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Based on a review of hospital documentation, observation and staff interviews, the governing body of Wellbridge Healthcare Greater Dallas failed to meet the Condition of Participation for Governing Body as evidenced by:

(1) Failing to ensure contracted services, including agency nursing staff temporarily employed by the hospital, met all hospital requirements and current standards of professional practice, as the hospital had no documented evidence of their meeting these requirements. (refer to A083)

(2) Failing to meet the requirements for the Condition of Participation for Patient Rights, as there were multiple issues with the use of seclusion at the hospital, psychoactive medications administered to patients without consent or court order, and patient observation levels not conducted according to physician order. (refer to A115, A144, A168, A174 and A175)

(3) Failing to ensure nurse staffing was implemented according to the approved nurse staffing grid, as multiple nurse assignments sheets providing documented evidence of staffing levels were unavailable for surveyor review. (refer to A392)

(4) Failing to meet the requirements for the Condition of Participation for Infection Control as there were issues with missing data related to infection control issues and antibiotic use, the maintenance of a sanitary hospital environment for patients, staff and visitors, and a lack of training for the current infection control coordinator. (refer to A747, A748 and A750).

(5) Failing to meet the requirements for the Condition of Participation for Quality Assessment and Performance Improvement as not all hospital departments collected, aggregated, and analyzed their outcome data and the facility did not take actions aimed a performance improvement and, after implementing those actions, the hospital failed to measure its success, and track performance to ensure that improvements were sustained (Refer A0273 and A0283).

A review of the "Bylaws of Wellbridge Healthcare Greater Dallas," revised 06/2020, revealed the following:
"Recognizing that the Governing Body (also referred to as the "Board of Directors" or "Board") of KINDRED BH ACQUISITION 1, LLC, d/b/a WellBridge Greater Dallas (the "Hospital") is responsible for planning the growth and development of the Hospital, as well as the evaluation and supervision of the conduct of the Hospital, including the care and treatment of patients, the control, conservation and utilization of physical and financial assets, and the procurement and direction of personnel, said Board members hereby accept and assume the responsibility to act in the best interest of the Hospital, and hereby organize themselves in conformity with the Bylaws hereinafter stated...

The Board shall carry out all committee functions by acting as a committee of the whole. In addition to those duties and responsibilities set forth elsewhere in these Bylaws, the Board shall have the following responsibilities:
a. 1) The Board shall conduct itself as a forum for discussion of matters of Hospital policy and practice, especially those pertaining to efficient and effective patient care so as to provide medico-administrative liaison between the Board, the Medical Staff, and the Hospital CEO. It shall further have the responsibility for development and continuing review of the Hospital's statutory, regulatory and accreditation program...The Board will require the medical staff and hospital staff as appropriate to revise policies and procedures as needed and to ensure review of all department policies and procedures at least annually...
d. The Board shall oversee the maintenance of the Hospital building and ground and ensure that proper repairs are made to maintain a safe and presentable Hospital building.
e. The Board shall have the responsibility to monitor and evaluate the quality of patient care within the Hospital...
g. The Board shall have the responsibility to adopt and oversee implementation of a quality management program that meets the requirements of Texas law and shall review and evaluate the effectiveness of that program at least once every twelve months...

6.02 Duties of Hospital CEO or Administrator. The duties of the CEO or Administrator shall include, but not be limited to, the responsibility for the following: ...
d. Carrying out all policies and procedures established by the Board, and ensure that all policies and procedures are established, documented, and implemented to protect the health and safety of a patient and are consistent with federal and state law requirements, including but not limited to those related to restraint and seclusion, quality management, admission and care of patients;...
i. Maintenance of physical properties in a state of repair and operating condition;
j. Selection, employment, evaluation and discharge of employees and maintenance of personnel policies and practices for the Hospital...
6.03 Authority of CEO or Administrator. The CEO or Administrator has the authority and responsibility to manage the Hospital..."


These failed practices resulted in multiple issues with hospital compliance with their own policies and procedures, as well as current healthcare standards of practice. The cumulative effect of these systemic deficient practices resulted in noncompliance with the Condition of Participation for Governing Body.

Based on a review of facility documentation and staff interviews, the governing body of Wellbridge Healthcare Greater Dallas failed to ensure that agency nursing staff met the requirements of their jobs, as 4 of 4 agency personnel records reviewed revealed no documented evidence of critical professional requirements as delineated in the contractual agreement with the temporary staffing agency.

Findings were:

Review of a contract with ACTRIV Healthcare, agency temporary healthcare staffing, stated in part:
" ...2. Actriv Healthcare Inc Responsibilities: ...B. Vendor shall maintain a worker file on each of its Employees and Vendor will provide copies of the following to facility:
i. Documentation of education and training.
ii. Skills inventory checklist.
iii. Two recent work references.
iv. TB [Tuberculosis] test and evidence of satisfactory health status.
v. Current CPR/BLS [Cardiopulmonary Resuscitation/Basic Life Support].
vi. Food Handler Card (for CNAs Only).
vii. Performance evaluation.
viii. Copy of current license, Nursys Report, DADS Nurse Aide Registry check, registration or certification.
ix. Criminal background checks - Texas Department of Public Safety Criminal History Search, National Background (multi-State)- open/closed complaints with TX Board of Nursing and DADS - National & Texas Sex Offender, National and Texas OIG, SAM Search ..."

Review of the job description for a behavioral health registered nurse at Wellbridge included the following:
"...Qualifications:
Education: Graduation from an accredited Bachelors of Science in Nursing, Associate Degree in Nursing or Nursing Diploma program.
Licenses/Certification: Current state licensure as Registered Nurse. BCLS certification. ACLS [Advanced Cardiovascular Life Support] preferred.
Experience: Minimum one year in an inpatient psychiatric setting..."

