HospitalInspections.org

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It was determined that the governing body failed to ensure the provision of safe and appropriate care to the hospital's vulnerable psychiatric population in a manner that complied with all Conditions of Participation. The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the hospital to provide safe and adequate care. This CoP refers to the following CoPs which are out of compliance.
* Tag A-115, CFR 482.13 - CoP: Patient's Rights
* Tag A-263, CFR 482.21 - CoP: QAPI
* Tag A-385, CFR 482.23 - CoP: Nursing Services
* Tag A-700, CFR 482.41 - CoP: Physical Environment
* Tag A-1600, CFR 482.60 - CoP: Special Provisions for Psychiatric Hospitals
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29708

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It was determined that the governing body failed to ensure each patient's rights were protected and promoted, including the right to receive care in a safe setting. Those failures created an unsafe Environment of Care ("EOC") that likely contributed to patient harm and death and created the likelihood of harm to other patients. The hospital failed to screen visitors; monitor in-person visits between patients and visitors; prevent contraband; observe and monitor patient condition, status, and location to ensure patients were safe and alive (Tag A-144). It further failed to conduct clear and complete investigations of adverse events that addressed all potential gaps and deficient practices; and failed to implement and monitor corrective actions to prevent recurrence for other patients (Tag A-145).
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29708

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Based on observations, review of video recordings, interviews, review of incident and patient care documentation for 19 of 23 patients (Patients 1, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23), review of P&Ps, review of hospital directives, review of equipment inventory lists and manufacturer's instructions, and review of OSH internal investigation and corrective action plan documentation, it was determined that the hospital failed to fully develop and implement P&Ps that ensured each patient's right to receive care in a safe setting. The hospital's failures to monitor and observe patients' condition and location, to screen and monitor in-person visitation between patients and visitors, to prevent drugs and other contraband, to thoroughly investigate adverse events and to implement corrective actions, likely contributed to patient harm and death and created the likelihood of harm to other vulnerable psychiatric patients. Those failures included:
* For Patient 5 and other patients, failure to ensure situational awareness and diligent observation and monitoring of patient condition and status, including whether patients were alive and breathing.
* For Patient 22, failure to ensure situational awareness and diligent observation and monitoring of patient location to ensure patients were not in unauthorized areas.
* Failure to ensure diligent and consistent registration/check-in of visitors prior to in-person patient visitation sessions.
* Failure to ensure diligent and consistent screening of visitors prior to in-person patient visitation sessions to prevent the entry of drugs and other contraband into the hospital, and to prevent the passing of those from visitor to patient.
* Failure to ensure situational awareness and diligent observation of patient and visitor behaviors and interactions during in-person visitation sessions to prevent the passing of drugs and other contraband from visitor to patient.
* Failure to investigate causes of the recurring presence of, and patient possession of, drugs and other contraband that created an unsafe EOC in the hospital.

Findings 1.a. through 1.j. of this Tag reflect it was determined that a possible IJ situation existed based on findings that staff failed to conduct continuous rounds as required to ensure that patients were alive and breathing on the shift prior to Patient 5's death and on subsequent shifts after Patient 5's death, and that staff failed to ensure during continuous rounds that patients did not enter unauthorized areas and allowed Patient 22 to enter an unauthorized room. On 06/05/2024 the SA survey team and manager met to review possible IJ. On 06/06/2024, hospital leadership staff were presented with the IJ template. IJ Removal Plans submitted on 06/13/2024 and 06/24/2024 were not acceptable and were not approved. The third IJ Removal Plan submitted on 07/03/2024 was determined to be minimally acceptable after clarifications were provided at the request of the SA and was approved. The details of the IJ Removal Plan with a plan implementation date of 07/12/2024 at 2359 are described further in Finding 1.j. of this Tag. An onsite IJ Removal Verification Visit was conducted on 07/23/2024 and 07/24/2024 and the SA determined that IJ Removal Plan had been implemented.

Tag A-144 is a repeat deficiency previously cited on complaint and revisit surveys completed on 01/17/2022, 08/01/2022, 11/17/2022, 10/05/2023, 03/14/2024, and 05/06/2024.

Findings include:

1.a. During interview on 05/29/2024 beginning at 1115, hospital staff that included the Chief Medical Officer/Interim Oregon State Hospital Superintendent/Administrator ("CMO/Interim OSHS"), Interim Director of Security ("DS"), Chief Nursing Officer ("CNO"), Chief of Psychiatry ("COP"), Director of Quality Management ("DQM"), Director of Standards and Compliance ("DSC"), Program Director ("PD"),
Director of Security ("DOS"), and OSH's DOJ Assistant Attorney General ("AAG") confirmed that on 05/24/2024 Patient 5 died unexpectedly on the Flowers 2 unit @ OSH-Salem ("FW2"). They provided the following information:
* Patient 5 had an in-person visitation with their parent during the evening on 05/23/2024.
* The next morning on 05/24/2024 at ~ 0815 Patient 5 was found unresponsive in their bed.
* A code blue [response to a medical emergency] was initiated by hospital staff, and Emergency Medical Services ("EMS") was called and responded. Resuscitation efforts were not successful and EMS pronounced Patient 5 deceased.
* During the resuscitation efforts, another patient on the FW2 Unit reported to staff that the night before on 05/23/2024 Patient 5 had told them they had received something from their parent during visitation that might be drugs.
* Powder residue was found at Patient 5's bedside and was seized by Oregon State Police ("OSP").
* The hospital suspended in-person patient visitation until further notice on 05/24/2024 during their internal investigation into whether drugs were passed during visitation.
* Several staff who worked on the FW2 Unit the night shift after the patient visitation had been "duty-stationed" as there were questions about whether staff were performing rounds and checking patients during the night as required.

1.b. An untitled summary of actions taken dated and timed as 05/29/2024 at 1244 was provided as result of the interview conducted at 1115 above and reflected:
"* Suspended all on-site visits on both campuses before scheduled visitation was due to start on 5/24/2024.
* Notified patients * Notified all people scheduled to visit * Notified staff * Notified press * Posted notification on OSH social media page * Posted notification on OSH Internet page
* Security department searched Flower 2 for contraband on Friday, 5/24/2024, and on Saturday, 5/25/2024.
* Confirmed the patient did not interact with patients on other units following the visit on 5/23/2024. Between the visit, and the time patient returned to the unit, and the time of the medical emergency the patient did not have opportunities to receive or pass substances to other patients on other units. Because of this, no search of other units was done.
* Draft of a directive to staff is underway to enter
patients' rooms if the patient is asleep to verify viability if it cannot be determined from the door.
* Communication to patients regarding change to viability checks is underway.
* Security staff who were involved have been
removed from patient contact. This was the screener and security staff supporting visitation. Occurred 5/29/24 in the AM after a discussion with [Human Resources ("HR")]. Not in response to [Centers for Medicare & Medicaid Services ("CMS")] arrival, just a coincidence. One staff works swing shift and will be notified at 1400 on 5/29/24.
* Nursing staff who were involved have been duty stationed (on the unit, after the visitation, working during the night/day crossover on 5/24, prior to the medical emergency). Notice was given to staff at night on 5/24 - some staff work night shift.
* Clinical Administrative Debrief Meeting (CADM) was initiated on 5/28/2024."

During the interview on 05/29/2024 at 1115 the CMO/Interim OSHS confirmed that no other actions had been taken up to that time.

1.c. The 18-page "Protocol" titled "2.020 Continuous Rounds, Census, and Milieu (RCM) Management.pdf" dated as revised on 02/27/2024, included detailed direction for staff in relation to continuous rounds, including, but not limited to:

* "The purpose of this protocol is to establish performance expectations for nursing staff at Oregon State Hospital (OSH) related to conducting continuous rounds for the purpose of monitoring and verifying patients' status and whereabouts."

* Definitions included:
" 'Continuous' means on-going at all times."
" 'Viability' means the quality of being alive and breathing adequately to sustain life."

* "A. Nursing staff must perform continuous rounds focused on census and milieu management (RCM) at all times on each unit when patients are present."

* "C. ... No matter how scheduled, RCM assignments must cover all times during a shift and the following activities must be completed and documented on the RCM Flowsheet. i. Hourly Patient Census and Viability Checks, within 10 minutes of the top of every hour. ii. Hand-off report, at each change in RCM staff assignment, as described in this protocol."

