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Based on a review of hospital records and interview, it was determined the hospital failed to ensure the Governing Body evaluated hospital services related to patient rights, nursing services, and emergency services. This deficient practice poses the risk of the Governing Body being unaware of the overall function and management of the hospital and the inability to improve patient care services.

This was demonstrated by a failure to ensure:

Cross reference A-0049: Medical staff were held accountable when patients did not receive a Medical Screening Exam when coming to the Intake Department or receive a one hour face to face evaluation after a restraint episode.

Cross reference A-0057: The Chief Executive Officer (CEO) was responsible for hospital operations.

Cross reference A-0130: A patient's guardian was involved in the discharge planning;

Cross reference A-0131: Patients receiving psychotropic medications had informed consent;

Cross reference A-0144: Patient safety after receiving a chemical restraint by having appropriate monitoring, so as not to result in the death of a patient;

Cross reference A-0168: Patients have an order before receiving chemical restraints;

Cross reference A-0178: Patients receive a one hour face to face evaluation when requiring the use of
restraints;

Cross reference A-0179: RNs performing face to face evaluations with the use of restraints are trained appropriately;

Cross reference A-0182: Physicians receive results of a one hour face to face evaluation after ordering chemical restraints for a patient;

Cross reference A-0185: Documentation of a patient's behavior leading up to the need for a chemical restraint;

Cross reference A-0213: Notification of CMS within 24 hours after a death associated with a chemical restraint;

Cross reference A-0386: The CNO was responsible for the quality of care provided by nursing services;

Cross reference A-0395: 1. Patients seeking emergency psychiatric care receive an RN assessment; 2. Patients receiving chemical restraints were appropriately monitored.

Cross reference A-0405: Medications are only given in compliance with an order;

Cross reference A-1104: A medical screening exam is performed by a qualified medical provider by patients seeking emergency psychiatric care.

The cumulative effect of these systemic deficient practices resulted in the facility's failure to meet the requirement for the Condition of Participation for Governing Body.

Based on a review of medical records and interview, it was determined the Governing Body failed to ensure medical staff was held accountable when:
1. Patients seeking emergency psychiatric medical care did not receive a medical screening exam by a Qualified Medical Professional (QMP);
2. Physicians did not review the results of a one hour face to face evaluation or perform a one hour face to face evaluation after a patient received a chemical restraint on physician order.
This failure poses the risk of a patient suffering poor outcomes, with an increased risk of morbidity and mortality, due to not having an appropriate evaluation by a QMP.

Cross reference: A-0347, A-0092

Findings Include:
1. Hospital document titled "Valley Hospital Medical Staff Bylaws," revealed: "...The responsibilities of the Medical Staff are to account to the Board for the patient care processes and outcomes rendered by all Members, Residents, Interns, and Allied Health Professionals authorized to practice in the Facility through the following means...a procedure for monitoring patient care practices, including intake, assessment...analysis of patient care processes and outcomes...obtain appropriate informed consent...The Governing Body of Valley Hospital, having final authority for the provision of the quality of care of patients, has delegated the authority and responsibility for such provision of high quality care to the medical staff...."

Hospital policy titled "Patient Transfers to Another Facility From Intake," revealed: "...Providing an Emergency Medical Screen 1. All individuals presenting for examination or treatment for an Emergency Medical Condition (EMC) at Valley Hospital will receive a Medical Screening Examination (MSE)...2. The Medical Screening Examination is composed of two parts: a. The Initial Medical Screen, Part 1 is performed by a Qualified Medical Professional (QMP), who is defined by the Medical Staff Bylaws as being an RN or Physician. B. The Medical Screening Examination, Part 2 (Level of Care Assessment) is performed by a Qualified Mental Health Professional (QMHP), who is defined by the Med Staff Bylaws as a RN, Physician or clinicians with a master's degree in counseling or mental health. 3. At the conclusion of the two-part screening examination, a physician is consulted and a determination is made as to whether an Emergency Medical Condition exists...."

Hospital document titled "Valley Hospital Medical Staff Rules and Regulations," revealed: "...Licensed Independent Practitioner/Qualified Medical Provider" is defined as, for the purposes of these Rules and Regulations, any individual permitted by law and by the Hospital, in accordance with limits established by the Governing Board and the Medical Staff, to provide patient care and services at the Hospital without direction or supervision, but with the scope of the individual's license and consistent with individually granted Clinical Privileges, including without limitation the following: (a) Physician's; (b) Nurse Practitioners; (c) Physician's Assistant...."

Hospital document titled "Standardized Intake Assessment," revealed: "...Level of Care Determination: The level of care recommendation was made by the clinician examining the patient and the physician...."

