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Based on review of hospital policies and procedures, observations, facility documents, medical record reviews and staff and physician interviews, the hospital's governing body failed to provide oversight and have systems in place to ensure the protection and promotion of patient's rights to provide a safe environment in the Emergency Department, failed to have an effective Quality Assessment and Performance Improvement program for analyzing adverse events, implementing improvement actions and monitoring actions for success, and failed to have an effective Infection Control program for oversight of infection prevention and control processes.

The findings included:

1. The hospital failed to promote and protect a patient's rights by failing to provide a safe environment for an Emergency Department patient.

~cross refer to 482.13 Patient Rights' Standard: 0144

2. The hospital staff failed to have an effective Quality Assessment and Performance Improvement program for patient safety.

~cross refer to 482.21 QAPI Standard: 0286

3. The hospital staff failed to provide an effective Infection Control program by failing to provide oversight of infection prevention and control processes.

~cross refer to 482.42 Infection Control Standard: 0750

~cross refer to 482.42 Infection Control Standard: 0792

Based on policy and procedure review, medical record review, and staff and physician interviews, the hospital failed to promote and protect a patient's rights by failing to provide a safe environment to Emergency Department patients.

The findings included:

1. The hospital failed to provide care in a safe environment by failing to communicate, escalate and resolve issues while a patient was in the ED.

~cross refer to 482.13 Patient Rights' Standard: Tag 0144

2. The hospital staff failed to provide the discharge Important Message from Medicare.

~cross refer to 482.13 Patient Rights' Standard: Tag 0117

3. The hospital staff failed to notify a patient's family of the use of a chemical restraint to manage the patient's behaviors.

~cross refer to 482.13 Patient Rights' Standard: Tag 0131

4. The hospital staff failed to obtain a new order for a restraint, failed to assess a patient in restraints, and failed to document discontinuation of a restraint.

~cross refer to 482.13 Patient Rights' Standard: Tag 0167

Based on policy review, medical record review and staff interviews, hospital staff failed to provide the discharge Important Message from Medicare in 2 of 3 Medicare inpatient records reviewed. (Pts #4, #8)

The findings include:

Review of a policy titled "Important Message from Medicare" (IMFM), effective 03/2019, revealed "...The purpose of this policy is to ensure the Important Message from Medicare is provided to all Medicare beneficiaries as required by the final rule made by CMS (Centers for Medicare and Medicaid Services)....Procedure....3. No more than two calendar days prior to discharge - but not less than 4 hours prior to discharge, Care Management prints a copy of the IMFM with the patient's electronic signature and gives the copy to the patient. ..." Policy review did not reveal the documentation to be placed in the medical record.

Medical record review on 06/07-08/2022 revealed Patient #8, an 88 year-old, was admitted to the hospital's Campus B on 03/20/2022 with encephalopathy (damage or disease that affects the brain), a urinary tract infection, and MSSA (Methicillin-susceptible Staphylococcus Aureus) bacteremia (bacteria in the blood). Medical record review revealed on 03/26/2022 Patient #8 was discharged to a long-term care facility. Record review failed to reveal evidence Patient #8, or a patient representative was presented with the Important Message from Medicare prior to discharge from the facility.

Interview with Utilization Manager #41, for both hospital campuses, on 06/09/2022 at 1040, revealed the IMFM discharge process was for the Utilization Management nurse to give the document to the patient or to the appropriate representative/family if the patient was unable to understand. Interview revealed the nurse should sign that the IMFM was given, but in this case, nothing was signed. The Manager stated Campus B leadership had also backtracked with staff and there was no evidence the IMFM was given prior to discharge. Interview revealed policy was not followed.




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2. Review on 06/08/2022 of a closed medical record revealed Patient #4 was an 82-year-old male admitted to the hospital on 02/02/2021 complaining of leg weakness and a fall at home. Medical record review revealed Patient #4 had a history of left-side stroke and impaired mobility. Medical record review revealed on 05/19/2021 Patient #4 discharged to a long-term acute care hospital. Medical record review failed to reveal evidence Patient #4 or a patient representative was presented with the "Important Message from Medicare" prior to discharge from the facility.

Interview on 06/09/2022 at 1040 with the Manager of Utilization Management (over both Campus A and B) revealed the IMFM discharge process was for the Utilization Management nurse to give the document to the patient or to the appropriate representative/family if the patient was unable to understand. Interview revealed the nurse should sign that the IMFM was given. Interview revealed policy was not followed.

Based on review of policy, medical record reviews and staff interview, the facility staff failed to notify a patient's family of the use of Haldol to manage the patient's behaviors in 1 of 2 chemical restraints records reviewed (Patient #3).

The findings include:

Review on 06/07/2022 of the facility policy titled "Restraint and Seclusion Use" effective January 2021 revealed "...A. Definitions 1. Restraint A restraint is:...2) a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment...for the patient's condition...IV. Procedure B. Patient/Family Education When practical, efforts should be made to discuss the issue of restraint...with the patient and the family at the time of its use..."

Review on 06/07/2022 of a closed medical record revealed Patient #3 was a 74-year-old male admitted to the hospital on 06/03/2021 for management of a pericardial effusion (excess fluid in sac around the heart). Medical record review revealed Patient #3 had a history of atrial fibrillation (irregular heartbeat that causes low blood flow), colon adenocarcinoma (colon cancer) and chronic pericardial effusion. Review of a physician's "Medicine Transfer Note" signed by MD #31 on 06/04/2021 at 1709 revealed "...Assessment/Plan...AMS (altered mental status)/Anxiety From patient and wife report, seems to be waxing and waning. Seems to happen more often at night and when wife is not around to orient..."

Review of a progress note signed by Registered Nurse #29 on 06/05/2021 at 0149 revealed "Around 2230, pt woke up and started pulling off his EKG (electrocardiogram) leads, BP (blood pressure) cuff, SPO2 (oxygen saturation), NGT (nasogastric tube) and condom cath. Pt now confused, agitated and impulsive. Provider notified and ordered Haldol (antipsychotic medication). Pt slept for about 20 mins then woke up and kept trying to pull off EKG leads and get out of bed. Provider notified and ordered a larger dose of Haldol. Pt slept for about 45-60 mins, then woke up again agitated and confused and wanted to go outside. Staff remains with pt at bedside and re-orients pt, but pt remains confused and agitated..." Medical record review failed to reveal evidence Patient #3's wife was notified or consented to the use of Haldol to manage Patient #3's behaviors. Medical record review revealed Patient #3 expired 06/07/2021 at 0445.

An interview was requested with Registered Nurse #29 who was not available for interview.

An interview was requested with MD #31 who was not available for interview.

Interview on 06/15/2022 at 1105 with the Nurse Manager of the Cardiac Intensive Care Unit (NM #30) revealed based on review of the medical record, the Haldol was ordered and administered because the patient was removing the medical equipment. Interview revealed the Haldol should have been ordered as a chemical restraint. Interview revealed the expectation would be the nurse or physician notify the patient's family that a restraint was used, per policy.

