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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.12 Condition of Participation: Governing Body, was out of compliance.

A-0043 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body.

Based on interviews and document review, the facility failed to have a governing body that carried out its responsibilities to implement a quality assurance and performance improvement (QAPI) program that defined issues and goals, measured outcomes, analyzed data and implemented quality controls to reduce risks to patients. (Cross reference Tag A-0286)

Findings include:

Facility documents:

The Quality Assurance and Performance Improvement (QAPI) Plan for 2021 read, the purpose is to provide a mechanism for the facility to define issues and goals, measure outcomes, analyze data and implement quality controls to ensure the best experience for all patients across the continuum of services. The QAPI plan includes policies to analyze underlying causes of systemic problems and adverse events and develop corrective action plans or performance improvement activities.

The facility's governing body is responsible for the quality of all services delivered at the facility. The governing body's authority is delegated to the facility's Chief Executive Officer (CEO). The governing body monitors, revises and assures compliance with by-laws to assure compliance with Conditions for Medicaid and Medicare (CMS) conditions of participation. The governing body provides direction and guidance to ensure necessary staffing, training, resources, equipment and environment to provide patients with active treatment.

The Governing Body Bylaws revised in 2018 read, the governing body is responsible for overseeing the development and implementation of the QAPI program.

1. The governing body failed to implement an effective quality assurance and performance improvement (QAPI) program that defined issues and goals, measured outcomes, analyzed data and implemented quality controls to reduce risks to patients.

A. Interviews revealed not all incidents/safety events were investigated, followed-up and brought forward to the governing body.

On 8/10/21 at 2:27 p.m., an interview was conducted with the Chief Nursing Officer (CNO) #12. CNO #12 stated she was a governing body member. CNO #12 stated the governing body was similar to a supervisor over the hospital. CNO #12 stated the governing body made the ultimate executive decisions over what was best for the patients based on the evidence presented by the QAPI program.

CNO #12 stated it was important for the governing body to be involved with the QAPI program in order to take actions to implement interventions and prevent recurrent of incidents/events. CNO #12 further stated if the governing body was not aware of adverse patient events or their contributing causes, the governing body could not implement measures to prevent reoccurrence.

CNO #12 stated she was responsible for reporting issues such as nursing concerns to the governing body. She further stated not all incident reports were reviewed or presented to the governing body at the meetings; rather, the QAPI program tracked and trended their data during the governing body meetings.

b. Further interviews revealed the QAPI program was ineffective due to a lack of resources to ensure timely and thorough investigations of incidents/safety events, communication of investigation results and the development of measures to prevent recurrent incidents/events.

i. On 8/4/21 at 9:43 p.m., an interview was conducted with the Director of Quality (Director) #2. Director #2 stated after an incident report had been completed by a staff member, the form went to the lead nurse for the unit if the incident was a medical or psychiatric concern or went to the program team coordinator (PTC) if the concern involved an environmental or safety/security concern. She stated the quality department did not receive follow up from the unit staff without prompting and even then, sometimes, the quality department did not get a follow up report.

ii. On 8/4/21 at 12:49 p.m., an interview was conducted with the Incident Manager (Manager) #21 who was a member of the quality program. Manager #21 stated it was difficult to receive reports and investigation information from the units. Manager #21 stated she was the main investigator for incident reports. Manager #21 stated the facility did not have enough staff to thoroughly investigate incidents when they occurred. She stated events for July had not been reviewed in a meeting with staff since she was on vacation and there was no one else to run the meeting.

2. Review of incidents/safety events revealed numerous events had occurred with no investigation, no follow up and no report to the governing board in order to develop and implement measures to prevent their recurrence.

a. Staff reported unlocked doors in the dining room on both 7/25/21 and 7/26/21.

i. On 7/25/21 at 12:15 p.m., a staff member performed locked door checks in the dining room and discovered an exit door was unlocked.

ii.. On 7/26/21, another staff member performed a locked door check in the dining room and discovered an exit door was unlocked.

iii. There was no evidence of an incident investigation or a quality program follow-up to determine why staff were finding unlocked doors in a locked psychiatric facility and a patient eloped on 7/30/21. (Cross-reference A286).

There was no evidence the governing body was made aware of the above incidents or implemented measures to prevent their recurrence.

b. On 6/25/21, a contracted electrical workers left a 15-20 inch metal pipe in the hallway of the facility. There was no evidence an investigation was completed or interventions implemented to prevent reoccurrence. Further, there was no evidence the governing body was made aware of the incident in order to implement measures to prevent a recurrence.

c. On 7/22/21, a rusty metal wire was found in a patient's room. There was no evidence an investigation was completed or the event was reported to the governing board to develop and implement measures to prevent reoccurrence.

d. On 8/2/21, a sock full of rocks was discovered in a patient's room. A police report had been filed but there was no evidence the facility completed an investigation or made the governing board aware of the event.

3. Review of governing body meeting minutes from May 2021 to July 2021 revealed no evidence the QAPI program reported tracking and trending of safety events during the governing body meetings or that patient safety events were reviewed, discussed, and measures implemented to reduce risks to patients.

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

A-0144 CARE IN SAFE SETTING The patient has the right to receive care in a safe setting. Based on observations, interviews and document review, the facility failed to ensure a safe patient care environment in multiple areas throughout the facility. Specifically, the facility failed to ensure nursing staff performed patient wellness checks, environmental safety checks, ligature risk assessments and mitigation (appropriate interventions to reduce patient self harm by means of strangulation or hanging) and patient rooms were monitored for the presence of extra linens and/or contraband (an item, material or object which present a risk for harm to self and others or interferes with patient safety). Furthermore, the facility failed to ensure patients were not transported through unapproved transportation routes and unauthorized underground tunnels at the facility. (Cross Reference 0043, 0286 and 0397)

A-0154 USE OF RESTRAINT OR SECLUSION Patient Rights: Restraint or Seclusion. All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. Based on observations, interviews and document review, the facility failed to ensure patients were free from physical confinement/restraint except when there was a risk of serious injury and harm or deemed otherwise medically necessary. (Cross Reference 0043)

Based on observations, interviews and document review, the facility failed to ensure a safe patient care environment in multiple areas throughout the facility. Specifically, the facility failed to ensure nursing staff performed patient wellness checks, environmental safety checks, ligature risk assessments and mitigation (appropriate interventions to reduce patient self harm by means of strangulation or hanging) and patient rooms were monitored for the presence of extra linens and/or contraband (an item, material or object which present a risk for harm to self and others or interferes with patient safety). Furthermore, the facility failed to ensure patients were not transported through unapproved transportation routes and unauthorized underground tunnels at the facility. (Cross Reference 0043, 0286 and 0397)

Findings include:

Facility policy:

The Patient Wellness Policy effective 4/14/21 read, the safety of all patients is continually monitored by staff who are aware of the behavior, location and well-being of patients at all times. Patient safety and patient wellness checks will be performed, monitored and verified throughout each shift. Care staff will document medical and behavioral concerns, patient incidents and any pertinent clinical information related to patient safety within a progress note in the patient's electronic medical record.

The Charge Registered Nurse (Charge RN) will assign trained staff to perform patient wellness checks throughout the shift. Staff members must use the Patient Pictorial Census and Patient Wellness Form while performing patient wellness checks. The Pictorial Patient Census will be used as a visual aid to identify each patient during each patient wellness check. The following must be observed by nursing staff during each wellness check: The patient's face, neck, chest rise and fall, skin tone color, physical condition, emotional state, body language and tone of voice. Staff must document patient behavior and physical location on the Patient Wellness Form. Nursing staff members conducting patient wellness checks are responsible for the accuracy of the documentation entered on the Patient Wellness Form.

