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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 The patient has the right to receive care in a safe setting. Based on interviews and document review the facility failed to ensure patients in the facility, who were at risk for harm to self were consistently observed in a safe environment. Specifically the facility failed to ensure patient belongings were safeguarded from patients on mental health holds in order to ensure patients did not access items which could be used for harm to self or others and did not maintain continuous monitoring of patients who were on high risk mental health holds.

Based on interviews and document review the facility failed to ensure patients who were at risk for harm to self or others were consistently observed in a safe environment. Specifically, the facility failed to ensure patient belongings were safeguarded from patients on mental health holds in order to ensure patients did not have access to items which could be used for harm to self or others and did not maintain continuous monitoring of patients who were on mental health holds.

Findings Include:

Facility Policies:

The Suicide Precautions Policy read, all patients over the age of ten must be assessed for risk of suicide. The assessment was to be completed in the emergency department (ED), perioperative area and all inpatient units, to include any change in a patient's behavior which would lead staff to believe the patient was at risk of self-harm. The policy further stated safety precautions were the responsibility of all staff, in an effort to provide a safe environment of care for all patients, at all times. This included but was not limited to searching the patient's room for harmful objects (some examples include: scissors, razors, lighters, belts, scarves, pocket knives etc., if found should be taken by security), removing all items to be sent home or labeled and secured safely apart from the patient. The patient was expected to remove personal clothing to be placed in a patient safe green hospital gown without ties. The patient room will be checked again at the beginning of each shift or when an increase in observation was needed due to patient behavioral change. These safety precautions should be documented in the patient record at intervals requested by the order.

The Safety Attendant and Protective Observation policy read, patients under the care of a one to one, personal safety attendant (PSA) or through a virtual safety attendant (VSA) via video monitoring, patient safety should always come first. The patient at risk for harm must always remain under observation. A VSA observing a patient on the video monitor must use the facility escalation plan to alert a Registered Nurse (RN) or other nursing staff to immediately respond to the room of a patient at risk of harm through the safety alert notification plan. A patient under the care of a PSA for a high risk mental health hold was to be continually visualized by the PSA regardless of whether the patient had family or visitors in the room. The PSA or VSA must document observations every 15 minutes or per order, and minimize any distractions for example use of a personal phone, reading/studying or watching television while working as a PSA or VSA.

The Allied Universal Security Services Violent/Combative Patient Guidelines for Security Officers procedure read, security will be notified when a behavioral health patient was in the ED. Security will verify the patient had been processed and all personal clothing and personal effects were removed. Security will inspect the room and remove anything the patient can use as a weapon to harm the patient or others. Once security monitoring had begun, it would not stop until the patient was released, transferred or security was informed by clinical staff the monitoring had been discontinued. Security must maintain monitoring at all times, unless relieved by another security officer or clinical staff member.

1. The facility failed to ensure patient rooms and personal belongings had been searched for patients in the ED on a mental health holds and were continually visually monitored to maintain patient safety.

a. On 11/18/2020 at 1:14 p.m., an interview with RN #4 was conducted. RN #4 stated when a mental health hold was initiated the RN would immediately notify security and the RN would stay with the patient until the VSA had started monitoring the patient or the PSA, if ordered, had arrived. He stated the patient would not be left alone with their belongings. RN #4 stated the security team would ensure the patient changed out of their clothing and into the patient safe green gown. RN #4 stated the clothing and belongings would then be searched for items which the patient could use for self-harm and these items would be removed from the patient room for patient and staff safety.

b. Review of Patient #2 medical record, who was admitted for an overdose of narcotics, revealed Physician #2 at 4:36 p.m., placed the patient on a mental health hold which required both a PSA and VSA. The record showed the VSA started monitoring the patient at 4:44 p.m. The RN notes showed the RN noticed blood on the patient's clothing at 5:00 p.m. When the RN asked Patient #2 what had happened, the patient stated she had self-harmed with a razor from her belongings. The wound repair required sutures. The RN had paged security to secure Patient #2's belongings, however a search of the patient room and belongings had not occurred, belongings had not been secured and the patient was still in her own clothing. Suicide Precautions policy read the patient with suicidal ideation required a personal, room and belonging search, and belongings would be removed from the patient.