Based on medical record review, EMS run report review, root-cause analysis, staff meeting review, morbidity and mortality review, internal document review, staff and physician interviews, the hospital staff failed to maintain a safe environment for patients in the Emergency Department (ED) by failing to communicate, escalate and resolve issues while a patient was in the ED for 1 of 2 post-discharge suicides on hospital property (Patient #11).

The findings include:

Review of the medical record revealed Patient #11 was a 29-year-old male who presented to the emergency department (ED) via air ambulance on 04/21/2022 at 1331 following a motor vehicle crash (MVC). Patient #11 was the unrestrained driver who had a frontal collision with a tree at high speed, positive LOC (loss of consciousness), and airbag deployment. Patient #11 had a history of ADHD (attention-deficit/hyperactivity disorder-chronic condition including attention difficulty, hyperactivity, and impulsiveness). Patient #11's chief complaint was back and abdominal pain. Review revealed at 1331 Patient #11 had a GCS (Glasgow coma scale-scoring system used to describe the level of consciousness, 15 is considered normal) of 14 due to confusion. Review revealed at 1333 Patient #11's "Columbia Suicide Severity Rating Scale-Initial" (suicidal and homicidal scale intended to help establish a person's immediate risk of suicide) was "unable to assess." Review of MD (medical doctor) #17 progress note dated 04/21/2022 at 1531 revealed "Received signout from previous resident (named). Briefly, this is a 29 y.o. male who presented as a yellow trauma after MVC versus tree. Patient with no obvious trauma and CT (cat scan) unremarkable. At time of signout CT head is pending. Patient disposition pending trauma recommendations. Patient with concussive symptoms so we will plan for referral to (named) concussion clinic if discharged. 5:18 PM: I spoke with trauma surgery. Patient has been cleared from their perspective. 6:30 PM: I went to reassess patient and he is lucid. He knows his name, date, and place. He remembers that he was in a car accident. He is responding to questions appropriately. He is requesting food and water as he is hungry and thirsty. Given nature of injury and initial confusion, will refer patient to (named) concussion clinic for follow-up. Provided him with concussion precautions. Patient did state to me that he has been hearing voices for the last 2 days but attributes this to his ADHD medication. I asked him if he had any thoughts of harming self, killing himself, or harming anyone else. Patient denies SI (suicidal ideation) or HI (homicidal ideation). Asked him if he has a psychiatrist or therapist and he said that he does not at this time. However, he does have a PCP (primary care provider). instructed him that he should discuss this with his PCP and will likely need psychiatry referral as an outpatient. Patient states that his family lives in (named state) and he has no one to pick him up right now. Will consult case management to assist with a ride ...Strict return precautions reviewed." Review of RN #18's "ED Quick Updates" at 1804 revealed "Spoke with patients' mother and updated situation." Review of the "Columbia Suicide Severity Rating Scale-Initial" at 1818 revealed Patient #11 denied SI or HI. Further review revealed "Behavioral Patient Interventions ...Charge RN Notified; Provider Notified (pt endorsing auditory hallucinations)." Review of RN #18's "ED Quick Updates" at 1818 revealed "Updates: MD (#17) at bedside. Quick Updates-Free Text: Columbia screening completed. Pt (patient) denies HI/SI. Pt endorses auditory hallucinations. (Named-MD #17) at bedside and notified." Review revealed Patient #11's ED disposition was set to discharge at 1827. Review of RN #18's "ED Quick Updates" at 1832 revealed "Contacted Case Management for pt transport to (named town)." Review revealed shift change occurred and RN #18 gave report to RN #20 at 1857. Review of RN #20's note at 1914 revealed "Patient listened to this writer's discharge instructions but refused to take the discharge papers. He also does not want the taxi voucher this writer offered. He said, 'I'll take a taxi to a friend's house.' Patient ambulated independently out of ED." Patient #11 was discharged on 04/21/2022 at 1920.

Review of (Named) County EMS run report dated 04/21/2022 revealed local EMS received a 911 call for a patient fall at 2002 (42 minutes after discharge), dispatched at 2005, and onscene at 2006. Review of the run sheet revealed "Hx (history) gathered from witnesses on scene. Pt fell from skybridge that connects the hospital to the parking deck ...Height of fall estimated to be two stories. Pt fell and immediately attended to by hospital staff that were leaving for the day ...Per ER staff, pt was recently discharged from the ER today. Pt was found wearing hospital bracelet and in a hospital gown ...Arrived to find 29 y/o male, not conscious and not breathing ...CPR being performed by healthcare providers from (named hospital) who witnessed the fall ...Pt expired in ED."

Review of Patient #11's 2nd ED visit on 04/21/2021 revealed he arrived via EMS at 2015 due to "unwitnessed jump off skybridge, CPR in progress ..." Review of MD #17's provider note dated 04/21/2022 at 2020 revealed "This is a 29 y.o male brought in by EMS to the (named) Emergency Department for evaluation of unresponsive after a fall ...Given he is now s/p (status post) at least 25 minutes of compression ...and appears to have a devastating posterior head injury with no neuro (neurological) response, time of death was called at 2034 ...9:24 PM: I was informed that this patient is (Patient #11), the patient that I discharged earlier this evening. He presented earlier today after being involved in an MVC. His work-up was unrevealing. He initially was experiencing some confusion with concern for concussion. On my final evaluation, he was not confused and was responding to all my questions appropriately. Patient did state that he had been hearing voices for 2 days but attributed this to his ADHD medications and said that he had discontinued them. At that time, I specifically asked him if he was feeling suicidal, intended to harm himself, or harm anyone else. He told me that he had no intention to kill himself or to harm himself or others. He informed me that he had no family in the area or friends that can pick him up. I consulted case management who arranged for him to have a taxi voucher home ...Disposition: Expired ..."

Review on 06/08/2022 of the RCA [no date] (root-cause analysis-a process of discovering the root causes of problems in order to identify appropriate solutions) that was provided by the hospital on 06/08/2022 revealed one of the contributing factors was identified as a lack of a standardized process for escalating and communicating family concerns to the provider. Review revealed the HUC (health unit coordinator-secretary) received several phone calls from Patient #11's mother and father during his ED visit. Review revealed Patient #11's mother at one point requested her son not to be discharged and wanted to speak to his primary ED MD (MD #17) because he was on the way to another ED (local to Patient #11) for an emergency mental health evaluation at the time the MVC occurred. Following the conversation, the HUC verbally passed along the mothers' concerns to Patient #11's primary RN (RN #18) however, MD #17 was never made aware of Patient #11's mothers' request to speak to him. Review of the RCA revealed a standardized process for communication was currently being drafted and had a due date of 08/15/2022. An additional contributing factor was identified as lack of obtaining collateral information from Patient #11's family following reports of auditory hallucinations. Review revealed a standardized process would be created to assist providers to know when it was appropriate and how to obtain collateral information by 08/15/2022. Review revealed a standardized process would be developed by 08/15/2022 for ED MDs to consult with the PES (psychiatric emergency services) team for guidance. Development of an escalation pathway to incorporate collateral information and/or staff concerns was in process and to be completed by 08/15/2022. Review also revealed education on escalation and identifying concerns would be incorporated into resident training by 08/15/2022. RCA review revealed no new written process had been developed and implemented as of 06/08/2022.