A review of 4 agency staffing files [Staff #40-43] revealed no documented evidence of any of the above items. The records contained only a passing test result on a nursing competency test.

During an interview with Staff #44, Director of Human Resources, on the morning of 11/9/22 at approximately 10:38 a.m., he reported he did not have personnel files for the requested agency staff. He reported he only had listing of competencies for each. Thus, the facility could provide no documented evidence of the agency staff having training in basic life support, required state licensure, or other items as noted in the contract agreement. Staff #44 stated, "It is what it is. I only have competencies for these staff members. I do not have the other information for these staff members onsite ..."

On the afternoon of 11/9/22, Staff #44 provided surveyors with the following written statement:
"This letter is to serve as supporting documentation that the previous Director of Nursing was responsible for obtaining and maintaining Nursing Agency employment and competency files ..."

Based on a review of documentation and interview, the facility failed to protect and promote each patient's rights, as evidenced by issues with seclusion use at the facility, as well as giving patients psychoactive medications without obtaining consent and failing to monitor patients at the monitoring level ordered by the physician. There was risk of patient harm due to inconsistency in documentation, and monitoring.

Findings were:

* The facility failed to ensure that the use of seclusion was in accordance with the order of a physician who is responsible for the care of the patient and authorized order restraint or seclusion by hospital policy in accordance with State law. Please refer to A0168.
* The facility failed to ensure that seclusion was discontinued at the earliest possible time, regardless of the length of time identified in the order. Please refer to A0174.
* The facility failed to effectively monitor patients in seclusion, as evidence by failing to correctly document patient observation and locations. Please refer to A0175.
* The facility failed to obtain informed consent prior to administering psychoactive medications to 5 of 5 patients. Please refer to A0131.
* The facility failed to provide care in a safe setting, as 5 of 5 patients who had fallen had not been monitored at the level ordered by their physician. Please refer to A0144.

Based on a review of clinical records and facility documentation, the facility failed to ensure that the patients had the right to make informed decisions regarding their care, as 5 of 5 patients received psychoactive medications without giving prior, informed consent.

Findings were:

The records of 5 patients (#24 - #28) were reviewed for accuracy of psychoactive medication consents. Findings were as follows:
o Patient #24 was admitted on 10-20-22. This patient began receiving Lexapro on 10-21-22 at 9:10 am and received 4 doses total prior to consent being obtained on 10-24-22 at 8:00 pm. The same patient began receiving Seroquel on 10-21-22 at 9:11 am and received 2 doses total prior to consent being obtained on 10-22-22 at 9:00 pm.
o Patient #25 was admitted involuntarily on 10-20-22. An application to administer court-ordered, psychoactive medication was approved on 10-31-22. Prior to the court order, the patient received Clozaril on 10-22-22 at 12:40 pm prior to the consent being obtained at 1:32 pm. The same patient received a dose of Invega Sustenna on 10-28-22 at 10:05 am prior to consent not being obtained until 9:32 pm the same day. The patient received a dose of Haldol Decanoate (extended release) on 10-25-22 with no consent obtained.
o Patient #26 was admitted on 10-20-22. The patient received 1 dose of Trileptal (on 10-30-22 at 9:10 am) and a total of 6 doses of Seroquel (beginning 11-3-22 at 3:00 pm), without obtaining consent for either medication.
o Patient #27 was admitted on 10-23-22. The patient received a dose of Risperdal on 10-24-22 at 12:44 pm (consent not obtained until 12:45 pm), a dose of Depakote on 10-24-22 at 12:44 pm (consent not obtained until 12:45 pm) and a dose of Invega Sustenna on 11-1-22 at 4:38 pm (consent not obtained until 4:40 pm).
o Patient #28 was admitted on 10-27-22. The patient received a dose of Valium on 10-28-22 at 2:06 pm (consent not obtained until 2:18 pm), a dose of Wellbutrin on 10-28-22 at 2:06 pm (consent not obtained until 8:00 pm on 10-30-22) and a dose of Prazosin on 10-28-22 at 2:04 pm (consent not obtained until 8:00 pm on 10-30-22).

Facility policy B-MM-05-012 titled "Psychoactive Medication Informed Consent" states, in part:
"Purpose: It is the policy of the facility to seek informed consent from the patient or guardian for the psychoactive medications ...and to respect the rights of the patient or guardian if he or she refuses consent. Patients must consent to take psychotropic drugs unless otherwise stipulated by psychiatric crisis or legal order."

Facility policy WHB-PC 09-001 titled "Patient Rights and Responsibilities" states, in part:
"Purpose:
This policy establishes guidelines to provide an environment that both respects and protects the rights of patients and patients' families; and to conduct all activities related to care with primary concern for the values and dignity of patients. This policy also provides a systematic process for informing patients about their rights and responsibilities and the hospital complaint and grievance process.
The rights and responsibilities referred to in this policy shall be protected and exercised for each patient and his/her family/guardian at The Hospital. This policy applies to all patients, parents of minor children and guardians. If any violations occur, the patient and/or family shall follow the established complaint/grievance process or contact the Chief Clinical Officer immediately.

Policy:
The policy of The Hospital is to ensure the following:
1. The list of Patient Rights and Responsibilities (PRR) is provided to each patient at admission as part of the admission packet. The PRR prints from Meditech as a part of the admission package."

Facility document titled "Patient's Bill of Rights" states, in part:
" ...
Care and Treatment
...
29. You have the right not to be given medication you don't need or too much medication, including the right to refuse medication (this right extends to your parent or conservator if you are a minor, or your legal guardian when applicable). However, you may be given appropriate medication without your consent if:
o Your condition or behavior places your(sic) or others in immediate danger; or
o You have been admitted by the court and your doctor determines that medication is required for your treatment and a judicial order authorizing administration of the medication has been obtained."

The above was confirmed in an interview with staff #2 on 11-9-22.

