HospitalInspections.org

Based on record review and interview the hospital did not have a governing body that was responsible for the conduct of the hospital. Failure to have an effective governing body that is legally responsible for the conduct of the entire hospital can contribute to systems problems, continued non-compliance and could potentially lead to negative outcomes associated with the provision of care/services within the facility.

Findings include:

Records reflect during March 13, 2020 complaint survey the facility had condition level noncompliance with:
-Governing Body
-Patient Rights
-Quality Performance Improvement Program
-Nursing Services
-Radiological Services, and
-Emergency Services

Records reflect during the November 19, 2020 Focused Infection Control survey the facility had condition level noncompliance with:
-Infection Control; an Immediate Jeopardy was cited

For the March 26, 2021 recertification, revisit and complaint survey cross refer to the referenced findings.
The hospital failed to develop an emergency plan based on a risk assessment and incorporating an all-hazards approach (E0004); failed to conduct a facility-based risk-assessment (0007); failed to develop emergency preparedness policy and procedures (E0013); failed to develop evacuation procedures (0020); failed to develop communication plan (0029); and failed to develop an Emergency Preparedness (EP) training and testing program (0036).

The hospital failed to promote each patient's rights (A115); failed to operationalize a process for prompt resolution of patient grievances (A119); failed to provide written notice regarding its decision on submitted grievances (A123); and failed to provide care in a safe setting.

The hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide data-driven quality assessment and performance improvement (QAPI) program that involves all hospital departments and services (A263); failed to measure, analyze, and track quality indicators ...and other aspects of performance that assess process of care (A273); failed to use collected data to identify opportunities for improvement (A283); failed to ensure performance improvement activities must track and reduce medical errors and adverse patient events (A286); and failed to ensure the ongoing program for QAPI addresses a reduction in medical errors, improves quality of care and promotes patient safety (A309).

The hospital failed to ensure the radiological services met standards for safety and personnel qualifications (A528); failed to ensure radiological staff followed policy and procedures that promoted patient safety (A535); and failed to ensure a part-time or consulting radiologist must supervise the service (A546).

The hospital failed to ensure the hospital is constructed, arranged and maintained to promote the safety of patients (A700); failed to ensure the condition of the physical plant and overall hospital is developed and maintained to promote patient safety (A0701); failed to provide a system demonstrating emergency gas and water were available if needed (A703); and the hospital failed to ensure the Life Safety from Fire requirements were met (refer to A709 [the current Life Safety Code Survey that occurred during the recertification survey time period]).

The hospital failed to have an active hospital wide infection prevention and control program that was inclusive of an antibiotic stewardship program (A747); failed to operationalize policies and procedures to prevent/control the spread of potential infections (A749); failed to maintain a clean and sanitary environment to avoid sources and transmission of infection (A750); and failed to develop, implement and maintain a hospital-wide antibiotic stewardship program (A778).

The hospital failed to ensure the anesthesia services were actively participating in the hospital-wide QAPI program (A1000).

The cumulative effect of these systemic practices resulted in the failure of the hospital to comply with the statutorily mandated regulations under Governing Body.

Based on observation, record review and interview, the hospital failed to assure that Ligatures and ligature points were not accessible in all patient bedrooms and bathrooms for patients in the Adolescent Care Unit (ACU -a unit providing subacute mental and behavioral health services to patients between 13 and 17 years old.). In addition the facility did not assure that loose bricks were not assessable to patients in the ACU outdoor area. As a result 1. On 3/22/2021 at 5:30 PM one of seven patients (Patient 19) attempted to hang herself with a bed sheet attached to a latch on the closet door in the bedroom; and 2. Patient 20 (a discharged patient) threw bricks at staff and other patients on 11/26/2020 at 1:10 PM.

On 3/23/2021 at 11:50 AM Staff 64 informed the survey team of this suicide attempt. After further investigation the survey team identified an immediate jeopardy situation (IJ) for (0144) on 3/23/2021 at 4:15 PM.

A0119 - Review of greivance
A0123 - Notice of Greivance Decision
A0131 - Informed Consent

The cumulative effects of these systemic practices resulted in the hospital's failure to comply with statutorily mandated regulations under Patients Rights.

Based on policy review, record reviews, and interview, the hospital failed to ensure implementation of an effective grievance process as evidenced by failure to conduct and document thorough investigation of five (Patient (P) 31, P32, P33, P34, P35) of five patient grievances reviewed. This failure had the potential to affect any patient who submitted a grievance or had a grievance submitted by their representative.

Findings include:

Review of the policy titled "Patient Grievance and Complaint Policy," revised June 2020, indicated a grievance was defined as " ... a written or verbal complaint by a patient or patient's representative regarding patient care, abuse or neglect as outlined in the patient bill of rights. If a verbal patient care complaint cannot be resolved at the time of the complaint by staff present and/or requires an investigation and further actions for resolution, the complaint is considered a grievance. If the patient or patient's representative requests their complaint to be handled as a formal grievance or requests a response from the hospital, the complaint is considered a grievance. . . The Patient Experience Liaison (s) (PEL) shall: a. Serve as an intermediary between the patient, the healthcare provider, and the healthcare system, and provides a specific channel through which patients and families can seek solutions to problems, concerns, and unmet needs. . . c. Assist department supervisors in determining appropriate corrective action(s). d. Attempt to resolve grievances(s) within thirty (30) calendar days of notification. i. An investigation will start upon notification of the grievance. . . 2. Department Supervisors shall be primarily responsible for: a. Attempt to resolve the patient's and/or Patients representative complaint before the patient leaves the facility. If complaint is not resolved within the same day the complaint will escalate to a grievance. . . c. Notifying the PEL of any corrective action initiated or implemented . . . d. Ensuring staff are trained on their role in the grievance process. . ."

1. Grievance reported to Staff 25, Patient Experience Liaison, by P31:
Date of incident: 10/28/20
Grievance details: ". . . patient arrived to the emergency department [ED] regarding a health issue. Patient states he/she was treated in the Emergency department and later to the Observation Department [part of the emergency department]. Patient states he/she was told he/she had to wait for 2 hours to have additional labs, so he/she was then transferred to the Observation Department. At around 1330 [1:30 PM], patient pressed the call light to ask some questions about lab work that will be due. Patient asked the nurse how the labs are going to be drawn and how long it will take for results to return. The Nurse told him/her blood will be drawn from him/her IV [intravenous] line and that it will take 45 minutes for the results, but a provider will have to review the results before the information can get to him/her. At this time, the patient asked to go to the restroom, so everything was disconnected for her (BP [blood pressure] cuff, etc.) Patient states he/she was trying to get up out of bed and was having a hard time, so he/she asked the two ladies (Staff 11, RN [registered nurse] Agency ED, and another Navajo female) to help him/her get up but they ignored him/her and walked away. Further concerns documented included the following:
"Patient made comment and said "Geez, you could help." That is when Staff 11, RN Agency ED, turned around and said "What! The restroom is right there!" (Pointing to the restroom) and walked away."
"Provider returned to his/her room and told her everything was negative and that he/she could go home. . ."
Patient " ... pressed the call light again to get assistance in getting dressed to go home. Patient states Staff 11, RN Agency ED, answered the call. The patient asked the nurse when he/she was going to be discharged and that he/she will need help getting dressed Patient states Staff 11, RN Agency ED, asked the patient "did the Doctor release you?" . . . "
"When he/she [Cristine Vale, RN] returned with the papers, patient was instructed to sign the paper without proper instructions. Patient states he/she also noticed the Nurse did not change him/her gloves when he/she entered the room, so the patient asked him/her "Do you change your gloves?" Patient states this is when Staff 11, RN Agency ED, became upset with patient and said "Why would I change my gloves? This is not an emergency." Patient replied his/her concerns for spreading the virus patient to patient due to going room to room for patient care. Staff 11, RN Agency ED, told the patient "you are in a big stream of Coronavirus". Staff 11, RN Agency ED, then added "your mask is not safe because it does not have a filter." . . . Patient states as Staff 11, RN Agency ED, was leaving the room he/she turned around and said, "do you have a problem with me?" Patient states he/she said "yes" and Staff 11, RN Agency ED, laughed and walked out of the room. . . He/she [Staff 11, RN Agency ED] was very confrontational with me the whole time I was in Observation. . . he/she treated me like he/she didn't like me. That kind of treatment is not a part of my healing. . . The treatment I received from Staff 11, RN Agency ED, was not appropriate or professional."
Person Involved: Staff 11, RN Agency ED; Female [last name only documented]
Follow-up done by Staff 34, Assistant Nurse Executive, on 11/03/20: "met with Nursing staff and provider involved in care of patient. . ."
Follow-up done by Staff 33, Nurse Executive, 11/03/20 with Staff 11, RN Agency ED - " Staff 11, RN Agency ED, stated that this patient was moved from the ED [emergency department] to OBS [observation] 5 after receiving care. He/she was moved . . .to receive a repeat Troponin. This patient was upset due to being held for a troponin redraw, therefore asked her provider, Staff 47, Deputy Chief of EM, to speak with patient about why he/she was being placed in OBS unit." . . . The patient wanted to go to the restroom, the patient was disconnected from monitors and shown where the restroom was located which was next to the room that he/she was in. . . "Since this patient was upset with him/her care, Staff 47, Deputy Chief of EM, notified the patient advocate to come see the patient. Staff 11, RN Agency ED, stated that he/she was with this patient in OBS for about 5 minutes and this patient was not him/her patient. Troponin redraws are done 6hrs after the initial draw. . . This was explained to the patient numerous times."
Resolution Summary by Staff 25, Patient Experience Liaison: "All adequate and appropriate care was attained for this patient. Patient was continuously updated regarding the care he/she was receiving. Reason for wait times were also explained periodically by nursing staff. . . ED staff did what they could to accommodate the patient, but patient was still not satisfied with the outcome."

There was no documented evidence that a chart review was done, interviews were conducted with or written statements obtained from each staff involved (the patient's nurse assigned to care for the patient), and concerns regarding communication were not addressed in the investigation.

In an interview on 03/25/21 at 10:26 AM, Staff 28, Patient Experience/HIPAA [Health Insurance Portability and Accountability Act] stated interviews were not conducted with all staff involved in P31's care provided in the emergency room.

2. Grievance received by Staff 32, Patient Experience Liaison, from P32:
Date of incident: 12/14/20
Date reported: 12/14/20.
Description of incident: received complaint from MSU [Multi-Service Unit] "regarding missing belongs, . . . Items went missing on December 14, 2020. Patient was admitted through ED Fast Track to ICU [intensive care unit]. On December 5, 2020 patient was transferred to MSU and from there made inquiries into his/her belongings. As of today, 12/18/2020 nothing has been found. . . Patient is frustrated and would like his/her belongings back."
Follow-up Actions:
12/28/20 Staff 33, Nurse Executive, did chart review - "a clothing inventory list was done on this patient and is present in the Clothing items book. This patients clothing was taken with him/her to MSU. The nurse in MSU who received the patient documented: Personal Belongings/Valuables Belongings/valuables did accompany pt [patient] to unit. This patient's clothing should be found on MSU.
Documentation 12/18/20 by Staff 32, Patient Experience Liaison, of follow-up with the discharge planner, Staff 4, Interim Chief Nursing Officer, the House Supervisor - "Did investigation regarding patient belongings, 1 Nike Shoe and 2 Black jackets. Belongings missing when patient moved to MSU. Tasked to Nurse Executive ER, Chief of Emergency Medicine, and CNO for follow-up."
12/22/20 by Staff 32, Patient Experience Liaison - telephone "follow-up with Staff 4, Interim Chief Nursing Officer, who assigned it to Nurse Executive MSU for follow-up, Staff 29, Resource RN
12/28/20 by Staff 32, Patient Experience Liaison, by telephone - "follow-up call to Staff 29, Resource RN, regarding patient belongings"
12/29/20 by Staff 32, Patient Experience Liaison - "email attached."
12/31/20 follow-up by Staff 29, Resource RN: "Description Reviewing the chart and the documentation: The patient was admitted on 12/14/20 by ICU RN. He/she documented in the EHR [electronic health record] the belongings were at bedside with the inventory sheet. 12/15/20 Staff 14, RN Agency ICU (intensive care unit) transferred care to a RN assigned to MSU Room 15. Staff 14, RN Agency ICU, documented "patient transferred with all of his/her belongings."
. . . 12/19/20 Patient was discharged home aware he/she did not get her jacket and shoes back."
"I searched through the patients EHR chart reviewing images for scanned belongings sheet for the 12/14/20 admission. None were found. The belonging sheet from the ER was not found also. . . This sheet was not found in the EHR nor was it found in the patient's hard chart. This author will call the patient, inform the patient his/her items were not found. Will then inform the patient if you choose to purchase new shoes bring the receipt to me on MSU and I will request a check to reimburse his/her shoe purchase. . ."
12/31/20 telephone message left by Staff 29, Resource RN, to patient regarding his/her belongings.
01/04/21 Phone conversation with Staff 29, Resource RN, and patient at 8:35 AM informing patient "we were unable to account for her shoes and jacket. Informed patient once she chooses to purchase his/her items to bring the receipt to me and I will request for compensation for those items. . .
There was no documented evidence that interviews with all staff involved in P32's care were conducted.

At 10:14 AM on 03/25/21, Staff 28, Patient Experience/HIPAA, stated when they interview staff, the employee sometimes works the night shift, so they may not interview that staff member. They try to have the supervisor do the investigation and the resolution. Her department tries to facilitate the resolution and assist where needed. She confirmed that all staff involved in P32's care were not interviewed.

3. Grievance received by Staff 25, Patient Experience Liaison, from P33:
Date of incident: 01/24/21
Date reported: 01/27/21.
Description of incident: "Patient called to express his/her concern about his experience in the Emergency Department on Sunday 01/24/2021. . . P33 checked in at the Emergency Department for a medical concern he/she had to address but ended up leaving without being seen due to his/her experience. P33 and another patient were waiting in the waiting room with another individual who was the spouse of a patient. P33 states Security Officer allowed this individual to wait in the waiting room to watch the football game on TV [television]. This other individual kept coughing and coughing while drinking a cup of coffee. As they were waiting, an anglo [white American who is not of Hispanic or Latino origin] nurse wheeled in an elder patient who was slumped over in the wheelchair. Upon entering the ED waiting area, this nurse announced "He/she is COVID positive and has chest pain!" and parked the patient in the ED waiting room. Per P33, with that announcement, both P33 and the other patient left ED without being seen. . . P33 states the individual who was waiting for spouse, should have been waiting in his/her vehicle and not in the waiting room. P33 states the Security Officer and 6 other nursing staff conveniently watched this football game along with this individual in the waiting room. . ."
Follow-up by Staff 36, Director of Security Services, on 01/28/21: ". . . Based on the limited information provided, from a Security perspective the concern does not clearly define specifically how the Security Officer contributed to this unsatisfactory patient experience. Our Security Officer(s) do not have access to the information needed to determine why patients are waiting in the ED waiting room. Additionally, I believe all patients are allowed a caregiver. Therefore, I believe this concern can best be addressed by the ED Nursing and Medical Staff.
Follow-up by Staff 33, Nurse Executive, on 02/03/21: "This incidence was brought to the attention of the ED Nursing staff during AM Huddle [meeting with staff before the morning shift begins] and was addressed as a scenario. Situation: You receive a patient who is COVID + [positive] in triage, how should you handle the patient and communicate that to your team? . . . Situation: the waiting room is full, what do you do? . . . Situation: patients have family members sitting by them, what should you do? . . . Question: Can you yell outloud [sic] that a patient is COVID + in the lobby? . . . Then it was emphasized that it was everyone's job to protect the patient's privacy. This was done for AM Huddles over a week that covered all matrix's. The ED staff shows good understanding of this subject and will practice it."

There was no documented evidence interviews were conducted with or written statements were obtained from staff working at the time, inclusive of the Security Officer.

In interview on 03/25/21 at 10:20 AM, Staff 28, Patient Experience/HIPAA Manager, stated Staff 33, Nurse Executive, told her he/she was unable to identify which employee was in the lobby. Staff 28, Patient Experience/HIPAA Manager, stated there was no documentation of the methods used by Staff 33, Nurse Executive, to attempt to gather this information. He/she confirmed there was no documentation that staff working at the time of the incident had been interviewed to obtain specific information related to P33's grievance.

