 9/4/25. She said staff have access to a the current Hospital Organization’s suicide policy, which is the current policy the hospital is practicing for patient care. She said the current Hospital Organization’s suicide policy is under review and there is a scheduled meeting to cross walk/discuss the suicide policy, along with the observation policy as it referenced the previous Organization’s policy for details. She said Hospital staff do not have access to the previous Organization’s policy. She said the current Hospital Organization’s suicide policy does not reference that it applies to the Hospital, as it does for other policies implemented by the Organization. During an interview with RN#8 on 9/11/25 at 11:15 A.M., she said She said the ED has been following the older policies and procedures, and the ED staff have been unable to access the current policy and procedure for managing patients at risk for suicide. During an interview with RN #9 on 9/11/25 at 11:30 A.M., she said the ED staff have been unable to access the up-to-date Hospital policies and procedures. During an interview with the Interim President/CNO on 9/15/25 at 12:30 P.M., she said the Hospital Organization’s policy titled “Observation Levels” (Policy stat ID 14589625), dated 12/2023, was the active policy at the at the time of Patient #1’s incident on 9/4/25. She said the Hospital staff did not have training regarding this policy and the policy was not updated to the Hospital.”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 41143 Based on record review and interview, the Hospital failed to ensure one Patient (#2) out of a total sample of 17 patients was transferred to an outside hospital for inpatient psychiatric care in accordance with Hospital policy. Patient #2 was transferred back to the Hospital’s Emergency Department from the receiving hospital, delaying admission to an inpatient psychiatric unit. Findings include: Review of the Hospital policy titled “Evaluation and Care of the Behavioral Health Patient in the Emergency Department (ED), ES 10”, dated February 2023, indicated the following: -Once a patient is medically assessed by an ED provider; a determination as to necessity to apply for involuntary hospitalization of the patient for a 3-day period according to Massachusetts General Law (M.G.L) chapter 123, section 12(a) may be warranted at any point in time during the patient’s ED evaluation. The necessity for an ED physician, nurse practitioner, qualified psychiatric nurse mental health clinical specialist, a licensed psychologist, or a licensed independent social worker to apply for the involuntary hospitalization of the patient for a 3-day period according to M.G.L chapter 123 section 12(a) Is determined on a case-by-case basis. Patient #2 presented to the Hospital’s ED on 6/7/25 with diagnoses of psychosis, paranoia, and suicidal ideation. Review of Patient #2’s medical record indicated the Patient was admitted to Hospital’s ED for observation on 6/7/25 and had a crisis/psychiatric consult ordered. On 6/7/25 at 10:10 P.M., the crisis team social worker evaluated Patient #2 and recommended the Patient required inpatient psychiatric admission. A bed search was initiated for Patient #2. On 6/9/25, Patient #2 was accepted for inpatient admission at an outside hospital. On 6/9/25 at 11:30 P.M., Patient #2 was discharged to the outside hospital via Emergency Medical Services (EMS). On 6/10/25 at 12:38 A.M., Patient #2 arrived back at the Hospital’s ED as the receiving hospital sent the Patient back due to the Patient not having a section 12a form/application on arrival at the outside hospital. Patient #2 was admitted to Hospital ED observation and was transferred back to the outside Hospital later on 6/10/25. Further review of Patient #2’s medical record failed to indicate a section 12a form/application was ever filled out for Patient #2 prior to his/her transfer from the ED on 6/9/25. During an interview with Risk Manager #2 on 9/10/25 at 1:00 P.M., she said the Hospital should have section 12a forms available in patient records. She acknowledged Patient #2 did not have a section 12a form/application for his/her transfer on 6/9/25 available in his/her medical record. During an interview with Registered Nurse # on 9/10/25 at 4:40 P.M. she said Patient #2 was transferred to the outside hospital without a section 12a form. She said the outside hospital sent Patient #2 back and called the Hospital ED to inform the staff because the Patient had arrived at the outside hospital without a section 12a application. She said the typical practice for transferring a patient to another hospital for inpatient psychiatric admission is to send a packet with the Hospital’s ED summary, physician notes, any diagnostic/laboratory results, authorization to transfer forms, and the section 12a application/form.”