Furthermore, environmental safety checks must be performed in conjunction with the patient wellness checks. Environmental safety checks will be conducted for the following items and areas: egress doors (doors which remain locked until they are unlocked by staff), properly locked doors, total number of laundry bags in laundry room, torn or damaged linen and towels, extra linen and towels, intact ceiling tiles, unlocked or missing trash receptacles and inspection of vacant rooms. Additionally, staff are to perform environmental safety checks in all patient rooms and all areas accessible by patients. Environmental safety checks will be documented on the Patient Wellness Form within the designated section. Should an environmental safety concern arise, an explanation and the corrective action which occurred must be provided on the back of the Patient Wellness Form.

Staff members must perform and document patient wellness checks and environmental safety checks every 15 minutes for the following patient units: High Security Admissions Units (E1, E2, C2, 67), Restoration Program Units (C1, J1, L1), Continuum of Recovery Unit (CORe), Cognitive Behavioral Units (L2), Restoration & Recovery Unit (RNRU), Adolescent Behavioral Treatment Unit (ABTU), Behavioral Treatment Unit (BTU), Recognizing Emotions Acceptance Care and Hope (REACH) unit, Strategies to Achieve Recovery (STAR) unit, Social Learning Program (SLP) unit and Geriatrics Units (GTC and GTC-H).

Supervisory second level patient wellness checks are required at least once a shift. The Charge RN or designated Registered Nurse (RN) assigned to the unit will perform the supervisory second level patient wellness check. The Charge RN or designated RN will observe and verify proper completion of the patient wellness check and the environmental safety check by the assigned nursing staff member are observed by either the Charge RN or designated RN during a second level patient wellness check. Documentation verifying the second level check was performed will be entered on the Patient Wellness Form in the designated section.

The Declaration of Contraband policy effective 2/25/21 read, the purpose of this policy is to ensure a safe patient environment. Contraband is defined as any article, item or substance which poses a potential threat to the safety and security of patients and staff. Contraband is not allowed in patient areas. The following items have been declared contraband: Sewing and personal hygiene items (such as nail clippers, tweezers, sewing needles and scissors) which could be used to slice, stab, gouge or lacerate (to rip, cut or tear flesh or skin) unless approved and authorized for patient use within an authorized area supervised by staff. Pieces of fabric, material or clothing such as belts, strips of sheeting, shoelaces and torn or ripped towels and sheets and any item, material, tool or device which is capable of causing harm, bodily injury, fear or death. Additionally, housekeeping items, cleaning items, tools, material and objects such as trash cans, mops, brooms and trash bags are treated as contraband within patient care areas unless directly in use by a staff member who is actively overseeing the use of the item and will maintain possession and control of the item.

The Clinical Precautions/Alert policy effective 3/11/20 read, clinical precautions will be implemented when patient safety concerns have been identified. Patients may be placed on protective precautions for suicide attempts, self-harming, suicidal ideation and attempted elopement/escape from the facility. Nursing staff, clinical staff, medical providers and psychiatric providers are responsible to identify, promote and increase patient safety when warranted.

Escapes/AWAU/AWA - Reporting Unauthorized Absences policy effective 2/25/21 read, an unauthorized absence occurs when the location of the patient is unknown or when a patient has purposefully left their assigned location without the appropriate approval or authorization from staff to leave. Patient elopement is defined as unsupervised and unnoticed patient departure from the facility without staff observation or knowledge of the patient's absence.

The Off-Unit Transport of Patients and Police Escort List Process policy read, the facility was to transport patients in a safe, secure, and humane manner, in accordance with the facility's legal obligations to the courts.

Facility procedures:

The Department of Nursing Procedures, Titled: Procedure for Linen Check In and Out read effective 3/14/16 read, nursing staff are required to monitor patient assigned linen. Linen is defined as one fitted sheet, one flat sheet, one pillow case, one bedspread or blanket, two towels and one washcloth. Staff will count and inspect used patient linen for holes, tears, and missing pieces. Staff will conduct unit and patient room searches when missing linen is reported or returned damaged. Staff will document distribution of additional blankets to patients on the daily assignment sheet. The number of extra blankets provided to the patient will be verified and documented every shift until the extra linen has been returned by the patient. Staff are to verify patients are not in possession of unapproved extra linens. An incident report will be completed when extra linen has been discovered and when linens are missing.

The Department of Nursing Procedures, Titled: Procedure for Escorting Patients to the Dining Room and Dining Room Procedure effective 3/6/20 read, care staff will bring the Patient Wellness Form and dietary verification sheet when transporting patients to and from the dining hall. Staff will instruct patients to form a single file line. Once the patients have lined up, staff members will perform a head count and verify the count aligns with the patient count indicated on the Patient Wellness Form. A patient count will be performed and verified with the Patient Wellness Form prior to leaving inpatient units, upon arrival at the dining hall, prior to leaving the dining hall and upon return to the inpatient unit. A staff member will be positioned at the front of the patient line, another will be positioned in the middle of the line and a third staff member will be positioned at the end of the line during transport. The staff member at the end of the line will monitor and ensure patients do not exit or join the line during patient transport. Staff will strategically position themselves throughout the dining hall to ensure patients are visually monitored while eating and do not elope from the area.

The CMHIP Form Instructions, Titled: Instructions for Patient Wellness Form effective 3/18/19 read, when performing continuous patient monitoring, staff will observe and record the patient's physical well-being, behavior, emotional condition and physical location on the patient wellness form. Furthermore, environmental safety checks will be continuously performed and documented on the patient wellness form. A new patient wellness form will be utilized every day at midnight.

The following will be continuously monitored and documented during wellness rounds: Visually check to ensure the patient is breathing and maintaining personal safety. Environmental safety checks are performed on egress doors, laundry rooms, laundry bags, patient restrooms, patient showers, locked external exit doors, locked internal doors, restraint and seclusion rooms, unoccupied patient rooms, torn or ripped linen, presence of extra linen or towels, knotted sheeting and linen, intact mattresses, locked electrical outlets, contraband, damaged or unsanitary flooring, blocked fire or emergency exits, intact pull station covers, locked and secured trash receptacles, intact ceiling tiles and visual scanning of patient areas for potential safety hazards. Staff initials, markings and documentation within each section of the patient wellness form indicates the staff member has verified and ensured the wellness of the patient and the safety of the environment.

All staff members are responsible for the accuracy of their documentation on the patient wellness form. Patient wellness check observations will be performed by the Charge RN for each unit at least once per shift. Once complete patient wellness forms will be reviewed by the Lead Nurse (LN) to ensure significant patient findings, concerns and issues were appropriately addressed. Documentation errors and non-nursing related concerns noted on the patient wellness form will be forwarded to the Clinical Team Leader/Coordinator for further review.

Updated facility policy:

The Patient Wellness Policy effective 7/28/21 (the facility amended the policy with the following updates due to identification of an immediate patient safety risk) read, patient wellness checks performed every 15 minutes on units: C1, C2, E1, E2, L1, L2, J1, 67, ABTU, BTU, CORe, REACH, RNRU, SLP, STAR, GTC and GTC-H will document the number of blankets each patient has in their room. Staff members are required to record their initials on the Patient Wellness Form to indicate the patient wellness check was performed according to facility policy and the patient's behavior, physical condition, and location were observed and verified by staff.