4. Grievance documented by Staff 25, Patient Experience Liaison, from P34's mother:
Date of incident: 02/02/21
Date reported: 02/03/21.
"Additional notes: 2/9/21: Employee not here today. Rtns [returns] 2/10/21. Will meet [with] him/her then."
Grievance details" "Patient [1 year old] was brought into the ER for diarrhea. Patient was brought in by older sister, not mother. Patient's mother was outside in the car. When patient got to the registration for update, the Staff 31, Patient Access Representative [PAR], informed him/her patient cannot [sic] be seen without parent. The mother states he/she was very rude to her daughter. . ." Patient and mother left. "While mother was driving to another hospital [initials of other hospital] Staff 37, RN charge nurse, called the mother and told her to bring the child back and he/she will get seen. The mother refused and Staff 37, RN charge nurse, threatened to call child welfare on her for neglect and abuse of the child. . ."
02/05/21 by Staff 33, Nurse Executive: "The PAR was correct in that the parent of the patient needed to be present in order for the patient who is a minor to be seen. The ED Charge nurse was aware that the unknown party who presented with the patient was not the legal guardian of the patient. . . Staff was advised that the mother was in the car but did not want to come in because she didn't want to miss work "for this." The party left before triage. The Charge Nurse then called the patients mother on the phone to encourage her to return for the patient's assessment."
02/16/21 by Staff 18, Patient Registration Manager, with Staff 31, Patient Access Representative: ". . . he/she updates he/she did not refuse or inform mother had to be present to check in the patient. The daughter who brought in the patient, did not know the patients date of birth, the nurse [first name only of nurse] and Staff 31, Patient Access Representative, asked if they can call the mother to get the information. The mother then became upset and came into the ED Registration section and indicated she did not have time for this. The Staff 37, RN charge nurse, then tried to intervein [sic] to see the patient in the ED, but she stormed off and indicated she will file a formal complaint. Reminder of the EMTALA [Emergency Medical Treatment and Labor Act] and Expectation of behavior policy reviewed, to ensure our team is aware, and to always utilize good customer service at all times."
"Immediate Corrective action": by Staff 25, Patient Experience Liaison: "There are no corrective actions necessary due to the limited information obtained. Mother was in the vehicle and when the Charge Nurse attempted to intervene, Mother became upset. . ."

There was no documented evidence of an interview conducted with or written statements from Staff 37, RN charge nurse, or the nurse named by first name only to obtain more information related to the grievance.

In interview on 03/25/21 at 10:24 AM, Staff 28, Patient Experience/HIPAA Manager, stated a thorough investigation was not done for the grievance submitted by P34's mother.

5. Grievance documented by Staff 32, Patient Experience Liaison, regarding P35:
Date of incident: 02/16/21
Date Reported: 02/16/21
Description of incident: Patient called PEL (Staff 32, Patient Experience Liaison) stated that "he/she came into pharmacy to pick up medication which he/she was informed that were ready. Patient stated he/she checked in at front window, was told that he/she would be called and to have seat. . . Patient stated he/she entered the room and informed pharmacist that he/she was here on Thursday 2/11/21 and Saturday 2/13/21 to pick up medications. Patient stated that pharmacist was looking up medication in computer and stated a loud "Oh well it's only Viagra!" . . . Patient got further upset at that remark and again cussed at pharmacist. . . Patient would like his/her behavior addressed, patient states that pharmacist was wearing pink scrubs and he/she was Latino."
02/22/21 by Staff 32, Patient Experience Liaison - emailed reminder to Staff 24, Chief Pharmacy, "regarding assistance with Closure of RL [incident reporting system] Patient Grievance regarding an unfortunate experience a patient had in pharmacy which is due in two days."
02/24/21 follow-up done by Staff 24, Chief Pharmacy - looks like email but not documented as such to P 35. The information included "I have reviewed your statement and I have interviewed the staff that spoke to you on that day. Your visits to the Pharmacy on 2/11/21 and 2/13/21 were a little unclear. I do not know if you were looking for the same medications on all three occasions or if different items on each visit. . . My staff does not agree with your view of the reported events. They did not say Viagra in a loud manner. . ."

There was no documented evidence of the interview with or written statements from the specific pharmacy staff involved in the encounters with P35.

In an interview on 03/25/21 at 10:26 AM, Staff 28, Patient Experience/HIPAA Manager, stated the email was information being sent to Staff 32, Patient Experience Liaison, to have for documentation of the resolution letter. He/she agreed there was no documentation of a thorough investigation done related to P35's grievance.

In an interview on 03/25/21 at 9:40 AM, Staff 28, Patient Experience/HIPAA Manager, stated he/she agreed the investigation should include interviews or written statements from all staff involved in the patient's care. He/she stated the patient advocates have come across some roadblocks with the ER (emergency room) staff, "so that's something we've been trying to address." He/she stated they have gone to the Chief Nursing Officer to address this on some cases. He/she stated he/she is not sure if "the reason is short staffing or that their staff do not make mistakes and are sticking up for their staff." He/she stated they do recognize there is some concerns with some departments. He/she stated it is the responsibility of the patient liaison to assure the grievance is complete and finalized based on what the department supervisor's resolution was. He/she stated the patient liaison should go back to the supervisor if he/she sees that all staff involved in the patient's care have not been interviewed or written statements have not been obtained. After review of the grievances, Staff 28, Patient Experience/HIPAA Manager, stated "I probably haven't pushed my staff enough to document their interviews" that were done related to grievances.

Based on policy review, record reviews, and interview, the hospital failed to ensure the patient was provided written notice of its decision regarding a submitted grievance, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion for five (Patient (P)31, P32, P33, P34, P35) of five grievance resolution letters reviewed. The hospital's grievance policy did not include the required components of a resolution letter.

Findings include:

Review of the policy titled "Patient Grievance and Complaint Policy," revised June 2020, indicated the Patient Experience Liaison (PEL) was responsible for sending a resolution letter "upon resolution. iii. If additional time is required beyond the 30 calendar days the patient or representative will be notified within three (3) business days of the delay in resolution. . ." There was no documented evidence that the policy contained the required components that were to be included in the resolution letter, such as the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

1. Review of the resolution letter addressed to P31 by Staff 25, Patient Experience Liaison, on 11/06/20 indicated the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion were not included in the resolution letter.

2. Review of the resolution letter addressed to P32 by Staff 32, Patient Experience Liaison, on 01/04/21 indicated the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion were not included in the resolution letter.

3. Review of the resolution letter addressed to P33 by Staff 25, Patient Experience Liaison, on 02/03/21 indicated the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion were not included in the resolution letter.

4. Review of the resolution letter addressed to P34 by Staff 25, Patient Experience Liaison, on 02/16/21 indicated the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion were not included in the resolution letter.

5. Review of the resolution letter addressed to P35 by Staff 32, Patient Experience Liaison, on 02/24/21 indicated the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion were not included in the resolution letter.

In an interview on 03/25/21 at 9:40 AM, Staff 28, Patient Experience/HIPAA (Health Insurance Portability and Accountability Act), stated the components required by regulation to be included in the resolution letter are not addressed in the grievance policy or included in the resolution letter used by the facility. He/She stated the resolution letter is a template and is the same letter used for all Indian Health Services Hospitals.

Based on observation, interview, record review and video review the facility did not assure that Ligatures and ligature points were not accessible in all patient bedrooms and bathrooms for patients in the Adolescent Care Unit (ACU -a unit providing subacute mental and behavioral health services to patients between 13 and 17 years old.). In addition the facility did not assure that loose bricks were not assessable to patients in the ACU outdoor area. As a result 1. On 3/22/2021 at 5:30 PM one of seven patients (Patient 19) attempted to hang herself with a bed sheet attached to a latch on the closet door in the bedroom; and 2. Patient 20 (a discharged patient) threw bricks at staff and other patients on 11/26/2020 at 1:10 PM.

On 3/23/2021 at 11:50 AM Staff 64 informed the survey team of this suicide attempt. After further investigation the survey team identified an immediate jeopardy situation (IJ) on 3/23/2021 at 4:15 PM.
Seven patients remained on the ACU after the suicide attempt. Patient 19 was placed on 1:1 staff to patient care. Ligature points remained a risk to the other six patients on the unit.
The facility provided three abatement plan. The third one was accepted on 3/24/2021 at 2:45 PM. The CMO3 and the Interim Executive VP for Medical Services (EVPMS-2) stated they reviewed the unit and realized they needed to re-structure the unit and the program. They will discharge all patients and would send Patient 19 to a higher level of care. Patients will be in the presence of staff at all times until discharge. The plan also read "The unit will not re-open to patient services until the ligature risk is remediated and policies are revised to reflect increased screening and observation of any patient who exhibits the potential for self-harm. "
The IJ was abated on 3/25/2021 at 8:45 AM after verification that all patients had been discharged.

Findings include:

1. On 3/22/2021 at 2 PM in the ACU observed two rooms - 34, and 38 - Ligature points noted in patient rooms, bathrooms, the faucet and piping for the sinks and toilets. Dining rooms, class rooms, group rooms, bathrooms in hallways have multiple ligature risks. All resident rooms were the same.
Rm 34 had etching on the windows. Mirrors in rooms. (Window and mirrors were Plexiglas). When asked what the patients could use to etch the Plexiglas Staff 55 and 59 shrugged their shoulders.
When asked about the ligature points Staff 59 stated they did not have any patients that were at risk for suicide. Staff 59 stated the unit was a sub-acute unit for stable patients.

During an interview on 3/22/2021 at 2:15 PM, Staff 63 stated she received report by 7:30 AM on the status of the patients. They were all on every 15 minute checks. She stated they had to see every patient to make sure they were ok. She stated they do rounds for safety checks every time in the room. When asked what was included in the safety checks. She stated items the patient could use to harm themselves and unacceptable items like cigarettes or drugs or alcohol.
On 3/23/2021 at 10:55 AM, upon entering ACU unit Staff 64 sat outside room 35A.

During an interview in Staff 52's office, on 3/23/2021 at 11:20 AM, with Staff 52 present when asked Staff 64 why he was sitting outside Room 35. He stated that Patient 19 attempted suicide last night. "She tried to hang herself with a sheet."
Staff 64 stated that Patient 19 spoke with psychiatrist, therapist, and nurse, attended groups and classes and went to treatment team meeting during the day. Staff 52 and Staff 63 attended the treatment meeting and met the patient multiple times during the day. Patient 19 denied wanting to hurt herself.
Staff 52 stated that the treatment team decided to increase staffing until they could find placement in a higher level of care for Patient 19.

Reviewed Patient 19's medical record after the above interview. The medical record revealed in the Adolescent Psychiatry Admission Evaluation dated 3/11/2021 written by Staff 49, that the patient was 16 years old with diagnoses including Major depression severe recurrent, bulimia (an eating disorder), substance abuse and many chronic social problems. In addition Staff 49 wrote; " ...has chronic off and on suicide ideation ...2 months ago she tried to overdose on her medication but did not go to the hospital ...She admits to off and on suicide ideation but denies a plan ...(2017 she made several suicide attempts here). The plan included: " ...She will be assessed for suicide thinking and will be on 15 minute precautions..."
A Mental Health Inpatient Treatment Plan Note written by Staff 54 dated 3/12/2021 at 11:33 AM, indicated Patient 19 had suicidal ideations.

On 3/23/2021 at 1:15 PM in the ACU Nurse's Station, during an interview Staff 58 stated she had worked on the ACU one week. She had orientation to the unit last week and thought the ligature points were a problem; however did not feel comfortable saying anything since these must have been there for a long time. When asked if she had done a suicide assessment on Patient 19, Staff 58 stated she just asked her if she wanted to hurt herself. She stated the nurses did not have a specific suicide assessment form they just asked the patients if they wanted to hurt themselves one time per day. Patients also saw the therapist and psychiatrist who also ask if they wanted to hurt themselves. Patient 19 had a history of suicide attempts three years ago. After Patient 19 made the suicide attempt last night the nurse called the pediatrician come to the unit to assess the patient. When asked why they had not sent the patient to the emergency department she stated Patient 19 was ok.

During an interview on 3/24/2021 at 9:35 AM, when asked about her training for suicide assessments in teenagers, Staff 59 (who was the assistant director of nursing for the ACU) stated the nurses just ask if the patient felt like hurting him/herself. Staff 59 stated she did not do suicide risk assessments. She stated she had no formal training on how to conduct suicide risk assessment. She stated the Program Director did the "Columbia Assessment" upon the patient admission to the ACU.

During an interview on 3/23/2021 at 1:45 PM, when asked to describe what happened to Patient 19 last evening, Staff 63 stated Patient 19 was exhibiting behaviors of concern since admission on 3/11/2021. She stated the leadership did not provide pertinent information to her about the patient because of patient confidentiality. She stated she had not known of Patient 19's previous attempt to hang herself with a sheet when she was here three years ago.
Staff 63 was visibly shaken and upset when she stated that she had informed Staff 58 and Staff 52 of her concerns last week. She stated she also told Staff 55 who was covering for the program director, Staff 52, yesterday 3/22/2021 that Patient 19 could not stop crying and stated she wanted to disappear. She stated she was concerned because Patient 19 was unpredictable. She checked on her every 5 minutes since this morning.

During a concurrent review of the Patient Behavior Observation Log and interview with Staff 63. The log showed pre-printed times at 15 minute intervals. Review of the notes on the back of the log showed that at 10:10 AM the patient was agitated during "Morning Blessing" (a cultural tradition). When she returned to her room she began hitting wall. "Will check on patient every 5 minutes." The notes indicated the patient continued to exhibit concerning behavior all day including crying, isolating, and irritability and throwing things. Patient was crying in her room between 5:07 PM and 5:30 PM
The note dated 3/22/2021 at 5:30 PM read as follows: "Writer went to check on PT (patient) ... PT was crying loudly. Writer observed patient in a sitting position beside her closet, Pt tried holding the [closet] door when writer opened Pt's room door, holding the [closet] door as if PT were hiding from writer. Writer walked carefully to see PT and noticed PT had her bed sheet wrapped around her neck. RN's [Staff 59 and Staff 60], MHT (Mental Health Technician) [Staff 62] and writer were in the room trying to help PT remove the sheet from her neck. While this was happening PT seem to not want to remove sheet from her neck (holding sheet w/hands), then PT let go (crying) saying she's sorry. PT will continue to be monitored for safety. At this time ACU staff made a decision to put PT on in line of sight. Pt currently being observed one-on-one [Staff 62 and 63] ..." (SIC)
When asked what type of training she had on environment safety checks she stated "The only training I received was TCI training not ligature risks." TCI means Therapeutic Crisis Intervention.
When asked what 1:1 care meant, Staff 63 stated the staff have to be physically with the patient at all times except when they use the bathroom. They wait outside the closed bathroom door to give them privacy for 5 minutes.
Staff 63 stated the around lunchtime on 3/22/2021 Patient 19 asked to speak with her therapist, Staff 54.

Review of Patient 19's medical record in Staff 54's progress note titled Adolescent Care Unit Group/Individual Therapy dated 3/22/2021 11:20 AM, read in pertinent part: " ...Patient was tearful for a long time ... stated how long they (sic) had been depressed, hearing voices (and the increase of them over time)... Pt. disclosed multiple assaults and when pt reached out for help pt was not believed ..."

Review of Mental Health Inpatient Note dated 3/22/2021 at 11:45 AM written by Staff 49, read in pertinent part: "..(Patient 19 said) 'I can't handle it. I want to go home. I'm tired of being with people' ...She denied suicide and homicide ideation ..."

Review of ACU RN Note Dated 3/22/2021 at 9:40 PM written by Staff 60, read in pertinent part after dinner " ...did not eat and dumped her tray into the trash then left the dining room-went into her room and stated she wanted to be left alone- alternated between laying on the bed and sitting on the floor while crying very loudly- staff checked on pt every 5-10 mins- pt continued to sit on the floor loudly crying- At 5:30 pm, pt was seen sitting on floor beside her closet and noted to be holding the closet door as if she was trying to conceal something- pt observed to have a bed sheet wrapped around her neck and door handle- sheet was removed from her neck after approx. 1 minute- while staff was trying to remove the sheet from her neck, pt was holding onto the sheet crying "No! No! Leave me alone! I'm sorry!" Pt lay on the floor loudly sobbing. [Vital signs within normal limits except oxygen saturation was a little low at 94%] ...no redness or skin discoloration noted around neck: ...Staff ...provided emotional support ...She cried like this for approx[imate] 20 minutes then staff escorted her to bed - continued to cry but quieter and now asked for something to eat and drink.- Staff 49, Staff 55 and Staff 59 [were] notified - Placed on 1:1, safety level and line of sight at all times at 5:30 PM; PEDS[Pediatrician] (Staff 50) in to assess and medically cleared - instructed to monitor for difficulty swallowing, and /or stridor [Stridor is a sound made when the wind pipe is blocked] ...patient said she heard a voice "telling her to kill myself and disappear ..." (Sic).

Review of Mental Health Inpatient Note dated 3/23/2021 at 9:03 AM written by Staff 49, read in pertinent part: " ...She took a bed sheet and tried to hang herself on different object (the bathroom door, the desk, the closet) ...Today she ...still looked depressed ...She stated that last night she heard command hallucinations telling her to kill herself. She denies these hallucinations this morning ...She attempted to hang herself when she was here 3 years ago. The staff and I need to decide if this is the most advantageous place for her ...The fact that she attempted to hang herself 3 years ago, has been in her room [at home] for the last year not doing anything but smoke MJ (marijuana) point to a poor prognosis ...."

An Inpatient Nursing Care Plan Progress note dated 3/21/2021 at 1:33 PM written by Staff 59, identified Problem #1: Ineffective coping ...Ineffective coping strategies AEB (as evidenced by) suicide ideation and suicide attempt as well as diagnoses of recurrent bulimia and marijuana addiction ...Problem #2 Potential for Self-Injury related to past history of self-mutilation and suicide attempt. Nursing interventions; Institute suicide precautions as warranted. Provide a safe environment ...Assess skin for injury as needed. Monitor patient while using sharp objects."