Based on a review of clinical records and facility documentation, the facility failed to protect the patient's right to care in a safe setting, as 5 of 5 patients who fell had not been observed/monitored appropriately at the level ordered by their treating physician.

Findings were:

The records of 5 patients (#4 - #8) that had suffered the most recent falls at the facility were reviewed for accuracy of monitoring. Findings were as follows:

o Patient #4 was admitted to the facility on 11-4-22. At the time of admission, the patient was placed on q (every) 15 minute checks and fall precautions. A review of observation sheets revealed that, on 11-5-22, the patient was observed at intervals greater than every 15 minutes on 6 separate occasions. In addition, her fall precautions were never implemented and added to her observation sheets. The patient fell on 11-5-22 at 4:32 pm.

o Patient #5 was admitted to the facility on 10-28-22. At the time of admission, the patient was placed on q 15 minute checks and fall precautions. A review of observation sheets revealed that, on 10-28-22, the patient was observed at intervals greater than every 15 minutes on 5 separate occasions; 10-29-22, 6 separate occasions;10-30-22, 3 separate occasions; 10-31-22, 3 separate occasions; 11-1-22, 8 separate occasions; 11-2-22, 5 separate occasions. The patient fell on 11-2-22 at approximately 2:25 pm. Following the fall, she was placed on fall precautions. On 11-3-22, the patient was observed at intervals greater than every 15 minutes on 8 separate occasions; 11-4-22, 8 separate occasions; 11-5-22, 12 separate occasions; 11-6-22, 12 separate occasions; 11-7-22, 3 separate occasions. The fall precautions, ordered after her fall on 11-2-22, were never implemented and added to her observation sheets.

o Patient #6 was admitted to the facility on 10-26-22. At the time of admission, the patient was placed on q 15 minute checks and fall precautions. A review of observation sheets revealed that, on 10-26-22, the patient was observed at intervals greater than every 15 minutes on 7 separate occasions; on 10-27-22, 8 separate occasions; on 10-28-22, 9 separate occasions; on 10-29-22, 6 separate occasions; on 10-30-22, 8 separate occasions; on 10-31-22, 6 separate occasions. The patient fell on the morning of 11-1-22. On 11-2-22, her observation frequency order was increased to q 5 minutes at 2:50 pm and she was placed on 1:1 monitoring level [a level of observation in which a specified and dedicated staff member stays within approximately one arm's length of the patient at all times] at 6:19 pm. Her q 5 minute monitoring level was never implemented. Her 1:1 monitoring level was not implemented 11-3-22 at 7:35 am. A review of subsequent monitoring sheets revealed that, on 11-3-22, the patient was observed at intervals greater than every 15 minutes on 7 separate occasions; on 11-4-22, 1 occasion; on 11-5-22, 5 separate occasions; on 11-6-22, 6 separate occasions and on 11-7-22, 9 separate occasions.

o Patient #7 was admitted to the facility on 10-11-22. At the time of admission, the patient was placed on q 15 minute checks and fall precautions. A review of observation sheets revealed that his fall precaution was not implemented and added to his observation sheets until 3:23 am on 10-12-22, after he had already fallen at 3:15 pm on 10-11-22. On 10-12-22, the patient was observed at intervals greater than 15 minutes on 4 separate occasions; on 10-13-22, 4 separate occasions; on 10-14-22, 15 separate occasions; on 10-15-22, 4 separate occasions; on 10-16-22, 10 separate occasions; on 10-17-22, 6 separate occasions; on 10-18-22, 6 separate occasions; on 10-19-22, 10 separate occasions; on 10-20-22, 7 separate occasions; on 10-21-22, 4 separate occasions; on 10-22-22, 10 separate occasions; on 10-23-22, 10 separate occasions; on 10-24-22, 3 separate occasions; on 10-25-22, 3 separate occasions and on 10-26-22, 3 separate occasions.

o Patient #8 was admitted to the facility on 9-28-22. At the time of admission, the patient was placed on q 15 minute checks and fall precautions. A review of observation sheets revealed that, on 9-28-22, the patient was observed at intervals greater than 15 minutes on 3 separate occasions; on 9-29-22, 6 separate occasions; on 9-30-22, 4 separate occasions, on 10-1-22, 6 separate occasions. The patient fell at approximately 4:00 am on 10-2-22. On 10-2-22, the patient was observed at intervals greater than 15 minutes on 7 separate occasions; on 10-3-22, 7 separate occasions and on 10-4-22, 4 separate occasions. An order was written on 10-4-22 at 6:32 am for the patient's monitoring to increase to q 5 minutes, but this order was not implemented until 10-6-22 at 12:25 am. On 10-6-22, the patient was observed at intervals greater than 5 minutes on 25 separate occasions; and on 10-7-22, 10 separate occasions.

Facility policy B-PC-01-010 titled "CORE: Observation Precautions" states, in part:
"Purpose: The purpose of observations is to provide a system of progressive intensity of patient observation, precaution and oversight based on patient acuity, severity and type of symptoms and overall needs. This policy establishes guidelines for the delivery of patient care and to promote the safety of all patients in care.
Policy: The policy is to provide all patients with a safe environment conducive to effective treatment of and improvement in the condition for which the patient admitted to the hospital. Precaution levels are used to promote these goals. It is the policy of the facility to provide levels of observation in compliance with physician orders and prescribed protocols.
Procedure: The physician orders observation level at admission, and may change the level if the patient's condition warrants a change:
o Q15 minute
o Q5 minute
o One-to-one