Staff will perform an environmental safety check and the environmental safety check will coincide with when patient wellness checks are performed. During the environmental safety check staff will look for safety concerns/issues or items out of place such as torn bed sheets, extra linen, extra towels, contraband, water on the floor, fire exits blocked, intact ceiling tiles, unlocked doors and inappropriate placement of trashcans. Patient bed rooms indicated as vacant must be unlocked and the room checked for patient safety. Once checked the door to the vacant room will be closed and re-locked.

Updated facility procedures:

The CMHIP Form Instructions, Titled: Instructions for Patient Wellness Form effective 7/28/21 (the facility amended the procedure with the following updates due to identification of an immediate patient safety risk) read, the patient wellness form will be printed for all shifts. Staff will ensure the following information is updated on the form per shift: patient name and room number, patient precautions, the number of blankets each patient has and is allowed to have, the date and the number of cloth laundry bags present in the laundry room.

Environmental scans (environmental safety checks) will be performed and completed by the staff member designated to conduct patient wellness rounds (a structured method of checking on patients to promote patient safety and reduce potential harm). Staff are to ensure the following have been inspected when performing environmental safety checks: properly locked egress doors, external doors, and designated internal doors, count and document the total number of laundry bags in laundry room, remove torn or damaged linen and towels, monitor trash receptacles and ensure unoccupied patient rooms remain vacant and locked. Additionally, all patient rooms are to be observed for linen and the quantity of blankets present in each patient room will be counted, verified and documented on the patient wellness form. Environmental safety concerns will be documented with an explanation of the concern and the corrective action taken to resolve the concern.

1. The facility failed to ensure patients did not acquire extra linen without authorization or a written order from the patient's provider. Additionally, items which could be used as contraband to inflict patient harm were not monitored by staff.

A. Observations and document review revealed Patient #2 was involved in an adverse safety event (an incident which resulted in harm or injury to a patient).

a. According to the Patient Wellness Policy effective 4/14/21, environmental safety checks would be conducted for patient rooms. Staff were to observe patient rooms for torn or damaged linen and towels, extra linen and towels and items which could potentially cause harm or an unsafe patient environment. Environmental safety checks would be performed simultaneously with patient wellness checks. The following must be observed during each wellness check: The patient's face, neck, chest rise and fall, skin tone color, physical condition, emotional state, body language and tone of voice. Staff must document patient behavior and the physical location of the patient on the patient wellness form.

b. According to the Department of Nursing Procedure for Linen Check In and Out effective 3/14/16, nursing staff were required to monitor patient bedding and count the number of linens present in each patient's room. Linen would be inspected for the presence of holes and tears. Additionally, staff were required to check for extra linens and/or missing linens assigned to the patient. Patients were not to be in possession of unauthorized extra linens.

According to Program Chief Nurse (PCN) #1 and Program Directors (Director) #31, the communication report sheet documented which patients were authorized to have extra linen and the number of linen the patient was allowed.

c. According to the Declaration of Contraband policy effective 2/25/21, contraband was defined as any material, article, item or substance which posed a potential threat to the safety and security of patients. Such as strips of fabric and any torn or shredded material or article of linen. Damaged, torn or frayed clothing, linen or towels, and any unapproved or unauthorized items, objects or materials obtainable at the facility. Patients were not allowed to be in possession of contraband at the facility.

d. On 7/27/21, the following adverse safety event occurred: Patient #2 hung himself in his room.

i. Document review of the adverse safety event revealed that prior to the adverse safety event, Patient #2, who resided on patient care unit L2, was able to obtain extra bed linen and a large trashcan. He used both items to hang himself in his room on 7/27/21. Patient #2 placed part of the extra bed linen over the right upper corner of the door to his room and closed the door. Patient #2 secured the bed linen around his neck, stood on top of the large upside down trashcan and hung himself.

At 2:03 p.m. another patient on the unit alerted staff Patient #2 hung himself and rushed to his room. Upon arrival, staff forced the door open and Patient #2 fell to the ground unconscious, discolored and ashen (a pale grayish color). Staff untied the bed linen from around Patient #2's neck and assessed the patient for a heart rate and respirations. A heart rate was unable to be located and Patient #2 was not breathing. Staff initiated cardiopulmonary resuscitation (CPR) (a procedure performed to maintain breathing and circulation) on Patient #2 and activated a medical emergency alert.

At 2:18 p.m., Emergency Medical Technicians (EMTs) assumed care of Patient #2 and transported the patient to an acute care hospital for further medical evaluation and treatment.

ii. An observation was performed of Patient #2's room on 7/28/21 at 9:05 a.m. At the time of the observation, multiple articles of linen were present. A fitted sheet, a flat sheet, two pillowcases and two blankets were on the bed in Patient #2's room. According to Assistant Director of Quality Support Services (Assistant Director) #3 and PNC #1, a second flat sheet and a large trashcan were removed from Patient #2's room on 7/27/21 after he attempted suicide.

However, document review of the adverse safety event and communication report for L2, revealed prior to the adverse safety event on 7/27/21, there was no evidence Patient #2 was authorized to have an extra flat sheet, an extra blanket or a large trashcan in his room. Furthermore, the facility was not able to provide evidence staff performed the scheduled environmental safety checks every 15 minutes in Patient #2's room on 7/27/21 prior to the adverse safety event.

Facility document review of the adverse safety event, unit communication reports and Patient Wellness Form for 7/27/21 were in contrast with the facility Department of Nursing Procedure for Linen Check In and Out effective 3/14/16, which stated patients were provided one fitted sheet, one flat sheet, one pillowcase and one blanket. Furthermore, staff were to verify patients did not have extra linen. Additionally, review of communication reports revealed neither the extra sheet, extra blanket nor the large trash can found in Patient #2's room on 7/27/21 had been assigned to him. This was in contrast to the Declaration of Contraband policy effective 2/25/21, which stated items which posed the potential for patient harm were not to be accessible by patients or allowed in designated patient areas.

iii. Surveillance video for 7/27/21 was reviewed. Surveillance video review showed Clinical Care Associate (CCA) #22 performed patient wellness checks on L2 between 1:15 p.m. and 2:45 p.m.

Surveillance video review confirmed CCA #22 did not enter patient areas (rooms) to conduct patient wellness and environmental safety checks. CCA #22 did not go into Patient #2's room to perform environmental safety checks prior to the adverse event on 7/27/21.

Moreover, surveillance video revealed CCA #22 was observed standing in patient doorways for one and two seconds per patient room while he completed patient wellness and environmental safety checks,

e. Patient rooms on unit L2 were observed.

i. On 7/28/21 at 9:36 a.m., patient room observations on L2 revealed seven patient rooms (L103E, L105E, L106E, L107E, L111E and L112E) had extra linen in their rooms.

There was no evidence in the communication report that indicated patients on the unit were authorized to have extra linen.

f. Staff were observed performing patient wellness checks on L2.

i. On 7/28/21 at 9:10 a.m., Health Care Technician (HCT) #24 conducted patient wellness checks on t L2. HCT #24 did not open the door to room L109F when she performed the patient wellness and environmental safety check. Rather, HCT #24 briefly observed the patient in room L109F through the window located in the door.