* "D. Between swing and night shifts, and between night and day shifts, an off-going RN (or Lead LPN) and an on-coming RN (or Lead LPN) must conduct a collaborative patient viability round. (This round is not required to be completed between day and swing shifts.) 1. The off-going nurse and the on-coming nurse must together visualize each patient to verify both identity and viability. This verification may require pulling back the covers on a patient whose head is covered by bed linens or removing articles of clothing that may obstruct proper identification. a. The off-going nurse and the on-coming nurse must document the successful completion of these rounds by signing on the indicated signature lines at the top of the on-coming nurse's RCM Flowsheet."

* "E. The RN (or Lead LPN) must verify that RCM duties are being continuously and accurately performed and documented by observing the RCM's actions and reviewing the RCM Flowsheet at least twice per shift. This verification does not require documentation."

* "J. RCM staff must maintain awareness of the location and status of all patients assigned to the unit, including knowing if and when individual patients are off unit. This information must be accurately reflected on the RCM Flowsheet."

* "K. RCM staff must verify that patients are remaining in authorized areas of the unit and must intervene if patients enter, or attempt to enter, unauthorized areas."

* "L. RCM staff must verify that patients are not engaging in unsafe or unlawful behavior and must intervene if such behavior is noted. This includes but is not limited to: ... monitoring for potential sexual contact between patients and intervening ..."

* "M. RCM staff must verify the presence and viability of each patient on the unit at least once per hour, at random intervals (within 10 minutes before or after the top of each hour). These checks must be documented on the RCM Flowsheet. 1. Verbal contact is not required during these checks, as long as visual verification of the patient's status is made. 2. To determine viability when a patient has their eyes closed or is non-verbal, staff must unobtrusively stand by to either visually or audibly confirm patient respirations. 3. When a patient is using a bathroom or shower, verbal confirmation of presence and status is sufficient to verify viability ... For staff and patient safety, when entering patient bedrooms to perform patient checks, it may be preferable to utilize two staff, one stationed at the door and the other entering the room ... 6. RCM staff must document census and viability rounds on the RCM Flowsheet as follows ..."

* "P. The primary responsibility of RCM staff is the thorough completion of the RCM duties described previously."

1.d. Video observations of nursing staff continuous and hourly rounds and milieu presence protocols to ensure patients were alive and breathing were not followed during the night shift on 05/24/2024 prior to discovery of Patient 5 who was found unresponsive, cold to the touch, and not breathing in their room ~ four and ½ hours after they had last been observed alive.

* As described under Finding 1.c. above in this Tag, the hospital protocol for "Continuous Rounds, Census, and Milieu (RCM) Management" required staff to conduct "continuous rounds" for the purpose of monitoring and verifying the "status and location" of every patient and that "Hourly Patient Census and Viability Checks, within 10 minutes of the top of every hour" were to be conducted. "Viability" was defined as "the quality of being alive and breathing adequately to sustain life" and "To determine viability when a patient has their eyes closed or is non-verbal, staff must unobtrusively stand by to either visually or audibly confirm patient respirations."

* The 05/24/2024 patient census report for the FW2 South Hall reflected that four of the South Hall rooms had one patient each, and the other four of those rooms had two patients each, for a total of 12 patients on that hall. Video review of four hourly rounds of those eight patient rooms during the night shift on 05/24/2024 between the hours of 0415 and 0830 showed staff who conducted those rounds to stand in the hallway outside closed patient room doors, look momentarily through door windows into darkened rooms, and then move to the next rooms. As an example: On 05/24/2024 the rounds that began at 0457:51 at the first room were concluded when the staff person walked away from the last room and the 12th patient at 0458:28, for a total of 37 seconds. Those 37 seconds also included the time required to navigate from room to room down one side of the hall and back on the other side of the hall. Although a reasonable person could conclude that staff could not have both navigated the hallway and confirmed patient respirations visually or audibly for 12 patients during a 37 second period of time, the staff recorded on the RCM flowsheets that each of the 12 patients had "Eyes closed, [Respirations] Confirmed."

* The hospital protocol also stipulated that at shift change between evening shift and night shift, and between night shift and day shift, "the off-going nurse and the on-coming nurse must together visualize each patient to verify both identity and viability. This verification may require pulling back the covers on a patient whose head is covered by bed linens or removing articles of clothing that may obstruct proper identification."

* The video for 05/24/2024 South Hall shift change showed for rounds conducted by RN 2 and RN 7 at ~ 0700 only one RN looked through door windows or briefly opened some patient room doors while the other RN stood in the hallway and held a clipboard. In addition, although RN 2 and RN 7 recorded that at 0700 eight of the 12 patients had "Eyes closed, [Respirations] Confirmed" at that time, documentation on the back of the report reflected that at 0700, seven of those eight patients departed for an "Off-Unit," "2nd floor Leisure" activity.

1.e. Video observations of Patient 5 and their room, Room 225, for 05/24/2024 night shift showed the following:

* ~ 0421 Patient 5 was observed to walk back into their room, Room 225, after they had spent time outside of their room walking around the unit. They were not seen to exit their room after that until they were moved from the room into the hallway after 0900 by EMS during unsuccessful resuscitation attempts.

* ~ 0457:51 video showed continuous rounds began. Mental Health Therapy Technician ("MHTT") 9 approached the door windows of patient Rooms 222 and 224 for 2/10th of a second then turned toward Room 225 on the opposite side of hallway took three steps toward Patient 5's Room 225 to within ~ 2 feet of the door, glanced toward the door window for 1/10th of a second then proceeded down the hall. MHTT 9 recorded on the RCM flowsheet that Patient 5 was in their room and had "Eyes closed, [Respirations] Confirmed" at that time.

* ~ 0556 video showed continuous rounds began. Those were conducted similarly to the 0457 rounds and MHTT 8 similarly recorded that Patient 5 was in their room and had "Eyes closed, [Respirations] Confirmed" at that time.

* ~ 0700 video showed continuous rounds began. Those were conducted by RN 2 and RN 7 as described above in Finding 1.d. and the RNs recorded that Patient 5 was in their room and had "Eyes closed, [Respirations] Confirmed" at that time.

* During interview on 05/30/2024 at 1520 with day shift RN 2 the following information was provided regarding Patient 5:
- RN 2 stated at "probably" 0655 or 0700 they did shift change viability rounds with night shift RN 7, who was an agency nurse. During the rounds, RN 7 visualized the patients and they, RN 2, did the writing on the RCM continuous rounds report. RN 2 told RN 7 "I'll do the writing and you do the visualization."
- RN 2 stated they "obviously" had no interactions with the patient.
- RN 2 stated RN 7 opened the door and "I believe" used a flashlight and said the patient was sleeping "so I wrote down [they were] sleeping and carried on." RN 2 stated "I visualized [the patient] and could see [they were] laying there." RN 2 stated the patient "looked like [they] always [do], curled up in bed with blankets." RN 2 stated they did not go into the patient's room to see if they were breathing.
- RN 2 stated later in the shift they went out to cue patients who still needed their medications ("meds") and they went to the patient's room, opened the door and said "It's Friday ... time for meds ... biscuits and gravy for breakfast." They stated the patient did not respond and that was typical for the patient. They stated the patient "plays possum" and usually gets up on their own. RN 2 stated the patient did not respond, they did not see the patient move, and they did not go into the room.

Refer also to RN 2's incident documentation under Finding 1.f. below.

* ~ 0800 video showed that no rounds were conducted. However, MHTT 1 recorded that at 0800 Patient 5, and six other patients on that hall, were in their rooms and had "Eyes closed, [Respirations] Confirmed" at that time.

* ~ 0806 video showed that MHTT 3 approached Patient 5's door, knocked on the door, opened the door, closed the door, then without urgency walked to check another patient ("pt") room then walked back down the hall to the Nurses Station ("NS").