The physician will order a specific precaution for (including but not limited to):
o Suicide
o Assault
o Elopement
o Self-harm
o Sexually acting out
o Fall
o Detox
o Seizure
o Other
...
Assignment of Rounding:
o The Nurse Supervisor assigns staff to perform observations on a designated set of patients. These assignments are communicated at the beginning of the shift.
o Patients placed on special precautions or are identified as high risk are identified to the assigned staff.
o The Unit Nurse arranges for assigned staff to be relieved for breaks and meals.
o Staff will complete the patient observation as rounds are made, using the record described coding system.
o Staff assigned to observations of patients are responsible for hand-off to other staff in order to maintain observations for any break. Change in assignment of rounding should be verbally communicated to the charge nurse/house supervisor prior to the staff member leaving the unit.
Completing Observation Rounds:
o Staff will observe patient and document on the correlating Level of Observation Sheet (Q5, Q15, or 1:1) or rounding device.
o Assigned staff make direct visual contact with patients and confirm they are in no danger or distress.
o Staff are vigilant for potential risk factors identified for specific patients (levels of assigned precautions).
o If a patient is sleeping or in bed, staff conducting observation rounds enter the room, approach the patient, check their identity and ensure that they are not in distress. To determine the patient is not in distress, the staff member watches, at a minimum, of three respirations (rise and fall of the chest).
o Staff attempt to maintain the patient's privacy as much as possible. However, patient safety much be the main consideration. Therefore, rounding should never be omitted due to activities of daily living of hygiene.
o Staff will log on and off rounding tool, as applicable, as they assume responsibilities.
One-to-One (1:1) and One-to-One observation with decreased proximity to maintain safety:
o A specified and dedicated staff member will stay within approximately one arm's length of the patient on 1:1 observation and maintain continuous direct visual observation. This observation will continue even when patients shower, change clothes or use the bathroom. Staff will attempt to maintain the patient's privacy as much as possible; however, the safety of the patient must be the main consideration.
o One-to-one observation with decreased proximity may be utilized in situations of severe patient aggression towards staff completing the 1:1 observation. This will be utilized only if the patient is in their room with no other patients and the safety of staff is at risk being alone with the patient. Physician order must state if decreased proximity is to be utilized."

Facility policy WHB-PC 09-001 titled "Patient Rights and Responsibilities" states, in part:
"Purpose:
This policy establishes guidelines to provide an environment that both respects and protects the rights of patients and patients' families; and to conduct all activities related to care with primary concern for the values and dignity of patients. This policy also provides a systematic process for informing patients about their rights and responsibilities and the hospital complaint and grievance process.
The rights and responsibilities referred to in this policy shall be protected and exercised for each patient and his/her family/guardian at The Hospital. This policy applies to all patients, parents of minor children and guardians. If any violations occur, the patient and/or family shall follow the established complaint/grievance process or contact the Chief Clinical Officer immediately.

Policy:
The policy of The Hospital is to ensure the following:
1. The list of Patient Rights and Responsibilities (PRR) is provided to each patient at admission as part of the admission packet. The PRR prints from Meditech as a part of the admission package."

Facility document titled "Patient's Bill of Rights" states, in part (beginning on 2nd page):
"Basic Rights for All Patients
...
3. You have the right to a clean and humane environment in which you are protected from harm, have privacy with regard to personal needs, and are treated with respect and dignity."

The above was confirmed in an interview with staff #2 on 11-9-22.

Based on a review of the documentation and interview, the facility failed to ensure that the use of seclusion was in accordance with the order of a physician who is responsible for the care of the patient and authorized order restraint or seclusion by hospital policy in accordance with State law.

Findings were:

Facility based policy B-PC 07-09, entitled, "CORE: Physical Restraints (Violent and Non-Violent Behavior) and Seclusion" stated in part,
"6. Clinical/Nursing Staff and Physician/Licensed Practitioner (LP)/Allied Health Practitioner (AHP) Responsibilities:
a. Physician/LP/AHP Responsibilities-Under this policy AHP's are NOT LPs for the purposes of ordering restraints. An AHP may order restraints however, the attending Physician or LP must examine the patient as required by this policy".

The above policy is contradictory regarding whether advance practice nurses can order restraint at the facility. In interview on 11/08/22, staff member #38 verified that at the sister facility they work at only physicians order restraints and seclusions.

Review of medical records revealed that 5 of 10 seclusion episodes (Patients #13, 14, 16, 20, and 21) that occurred in September and October 2022 were ordered by nurse practitioner, not a physician per regulatory requirements and facility policy.
* Patient #13 had a seclusion episode on 10/07/22. This seclusion order was entered by a nurse practitioner (staff member #32), not a physician per regulations.
* Patient #14 had a seclusion episode on 10/04/22. This seclusion order was entered by a nurse practitioner (staff member #32), not a physician per regulations.
* Patient #16 had a seclusion episode on 09/23/22. This seclusion order was entered by a nurse practitioner (staff member #32), not a physician per regulations.
* Patient #20 had a seclusion episode on 09/21/22. This seclusion order was entered by a nurse practitioner (staff member #32), not a physician per regulations.
* Patient #21 had a seclusion episode on 10/04/22. This seclusion order was entered by a nurse practitioner (staff member #32), not a physician per regulations.

Review of the credentialing file for staff member #32 revealed this staff member was an advanced practice nurse practitioner.

In interview on 11/08/22, staff member #38 verified the above restraint orders were written by a nurse practitioner not physician/psychiatrist, per facility policy. In interview on 11/09/22, staff member #1 (Interim Chief Executive Officer), also verified that restraints and seclusions should only be ordered by a physician, not an advanced practice nurse.

Based on a review of documentation and interview, the facility failed to ensure that seclusion was discontinued at the earliest possible time, regardless of the length of time identified in the order.

Findings were:

Facility based policy B-PC 07-009 entitled, "CORE: Physical Restraints (Violent and Non-Violent Behavior) and Seclusion" stated in part,
"7. Criteria for Release of Restraint(s): The clinical team (Physicians/LP, RNs, and all direct care staff) work collaboratively to observe the patient and remove the restraints (or discontinue seclusion) as soon as possible, based on an assessment. This includes documentation that indicates:
a. The unsafe situation is resolved.
b. Determination is made that the patient's behavior is no longer a threat to the patient's safety and/or safety of others...