HCT #24 was observed performing one second patient wellness and environmental safety checks for the remainder of the patients on the unit.

ii. On 7/28/21 at 9:59 a.m., HCT #9 and Clinical Safety Specialist (CSS) #30 were observed performing patient wellness checks together on unit L2. During the 9:59 a.m. patient wellness check, HCT #9 and CSS #30 did not visually observe four patients who were asleep in their room at the time the patient wellness checks were performed.

iii. On 7/29/21 at 12:15 p.m., patient wellness checks were performed by CCA #10. CCA #10 did not open the door to room L105D; instead, she looked through the window in the door. The patients assigned to room L108D and L112D were in their rooms when CCA #10 performed patient wellness and environmental safety checks. CCA #10 opened the door to both patient rooms and performed a one second patient wellness and environmental safety check.

These observations were in contrast to the Patient Wellness policy effective 4/14/21 which stated nursing staff must observe the patient's face, neck, chest rise and fall, skin tone color, physical condition, behavior and physical location when patient wellness checks were performed. Additionally, facility procedure Instructions for Patient Wellness Form effective 3/18/19 stated nursing staff must visually check and ensure patients were breathing and the personal and environmental safety of the patients was maintained.

B. Interviews with staff were conducted and revealed staff failed to follow facility policy and conduct the environmental safety checks outlined in facility policy and procedures when patient wellness checks were performed.

a. On 7/28/21 at 4:53 p.m., an interview was conducted with CCA #22. CCA #22 stated he had been working at the facility for over a year and staffing needs determined which patient unit he worked on. CCA #22 stated he performed patient wellness checks when he was assigned to do them. He stated he was required to see the patient's face and ensure the patient was safe when patient safety checks were performed. He stated he did not check or inspect patients' rooms when he performed environmental safety checks.

Rather, CCA #22 stated during environmental safety checks, he would check patient rooms and the areas outside of the patients' rooms for harmful objects or items which could be used to inflict harm. CCA #22 stated he was not aware patients could not have extra blankets or a large trashcan in their room.

CCA #22 stated he worked on unit L2 and was present on the unit prior to and after Patient #2 attempted suicide. CCA #22 confirmed that on 7/27/21, he was assigned to perform patient wellness checks from 1:15 p.m. to 2:45 p.m. He stated he was not aware Patient #2 had extra linen and a large trashcan in his room when he performed wellness checks on the patient. CCA #22 stated he was unsure when Patient #2 took the large trashcan to his room.

See the above review of the video surveillance of CCA #22 performing wellness checks on 7/27/21 revealed he did not perform them as required. CCA #22 did not enter patient rooms, including Patient #2's room to complete patient wellness and environmental safety .checks. His was evidenced by the amount of time in which it took him to perform patient wellness and environmental safety checks on each of the three hallways in one minute and on the entire unit in three minutes.

b. An interview was conducted with RN #23 at 6:02 p.m. on 7/28/21. RN #23 stated she was assigned to work on L2 at the time of the interview. She stated she did not perform environmental safety checks for patient rooms unless patient safety was a concern.

RN #23 stated environmental safety checks ensured egress doors, the laundry rooms and vacant patient rooms were locked. RN #23 stated cloth laundry bags were counted when the laundry room was inspected to verify linens were not missing. RN #23 stated patient linens were checked for tears, rips and holes but did not state linens were checked for possession of extra or missing linen. RN #23 stated patients were not allowed to have extra linen in their rooms, yet acknowledged she was not aware seven patients on L2 currently had unauthorized extra linen in their rooms. RN #23 stated there was potential for patient harm when patients had extra linen; she stated patients could use the linen to harm themselves or potentially cause harm to others.

c. On 7/28/21 at 9:20 a.m. an interview was conducted with Program Chief Nurse (PCN) #1. PCN #1 stated staff did not count the number of linens each patient had in their room to verify patients were not in possession of unapproved extra linens. He stated L2 performed weekly linen exchanges and staff were required to check linen at that time for damage, tears and rips but did not state linens were checked for possession of extra or missing linen.

d. On 7/28/21 at 9:58 a.m. an interview was conducted with HCT #9. She stated the number of linen each patient had was tracked to ensure patient safety and prevent patient harm. HCT #9 stated after Patient #2 attempted to hang himself, staff were informed the number of linens each patient had was to be counted and documented on the patient wellness form. She stated prior to 7/27/21, staff would count the number of linen each patient had once a week when the linen exchange was performed. HCT #9 stated patients were allowed to have extra blankets if there was a physician order.

e. An interview was conducted with CCA #10 on 7/29/21 at 12:30 p.m. CCA #10 stated she did not enter patient rooms when she performed the patient wellness and environmental safety checks. She said she was unaware staff were required to enter and inspect patient rooms and prior to 7/27/21, she was unaware staff were check for extra or missing linen in the patient room when performing environmental safety checks. CCA #10 stated counting the number of linen and verifying patients were safe and not trying to harm themselves was not clearly explained before the event on 7/27/21, she further stated patients could be seriously harmed or injured when staff perform patient safety and wellness checks incorrectly.

These interviews were in contrast with facility procedure, Instructions for Patient Wellness Form effective 3/18/19, which stated environmental safety checks would be performed in patient areas for potential safety hazards. Staff were to check for torn or ripped linen, extra linen or towels in patient rooms, knotted sheeting and linen, contraband, damaged or unsanitary areas, items and materials and inappropriately placed or unlocked trash receptacles and verify and ensure through documentation (initials, markings and medical record documentation) within each section of the patient wellness form, the wellness of the patient and the safety of the environment.

2. The facility failed to ensure patient wellness checks were performed per the Patient Wellness Policy effective 7/28/21. Specifically, the staff failed to ensure internal and external doors remained locked during environmental safety checks that were performed in conjunction with patient wellness checks.

A. Dining hall surveillance, document review and observations revealed Patient #6 eloped from the facility, an adverse safety event, on 7/30/21.

a. According to the Escapes/AWAU/AWA - Reporting Unauthorized Absences policy effective 2/25/21, unauthorized patient absence was defined as purposeful departure of the patient from their assigned location; specifically, patient departure without appropriate approval or authorization from staff to leave a designated location. Patient elopement was defined as unsupervised and unnoticed patient departure from the facility without staff observation or knowledge of the patient's departure and absence.

b. According to the Procedure for Escorting Patients to the Dining Room and Dining Room Procedure effective 3/6/20, staff were to bring the Patient Wellness Form and dietary verification sheet when patients were transported to and from the dining hall. Patients were to line up at the front door and a head count performed prior to being escorted to and from the dining hall. A staff member would be placed at the end of the single file line and ensure patients did not leave or attempt to join the line before and during transport. Another staff member would perform a headcount and match the count against the Patient Wellness Form. A staff member will be positioned at the front of the line, a second staff member will be positioned in the middle of the line and a third staff member will be positioned at the end of the line when patients were transported. This process would be performed prior to leaving inpatient units, upon arrival at the dining hall, prior to leaving the dining hall and again upon return to the inpatient unit.

Once in the dining hall, one staff member will be stationed at the entrance and the remaining staff members will strategically positioned themselves throughout the dining hall. Staff were required to monitor patients while they ate and make sure patients did not elope from the area.

c. According to facility procedure Instructions for Patient Wellness Form effective 7/28/21, staff were to conduct continued patient monitoring at all times. Staff were required to observe and record the physical well-being, behavior, emotional condition and location of the patient when wellness checks were performed. Furthermore, environmental safety checks were to be conducted and documented simultaneously with patient wellness checks. Environmental safety checks were performed to ensure the following: Internal and external doors designated as locked were locked and vacant patient rooms were locked and not accessible by patients. Staff were to verify fire and emergency exits were not blocked and trash receptacles were secured and located only in approved areas. Lastly, staff were to visually scan all patient areas for potential safety hazards.