* During an interview with MHTT 3 on 5/31/2024 beginning at 1300, the following information was provided regarding Patient 5:
- MHTT 3 stated they remembered the incident involving the patient. They normally worked day shift on FW2 and they came into FW2 at 0715 on the day the patient "passed away".
- MHTT 3 stated that they normally conducted rounds, called "visual rounds" every hour and those were documented on RCM forms. Their responsibilities during rounds were "Just to see if the patient is OK and what they are doing and check for breathing and stuff like that." The MHTT stated that during rounds they walk by each patient room and "only open the door if I can't see them moving from the [door] window." If they saw a patient moving from the window, they would document a "C" on the RCM which meant "active." If they did not see the patient moving, they would open the door, say the patient's name "to get their attention" and if the patient did not respond, they would get a second staff person to go check the patient with them. After getting a second staff person, they would both go in the room and tap the patient to check for breathing. The MHTT stated they were not allowed to go in patient rooms by themselves.
- MHTT 3 stated that "around 8:00ish the LPN told me a few patients had not gotten their meds so I went to Patient 5's room and I opened the door." The MHTT stated that the light was not on in the room. MHTT 3 stated, "I said Patient 5's name three times." The patient had headphones on so they didn't think the patient could hear them call their name. The MHTT stated the patient "looked totally normal." The patient was in bed "kind of sitting up, lying down but with [their] head up on the pillow, on [their] back." MHTT 3 did not think they could see the patient's eyes because "It was pretty dark in the room."
- The MHTT stated the patient had clothes on and they were "pretty sure" they had a blanket over them. The MHTT stated they did not go inside the patient's room at any time.
- The MHTT was asked by the surveyor if they could tell if the patient was breathing and they stated, "No, I didn't look for that." The MHTT stated that when the patient didn't answer, they let the License Practical Nurse ("LPN") know that they would have to take the patient's meds to them. The MHTT stated they did not say anything else to the LPN about the patient. The MHTT was asked by the surveyor if they saw anything suspicious in the room such as contraband and they stated, "No, I didn't look around."

Refer also to MHTT 3's incident documentation under Finding 1.f. below.

* ~ 0825 video showed continuous rounds began. Those rounds by MHTT 1 who documented they conducted rounds at 0800. During those rounds the MHTT 1 did not look into or open the door to Patient 5's room.

* ~ 0834 video showed that the day shift RN 2 approached Patient 5's door, looked in the window, opened the door and looked in, closed the door, then without urgency walked away from the room and back down the hall.

* ~ 0847 video showed that LPN 5 approached Patient 5's door, opened the door, entered the room, and left the room with urgency after which staff began to urgently respond to Patient 5's room.

* On 05/30/2024 beginning at ~1320, during video review of the 05/24/2024 incident involving Patient 5, interviews with hospital staff present that included the CMO/Interim OSHS, the DS, CNO, Chief of Operations ("CFO/COO"), DQM, DSC, Incident Reporting System Incident Director "IRSID", DNS and others confirmed the following:
- Regarding checking for respirations if patient appeared asleep, staff stated "Protocol could include pulling down the blanket. They have to see the chest rise and fall."
- Regarding RCM rounds that began at ~ 0401 the video showed that the Mental Health Therapist ("MHT") walked up and down the South Hall and barely glanced in rooms, in some cases for less than one second, as they walked by. The DNS stated, "I don't think that is sufficient. We're in agreement."
- Regarding viability rounds at the beginning of each shift, staff stated that two RNs were required to conduct those rounds and "Both nurses should assess viability." However, regarding the RN viability rounds observed on video that began at ~ 0653 the DNS and DQM stated that viability checks by the two RNs was not happening and confirmed that the video showed that only one of the two RNs was looking into patient rooms to evaluate viability.
- Staff confirmed the video showed that no RCM rounds were conducted at 0800. RCMs did not happen until 0825 and the staff that conducted those rounds did not open Patient 5's door.

1.f. Incident documentation related to Patient 5 was reviewed and included the following:

* An incident report with incident date and time 05/24/2024 at 0900 was written by MHTT 1 and reflected the following: They were "tasked with RCM imedietly [sic] after at 0800 and was starting viabilitly [sic] with the RCM which included 3 close observations. I had started to do my check at 0800 ... I had walked down into the south hallway where one of my close observations was, looked into their room and they were awake so I went directly across the hall to look into the room which was Patient 5's room. When I looked into [their door window] the light was off and [they were] sitting upright as [they do] typically everyday at different points through the day. I have observed [them] previously in this position and it appeared to be [their] most preferred sleeping position. [Patient 5's] eyes were closed and [their] room darkened but not dark enough to not be able to see. As I was looking into [their] room one of my close observations from the room behind me came out of [their] room and said to me 'goodmorning' [sic] so I turned to [them] and replied 'good morning, it's good to see you.' At that point I was turned from [Patient 5's] bedroom window and I continued on checking the next room. I had finished viability and continued to do my close observation checks throughout the hour."

* An incident report with incident date and time 05/24/2024 at 0830 was written by RN 2 and reflected the following: "At about 0830 I spoke with LPN who was passing meds, and got a list of what patients who still needed their medications. I proceeded to [Patient 5's] room, and opened the door. The room was dark, and I said 'hey [Patient 5], it's time to get up for medication'. 'It is buscuit [sic] and gravy day for breakfast'. There was no response, which is typical of [them], who doesn't respond at times. When I returned to the nurses station I informed the LPN we should just delivery [sic] [their] meds to [their] room. Shortly later, about 0840ish, staff yelled 'We need a nurse to [Patient 5's] room right now'. Myself and [another staff] ran to [Patient 5's] room, and found [Patient 5] unresponsive. [Cardiopulmonary resuscitation ("CPR")] was immediately started ..."

* An incident report with incident date and time 05/24/2024 at 0840 was written by MHTT 3 and reflected the following: "Around 8am the LPN had asked me to get certain patients up to take their meds. [Patient 5] was one of those patients, I then went to knock on [their] door and said [their] name three times, I saw that [they had their] headphones in and assumed that's why [they] could not hear me. We are not allowed to go into patient bedrooms alone, so I told the LPN [Patient 5] was not getting out of bed. So [the LPN] could bring [them their] meds."

* An incident report with incident date and time 05/24/2024 at 0847 was written by MHTT 4 and reflected the following: At 0847 "The [LPN 5] and I ... knocked on [Patient 5's] door so the Nurse can give [them their] medications. We opened the door and called out [Patient 5's] name but no response. [They were] laying in bed in a upright postion [sic] with headphones in [their] ears. So we turned on [the room] light and knocked on [the] wall to try and wake [them] up and still no response. I noticed then that [Patient 5] looked pale and stated to the nurse, '[Patient 5] looks pale.' I then went into [their] room and shook [their] shoulder and called [their] name once more but no response. At that time [Patient 5's] left arm went limp and fell to [their] side. I then felt [their] hand and [Patient 5] was really cold. I continued to check [their] pulse and notice that [they were] not breathing. I told the nurse [Patient 5] was not breathing and called a code blue and looked out the door and told the RN to come. RN rushed to the room and and [sic] stated, 'Call a code blue.' CPR was started right away at 0848 AM By [sic] LPN on the bed where [the patient] was lying ..."

* An incident report with incident date and time 05/24/2024 at 0845 was written by LPN 5 and reflected the following: "During AM medication pass, writer noticed [Patient 5] did not come to med window and nursing staff requested floor staff to prompt patient. After noticing that patient did not come, writer decided to bring [the patient's] AM medication to [them]. Writer requested assistance from floor staff due to writer not being familiar with unit or patient. Writer and [MHTT 4] approached patient's room and knocked on the door. Writer called out to patient that its time for [their] medications and can [they] please sit up. Patient did not respond after multiple attempts from both writer and [MHTT 4]. Writer turned on the light and [MHTT 4] approached the patient to try to get [them] to wake up. [MHTT 4] turned to writer, said [Patient 5's] cold and tried to shake [the patient] awake. Writer closed the door to the patient room, cleared the hallway, called down to the hub to call the charge nurse and initiated CPR while patient was on the bed. [MHTT 4] called the code blue over the walkie."

* An incident report with incident date and time 05/24/2024 at 0847 was written by Nurse Manager ("NM") 6 and reflected the following: "Arrived in response to CODE BLUE. Found in room between two patient beds with staff performing CPR. Multiple doctors, nurses, and floor staff in room and immediate area to assist with emergency. Staff were actively moving other patients off unit. EMS notified and on the way. Arrived around 0900. CPR continued in room until EMS arrived. EMS staff on site, took over scene a little after 0900. [Emergency Medical Technicians ("EMTs")] noted rigor mortis had set in pt's jaw causing what looked like difficulty intubating pt. CPR continued until patient [death] called by EMTs @ 09:09:40. While in the nurses station, I overheard staff saying this patient had a visit last evening and there was a discussion about the possibility family passed the patient something, potentially contraband. While walking out of room after code over, EMT noted rolled up currency and what appeared to be a small amount of white powder noted. Room secured by [Security Manager] and [another] security staff. This information passed along to [Security Manager]."