Ongoing assessment (at least every four hours) by an RN of the patient's behavior, whether the unsafe situation is resolved and whether the criteria for discontinuing the restraints are met."

The Locations Legend on the facility "Behavioral Health-Patient Observation Sheet" included the following abbreviations: COA: Common Area and SECA: Seclusion Area.
The Behavior Legend on the facility "Behavioral Health-Patient Observation Sheet" included the following abbreviations: COC-Cooperative/Calm, AS-Appears Sleeping, ANX-Anxious, and UNCO-Uncooperative.

Review of documentation revealed that 6 of 10 patients (Patients 12, 13, 14, 15, 16, and 19) with restraint episodes were not released at the earliest possible time, as evidence by behaviors that would not necessitate a continuation of the seclusion episode, behaviors such as calm and cooperative and anxious:
o Patient # 12 had a seclusion episode (per the S/R [Seclusion/Restraint] Assessment form) due to aggression, on 10/31/22 from 1:56 AM to 3:16 AM, per this form the patient was released due to, "discontinued seclusion because patient fell asleep". For this date, Patient #12 had AS (Appears Sleeping) as the behavior documented from 0230-0315. The documented behavior of "appears sleeping" does not reflect behaviors or actions that support continued seclusion of this patient. Per regulatory, requirement, once asleep in seclusion, individuals should immediately be released.

o Patient # 13 had a seclusion episode (per the S/R Assessment form) due to aggression, on 10/07/22 from 04:20 PM to 5:00 PM. For this date, Patient #13 had COC (Cooperative/Calm) behavior documented from 1630-1700. The documented behavior of calm/cooperative does not reflect behaviors or actions that support continued seclusion of this patient.

o Patient #14 had a seclusion episode (per the S/R Assessment form) due to aggression, on 11/04/22 from 11:15 AM to 12:00 PM. For this date, Patient #14 had COC (Cooperative/Calm) behavior documented from 1130-1215. The documented behavior of calm/cooperative does not reflect behaviors or actions that support continued seclusion of this patient.

o Patient #15 had a seclusion episode (per the S/R Assessment form) due to aggression, on 10/03/22 from 03:50 PM to 4:30 PM. For Patient #15 had COC (Cooperative/Calm) documented from 1554-1615. The documented behaviors of calm/cooperative does not reflect behaviors or actions that support continued seclusion of this patient.

o Patient #16 had a seclusion episode (per the S/R Assessment form) due to aggression, on 09/23/22 from 04:00 PM to 6:15 PM. For behaviors, Patient #16 had COC (Cooperative/Calm) documented from 1600-1630 and ANX (Anxious) documented from 1645-1800. The documented behaviors of calm/cooperative and anxious do not reflect behaviors or actions that support continued seclusion of this patient.

o Patient # 19 had a seclusion episode (per the S/R Assessment form) due to aggression, on 09/22/22 from 09:30 AM to 11:00 AM For behaviors, Patient #19 had COC (Cooperative/Calm) documented from 0945-1000 and ANX (Anxious) documented at 1030. The documented behaviors of calm/cooperative and anxious do not reflect behaviors or actions that support continued seclusion of this patient.

The above 6 patients were kept in seclusion after demonstrating appropriate behavior for release. All 6 patients had seclusions that continued with no behaviors requiring continued seclusion, such as aggression or self injurious action, documented. In one case, (Patient #12) the patient was documented as sleeping, which would mandate an immediate release from seclusion. The failure of staff to release Patients #12, 13, 14, 15, 16, and 19 from seclusion after not demonstrating behaviors requiring seclusion was verified in interview on 11/09/22 with staff member #38.

Based on a review of documentation and interview, the facility failed to effectively monitor patients in seclusion, as evidence by failing to correctly document patient observation and locations.

Findings were:

Facility based policy B-PC 07-009 entitled, "CORE: Physical Restraints (Violent and Non-Violent Behavior) and Seclusion" stated in part,
"Ongoing Safety Checks & Monitoring (at least every 15 minutes or as noted on the designated forms) by the patient's clinical team of the patient's response to the restraint, including any condition changes. These must be communicated and addressed accordingly to hospital policy.
o Visually observe the patient at least 15 minutes for safety needs...
o All documentation of patient status should be in real time."

The Locations Legend on the facility "Behavioral Health-Patient Observation Sheet" included the following abbreviations: COA: Common Area and SECA: Seclusion Area.

Review of documentation revealed that of 5 out of 10 patients (Patients 12, 13, 14, 16, and 19) with restraint episodes had documentation that did not reflect continuous face-to-face observation, as evidence by failing to correctly document patient observation and locations:
o Patient # 12 had a seclusion episode (per the S/R Assessment form) due to aggression, on 10/31/22 from 1:56 AM to 3:16 AM, per this form the patient was released due to, "discontinued seclusion because patient fell asleep". From 0215-0230 "+0 min" was documented on the "Behavioral Health-Patient Observation Sheet", while reviewing the electronic record staff member #38 verified there was a gap from 0201-0230, almost 30 minutes, in monitoring/observing the patient in seclusion. On the "Behavioral Health-Patient Observation Sheet" for this date, conflicting locations were recorded: from 02:30-5:00: SECA was listed. The locations documented for this patient were not correct and should have reflected SECA only from 0200-0315.

o Patient # 13 had a seclusion episode (per the S/R Assessment form) due to aggression, on 10/07/22 from 04:20 PM to 5:00 PM. On the "Behavioral Health-Patient Observation Sheet" for this date, conflicting locations were recorded: at 1630: SECA and 1645-1700: COA. The locations documented for this patient were not correct and should have reflected SECA from 1620-1700.