Staff were required to check and initial that patient wellness and environmental safety were performed to ensure the wellness and safety of the patient. Each staff member was responsible for the accuracy of the documentation entered on the patient wellness forms.

d. The RNRU dining hall surveillance revealed on 7/30/21 at 5:02 p.m. the following adverse safety event occurred: Patient #6 eloped from the facility.

i. RNRU dining hall surveillance review on 7/30/21 at 4:58 p.m. revealed MHC #18 was seated at a table in the RNRU dining hall. There were no patients and no additional nursing staff present in the dining hall while MHC #18 was seated at the table.

At 4:59 p.m. MHC #18 positioned herself at the beverage station located at the end of the food line. Food service staff were seen entering the dining hall through a swing door located at the end of the food line. Food service staff entered the dining hall to place plastic food trays at the front of the food service line for the patients to use.

CCA #17 entered the dining hall and stood near the entrance of the food service line. Fourteen (14) patients entered the dining hall after CCA #17 and formed a single file line where the food service line began. Shortly after the patients entered, HCT #14 and CSS #11 entered the dining hall and stood by the swing door near MHC #18.

There was no evidence MHC #18 or CCA #17 had performed an environmental safety check prior to the patients' arrival from the RNRU unit.

ii. Surveillance revealed on 7/30/21 at 5:01 p.m., Patient #6 exited the line of patients, walked past CCA #17, CSS #11, HCT #14 and MHC #18 and through the unlocked swing door into the kitchen area. Patient #6 continued to walk past one food service staff member to the unlocked exterior door located in the back of the kitchen area.

At 5:02 p.m. Patient #6 exited the facility through an unlocked exterior door and eloped from the facility.

iii. On 7/30/21 from 4:59 p.m. to 5:06 p.m., surveillance revealed HCT #14, CSS #11 and MHC #18 stood next to the swing door at the end of the food line together. CCA #17 was at the dining hall entrance where the food line began. CCA #17 faced the external kitchen door and the food service staff members located in the kitchen area.

iv. Document review of the patient wellness form on 7/30/21 between 5:00 p.m. to 5:30 p.m. showe

Based on observations, interviews and document review, the facility failed to ensure patients were free from physical confinement/restraint except when there was a risk of serious injury and harm or deemed otherwise medically necessary. (Cross Reference 0043)

Findings include:

Facility policy:

The Locked Door Seclusion Policy effective 6/9/21 read, locked door seclusion is defined as involuntary patient confinement in a locked room or the restriction of a patient within a specific area such as prohibiting the patient from leaving a specified area or location. Patients have the right to be free from locked door seclusion and any form of restraint which is not deemed medically necessary. Restraint use will not be imposed to coerce or discipline patients and will not be implemented due to convenience or retaliation. Restraint use will be initiated in situations in which a patient's behavior and actions pose a grave and serious risk of harm. Additionally, implementation and continued use of manual restraint, locked door seclusion or open door restraint must be justified and documented in the patient's electronic health record.

Locked Door Seclusion will be used for the management of violent or self-destructive behavior. A provider order is required and will state the type of seclusion to be implemented and the clinical rationale for use. A provider order is required in addition to a Registered Nurse (RN) face-to-face assessment within one hour of initiation. Locked door seclusion continuation beyond four hours requires the RN to perform an additional face-to-face assessment with the patient and assessment will occur within one hour of the renewal of the provider order.

The patient must be provided an explanation and reason for why locked door seclusion has been implemented and the condition based behavior criteria the patient must meet in order for locked door seclusion to be terminated. A provider order for seclusion/restraint, current and updated progress notes, and a face-to-face assessment performed by the RN must be documented in the patient health record. The provider and RN will update the patient plan of care to include an immediate patient risk assessment.

Nursing staff along with the treatment team will be responsible for ensuring the patient is appropriately monitored and remains safe while placed in locked door seclusion. Continuous face-to-face monitoring must occur for patients placed in locked door seclusion. Nursing staff must document continuous 1:1 monitoring every 15 minutes for patients in locked door seclusion. Documentation in the electronic health record will note patient behavior only and indicate the ongoing or imminent danger the patient has engaged in to warrant continued use of locked door seclusion. Additionally, patients are to be offered personal hygiene, fluids and food while placed in locked door seclusion.

The Patient Wellness Policy effective 4/14/21 read, patients are not to be locked in their rooms unless placed on a patient unit in which patient doors automatically lock when the patient's door is closed. Patient rooms located on units E1 and E2 are equipped to lock as soon as the door is closed. Patient rooms on E1 and E2 are to remain locked during sleeping hours and require a staff member to unlock/open the door. Patients are physically unable to leave the room when the door locks and a staff member must unlock/open the door in order for the patient to not be confined.

The Patients' Rights policy effective 6/10/20 read, patients have the right to receive care and treatment configured to meet the needs of the patient. Patient treatment and care will be provided in the least restrictive manner and environment. Patients have the right to be free from any type of physical restraint and the right to not be placed in seclusion against his/her will except during emergency situations.

1. The facility failed to ensure patients were free from physical confinement/restraint while in their rooms except when there was a risk of serious injury and harm or deemed otherwise medically necessary.

A. Observation of a patient wellness checks.

a. On 8/3/21 at 10:56 p.m., observations of the Behavioral Treatment Unit (BTU) unit revealed a patient bedroom was locked when wellness checks were conducted.

i. During the wellness check, RN #29 pushed on Patient #7's door and it did not open. Registered nurse (RN) #29 looked into Patient #7's room through a window located in the door to ensure the patient had not physically blocked the door. RN #29 unlocked the door with his key and entered the Patient #7's room.

Inside the room, Patient #7 was asleep in bed. RN #29 watched the patient's chest rise and fall four times before he exited Patient #7's room.

B. Interviews with staff revealed a practice of patients being locked in their rooms during the night on various units.

a. On 8/3/21 at 11:09 p.m. an interview was conducted with RN #29. RN #29 stated he was unaware the door to Patient #7's room was locked prior to the wellness check (see above). RN #29 stated he was unsure if the door to Patient #7's room should have been locked. He stated the patient care plan for Patient #7 had an order for the door to be locked at night while the patient slept. This was in contrast to facility policy which read, patients have the right to be free from locked door seclusion and any form of restraint which is not deemed medically necessary.

RN #29 stated he spoke with the Charge RN after the wellness check and was informed as of the time of the interview, Patient #7 was not to be locked in his room at night.

RN #29 stated he previously worked on the admission units, E1 and E2 during the night shift. He stated staff on E1 and E2 locked all patients in their rooms at night and the patients could not exit their room until a staff member unlocked the door. RN #29 stated there were no written provider orders for the patients on E1 and E2 to be locked in their rooms at night but instead was a known practice amongst staff.

b. Facility leadership was aware patients on E1 and E2 were being locked in their rooms at night. They stated there was not an option for the patients on these two units to have the door to their room unlocked at night. They also stated it was facility policy to lock patients on E1 and E2 in their rooms while during the night while the patient was sleeping.

i. On 8/4/21 at 4:04 p.m. an interview was conducted with Chief Clinical Officer (CCO) #16. CCO #16 confirmed the facility locked patient doors at night on units E1 and E2. He stated the patient rooms on units E1 and E2 were remotely monitored with video and voice surveillance at night when the patients' doors were locked. CCO #16 stated both units E1 and E2 were constructed to have patient doors locked at night which was why they were locked. CCO #16 stated the patient doors were not locked due to a medical necessity; rather, the CCO said the doors were locked because they were made to lock. CCO #16 stated the Executive Committee (EC) knew patient doors were locked at night on units E1 and E2.