1.g. Attempts to resuscitate Patient 5 by hospital staff and EMS who responded to the patient unit were not successful and Patient 5 was pronounced dead at 0909. Had continuous rounding been conducted as required by hospital protocol during the hours after Patient 5 re-entered their room at 0421, Patient 5 may have been identified to be in distress, struggling to breath, or unresponsive earlier and may have survived. However, Patient 5 was not "visualized" per the protocol during continuous rounds. Further, when Patient 5 was "visualized" at 0806, 0825, and 0834 and was unresponsive to staffs' verbal communications and had closed eyes, staff did not approach the patient's bedside to determine whether the patient was alive and breathing, rather they walked away with no sense of urgency to conduct other business. Only at 0847 when staff finally approached the patient's bedside and determined that they were "cold" and "not breathing" did staff respond.

1.h. On 05/29/2024, five days after Patient 5's death, and after the State Agency ("SA") investigation had been initiated, an email from the CNO was dated and timed as sent on 05/29/2024 at 1354. The "Subject" was "Nursing RCM Reminder" and an "Attachment" was identified as "2.020 Continuous Rounds, Census, and Milieu (RCM) Management.pdf" The email reflected: "This email is intended for all OSH Nursing staff. Good afternoon OSH Nursing, Last week we experienced the loss of a patient. This has been incredibly hard and traumatizing to people across the hospital. Please reach out to your manager if you need support. We have on-site and virtual support options. This event is under investigation, so details cannot be shared yet. What we want to highlight for now, is the importance of viability checks while doing RCM rounds. It is particularly tough when the patient is in bed. Being able to confirm respiration by watching for the rise and fall of the chest from the doorway is difficult at best. As a reminder, anyone assigned to RCM rounds must enter the patient's room to assure viability if that cannot be obtained from the doorway. Please use a second staff to enter when needed. We know this will likely result in sleep disruption for the patients as we begin to enter the room more frequently. We hope this will be a short-term directive as we are looking for a technology solution. Thank you, [CNO]"

There was no other evidence provided that other actions had been taken after the patient's death to monitor and observe staff practice to ensure staff were conducting RCM continuous rounds as required to determine "viability" or that patients were alive and breathing.

1.i.i. Video recordings and documentation of incidents that occurred after Patient 5's 05/24/2024 death and after the 05/29/2024 email referenced under Finding 1.h. above in this Tag had been sent to staff were reviewed. Those reflected that nursing staff hourly rounding and milieu presence processes to monitor and confirm patient condition and status showed minimal improvement. The rounding processes which were also required to monitor and confirm patient location were additionally not effective as a patient was allowed to enter and remain in the room of two opposite gender patients during the middle of the night.

1.i.ii. Video review of 17 RCM continuous rounds on the night shifts of 06/01/2024 and 06/02/2024 on the FW2 South Hall showed minimal to no change in the way staff conducted the continuous rounds and assessed "viability" or whether the patients were alive and breathing, in comparison with how those were conducted on 05/24/2024. The time taken and the proximity of RCM staff in relation to the patients, from the hallway looking through windows of closed doors into darkened patient rooms, were not sufficient to assess whether patients were alive and breathing.

* During review of the FW2 06/01/2024 and 06/02/2024 videos on 06/05/2024 beginning at 1105, with staff present that included t

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Based on observations, review of video recordings, interviews, review of incident and patient care documentation for 19 of 23 patients (Patients 1, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23), review of P&Ps, review of hospital directives, review of equipment inventory lists and manufacturer's instructions, and review of OSH internal investigation and corrective action plan documentation, it was determined that the hospital failed to ensure each patient's right to be free from all forms of abuse and neglect. Prevention of, identification of, investigations of, and response to, incidents that reflected potential neglect that resulted in actual and potential patient harm, were not clear, complete, and accurate to ensure those incidents and events did not recur for the hospital's vulnerable psychiatric patients. Failures included:
* For Patient 1, failure to conduct and provide clear and complete investigation to identify and address all evident gaps and findings, and to document the analysis of those gaps and findings to reflect whether all potential concerns were substantiated or not.
* For Patient 1, failure to implement the corrective actions planned as result of internal investigation findings.
* Failure to prevent patient harm and potential harm as result of failures to provide care and services necessary to prevent the presence of contraband and prohibited items, and to assess, observe, and monitor patient condition and location.

The CMS Interpretive Guidelines for this requirement at CFR 482.13(c)(3) reflects "Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness."

Further, the CMS Interpretive Guidelines reflect those components necessary for effective abuse protection include, but are not limited to:
o Prevent.
o Identify. The hospital creates and maintains a proactive approach to identify events and occurrences that may constitute or contribute to abuse and neglect.
o Investigate. The hospital ensures, in a timely and thorough manner, objective investigation of all allegations of abuse, neglect or mistreatment.
o Report/Respond. The hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs, in accordance with applicable local, State, or Federal law.

Tag A-145 is a repeat deficiency previously cited on complaint surveys completed on 01/17/2022, 08/01/2022, 11/17/2022, 10/05/2023, and 03/14/2024.

Findings include:

1.a. Interview with staff that included the CMO/Interim OSHS, the DQM, DSC, and IRSID on 05/30/2024 at ~ 1635 during review of patient deaths that had occurred at the hospital in 2023 and 2024 revealed that:
* Patient 1 unexpectedly died on the FW2 Unit on 11/02/2023.
* The patient was in a closed seclusion room at the time of their death.
* During a "medical situation" the patient started having psychotic symptoms and requested to go into seclusion.
* The hospital had reported the death to CMS by means of the electronic submission required for deaths associated with restraint or seclusion.

1.b. On 05/30/2024 surveyors requested incident and investigation documentation related to Patient 1's 11/02/2023 unexpected death. The following documents were provided:
* One incident report #66633 written by an RN on 11/02/2023
* Copy of an electronic form titled "CMS Report of a Hospital Death Associated With The Use of Restraint Or Seclusion" dated as submitted to CMS on 11/03/2023 at 1426.
* Form CMS-10455 titled "Report of a Hospital Death Associated With Restraint Or Seclusion"

2. On 06/11/2024 at 1613 surveyors sent OSH an email with a request for the incident, internal investigation, and follow-up documentation. The email specified:
* "Regarding 11/02/2023 [Patient 1's] death:
- All incident investigation and corrective actions taken
- All restraint and seclusion documentation
- All medical record documentation for October and November 2023
- Patient's Treatment Plan in place for October and November 2023
- Code documentation
- More will be requested as needed."

3. On 06/13/2024 beginning at ~ 1220 with staff that included the CMO/Interim OSHS, Interim DS, DQM, DSC, COM ("Chief of Medicine"), Medical Clinic Manager ("MCM"), and AAG the following information was provided:
* The DQM stated the hospital did a CADM investigation and an Root Cause Analysis ("RCA") investigation for Patient 1's 11/02/2023 unexpected death.
* Investigation "action items" were submitted to the hospital's Accreditation Organization ("AO"), the Joint Commission, on 01/10/2024 and "approved" on 02/20/2024. Staff stated that the Joint Commission "sets the schedule for RCA events and follow-up."
* The patient's symptoms were "distressing" and included auditory hallucinations that were difficult to manage. The patient took medications that caused weight gain. The patient had sleep apnea and other diagnoses.
* On 10/13/2023 the patient was seen in the hospital's medical clinic for complaints of shortness of breath. Cholesterol medications were started, and a cardiac referral was made.
* There were no medical clinic progress notes written for the visit at that time.
* Diagnoses related to the patient's medical conditions were not updated in their medical record.
* Regarding the incident on the morning of 11/02/2023, staff provided a high-level summary of the events surrounding the patient's death that included: the patient walked up to the NS and reported they had difficulty breathing, they fell on the floor, and bumped their head. Nursing staff members responded, took vital signs, and got a chair for the patient. The patient had a history of "somatic symptoms." The patient got up and made threatening statements and requested seclusion. Staff helped the patient walk to seclusion and the patient fell onto their knees at the threshold of the seclusion door. The patient laid in a prone position on the floor. Staff moved the patient so the door would shut. The patient requested the seclusion room door be locked. The patient was rocking their head and rolling on the floor. The patient rolled onto their side, then stopped moving. Staff tried to wake the patient, the patient did not respond, a code was called and staff began resuscitation efforts, EMS responded, resuscitation efforts were not successful and Patient 1 died.
* Gaps identified and corrective actions planned in conjunction with the Joint Commission as result of the hospital's investigation were related to medical clinic integration with care plans, communications between the medical clinic and inpatient unit, and standardization of medical guidelines for patients with metabolic syndrome. Those corrective actions plans were to be implemented by March 2024.
* The DQM stated there were no findings or corrective action related to nursing. Nursing response to the patient's medical concerns in light of the patient's psychiatric symptoms was considered and discussed with nursing leadership but was not a causal finding.