o Patient #14 had a seclusion episode (per the S/R Assessment form) due to aggression, on 11/04/22 from 11:15 AM to 12:00 PM. On the "Behavioral Health-Patient Observation Sheet" for this date, conflicting locations were recorded: from 1115-1145: COA and 1200: SECA. The locations documented for this patient were not correct and should have reflected SECA 1115-1200.

o Patient #16 had a seclusion episode (per the S/R Assessment form) due to aggression, on 09/23/22 from 04:00 PM to 6:15 PM. On the "Behavioral Health-Patient Observation Sheet" for this date, conflicting locations were recorded: at 1600: SECA, 1615: COA, 1630: COA, and 1700-1800: SECA. The locations documented for this patient were not correct and should have reflected SECA from 1600-1800.

o Patient # 19 had a seclusion episode (per the S/R Assessment form) due to aggression, on 09/22/22 from 09:30 AM to 11:00 AM. On the "Behavioral Health-Patient Observation Sheet" for this date, conflicting locations were recorded: at 0930: SECA, 0945: COA, and 1000-1045: SECA. The locations documented for this patient were not correct and should have reflected SECA from 0930-1100.

In interview on 11/08/22 staff member #38 verified that the above documentation did not accurately reflect the correct location of the above patients that, per the S/R Assessment form, were in the seclusion room. Staff member #38 also verified that there was almost a half hour gap in the observation monitoring of Patient #12.

Based on review of hospital documentation, observation, and staff interview, the facility leadership of the Division Director of Quality and Risk and the Director of Quality Management [DQM] under the guidance of the facility CEO failed to meet the Conditions of Participation for Quality Assessment and Performance Improvement as evidenced by:

1. Failure of the facility DQM to ensure all hospital departments collect, aggregate, and analyze their outcome data and data was reported to the Quality Council and Medical Staff per hospital policy. (Refer A0273)

2. Failure of the facility to take actions aimed a performance improvement and, after implementing those actions, the hospital failed to measure its success, and track performance to ensure that improvements were sustained (Refer A0283).

Based on review of documents and staff interview, the facility failed to ensure all hospital departments collected, aggregated, and analyzed their outcome data and data was reported to the Quality Council and Medical Staff per hospital policy.

Findings were:

In review of Policy B-ML 02-005, titled, CORE: Outcomes Management-QAPI and Survey Readiness, original date: 08/2021, states in part, "...This policy establishes guidelines to develop and manage systems and processes for the identification, collection, analysis and reporting of key hospital performance measures and outcomes.

POLICY
The policy of The Hospital is to ensure the following:
1. Outcomes Management within the Behavioral Health Division is under the leadership of the Division Director of Quality and Risk and at the facility level, the Director of Quality Management (DQM) under the guidance of the facility CEO.

2. Outcomes Management shall provide a mechanism to allow facilities to continuously improve performance, compare performance both internally and externally, and to benchmark performance wherever possible to assist in the achievement of the Hospital Division's mission, vision and goals. Areas of focus include:
a. Collection, analysis, and reporting of key indicators and performance outcomes for clinical operations
b. Tracking, trending and reporting of regulatory and accreditation survey activities and requirements for public reporting
c. Serves as a resource to hospitals, region and Support Center staff in outcomes management and performance improvement activities and methodologies
d. Participates/facilitates other outcomes research studies and related projects

3. Outcomes Management is responsible for collecting, aggregating, analyzing and reporting Hospital data from Benchmark Reports, the Event Reporting System (ERS), Customer Satisfaction Surveys, feedback·or results from an auditing or accrediting body and CMS Mandatory Quality Reporting.
4. Each hospital's DQM shall facilitate and coordinate the hospital-wide Performance Improvement Process to assure compliance with TJC, CMS, DHS and other healthcare regulatory and accrediting standards, including federal and state mandated reporting requirements.
5. Each hospital's DQM shall assure the collection, aggregation, and analysis of outcome data and report it through the Quality Council and Medical Staff structure as defined in the Strategic Quality Plan. The Governing Board receives reports describing the results of monitoring and evaluation and trends and actions taken to resolve problems or respond to opportunities for improvement..."

Review of the Quality Meeting minutes dated 10/21/22 for 9/27/22 stated in part,
"Intake - No data collected due to assistant director leaving
Infection Control - There was no data collected. Infection control nurse is hired and will be provided data starting September 2022 ...
Nursing - There was no data collected due to Director of Nursing leaving"

Further review of the Quality Meeting Minutes dated 9/27/22 reflected no data collected for the following in 2022:

High Reliability Indicators:
*Deference to Expertise: Staff member attends Safety/EOC of PI committee as scheduled for the months of January, May, June

Quality Indicators:
*Unit shifts failing to meet minimum staffing for the months of June, July, August, or September
*C-SSRS [scale used to determine suicide risk] completed at admission and is signed, dated and timed for the months of August or September
*C-SSRS re-assessment is completed daily for the months of June, July, August, or September

Performance Indicators for Human Resources:
*New Hire competency completion rate for the months of January through September
*Handle with Care Compliance for the months of January through August
*CPR Compliance for the months of January through August
*Terminations for the months of January through August

Performance Indicators of Infection Control:
*Expiration dates are present for all individually packaged foods (Monthly Audit) for the months of January through August
*Compliance with employee TB Testing for the months of April through August (September was only 54%)
*Staff influenza compliance and declination for the months of January through September
*Appropriate hand hygiene for the months of January through August
*Infection control environment of care rounds conducted weekly for the months of January through August

Performance Indicators of Intake:
*Medical Screen is within 15 minutes of arrival for the months of May through September
*Intake process and disposition for the months of May through September
*SAFE-T with CSSRS Completed on admission for the months of July through September (For February and April their target was not met)
*Precerts completed within 24 hours of admission for the months of January through September

Performance Indicators of Nursing:
16 of 21 indicators were not reported January through August

Performance Indicators of Quality:
8 of 9 indicators were not reported January through September

Performance Indicators of Outpatient:
5 of 5 indicators were not reported January through August

Facility-based Strategic Quality Operations Plan Behavioral Health for 2022 stated in part, "Section V: Quality indicators (or measures) are important as a way to document the outcomes of care, treatment and services provided and to identify opportunities for improvement."