Review of April and May ED staff meetings revealed re-education on communication was provided but did not reveal a standardized process had been developed. Review revealed less than 75 % of staff had completed the education by 06/08/2022.

Review of a Morbidity and Mortality (M&M) Peer Review dated 05/25/2022 (34 days following Patient #11's event) revealed an ED MD presented on another case that occurred in the ED. Review of the M&M revealed discussion on obtaining collateral information from families was important and should be obtained early in the patient's ED visit.

Interview on 06/08/2022 at 1546 with MD #19 (ED Medical Director) and Administration #16 (Vice President of Risk and Accreditation) revealed Patient #11 was transported to the hospital following an MVC. MD #19 stated Patient #11 was cleared by trauma and set to discharge. MD #19 stated Patient #11's mother reported he was on the way to another ED for a mental health evaluation due to hearing voices when the MVC occurred. MD #19 stated MD #17 was made aware that Patient #11 reported having hallucinations and reassessed Patient #11. Interview revealed after MD #17's reassessment, Patient #11 denied SI or HI therefore he was discharged. Interview revealed MD #17 was never made aware that Patient #11 was on the way to the local ED for a mental health evaluation at the time of the MVC. Interview revealed leadership took immediate action and held a formal debrief with staff involved the following day (4/22/2022). Administration #16 stated the RCA process started 05/13/2022, another meeting on 05/17/2022 and 05/20/2022. MD #19 stated MD #17 was scheduled to present the case at a M&M meeting on 06/15/2022.

Interview on 06/09/2022 at 1015 with RN #20 revealed he discharged Patient #11 on 04/21/2022. RN #20 stated he reviewed discharge instructions with Patient #11 and provided him with a taxi voucher so he could get back home. RN #20 stated Patient #11 refused the discharge instructions and taxi voucher and stated he would get his own taxi. RN #20 stated Patient #11 seemed to be in a hurry to leave which was not uncommon. RN #20 stated he was not aware Patient #11 had endorsed hallucinations earlier in his visit. RN #20 stated during report, he was told Patient #11 was here due to a MVC and just needed to be discharged. RN #20 stated Patient #11 did not display any cognitive impairments and he was alert and oriented to person, place, time, and situation at the time of discharge.

Interview on 06/09/2022 at 1312 with the Clinical Risk Manager (CRM) #26 and Director of Clinical Risk Manager (DCRM) #32 revealed following Patient #11's incident, the only action that had been completed was reeducation regarding communication which was presented in April and May staff meetings. CRM #26 stated she interviewed staff involved following the incident. CRM #26 stated it was revealed during her interview with MD #17, he was never made aware Patient #11's parents had called and requested to speak to him. Interview revealed it was discovered following staff interviews, additional calls from the mother did not get relayed to RN #18 or MD #17.

Interview on 06/09/2022 at 1346 with MD #17 revealed he was Patient #11's primary resident on 04/21/2022 during his first visit. MD #17 stated he was made aware Patient #11 had endorsed auditory hallucinations, so he reassessed him. MD #17 stated Patient #11 stated he had been having "some hallucinations I think the last two days" due to his ADHD medications. MD #17 stated Patient #11 stated he stopped taking his ADHD medications a few days prior. MD #17 stated he asked Patient #11 if he had thoughts of harming or killing himself or others and Patient #11 denied. MD #17 stated that was the extent of the conversation, he did not "pry" about what the hallucinations were saying to Patient #11. Interview revealed Patient #11's report of auditory hallucinations did not warrant a psychiatric consult with the PES team because he did not appear "disheveled on exam, didn't have a flat affect, wasn't responding to internal triggers, and denied SI/HI." MD #17 stated the message was never relayed to him that the family called with concerns for his mental health, he was just made aware of the auditory hallucinations. MD #17 stated if he had been notified of the family's request to speak with him, he would have called them. MD #17 stated when Patient #11 arrived into the ED as a trauma patient, he was registered in the computer system as a "generic" patient so treatment could be initiated. MD #17 stated due to his "generic" patient name, "care everywhere" (allows medications, allergies, immunizations records from other health systems to be presented to the providers automatically in the chart) was not available and did not reveal if he had a mental history. MD #17 stated he notified MD #33 who was the attending provider. MD #33 verified Patient #11 had been reassessed for SI/HI. MD #17 reported he reassessed Patient #11 for SI/HI and he denied. MD #33 advised Patient #11 was stable for discharge. MD #17 stated he was scheduled to present Patient #11's case at a M&M meeting on 06/15/2022. MD #17 stated there had been discussions regarding implementing a new process, but a process had not yet been developed or implemented prior to 06/09/2022.

Interview on 06/09/2022 at 1805 with RN #18 revealed he was Patient #11's primary RN during the first visit on 04/21/2022. RN #18 stated he was made aware the mother had called and had concerns about Patient #11's mental health. RN #18 stated he did not call Patient #11's mother back until Patient #11 was ready for discharge in attempts to arrange transportation. RN #18 stated that was when his mother made RN #18 aware of Patient #11's auditory hallucinations and he was on the way to the local ED for a mental health evaluation when the MVC occurred. RN #18 stated he did not recall if HUC #24 notified him of Patient #11's mother requesting a return phone call and her concerns. RN #18 stated the HUC would notify the primary RN of family request/concerns verbally, or by overhead page, or a sticky note in the computer (area where a message can be left) or write the message on a posted note and put at the nurse's computer. RN #18 stated himself and MD #17 reassessed Patient #11 for SI/HI and he denied. RN #18 stated they had a "very casual conversation", and nothing was alarming about the conversation.

Interview on 06/10/2022 at 0922 with RN #21 revealed she was the charge nurse on duty during Patient #11's first ED visit on 04/21/2022. RN #21 stated she spoke with Patient #11's mother at one point she the mother expressed to her Patient #11 was on his way to a local ED for "depression" and wanted to speak with him (Patient #11). RN #21 stated she told the mother she would make RN #18 aware. RN #21 stated she approached RN #18 and RN #23 (RN #18s preceptor) and verbally advised them of the mothers' concerns. RN #21 stated RN #18 stated he had already spoke with Patient #11's mother and was aware. RN #21 stated the HUC had notified her the mother had called multiple times so RN #21 spoke with her to try and resolve her concerns. RN #21 stated she was unaware if MD #17 was ever made aware of the mothers' concerns and request to speak to him.

Interview on 06/10/2022 at 0952 with HUC #22 revealed she received a call from Patient #11's mother stating she needed to talk with someone involved in his care and he was on the way to a local ED for a "mental health crisis" prior to the wreck. HUC #22 stated she placed the message in a "sticky note" in the computer system for RN #18 to see. HUC #22 stated Patient #11's mother called back and HUC #22 "vocera" (instant, wireless voice communication delivered through a wearable vocera badge) RN #18 and delivered the message that the mother requested a phone call. HUC #22 stated she did not "go in details" over the vocera because RN #18 was with another patient. HUC #22 stated she did not recall if Patient #11's mother requested to speak to MD #17. HUC #22 stated there had been a change in their process of notifying team members of family notifications.