4. On 06/13/2024 the following documents related to Patient 1's death were provided to the surveyors. Those did not include all of the documents requested on the 06/11/2024 email to the hospital specified under Finding 2 above:
* A "CADM Questionnaire Report_Redacted final," nine-page document titled "Clinical Administrative Debrief Meeting Process Questionnaire & Executive Report," that had a last date of 11/09/2023.
* A "ReportandActionItem_Submission_FINAL," 38-page document titled "ALT-0 Summary Report for Sentinel Event Number 445710" that had a footer date of 01/10/2024 at the bottom of each page. There were no other dates that reflected completion of the document.
* "[Attorney Client Privilege] Work Product Inc#445710 ... unexpected death" that was an email dated 03/19/2024 at 1720 from hospital staff to the hospital's AO, the Joint Commission, regarding a 02/20/2024 conference call discussion related to Patient 1's death incident corrective actions.
* Three "Clinic Protocols":
- "Metabolic Syndrome Practitioner Care" dated as "New" on 02/20/2024.
- "Medical Clinic Provider Documentation Standards" dated as "New" on 03/14/2024.
- "Clinical Practice Guideline for Metabolic Syndrome" that was not dated.
* "Rolling Monthly Averages, Note Submissions," undated, one-page audit results document titled "% of Medical [Primary Care Provider ("PCP")] OnTime Note submission."
* Seven documents related to Code Blue training and staff attendance.

5. The CADM with a final date of 11/09/2023 was reviewed. It reflected the following:
* The following sections of the report were fully redacted:
- "What potential immediate actions, if any, should be considered to reduce the risk of recurrence?"
- "What communication and/or training needs are recommended?"
- "[Clinical Advisory Team ("CAT")] CADM Report Review Summary"
* "Information sources included ... chart notes, and 19 incident reports."
* Other referenced documentation that was not provided included the "seclusion entry note" and the on-call physician's documentation and note.
* In the CADM section for "Did this event identify potential gaps in care/treatment?" the only response was "Medical clinician documentation: there was inadequate documentation of treatment and diagnosis following an appointment for complaints of chest pain on October 13. Diagnosis of hyperlipidemia was not updated in the chart and there was no treatment note. Patient did receive appropriate care and follow up and was placed on medications. Related to this, the [Treatment Care Plan ("TCP")] was not updated to reflect new medical problem."

6.a. The RCA or "Report for Sentinel Event Number 445710" that was dated 01/10/2024 was reviewed. It reflected "Patient is a [age] African American [gender] admitted to [OSH] on 12/22/2016 ... This was the patient's fourth admission ... due to [the patient's] ongoing severe psychiatric symptoms which consisted of auditory hallucinations (often of [one of their family members], which could be command in nature to harm [themselves] or others), paranoid delusions, intermittent agitation and physical aggression. [Patient 1] had undergone numerous medication trials to target [their] psychiatric symptoms. [Their] symptoms had improved over time but had continued to be quite prominent and highly distressing to the patient. Providing medications to treat [their] psychiatric symptoms was quite challenging due to [their] reluctance to agree to changes in [their] regimens as well as the patient experiencing significant side effects from the medications. Side effects included marked weight gain, prediabetes/insulin resistance, deconditioning, sleep apnea, and hyperlipidemia. When experiencing auditory hallucinations of [their family member], [they] often would take on the persona of [their family member] and at times could be highly assaultive resulting in serious staff injury. As a result, one element of [the patient's] treatment care planning was that if the patient asked to be placed in locked seclusion, [they were] allowed to do this as it was a way [they] would keep [their self] and others safe."

6.b. The RCA reflected "analysis" of the following four of 24 "items" :
* "Question: 14. To what degree was all the necessary information available when needed? Accurate? Complete? Unambiguous? Organization Response: No process for Medical Clinic integration into treatment care planning."
* "Question: 15. To what degree is communication among participants adequate for this situation? Organization Response: No process developed for communication between unit and Medical Clinic."
* "Question: 20. What are the barriers to communication of potential risk factors? Organization Response: refer to Question #15."
* "Question: 21 . How is the prevention of adverse outcomes communicated as a high priority? Organization Response: No standardized medical guidelines for the care of patients with metabolic syndrome."
* The RCA included three "Root Cause Details ... Plan of Action ... [Measures of Success ("MOS")]" for three "items" identified in Questions 14, 15, 20, and 21. Refer to Findings 19.a. through 19.e. below that reflect those action plans had not been implemented as of the date of this survey.
* There was no analysis or organization response to the other 20 items.

7. The email dated 03/19/2024 at 1720 from hospital staff to the hospital's AO, the Joint Commission, regarding a 02/20/2024 conference call discussion related to Patient 1's death incident corrective actions was reviewed. The email reflected the hospital's three actions plans identified in the RCA had been re-stated (Refer to Findings 19.b. through 19.d. below) and a fourth action plan had been added. The fourth action plan was that the hospital would "offer at least 8 Code Blue drills throughout the year to the nursing staff during the regularly scheduled Code Green [response to a behavioral emergency] Drills, focusing on providing necessary medical care to aggressive or potentially aggressive patients. The first combined drill (Code Blue + Code Green) will be completed by 04/15/2024. MOS is implementation of this item to our calendar of drills. Frequency will be once a quarter on each of two campuses. Responsible Organization Leader is CNO."

8.a. On 07/03/2024 at 1405 the survey exit conference was conducted. Staff present included the CMO/Interim OSHS, the Interim DS, the DQM, DSC, CNO, AAG, DOS, IRSID, and others. During the exit conference preliminary findings for the survey, including related to Patient 1's death based on the information provided by the hospital to that point, were shared with the hospital staff. Those preliminary findings included potential gaps evident during surveyors' review of the internal investigation documentation provided by the hospital, that was also found to lack references to those potential gaps.

8.b. Hospital investigation event timelines showed that on the morning of 11/02/2023 while the pt stood at the medication window their legs buckled and they subsequently fell to the floor and complained of trouble breathing and chest pain. Staff responded to the patient and ~ 15 minutes later they were walked into the seclusion room. Upon entry to the seclusion room the description of the pt's condition at that time included that their "skin normal but clammy; difficulties with respirations/speaking; Obvious signs of physical distress: Reports [they] can't breathe, had chest pain, kept repeating 'I feel like I'm going to die.'" ~ six minutes later staff entered the room and then left. ~ eight minutes later the patient stopped moving. ~ two minutes later staff responded and did sternal rub with no response. At 0754 Code Blue was initiated and CPR started at 0755. Resuscitation efforts continued, but EMS was not called for ~ seven minutes after the code was called, at 0801. EMS arrived and the pt was pronounced dead at 0845.

8.c. There was no documentation in the investigation documents provided to reflect that nursing staff member practices and management of the patient's change of condition had been evaluated by the hospital to determine whether response to and assessment of the patient's change of condition was timely and appropriate. That includes a gap of several minutes between the time of observation of the patient in seclusion with obvious physical distress and the time they stopped moving, and a gap of several minutes from the time a code was called to the time EMS was called. The only gaps identified by the hospital's investigation were related to medical staff visits and documentation practices

8.d. On 07/03/2025 at the end of the exit conference, in response to the hospital's assertion that some of the preliminary findings related to the hospital's investigation of Patient 1's death were unfounded, the hospital was provided an opportunity to submit additional information it believed was pertinent to the incident. They were reminded that the surveyors had made prior requests for all incident, investigation, follow-up, and corrective action documentation related to Patient 1's unexpected death, including that all investigation documentation referenced in the CADM had also not been provided such as "... chart notes, and 19 incident reports."

9. On 07/05/2024 the following documents related to Patient 1's death and the hospital's investigation, previously requested by surveyors, were provided:
* 18 incident reports related to events and circumstances around Patient 1's death on 11/02/2023, including the one solely provided to surveyors on 05/30/2024.
* Nine pages of "Progress Notes 11-2-2023" written about Patient 5's death by five nursing staff members.
* "[Psychiatric Security Review Board ("PSRB")] Hearing Notes" titled "Psychiatry PSRB Update Note dated 02/07/2023
* "Risk Review-Forensic" dated 08/24/2023
* "Forensic Risk Review" dated 08/25/2023
* "Treatment Care Plan" dated with "Plan Date" of 10/17/2023.
* Fourteen pages of 11 "Patient Progress Notes" written by RN and medical staff members from 06/30/2022 through 11/01/2023
* 29 incident reports for 21 incidents that occurred between 07/17/2022 and 11/01/2023.