CCO #16 was interviewed about the observation on in the BTU on 8/3/21 (see above), that revealed Patient #7's door was locked. The CCO said stated Patient #7 previously had an Intractable Injurious Behavior Protocol (IIBP) which included locking Patient #7's door at night as a therapeutic treatment intervention. CCO #16 stated the EC had met monthly and discussed Patient #7's IIBP. CCO #16 stated the EC reviewed and approved Patient #7's door to be locked at night for several years. He stated this intervention was discontinued for Patient #7, but he could not recall exactly when it was discontinued. CCO #16 stated Patient #7's door should not have been locked on 8/3/21.

ii. On 8/4/21 at 2:43 p.m. an interview was conducted with Program Chief Nurse (PCN) #15. PCN #15 further confirmed patients were locked in their rooms at night on units E1 and E2 and physically unable to leave their room. PNC #15 stated patients admitted to unit E1 or E2 were acutely sick and experienced increased psychiatric emergencies and required administration of emergency medications. She stated newly admitted patients were not medication compliant prior to admission and experienced increased psychosis.

PCN #15 stated patients admitted to E1 and E2 were told the doors to their room would be locked during the night. PCN #15 also confirmed the patients on units E1 and E2 did not have a written provider order for their doors to be locked while they slept at night. PNC #15 stated the patient on E1 and E2 were not able to choose to have the doors to their rooms unlocked and were not able to choose to leave their doors unlocked at night. Further, PCN #15 explained patients locked in their rooms did not have an RN face-to-face assessment and did not receive 1:1 monitoring. PCN #15 stated she did not perceive the patients as restrained and/or secluded when room doors were locked at night. However, PNC #15 acknowledged there was a potential for the patients on unit E1 and E2 to be harmed when the door to their room was locked.

iii. On 8/4/21 at 3:25 p.m. an interview was conducted with PCN #1. PCN #1 stated he was aware patients on unit E1 and E2 were locked in their rooms at night and stated facility policy authorized patients on units E1 and E2 to be locked in their rooms without a physician order. PCN #1 stated the doors on units E1 and E2 were required to be locked and patients were instructed the doors were locked for their safety. PCN #1 stated he followed facility policy to lock patients in their rooms at night when he worked. However, PNC #1, too, acknowledged patients were at risk for harm when locked in their rooms at night.

The above Patient Wellness policy and staff interviews were in contrast to the facility's policy Locked Door Seclusion, effective 6/9/21 which stated seclusion was defined as intentional confinement of the patient in a locked room and locked door seclusion was to be implemented in emergency situations when deemed medically necessary for the safety of the patient or others. Further, the Locked Door Seclusion policy required 1:1 monitoring of the patient every 15 minutes and RN face-to-face assessments. Finally, it provided Locked Door Seclusion must be justified and documented in the patient's electronic medical record.

There was no documentation from policy review or information from interviews with to staff to explain and support the practice on E1 and E2 of locking doors at night without orders, medical necessity, and continual face-to-face monitoring as outlined in the Locked Door Seclusion Policy.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 Condition of Participation: Quality Assessment and Performance Improvement Program, was out of compliance.

A-0286 (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. Based on interviews and document review, the facility failed to investigate and analyze adverse patient events (incidents/safety events) to identify contributing factors and implement preventive actions and mechanisms that included feedback and learning throughout the hospital. (Cross reference Tag 0144).

A-0315 [The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following:] (4) That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and reducing risk to patients. Based on interviews and document review, the facility failed to ensure adequate resources were allocated to operate a quality assurance and performance improvement (QAPI) program which analyzed underlying causes of adverse patient events and developed performance improvement plans to reduce risk to patients. (Cross Reference Tag 0043, Tag 0286)

Based on interviews and document review, the facility failed to investigate and analyze adverse patient events (incidents/safety events) to identify contributing factors and implement preventive actions and mechanisms that included feedback and learning throughout the hospital. (Cross reference Tag 0144).

Findings include:

Facility policy:

The incident reporting policy effective 2/25/21 read, the purpose is to collect, analyze and report data on critical incidents in order to improve patient safety through quality improvement (QI) initiatives. Once an incident form has been completed, the lead nurse or designee will review the incident and decide if it is a medical condition/psychiatric issue or an environmental/safety issue. If it is a medical/psychiatric issue, the lead nurse will complete the report. If it is a contraband/safety issue, the lead nurse will place the incident report in the Program Team Coordinator's mailbox to be completed.

Information management will review and compile the data from the incident database and provide data for analysis. The incident team manager will provide the Critical Incident Committee (CIC) with a weekly report of critical incidents.

Facility document:

The Quality Assurance and Performance Improvement (QAPI) Plan for 2021 read, the purpose is to provide a mechanism for the facility to define issues and goals, measure outcomes, analyze data and implement quality controls to ensure the best experience for all patients across the continuum of services. The QAPI plan includes policies to analyze underlying causes of systemic problems and adverse events and develop corrective action plans or performance improvement activities.

The facility's governing body is responsible for the quality of all services delivered at the facility. The incident coordinator reviews daily for completion and timely follow up actions. Incident reports for critical incidents are made within established timelines. The Quality Support Services (QSS) ensures patient safety concerns are addressed and corrected immediately upon identification. Other outliers identified as a result of the individual, systems, program or environmental tracer that warrant further examination are referred to a QA specialist for analysis of interventions, trends, timeliness of services delivered and recommendations for improvement.

1. The facility failed to analyze incidents/safety events and implement preventive measures in order to prevent their recurrence.

a. Review of patient incidents/safety events revealed a number of incidents/ safety events had occurred and no follow-up or investigation was completed in order to prevent their recurrence.

i. On 7/25/21 at 12:15 p.m., a staff member performed locked door checks in the Restoration and Recovery Unit (RNRU) dining room and discovered an exit door was unlocked.

ii. On 7/26/21, another staff member performed a locked door check in the RNRU dining room and discovered an exit door was unlocked.

Review of both of the incidents/safety events above revealed the facility had not completed an investigation or implemented preventive measures to prevent recurrence.

iii. An incident/ safety event report for Patient #6 was reviewed and revealed on 7/30/21 at 5:37 p.m., a police report that read, Patient #6 was unaccounted for and subsequently had eloped. Review of video footage provided by the facility revealed the patient eloped through the RNRU internal dining room swinging door at 5:01 p.m. and then left through the external door at 5:02 p.m.

iv. On 8/2/21 at 10:15 a.m., an interview was conducted with Director of Quality (Director) #2. Director #2 stated the video footage of the patient's elopement was reviewed by Director #2. The video footage revealed the staff members did not complete wellness checks which included to ensure doors were locked in the dining room. Subsequently, the patient was able to walk through an unlocked kitchen door and exit the facility.