Interview on 06/10/2022 at 1530 with RN #23 revealed she was RN #18's preceptor on 04/21/2022 and she did not speak to Patient #11's mother. RN #23 stated she "observed" MD #17 stated to RN #18 that Patient #11 was ready for discharge, so RN #18 called Patient #11's mother to arrange transport following discharge. RN #23 stated she was unaware of any further conversations between RN #18 and the mother. RN #23 stated RN #18 was on his last day of orientation and was working independently.

Interview on 06/13/2022 at 1002 with HUC #24 revealed she also received calls from Patient #11's mother on 04/21/2022. HUC #24 stated one phone call from Patient #11's mother, she requested to speak with the primary nurse or physician because she didn't want him discharged due to him seeking a "psych exam" at the local ED when he was involved in the MVC. HUC #24 stated she "overhead paged" RN #18 twice and he never took the phone call. HUC #24 stated she then placed a sticky note in the computer with the message as well as physically wrote the message on a posted note and delivered it to RN #18. HUC #24 stated she was unaware if MD #17 was ever made aware of the mothers' concerns. HUC #24 stated the charge nurse, RN #21, also spoke with the mother but she did not know the details of the conversation.

Interview on 06/15/2022 at 1114 with the Chair of Emergency Medicine (MD #42) revealed the PES (psychiatric emergency services) team were employed by the hospital and staffed in the ED. The PES team is composed of Psychiatrist, Licensed Clinical Social Workers, and Advanced Practice Providers. Interview revealed the PES team will see any patient that is endorsing SI/HI. MD #42 explained a PES consult would not be warranted for auditory hallucinations alone, as "many people walk around with hallucinations every day" and they could be addressed in an outpatient setting.

Interview requested for MD #33 (MD #17s attending) revealed he was unavailable.

Based on facility policy, medical record review and staff interview, the facility staff failed to obtain a new order for a restraint, failed to assess a patient in restraints, and failed to document discontinuation of a restraint for 1 of 1 violent restraint record reviewed (Patient #26).

The findings include:

Review of the facility policy titled "Restraint and Seclusion Use" effective 09/2021 revealed "...D. Practice...Any time you add or reduce any restraint, you must obtain a new order...If the nurse decides not to reapply the restraint for a particular limb after care provision, while maintaining the other restraints, a new order must be obtained reflecting the reduction in restraints...2. Restraints for Patients with Violent Behavior o. The restrained patient will be monitored by a Qualified Staff Member for at least the following six parameters of care at intervals not to exceed two hours and the results will be documented on the Violent Restraint flow sheet in the patient's medical record: response to restraint (e.g., level of distress and agitation, mental status, cognitive functioning); circulation and skin integrity; need for nutrition and fluids; toileting; repositioning; and range of motion exercises to restrained extremities...E. Documentation The RN will document...5. the time of restraint discontinuation, including observations leading to this intervention, the patient's response to discontinuation..."

Review on 06/09/2022 of a closed medical record revealed Patient #26 was a 35-year-old female that presented to the hospital's emergency department on 04/22/2022 at 0102 with a complaint of left knee pain. Medical record review revealed Patient #26 had a history of Schizophrenia (mental health disorder causes abnormal interpretation of reality). Medical record review revealed during triage Patient #26 endorsed passive suicide ideation (thoughts of suicide). Medical record review revealed on 04/22/2022 at 1030, the facility staff placed Patient #26's left and right wrists and left and right ankles in "4 Point Synthetic/Velcro Restraints." Medical record review revealed at 1046 an emergency room physician ordered 4-point violent restraints continuous times four hours due to Patient #26's imminent risk of harm to self or others.

Medical record review revealed at 1127 Registered Nurse #28 released Patient #26's right wrist and left ankle from the restraints. Medical record review failed to reveal evidence of a new order for the limbs (left wrist and right ankle) remaining in restraints.

Medical record review failed to reveal evidence of nursing assessment of response to restraint; circulation and skin integrity; need for nutrition and fluids; toileting; repositioning; and range of motion exercises to the restrained extremities every two hours per facility policy.

Review of the medical record failed to reveal documentation of the time Patient #26's left wrist and right ankle were released from the restraints. Medical record review revealed on 04/23/2022 at 2104, Patient #26 discharged to home.

An interview was requested with Registered Nurse #28 who was unavailable for interview.

An interview was requested on 06/15/2022 at 0900 with the emergency department Nurse Manager who was unavailable for interview.

Interview with the Associate Director of Inpatient Psychiatry Services on 06/15/2022 at 1145 revealed based on the hospital's policy, he would expect to see a nurse's assessment documented every two hours while the patient was in restraints. Interview revealed based on hospital policy, the nurse should have obtained a new restraint order for 2-point restraints at the time the patient's right wrist and left ankle were released from the restraints. Interview revealed the nurse was expected to document the time restraint was discontinued and the patient's condition on the restraint flow sheet. Interview revealed the restraint policy was not followed.

Based on reviews of policies and procedures, medical records, root cause analyses, other hospital documents and staff and physician interviews the hospital failed to maintain an effective on-going Quality Assessment and Performance Improvement program for patient safety.

The findings include:

The hospital failed to provide timely Root Cause Analyses (RCAs) which included implementation of actions and follow-up monitoring for 2 of 3 RCAs reviewed (Pts #11, 12)

~cross refer to 482.21 QAPI Standard: Tag 0286

Based on policy and procedure review, medical record reviews, root cause analysis review and staff interviews hospital staff failed to implement and monitor measures identified from adverse events for two of three root cause analyses reviewed (#11, 12)

The findings included:

Review of the "Sentinel Events" policy, effective 01/2022, revealed " ...(Hospital Name) is committed to designing processes that protect patients and staff from systems failures and human error ....3. A sentinel event is also one of the following ....Suicide of any individual receiving care, treatment or services in a staffed around-the-clock care setting or within 72 hours of discharge ....Any elopement of a patient from a staffed around-the-clock care setting (including the ED) leading to death, permanent harm, or severe temporary harm ...,A root cause analysis will be completed and follow-up action plans will be developed within 45 days of the occurrence. ..." Review did not reveal the policy specified timing of action plan implementation.