10. Review of Patient 1's 10/17/2023 "Treatment Care Plan" revealed the following:
* "Psychiatric - [Patient 1] has a psychiatric diagnosis of Schizoaffective disorder, bipolar type, and [they attribute] these voices with an inability to control [their] violent impulsive behaviors. Historically, [the patient] states that [they continue] to hear voices even after multiple medication trials. [The patient] has expressed a desire to maintain safety and move forward in their treatment with a short-term goal of moving to a lower acuity program of care and earning privileges after meeting with the PSRB."
* Patient 1 "attended [their] 30 day treatment team meeting. [They] shared [they were] doing 'good.' 'My left leg hurts.' 'I'm kind of getting use [sic]to it.' (Medications for cholesterol) Regarding interactions with peers, 'I'm just minding my own business.' Family visits are 'good.' [They] questioned 'Are we still taking me down from that Zoloft?' [They are] open to submitting an application for patient paid employment. [Their] personal goals include obtaining a degree in 'psychology.' [They have] 'no' thoughts to harm [themselves] nor others. Regarding symptoms, 'First thing in the morning I hear the voices.'"
* Patient 1 "is doing well. [They are] medication adherent. [They] partially [attend] social dining and will get a clamshell if [they choose] to eat on the unit. [They enjoy] engaging in valued therapeutic treatment activities such as music therapy, watching movies on [their] tablet, supported education, emotional wellness and fitness. [They engage] in 1: 1 assessments with clinical staff when requested."
* "Moderate risk of violence - Progressing - [Patient 1] has a history of physical assaults to staff and peers. [They state] that voices and command hallucinations create an inability to control impulses to physically assault others. [The patient] has been able to remain violence free for a satisfactory a [sic] period of time such that [their] need to have enhanced precautions has been discontinued and [they have] expressed a desire to remain safe and has a goal of moving forward to a lower acuity program of care and working with the PSRB to gain privileges which are currently on and off ground privileges with staff supervision."
* "RN and unit nursing staff will allow and encourage the use of the [seclusion] room for [Patient 1], as needed for reducing the risk of aggression and to allow [them] to feel safe when [they are] having trouble with urges to be physically aggressive to others ... After 9 p.m., if [they are] having significant overt symptoms causing milieu disruption staff will ask [them] to use the [seclusion] room. 1. If [Patient 1] requests to use unlock [sic] seclusion, nursing staff will let [them] in without asking questions. 2. If [Patient 1] requests to be locked in seclusion, nursing staff will lock [them] in without questions and tell RN. RN will follow seclusion and restraint procedures."
* Patient 1 "made homicidal threats 10/11/23 and requested to go to seclusion."
* "PSRB - Privileges - Risk Review approved the privileges of 2: 1 on-grounds and 2: 1 off-grounds for medical; all of these privileges must be supervised by at least one familiar staff. This approval was based on [Patient 1's] notable improvements over the past months, including medication adherence, actively coping with known triggers, proactively requesting the [seclusion] room for safety, engaging in individual treatment, and [their] [Interdisciplinary Team's ("IDT's")] familiarity with [the patient's] risks and mitigation."
* "Other things that are important to my health (items stable with treatment) - [Patient 1] has multiple medical concerns including chronic pain, asthma, and metabolic syndrome, which are all being managed with routine care and tracked by medical clinic."

During the 10/17/2023 treatment plan session the patient complained that their "left leg hurts." That was three days after the 10/13/2023 medical clinic appointment for which no progress notes were written. There was no indication in the treatment plan documentation that the patient's left leg pain had been assessed or evaluated on 10/17/2023 or thereafter.

11. Review of the 29 incident reports for 21 incidents/events between 07/17/2022 and 11/01/2023 revealed the following that supported the behavioral evaluation in the Treatment Care Plan dated 10/17/2023:
* Patient 1 had not assaulted other patients or staff since 02/03/2023.
* On four occasions between 12/19/2022 and 02/03/2023 Patient 1 assaulted staff persons.
* On seven occasions between 07/24/2022 and 01/08/2023 Patient 1 assaulted or was involved in physical altercations with other patients.
* On three occasions between 10/28/2022 and 11/01/2023 Patient 1 hit themselves or banged their head against a wall.
* On seven occasions between 07/17/2022 and 12/09/2022 Patient 1 requested to go to the seclusion room for reasons the patient stated that included "before [they hurt] anyone" and "voices are telling [the patient] to attack someone and that's the only way to prevent it."
* The 10/11/2023 seclusion event referenced in the TCP under Finding 10 above was not included in the incident reports provided dated from 07/17/2022 through 11/01/2023.

12.a. On 07/12/2024 at 1305 surveyors met with hospital staff that included the CMO/Interim OSHS, the Interim DS, the DQM, DSC, CNO, AAG, and others to review the preliminary findings related to the review of the investigation documentation provided through 07/05/2024. Again, those findings included potential gaps evident during surveyors' review of the internal investigation documentation provided by the hospital, that was also found to lack references to those potential gaps. For example:

12.b. An RN Progress Note written by [RN 13] on 11/02/2023 reflected that "At 0730 [Patient 1] came to medication window for [their] morning medications. At the window [they] stated 'I can't breathe. I feel like I can't breathe.' Patient then slumped onto the ground. This RN ran around the window to talk to patient. Patient was awake and alert per [their] norm, but lying on the ground on [their] back. [They] stated, 'I just feel like I can't breathe' ... [Another RN] called the [On-Call Doctor ("OD")] and requested they come to the unit to assess the patient due to complaints of chest pain and shortness of breath" ... [Patient 1's] vitals were [Blood Pressure ("BP")] 120/78, 02 was 90%, pulse 97. While obtaining vitals, 02 went up to 98% "... Assisted patient to lie on the ground. After a few moments, patient sat up and stated that [they] wanted to go the [seclusion] room and then started talking as if [they were their family member]. As [their family member they] said 'you go to the [seclusion] room or punch everyone' ... At one point the [Unit Administrator] walked onto the unit and patient stated 'you've hit old [people] before. Hit that old [person].' [Unit Administrator] walked away from patient and patient voiced that [they] wanted to walk into the [seclusion] room."

The note continued, reflected patient was assisted to the seclusion room and at ~ 0742 an RN "called OD again requesting that they come to see patient, again reporting that patient was complaining of shortness of breath and chest pain. A few moments later the staff in the [seclusion room] anteroom requested RN to come assess. 0753 This RN walked into the [seclusion] room and patient was lying on the ground on [their] side. [Patient 1] was not responding to voice. This RN pushed patient over onto [their] back and performed sternal rub while directing staff to grab a crash cart. A code blue was called at 0754. Staff started to respond. Patient opened [their] eyes and was breathing but lips were pale. There was a pulse initially but patient's eyes rolled back into [their] head while waiting for the crash cart. Another RN entered the room and compressions were started at 0755 ... Three rounds of epi 0.3 [milligrams ("mg")] were given [Intramuscular ("IM")] left thigh per [DO 11], [Epinephrine ("Epi")] given 0802, 0805, 0808 per instructions over the course of the code without effect. EMS called at 0801."

12.c. Another RN's Progress Note written on 11/02/2023 reflected that that the RN was connected with a physician on the phone and that they reported to the physician the patient had fallen and the vital signs taken. Another RN "called on call doctor again and requested that they come see patient, again reporting that patient was complaining of shortness of breath and chest pain." Another physician was also notified by the RN of the event and per that physician the RN was directed to "call on call provider and have them see pt; on call provider notified of this request to see pt." The note reflected that "pt stated to [themselves] 'You're going to die in here'".

12.d. An MHT Progress Note written on 11/02/2023 reflected that when [Patient 1] complained of "difficulties breathing" at the NS window, the "[RN 13] grabbed the vital machine and started taking vitals. [The RN] had to do manual Blood Pressure Check ..." Further, the note reflected that the RN was "reassuring" the patient that "the On Call doctor was being notified."