i. On 11/18/20 at 5:12 p.m., an interview was conducted with RN #8. RN #8 stated Patient #2, who had scored as high risk on the physician's assessment, was monitored on video by a VSA. He stated security had been paged to secure the patient's belongings, however the patient was left alone with only video monitoring. A PSA had not yet arrived. RN #8 stated when he returned to the room he saw blood on Patient #2 and the patient told RN #8 she had self-harmed with the razor. RN #8 stated the ED staff and security as a team did not follow facility process for Patient #2.

ii. On 11/18/20 at 4:05 p.m., an interview was conducted with Supervisor #7. Supervisor #7 stated all patients were screened for suicide risk. She stated the assessment scored the patients with a low, medium or high risk, and interventions were then initiated to meet the level of risk. Supervisor #7 stated when a patient was changed to high risk, security was primarily responsible to get the patient into a patient safe green gown, secure the patient belongings, inventory them and search for any potential objects of harm. Supervisor #7 stated an RN accompanied by another RN could perform a search of the patient's belongings, remove the patient's clothing and place them in a patient safe green gown if security were unavailable. Supervisor #7 stated security would still need to be involved to inventory and securely lock up the patient's belongings. Supervisor #7 stated she was aware Patient #2 injured herself with a razor from her belongings. Supervisor #7 stated the situation brought to light disconnects in their process, security and nursing had not searched the patient, her belongings, placed her in a patient safe green gown and the VSA did not notify the RN of patient activity when Patient #2 was able to cut herself with the razor.

iii. On 11/18/20 at 2:19 p.m., an interview was conducted with Director of Hospital Security (Director #5). Director #5 stated security officers in the ED who were assigned the role of VSA were expected to remain at the monitors at all times. He stated the security officer assigned as the "roving" security officer would be responsible to conduct patient and belonging searches and place the patient in a patient safe green gown. Director #5 stated the roving security officer was responsible to search and gown the patient if they were available, however if security was not available the clinical staff was responsible to complete these actions. Director #5 stated a patient who scored as high risk for their mental health hold would need a PSA, the VSA would then become a second set of eyes to monitor the patient. Director #5 stated the security team was a support role for the clinical team, and he stated if security was not available the clinical team was responsible to keep the patient safe by gowning, searching and securing patient belongings away from the patient. Director #5 stated patients who scored as high risk on mental health holds were all placed in a patient safety green gown, and either clinical staff or security officers could get a patient into a patient safe green gown.

Director #5 stated was informed Patient #2 harmed herself in the ED. He stated the roving security officer was engaged elsewhere and unable to respond to the RN's request for security to search Patient #2. When asked who was ultimately responsible for patient safety, Director #5 stated clinical staff were in care of the patient, security supports the care. However the Allied Universal Security Services Violent/Combative Patient Guidelines for Security Officers procedure read after security was notified of a mental health hold patient in the ED, security would verify the patient personal clothing and effects had been processed and removed.

iv. On 11/18/20 at 10:02 a.m., an interview was conducted with Physician #2. Physician #2 stated the ED physician placed any patient admitted with suicidal, homicidal or psychotic tendencies on a mental health hold. Physician #2 stated once the patient was placed on a mental health hold and assessed at high risk the patient was immediately put on video with a VSA, placed in a green gown, and a PSA was established. She stated security would secure and search the patient's clothing and belongings. Physician #2 stated the purpose of the high risk score assessment and mental health hold was specifically to keep patients and staff safe.