A review of 20 patient medical records from the Intake Department revealed four patients (Patients #25, #26, #27, #28), were not seen or consulted by a physician and had the Level of Care determination of "Outpatient-Referred to Community."

Employee #1 confirmed in an interview on 10/05/2023, that the physician does not have to see the patients that come into the intake department if they do not have a medical issue. Employee #1 also confirmed that the RN or the clinicians staffed in the intake department, none of which are nurse practitioners, physician's assistants, or physicians, are able to determine if the patient can be discharged from the intake department, without consulting with a physician. Employee #1 further confirmed the current hospital policy stated a Qualified Mental Health Provider could determine if an emergency medical condition existed and if a patient was stabilized from an emergency medical condition.

2. Policy titled, "Proper Use and Monitoring of Physical/Chemical Restraints and Seclusion", revealed: " ...V. PROCEDURE: ...5.0 Face to Face Evaluation by the Physician, or trained RN: Within one hour of the initiation of restraint or seclusion, the patient shall be evaluated in person by a physician or trained RN. A telephone call or telemedicine methodology is not allowed for these evaluations ...If the evaluation is conducted by a trained RN, he/she must consult with the attending physician responsible for the patient's care as soon as possible (within 30 minutes) after the evaluation. This consultation should be included a discussion of the finding of the 1-hour evaluation, the need for other interventions or treatments, and the need continue or discontinue the use of restraint/seclusion. The consultation must always be conducted prior to a renewal of the order...."

A review of patient medical charts with restraint/seclusion episodes was conducted on 10/11/2023. Nineteen (19) out of twenty-two (22) restraint episodes reviewed revealed that the physician ordering the restraint did not receive the results of a face to face evaluation or perform the one hour face to face evaluation.

An interview conducted on 10/12/2023, with Provider #2 confirmed that they do not remember receiving a call from a trained register nurse to review the finding of a face to face that was performed on a patient after a restraint/seclusion episode.

Employee #1 and Employee #13 confirmed during a interview on 10/11/2023 that trained registered nurses should consult with the attending physician within 30 minutes of a face to face evaluation.

Based on review of hospital records, and interview, it was determined the Chief Executive Officer (CEO) failed to manage the daily operation of the hospital. This deficient practice poses a risk to the health and safety of patients when leadership does not provide proper guidance, enforcement of policies and procedures and provide resources to provide care to meet the needs of patients.

Findings Include:

Document titled "UHS Job Description," revealed: "...Job Title: CEO - BH...manages the day-to-day operations and actively markets the services of the facility...Required Knowledge, Skills, Licensure, Training & Travel Requirements: Working knowledge of behavioral health management practices and clinical operations. Working knowledge of state and federal regulatory requirements related to behavioral health management...."

Document titled "Valley Hospital Job Description," revealed "...Job Title: Chief Nursing Officer...The CNO functions in an advisory capacity to administration in evaluating proposed procedural changes as they relate to patient care...directs the implementation and ensures compliance with the Standard of Nursing Practice that promotes optimum health care delivery...Supervision Exercised: All nursing staff. Supervision Received: CEO...."

Document titled "Director of Intake Admissions," revealed: "...The Director of Intake is accountable for the oversight and direction of the hospital's Admissions/Intake Department. This position provides direction to a staff of specialists in the provision of patient access to care and behavioral health assessment services, including call management, clinical evaluations for level of care...The Director of Intake reports directly to the hospital's CEO...."

It was determined the CEO failed to manage to manage the day-to-day operations of the hospital as demonstrated by the following:

Cross reference A-0130: Failure to ensure a patient's guardian was involved in the discharge planning;
Cross reference A-0131: Failure to ensure patients receiving psychotropic medications had informed consent;
Cross reference A-0144: Failure to ensure patients safety after receiving a chemical restraint by having appropriate monitoring, so as not to result in the death of a patient;
Cross reference A-0168: Failure to ensure patients have an order before receiving chemical restraints;
Cross reference A-0178: Failure to ensure patients receive a one hour face to face evaluation when requiring the use of restraints;
Cross reference A-0179: Failure to ensure RNs performing face to face evaluations with the use of restraints are trained appropriately;
Cross reference A-0182: Failure to ensure physicians are consulted immediately after the completion of a one hour face to face evaluation when it is performed by a trained RN;
Cross reference A-0185: Failure to ensure documentation of a patient's behavior leading up to the need for a chemical restraint;
Cross reference A-0213: Failure to ensure that there was notification to CMS within 24 hours after a death associated with a chemical restraint;
Cross reference A-0386: Failure to ensure the CNO was responsible for the quality of care provided by nursing services;
Cross reference A-0395: Failure to ensure:
1. patients seeking emergency psychiatric care receive an RN assessment;
2. Patients receiving chemical restraints were appropriately monitored.
Cross reference A-0405: Failure to ensure medications are only given in compliance with an order;
Cross reference A-1104: Failure to ensure a medical screening exam is performed by a qualified medical provider by patients seeking emergency psychiatric care.