12.e. An "Emergency Seclusion Or Restraint Entry Note" was reviewed. The only staff name/signature was [RN 13] who wrote the progress note above. It was dated as signed by [RN 13] on 11/02/2023 at "0745." The note reflected the following:
- Differences in ink color and differences in handwriting reflected at least two staff's entries on the form, and possibly three. Not all of those different entries had been signed and dated and timed.
- The date and time the patient was placed in seclusion was not documented.
- It was not clear if the vital signs on the form were the ones taken at the NS after the patient's fall, or had been taken and reassessed during the time the patient was in seclusion.
- Patient assessment information on the form reflected:
"BP 120/78 ... Pulse 97 ... [Respiratory Rate Unable to obtain]"
"Skin integrity: [Normal] ... Clammy"
"Difficulties with respirations or speaking? [Yes]"
"Obvious signs of circulatory compromise? [No]"
"Obvious signs of injury or skin integrity issues? [No]"
"Obvious signs of physical distress? [Yes]"
"Reports [they] can't breathe, has chest pain, kept repeating 'I feel like I'm going to die'"
"Patient's mood, affect, mental status, response to emergency measures, and any significant findings from physical assessment: Patient talking as though [they were their family member] saying [they] couldn't breathe, 'I feel like I'm going to die' and then alternating with 'Go to the [seclusion] room or punch everyone,' and made threats against [Unit Administrator] saying 'you know I've made you hurt old [people] before. Hit that old [person].'"
"Criteria for Release: ... Unable to discuss Patient in seclusion per request while awaiting OD to come assess further Code blue intiated [sic] at 0754 - See notes Seclusion ended at 0754."
"RN Exit Note After Release of Patient ... Seclusion ended at 0754 due to code blue. Pt expired 0845 per EMS"

12.f. The notes referenced under Findings 12.b., 12.c., 12.d., and 12.e. above raised questions about the following:
* Timeliness of the on-call physician's response to nursing staff members requests for the physician to come to the unit to see the patient.
* There was no documentation of a second set of vital signs after the ones taken at the NS shortly after "0730" before the patient went into seclusion. The vital signs recorded on the Seclusion Entry Note are duplicative of those recorded in the progress notes taken at the NS. There is no evidence that vitals were taken while the patient was in seclusion and experienced further change of condition. Further the description of the patient's threats against the Unit Administrator had occurred outside of the seclusion room.
* Timeliness of the EMS call ~ seven minutes after hospital staff found the patient unresponsive and initiated CPR.
* Why the RN "had to do" a manual BP check even though they had "grabbed the vital machine." Was the vital machine not working, or broken?

There was no documentation in the investigation information provided to reflect that those potential gaps had been evaluated and analyzed to determine whether there were opportunities for improvement and if corrective actions were indicated to prevent recurrence.

12.g. During the review on 07/12/2024, hospital staff confirmed that all of the potential gaps discussed during the review, including those identified above, had either not been investigated or that analysis of the potential gap had not been documented. During that review hospital staff disclosed that there was other investigation documentation of Patient 1's death that had still not been provided, for example: Staff interview notes. This in spite of previous surveyor verbal and written requests for all of the incident and investigation documentation. The hospital was given yet another opportunity to submit that documentation by the end of day on 07/12/2024.

13. On 07/12/2024 at 1644 the DQM sent an email that stated: "OSH is in the process of providing the following documents, which will be uploaded to the shared drive by Monday morning ...
- Interview notes from the RCA.
- Provider notes associated with the event.
- Incident reports associated with the event and pertaining to typical patient behavior that influenced staff response during this event.
- Documents associated with the investigation, with the exception of those protected under Attorney Client Privilege.
- Written description of this RCA process."

This email further reflected that all investigation documentation was not provided and the hospital had determined to make its own "exception" to the SA's request.

14. On 07/12/2024 at 1710 the DSC sent an email that stated the investigation documents had been submitted and consisted of the following incident and investigation documentation related to Patient 1's death incident. Those documents included significant previously requested documentation that had not been provided such as all investigation documentation, including the seclusion note requested on 06/11/2024 as described under Finding 2 above:
* "[Seclusion-Restraint ("S-R")] Entry," one-page document titled "Emergency Seclusion or Restraint Entry Note" dated 11/02/2023.
* Four pages of "Provider Progress Notes - 11.02.23" written by Medical Doctor ("MD") 10, DO 11, and MD 12.
* "Written description of RCA Process," three-page undated document titled "RCA."
* Fourteen untitled "Investigation Notes" 1 through 14.
* Six untitled "Documents associated with the investigation" were provided, however, it was unclear what the relevance of many of the documents was to the hospital's internal investigation and the SA's request:
- An untitled 50-page document provided included an 11/02/2023 video timeline, Patient 1's death certification, and chart progress notes not in chronological order from 2016, 201

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It was determined that the governing body failed to ensure, through the QAPI program, the prevention and reduction of adverse events analyzing findings, and implementing actions to prevent recurrence of those (Tag A-286).

Refer to the findings cited under this Condition at Tag A-286 under CFR 482.21(a), (c)(2), (e)(3) - Standard: Patient Safety, that reflects the QAPI program failed to ensure that incidents and adverse patient events were clearly investigated and analyzed, and that corrective actions were planned and implemented to prevent recurrence of those, to promote learning throughout the hospital, and to establish clear expectations for patient safety. Those failures reflect the investigation of the unexpected death of Patient 1 was unclear and incomplete. All potential gaps or concerns evident in documentation related to Patient 1's death had not been analyzed to determine whether corrective actions were indicated, and corrective actions planned to address gaps that had been identified had not been implemented.

Refer to the findings cited at Tag A-115, CFR 482.13 - CoP: Patient's Rights, that reflects the QAPI program failed to ensure each patient's rights were protected and promoted, including the right to receive care in a safe setting. Those failures created an unsafe EOC that likely contributed to patient harm and death for Patient 5 and created the likelihood of harm to other patients. The hospital failed to screen visitors; monitor in-person visits between patients and visitors; prevent contraband; observe and monitor patient condition, status, and location to ensure patients were safe and alive (Tag A-144). It further failed to conduct clear and complete investigations of adverse events that addressed all potential gaps and deficient practices; and failed to implement and monitor corrective actions to prevent
recurrence for other patients (Tag A-145).

Refer to the findings cited at Tag A-385, CFR 482.23 - CoP: Nursing Services, that reflects the QAPI program failed to ensure patient nursing and safety needs were met by nursing personnel, under the supervision of the RN. The RN responsible for the care of each patient failed to ensure ongoing assessment, observation, monitoring, and provision of care and services. Those failures occurred during in-person visitation sessions between patients and visitors, and on the inpatient units. (Tag A-395).

Refer to the findings cited at Tag A-700, CFR 482.41 - CoP: Physical Environment, that reflects the QAPI program failed to ensure the physical environment was maintained and arranged to provide a safe EOC. The hospital failed to ensure safety and security measures were sufficient to prevent the presence of drugs and other unsafe contraband in the EOC. Those measures were not fully developed, security personnel were not trained, and the failures occurred during visitor check-in, screening, and during in-person visitation sessions between patients and visitors (Tag A-701). In addition, screening equipment or devices had not been subject to preventive maintenance to ensure those operated as intended (Tag A-724).

Refer to the findings cited at Tag A-1600, CFR 482.60 - CoP: Special Provisions for Psychiatric Hospitals, that reflects the QAPI program failed to ensure the hospital complied with all CoPs specified in CFRs 482.1 through 482.23 and CFRs 482.25 through 482.57 as the following CoPs were determined to be out of compliance. (Tag A-1605).
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29708

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Based on interviews, review of incident and patient care documentation for 1 of 1 patient (Patient 1), review of P&Ps, and review of OSH internal investigation and corrective action plan documentation it was determined that the hospital failed to ensure that incidents and adverse patient events were clearly investigated and analyzed, and that corrective action plans it developed were implemented, to prevent recurrence of such events, to promote learning throughout the hospital, and to establish clear expectations for the safety of the hospital's vulnerable psychiatric population.

Tag A-286 is a repeat deficiency previously cited on complaint and revisit surveys completed on 01/17/2022, 08/01/2022, and 03/14/2024.

Findings include:

1. Refer to the findings for Patient 1 cited at Tag A-145, CFR 482.13(c)(3) - Standard: Freedom from Abuse, that reflects the investigation of the unexpected death of Patient 1 was unclear and incomplete. All potential gaps or concerns evident in documentation related to Patient 1's death had not been analyzed to determine whether corrective actions were indicated, and corrective actions planned to address gaps that had been identified had not been implemented.
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29708

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It was determined the governing body failed to ensure patient nursing and safety needs were met by nursing personnel, under the supervision of the RN. The RN responsible for the care of each patient failed to ensure ongoing assessment, observation, monitoring, and provision of care and services. Those failures occurred during in-person visitation sessions between patients and visitors, and on the inpatient units. (Tag A-395).