Review of the Pediatrics Note dated 3/22/2021 8:11 PM written by Staff 50, read in pertinent part: "Called to ACU for medical consult after suicide attempt. Per nurse patient was found in her room approximately 2 hours prior to the call trying to use her bed sheets to strangle herself. She was found prior to LOC (loss of consciousness) ...Neck: small amount of linear bruising located midline with mild overlying tenderness, no swelling notable ...Discussed with nurse that there appears to be no internal injury but that she should be monitored closely overnight ..."

During an interview on 3/24/2021 at 9:35 AM, when asked about her training for suicide assessments in teenagers, Staff 59 (who was the acting director of nursing for the ACU) stated the nurses just ask if the patient felt like hurting him/herself. Staff 59 stated she did not do suicide risk assessments. She stated she had no formal training on how to conduct suicide risk assessment. She stated the Program Director did the "Columbia Assessment" upon the patient admission to the ACU.

On 3/24/2021 at 11:00 AM during an interview in Staff 52's office, Staff 52 stated the unit was going to be closed and Patient 19 will be sent home with her father. When asked why she would be going home so soon after a suicide attempt, Staff 52 stated the Navajo Nation did not have any laws that allow for involuntary hold of a minor. She would refer the patient to the Nation's social services who would follow up at the family home. Staff 52 stated she was worried because there was someone in the family home who had sexually abused Patient 19. She indicated this person was not family.

Review of the Mental Health Counselling Note Emergency Department dated 3/24/2021 at 2:31 PM written by Staff 56 read in pertinent part: " ...HPI [History of present illness]: Pt transferred from ACU due to ACU closing and treatment team assessment that pt is not safe to be sent home ...On assessment the pt is noted to have many scars on her arms from superficial cutting. Her affect is flat. She describes her mood as "tired, frustrated" She denies AH/VH and does not appear to be responding to internal stimuli ...She is cooperative at times but vague when safety or suicidality is brought up ...When asked about prior suicide attempts she responds "I don't want to talk about it." ...I called her father ...he agreed that pt probably needed support for safety at this time and agreed to sign consent for transfer ...I called her therapist in [place of residence] ...Her therapist has been worried about her for years ...SI in pt in the past had plans with less lethal means and is agreement that pt needs immediate intervention. Based on her history and recent suicide attempt. She also reports that CPS [Child Protective Services] has been contacted many times for this pt without intervention ...Impression: Pt is at high risk for suicide and in need of immediate inpatient intervention. Risk factors include past attempts, increased capacity (cutting, Thwarted belongingness, age, ethnicity, substance use, recent discharge from treatment, impulsive behavior (threw can at notewriter), recent perceptual disturbances ..." (SIC)

During interview and concurrent record review conducted with the Behavioral Health Outpatient Services on 3/25/2021 at 10:30 AM Staff 51, obtained copies of Patient 19's 2017 outpatient note titled Mental Health Counseling note (discharge summary) dated 10/17/2017 at 10:11 AM written by Staff 55 cosigned by Staff 52 and 53 and the Mental Health Counseling Note Intake assessment) dated 2/22/20-21 written by Staff 53.

Review of these notes read in pertinent part: 10/17/2017 was admitted to ACU on 8/12/2017 and discharged on 10/12/2017. " ...[Patient 19] reason for coming to the ACU is 'cutting my arms, I like focusing on cutting' ...pt nodded yes when pt was asked if pt cut self to die ...Pt completed the program and was not experiencing any active ideation or feelings to harm self, harm others or contending with any active psychosis." Referred to outpatient follow up.

Review of the 2/22/2021 note read in pertinent part: 2/22/2021 ..."Presenting issues: ...abuse victim- yes, self-mutilating- indicated - yes! Superficial cuts- cut two weeks ago. Trauma victim-yes ...sleep disturbance, anger issues ...'Sometimes I hit the wall' ..." patient ran away from home was missing. Family said she had a/v [auditory/visual] hallucinations, negative suicidal thoughts, suicide attempt about one year before."

On 3/25/2021 at 2:05 PM, during a phone interview with Staff 54, when asked what symptoms she would consider as high risk for suicide, Staff 54 stated hopelessness, no plan for the future, not wanting to be here, apologizing for behavior, history of suicide attempts and command hallucinations. When asked specifically about Patient 19, Staff 54 stated Patient 19 did exhibit all the symptoms of someone who was high risk; however when asked if she wanted to hurt herself Patient 19 got upset and said she did not want to talk about it. She stated she did not inform her colleagues about this. Read a copy of her notes dated 3/12/2021 at 2:45 PM to her. The note was titled Individual Crisis Support Plan - "High risk behaviors; list behaviors that are common for person with high risk for suicide." When asked if ACU was set up to care for someone at high risk for suicide she stated "We are capable but it is a burden."

On 3/25/2021 at 2:30 PM, during an interview with Staff 49 (Patient 19's psychiatrist), stated Patient 19 had five inpatient psychiatric hospitalizations in the last two years for threatening suicide. Staff 49 stated, "[Patient 19] meets criteria for 'Borderline Personality' so she complains all the time" "I think she works at looking miserable" "She says she is hearing voices, the nurse gave her Tylenol® and the voices went away."

According to National Institute for Mental Health (NIMH) "Borderline personality disorder is an illness marked by an ongoing pattern of varying moods, self-image, and behavior. These symptoms often result in impulsive actions and problems in relationships." (https://www.nimh.nih.gov/health/topics/borderline-personality-disorder/index.shtm)
The father did not want to send her to a higher level of care. "I didn't know what to do."
When asked what the criteria for admission to ACU was, Staff 49 stated "They were not supposed to be suicidal or homicidal. The unit was meant for stable patients"
Staff 49 stated there was an intake person who did an assessment to see if the individual met criteria for the ACU program. That person presented the potential patient to the treatment team and the team makes the final decision for or against admission. Staff 49 stated he was not present when the team made the decision to accept Patient 19 to the program. He stated the decision was border line to accept her because she was suicidal; however Patient 19 agreed to keep herself safe.
When asked how often the nurse should conduct a suicide assessment on Patient 19 he stated daily for three to four days after admission and then not needed.
When asked what his expectation for assessment was after Patient 19's attempted hanging, he stated the staff on the unit could assess her not the Emergency Department.
Staff 49 stated "I made a mistake in admitting her. She had on and off suicidal thinking was bulimic and looked much worse."

On 3/26/2021 at 11:00 AM during an interview in the office, Staff 52 stated that suicide rates were high on the Navajo Nation. She stated it was difficult to assess patients for suicide because the Navajo believe that talking about death is "wishing death" on a person. They often just say they want to disappear. When asked if Patient 19 had said this, Staff 52 stated Patient 19 had said that often. When asked why she had used the Columbia Suicide Assessment for a teenager she stated that is what the doctor who had a grant program titled Zero Suicide Incidents told her to use.

Reviewed the facility policy and procedure (P&P) titled "Identification and Intervention for Patients at Risk for Suicide" PolicyStat ID: 6825544 dated 11/2020 read in pertinent part as follows:
" ...II. Policy: Universal screening for suicide risk is conducted at e ach outpatient visit and inpatient admission for patients 10 years and older. Each patient determined "at risk" shall receive an additional suicide risk full assessment and will be offered intervention(s) appropriate to suicide risk level as outlined in the following procedure. III. Procedure: A. Training 1. All staff will receive basic suicide prevention or 'gatekeeper' training designed to equip all personnel with tools to recognize potential suicide risk and make a referral to next level of care. 2. All staff who perform intake, triage, and/or other direct patient care will receive training in suicide risk screening, assessment, safety planning and treatment as indicated based on their position and scope of practice.
B. Identification
1. Use the Columbia Suicide Severity Rating Scale Quick Screen Questions 1 and 2 (CSSR-S ...) to screen for suicide risk for ADULT PATIENTS age 18 and older.
2. Use the ASQ Suicide Risk Screening Tool ... for patients age 10 -17 ...
3. Screening for suicide risk will be conducted at the following patient encounters: ...b. Inpatient i. on admission, ii. As needed at the discretion of the provider/nurse. Iii. Re-screen prior to discharge ...C. Full Assessment and Interventions 3. Patients screening positive for suicide risk in inpatient units remain on the unit until imminent risk of suicide is no longer evident as determined by periodic full assessment and an appropriate follow-up disposition has been determined ....7. The evidence-based safety plan (Stanley-Brown) will be completed collaboratively with the patient by a nurse, Nurse Practitioner (NP), Physicians' Assistant (PA), or Physician who has completed training in suicide risk screening, assessment, safety planning, and treatment or by a licensed mental health provider ...8. Patient safety precautions ...d. The environment will be prepared to minimize risk of self or other harm. i. Unnecessary supplies and equipment will be removed from the room including: ...side tables, garbage cans, ...extra linens, garbage can liners, plastic bags, sharp items ...cleaning supplies/chemicals, items/objects that can be picked up and thrown or cause harm to the patient or staff ...e. Direct observation of the patient is maintained at all times by a patient safety attendant, see One to One observation Policy. i. Attendant is to remain with patient at all times ...ii. Attendant must accompany patient is patient leaves the unit/clinic or utilizes the restroom ..."

Review of the ASQ Suicide Risk Screening Tool (for children age 10 - 17) included a list of questions to ask the patient. Under "Next Steps" directions include: " ...If patient answers ... refuses to answer, they are considered a positive screen ...Acute positive screen (imminent risk identified) ...keep patient in sight. Remove all dangerous objects from room. Alert physician or clinician responsible for patient's care ..."

Although Staff 63 recognized the imminent risk for Patient 19 and she informed the clinician responsible, the treatment team did not recognize ligature risks (bed sheet) or ligature points (closet door latch/handle). In addition the intake social worker, psychiatrist and program director knew of Patient 19's history of suicide attempts, self-harm by means of cutting her arms, and troubled family dynamics the treatment team approved admission to the sub-acute ACU meant for stable patients.

The facility had taken steps at a previous time to install ligature resistant hardware on door hinges on some of the doors and in patient room bathrooms installed breakaway door hooks (for towels or clothing) and hook and loop attachment for shower curtains, ligature free shower heads they did not assure other items in the bathroom (plumbing for sink and toilet, faucet for sink) and bedroom (closet door latches/handles- bedside desk) were ligature free or resistant.

2. Patient 20 was a 16 year old female admitted 10 /29/2020 with extensive psychiatric, criminal and placement history. Patient 20 was admitted from a detention placement for treatment of polysubstance use and depression. Patient 20 was a victim of emotional, physical and sexual abuse from a young age. Patient 20 had a history of street fights, suicidal thought, the wish to die and has overdosed in a suicide attempt. Patient 20 had two hospitalizations for previous suicidal attempts. Diagnoses include PTSD, Major depression and congenital hip dysplasia causing chronic hip pain. The patient was discharged due to the pandemic in February 2021.

During interviews with Staff 52 in her office 3/23/2021 at 11:22 AM, when asked if they kept an incident log Staff 52 showed the surveyor the ACU's incident log. The log was a ledger type book with hand written entries. It had several entries that were incomplete. One incident that stood out was dated 11/26/2021 listed Patient 20 who security guards placed in handcuffs. When asked about this, Staff 64, who had entered Staff 52's office at 11:25 AM, stated he was there when Patient 20 was placed in handcuffs. Staff 65 and another staff were working with the young ladies outdoors. Patient 20 was unable to control her emotions and was throwing bricks at the wall. She wouldn't stop. Staff 65 was working closely with Patient 20. The other staff brought the other girls indoors. Patient 20 threw a brick at Staff 65. Nursing staff called security. Security came and put Patient 20 in handcuffs. They escorted her to her room and she was placed on 1:1 while the team provided counseling.
When asked why there were loose bricks in the patient's outdoor space, Staff 52 stated the facility was going to build a brick walkway to the Hogan and Sweat Lodge (Traditional cultural religious buildings) that were located within the ACU yard. Staff 64 stated there were piles of the large bricks stacked along the pathway to the Hogan.

On 3/23/2021 at 2:22 PM, during a phone interview with Staff 65, when asked what happened on 11/26/2020 between 1 PM and 2:45 PM with Patient 20, Staff 65 stated they had the girls outdoors playing volleyball when the ball was hit towards the stack of bricks. Patient 20 went to get the ball and sat on the stack of bricks. She began stacking the bricks. One of them fell and broke. The other staff told Patient 20 to leave the bricks alone and come back to the game. Patient 20 did not listen and continued dropping and breaking bricks. The she began to throw the bricks at a nearby wall. Staff 65 motioned to the other staff to take the other girls back indoors. The girls tried to calm down Patient 20 before they went inside. The one of the girls came back outside to help Patient 20. Patient 20 threw a brick at the girl, but missed her. Staff 65 stated she tried to use the Therapeutic Crisis Intervention (TCI) techniques to contain Patient 20; however Staff 65 stated she was afraid to get close enough to put Patient 20 in a therapeutic hold. Staff 65 called to other staff for help and then Patient 20 threw a brick at her and the other staff. Then Patient 20 picked up a large plastic trash can and broke it to pieces. That's when the security guards came and placed her in handcuffs.

During an interview on 3/23/2021 at 2:44 PM at the security desk outside the entrance of ACU, Security Staff 66 when asked what type of training he had to care for patients on ACU, he stated Hospital Defensive Training System. He stated it was different that the one ACU used. He escribed what happened with Patient 20 on 11/26/2020. He stated security got a call for assistance because ACU staff were afraid of Patient 20. She was throwing bricks at them. He approached her and tried to talk to her; however she did not respond. He tried to get her away from the wall. She started to punch the wall. He placed her in handcuffs and pulled her away from the wall so she wouldn't hit her head. Once they [he and four other guards] got her away from the wall and she agreed she would cooperate with staff the officer in charge took off the handcuffs. She went with staff willingly and was calm when the officers left the unit.

Reviewed the Security Department Incident Report # FDIHB-IR-2155. The report indicated the above incident took place on 11/26/2020 at 1330 (1:30 PM). Type of incident "Destructive Female student. Location of incident; Adolescent Care Unit, Courtyard. Reviewed the four officers, who responded to the incident, reports. In summary the incident occurred as detailed above.

During an interview with CMO3 and IVEMS2 on 3/26/2021 in the afternoon, when asked why bricks were stacked in the ACU yard and patients had access to these bricks, CMO3 stated the contractors probably just placed them there; however the bricks should have been separated and the yard blocked off to patient access until the walkway was finished.

Review of the Policy titled "Safety (Accidents/Incident) PolicyStat Id: 5677552" read in pertinent part: "Purpose: Responsibility for the prevention of accidents/incidents must be accepted by the Nursing Administration, staff and all employees. Patients and the public must be protected from unsafe acts or unsafe conditions. Definitions: The duties of all employees, in order to carry on an effective safety program are as follows: ...B. Participate in continuing in-service training program for employees: 1.Emphasize the absolute need for the patient safety at all times and in all circumstances. 2. Include safe work habits so employees will recognize hazards. C. All employees should be aware of all safety rules for their respective areas...F. Report promptly all accidents and indicate if injuries have occurred so that injuries can be properly treated ..."

During an interview with the CMO3 and IVEMS2 on 3/23/2021 when informed of Patient 19's suicide attempt and Patient 20's episode with the bricks, including injuring her had from punching the outside wall and placed in handcuffs, CMO3 and IVEMS2 appeared shocked and stated they had not been informed of these incidents.
Cross reference tag A0286 .

Based on observation, interview, and record review the hospital failed to develop, implement, and maintain an effective and ongoing hospital-wide and data driven quality assessment and improvement program (QAPI). The QAPI program did not involve all hospital services and departments and did not focus on indicators related to prevention and reduction of medical errors (medication errors) and high volume high risk area of falls.

The cumulative effects of these systemic practices resulted in the hospital's failure to comply with the statutorily mandated Condition of Participation: Quality Assessment and Performance Improvement Program.

Findings include:

1. Based on record review and interview, the hospital did not develop, implement, and maintain an effective, ongoing, hospital-wide, data driven quality assessment and performance improvement program that involved all hospital departments and services.

Review of the hospital's list of "Active Indicators" revealed that quality indicators were assigned to all hospital departments and services for quality assessment and performance improvement (QAPI) projects for 2020 - 2021. During an interview on 3/24/21, Staff 16 stated that the indicators were identified based on high-risk, high-volume, and problem-prone areas and processes that were priorities for performance improvement from 10/01/20 through 9/30/21, the hospital's fiscal year.

Further review of the document, however, indicated that there were many departments and services that were not participating and submitting data so that the quality department could not assess and measure hospital-wide performance and determine whether benchmarks indicating performance improvement were being achieved.

Departments and services identified as not submitting data included anesthesia; pharmacy; dietary (none for the Covid-19 period); the primary care units consisting of orthopedics, surgery clinic, podiatry, ENT, optometry, wound clinic, chest/TB clinic, and infusion clinic; the ACU-behavioral health clinic; risk management; patient relations; pediatric clinic; outpatient women's health; well-child clinic; medical records; respiratory therapy; rehabilitation services; physical therapy; the diabetes clinic; and the dental clinic among others. These departments and services, according to Staff 16, had not been submitting data for over 6 months.

During an interview on 3/25/21, a nursing administrative staff member (Staff 27) stated that the primary clinics were not collecting and submitting indicator data to the quality department. In a separate interview on 3/25/21, Staff 43, a medical assistant stated that the orthopedic clinic was not engaged in QAPI.