Based on a review of medical record and interview, it was determined the hospital failed to ensure patients seeking emergency medical psychiatric care received:
1. A medical screening exam by a qualified medical practitioner (QMP).
2. An assessment performed by an RN.
This failure poses the risk of a licensed staff member working outside their scope of practice, an emergency medical and/or psychiatric condition going undiagnosed, and a patient having an unsafe disposition from the facility if deemed to not have an emergency medical condition by an unqualified staff member.

Cross reference: A-1104, A-0049, A-0395

Findings Include:

Hospital document titled "Valley Hospital Medical Staff Bylaws," revealed: "...The responsibilities of the Medical Staff are to account to the Board for the patient care processes and outcomes rendered by all Members, Residents, Interns, and Allied Health Professionals authorized to practice in the Facility through the following means...a procedure for monitoring patient care practices, including intake, assessment...analysis of patient care processes and outcomes...obtain appropriate informed consent...The Governing Body of Valley Hospital, having final authority for the provision of the quality of care of patients, has delegated the authority and responsibility for such provision of high quality care to the medical staff...."

Hospital policy titled, "Emergency Services and Patient Transfers-EMTALA," revealed: " ...The governing body of Valley Hospital has adopted the following policy in accord with the rules adopted by the Arizona Department of Health Services and The Centers for Medicare and Medicaid (CMS) regarding the provision of emergency services..."Emergent medical condition" means a condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbance, and symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in: a. Placing the health of the individual...in serious jeopardy...When a patient comes to the hospital requesting examination or treatment, the patient must be evaluated by qualified medical personnel (QMP), or a qualified mental health professional (QMHP) as determined by the Hospital in its bylaws...."

Hospital policy titled "Patient Transfers to Another Facility From Intake," revealed: "...Providing an Emergency Medical Screen 1. All individuals presenting for examination or treatment for an Emergency Medical Condition (EMC) at Valley Hospital will receive a Medical Screening Examination (MSE)...2. The Medical Screening Examination is composed of two parts: a. The Initial Medical Screen, Part 1 is performed by a Qualified Medical Professional (QMP), who is defined by the Medical Staff Bylaws as being an RN or Physician. B. The Medical Screening Examination, Part 2 (Level of Care Assessment) is performed by a Qualified Mental Health Professional (QMHP), who is defined by the Med Staff Bylaws as a RN, Physician or clinicians with a master's degree in counseling or mental health. 3. At the conclusion of the two-part screening examination, a physician is consulted and a determination is made as to whether an Emergency Medical Condition exists...."

Hospital document titled "Valley Hospital Medical Staff Rules and Regulations," revealed: "...Licensed Independent Practitioner/Qualified Medical Provider" is defined as, for the purposes of these Rules and Regulations, any individual permitted by law and by the Hospital, in accordance with limits established by the Governing Board and the Medical Staff, to provide patient care and services at the Hospital without direction or supervision, but with the scope of the individual's license and consistent with individually granted Clinical Privileges, including without limitation the following: (a) Physician's; (b) Nurse Practitioners; (c) Physician's Assistant...."

Hospital document titled "Standardized Intake Assessment," revealed: "...Level of Care Determination: The level of care recommendation was made by the clinician examining the patient and the physician...."

A review of 20 patient medical records from the Intake Department revealed four patients (Patients #25, #26, #27, #28), were not seen or consulted by a physician and had the Level of Care determination of "Outpatient-Referred to Community."

A review of 20 medical records from the Intake Department revealed three (Patient #26, #27, and #30) did not have documentation of an RN assessment performed in the Intake Assessment.

Employee #1 confirmed in an interview on 10/05/2023, that the physician does not have to see the patients that come into the intake department if they do not have a medical issue. Employee #1 also confirmed that the RN or the clinicians staffed in the intake department, none of which are nurse practitioners, physician's assistants, or physicians, are able to determine if the patient can be discharged from the intake department, without consulting with a physician. It was also confirmed that three patients did not have nursing assessments performed. Employee #1 further confirmed the current policy of the hospital stated a Qualified Mental Health Provider could determine if an emergency medical condition existed and if a patient was stabilized from an emergency medical condition.