In an interview with staff #4, Interim Director of Quality, on the afternoon of November 09, 2022, staff #4 stated, "There has been significant turnover in critical leadership positions at Wellbridge Greater Dallas Hospital in 2022. Specifically, 6 CEO's, 4 Intake Directors, 2 Directors of Clinical Services, 5 Directors of Nursing, 2 Plant Operations Directors, 2 Human Resource Directors, 4 Infection Control Nurses, 2 Directors of Information Management, and 2 Directors of Quality. This massive turnover made it difficult to report QAPI data consistently. Several departments, Intake, Nursing, Infection Control, and Plant Operations were inconsistent for some months of the year. Leadership at the facility level in partnership with our corporate partners are aware of the issue, resources are being allocated to remedy this situation, and the remainder of the year will be reported appropriately."

The above was discussed in an interview on the afternoon of 11/9/22 with Staff #4.

Based on review of documents and staff interview, the facility failed to take actions aimed a performance improvement and, after implementing those actions, the hospital failed to measure its success, and track performance to ensure that improvements were sustained.

Findings were:

Review of the QAPI Committee Meeting Minutes dated 10/21/22 for 9/27/22 reflected the following:
"Clinical Scorecard:
...Fall rate increased in the month of August
*There was an increase in restraints and seclusion for the month, mainly due to one patient
*Emergency IM medications also increased for the moth
...Post DC calls is still below the benchmark. Plan: Submit request to modify high risk assessment in pinpoint."

...Dietary: All indicators except for one indicator are within benchmark for the month; there is still a struggle in getting a dietary profile before the next shift."

...Utilization Review:
*Precerts are not being completed over the weekend in intake. Precerts is a task for intake.
*Previous action plan for precerts was to get the Assistant Director of Intake to be trained so he can trained [sic] his staff but he left the company

...Other: Fall rates increased in the month of August
*Seclusion and restraints increased for the month, mainly due to one patient."

The action items for the above indicators were all documented as "Reviewed and Discussed."

The above was discussed in an interview on the afternoon of 11/9/22 with Staff #4.

Based on a review of facility documentation and staff interviews, the governing body failed to provide documented evidence that adequate numbers of nurses and behavioral health technicians were available to meet patient care needs as multiple pages of staffing/assignment sheets for August through September 2022 were unavailable for surveyor review.

Findings were:

A review of facility staff sheets for August - September 2022 revealed no staffing sheet for one or more shifts on numerous dates as follows:

August 2022 - The facility could provide no staffing/assignment sheets for 36 of 62 shifts

September 2022 - The facility could provide no staffing/assignment sheets for 24 of 60 shifts

October 2022 - The facility could provide no staffing/assignment sheets for 24 of 62 shifts

In an interview with Staff #2, Interim Director of Nursing [DON], on the morning 11/8/22, unit staffing sheets were requested for August through October 2022. Surveyor clarified that the requested evidence would detail which staff were actually at the facility for the shift.

In a subsequent interview with Staff #2, on the afternoon of 11/9/22, she stated she had brought the only staffing sheets she could find. She confirmed that multiple shift sheets were unavailable. She stated, "I don't have access to all the dates and shifts." She provided a signed, written statement as follows:

"To whom it may concern:

During a regulatory survey, nursing assignment sheets were requested for a period covering August, September, and October of 2022. The facility was unable to produce assignment sheets for multiple dates as requested. There are two significant contributing factors leading to the facility being unable to produce this data. First, there was a failure in leadership within the nursing department. The previous DON resigned with only hours of notice in mid-September. After her abrupt exit, as the hospital attempted to organize the DON office and locate critical data related to nursing, it became apparent that many nursing director functions and tasks were unfulfilled, and a significant amount of data was unaccounted for ...

Upon discovery of the missing data and recognizing the issues associated with storing data electronically without secondary storage, the nursing department began retaining paper copies of assignment sheets to prevent recurrence of similar issues.

The dates in question are as follows:

August: Day Shift - 1st, 4th, 5th, 7th, 11th, 14th, 21st, 28th, 29th, 30th
August Night Shift - 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 14th, 15th, 16th, 17th, 18th, 19th, 20th, 21st, 22nd, 23rd, 24th, 25th, 26th, 27th, 28th

September: Day Shift - 3rd, 4th, 10th, 13th, 25th, 26th, 28th
September: Night Shift - 1st, 2nd, 3rd, 4th, 5th, 7th, 10th, 13th, 15th, 16th, 17th, 18th, 19th, 20th, 26th, 29th, 30th

October: Day Shift - 1st, 2nd, 7th, 8th, 9th, 14th, 15th, 21st, 22nd
October: Night Shift - 1st, 2nd, 6th, 7th, 8th, 9th, 10th, 11th, 12th, 13th, 14th, 15th, 19th, 21st, 22nd ..."

Though the previous DON resigned in mid-September of 2022, the lack of staffing sheets continued to go unnoticed through the dates requested by surveyor.

Based on a review of hospital documentation, observation, and staff interview, the facility failed to have an active hospital-wide program for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship as evidenced by:

1. Failure to ensure an individual, who is qualified through education, training, experience, or certification in infection prevention and control, was appointed by the governing body as the infection preventionist/infection control professional responsible for the infection prevention and control program and that the appointment is based on the recommendations of medical staff leadership and nursing leadership (Refer A748).

2. Failure to maintain a clean and sanitary environment in the laundry and medication areas (Refer A750).

3. Failure to communicate and collaborate with the hospital's QAPI program on infection prevention and control and antibiotic use issues (Refer A774).