While attempts were made by the quality department to provide training regarding QAPI to assist hospital departments and services implement and maintain their own programs, there was no indication that these increased participation.

For example:

a. Minutes following a meeting about "Quality 101: PCC" (primary care clinic) on 2/27/20 revealed that nurse executives in the primary care clinic (PCC) were in attendance during a presentation on the conditions of participation on QAPI and outpatient services. In addition, the presentation emphasized that the quality department "has to be involved with all QA PI." During the meeting, several "Action Items" were requested by the quality department for review, including the clinic's policies and procedures, the organizational chart, nurse competency, spreadsheet for privileges, and work flow approval process." None of these items were submitted, according to Staff 16 during an interview on 3/24/21.

b. Review of reminder notices revealed that the pharmacy department had not been submitting performance measures data. One notice from the quality department, for example, dated 3/13/19 indicated that the pharmacy was "lacking data from last year," and was requesting (the pharmacy supervisor) that data needed to be entered "At your earliest."

On 7/24/19, another notice was sent to the supervisor that the pharmacy was still "lacking data from the past year," and that "Data is due by the 10th of each month."

During the survey on 3/24/26, review of the 2020 - 2021 active hospital indicators revealed that the pharmacy had not submitted data on "Med Dispensing System Inventory Discrepancy," Med Dispensing System Override; Medication Order Accuracy, Narcotic Reconciliation Deficiency Rate, USP Daily Compliance Rate, and Written Information on Discharge Medications."

In addition, there was no indication that the pharmacy was engage in any QAPI activity pertaining to medication errors including the investigation of reported incidents from 11/05/19 through 3/22/21.

During an interview with quality and risk management departments on 3/25/21, Staff 21, a safety manager, stated that she did not know the hospital's current medication error rate but added that "it could be higher" than previous.

2. The dental clinic did not participate in the hospital-wide QAPI program. The dental clinic did not report adverse events to QAPI. (A273)

3. Quality Improvement did not set priorities to focus on high-risk, high-volume volume, or problem prone areas. QAPI program did not include event reporting data for high-risk and high volume area of falls and medication areas. The facility did not conduct root cause analysis and did not develop action plans to address falls (44 in 6 months) and medication errors (90 in 6 months). Medication errors were not reviewed since 2019. (A283)

4. . The QAPI program did not involve all services and departments in the QAPI program. The routine and preventive maintenance and testing of fire life safety systems were not incorporated into the QAPI plan. QAPI did not include LSC inspection and test data to set priorities for QAPI activities to ensure and improve environmental safety for patients, staff, and visitors. QAPI did not involve (EP)emergency preparedness (high risk, patient safety) in the QAPI program. (E001 and A286)

5. The hospital did not ensure that quality improvement projects being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects were documented. (A297)

6. The QAPI program did not fulfill executive responsibilities to ensure the hospital-wide QAPI efforts addressed priorities for improved quality of care and patient safety. QAPI did not address high-risk and high-volume: falls and medication errors. QAPI did not address safety risks (ligature risk and emergency preparedness) (A309)

Based on record review and interview, the hospital did not always measure, analyze, and track quality indicators and other aspects of performance that assess processes of care and hospital services and operations.

Findings include:

1). Review of QAPI data revealed that hospital departments and services which were assigned to monitor and track key indicators as part of performance improvement projects for 2020 - 2021 were not collecting and submitting data to the quality department in the effort of measuring and analyzing performance improvement hospital-wide. (Cross-refer to A263.)

2). Review of PI (performance improvement) tracking from March 2020 to February 2021 for suicide risk management compliance in the ICU (intensive care unit) revealed that the benchmark was not met from June 2020 to December 2020. The PI which measured completion of the suicide risk screening tool for each patient upon admission to the unit noted that the hospital had established a goal of 90% - 100%.

The average compliance rate for this time period (June 2020 - December 2020) was noted to be about 2% per month.

When asked whether an investigation was conducted to determine the reasons for the low compliance, Staff 44, a nursing administrative staff member stated during an interview on 3/24/21 that temporary licensed staff nurses were unfamiliar with the use of the screening tool. In light of this, however, there was no documentation that appropriate corrective actions were undertaken address the cause; institute corrective actions, including training, for example, so ensure that patients received a suicide risk assessment. In the same interview, Staff 44 stated that the community served by the hospital has a high suicide risk which was a major concern.

3). Review of documents evidencing additional QAPI activities from March 2020 - February 20121 on the MSU (multi-services unit) and ICU revealed that performance measures being monitored and tracked included Pain Assessment and Management Standards; and Reassessment of PRN Medications, with benchmarks established at 95% and 92% respectively. While benchmarks were not being met, there was no indication that an analysis of the data was being conducted to identify challenges to performance improvement so that they could be addressed.



44720

4). Based on interview, the hospital failed to include the dental clinic in the QAPI program. This resulted in adverse events not being reported to QAPI or the hospital-wide event reporting system. Opportunity for improvement was lost and could increase the potential for dental clinic patients to experience and adverse event.

An interview was conducted on 3/25/21 at 9:40 A.M. with DDS73. DDS73 stated the outpatient dental clinic had not participated in a hospital-wide quality assessment and performance improvement program (QAPI). DDS73 stated the department monitored their own quality activities and had not reported these activities to the hospital QAPI program. DDS73 further stated the dental clinic had not participated in reporting adverse events to the hospital QAPI program and did not report adverse events through the hospital adverse events computerized reporting system.

Based on interview and record review Quality Improvement did not include event reporting data for high-risk and high-volume area of falls and medication errors. The hospital did not conduct root cause analysis and did not develop action plans to address falls (44 in 6 months) and medication errors (90 in 6 months) with no review of medication errors since 2019. This placed patients at increased risk for injury from falls and medication errors.

Findings include:

Review of the "Quality Assessment Performance Improvement Program & [and] Plan 2015" indicated ". . . Key elements of performance improvement QAPI [quality assessment performance improvement] are systematically and continuously to measure, analyze, and track through" 1. Measurable improvement of indicators that will improve health outcomes; 2. Assessing processes of care, hospital services, and operations; 3. Monitoring the effectiveness and safety of services and quality of care; 4. Identifying changes that enhance performance; 5. Monitoring performance to ensure that improvements are sustained; 6. Focusing on health outcomes, quality of care, patient safety and patient experiences; 7. Incidence, prevalence and severity of problems will be considered; and 8. Emphasis on high risk, high volume and/or problem prone areas that require immediate and ongoing attention to provide a safe environment for patients and staff. . . The Department of QS [quality services] will collect quality indicator data, patient care data, and other relevant data to submit, or receive from, the hospital's Quality Improvement organization. Data will be collected to monitor the effectiveness and safety of services and quality of care; and identify opportunities for improvement and changes that will lead to improvement. . ." A Root Cause Analysis is "a problem-solving tool used . . . for identifying the causes of an event, mishap or incident. . . and focuses primarily on systems and processes, not on individual performance. . ." Further review indicated the "2015 Facility-Wide Indicator List" included ". . . Multi-Service Unit/Intensive Care Unit (MSU/ICU) Falls Rate . . . Pharmacy: Medication Error Rate. . ."

Review of the "Event Report from September 2020 to March 24, 2021" indicated there were 44 fall incidents and 90 medication errors. The report was presented as a whole and not separated by month to be able to determine if there was an increase or decrease in falls and/or medication errors month-to-month. There were 27 medication errors related to the emergency department (ED), 25 medication errors related to Pharmacy, and 17 medication errors related to MSU (multi-service unit).

In an interview on 03/24/21 at 1:30 PM, Staff 16, Director of Quality, stated the incident/adverse event report does not go through the quality department. He/she stated the reports go through the Risk Management department. He/she stated the only time his/her department would initiate an action plan for improvement would be if the specific department contacted his/her department.

In an interview on 03/24/21 at 1:57 PM, Staff 26, Director of Risk Management and Acting Chief of Quality, stated as far as the system for medication errors, "that's not something I have oversight over" (referring to the medications errors). He/she stated that oversight was done by Staff 24, Chief of Pharmacy. Staff 26, Director of Risk Management and Acting Chief of Quality stated Staff 24, Chief of Pharmacy, has not reported to her regarding medication errors other than those related to the narcotic program. Staff 26, Director of Risk Management and Acting Chief of Quality, and Staff 21, Safety Manager and Acting Director of Risk Management, both stated they agree there is room for improvement in QAPI and Risk Management related to the incident/adverse event reporting.

In an interview on 03/25/21 at 9:08 AM, Staff 26, Director of Risk Management and Acting Chief of Quality, when asked if an action plan or root cause analysis had been developed that addressed falls, he/she stated, "I don't have one."

In an interview on 03/25/21 at 2:00 PM, Staff 21, Safety Manager and Acting Director of Risk Management, stated he/she did not know what the medication error rate was. When asked if she knew that Staff 24, Chief of Pharmacy, had not looked at medication error reports since he/she came here in 2019, Staff 26, Director of Risk Management and Acting Chief of Quality, who was present during the interview, stated he/she knew Staff 24, Chief of Pharmacy, "had not done medication error reviews, and nothing had been done since 2019."

In an interview on 03/26/21 at 10:03 AM, Staff 4, Interim Chief Nurse Officer, stated when there is a medication error, it is reported to the Nurse Executive. He/she stated the Nurse Executive "coaches and directly speaks with the nurse who has made the error. The RL System [incident reporting system] does go to pharmacy, but it does not go directly to the Nurse Executive." He/she confirmed he/she does not have any corrective action plan or root cause analysis developed at present to address medication errors. Staff 4, Interim Chief Nurse Officer, stated the Nurse Executives get a post-fall report completed after each fall. He/she confirmed they get the RL System for falls. He/she stated they do not have a formal action plan or root cause analysis developed to address falls.

Based on interview and document review the facility failed to assure that the Adolescent Care Unit (ACU) participated in the hospital wide QAPI program. ACU is a specialized program whose patients include children from age 13 - 17 that have mental and behavioral health challenges. This resulted in the ACU not receiving program improvement support and guidance to assure the patients on this unit were receiving quality care and services to prevent sentinel events, accidents and adverse effects from treatments. 2. The hospital failed to analyze and develop action plans to adress the high risk, high volume and problem prone incidents of falls (44 in 6 months) and medication errors (90 in 6 months). 3. The routine and preventive maintenance and testing of high risk life safety system activities; environmental safety risks and emergency preparedness were not integrated into the hospital's QAPI plan. This resulted in ongoing environmental safety risk asociated with fire and ligature risk to patients, and risk for unmet subsustence needs due to lack of emergency preparedness plan.

Findings include:

1. On 3/22/2021 at 5:30 PM, Patient 19 attempted suicide in the ACU. On 11/26/2020 at (See TAG A0144 for details)

On 3/23/2021 at 4 PM, during an interview informing CMO3 and IEVMS2 that the survey team had identified an Immediate Jeopardy situation (IJ)) of Patient 19's suicide attempt and Patient 20's attack toward staff and peers that ended up with the hospital security placing her in law enforcement handcuffs, both appeared shocked. Each one stated staff had not notified them of these serious events. IEVMS2 stated the hospital had an automated system where staff should enter incidents data. The Safety team would automatically be notified of the incident through the email system. If the incident rose to a level that required the Administration's attention the Safety team would let CMO3 and IEVMS2.

During an interview on 3/24/2021 at 1:30 PM in the conference room, the survey team conducted an interview with the Director of Quality Services (DQS16). DQS16 stated that she was not involved in the Quality Committee. She stated there was an "Action Plan" Titled "Suicide Risk Management Compliance dated 6/30/2017; however it was never completed. She stated it was due to the "Owner" of the document no longer working at the facility.
She stated there was no system in place to assure that as individuals in charge of "Action Plans" or "Program Improvement Action Plan" (PIAP) left the hospital the plans would be the responsibility of another staff member.
She stated that ACU was not included in the hospital-wide QAPI program. Each unit were responsible for their own QAPI program.
She stated they had "environment of care measures that included liaisons who observed each unit for infection control and safety. Each unit's Nurse Executive was responsible to t conduct these observations and note any outliers for compliance.
The Quality Services Summary report for months of 6/202 through 22/2020 showed that mental health needs had increased. The started a PIAP for "Inadequate Staffing"
For months 9/2020 through 11/2020 the measures indicated 51 % of the Suicide Risk Assessments had been done hospital wide. DQS16 stated the hospital did not meet the goal of 100% compliance.

On 3/24/2021 at 2 PM, the survey team interviewed Safety Manager (SM21) in the conference room. The Director of Risk Management (DRM26) was also in the room. When asked if they received reports from ACU on the Patient 19's Suicide attempt on 3/22/2021 at 5:30 PM and Patient 20's outburst and placed in law enforcement handcuffs, SM21 stated they had not received the report as of this meeting. DRM26 stated their departments did receive reports from ACU. Any staff may enter incident reports in their electronic system. However she stated staff can report incidents by telephone, in person, by email or through the reporting system.
Reports should be made within 72 hours or ASAP if it is a serious incident. Suicide Attempt would require an immediate telephone report; however none was made as of this meeting.

During an interview on 3/26/2021 beginning at 12:20 PM in the conference room, When asked how he expected staff to respond to a suicide attempt, such as Patient 19, CMO3 stated that anyone who had suicidal ideations or suicide attempt should be taken to the emergency room and held there until they can find placement at a psychiatric hospital. The patient should be placed on 1:1 staff to patient care until the patient is transferred.
When asked who was responsible for the care of patients on ACU, IVEMS2 stated the CMO (Chief Medical Officer) had direct supervision of the ACU.











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2. Review of the "Quality Assessment Performance Improvement Program & [and] Plan 2015" indicated ". . . Key elements of performance improvement QAPI [quality assessment performance improvement] are systematically and continuously to measure, analyze, and track through: 1. Measurable improvement of indicators that will improve health outcomes; 2. Assessing processes of care, hospital services, and operations; 3. Monitoring the effectiveness and safety of services and quality of care; 4. Identifying changes that enhance performance; 5. Monitoring performance to ensure that improvements are sustained; 6. Focusing on health outcomes, quality of care, patient safety and patient experiences; 7. Incidence, prevalence and severity of problems will be considered; and 8. Emphasis on high risk, high volume and/or problem prone areas that require immediate and ongoing attention to provide a safe environment for patients and staff. . ."

Review of the "Event Report from September 2020 to March 24, 2021" indicated there were 44 fall incidents and 90 medication errors. The report was presented as a whole and not separated by month to be able to determine if there was an increase or decrease in falls and/or medication errors month-to-month. There were 27 medication errors related to the emergency department (ED), 25 medication errors related to Pharmacy, and 17 medication errors related to MSU (multi-service unit). No documented evidence was presented during the survey of measurement of and analysis of medication errors and fall incidents.

In an interview on 03/24/21 at 1:57 PM, Staff 26, Director of Risk Management and Acting Chief of Quality, stated as far as the system for medication errors, "that's not something I have oversight over" (referring to the medications errors). He/she stated that oversight was done by Staff 24, Chief of Pharmacy. Staff 26, Director of Risk Management and Acting Chief of Quality stated Staff 24, Chief of Pharmacy, has not reported to him/her regarding medication errors other than those related to the narcotic program. Staff 26, Director of Risk Management and Acting Chief of Quality, and Staff 21, Safety Manager and Acting Director of Risk Management, both stated they agree there is room for improvement in QAPI and Risk Management related to the incident/adverse event reporting and measurement and analysis of medication errors and fall incidents.

In an interview on 03/25/21 at 9:08 AM, Staff 26, Director of Risk Management and Acting Chief of Quality, when asked if an action plan or root cause analysis had been developed that addressed falls, he/she stated "I don't have one."

In an interview on 03/25/21 at 2:00 PM, Staff 21, Safety Manager and Acting Director of Risk Management, stated he/she did not know what the medication error rate was. When asked if he/she knew that Staff 24, Chief of Pharmacy, had not looked at medication error reports since he/she came here in 2019, Staff 26, Director of Risk Management and Acting Chief of Quality, who was present during the interview, stated he/she knew Staff 24, Chief of Pharmacy, "had not done medication error reviews, and nothing had been done since 2019."

In an interview on 03/26/21 at 10:03 AM, Staff 4, Interim Chief Nurse Officer, stated when there is a medication error, it is reported to the Nurse Executive. He/she stated the Nurse Executive "coaches and directly speaks with the nurse who has made the error. The RL System [incident reporting system] does go to pharmacy, but it does not go directly to the Nurse Executive." He/she confirmed he/she does not have any corrective action plan or root cause analysis developed at present to address medication errors. Staff 4, Interim Chief Nurse Officer, stated the Nurse Executives get a post-fall report completed after each fall. He/she confirmed they get the RL System for falls. He/she stated they do not have a formal action plan or root cause analysis developed to address falls.



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3. environmental safety ligature risk
In an interview on 3/26/21 at 10:35 AM Staff 21 said she was the Safety Manager. When asked about environmental risk assessments, Staff 21 said the facility conducted EOC (environment of care) rounds but to her knowledge the facility did not conduct an environmental risk assessment. Staff 21 said an environmental risk assessment would have fallen under the patient safety officer. Staff 21 said she supervised the patient safety officer and knew he did not conduct environmental risk assessments.