Physician #2 stated she was the physician for Patient #2 when the patient self-harmed in the ED. Physician #2 stated she assessed Patient #2 at high risk and placed Patient #2 on a mental health hold when she had received collateral information from Patient #2's family regarding the overdose of narcotics. She stated she informed the patient's clinical staff of the need for a mental health hold at 4:36 p.m. Physician #2 stated in the time between the initiation of the mental health hold order and 5:00 p.m. when the patient's self-inflicted injury was observed by staff, the patient was left alone with her belongings and had remained in her own clothing. Physician #2 stated Patient #2 was moved to the higher acuity area of the ED after the event, belongings were searched and she was placed in a patient safe green gown. Physician #2 was unaware of any follow up on the event.

c. Review of facility documents revealed Patient #6 was in the ED on 10/2/20. Patient #6 was on a mental health hold and scored as high risk for suicidal ideation she had a PSA. The document revealed Patient #6 walked to the bathroom and the PSA did not immediately follow the patient. The patient's nurse observed the delay and went to check on the patient approximately 1 minute later. The patient's nurse found Patient #6 on the bathroom floor with a pulse oximetry (POX) cord held around her neck. The nurse immediately removed the cord from around the patient's neck, assessed the patient and returned Patient #6 to her room. No injury or ligature marks were noted on the patient. The charge RN, Physician and ED supervisor were informed.

i. On 11/19/20 at 11:15 a.m., an interview was conducted with RN #9. RN #9 stated green gowns signified to staff the patient had been assessed as high risk and was on a mental health hold. She stated the purpose of the gown was to ensure the patient was not able to hide harmful objects. RN #9 stated when she arrived for her shift Patient #6 was in the higher acuity area of the ED and was still in her personal clothing. She stated this was not normal, as the patient was supposed to be in the patient safe green gown. RN #9 stated after she had removed the cord from Patient #6's neck, she and the PSA changed the patient into the patient safe green gown and removed her belongings.

RN #9 stated she did not know how Patient #6 acquired the POX cord. RN #9 stated the patient rooms in the higher acuity area of the ED were already free of harmful objects, however staff needed to check the rooms prior to patients entering the rooms. RN #9 stated Patient #6 was sleeping upon her arrival to her shift, and she observed the patient but did not uncover Patient #6 to search her at the time. This was in contrast to facility policy, which stated a patient was to be searched at the beginning of each shift. RN #9 stated she had had conversations with Supervisor #7 about the event, but she had not noted any changes to procedure or staff education after the event.

d. Review of facility documents revealed Patient #5 was in the ED on 10/29/20. Patient #5 was on a mental health hold, assessed as high risk and had a PSA. The document revealed RN #9 assumed care of Patient #5 at 5:00 p.m.. At 5:45 p.m. the RN discovered Patient #5 was in her personal clothing and her belongings had not been secured. When RN# 9 inquired why Patient #5 had not been gowned and her belongings were not secured, the security officer replied the information had not been passed to them during the change of shift report.

i. On 11/19/20 at 11:15 a.m., an interview was conducted with RN #9. RN #9 stated Patient #5 had returned to the ED from the high acuity area of the ED in her personal clothes and with her belongings because she needed to be medically stabilized. RN #9 stated the patient was on a mental health hold and assessed as high risk, which required her to be placed in the patient safe green gown, and required her belongings to be secured and searched. RN#9 stated removing patient clothing decreased the risk of harm to patients and staff.

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

A-0286 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. The hospital must measure, analyze, and track adverse patient events. Program Activities. 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. 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: That clear expectations for safety are established. Based on document or record review and interviews, the facility's quality department failed to analyze reported patient occurrences in order to identify contributing factors and implement preventative actions in three of six patients admitted to the Emergency Department (ED) or Progressive Care Unit (PCU), either on a high risk mental health hold or placed on a high risk mental health hold while in the ED (Patient #2, Patient #5 and Patient #6).

Based on documents, record review and interviews, the facility's quality department failed to analyze reported patient safety events in order to identify contributing factors and implement preventative actions in three of ten patient safety events reviewed for patients on a mental health hold. (Patient #2, Patient #5 and Patient #6)

Findings Include:

Facility Policy:

The Facility Event and Close Call Reporting policy read, the policy was intended to minimize risks to patients, non-patients, visitors and staff by implementing a close call reporting system based upon the affirmative duty of all health care providers and all agents and employees of the licensed healthcare facility to report occurrences and close calls to the risk manager, patient safety director, or to his or her designee.