See above; staff had reported unlocked doors in the dining room on both 7/25/21 and 7/26/21. There was no investigation or follow up of these incidents/safety events to determine why staff were finding unlocked doors in a locked psychiatric facility in order that patient safety could be improved through new interventions. As a result , a patient eloped from the unit on 7/30/21.

b. An additional review of incidents/safety events revealed other incidents/safety events where investigations were not completed to determine their cause and interventions were not developed and implemented to prevent recurrence.
Examples of the incidents include:

a. On 6/25/21, contracted electrical workers left a 15-20 inch metal pipe in the hallway of the facility. There was no evidence an investigation was completed or preventive interventions implemented to prevent reoccurrence.

b. On 7/22/21, h a rusty metal wire was found in a patient's room. There was no evidence and investigation was completed or preventive interventions were implemented.

c. On 8/2/21, a sock full of rocks was discovered in a patient's room. A police report had been filed but there was no evidence the event was investigated.

2. Staff interviews revealed the facility lacked a clear and consistent process for investigating incidents/safety events and implementing preventive measures.

a. On 8/4/21 at 2:41 p.m., an interview with Program Chief Nurse (PCN) #15, who oversees multiple units, was conducted. PCN #15 stated when a medical patient incident/safety event occurred, she would investigate after the program's lead nurse had performed their investigation. PCN #15 stated she only supervised the nursing aspects of patient incidents/safety events. She stated if she had to investigate, a summary was required to be reported to the quality program once she had completed her investigation. PCN #15 stated there was no deadline when information was due; rather, it was due as soon as her investigation was complete. PCN #15 stated she used her experience and judgment along with facility policies to guide her when performing an investigation.

b. On 8/4/21 at 9:43 p.m., an interview was conducted with Director of Quality (Director) #2, who was the head of the quality program. Director #2 stated after an incident/safety event report had been completed by a staff member, the form went to the lead nurse for the unit if the incident was a medical or psychiatric concern or went to the PCN who oversaw that unit f the concern involved an environmental or safety/security concern. The follow up section was to be completed once the lead nurse of PCN received the form.

Director #2 stated the follow-up included the lead nurse or PCN reviewing and ensuring the correct assessments and a room search were completed. Contrary to the PCN, Director #2 stated the lead nurse or PCN had seven days to complete the investigation and follow-up. However, she stated the quality department did not receive follow up from the unit staff without prompting and even then, sometimes, the quality department did not get a follow up report, or the reports were late.

Director #2 stated she was not informed if the PCN on the units provided additional education or took disciplinary action against staff. She stated the facility needed a policy which outlined what each team member was supposed to do for an incident/safety event investigation and the timeframes, but the facility did not have one.

c. On 8/4/21 at 12:49 p.m., an interview was conducted with Incident Manager (Manager) #21. Manager #21 stated it was difficult to receive reports and investigation information from the units. Manager #21 stated investigations and causation were needed to determine if further follow up was needed. Manager #21 stated staff needed to take investigations of incidents/safety events seriously, but did not. Manager #21 stated a meeting was held every week and critical incident/safety events were reviewed. She stated during the critical incident/safety event meetings, there was very little input and participation from the PCNs in regard to the follow up and actions taken on the units after an incident/safety event had occurred.

Manager #21 stated in regards to the above pipe incident, she had encouraged all staff members to attend the weekly meeting to review critical incidents/safety events, however, staff did not attend as they believed the concern had already been addressed.

Manager #21 stated she was the main investigator for incident/safety event reports that she received from the units. Manager #21 stated the facility did not have enough staff to thoroughly investigate incidents when they occurred. She stated patient incident/safety events for July had not been reviewed in the weekly meeting with staff since she had been on vacation and there was no one else to run the meeting.

Based on interviews and document review, the facility failed to ensure adequate resources were allocated to operate a quality assurance and performance improvement (QAPI) program which analyzed underlying causes of adverse patient events and developed performance improvement plans to reduce risk to patients. (Cross Reference Tag 0043, Tag 0286)

Facility policy:

The Incident reporting policy effective 2/25/21 read, the purpose is to collect, analyze and report data on critical incidents in order to improve patient safety through quality improvement (QI) initiatives. Once an incident form has been completed, the lead nurse or designee will review the incident and decide if it is a medical condition/psychiatric issue or an environmental/safety issue. If it is a medical/psychiatric issue, the lead nurse will complete the report. If it is a contraband/safety issue, the lead nurse will place the incident report in the Program Team Coordinator's mailbox to be completed.

Information management will review and compile the data from the incident database and provide data for analysis. The incident team manager will provide the Critical Incident Committee (CIC) with a weekly report of critical incidents.

Facility document:

The Quality Assurance and Performance Improvement (QAPI) Plan for 2021 read, the purpose is to provide a mechanism for the facility to define issues and goals, measure outcomes, analyze data and implement quality controls to ensure the best experience for all patients across the continuum of services. The QAPI plan includes policies to analyze underlying causes of systemic problems and adverse events and develop corrective action plans or performance improvement activities.

The facility's governing body is responsible for the quality of all services delivered at the facility.

1. The facility's governing body failed to ensure the QAPI program had adequate resources to conduct its duties.

a. Interviews with staff revealed there were not adequate resources and staff to complete incident investigations, analyze underlying causes and develop corrective action plans or performance improvement activities.

i. On 8/4/21 at 12:49 p.m., an interview was conducted with the Incident Manager (Manager) #21. Manager #21 stated it was difficult to receive reports and investigation information from the units. Manager #21 stated investigations and causation were needed to decide if further follow-up was needed. Manager #21 stated staff needed to take the investigation of incidents/events seriously, to prevent reoccurence and identified lack of staff, time and resources all contributed to the lack of investigation and follow up for adverse events.

Manager #21 stated a incident/safety event meeting was held every week and critical incidents/events were reviewed. She stated during these meetings, there was very little input and participation from the program team coordinators (PCN) who assisted in the investigation of adverse patient events, in regard to the follow up and actions taken or that should be taken after an event had occurred. Manager #21 stated many of the incidents lacked an investigation entirely.

Manager #21 stated she was the main investigator for incident/event reports received from the units. Manager #21 stated the facility did not have enough staff to thoroughly investigate incidents/safety events when they occurred. She stated events for July had not been reviewed in the weekly meeting with staff since she had taken a vacation and there was no one else to run the meeting, therefore nothing had been done.

ii. On 8/4/21 at 9:43 p.m., an interview was conducted with the Director of Quality (Director) #2. Director #2 stated after an incident/event report had been completed by a staff member, the form went to the lead nurse for the unit if the incident/safety event was a medical or psychiatric concern or went to the PCN if the concern involved an environmental or safety/security concern. She stated the quality department did not receive follow up from the unit staff without prompting and even then, sometimes, the quality department did not get a follow up report, or the reports were late. She stated the facility needed a policy which outlined what each team member was supposed to do for an incident/event investigation and the timeframes, but the facility did not have one.

b. Documents were reviewed and revealed staff involved in the facility's QAPI program failed to perform their duty to investigate adverse patient incidents/safety events and implement preventive measures to reduce resident risk.

a. Patient incidents/safety events were reviewed (Cross Reference Tag 0286). There was insufficient evidence incidents/safety events were investigated to determine contributing factors and to prevent recurrent incidents/safety events. Finally, the facility lacked a process to determine if staff education or disciplinary action was needed or occurred after a patient safety event to improve performance and decrease patient risk.

Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.23 NURSING SERVICES, was out of compliance.