When asked about assessment for and mitigation of ligature risks on the Adolescent Care Unit (behavioral treatment), the hospital Safety Manager, Quality Coordinator, Facilities Maintenance Manager, and Director of Risk Management all said they were not informed about environmental ligature risk and were not aware of a need to evaluate the hospital environment for ligature risk and ligature points

At 3:30 PM, Staff 21 provided a copy of documents titled ACU Round Conducted April 10, 2014 and ACU F/U Round conducted on June 10, 2014. Both documents identified anchor (ligature) points on exposed sink and toilet plumbing, and the sink itself.
These documents indicated the hospital did know or should have known about ligature risk and should have known about 2017 regulatory requirements to ensure a ligature resistant environment in any area where patients may be at risk for suicide-such as the ACU.
The hospital failed to develop a plan to address the identified patient safety risk. The ligature points identified in 2014 in addition to others were still present and unmitigated on 3/22/21 on the ACU. A patient attempted suicide by hanging on such a ligature point on 3/22/21. Please see A144 and A701

When asked to describe environment of care rounds (EOC rounds), Staff 21 said EOC rounds focused on fire and life safety concerns such as blocked fire extinguishers. Staff 21 said safety observers and maintenance staff conducted monthly EOC rounds. Staff 21 and Staff 19 concurred that the improper storage of oxygen cylinders and lack of three consecutive monthly inspection of the ACU fire extinguishers (cited on the LSC report) should have been discovered on EOC rounds but were not.

Staff 79 concurred and said he was responsible for LSC and oxygen use and storage is regulated by the LSC but the property management staff placed the oxygen cylinders in the discharge lounge and did not tell him. Staff 79 said the property and supply staff report to finance department. Staff 79 said when LSC issues are brought up to finance "they just do not get responded to." Staff 79 said since a reorganization departments are too fragmented and there is no system of accountability.
Staff 21 agreed and said the Quality department/ committee did not look at LSC inspections. The routine and preventive maintenance and safety systems testing activities were not incorporated into the hospital QAPI so there was no double check. Staff 21 said she used to report results of EOC rounds to quality but that stopped some time ago and now the EOC results were just entered in the computer.

In an interview on 3/26/21 at 11:00 AM the Director of Quality Services Staff 16 agreed. Staff 16 said the organization was very confusing and disjointed: property management and supply management are under finance, safety reports to EOC, Quality is responsible for Safety, Facility Maintenance reports to EOC and now Support Operations and there is also environmental services and facility maintenance and risk management. Staff 16 said communications and dealing with so many departments and different components in different division has resulted in poor monitoring and follow up on environmental safety and other concerns. See A709 and A701.

Patient safety; emergency preparedness
In an interview on 3/26/21 at 12:30 PM Staff 20 stated he was the Emergency Preparedness Coordinator. Staff 20 said the hospital formed an emergency preparedness committee to focus on development of the EP Plan. Staff 20 said the EP charter was passed in November 2020 however the hospital still did not have a comprehensive EP Program.

Staff 20 said he knew the regulations required the EP Program to include a facility-based risk assessment. Staff 20 reported the hospital has been waiting for IHS to prepare an all-hazards plan. Staff 20 said he requested and still waited for direction and for a design structure or template to develop a written EP plan. Staff 20 said the most recent document presented to leadership regarding the Emergency Preparedness Plan and Program was from 2014.

Staff 20 stated he was aware of the required core elements of the EP Program but he was unable to get guidance, support, or assistance from hospital leadership to develop the EP plan. See E0001

Based on record review and interview, the hospital did not ensure that quality improvement projects being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects were documented.

Findings include:

During an interview on 3/25/12, Staff 29 and Staff 44, both of whom were nursing administrative staff members stated that the MSU had additional performance improvement projects for 2020 - 2021 which included pain management education on wellness, fall assessment completed on admission, PRN Reassessment (for pain meds), and Foley catheter and discontinuation.

There was no indication that the reasons for conducting these projects, the measurable progress achieved on these projects, or whether these projects were high-risk, high-volume, and problem-prone, were documented.

During a separate interview on 3/25/21, Staff 16 stated that she was not aware that the unit was working on these performance improvement projects as she had not been informed. Staff 16 added that the quality department needs to be involved in all QAPI activities.

Based on record review and interview, the hospital did not ensure that the hospital's governing body and administrative officials were responsible and accountable for ensuring that an ongoing program for quality improvement and patient safety was implemented and maintained; and did not fulfill executive responsibilities to ensure the hospital-wide QAPI efforts addressed priorities for improved quality of care and patient safety, high-risk falls, and medication errors.

Findings include:

1. While performance improvement indicators were assigned to all hospital departments and services to be monitored and tracked for year 2020 - 2021, review of indicator data, however, revealed that many were not engaged in a hospital-wide QAPI (quality assessment and performance improvement) program by failing to participate and submit data to the quality department monthly, as required. These included anesthesia; pharmacy; dietary; the primary care units consisting of orthopedics, surgery clinic, podiatry, ENT, optometry, wound clinic, chest/TB clinic, and the infusion clinic; the ACU-behavioral health clinic; risk management; patient relations; pediatric clinic; outpatient women's health; well-child clinic; medical records; respiratory therapy; rehabilitation services; physical therapy; the diabetes clinic; and the dental clinic.

During an interview on 3/24/21, Staff 16 stated that some of the departments and services had not been submitting data for over 6 months.

Review of the minutes of Quality Services Committee and Quality Committee meetings held monthly and quarterly, respectively, revealed the lack of action by the committees, the governing body, or administrative officials to address the non-compliance. While meeting minutes included discussion of agenda items pertaining to QAPI, no mention was made about the failure of the departments and services to submit data which could highly affect reporting of performance outcomes hospital-wide.

Further review of meeting minutes revealed the lack of indication that a line of communication had been established to ensure that these issues were reported periodically to the governing body and the CEO; and that the cause of non-participation and/or delay in data submission was investigated and addressed.

The failure to submit indicator data prevents the hospital from assessing and measuring performance improvement including, patient safety, quality of care, and health outcomes.



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2. Review of the "Quality Assessment Performance Improvement Program & [and] Plan 2015" indicated ". . . Key elements of performance improvement QAPI [quality assessment performance improvement] are systematically and continuously to measure, analyze, and track through: 1. Measurable improvement of indicators that will improve health outcomes; 2. Assessing processes of care, hospital services, and operations; 3. Monitoring the effectiveness and safety of services and quality of care; 4. Identifying changes that enhance performance; 5. Monitoring performance to ensure that improvements are sustained; 6. Focusing on health outcomes, quality of care, patient safety and patient experiences; 7. Incidence, prevalence and severity of problems will be considered; and 8. Emphasis on high risk, high volume and/or problem prone areas that require immediate and ongoing attention to provide a safe environment for patients and staff. . ." Further review indicated the "2015 Facility-Wide Indicator List" included ". . . Pharmacy: Medication Error Rate. . ."

Review of the "Event Report from September 2020 to March 24, 2021" indicated there were 90 medication errors. The report was presented as a whole and not separated by month to be able to determine if there was an increase or decrease in medication errors month-to-month. There were 27 medication errors related to the emergency department (ED), 25 medication errors related to Pharmacy, and 17 medication errors related to MSU (multi-service unit). No documented evidence was presented during the survey of measurement of and analysis of medication errors.

Review of the "Pharmacy Incomplete Task November 2019 to March 26, 2021" indicated there were 85 medication errors listed that had not been analyzed by Staff 24, Chief of Pharmacy.

In an interview on 03/24/21 at 1:57 PM, Staff 26, Director of Risk Management and Acting Chief of Quality, stated as far as the system for medication errors, "that's not something I have oversight over." He/She stated that oversight was done by Staff 24, Chief of Pharmacy. Staff 26, Director of Risk Management and Acting Chief of Quality stated Staff 24, Chief of Pharmacy, has not reported to her regarding medication errors other than those related to the narcotic program. Staff 26, Director of Risk Management and Acting Chief of Quality, and Staff 21, Safety Manager and Acting Director of Risk Management, who was present during the interview, both stated they agree there is room for improvement in QAPI and Risk Management related to the incident/adverse event reporting and measurement and analysis of medication errors.

In an interview on 03/25/21 at 2:00 PM, Staff 21, Safety Manager and Acting Director of Risk Management, stated he/she did not know what the medication error rate was. When asked if he/she knew that Staff 24, Chief of Pharmacy, had not looked at medication error reports since he/she came here in 2019, Staff 26, Director of Risk Management and Acting Chief of Quality, who was present during the interview, stated he/she knew Staff 24, Chief of Pharmacy, "had not done medication error reviews, and nothing had been done since 2019."

In an interview on 03/26/21 at 10:03 AM, Staff 4, Interim Chief Nurse Officer, stated when there is a medication error, it is reported to the Nurse Executive. He/she stated the Nurse Executive "coaches and directly speaks with the nurse who has made the error. The RL System [incident reporting system] does go to pharmacy, but it does not go directly to the Nurse Executive." He/she confirmed he/she does not have any corrective action plan or root cause analysis developed at present to address medication errors.

Based on interview and record review the facility failed to assure that medical staff were evaluated for patient care services at every patient care location for 2 of 6 physicians (Staff 49 and Staff 38). This deficient practice resulted in physicians not being evaluated to assure patients received quality care.

Findings include:

On 3/26/2021 at 10:20 AM during an interview with Medical Credentialing Coordinator (MCC67), when asked who reviewed Staff 49 psychiatrist file, she stated the Chief Medical Officer (CMO3) was the chief of Adolescent Care Unit (ACU) and Outpatient Mental Health Clinic. The record revealed that Staff 49 was a locum who worked intermittently at the facility on the ACU for the past several years. When asked to see his Professional Performance Evaluation, (PPE) MCC67 reviewed the record and stated there were none in Staff 49's file.

During an interview on 3/26/2021 at 11:00 AM, when asked how he provided oversight and evaluation of Staff 49, CMO3 stated he did not conduct evaluations of the psychiatrist because he was not qualified. He stated, "I'm an internist I do not do evaluation of Staff 49". When asked if he had any other physician provide oversight of Staff 49 he stated that he expected the Program Director (Staff 52) to oversee the psychiatrist.

When asked if she provided oversight of the psychiatrist Staff 52 stated, "No. I'm a social worker. The CMO would provide oversight."

Review of the Medical By-Laws, dated 9/27/19, read in pertinent part as follows "...1. Focused Professional Performance Evaluation (FPPE)...The FPPE process can...be implemented at any time if a practice quality concern is identified by report of events...2. Ongoing Professional Performance Evaluation (OPPE)...The Medical Staff will also engage in OPPE of current Medical Staff to identify professional practice trends that affect quality of care and patient safety...."

Based on interview and record review, the facility failed to enforce the Medical Staff Bylaws. This failure had the potential to affect quality of care.

Findings include:

During a record review on 3/25/21, the Chief Medical Officer's (CMO3) basic life support (BLS) certificate, issue date 1/24/19, expired on 1/2021.

An interview was conducted on 3/26/21, at 10:30 A.M., with the Medical Staff Credentialing Coordinator (MSCC). The MSCC stated she was responsible for ensuring medical staff meet requirements prior to reauthorizing physician privileges. The MSCC stated she had noticed CMO3's BLS had expired when she was renewing his credentials for privileging. The MSCC stated she had notified CMO3 via email in 2020, to complete the BLS training.

An email, dated 10/15/2020, from the MSCC to CMO3 stated " ...If I do not receive the reappointment packet by the deadline, your privileges with our hospital will lapse on January 16, 2021 ..."

On 3/26/21, at 2:30 P.M., an interview was conducted with CMO3. CMO3 stated he had known his BLS had expired but had been unable to schedule the training, the trainings had been cancelled due to social distancing, and the class could not be taken any other way.

On 3/26/21, at 2:45 P.M., an interview was conducted with the Clinical Director of Education (CDE41). The CDE41 stated the BLS classes had been suspended from March 2020 through June 2020. CDE41 stated in June 2020, the education department began offering additional trainings for BLS to meet the needs of the staff. The CDE41 stated if there had been a waiting list, the education department added more classes to accommodate staff. The CDE41 stated a reminder was sent to physicians to schedule their BLS training when their BLS certificate was near expiration. The CDE41 stated he reviewed CMO3's file, CMO3's BLS had expired January 2021, and CMO3 had not scheduled a class or requested to be on the waitlist in 2020 or 2021.

Per the Medical Staff Bylaws, dated 9/27/2019, " ...4. Qualifications ...d. All Members of the Medical Staff are required to have basic life support (BLS) certification ..."

Based on policy review, personnel record review, and interview, the hospital failed to ensure the registered nurse (RN) assigned the nursing care of each patient to nursing personnel in accordance with patient's needs and the specialized qualifications and competence of assigned staff. Staff 23, Patient Sitter, who was observing a patient one-to-one in the emergency department (ED) on 03/25/21 had not received orientation, training, and had not been evaluated for competency prior to performing the duties of a sitter. This failure had the potential to affect the care of any patient admitted to the ED who was to be observed one-to-one due to behavioral concerns.

Findings include:

Review of the FDIHB (Fort Defiance Indian Hospital Board) Nursing Division Plan for the Provision of Quality Patient Care" policy, revised November 2020, indicated "The hospital nursing services, under the direction of a Registered Nurse, provides holistic, comprehensive, and professional care to patients and their significant others, which requires specialized knowledge, judgment, and skills. . . E. Qualification of Staff 1. All staff must meet requirements established in specific position descriptions. . . 3. All Nursing staff participate in and must complete the Nursing Orientation Program. . ."

Review of the "Personnel Action Request" for Staff 23, Patient Sitter, indicated he/he/she was hired on 03/26/20. Review of the "Patient Sitter Position Description," signed by Staff 23, Patient Sitter, on 05/07/20, indicated "Mandatory Minimum Qualifications" included a "Valid American Heart Association Certification in BLS" [basic life support]. Further review indicated there was no documented evidence that Staff 23, Patient Sitter, had attended the "Nursing Orientation Program" and had been evaluated by a Registered Nurse for competency in performing the job duties of a Patient Sitter.

Observation on 03/25/21 at 8:30 AM in the ED revealed Staff 23, Patient Sitter, was observing a patient one-to-one.

In an interview on 03/25/21 at 8:43 AM, Staff 23, Patient Sitter, stated he/she did not have any training prior to being assigned as a sitter in the ED to observe patients with behavioral concerns.

In an interview on 03/26/21 at 10:03 AM, Staff 4, Interim Chief Nurse Officer, stated Staff 23, Patient Sitter, did not attend nursing orientation and had not been evaluated for competency in performing the job duties of a sitter. Staff 4, Interim Chief Nurse Officer, stated Staff 23, Patient Sitter, should have completed orientation and been assessed for competency before he/she was allowed to work in the ED as a patient sitter.

Based on observation, interview and record review the hospital failed to ensure outdated, mislabeled or otherwise unusable drugs and biologicals must not be available for patient use. Failure to ensure unusable drugs are not available for use could potentially subject patients to the use of drugs with questionable integrity and/or effectiveness.

Findings include:

1. At 11:30AM on March 24, 2021 the Primary Care Clinic (PCC) was toured in the presence of Assistant Nurse Executive Staff 27. There are 2 vaccine refrigerators located in that clinic. One of the refrigerators was located in the front of the clinic in room 1E5-18. That room was called the Primary Care Clinic Screening room. The 2nd refrigerator was located in the Medication Room, 1E1-29. Both refrigerators had multiple vaccines inside then. Some of the many vaccines/medications inside the refrigerators included: Hepatitis A, Hepatitis B, Tdap (Tetanus Toxoid, reduced diphtheria toxoid and acellular pertussis), Pneumococcal 13, Meningococcal group B, Influenza Fluzone vaccine, Tuberculin Purified Protein Derivative and injectable Bicillin. On that same day the refrigerated medications were inspected for appropriate labeling and expiration dates. One multi-dose vials of Fluzone Quadrivalent was observed in the front refrigerator and a second vial of the same multi-dose vaccine was observed in the back refrigerator. During a concurrent interview Staff 27 acknowledged she could not determine when the vials were opened. She continued stating the multi-dose vials should have been dated opened. Staff 27 was also requested to provide the temperature logs for the identified refrigerators for the past 6 months. Staff 27 provided logs from Jan 2020 to July 2020 and acknowledged the provided logs only demonstrated sporadic monitoring of the temperatures. Staff 27 also validated there were no current temperature monitoring logs; the most current monitoring logs were from 2020.

Later that day near 1:40PM the Director of Pharmacy was interviewed and the PCC medication/vaccine refrigerator temperature logs were shared. Staff 24 stated "the clinics should be monitoring temperatures of their medication refrigerators."

On March 24, 2021 near 3:00PM the Vaccine Storage/Maintenance/Handling policy dated 06/19/2014 was reviewed. It states: under the section addressing non frozen vaccines
-"All other vaccines shall be stored at temperatures between +35 degrees and +46 degrees F [Fahrenheit] (2 C to 8 degrees C [Celsius]), +40 F (4C) is ideal."
-"All vaccines dispensed from a multi-use vial shall be dated with the date opened and discarded after 28 days unless otherwise noted by the manufacture's expiration date."
-"Maintain proper temperatures in the refrigerator/freezer with designated calibrated thermometers."
-"Record temperatures of all vaccine storage units twice daily in designated temperature log book. If the facility is closed, the temperatures must still be recorded via either physical check or memory function of thermometers."