1. Review of the medical record revealed Patient #11 was a 29-year-old male who presented to the emergency department (ED) via air ambulance on 04/21/2022 at 1331 following a motor vehicle crash (MVC). Patient #11 was the unrestrained driver who had a frontal collision with a tree at high speed, positive LOC (loss of consciousness), and airbag deployment. Patient #11 had a history of ADHD (attention-deficit/hyperactivity disorder-chronic condition including attention difficulty, hyperactivity, and impulsiveness). Review revealed at 1331 Patient #11 had a GCS (Glasgow coma scale-scoring system used to describe the level of consciousness, 15 is considered normal) of 14 due to confusion. ....5:18 PM: I spoke with trauma surgery. Patient has been cleared from their perspective. 6:30 PM: I went to reassess patient and he is lucid. He knows his name, date, and place. He remembers that he was in a car accident. He is responding to questions appropriately ...Patient did state to me that he has been hearing voices for the last 2 days but attributes this to his ADHD medication. I asked him if he had any thoughts of harming self, killing himself, or harming anyone else. Patient denies SI (suicidal ideation) or HI (homicidal ideation). Asked him if he has a psychiatrist or therapist and he said that he does not at this time. However, he does have a PCP (primary care provider). instructed him that he should discuss this with his PCP and will likely need psychiatry referral as an outpatient. Patient states that his family lives in (named state) and he has no one to pick him up right now. Will consult case management to assist with a ride ...Strict return precautions reviewed." Review of the "Columbia Suicide Severity Rating Scale-Initial" at 1818 revealed Patient #11 denied SI or HI however "Behavioral Patient Interventions Patient Interventions: Charge RN Notified; Provider Notified (pt endorsing auditory hallucinations)." Review of RN #18's "ED Quick Updates" at 1818 revealed "Updates: MD (#17) at bedside. Quick Updates-Free Text: Columbia screening completed. Pt (patient) denies HI/SI. Pt endorses auditory hallucinations. (Named-MD #17) at bedside and notified." Review revealed Patient #11's ED disposition was set to discharge at 1827. Review revealed shift change occurred and RN #18 gave report to RN #20 at 1857. Review of RN #20's note at 1914 revealed "Patient listened to this writer's discharge instructions but refused to take the discharge papers. He also does not want the taxi voucher this writer offered. He said, 'I'll take a taxi to a friend's house.' Patient ambulated independently out of ED. Patient #11 was discharged on 04/21/2022 at 1920.

Record review revealed Patient #11 was returned to the ED via EMS on 04/21/2022 at 2015 due to "unwitnessed jump off skybridge, CPR in progress ..." Review revealed Patient #11 expired in the ED at 2034.

Review of the RCA [no date] (root-cause analysis-a process of discovering the root causes of problems in order to identify appropriate solutions) that was provided by the hospital on 06/09/2022 revealed root causes and action items were in process. Review revealed one of the contributing factors was identified as no standardized process for escalating and communicating family concerns to the provider. Review revealed the HUC (health unit coordinator-secretary) received several phone calls from Patient #11's mother and father during his ED visit. Review revealed Patient #11's mother at one point requested her son not to be discharged and wanted to speak to his primary ED MD (MD #17) because he was on the way to another ED (local to Patient #11) for an emergency mental health evaluation at the time the MVC occurred. Following the conversation, the HUC verbally passed along the mothers' concerns to Patient #11's primary RN (RN #18) however, MD #17 was never made aware of Patient #11's mothers' request to speak to him. Review of the RCA revealed a standardized process for communication was currently being drafted and had a due date of 08/15/2022. An additional contributing factor was identified as lack of obtaining collateral information from Patient #11's family following reports of auditory hallucinations. Review revealed a standardized process would be created to assist providers to know when it was appropriate and how to obtain collateral information by 08/15/2022. Review revealed a standardized process would be developed by 08/15/2022 for ED MDs to consult with the PES (psychiatric emergency services) team for guidance. Development of an escalation pathway to incorporate collateral information and/or staff concerns was in process and to be completed by 08/15/2022. Education on escalation and identifying concerns would be incorporated into resident training by 08/15/2022. RCA review revealed multiple action items were still ongoing with a due date of 08/15/2022, more than 3.5 months after the event.

Review of April and May ED staff meetings revealed re-education on communication was provided but did not reveal a standardized process had been developed. Review revealed less than 75 % of staff had completed the education by 06/08/2022.

While onsite the survey team received updated information of actions taken after 06/08/2022 when the team was on-site which included a new standardized process related to communication and receiving collateral information which was implemented 06/09/2022 (49 days following Patient #11's incident) along with additional education for staff and providers which had been provided.

Interview on 06/09/2022 at 1312 with the Clinical Risk Manager (CRM) #26 and Director of Clinical Risk Manager (DCRM) #32 revealed following Patient #11's incident, the only action that had been completed was reeducation regarding communication which was presented in April and May staff meetings.

Interview on 06/09/2022 at 1346 with MD #17 revealed he was Patient #11's primary resident on 04/21/2022 during his first visit. MD #17 stated he received an email just prior to the interview (06/09/2022) which discussed a process change where the HUC would start sending out secure chats to the patients care team and the escalation process if additional concerns arise. MD #17 stated there had been discussions regarding implementing a new process, but a process had not yet been developed or implemented prior to 06/09/2022.
Interview on 06/09/2022 at 1805 with RN #18 revealed he was Patient #11's primary RN during the first visit on 04/21/2022. RN#18 stated, "I believe we've adjusted how we handle answering phone calls to parents, the HUC will put epic secure chat ...better access to know there's been a call." RN #18 stated that new process had been verbally discussed with him "recently."

Interview on 06/10/2022 at 0922 with RN #21 revealed she was the charge nurse on duty during Patient #11's first ED visit on 04/21/2022. Interview revealed staff were now "moving towards" using secure chat to notify a patients treatment team of notifications from families.

Interview on 06/13/2022 at 1002 with HUC #24 they just received education on a new standardized process where the HUCs will send family concerns and messages in a secure chat to the team members involved in the patient's care.

2. Review of the (Named) ambulance run report dated 04/12/2022 revealed they responded to Patient #12 at his "Nursing Home" following a fall and transported to the ED for evaluation. Review revealed "Mental Status-normal for pt baseline, has dementia ...History ...Dementia ...Arrived to (named Hospital ED), report was given to charged (sic) nurse (CN #34) , got sent to triage. Assist pt from stretcher and onto wheelchair, gave report to nurse (RN #35) ..."

Review of the medical record revealed Patient #12 was an 85-year-old male who presented to the emergency department (ED) via ambulance on 04/12/2022 at 1508 following a fall. Review of the ED triage note entered by RN #35 on 04/12/2022 at 1515 revealed "Pt presents to ED via EMS (emergency medical services) with unwitnessed fall at SNF (skilled nursing facility) ..." Review of the ED timeline revealed on 04/12/2022 at 2140 (6 hours and 32 minutes after arrival to the ED) Patient #12's ED disposition was set to "LWBS (left without being seen) after triage."

Review revealed Patient #12 was transported back to Hospital A ED on 04/13/2022 at 0854 and admitted at 1750. Review of the History and Physical (H&P) dated 04/13/2022 at 1759 revealed "Assessment /Plan: NSTEMI (non-ST-elevation myocardial infarction is a type of involving partial blockage of one of the coronary arteries, causing reduced flow of oxygen-rich blood to the heart muscle) ...HPI: (history of present illness) Patient #12 is a 85 y.o male with PMHx (past medical history) HTN (hypertension-high blood pressure) ...cognitive impairment ...Patient #12 represented (sic) to ED s/p (status post) fall on 4/12 and wondering (sic) out of the hospital same day and was unable to be located until today at (named location). He was brought back to the ED in stable condition. Patient with severe cognitive impairment and unable to get a clear history of events ..."

Review of the elopement incident report for Patient #12 revealed "Pt arrived via EMS and was triaged at 1510. At 1910 CT tech attempted to locate patient for exam, unable to locate patient. Triage made 3 attempts to locate patient with no response. As we were unable to locate patient, he was discharged as left without being seen after triage following the 3 attempts. At 0101 received a call from the patient's son requesting update. Advised son that patient was not present in department. Pt's son advised he would call SNF to check with them. At 0106 (named) SNF called and advised that patient was not there and should be here in the ED. They advised that patient has hx of dementia. Description obtained from SNF. Hospital Police notified at 0115. House Supervisor notified at 0120."