The data was supplied by all employees and referred to managers after being entered. Facility managers were given 15 business days to review, document and provide actions. The managers were given 60 calendar days for the investigation to be finalized and provided to the risk manager. The risk manager was given 60 calendar days to finalize their review of actions and disposition. The risk manager was to ensure the Federal, State and local requirements for event and close call reporting, review and response was met.

The policy defined an event as a discrete, auditable and clearly defined occurrence. An adverse event was described as any deviation from standard medical care causing risk of harm or actual injury to the patient resulting in an undesirable outcome to the patient. Close calls were listed as any events or situations which may result in an adverse event. Harm was considered to be any disruption in structure or function of the person's body requiring intervention, including disease, injury or disability, up to and including death. Occurrence, event or incident were considered interchangeable.

The responsibility of reporting would fall to any staff member who was aware of an occurrence, without fear of disciplinary action. The policy stated the facility culture would encourage the use of the reporting system with ease of access, leadership support and shared learning to improve quality of patient care.

1. The facility failed to investigate patient safety events reported to the quality department for patients on a mental health hold in order to identify causes and contributing factors to prevent reoccurrence. Specifically, the quality department failed to investigate and analyze events involving patient self-harm, suicide attempts and lapses in monitoring for patients who required suicide precautions.

a. Patient #2's medical record was reviewed. The record revealed Patient #2 was admitted on 10/23/20 for an overdose of narcotic pain medication and was on a mental health hold. The record revealed the patient had a history of multiple self-inflicted wounds to her left forearm and was able to use a razor from her belongings to cut herself which resulted in the need for additional medical services while in the Emergency Department (ED). A personal safety attendant (PSA) or one to one sitter was not present, she had only a virtual safety attendant (VSA) watching her on video.

b. Review of facility documents revealed a report of the event in which Patient #2 injured herself with a razor was sent to the ED director and was reviewed within the policy timeline. The patient safety event filed for the incident revealed Security had been paged up to three times to search the patient and had not responded to the pages. An initial meeting was held with the ED director (Director #11), Security director (Director #5), Chief Nursing Officer, Assistant Chief Nursing Officer, and the Chief Operating Officer within four days of the occurrence. No further information was provided regarding the investigation of the event or actions taken to prevent reoccurrence.

i. On 11/18/20 at 5:12 p.m., RN #8 was interviewed. RN#8, who was in care of the patient stated security had been paged to secure the patients belongings and place her in a patient safe green gown and had not responded. Patient #2 admitted to cutting herself when staff returned to the room, Patient #2 surrendered the weapon to staff. In regards to the investigation of the patient safety event with Patient #2, RN #8 stated security had not followed the process, he had discussions with the Nurse Supervisor (Supervisor #7) and some reminders were put into pre-shift huddles to double check procedures. RN #8 was not aware of any changes made to prevent these safety events in the future.

ii. On 11/18/20 at 4:05 p.m. Nursing Supervisor (Supervisor) #7 was interviewed. Supervisor #7 stated she met with Director #11 and Director #5 to follow up on the event in which Patient #2 harmed herself with a razor in her belongings. Supervisor #7 stated the VSA monitoring Patient #2, had not notified the RN of Patient #2's actions. Supervisor #7 stated they discussed ways to increase communications between ED and Security staff for patient safety. Supervisor #7 stated she had informed staff through pre-shift huddles of communication changes with the security department. No documentation was provided of the information in the pre-shift huddles. Supervisor #7 stated the patient safety event with Patient #2 brought to light the disconnects in their process. Supervisor #7 did not mention any follow up with the quality department.