2. On March 24, 2021 the Pre-Operative and Post-Operative Recovery areas were toured near 2:45PM. A blanket warmer, at a temperature of 101 degrees Fahrenheit (F), was observed to contain multiple blankets, liter bags of intravenous solutions (IV) and bottles of irrigation solutions. During a random inspection of the solutions 3 liter bags of 0.9% Normal Saline IV bags were observed without a date marked on the outer wrapper of the solution indicating when placed in the warmer or the projected expiration date. Staff 22 acknowledged she/he could not determine the date the IV bags were placed in the warmer and did not know when the IV solutions may expire. Staff 22 then proceeded to discard the solutions. Staff 22 acknowledged the Operative area did not have a policy or procedure regarding placing solutions in the blanket warmers.

Later that same date Staff 24 was requested to provide the manufactures recommendations regarding recommendations for stability and shelf life of the solutions after being placed in blanket warmers. Staff 24 provided documentation indicating that manufactures recommends that INJECTION solutions packaged in VIAFLEX plastic containers with fluid volumes between 150 to 1000 ml, that are warmed "40 degrees Celsius (104 degrees F) and for a period of no longer than 14 days if greater than or equal to 3 months of expiry remain on the product."

On March 24 The Emergency Department policy titled The Temperature Check of Warmers for Intravenous Fluids, External fluids and Blankets (last revised 07/2020) indicates:
-Intravenous IV Fluids
"IV fluid storage is to be kept at 104 F/40 C or less for a period no longer than fourteen (14 days. ED warmers will be set no higher than 100 F. /37.8 C."

-External Fluids
"Solutions may be warmed to temperatures not exceeding 150 F /66 C and for a period no longer than 60 days." ... "When placed into the warmer a sticker with a 60 day expiration date and time will be affixed to the bottle."

Based on record review and interview the facility failed to investigate medication errors related to pharmacy services since March 2020. The patients are at high risk for harm when the medication errors investigations are incomplete. The Pharmacist Director failed to follow policies and procedures to minimize medication errors.

Findings include:

On 03/24/2021 at 11:00 AM conducted an interview concurrent with record review with the Director of Pharmacist Services regarding the increase percentage in medication errors in the hospital. The Director of Pharmacist acknowledged having an increase in medication errors in the hospital. He validated per policy an investigation of the reported medications errors are required and he have not had the opportunity to complete the task. When asked how many reports are pending to be investigated he stated, "Not sure of the number but since I started working in 2019."

On 3/26/2021 reviewed the facilities pharmacy medication error reports incomplete task list form November, 2019 to March 26, 2021 and there are70 medication error reports pending an investigation.

On 03/26/2021 reviewed the facilities policy titled "Pharmacy and Therapeutics Committee" revised date 2012 and it disclosed.
a). The pharmacy and Therapeutics Committee serves as the organizations line of communication between the medical staff and the pharmacy.
b). Review Adverse Drug Reactions, medication errors and drug usage to ensure that drugs are administered/dispensed in the fastest possible manner and to ensure compliance with CMS guidelines.

Based on record review and interview, the hospital did not provide radiology services according to the standard of practice and policy. As a result patients were potentially placed at risk for harm, serious injury or death (A0535) IJ cited; and the hospital did not ensure that a qualified full-time, part-time or consulting radiologist supervised the radiologic services (A546).

The cumulative effects of these systemic practices resulted in the hospital's failure to comply with statutorily mandated regulations under Radiologic Services.

Based on record review and interview, the facility failed to provide radiological services that met professionally approved standards for safety. This failure was evident when the radiologist technician administered Intravenous (IV) contrast without verifying a consent and screening for patient #1 and all patients coming from the emergency room (ER) department. The radiology staff department did not adhere to the hospital policy for Intravenous Contrast Administration. This deficient practice placed all the patients as risk for harm, serious injury or death.

On 03/23/2021 at 1:15 PM, in the presence of the CEO, Executive Vice President, and Medical Director, an Immediate Jeopardy was called based on the facility's failure to ensure all patients receiving IV contrast in the radiology department were consented and screened.
IJ abatement plan was accepted on 03/24/2021, at 9:15 AM.
Implementation of IJ abatement plan was validated and completed on 03/24/2021, at 1:15 PM

Findings include:

During an interview on 3/22/21, at 1:30 PM, with Manager Staff 8, she verbalized having concerns with IV contrast administration. She explained on September 2020, she received noticed from the emergency room (ER) department doctors to stop obtaining consent and screening for all the patients in the ER. She explained not obtaining the consent and screening is against radiological standard practice and hospital policy. Manager Staff 8 stated she only obtained consent and screening for the inpatients and outpatients. Manager Staff 8 stated she discussed the IV contrast concerns with leadership and she did not received any further directions. Additionally, Manager Staff 8 indicated she reported her concerns to the Medical Director since he is in charge of the department, but he had not addressed any of the concerns. When questioned whether or not she discussed her concerns with the Chief of Radiologist she indicated, "The radiology department currently does not have a Chief of Radiology, and the department only has tele-radiology contractors." Manager Staff 8 stated "The tele-radiology contractor does not help with concerns identified in the department."

On 2/22/21, at 1:50 PM, interviewed Radiology Staff 81. He validated since September of 2020 he received instructions from the ER doctors to no longer obtain consent and screening when administering IV contrast to the ER patients. Radiology Staff 81 confirmed not obtaining consent and screening prior to the IV administration is against hospital policy and radiological service standard.

On 3/22/2021, at 2:00 PM, Medical Administrative Staff 3 stated he was not aware radiology had not obtained consents for IV contrast per the emergency department directions. He indicated his expectation is to follow hospital policy for IV contrast administration. Medical Administrative Staff 3 also explained the leadership must bring all policies to the board prior to approval. He stated not being aware of a policy exemption for IV contrast administration consent and screening.

On 03/22/2021, a record review conducted for Patient 1. She presented in the ER at approximately 8:15 AM for abdominal pain and had a history of Diabetes, Hypertension, and hyperlipidemia. Her medication list included Metformin. The ER doctor ordered CT-Scan with IV contrast. The medical record does not have a signed consent or screening form. Patient 1 received the IV contrast in the radiology department per medical record.

During an interview on 03/24/21, at 2:00 PM, with the Medical Staff 82, Medical Staff 83, and Medical Staff 47 they all acknowledged being involved in the decision to stop obtaining consents and screening for the ER patients receiving IV contrast in radiology around September 2020. Medical Staff 82 explained the decision to stop consenting for the IV contrast came from best practice studies. All three Medical Staff acknowledged not following the hospitals policy and procedures for IV contrast administration.

Reviewed the drug manufacture recommendation for the IV contrast Omnipaque on 3/24/21, and the warning: Risk with inadvertent Intrathecal Administration of Omnipaque injection 140 and 350 mg Iodine/ML: Administration may cause death; Convulsions/seizures; Cerebral hemorrhage; Coma; Paralysis; Arachnoiditis; Acute renal failure; Cardiac arrest; Rhabdomyolysis; Hyperthermia and Brain edema.

On 03/24/2021, reviewed a blank undated copy of the hospitals consent titled "CT Intravenous Contrast Consent Form" The consent form disclosed the type of medication, risk involved when taking the contrast, patient and representative signature acknowledgement, screening questions for allergies, comorbidities such as kidney failure, diabetes, respiratory problems, heart disease and any previous history of reaction to contrast media, Iodine or x-ray dye.

On 03/24/2021, reviewed an email dated September 17, 2020, at 9:47 AM, sent by the Executive Vice president to Medical Staff 82, Medical Staff 47 and Medical Staff 83 and he recommended "To continue with informed consent for IV contrast until the current policy is revised."

On 03/23/2021, reviewed the facilities policy titled "Consent for Administration of IV Contrast Media" date of last review is 10/2011. The policy disclosed: "Patients who are to receive IV contrast media as part of a radiographic study will demonstrate informed consent and sign a consent prior to the study. Purpose: An understanding of the recommended medical action; The associated risks and Benefits; Alternatives to the recommended therapy; An opportunity to ask questions."

On 03/23/21, reviewed the Job descriptions of Staff 81 of the radiology department titled "Computed Tomography Technologist." It disclosed
"a). Performance expectations: Adhere to all professional and ethical behavior standards of the healthcare industry.
b). Essential duties, Function & Responsibility: Provides proper patient protection in accordance with prescribed safety standards related to radiography examination."

On 03/23/21, reviewed the Job descriptions of Staff 8 of the radiology department titled "Radiology Manager." It disclosed:
Performance expectations:
Adhere to all professional and ethical behavior standards of the healthcare industry.
Essential Duties, Functions and Responsibilities:
Implements and direct the radiology department. Establishes and maintains the working policies of the department (i.e., scopes of services, daily operations policy).
Establishes and maintains an effective Quality Control, Duality Improvement, Preventative Maintenance and Safety Program.

Reviewed the undated facility policy titled "TMC Guidelines for Contrast Administration" and it disclosed:
#3 Consider obtaining Baseline Creatinine in the following populations for non-emergent studies.
a. Age >60
b. History of Kidney Transplant
c. Single kidney
d. Renal Cancer
e. Renal surgery
f. History of Hypertension requiring medical Therapy
g. Metformin or metformin containing drugs combinations.

Based on record review and interview, the hospital did not ensure a qualified full-time, part-time or consulting radiologist supervised the radiology services per the regulatory requirement.

Finding includes:

During an interview with the Manager Staff 8 on 03/22/21, at 1:00 PM, she verbalized having concerns with the care provided to patients in the radiology department. Manager Staff 8 indicated since September 2020, she received instruction by the emergency room doctors to stop screening and obtaining consents for all emergency room patients receiving IV contrast. When asked who was responsible for the administrative and technical direction of the medical imaging services she indicated not having a Chief of Radiologist to oversee her concerns regarding patients. Manager Staff 8 indicated she reported her concerns to the Medical Director, since he is in charge of the department, but he had not addressed any of the concerns.

During an interview on 3/22/21, at 2:00 PM, Medical Staff 3 stated he was not aware radiology had not obtained consents for IV contrast per the emergency department directions. He indicated his expectation was to follow hospital policy for IV contrast administration. Medical Staff 3 acknowledged the hospital did not have a Chief of Radiologist to supervise the radiology department. He stated, "The tele-radiology contractor's only duties are to assist with the reading of radiological test results." He indicated the current tele-radiology agreement will include an addendum for the tele-radiology contractor to participate in QAPI, oversight of the radiology department policies and procedure. Medical Staff 3 also stated he had no professional training or experience in radiology but assumed supervisory responsibilities within the radiology department.

During an interview concurrent with a record review on 03/26/2021, at 2:30 PM, Staff 67 validated the radiology department remains without a Chief of Radiology. She explained the tele-radiology addendum contract agreement is pending approval, signatures expected by April 2, 2021. Medical Staff 90 will be the supervising physician from the tele-radiology group. Disclosed in the plan is to introduce Medical Staff 90 to the Medical Executive Committee on April 8, 2021, discuss responsibilities, and credentialing.

Based on interview and record review the facility failed to assure they had A current therapeutic diet manual approved by the dietitian and medical staff. This deficient practice resulted in medical, nursing, and food service personnel not having access to a therapeutic diet manual to guide nutritional treatment for patient who needed it.

Findings include:

On 3/26/2021 at 1:30 PM in the conference room Staff 68 (Dietician). When asked to see the facilities Therapeutic Diet Manual, Staff 68 stated they had one in draft form for a long time; however the medical staff had not approved it for.
Staff 68 provided a copy of the "Standardized Diet Manual" PolicyStat ID: 5790211. The policy date was 1/2019. The last page of the manual listed "Approval Signatures" There was not medical staff approver listed.

Based on observation, interviews, and record review the hospital failed to maintain the overall hospital environment to ensure the safety and well-being of all patients, staff, and visitors.

The hospital:

Failed to conduct risk assessments to identify environmental safety concerns and failed to identify and mitigate ligature risk on a behavioral treatment unit. The hospital failed to incorporate routine and preventive maintenance and testing into the QAPI program
(A701). Failed to ensure water and gas to maintain subsistence needs for patients, visitors, and staff during a prolonged emergency(A703). Failed to maintain fire sprinklers, portable fire extinguishers, and exit signage. Failed to provide protection for oxygen storage and maintenance of alcohol hand sanitizer dispensers (flammable liquid and vapors). Failed to develop procedure to protect patients, staff, and visitors in the event of sprinkler or fire alarm outage (A709).

The cumulative effects of these systemic practices resulted in the hospital's failure to comply with the statutorily mandated Condition of Participation under Physical Environment and Life Safety,

Based on observation, interviews, and record review the hospital failed to maintain the overall hospital environment to ensure the safety and well-being of all patients. The routine and preventive maintenance and testing activities were not incorporated into the hospital's QAPI plan. The hospital failed to conduct an environmental risk assessment to identify environmental safety concerns. The facility failed to ensure a ligature resistant environment on the Adolescent Care Unit. These failures resulted in an unsafe environment in which a patient on ACU attempted suicide.

Findings include:

Please refer to A0144 care in a safe environment.
Ligature-resistant means lacking points where a cord, rope, bed sheet or other material can be looped or tied to fashion a point of attachment that may lead to loss of life or self-harm
A ligature risk (point) may include anything which could be used to create a sustainable attachment point such as a cord, rope, or other material for the purpose of hanging or strangulation.

Seven patients were on the Adolescent Care Unit, a behavioral treatment program for adolescents. Observations conducted on 3/23/21 at 1:00 pm with Facilities Maintenance Staff 79 and Quality Coordinator Staff 35 revealed ligature points throughout the ACU. Ligature points included but were mot limited to; metal wall-mounted fire extinguisher boxes could be opened with a ligature fastened over the door. Exposed sink and toilet plumbing, sink faucets, hardware on free-standing wardrobe closet doors, four double coat hooks mounted on each corridor wall at a height between 5.5 and 6 feet.
Towel hooks attached on the inside of patient bathroom doors were designed to swivel down when too much weight (more than a towel) was applied. When the hooks were tested they were extremely tight and would not swivel as designed and turned the towel hook into a ligature risk. Staff 79 said the towel hooks required lubrication to "free them up." Staff 79 and Staff 35 said they were not aware the towel hooks required routine maintenance. Observation of the ACU laundry room found the dryer vent tubing crushed nearly flat. Staff 79 examined and stated no air could flow through creating a fire hazard due to heat build-up.

Staff 35 said he conducted rounds on the ACU but ligature risk and the dryer vent were not on any checklists.

Staff 79 and Staff 35 denied knowledge about ligature risk and denied knowledge of requirements for a ligature resistant environment for areas of the hospital in which patients at risk for suicide were treated. Both staff said they did not know environmental risk assessments should be conducted to identify safety concerns unique to each hospital unit.

In an interview on 3/26/21 at 10:35 AM Staff 21 said she was the Safety Manager. When asked about environmental risk assessments, Staff 21 said the facility conducted EOC (environment of care) rounds but to her knowledge the facility did not conduct an environmental risk assessment. Staff 21 said an environmental risk assessment would have fallen under the patient safety officer. Staff 21 said she supervised the patient safety officer and knew he did not conduct environmental risk assessments.

When asked about assessment for and mitigation of ligature risks on the Adolescent Care Unit (behavioral treatment), Staff 21 said she was not informed about environmental ligature risk and was not aware of a need to evaluate the hospital environment for ligature risk and ligature points

At 3:30 PM, Staff 21 provided a copy of documents titled ACU Round Conducted April 10, 2014 and ACU F/U Round conducted on June 10, 2014. Both documents identified anchor (ligature) points on exposed sink and toilet plumbing, and the sink itself. Ligature points identified in 2014 were still present in addition to others.

When asked to describe EOC rounds, Staff 21 said EOC rounds focused on fire and life safety concerns such as blocked fire extinguishers. Staff 21 said safety observers and maintenance staff were assigned to conduct monthly rounds and document the EOC findings. Staff 21 and Staff 19 concurred that the improper storage of oxygen cylinders and lack of three consecutive monthly inspection of the ACU fire extinguishers (cited on the LSC report) should have been discovered on EOC rounds but were not.

Staff 79 concurred and gave an example. He is responsible for LSC and oxygen use and storage is regulated by the LSC but the property management staff placed the oxygen cylinders in the discharge lounge. Staff 79 said property and supply staff report to finance department. Staff 79 said when LSC issues are brought up to finance "they just do not get responded to." Staff 79 said since a reorganization departments are too fragmented and there is no system of accountability.
Staff 21 agreed and said the Quality department/ committee did not look at LSC inspections. The routine and preventive maintenance and testing activities were not incorporated into the hospital QAPI so there was no double check. Staff 21 said she used to report results of EOC rounds to quality but that stopped some time ago and now the EOC results are just entered in the computer.

In an interview on 3/26/21 at 11:00 AM the Director of Quality Services Staff 16 agreed. Staff 16 said property management and supply management are under finance, safety reports to EOC, Quality is responsible for Safety, Facility Maintenance reports to EOC and now Support Operations and there is also environmental services and facility maintenance and risk management. Staff 16 said communications and dealing with so many departments and different components in different divisions has resulted in poor monitoring and follow up on environmental safety and other concerns,

Based on interview and record review the facility failed to ensure a system to provide emergency gas and water as needed to provide care to inpatients and to other persons who may come to the hospital in need of care. Patients, staff, and residents were placed at risk for unmet basic needs such as water and medical care.