Based on interview and record review the facility failed to ensure that an individual, who is qualified through education, training, experience, or certification in infection prevention and control, is appointed by the governing body as the infection preventionist/infection control professional responsible for the infection prevention and control program and that the appointment is based on the recommendations of medical staff leadership and nursing leadership.

Findings were:

During an interview on the afternoon of 11/7/2022 with Staff #27 revealed that she has been the infection control nurse since 8/22/22. She continued that she has had no formal training in Infection Prevention. She stated that she has signed up for a class but has not taken one yet. She continued that she has looked at the CDC [Centers for Disease Control and Prevention] website.

Review of Staff #27 employee file, on the afternoon of 11/7/22, reflected no job description in the file. Further review revealed no Infection Prevention Training. Interview on 11/9/2022 with Staff #44, Human Resources, verified that the training was completed on 11/7/2022 and the job descriptions were signed on 11/8/2022.

Review of the Governing Body minutes reflected that Staff #27 has not been approved or recommended for the position of infection preventionist.

During an interview on 11/8/22 with Staff #39, Administrative Assistant, revealed that she takes notes at all Governing Body Meetings and Staff #27 had not been formally appointed to be the Infection Preventionist.

The above information was verified by Staff #3 in an interview on 11/8/22.

Based on observation and interview the facility infection prevention and control program failed to maintain a clean and sanitary environment in the laundry and medication areas.

Findings were:

Observation on the afternoon of 11/8/22, of Staff #41 performing a glucometer glucose check. Staff #41 carried the basket of supplies to the patient, performed the test, wiped the meter down with alcohol, and placed the retractable lancet, test strip and glucometer in the basket. Staff #41 then took the supply basket to the nurse's station. She then wiped the glucometer with a Saniwipes disinfection wipe and placed the meter back into the basket. Review of the manufacturer directions for use reflected the minimum contact time for the wipes is 2 minutes. Staff #41 was unaware of the minimum contact time or that there was a minimum contact time.

Review of facility policy "CORE: Capillary Blood Glucose Monitoring (BGM)", B-LS 01-002 dated 7/2021, reflected:
" ...Procedure:
...17. Place retractable lancet in sharps container. Remove test strip from meter and place in the trash can. Remove test strip from meter and place in the trashcan. Remove gloves and place in trash can. Wash hands or use hand sanitizer ...
...Cleaning the glucometer:
...4. To disinfect the meter, dispense a wipe from the approved cleaning disinfectant contester. Oily substances must be removed prior to disinfection. Wipe all external areas of the meter including both front and back surfaces until visibly wet. Avoid wetting the test strip holder and data port.
5. Allow surface of the meter to remain wet at room temperature for at least 2 minutes from approved cleaning and disinfecting wipe ..."

Review of Staff #41's employee file reflected her last Capillary Blood Glucose Monitoring Competency was completed on 4/20/2018.

During an interview on the afternoon of 11/8/22, with Staff #2, Interim Director of Nursing, she verified these findings.

During a tour of the lab area on the morning of 11/8/22 with Staff #2, Interim Director of Nursing, on the geriatric patient side revealed the following:
- an entire bag of COVID-19 PCR test supplies that expired on 1/11/2022.
- Sealed container of gray top lab tubes that expired on 9/30/2021.
- A opened urine specimen container labeled with a patient name in the drawer with other urine specimen containers ready for use.

During a tour of the medication room on the morning of 11/8/22 with Staff #2, Interim Director of Nursing, on the geriatric side revealed the following:
- Basket of glucometer supplies had visible hair and dust in with the supplies.
- Cart with medication crusher, pill holder, and wound care supplies had old tape on the outside of the cart, fragments of pills inside the drawer, and dust inside the drawer.

During the tours on the morning of 11/8/22 with Staff #2, Interim Director of Nursing, she verified these findings.

During a tour of the patient laundry and linen storage areas on the morning of 11/9/22 with Staff #24, Director of Plant Ops, the following items were noted:

- The lint trap for each of the 2 dryers in the room were full of lint. A document entitled, "Laundry Daily Log" included a yes/no column to indicate "Dryer Vent Cleaned." The column indicated the vents/traps had been cleaned after each load on 11/7/22, 11/8/22 and 11/9/22.

- Clean Linen Room #1300 had uncovered clean linen available for patient use. Two of the three shelving units used for the storage of the linen did not have impermeable barriers on the bottom shelf. This potentially allows liquid splashes, as well as other contaminants, to reach the clean linen from below.

The above findings were verified by Staff #24 during the tour on 11/9/22.

Based on record review and interview the facility failed to communicate and collaborate with the hospital's QAPI program on infection prevention and control and antibiotic use issues.

Findings were:

Review of the facility Infection Control Committee minutes reflected only 2 committee meetings were held in the last 12 months, April 2022 and October 2022.

Further review of the facility Quality and Safety Committee minutes, dated 2/10/22, reflected:
"...Infection Control- Half of the indicators are within benchmark in the 4th quarter. Due to staffing there was not data for the month of October and November..."

Review of the facility Quality and Safety Committee minutes, dated 4/14/22, reflected:
"...Indicator for the 1st quarter that we have data for are within benchmark. There were not an infection control nurse in the 1st quarter..."

Review of the QAPI Committee minutes, dated 7/20/22, reflected:
"...Infection Control-Unable to obtain data due to no infection control staff..."

Review of the QAPI Committee minutes, dated 8/18/22, reflected:
"...Infection Control-Data for July are incomplete due to staffing issues we were not able to collect data..."

Review of the QAPI Committee minutes, dated 9/27/22, reflected:
"...Infection Control-There were no data collected. Infection control nurse is hired and will be provided data starting September 2022..."

The above information was verified by both Staff #3 and #39 in an interview on 11/7/22.