A-0397 A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available. Based on document review and interviews, the facility failed to ensure staff were provided the necessary tools to deliver safe patient care. Specifically, the facility failed to ensure all staff who were providing patient care attended the daily patient care report during which patient behaviors, precautions and the total number of patients on the unit was discussed. Furthermore, the facility failed to ensure all staff were orientated to the units they were required to work and provide patient care. This failure was identified facility wide.

Based on document review and interviews, the facility failed to ensure staff were provided the necessary tools to deliver safe patient care. Specifically, the facility failed to ensure all staff who were providing patient care attended the daily patient care report during which patient behaviors, precautions and the total number of patients on the unit was discussed. Furthermore, the facility failed to ensure all staff were orientated to the units they were required to work and provide patient care. This failure was identified facility wide.

Findings include:

Facility policies:

The Patient Wellness policy read, the safety of all patients were continually monitored by staff and staff were aware of the behavior, location, and well-being of patients at all times. During patient wellness checks, staff must observe the following: the patient ' s face, neck, chest rise and fall, skin tone color, physical condition, emotional state, body language and tone of voice. Environmental safety checks must be performed in conjunction with patient wellness check. Staff who perform environmental safety checks must check the following: egress doors (locked doors which are unlocked by staff), doors that should be locked (exit doors, vacant rooms, offices, and nursing station), total number of laundry bags in laundry room, torn or damaged linen and towels, extra linen and towels, intact ceiling tiles, unlocked or missing trash receptacles and inspection of vacant rooms.

The Staff Competency policy read, for an employee reassigned to a new position number or new location or when the employee assumes different job duties, a new position description, new performance plan, and competency assessment must be completed. When an employee transfers or promotes to a different position, the sending supervisor will complete a Performance Management Program interim evaluation within 30 days.

Supervisors are responsible to assess and communicate the training needs of individual employees in their direct reporting line and supporting training compliance of staff. Employees are responsible to assess their job related technical skills and knowledge, maintain a high level of performance throughout their employment, and seek approval for appropriate professional development and training opportunities in consultation with their supervisors.

Facility Plan:

The Safety Program Management Plan read, the program was designed to address the safety risks presented to patients, staff, and visitors and also to ensure compliance with applicable codes and regulations. All staff were required to attend hospital orientation which included an overview of the environment of care and the hospitals safety program, as well as unit-specific and assignment specific orientation. Safety training was required on an annual basis.

Completion of Unit Orientation Forms, Nursing Department Specific Competency Assessment Forms and guidance from Safety Program Management Plan, ensure staff and patient safety.

1. The facility failed to ensure orientation, training, education and competency checks of staff members according to facility policies and safety plan to ensure staff and patient safety.

A. Document review revealed multiple staff failed to receive timely training and/or unit specific orientation.

a. Review of the staff schedule revealed correctional officers transitioned into a new role of Clinical Safety Specialist (CSS) on 3/1/21. Yet, CSS document review revealed CSS training and unit specific orientation was not started until 4/15/21, more than 30 days after the CSS had been in their new roles and contrary to facility policies and safety plan.

b. Review of documents for the health care technician (HCT), clinical care aide (CCA), registered nurse (RN), and CSS revealed Nursing Department Specific Competency Assessment Forms were not complete for HCT #9, HCT #14, CCA #10, and CSS #11. Rather, review of the Unit Specific Orientation Form revealed leadership only signed off on the competency skill for wellness checks. The rest of the competency skills on the Unit Specific Orientation Form were blank. Specifically, competency skills which were not signed off included cross shift report communication, day hall monitoring, linen count and seclusion and restraint assessments.

c. Review of Unit Specific Orientation Forms for staff assigned to the L2 patient care unit on 8/11/21 revealed the orientation forms were signed by HCTs on 8/11/21 (during survey). The L2 unit is an expansion within the high security building.. Further review of the Unit Specific Orientation Form for HCT #9 and HCT #14 revealed they were assigned to the L2 unit on 5/10/21 when the L2 unit opened. There was no evidence the unit specific orientation for HCT #9 and HCT #14 was completed in the three months after they were assigned to the L2 unit.

B. Interviews confirmed staff 's lack of timely training and/or orientation.

a. On 7/29/21 at 10:00 a.m., an interview with HCT #9 was conducted. HCT #9 stated staff would perform linen count for each patient once a week on linen exchange day performed once a week. She stated linen counts were tracked to ensure patient safety and prevent patient harm. This interview contrast with the facility policy which read, environmental safety checks, as part of patient wellness checks, include checks on linen (extra linen and towels) and the integrity of the linen and towels.

b. On 7/29/21 at 12:30 p.m., an interview with CCA #10 was conducted. She stated a competency training on wellness checks was performed on 7/29/21 (during survey). She stated the wellness check training covered how to check patients and their environment, accountability on linen count, and unit specific programs.

c. On 8/2/21 at 5:18 p.m., an interview with CSS #11 was conducted. CSS #11 stated when the new position of CSS was implemented (3/1/21), the correctional officers transitioned to a nursing role. CSS # 11 stated he did not receive training on how to monitor patients when they were in the dining hall. He stated patient handoff reports were not provided unless he requested them.. He said handoff reports included unit patient count, shift report communication, day hall monitoring, linen count and seclusion and restraint assessments.

d. On 08/3/2021 at 8:26 a.m., an interview with HCT #14 was conducted. HCT #14 stated she received some training but did not receive unit orientation or training regarding 1:1 patient assignment, monitoring the dining hall and door checks. HCT #14 stated during dining hall checks, staff sat together at the table. He/she stated during wellness checks, patients' names were not called out and instead, staff counted the patients. HCT #14 stated the patient count number was not shared among staff and it was the wellness check staff who notified other staff members when ready to move into or out of the dining hall. He/she stated patients were not counted when they returned to the unit. HCT #14 stated there was no official training regarding how this process was to be performed and it was "just done that way." This interview contrasted with facility policy that read environmental safety checks are performed in conjunction with patient wellness checks.

e. On 8/3/21 at 3:12 p.m., an interview with RN #13 was conducted. RN #13 stated there was no orientation or training provided to staff on dining hall checks. She stated staff were not trained to check doors on off-unit assignment like the dining hall. She stated staff should be dispersed in the dining hall to maintain safety and to maintain the integrity of the entrances.

C. Adverse patient events

a. Record review revealed on 7/27/21, Patient #2 attempted suicide, using a sheet (extra linen was identified in his room after the incident) and a large trashcan. Neither the trashcan or the extra linen had been authorized. (Cross-reference Tag 0144).

b. Record review revealed on 7/30/21 at 5:01 p.m., Patient #6 eloped from the facility. Record review further revealed the dining room door had been found unlocked on the following two days at 5:03 p.m. and 5:17 p.m., prior to the patient's elopement. (Cross-reference Tag 0144).

D. Chief Nursing Officer (CNO) #12 confirmed facility policies to ensure patient safety.

a. On 8/10/21 at 2:26 p.m., an interview with Chief Nursing Officer (CNO) #12 was conducted. She stated Unit Orientation Forms were to be done for any staff in a new unit. She stated she was unaware correctional officers who transitioned into CSS role had not completed Unit Orientation Forms; she said she assumed it was done during their previous role as correctional officers. She stated the lead nurses were responsible to ensure competencies were completed for staff in a new unit.

CNO #12 stated unit orientation ensures patient safety. She stated every staff member must know the unit function and location of emergency items, and staff need to be familiar with the patient population as the population was different in each unit.