Findings include:

In an interview on 3/23/21 at 10:00 AM, Facilities Maintenance Director (staff 79) and Maintenance Staff 35 reported the hospital had two diesel fueled generators one powered Life Safety and emergency systems backed-up by the second generator. A third diesel generator powered everything else in the hospital in the event of an electric utility failure.

Staff 79 said electric power failure was a common occurrence due to weather conditions. Staff 79 described the area as rural with limited infrastructure. Staff 79 said the area experienced severe weather with snow, ice and wind. Staff 79 said severs storms come in quickly and could lead to a need to shelter in place.

Staff 35 indicated the hospital had underground storage tanks that held about 15,000 gallons of diesel. When asked how long the hospital could run on generator power with the stored fuel, Staff 70 and Staff 35 stated they did not know. Staff 79 said he had never thought about it and never calculated how much diesel fuel was used each hour the generators were running.

Review of emergency policies and procedures provided by the hospital found no plan to protect and conserve the fuel supply such as reducing the load on the generator by removing non-essential items. Staff 79 and Staff 35 were not aware of agreements or arrangements for emergency fuel delivery. Staff 79 said resources in the area were limited.

In an interview on 3/26/21 the Emergency Preparedness Coordinator Staff 20 said he did not know how much water was needed per day for the average census of patients, staff, and visitors on a daily basis. Staff 20 said he did not know how to calculate the amount of water needed. Staff 20 said he looked into various tools to calculate water needs. Staff 20 said he asked IHS leadership but got no number so it was never calculated. Staff 20 said he was not sure how many days water supply was on hand in the hospital.

Based on observation, interview, and record review the hospital failed to ensure life safety from fire requirements were met to ensure the safety of patients, staff and visitors in the event of a fire. This failure affected 3 of 3 hospital buildings.

Findings include:

The hospital failed to maintain fire sprinklers; failed to maintain portable fire extinguishers, failed to provide manual fire alarm pull station; failed to provide exit signage, failed to provide protection for oxygen storage, failed to maintain alcohol-based hand rub dispensers, failed to develop fire watch procedures for fire detection and fire suppression during fire alarm and fire sprinkler systems outages.

Please refer to the attached findings for the Life Safety Code (LSC) survey dated 3/26/21.

Based on observation, interview and record review, the hospital did not develop a system for identifying, reporting, and controlling infections and communicable diseases; and failed to ensure staff with skin lesions were excused from work. In addition, the facility failed to ensure employees received required vaccinations, respirator mask fit testing and annual tuberculosis testing, and followed hospital policy regarding the use and reuse of PPEs. These failures had the potential to spread infection to patients and staff in the facility (A749).

Based on observation, interview and record review, the facility failed to ensure patient care and cleaning items were stored in a sanitary manner, did not provide a clean and sanitary environment for the preparation of injectable immunizations/medications in the pediatric clinic, and failed to ensure sharps containers were appropriately secured in the pediatric and the orthopedic clinics. This failure had the potential to contaminate cleaning products, patient care items, medications and vaccine in preparation areas, and spread infection to patients. (A750)

Based on observation, interview and record review the facility failed to provide competency based training and education on the practical application of PPE use and isolation procedures. This failure had the potential for staff to spread infectious organism within the hospital. (A775)

Based on interview and record review, the facility failed to develop and implement an Antibiotic Stewardship Program. This failure had the potential to place patients at risk of adverse events from inappropriate antibiotic use and the spread of antibiotic resistant organisms (A778).

The cumulative effect of these findings resulted in the hospital's failure to comply with the statutorily mandated Condition of Participation: Infection Control.

Based on observation, interview and record review, the hospital did not develop a system for identifying , reporting, and controlling infections and communicable diseases; and failed to ensure staff with skin lesions were excused from work. In addition, the facility failed to ensure employees received required vaccinations, respirator mask fit testing, annual tuberculosis testing, and followed hospital policy and procedures regarding transmission-based precautions and the use and reuse of PPEs. These failures had the potential to spread infection to patients and staff in the facility.

Findings include:

1. On 3/25/21, at 8:15 A.M., Staff 23 was observed in the emergency department sitting outside a patient room. Staff 23 was wearing disposable gloves.

On 3/25/21, at 8:30 A.M., Staff 23 was observed inside a patient room wearing disposable gloves. Staff 23 touched the door, exited the room, touched her face, touched the chair outside the room, touched a clipboard, then took a cup from another staff member and handed it to the patient inside the room. Staff 23 did not remove the gloves or perform hand hygiene. Staff 23 was then observed writing on a clip board, using a highlighter and sitting in a chair outside the patient room without removing the gloves or performing hand hygiene.

An observation and interview was conducted with Staff 23 on 3/25/21, at 8:43 A.M. Staff 23 stated she was a patient sitter and monitored patients for safety needs, such as falls or suicide prevention. Staff 23 stated she had developed sores on her hands, had applied medication to her hands, and wore the gloves over the medication. Staff 23 stated she kept the gloves on for "a couple hours" then would take them off. Staff 23 stated she used hand sanitizer on the gloves to keep them clean. Staff 23 stated she had forgotten to use hand sanitizer when she left the patient's room.

Staff 23 removed the gloves and red, bumpy areas were observed between the fingers of both hands, red cracks in the knuckle ridges of both hands and a blister on the right palm. Staff 23 stated she had notified her supervisor of the sores and blisters on her hands and had been seen by a physician 8 times, but the physician did not know what caused it. Staff 23 stated she had notified her supervisor.

On 3/25/21, at 9:05 A.M., an interview was conducted with the House Supervisor (HS69). The HS69 stated he had been aware Staff 23 had "hypersensitivity" on her hands. The HS69 stated he should have notified the Occupational Health Nurse that Staff 23 had open sores on her hands. The HS69 stated using hand sanitizer on disposable gloves was not acceptable.

On 3/25/21, at 1:30 P.M., an interview was conducted with IP42. IP 42 stated staff could not use hand sanitizer on gloves in lieu of hand hygiene. IP 42 stated employees with sores on their hands should not be allowed to work and the supervisor of the employee should have contacted IP 42 and the Occupational Health Nurse for guidance.

On 3/25/21, at 2 P.M., an interview was conducted with the Occupational Health Nurse (OHN70). OHN70 stated she had seen Staff 23 many times for the sores on her hands. OHN70 stated the sores on Staff 23's hands were "a problem" and Staff 23 should not have worked until they were healed.

On 3/26/21, a record review was conducted. An Employee Charting Note, dated 9/23/19, signed by IP42, indicated Staff 23 had "cracked dry hands ...advised to follow up with employee health nurse.

An Employee Charting Note, dated 5/6/20, signed by OHN70, indicated Staff 23 had "sores and blister like areas that are weeping, advised employee to seek medical attention ...asap ..."

An Employee Charting Note dated 7/10/20, signed by OHN70, indicated Staff 23 had been seen in the emergency room for scabies. There was no documentation provided indicating Staff 23 had been treated, excluded from work, or had follow up from OHN.

Per the policy titled "Reporting Employee Infections," dated 9/2011, " ...B. Employees with open lesions 1 ...shall report the condition to the supervisor ...5. Exclude employee from direct patient care if lesion is on exposed areas of the body ..."

2. On 3/25/21 a record review was conducted. The Immunization Requirements for Employment, dated 7/2020, indicated "The following vaccinations and documentation are required to receive work clearance: Measles, Mumps, Rubella ... Tetanus, diphtheria, and Pertussis ... Annual PPD (TB [tuberculosis] skin test) ...Hepatitis B Vaccination ...N95 Respirator Mask Fit Testing..."

On Staff 7's Immunization Clearance For All Staff form, measles, mumps and rubella (MMR) immunizations were checked "yes," and Respirator Mask Fit Test was checked "no." No documentation of the MMR vaccination date or N95 fit testing was found.

Staff 71's file had no documentation N95 fit testing had been performed.

Staff 22's file had no documentation N95 fit testing had been performed.

Staff 8's file had no documentation for Hepatitis B vaccination.

Staff 72's file had no documentation of Annual Tuberculosis (TB) testing after 2/27/2018.

Staff 23's Tuberculosis Certificate, indicated Staff 23 had a TB test placed in her left forearm on 9/23/20. Per a note written on the certificate "10/02/2020 Did not return for reading [the results of the TB test]."

On 3/26/21 at 11:15 A.M., an interview was conducted with OHN70. The OHN70 stated the facility used a software program to record employee vaccinations, TB testing and N95 fit testing. The OHN70 stated she had not performed an audit or tracked employee health records to determine if employees had received TB testing, N95 fit testing or vaccinations required for employment. The OHN70 stated failure to ensure vaccination, TB testing and N95 fit testing for employees could potentially place patients and staff at risk of disease.

Per the job description, titled Occupational Health Nurse, dated 9/18/20, "Occupational Health Nurse Position Description ...Establishes and conducts an Occupational Health Clinic ...to ensure immunization and annual TB screening requirements are met ...Ensures that all permanent and/or long term ...employees are compliant with ongoing immunization and annual TB screening requirements ...."



25065

3. Observation in the hallway of the main emergency department on 03/22/21 at 1:40 PM revealed a rack attached to the wall that had 53 open plastic patient belonging bags with the name of an individual written on the bag. There was no date written on each bag. Observation revealed objects inside the open bags included a stethoscope, face masks, N-95 face masks, and/or face shields. These items were not enclosed in the original packaging.

In an interview on 03/22/21 at 1:40 PM, Staff 47, Deputy Chief of EM (Emergency Medicine) stated the names written on the bags were either the name of a registered nurse (RN), physician assistant, physician, nurse practitioner, or medical assistant who worked in the emergency department. He/She stated the individual bags were used by the staff to store personal protective equipment (PPE) that was to be reused by the respective staff to perform patient care. He/She stated the bags should be removed, because staff had been told the hospital had enough PPE for staff to use to provide care without reusing PPE between patients. He/She stated he/she did not know how long the bags and PPE had been stored Staff 47, Deputy Chief of EM offered no explanation why the bags were still stored in the hallway with PPE available for reuse.



13533

4. During the initial tour of the MSU (multi-services unit) at about 10:35 a.m. on 3/22/21, sixteen white plastic bags labeled "patient belonging bag" were observed hanging from metal brackets on the wall in an alcove at the end of the hallway where room 5 was located. The bags which were dated 1/21/21, 2/03/21, and 2/10/21 also had first names written on the outside which, according to Staff 16, were ICU employees.

Inside the bags, face shields and N95 masks, some of which were not inside breathable paper bags, the recommended storage for reused N95, were observed.

The same observation was made on the MSU where more than 20 white plastic bags were found hanging from metal brackets on the wall in the short hallway behind the nursing station and across from the administrative assistant office. The bags which were identified by first names of MSU employees were dated 2/2021, 3/02/21, 3/14/21, and 3/18/21. Face shields and N95 masks were observed inside the bags some without any protective use of breathable paper bags. Whether the masks and face shields were new or being reused could not be determined.

During an interview on 3/25/21 at 1:30 p.m., Staff 42, an infection preventionist stated that since the hospital had an adequate supply of N95 masks, that the masks should no longer be reused but discarded at the end of each shift. Staff 42 added that since face shields could not be appropriately disinfected with Sani-wipes "according to the manufacturer," that they should also be discarded.

5. Observed Registered Nurse staff 5 (RN 5) standing inside of Patient 13's room on the medical surgical unit at 10:40 AM on 3/22/2021. RN 5 was wearing a facemask. RN 5 exited the room at 10:45 AM, performed HH and walked down the hall. Observed RN 5 return and don (put on) personal protective equipment (PPE) prior to entering room 6 at 10:50 AM. She donned gown, gloves and wore a facemask.

Interviewed RN 5 on 3/22/2021 at 3:20 PM about Patient 13. She confirmed she was taking care of Patient 13 today and she was on contact precautions for cellulitis. RN 5 confirmed contact precautions required wearing a gown and gloves. RN 5 further confirmed she was in Patient 13's room without the required PPE this morning. She stated, "I did not get in report this morning, the patient was on Transmission Based Precautions." She further stated she saw the sign after she had already entered the room. She confirmed she should have been wearing a gown and gloves while in the room.

6. Observed signage outside of room 2A1-30 (ICU room 5) on 3/22/2021 at 10:41 AM. It read, "Contact Isolation," and indicated staff should wear a gown and gloves in the room.

Interview with a licensed staff (Staff 6) at 11:04 AM on 3/22/21, revealed that the patient who was in the room, Patient 36, was on contact isolation for methicillin-resistant staphylococcus aureus (MRSA, a staph bacteria) and was being ruled out for clostridium dificile (C-Diff) infection, that can cause inflammation of the colon and transmittable from person to person by spores.

At 11:05 AM on 3/22/21, a house keeping staff 7 (HK7) was observed performing cleaning tasks in room ICU 5. HK 7 wore a fabric long sleeved gown, 2 pairs of gloves, an N-95 with a facemask over it, and head and shoe coverings. HK 7 exited the room in full PPE and walked to the housekeeping cart in the hallway.

Immediately interviewed HK7, she stated she was new; "I started five weeks ago". She said the sign indicated she should wear a gown and gloves, and everyone wore a mask. When asked what the doffing process was, she pointed to the anti-chamber of room 2A1-30 and said, "We doff the PPE in here." When asked about wearing the PPE outside of the room, she stated, "For [Covid-19] positive rooms, you have to bring just what you need into the room, you can't come in and out. When asked about wearing PPE outside of rooms for patients on other types of transmission based precautions she stated, "It's ok to come in and out for the non-positive rooms." When "non-positive rooms" was clarified with HK7, she stated she meant rooms on other types of precautions such as "Contact Precautions". She also confirmed her understanding was that she was able to walk in and out of rooms wearing her PPE for rooms on transmission based precautions that were not COVID-19 positive rooms.

During an interview on 3/25/21 at 1:30 PM, , the infection preventionist, Staff 42, confirmed that the required PPE for contact precautions were a gown and gloves. He further described that all staff also wore a facemask due to the COVID-19 pandemic. When asked what the expectation was if a staff member was in a room under contact precautions and needed something outside of the room, he stated, they were "Not allowed to leave the room. That would be cross contamination and they would need to ask someone." During a subsequent interview on 3/26/2021 at 8:50 AM, Staff 42 confirmed the facility Infection Control Policies were based on CDC guidelines.

CDC guidance titled "Transmission-Based Precautions" for Contact Precautions read, "Use personal protective equipment (PPE) appropriately, including gloves and gown. Wear a gown and gloves for all interactions that may involve contact with the patient or the patient's environment. Donning PPE upon room entry and properly discarding before exiting the patient room is done to contain pathogens." Accessed at https://www.cdc.gov/infectioncontrol/basics/transmission-based-precautions.html.

Based on observation, interview and record review, the facility failed to ensure patient care and cleaning items were stored in a sanitary manner, did not provide a clean and sanitary environment for the preparation of injectable immunizations/medications in the pediatric clinic, and failed to ensure sharps containers were appropriately secured in the pediatric and the orthopedic clinics. This failure had the potential to contaminate cleaning products, patient care items, medications and vaccine in preparation areas, and spread infection to patients.

Findings include:

1. On 3/25/21 a concurrent observation and interview was conducted in the Dental Clinic clean storage room with the Dentist (DDS73). On the floor, underneath a storage shelf, were 1 box of single-use saliva ejectors, 2 boxes of tooth polishers and 6 bottles of environmental surface sanitizing wipes. DDS73 stated the patient care items and cleaning supplies should not have been stored on the floor.

On 3/25/21, at 1:30 P.M., an interview was conducted with Staff 42. Staff 42 stated rounding observations for infection control issues were conducted in outpatient clinics once or twice a year. He stated rounding had not been performed in the past year. IP42 stated items stored on the floor could become contaminated from contact with the floor, spills or contact with dirty mop water when the floors are cleaned.

The job description, titled Infection Preventionist, dated 9/18/20, indicated " ...Conducts ...Environmental Rounds, and notifies supervisors of identified deficiencies ...."

The facility did not provide a policy or guidance for storage of clean patient care items or cleaning products.

2. While touring the pediatric clinic with Staff 10 (house supervisor) and Staff 11 (a registered nurse), the immunization preparation area was observed on 2/24/2021 at 11:00 AM. RN 11 stated the area directly to the right of the handwashing sink was where injectable immunizations were prepared for administration. Observed the counter RN 11 pointed at was approximately 4-5 inches wide immediately to the right of a handwashing sink. Reusable ear-wash spray bottles hung above the faucets, and disinfectant wipes sat on the right hand surface of the sink, approximately 4-5 inches wide. RN 11 confirmed staff washed hands at this sink. She confirmed that the nurses utilized the small area immediately to the right of the sink to prepare vaccines for immunizations, and placed the prepared syringes on a small tray after preparation. In addition, approximately 5 computer desks in the office had unsecured sharps container on them.

Staff 46 sat at one of the computer desks. Interviewed Staff 46 about the sharps containers. She stated, "We put our immunization in there." She unscrewed the lid and used needles were visible inside the sharps container. When asked why she used the unsecured sharps container, she stated, "So we don't have to go to that one the wall" and pointed to a sharps container affixed to the wall near the doorway of the office. Staff 46 confirmed there was a risk of knocking over sharps containers and spilling contaminated needles if they were not secured to the wall.