Review of the RCA [no date] that was provided by the hospital on 06/09/2022 revealed it was in process. Review revealed one action item involved developing a standardized process for removing LWBS patient from the computer system. Review revealed re-education was provided in April and May staff meetings and audits would be performed. Review did not reveal any audits performed. Review revealed 2-hour reassessments were not performed on Patient #12 and re-education was provided in April and May staff meetings, and audits would be performed. Review did not reveal any audits had been performed. Review revealed another action item involved the ED doors that led from the ED waiting room into hospital corridors. Review revealed the action item had a due date of 05/25/2022 and was implemented on 06/07/2022 (56 days following Patient #12's elopement). Review revealed the lack of tracking patient movement while in the waiting room was identified as a contributing factor and effective 06/08/2022 (57 days following Patient #12's elopement) additional support personal were provided to round in the waiting room during high volume times (1100-2200).

Interview on 06/10/2022 at 1224 with the Director of Construction (DC) #44 revealed the two ED doors that were intentionally left open in the past. Interview revealed effective 06/07/2022 (56 days from Patient #12's incident) the doors were closed. DC #44 stated the doors could not be locked due to it being an egress with an exit sign. DC #44 stated the plan was to activate a delay exit which meant if a patient or visitor pushed on the door to open it, it would alarm for 15 seconds then open. DC #44 stated a PO (purchase order) had been issued on 06/10/2022 (59 days from Patient #12's incident), for security hardware, camera, and the badge reader. Interview revealed action items were not implemented until the week of 06/07/2022.

Interview on 06/14/2022 at 1532 with NM #9 revealed she the "action owner" for standardizing, implementing, and auditing a process for charge nurses only to remove patients who LWBS. NM #9 stated the process had been developed and implemented however she was not auditing the process. NM #9 stated she was also the "action owner" for auditing charts to ensure two-hour reassessments were being performed. Interview revealed she was not currently auditing 2-hour reassessments to ensure they were being performed. Interview revealed since Patient #12's incident, dementia patients that are in the ED were supposed to be changed into a green gown to serve as a visual cue for staff. Interview revealed audits for ensuring dementia patients had been placed in a green gown had not been performed. NM #9 stated more education regarding Patient #11's and Patient #12's incidents had been pushed out since the arrival of survey staff. Interview revealed no monitoring of these action items had occurred as of 06/14/2022 (2 months after the event).

Interview on 06/15/2022 at 1000 with PSO (patient safety officer) #43 revealed she was responsible for oversight of the RCA process. PSO #43 stated each RCA had a "process owner" and each action had a "action owner." PSO #43 stated she sent the "action owner" reminders of completion dates and request for updates periodically during the RCA process to ensure due dates were met. Interview revealed PSO #43 was the "process owner" for all RCAs and she "does the best I can" to ensure action items were completed and monitored. PSO #43 stated she assisted action owners setting up audits if needed. Interview revealed PSO #43 was not aware that some of the action items on Patient #12's RCA were not being monitored.

Based on policy and procedure review, medical record review, and staff interviews, the nursing staff failed to supervise and evaluate patient care by failing to ensure patient reassessments were completed per hospital policy for 2 of 4 ED (emergency department) elopement patients (Patient #12 & Patient #30)

Findings included:

Review of the policy and procedure titled "Triage in the Emergency Department" effective 11/2020 revealed " ...III. Policy Triage is the process of collecting pertinent information about patients who are seeking emergency care and initiating a decision-making procedure using a triage acuity designation system. Triage is considered to be a type of nursing assessment and may occur in any area of the Emergency Department ...D. Reassessment of patients 1. In the case where a treatment bed is not immediately available, patients waiting on a treatment bed will be reassessed every 2 hours, regardless of the patient's ESI level (emergency severity index-five level ED triage algorithm that provides clinically relevant stratification of patients into five groups from 1 [most urgent] to 5 [least urgent] on the basis of acuity and resource needs). More frequent reassessments may be performed based on nursing judgement. 2. Reassessments will include a full set of vital signs and a reassessment of the patient's ESI level ..."

1. Review of the medical record revealed Patient #12 was an 85-year-old male who presented to the emergency department (ED) via ambulance on 04/12/2022 at 1508 following a fall at his residence. Review revealed Patient #12's triage started at 1509 by CN (charge nurse) #34. At 1509 Patient #12's acuity level was a ESI 3. Review of the ED timeline revealed Patient #12's allergies, home medications, and medical history were documented as reviewed by CN #34 at 1509. Review revealed CN #34 performed a "ED Falls Assessment" on Patient #12 at 1509 in which he was determined to be a falls risk. Further review of the "ED Falls Assessment" at 1509 revealed "Falls precautions taken: Fall arm band applied; Placed near nursing station." Review of the ED triage note entered by CN #34 on 04/12/2022 at 1510 revealed "Pt (patient) had witnessed fall. Pt denies LOC (loss of consciousness) and is not on thinners (blood thinners)." Review of the ED triage note entered by RN #35 (triage nurse) on 04/12/2022 at 1515 revealed "Pt presents to ED via EMS (emergency medical services) with unwitnessed fall at SNF (skilled nursing facility). Pt c/o (complains of) pain to R (right) side of forehead that has small laceration. Denies any other injuries. Denies LOC. Not on blood thinners." Review revealed RN #35 performed "Focused Assessment" at 1515 of Patient #12's "Airway, Breathing, Circulation, and Disability" all of which were "Within Defined Limits." At 1516 Patient #12's vital signs were as follows BP (blood pressure)-151/64, HR (heart rate)-59, Resp (respirations)-18, Sp02 (oxygen saturation)- 95% room air, and T (temperature)-98.2. At 1519 orders were placed by MD (medical doctor) #36 for "Imaging-CT (cat scan) Head Wo (without) Contrast; CT Cervical Spine Wo Contrast." Review of the ED timeline revealed on 04/12/2022 at 2140 (6 hours and 32 minutes after arrival to the ED) Patient #12's ED disposition was set to "LWBS (left without being seen) after triage." Review failed to reveal nursing reassessments were performed on Patient #12.

Interview on 06/13/2022 at 1334 with RN #35 revealed she was the triage nurse on 04/12/2022 when Patient #12 presented to the ED. Interview revealed a patient awaiting an ED bed with a ESI level of 3-5 should be reassessed to include a set of vital signs every 4 hours. RN #35 stated the ED was busy that day and with only two triage nurses on duty, they were not able to get the reassessments done.

Interview on 06/14/2022 at 1532 with NM #9 (ED Nurse Manager) revealed she was constantly working on ensuring 2-hour reassessment for patients awaiting an ED bed were being performed. NM #9 stated she was not currently auditing 2-hour reassessments to ensure they were being performed per policy. Interview confirmed policy was not followed.