iii. In an interview with Director #11 on 11/19/20 at 1:35 p.m., Director #11 stated all reported events were reviewed daily and investigations were handled by Supervisor #7 and himself. He stated the ED staff educator and the Quality and Safety department were also involved. Director #11 stated medical records for patients involved in reported safety events were reviewed within 24 hours, however he stated no formal timeframe existed to complete investigations. Director #11 stated the follow up for the event involving Patient #2 had taken longer than usual and had not yet been entered into the computer to be reviewed by the quality department. Director #11 stated he and Supervisor #7 were unable to attend either of the two most recent Safety meetings to report on their investigational findings from Patient #2's event. These meeting were overseen by the Director of Patient Safety and Risk Management (Director #12) who followed up on the occurrences. Director #11 stated investigation of safety events was important in order to fix problems in facility processes.

c. Review of facility documents revealed Patient #6 who was admitted on 10/2/20 and was on a mental health hold in the high acuity area of the ED. The document revealed Patient #6 remained in her personal clothing with her belongings with her. The patient was found by the RN with a pulse oximetry (POX) cord held around her neck.

The event report revealed the investigation was pending. A note entered by Director #12 had requested further information regarding the follow up. No further information was filed regarding the event involving Patient #6.

i. On 11/19/20 at 11:15 a.m. an interview was conducted with RN #9. RN #9 stated Patient #6 was sleeping when she first arrived for her shift. RN #9 did not uncover and search Patient #6 as required by facility policy. Patient #6 later got up to use the restroom and was found by RN #9 with the POX cord around her neck. RN #9 stated POX cords were not kept in the high acuity area of the ED and she did not know how the patient had the cord. RN #9 stated she had a meeting with the ED charge RN and Supervisor #7 to review and discuss the event. RN #9 stated to her awareness no other follow-up or changes had occurred after the event involving Patient #6.

ii. On 11/19/20 at 1:35 p.m. an interview was conducted with Director #11. Director #11 stated after the event involving Patient #6, RN #9 and the other RN who cared for the patient were provided with re-education regarding process in the high acuity area of the ED. Supervisor #7 provided information in a pre-shift huddle to other staff members, however she stated there was no formal education provided to staff on procedures in the high acuity area of the ED. No further information was provided to show follow-up with the quality department.

d. Review of facility documents revealed Patient #5 admitted on 10/29/20 was on a mental health hold in the ED. The document revealed Patient #5 was not placed on VSA for video monitoring, her belongings were not searched, and she was not placed in a patient safe green gown. The security officer informed the RN they were unaware Patient #5 required a VSA, belongings search or green gown.

The event report revealed the ED educator followed up and performed coaching with all parties involved in the event. No further information was provided on the follow-up for the event with the quality department.

e. Staff interviews revealed staff changes or actions were not taken to prevent reoccurrence of patient safety issues which were reported to facility leadership.

i. On 11/18/20 at 10:58 a.m., an interview was conducted with ED Charge Nurse (CN) #3. CN #3 stated environmental checks or room searches were important to keep patients and staff safe. CN #3 stated security was responsible to inventory and secure all patient belongings. CN #3 stated the security delays were a patient safety issue. CN #3 stated he had filed patient safety event reports and discussed his concerns with ED leadership. CN #3 stated he had not received feedback or observed changes in response to the event reports he had filed.

ii. On 11/18/20 at 1:14 p.m. an interview was conducted with Registered Nurse (RN) #4. RN#4 stated the delayed security response had made him feel unsafe and he felt security staffing was inadequate. RN #4 stated staff had expressed concerns to leadership. In regards to the event involving Patient #2, RN #4 stated he had not been part of any debriefing after the event.

f. Interviews with facility leadership revealed the patient safety events involving Patients #2, #5 and #6 were not investigated according to facility policy, nor were preventive actions implemented to prevent re-occurrence of similar events.

i. An interview was conducted on 11/19/20 at 2:23 p.m., with the Director of Patient Safety and Risk Management (Director #12). Director #12 stated reported patient safety events were reviewed daily. She stated the reports were then sent to unit directors, who were responsible for investigations and follow-up actions. Director #12 stated unit directors reported the results of investigations back to her, and she would assist with implementing changes, send the report back to the unit director requesting more information, give guidance or close the report if she determined the investigation was complete.. Director #12 stated information from patient safety events were shared in daily huddles. Director #12 stated when trends were identified it assists with quality improvement projects.