Staff 43, an orthopedic tech provided a tour of the orthopedic clinic on 3/25/2021 at 9:59 AM. During the tour, observed a medication cart. Staff 43 stated they prepared medications on the cart. On top of the cart was an unsecured sharps container.

During the interview with Staff 42, the infection preventionist, on 03/25/2021 at 1:30 PM, he described the medication preparation area as a "Controlled space, usually in their med room." When asked if the space next to a handwashing sink was an appropriate space to prepare injectables, he stated, "No." When asked what the standard was for sharps containers, he stated, "Affixed to the wall ... They should never be loose." When asked if he had made rounds in the outpatient clinic area, he replied that he had not since 2019. He further stated the majority of the outpatient clinic areas had re-opened in August of 2020.

Facility policy titled "Immunization Administration" dated 4/2019 was provided by Staff 4, the Chief Nursing Officer (CNO4) on 3/26/2021. CNO4 confirmed the policy applied to all departments of the hospital. It read, "Prepare the vaccine(s) following standards of practice for medication preparation (see policy: Medication Administration)." Upon request, CNO4 provided an undated policy titled "Medication Administration". It read "Prepare medication in a clean location such as a medication cart or a designated medication area or room."

The Centers for Disease Control and Prevention (CDC) guidance, "FAQs regarding Safe Practices for Medical Injections" accessed on 3/27/2021 at https://www.cdc.gov/injectionsafety/providers/provider_faqs_med-prep.html read, "Medications should be drawn up in a designated clean medication preparation area that is not adjacent to potential sources of contamination, including sinks or other water sources."

Based on observation, interview and record review, the facility failed to provide competency based training and education for Staff 7 on the practical application of PPE use and isolation procedures. This failure had the potential for staff to spread infectious organisms within the hospital.

Finding includes:

At 3/22/21 on 10:41 AM, signage outside of room 2A1-30 was observed. It read, "Contact Isolation," and indicated staff should wear a gown and gloves in the room.

Observed house keeping Staff 7 perform cleaning tasks in Room 2A1-30 on 3/22/2021 at 11:05 AM. Staff 7 wore a long fabric sleeved gown, 2 pair of gloves, an N-95 with a facemask over it, and head and shoe coverings. Staff 7 exited the room in full PPE and walked to the housekeeping cart in the hallway.

Immediately interviewed HK 7, she stated she was new; "I started five weeks ago." She said the sign indicated she should wear gown and gloves, and everyone wore a mask. When asked what the doffing process was, she pointed to the anti-chamber of room 2A1-30 and said, "We doff the PPE in here." When asked about wearing the PPE outside of the room, she stated, "For [Covid-19] positive rooms, you have to bring just what you need into the room, you can't come in and out. When asked about wearing PPEs outside of rooms for patients on other types of transmission based precautions, she stated "It's ok to come in and out for the non-positive rooms." Clarification with Staff 7 about "non-positive rooms" revealed that she meant rooms on other types of precautions, such as "Contact Precautions." She again confirmed her understanding that she was able to walk in and out of rooms wearing her PPEs for rooms on transmission based precautions that were not COVID-19 positive rooms.

Facility records reviewed on 3/26/2021 included Staff 7's personnel record. A form titled "New Employee Orientation" dated 3/01/2021 read Staff 7 attended the orientation on 3/01/2021. Staff 7's training checklist titled "Environmental Services Department" listed training topics and a line for the "Instructor's Initials". It revealed Staff 48 was listed as the "Trainer." Item 11 read, "Isolation Rooms: a. Standard precautions will be explained." The trainer's initial observed beside item "a." Item "d" read "Types of isolation: airborne, droplet, and contact cleaning procedures and the use of PPE's for each isolation room(s) will be explained". The instructor's initial for item "d" was observed to be blank.

During an interview with the infection preventionist, Staff 42, and the director of clinical education, Staff 41, on 3/26/2021 at 8:50 AM, they described the orientation process for new employees. Staff 41 stated there were two orientations, one for the facility and one that was department specific. He explained that as Environmental Services (EVS) was not a clinical department, the Clinical Education Department did not provide education to them on PPE use and isolation procedures. He further stated that as he did not have authority to oversee non-clinical departments, his department could only provide that education if they requested it. He confirmed that the EVS department had not requested training on PPE usage or isolation practices, or a "train-the trainer" course on this topic from his department. When Staff 42 was asked about oversight he provided for the training of EVS staff, related to infection control practices, he stated, "I'm not involved in that."

Interview with the EVS manager, Staff 40, was conducted on 3/25/2021 at 10:45 AM. He confirmed that new staff "sit down and go through the policies" with him. Then they are released to do specific training, which includes "PPE and special training areas like MSU. They have a check off list." He then described a three-week process where they have a "trainer" initially follows them the first week and then act as a resource. When concurrent review of Staff 7's training list was conducted, he confirmed the training for PPE and isolation procedures were blank. Surveyor requested any additional records demonstrating Staff 7's training for PPE and isolation procedures and non was provided.

An interview with Staff 7's EVS supervisor, Staff 39, was conducted on 3/25/2021 at 11:17 AM. When asked about Staff 7's training on PPE use and isolation procedures, she stated, the "trainer" would have done that during the first week, and she had observed Staff 7 don and doff PPE but could not provide any documentation. She further confirmed there was not a person in the EVS department that had received "train-the-trainer" education from the Clinical Education department on PPE and isolation procedures. When asked how Staff 7 had been working for five weeks without documented training on PPE and isolation procedures, she stated she "did not realize [Staff 7] was not in the Relias system," a healthcare learning management system. She described the Relias training as computer-based, and did not include return demonstration of skills. She confirmed Staff 7 had not completed any of the required Relias trainings, and that it was the supervisor's responsibility to request access for new employees. When asked if she had requested resources for the training of EVS staff from the IP, she stated no. she confirmed there was not a standardized process to ensure all staff received the same education for PPE and isolation procedures.

Policy titled "2021 Infection Control and Prevention Plan" with review date "2/2018" read prevention activities under "Goals/Functions" included Staff Education. It further read, "2. Educational sessions will be provided for staff so that they can competently participate in infection prevention and control activities. 3. Training will address infection prevention and control measures, personal protective equipment, isolation precautions, hand hygiene ..."

Based on interview and record review, the facility failed to develop and implement an Antibiotic Stewardship Program. This failure had the potential to place patients at risk of adverse events from inappropriate antibiotic use and the spread of antibiotic resistant organisms.

Findings include:

On 3/26/21, at 11:30 A.M., an interview was conducted with the Executive Vice President (EVP2). EVP2 stated there had been no Antibiotic Stewardship Program for over a year. EVP2 stated the program was important to determine antibiotic resistance of organisms in the hospital and community, to encourage physicians to prescribe the most effective antibiotic, and for the patient to receive the appropriate treatment.

The facility was unable to provide an Antibiotic Stewardship Policy.

The facility guidelines, titled TMC Antimicrobial Guidelines 2018-2019, undated, provided no guidance on the development or implementation of an Antibiotic Stewardship Program.

Per the Centers for Disease Control, The Core Elements of Antibiotic Stewardship in Hospitals, dated 8/15/19, " ... antibiotics have serious adverse effects, which occur in roughly 20% of hospitalized patients who receive them. Patients who are unnecessarily exposed to antibiotics are placed at risk for these adverse events with no benefit. The misuse of antibiotics has also contributed to antibiotic resistance, a serious threat to public health. The misuse of antibiotics can adversely impact the health of patients who are not even exposed to them through the spread of resistant organisms ...Antibiotic stewardship is the effort to measure and improve how antibiotics are prescribed by clinicians and used by patients. Improving antibiotic prescribing and use is critical to effectively treat infections, protect patients from harms caused by unnecessary antibiotic use, and combat antibiotic resistance ..."

Based on interview and record review the hospital failed to ensure the anesthesia services were well-organized and integrated into the hospital's Quality Assessment Performance Improvement (QAPI) Program in order to assure the provision of safe care to patients. Failure for the anesthesia service to be integrated into the hospital wide QAPI contributes to missed opportunities to identify anesthesia quality of care concerns associated with high-risk, high-volume or problem-prone surgical cases.

Finding include:

On March 25, 2021 observations, interviews and record reviews occurred separately with anesthesia Staff 74 and 75. On that day Staff 74 reported the Anesthesia Service had NO Lead Certified Registered Nurse Anesthetist (CRNA). Additionally, it was his/her understanding that the QAPI task for the Anesthesia Service was delegated to the Lead CRNA. Staff 74 continued stating the Lead CRNA position has been vacant since December 2020 and that he/she was not aware of any current specific Anesthesia Service QAPI projects.

On March 25, 2021 concurrent observations and interviews occurred with Staff 75. The anesthesia equipment and carts in the operating rooms were inspected. Staff 75 verbalized it was his/her understanding that the QAPI task for the Anesthesia Service was a task delegated to the Lead CRNA position. Staff 75 continued to validate that the Lead CRNA position has been vacant since at least December 2020 and to his/her knowledge no one within the Anesthesia Service has been assigned the Anesthesia Service QAPI task or any other task associated with the Lead CRNA position.

On March 25, 2021 the Anesthesia Service Quality Assessment and Performance Improvement policy (with a revision date of May 216) along with the Duties and Responsibilities of the Chief Certified Registered Nurse Anesthetist (CRNA) of Anesthesia Services were reviewed. On page one of the QAPI policy under procedure it states:
"FDIHB (Fort Defiance Indian Hospital Board) Anesthesia Services will set priorities for it performance improvement activities that:
1. Focus on high-risk, high volume, or problem prone areas.
2. Review the incidences, prevalence, and severity of problem in those areas.
3. Affect heath outcomes, patient safety, and quality of care.
... The Chief CRNA is responsible for the implementation of the Quality Assessment and Performance Improvement (QAPI) plan and assuring the plan is ongoing, comprehensive, planned and systematic. The Chief CRNA is responsible for reporting results, improvement actions and end results to the Medical Executive Committee." On page one within the policy describing the Duties and Responsibilities of the Chief CRNA it states: "3. Implement the performance improvement plan using peer review to assess patient outcome. Findings, trends, conclusions, recommendations and actions are reported to the Medical Executive committee."

On March 25, 2021 the facility Medical Staff Bylaws and Rules Regulations dated September 27, 2019 were reviewed.
-On page 13 of the Rules and Regulations the document states: " ...the Anesthesia Department is responsible for all anesthesia administered in FDIHB facilities .... Anesthesia Services fall under the Surgery department. The Department Chair of Surgery will also be the Clinical Director of Anesthesia and supervise the CRNA staff and must be a qualified doctor of medicine (MD) or doctor of osteopathy (DO)."

-On page 45 of the Medical Staff Bylaws it states the Medical Executive Committee "Ensures that the Medical Staff shall monitor the quality and appropriateness of patient care and the clinical performance provided by all Medical Staff members with clinical privileges. These performance improvement activities shall be integrated into the organization-wide Quality Assurance Performance Improvement (QA/PI) plan."

On March 26, 2021, the Clinical Director of Anesthesia (Staff 38) was interviewed near 9:30AM. It was acknowledged that the Chief CRNA position had been vacant for at least 4 months. He also affirmed the Chief CRNA was responsible for the QAPI projects. He did not provide any additional comments nor refute the Quality Department's report demonstrating the Anesthesia Service's last report to Quality occurred at least six months ago (September 2020).

Based on interview and review of facility documents and policies the hospital failed to establish and maintain a comprehensive Emergency Preparedness (EP) Program to encompass the four core elements: 1. Emergency Plan 2. Policies and Procedures that address emergency preparedness 3. Communication Plan and 4. EP Training and Testing Program.

Findings include:

The facility failed to develop an emergency plan based on a risk assessment and incorporating an all-hazards approach (E0004); failed to conduct a facility-based risk-assessment (0007); failed to develop emergency preparedness policy and procedures (E0013); failed to develop evacuation procedures (0020); failed to develop communication plan (0029); and failed to develop an EP training and testing program (0036).

The cumulative effect of these findings resulted in the hospital's failure to comply with the statutorily mandated Condition of Participation: Emergency Preparedness.

Based on interview and review of facility documents the hospital failed to establish and maintain a comprehensive Emergency Preparedness Plan. This placed patients, staff, and visitors at risk for unmet basic needs and health care during a disaster or major emergency.

Findings include:

The facility administration designated Staff 20 to discuss the Emergency Preparedness (EP) Plan and EP Program In an interview on 3/26/21 at 12:30 PM Staff 20 stated he was the Emergency Preparedness Coordinator. Staff 20 said the hospital formed an emergency preparedness committee to focus on development of the EP Plan. Staff 20 and the EP charter was passed in November 2020 however the hospital still did not have a comprehensive EP Program.

Staff 20 reported efforts were initially made to start partnering with other local agencies and the hospital had a collaborative association with Indian Health Service (IHS) facilities. But collaboration with outside agencies was a challenge because the hospital is an IHS hospital situated on the borders of Arizona and New Mexico. Activation of emergency interventions would depend on which jurisdiction took charge during a major emergency or widespread disaster.

Staff 20 shared a copy of a regional all hazards risk assessment. Staff 20 said the all-hazards risk assessment needed to be individualized to the Fort Defiance area and specifically to the hospital. Staff 20 said he knew the regulations required the EP Program to include a facility-based risk assessment. Staff 20 reported the hospital has been waiting for IHS to prepare an all-hazards plan. Staff 20 said he requested and still waited for direction and for a design structure or template to develop a written EP plan. Staff 20 said the most recent document presented to leadership regarding the Emergency Preparedness Plan and Program was from 2014.

Staff 20 stated he was aware of the required core elements of the EP Program but he was unable to get guidance, support, or assistance from hospital leadership to develop the EP plan.

Based on interview and record review the hospital failed to specify the population served within the hospital and failed to identify unique vulnerabilities of the patient population and the community. This failure placed all patients, staff and visitors at risk for injury and unmet needs during a disaster or major emergency.

Findings include:

Review of all documents regarding emergency preparedness and emergency response provided by the hospital revealed no evidence the facility conducted an assessment or evaluation to identify the hospital's patient populations that would be at risk during an emergency event. Without this information the facility can not develop an effective plan to meet the unique needs of the average patient population.

On 3/26/21 at 12:30 PM, The Director of Emergency Preparedness Staff 20 confirmed the findings stating no such assessment or evaluation was conducted.

Based on record review and interview the facility failed to develop policies and procedures base on a facility and community-based risk assessment and communication plan. This failure placed all patients, staff, and visitors at risk for injury and unmet basic needs during a disaster or major emergency event.

Findings include:

All records and documents related to emergency preparedness provided by the facility was reviewed were revealed no policies and procedures based on facility and community-based risk assessments.

On 2/26/21 at 12:30 the Director of Emergency Preparedness confirmed the findings.

Based on record review and interview the facility failed to develop policies and procedures based on the emergency plan and risk assessment. This failure placed all patients, staff, and visitors at risk for injury and unmet basic needs during a disaster or major emergency event.

Findings include:

All records and documents related to emergency preparedness provided by the facility was reviewed were revealed no policies and procedures to ensure safe evacuation from the facility including care needs of evacuees, transportation based on the patient population and census in the event the hospital is inoperable or unsafe. The facility policies addressed only exit from the building in the event of an emergency.

On 2/26/21 at 12:30 the Director of Emergency Preparedness confirmed the findings.

Based on interview and record review the facility failed to develop an emergency preparedness communication plan. This failure placed patients, staff, and visitors at risk for unmet needs during a disaster or major emergency event.

Findings include:

The facility provided two binders labeled emergency plan. Review of the documentation found no written EP communication plan to indicate how the hospital would communicate with other providers and emergency management agencies by alternate means in the event the telephone and Internet fail during an emergency.

During an interview on 3/26/21 at 12:30 PM Staff 20 said he was the Emergency Preparedness Coordinator. When asked to describe the EP communication plan, Staff 20 said the plan was not yet developed. Staff 20 said he sought assistance and guidance from the hospital administration to develop an emergency communication plan but got no help. Staff 20 said he was instructed to write up a plan..

Staff 20 said he wrote a communication plan "But it got red-lined by management". Staff 20 said they wanted more radios. Staff 20 reported he tried to get the managers to understand he could not add radios. Staff 20 said he could not get administration to understand FCC and other agencies limit the number of radios for a license and or a particular area. Staff 20 said he received no guidance and no assistance and to date, the hospital did not have an EP communication plan. Staff 20 said he had concerns because communication will pose a challenge during an emergency due to the remote/rural area and lack of resources.

Based on record review and interview the facility failed to develop an emergency preparedness plan training and testing program. Untrained staff placed all patients, staff, and visitors at risk for injury and unmet basic needs during a disaster or major emergency event .

Findings include:

All records and documents related to emergency preparedness provided by the facility was reviewed were revealed no evidence of an emergency preparedness training and testing program..

On 2/26/21 at 12:30 the Director of Emergency Preparedness confirmed the findings. Staff 20 reported the hospital conducted internal drills such as fire drills and safety drills for internal events only such as security events or medical emergencies. However drills were placed on hold due to the COVID pandemic.