2. Review of the medical record revealed Patient #30 was a 51-year-old female who presented to the emergency department (ED) on 06/14/2022 at 1948 for "Back pain." Review revealed vital signs at 2000 were as follows: BP-108/86, HR-99, Resp-18, Sp02-100% room air, and T-98.6. Patient #30's triage started at 2003 and was assigned as a ESI level 5 at 2004. Review of RN #40's triage note dated 06/14/2022 at 2003 revealed "Patient states that she was kicked out of group home because she wouldn't stay in the building, and they were disrespectful to her. She states she was released from the hospital without medications." Review of the ED timeline revealed at 2004 Patient #30's chief complaint was updated to "Homeless." Review revealed Patient #30 was moved from the waiting room to PT (treatment area located behind the triage rooms) at 0555 (9 hours and 7 minutes after arrival to the ED) and the MSE (medical screening exam) started at 0556. Patient #30 eloped (exact time unknown) and was "discharged" out of the system on 06/15/2022 at 0956. Review failed to reveal nursing reassessments were performed on Patient #30.

Interview on 06/14/2022 at 1532 with NM #9 (ED Nurse Manager) revealed she was constantly working on ensuring 2-hour reassessment for patients awaiting an ED bed were being performed. NM #9 stated she was not currently auditing 2-hour reassessments to ensure they were being performed per policy. Interview confirmed policy was not followed.

Request for interview RN #40 (triage nurse) revealed she was unavailable.

Based on policy and procedure reviews, observations, hospital document reviews, and staff and physician interviews the hospital failed to provide an effective infection prevention and control program for oversight of infection prevention and control processes.

The findings include:

1. The hospital failed to ensure processes to mitigate the spread of COVID-19 by eliminating separate waiting areas and social distancing in the Emergency Department waiting rooms without securing Infection Control and Hospital Leadership approval and failed to prevent the risk for infection by hospital staff failing to wear personal protective equipment to cover facial hair in the operating room and central sterile processing areas.

~cross refer to 482.42 IC Standard: Tag 0750

2. The hospital failed to track and verify COVID-19 vaccination status of all persons in the hospital identified as Healthcare Personnel.

~cross refer to 482.42 IC Standard: Tag 0792

Based on review of policy and procedures, Centers for Disease Control and Prevention (CDC) documents provided by the hospital, observation, and staff interviews, the hospital failed to have a process in place to separate COVID-19 positive and COVID-19 symptomatic patients from patients without COVID-19 in the hospital emergency department (ED) waiting rooms for 2 of 2 ED waiting rooms and failed to prevent the risk for infection by hospital staff with facial hair failing to wear personal protective equipment (PPE) to cover the facial hair in the operating room and central sterile processing areas for 3 of 4 staff with facial hair observed.

The findings include:

A. Review of the COVID 19 Workflow - Isolation Precautions for COVID Positive and COVID PUI (patient under investigation) Patients revised 02/2022 revealed the policy did not reveal specific guidelines related to patients in the ED waiting rooms.

Review of the Centers for Disease Control and Prevention (CDC) document titled "COVID-19 Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic dated 02/02/2022 revealed "... Source control and physical distancing (when physical distancing is feasible and will not interfere with provision of care) are recommended for everyone in a healthcare setting. This is particularly important for individuals, regardless of their vaccination status, who live or work in counties with substantial to high community transmission or who have: ... Have suspected or confirmed SARS-COV-2 infection or other respiratory infection (e.g., those with runny nose, cough, sneeze); ... Encourage Physical Distancing; In situations when patients are not up to date with all recommended COVID-19 vaccine doses could be in the same space (e.g., waiting rooms, cafeterias, dialysis treatment room), arrange seating so that patients can sit at least 6 feet apart, especially in counties with substantial or high transmission."

Review of the CDC COVID Data Tracker (not dated) provided on 06/10/2022 revealed an image of the state of North Carolina divided by counties. Review revealed the image was of the Community Transmission levels for all the counties in North Carolina and all counties were colored red. The key under the image identified red as high community transmission level.

Observation conducted on 06/07/2022 at 1435 during tour of hospital A (main campus) ED (emergency department) waiting room revealed no separated area for COVID patients or suspected COVID patients to wait. Observation revealed seating in the ED waiting room was not set up for social distancing of 6 feet.

Observation conducted on 06/07/2022 at 1630 during tour of hospital B ED waiting room revealed no separated area for COVID patients or suspected COVID patients to wait. Observation revealed seating in the ED waiting room was not set up for social distancing of 6 feet.

Interview during tour on 06/07/2022 at 1430 with NM (Hospital A ED nurse manager) #9 revealed they had recently stopped segregating COVID or suspected COVID patients from waiting with non-COVID patients in the waiting room. NM #9 was not sure of the exact date that went into effect, but it had been "recently."

Interview during tour on 06/07/2022 at 1640 with the Director of Hospital B ED (EDD) #45 revealed in the past, COVID patients and PUIs (Patient Under Investigation) were separated from the other patients in the waiting room by a clear plastic partition. EDD #45 stated due to the patient volume and lack of space, the partition was removed April 1, 2022, and all patients were allowed to wait together in the waiting room. The Director stated all patients and staff were supposed to wear mask. The Director stated a "COVID committee" met and reviewed removing the partition and agreed it was safe to do so.

Interview on 06/09/2022 at 0950 with Director #8 revealed the hospital was no longer separating patients with a known positive COVID-19 test or patients suspected or having symptoms of COVID-19 from other medical patients that present to the hospital emergency department and have to wait in the waiting room to be seen.

Interview on 06/09/2022 at 1730 with Nurse Manager (NM) #9 revealed the number of COVID suspected patients had decreased and the number of medical patients presenting to the hospital emergency department for care had increased. Interview revealed the decision was made to utilize the space identified as team C, which had been used for COVID waiting to be used for another purpose and to commingle all waiting patients into one waiting room. Interview revealed the space formerly used for COVID-19 waiting room space would now be used for patients that needed a monitored bed, were on a stretcher, or needed oxygen while waiting to be seen by a medical provider. Interview revealed no COVID-19 waiting room space was now available in the ED. Interview revealed the patient would be tested for COVID in triage if they have symptoms. Interview revealed the patient was then placed back in the one waiting room for the test results while continuing to wear their mask. Interview revealed the test would take an hour to result.

Interview on 06/10/2022 at 0951 with Director #8 and MD #10 revealed infection prevention was not involved in the decision to move forward and no longer separate patients suspected of COVID. or known diagnosis of COVID positive from other medical patients waiting in the hospital emergency department.

Interview on 06/13/2022 with IP #11 revealed she was the infection prevention nurse that is assigned the ED. Interview revealed the change in the hospital emergency department (location Main) was made 06/01/2022. Interview revealed IP #11 did a walk through the emergency department with hospital ED leadership around February/March 2022. Interview revealed the waiting areas were discussed during that walk through as to when the ED could go back to just having one waiting room due to the number of patients with COVID symptoms and patients positive for COVID coming into the ED had decreased. Interview revealed during the walk through the recommendation was to continue as things were due to the new variant of COVID and not being sure if that would have promoted a spike in patients coming in with COVID symptoms. Interview revealed IP #11 was not involved in the decision to not separate COVID positive and COVID suspected patients from medical patients in the ED waiting room.