It was determined that the RN responsible for the hospital's nursing services failed to ensure that the nursing and safety needs of the hospital's vulnerable psychiatric patients were met and those failures likely contributed to patient harm and death and created the likelihood of harm to other vulnerable psychiatric patients.
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29708

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Based on observations, review of video recordings, interviews, review of incident and patient care documentation for 18 of 23 patients (Patients 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23), review of P&Ps, review of hospital directives, and review of OSH internal investigation documentation, it was determined that the RNs assigned to the provision and supervision of patient care failed to ensure that each patient's nursing and safety needs were met by ongoing assessment, observation, and monitoring, including in response to patient change of condition; and that all other nursing personnel provided care and services in a manner that ensured the ongoing health and safety of the hospital's vulnerable psychiatric population.

Tag A-395 is a repeat deficiency previously cited on complaint and revisit surveys completed on 01/17/2022, 08/01/2022, 11/17/2022, 10/05/2023, and 03/14/2024.

Findings include:

1. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety. Those findings reflect the failures of the nursing department and personnel to ensure:
* Situational awareness and diligent assessment, observation, and monitoring of patient condition and status, including whether patients were alive and breathing for Patient 5 as described in Findings 1.a. through 1.j.
* Situational awareness and diligent observation and monitoring of patient and visitor behaviors and interactions during in-person visitation sessions to prevent the passing of drugs and other contraband from visitor to patient for Patient 5 as described in Findings 2.a. through 2.c., and 5.a. through 6.
* Situational awareness and diligent observation and monitoring of patient location to ensure patients were not in unauthorized areas for Patient 22 as described in Finding 1.i.iii.
* Failure to prevent the recurring presence of, and patient possession of, drugs and other contraband for Patients 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, and 23 as described in Findings 7.a. through 7.f.
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29708

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It was determined the governing body failed to ensure the physical environment was maintained and arranged to provide a safe EOC. The hospital failed to ensure safety and security measures were sufficient to prevent the presence of drugs and other unsafe contraband in the EOC. Those measures were not fully developed, security personnel were not trained, and the failures occurred during visitor check-in, screening, and during in-person visitation sessions between patients and visitors (Tag A-701). In addition, screening equipment or devices had not been subject to preventive maintenance to ensure those operated as intended (Tag A-724).

Review of hospital directives, review of equipment inventory lists and manufacturer's instructions, and review of OSH internal investigation documentation, it was determined that the hospital failed to maintain an EOC free of hazards and risks to ensure the safety and well-being of the hospital's vulnerable psychiatric population and those failures likely contributed to patient harm and death and created the likelihood of harm to other vulnerable psychiatric patients.
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29708

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Based on observations, review of video recordings, interviews, review of incident and patient care documentation for 17 of 23 patients (Patients 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, and 23), review of P&Ps, review of hospital directives, review of equipment inventory lists and manufacturer's instructions, and review of OSH internal investigation documentation, it was determined that the hospital failed to ensure the provision of a safe EOC that was maintained to minimize security and safety risks for the hospital's vulnerable psychiatric population.

Tag A-701 is a repeat deficiency previously cited on complaint and revisit surveys completed on 01/17/2022, 08/01/2022 and 11/17/2022.

Findings include:

1. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety. Those findings reflect the failures of the security department and personnel to ensure:
* Diligent and consistent registration/check-in of visitors prior to in-person patient visitation sessions as described in Findings 3.a. through 3.e.
* Diligent and consistent screening of visitors prior to in-person patient visitation sessions to prevent the entry of drugs and other contraband into the hospital, and to prevent the passing of those from visitor to patient for Patient 5 and others as described in Findings 2.a. through 2.c., 4.a. through 4.h., and 6.
* Situational awareness and diligent observation and monitoring of patient and visitor behaviors and interactions during in-person visitation sessions to prevent the passing of drugs and other contraband from visitor to patient for Patient 5 as described in Findings 2.a. through 2.c., and 5.a. through 6.
* Safety and security measures were not sufficient to prevent the presence of, and patient possession of, drugs and other unsafe contraband in the EOC for Patients 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, and 23 as described in Findings 7.a. through 7.f.
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29708

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Based on observations, review of video recordings, interviews, review of equipment inventory lists and manufacturer's instructions, and review of P&Ps it was determined the hospital failed to ensure patient safety equipment/devices used for screening individuals, including visitors, for drugs and other contraband, were maintained in accordance with manufacturer's recommendations, to ensure they operated and functioned as designed and intended, and were efficient and accurate.

Tag A-724 is a repeat deficiency previously cited on the complaint survey completed on 10/05/2023.

Findings include:

1. Refer to the findings cited at Tag A-144 under CFR 482.13(c) - Standard: Privacy and Safety. Those findings reflect the failures of the security department and personnel to ensure that screening equipment/devices were subject to preventive maintenance as described in Findings 4.f., 4.h., and 6.
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29708

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It was determined that the governing body failed to ensure the hospital complied with all CoPs specified in CFRs 482.1 through 482.23 and CFRs 482.25 through 482.57 as the following CoPs were determined to be out of compliance (Tag A-1605):
* CFR 482.12 - CoP: Governing Body
* CFR 482.13 - CoP: Patient's Rights
* CFR 482.21 - CoP: QAPI
* CFR 482.23 - CoP: Nursing Services
* CFR 482.41 - CoP: Physical Environment

Refer to each CoP cited in this 2567 for the failures included in A1600.
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29708

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Based on observations, review of video recordings, interviews, review of incident and patient care documentation for 19 of 23 patients (Patients 1, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23), review of P&Ps, review of hospital directives, review of equipment inventory lists and manufacturer's instructions, and review of OSH internal investigation and corrective action plan documentation, it was determined that the hospital failed to ensure it complied with all CoPs specified in CFR 482.1 through CFR 482.23 and CFR 482.25 through CFR 482.57 as the following CoPs were determined to be out of compliance:
* CFR 482.12 - CoP: Governing Body
* CFR 482.13 - CoP: Patient's Rights
* CFR 482.21 - CoP: QAPI
* CFR 482.23 - CoP: Nursing Services
* CFR 482.41 - CoP: Physical Environment

Tag A-1605 is a repeat deficiency previously cited on the complaint survey completed on 05/06/2024.

Findings include:

1. Refer to the findings cited at Tag A-043, CFR 482.12 - CoP: Governing Body, that reflects the governing body failed to ensure the provision of safe and appropriate care to patients in the hospital in a manner that complied with all CoPs.

2. Refer to the findings cited at Tag A-115, CFR 482.13 - CoP: Patient's Rights, that reflects the hospital failed to ensure each patient's rights were protected and promoted, including the right to receive care in a safe setting. Those failures created an unsafe EOC that likely contributed to patient harm and death and created the likelihood of harm to other patients. The hospital failed to screen visitors; monitor in-person visits between patients and visitors; prevent contraband; observe and monitor patient condition, status, and location to ensure patients were safe and alive (Tag A-144). It further failed to conduct clear and complete investigations of adverse events that addressed all potential gaps and deficient practices; and failed to implement and monitor corrective actions to prevent recurrence for other patients (Tag A-145).

3. Refer to the findings cited at Tag A-263, CFR 482.21 - CoP: QAPI, that reflects the hospital failed to ensure, through the QAPI program, the prevention and reduction of adverse events including by conducting clear and thorough investigations of adverse events, analyzing findings, and implementing actions to prevent recurrence of those (Tag A-286).

4. Refer to the findings cited at Tag A-385, CFR 482.23 - CoP: Nursing Services, that reflects the hospital failed to ensure patient safety and nursing needs were met by nursing personnel, under the supervision of the RN. The RN responsible for the care of each patient failed to ensure ongoing assessment, observation, monitoring, and provision of care and services. Those failures occurred during in-person visitation sessions between patients and visitors, and on the inpatient units. (Tag A-395).

5. Refer to the findings cited at Tag A-700, CFR 482.41 - CoP: Physical Environment, that reflects the hospital failed to ensure the physical environment was maintained and arranged to provide a safe EOC. The hospital failed to ensure safety and security measures were sufficient to prevent the presence of drugs and other unsafe contraband in the EOC. Those measures were not fully developed, security personnel were not trained, and the failures occurred during visitor check-in, screening, and during in-person visitation sessions between patients and visitors (Tag A-701). In addition, screening equipment or devices had not been subject to preventive maintenance to ensure those operated as intended (Tag A-724).
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29708