Director #12 stated she had requested information regarding the event involving Patient #2, in which the patient was able to harm herself with a razor. She stated she had not received the requested information from the unit manager. Director #12 stated she had no knowledge of any investigation of the event or changes implemented as a result of the event, as she had not received the additional information requested.

Director #12 stated she remembered the event involving Patient #6, in which the patient was found in the bathroom with a cord wrapped around her neck. Director #12 stated she had not received any follow-up investigation from the unit director, and she was not aware of any investigation or preventive actions initiated as a result of the event.

Director #12 stated the unit directors were responsible to investigate patient safety events which occurred on their units, however she stated she was ultimately responsible to ensure investigations occurred and necessary preventive actions were implemented.

ii. On 11/19/20 at 4:18 p.m., an interview was conducted with the Vice President of Quality (VP) #6. VP #6 stated the unit directors were responsible to investigate and implement corrective action for reported patient safety events. She stated the quality and safety departments had oversight of the process. VP #6 stated the quality and safety departments supported the unit directors in the process of investigating safety events.

VP #6 stated Director #12 was responsible to close the loop with unit directors to ensure a thorough response had been received after an investigation.. VP#6 stated the reported patient safety events and investigations of the events told the facility's story of what happened and what was done to correct it. VP #6 stated the facility improved on patient care and safety through reported patient safety events.

2. Facility staff failed to report a serious safety event to the quality department according to facility policy.

a. Interviews conducted on 11/18/20 and 11/19/20 revealed an event involving Patient #2 during the patient's admission on 9/30/20 to the Progressive Care Unit (PCU).Two staff who cared for Patient #2 on the PCU stated she had two razor blades in her phone case. There was no documentation of the event in the facility reporting system or in Patient #2's medical record.

b. On 11/18/20 at 7:38 a.m., an interview was conducted with Certified Nursing Assistant (CNA) #1. CNA #1 stated she worked on the PCU as both a CNA and a PSA. CNA #1 stated if patients were on suicide precautions, the patients were allowed to keep their cell phone if the phone had been searched. When asked why a phone would need to be searched, CNA #1 stated she had previously cared for a patient on a mental health hold who had surrendered two razor blades she had hidden in her phone case to staff on the previous shift. CNA #1 stated she was informed of this during the shift change report.

CNA #1 stated she did not file a patient safety event report because the event occurred on a different shift and she assumed the previous shift made a report. CNA #1 stated there were no meetings or follow-up as a result of the event and she was not informed of any changes to procedure regarding patient searches.

b. On 11/19/20 at 12:43 p.m. an interview was conducted with CNA #10. CNA #10 stated she had cared for Patient #2 on previous admissions due to suicide attempts. CNA #10 stated when she cared for Patient #2 on the PCU, the patient surrendered two razors from her phone case.

CNA #10 stated she notified the RN and the charge RN on PCU of the razors being surrendered. CNA #10 stated she did not file a patient safety event report as she had not been trained on how to file a report.. CNA #10 stated the event should have been reported because it would ensure future patients remained safe and other staff could learn from the event. CNA #10 stated she had not received any follow-up regarding the event.

Facility Event and Close Call Reporting policy stated the responsibility of reporting patient safety events was the responsibility of all staff members who were aware of a patient safety event. Reporting of the events was encouraged by leadership to support shared learning and improve processes.

c. On 11/19/20 at 2:23 p.m. Director #12 was interviewed. Director #12 stated she was not aware of an event involving a patient on PCU who had razors in her belongings. She stated there was no event filed to report this event, and therefore no follow-up or investigation had occurred. Director #12 stated due to the safety risk to both patient and staff, facility staff should have reported the event.