B. Review of the hospital policy titled "Infection Prevention Guidelines for Perioperative Services" revised 12/2021 revealed "C. Intraoperative Care (Operating Room) ... c. Semi-Restricted Zone: Defined as the main surgical suites which include ... operating rooms, ... scrub rooms, ... instrument processing rooms, sterile supply rooms/sterile core, and connecting corridors. Personnel entering the Semi-Restricted Zone must dress in hospital laundered scrubs or disposable, single use jumpsuit's (bunny suits) provided by the department. Hair must be contained in a disposable cap or hood ... i. Restricted Zone (Refer to Attachment 1 - Infection Prevention Attire in Restricted Zones) Defined as each operating room within the Semi-Restricted Zone, where surgery is performed ... Attachment 1: Infection Prevention Attire in Restricted Zones (Operating Rooms, Procedural Rooms) ... Personnel include all persons who enter the Semi-restricted and Restricted Zones ... Hair *Hair on the head and face (i.e. beards) must be fully covered to prevent shedding of hair and squamous cells."

1. Observation on 06/07/2022 at 1140 revealed a male, identified as central sterile technician (CST) #1, walking around in and working in the central sterile processing department with facial hair not covered. CST #1 was observed to be on the clean side of the department where instruments are taken out of the washer, allowed to dry, and then wrapped to go in the sterilizer.

Interview on 06/07/2022 at 1141 with Central Sterile Manager (CSM) #2 revealed CST #1 should have a beard cover on. Interview revealed facial hair should be covered in the department. Interview revealed the hospital has plenty of beard covers for the staff to use.

Interview on 06/07/2022 at 1613 with Director #8 revealed facial hair should be covered in Central Sterile.

2. Observation on 06/08/2022 at 1024 in operating room (OR) #6 revealed MD #4 entered the room without facial hair covered. Observation revealed the sterile field with sterile instruments to be used for the surgery were already opened in the room. Observation revealed RN #6 addressed the facial hair with MD #4 and MD #4 continued to discuss case needs. Observation revealed MD #4 left OR #6 room at 1027.

Interview on 06/08/2022 at 1025 with RN #6 and RN #7 revealed MD #4's facial hair should have been covered. Interview revealed the sterile field and instruments were already open and set up for the next surgical case that would be in the room.

Interview on 06/07/2022 at 1613 with Director #8 revealed facial hair should be covered at all times in the OR once the sterile field is open.

3. Observation on 06/08/2022 at 1049 in the scrub area between OR #2 and OR #6 revealed a male, identified as Anesthesia #5, was in OR #2 with facial hair not covered. Observation revealed there was a surgical procedure being performed on a patient at the time.

Interview on 06/08/2022 at 1050 with RN #6 and RN #7 revealed Anesthesia #5 should have had a beard cover on.

Interview on 06/07/2022 at 1613 with Director #8 revealed facial hair should be covered.

Based on review of policy and procedures, COVID vaccination percentage for employees, review of COVID Leadership Team minutes, vendor /supplier letter, and staff interview, the hospital failed to have a process in place to verify all healthcare personnel are fully vaccinated for COVID-19 or have an exemption in place for 4 hospital staff members and unknown number of vendors.

The findings include:

A. Review of the hospital policy COVID-19 Immunization of Healthcare Personnel last revised 03/2022 revealed "... Due to the growing spread of coronavirus/COVID-19 in North Carolina, and to ensure we are providing a safe environment for patients, and healthcare personnel, (Health System Name) requires employees, medical staff, students, volunteers, research monitors, and contract workers and vendors who are required to comply with (Health System Name) immunizations policy (collectively, "healthcare personnel" or "HCP") are vaccinated against COVID-19, subject to a small number of exemptions. III. Policy A. COVID-19 Vaccination required A. All HCP must be vaccinated against COVID-19 unless an exemption has been granted pursuant to this policy. This policy applies to all HCP, regardless of whether the employee works remotely or on site at a (Health System Name) facility mention above..."

Review of the COVID-19 Vaccine Compliance Summary (not dated) provided to this surveyor on 06/15/2022 revealed 99.78 % (Health System Name) Employees were compliant with vaccination or having an exemption in place. Review revealed 2.57% (Health System Name) Employees had exemptions and 6 Non-Compliant Employees (no percentage provided).

Review of the (Health System Name) COVID Leadership Team dated 08/19/2021 revealed "Vendor Vaccine Policy:...(Health System Name) won't verify each vendor's compliance, but will reserve right to request/audit records ..."

Review of the Vendor/Supplier letter dated 09/07/2021 revealed "... Please arrange to have your employees and other agents who may or will visit (Health System Name) facilities certify compliance through RepTrax ... Please do not submit vaccination records or exemption request to (Health System Name). Prior to entering (Health System Name) facilities, vendor employees and/or agents will be asked to confirm that they have received a complete COVID-19 vaccine or that they have an approved exemption on file with their employer ..."

Interview on 06/13/2022 at 1351 with Registered Nurse (RN) #12 and Project Coordinator (PC) #13 revealed the percentage numbers on the COVID-19 Vaccine Compliance Summary did not include vendors, contract staff, Attending Providers, or students. Interview revealed the percentages were only the hospital staff and the resident providers.

Interview on 06/15/2022 at 1136 with Director #14, PC #13, and AD #25 revealed the dashboard provided is a working document and as of today the number of staff non complaint is four. Interview revealed the four staff are nurses and a resident that work in patient care areas of the hospital.

Interview on 6/14/2022 at 1222 with Director #14, RN #12, and Associate Director (AD) #25 revealed hospital occupational health staff do not track contract, vendors, or attending staff. Interview revealed the percentage numbers do not include vendors, contract staff nor attending staff. Interview revealed the hospital relied on the agencies to track the employees that are not hired by the hospital and are not resident medical providers.

Interview on 06/14/2022 at 1525 with Medical Doctor (MD) #15 and Administration #16 revealed the COVID Leadership Team met and required all vendors to have COVID-19 vaccines. Interview revealed all venders received a letter outlining the vaccine requirements or have an approved exemption with their company. Interview revealed the hospital would not be able to provide the vendor information. Interview revealed MD #15 and Administration #16 did not know how many vendors go into patient care areas and would require the vaccination or exemption information. Interview revealed the hospital worked very closely with the School of Nursing (SON) and the School of Medicine (SOM) to ensure they are aware of the requirements and that they (the SON and SOM) are vetting the information related to COVID vaccine and exemptions. Interview revealed the vaccination information for Attending Providers, Contract staff and Agency staff can be obtained from the different areas that keep up with that information. Interview revealed the Attending Providers, Contract staff, Agency staff, and students' vaccinations were not centrally maintained and were not included in the percentages of compliance provided.

Interview on 06/15/2022 at 0947 with MD #15, PC #13, AD #25, and Director #14 revealed the hospital did not have all the vendor or contract vaccination information. Interview revealed the hospital staff have reached out to get the information for travel nurses and students currently doing rotations at the hospital.


NC00189865, NC00189723, NC00189405, NC00187602, NC00187141, NC00186464, NC00184520, NC00183899, NC00177436