Based on review of hospital records and staff interviews, it was determined that the hospital failed to comply with protecting and promoting each patient's rights as evidenced by:

Cross reference A-0130: Ensure a patient's guardian was involved in the discharge planning;

Cross reference A-0131: Ensured patients receiving psychotropic medications had informed consent;

Cross reference A-0144: Ensure patients safety after receiving a chemical restraint by having appropriate monitoring,
so as not to result in the death of a patient;

Cross reference A-0168: Ensure patients have an order before receiving chemical restraints;

Cross reference A-0178: Ensure patients receive a one hour face to face evaluation when requiring the use of restraints;

Cross reference A-0179: Ensure RNs performing face to face evaluations with the use of restraints are trained appropriately;

Cross reference A-0182: Ensure physicians are consulted immediately after the completion of a one hour face to face evaluation when it is performed by a trained RN;

Cross reference A-0185: Ensure documentation of a patient's behavior leading up to the need for a chemical restraint;

The cumulative effect of these systemic deficient practices resulted in the facility's failure to meet the requirement for the Condition of Participation for Patient Rights and provide a safe environment for patients to protect them from harm.

Based on a review of facility records and interview, it was determined the hospital failed to discuss a discharge plan with the court appointed guardian of an adult patient. This failure poses the risk of a guardian being unaware of the discharge plan, a vulnerable adult being discharged without guardian knowledge, and having an unsafe discharge.

Findings Include:
Policy titled "Discharge Planning," revealed: "...The patient's identified family member's/other will be involved in the discharge planning process whenever the patient is willin. Progress notes will be kept about the attempts to involve the family and any actual meetings or phone conversations which occur...Progress notes will kept regarding the discharge process as it develops and why or why not certain choices are made for/by a patient...Aftercare plans are communicated to the patient and family, as appropriate, and documented on the Aftercare/Discharge Plan Part 2...The patient/guardian will signify understanding of the aftercare plan by signing the Aftercare/Discharge Plan Part 2...."

Patient #23's medical record contained a document dated 03/24/2015, titled "In the [White Mountain Apache] Tribal Court In and for the [Fort Apache] Indian Reservation," which revealed: "...In the matter of the guardianship of: (Patient #23)...continuing guardianship is required to further the care of the above named adult...(Patient #23) shall permanently be made a ward of the Court committed to [White Mountain Apache] Tribal Social Services to monitor the care and custody...."

Patient #23's medical record contained a note titled "Admission Narrative Summary," dated 01/23/2023, which revealed: "...[She] reports having a guardian. The guardian is [Eleen King, phone number]...."

Patient #23's medical record contained a note titled "Progress Note," dated 02/02/2023, which revealed: "...Writer met with (Patient #23) and began coordinating [her] discharge with [her Apache] Behavioral Health team and [her] guardian. Initially they wanted to transfer [her] to another state hospital. After I was informed that they did not have the ability to transfer [her] to another state hospital. {sic} I began reaching out to BHRF's to see who could possibly take (Patient #23) and was informed by [P&M Healing House] that they could take [her] on 2/3...."

Patient #23's medical record contained a note titled "Aftercare/Discharge Plan Part 2," dated 02/03/2023, which revealed: "...Family Involvement: Was family meeting held? Yes...." The spaces for date, time, and participants of the family meeting was blank. The Discharge Plan was signed by Patient #23 and the Parent/Guardian Signature was unsigned.

Employee #5 confirmed in an interview conducted on 10/05/2023, that there were no progress notes made by the discharge planner that the plans for discharge were discussed with Patient #23's guardian. It was also confirmed that Patient #23 signed the discharge plan, and the guardian did not. Employee #5 confirmed that when a patient has a guardianship in place, the guardian needs to sign discharge paperwork as well, indicating they are aware of the plan.

Based on a review of hospital records and interview, it was determined the hospital did not receive informed consent from two (2) patients before administering psychotherapeutic medications. This failure poses the risk of patients receiving psychotropic medications without understanding the risks, benefits, and effects the medications may have.

Findings Include:
Policy titled "Informed Consent," revealed: "...All patients who are to be treated with psychotherapeutic medications shall be given medication informed consent for such treatment...No medication as defined in this policy shall be administered without presence of a signed consent form except in the case of an emergency...Any member of the nursing staff administering such a medication in the absence of the required consent, except in the case of an emergency, shall be subject to disciplinary action...Upon reviewing the benefits, risks, and associated side effects the physician shall obtain and complete the required consent upon an order for: a. Antipsychotic(s) b. Antidepressant(s) c. Benzodiazepines/Anti-Anxiety d. Clozaril (Clozapine) e. Mood Stabilizers f. Psychostimulants...."

A review of Patient #22's medical record dated 12/04/2022 through 12/09/2022, revealed s/he received olanzapine for the "...Indication: voices...", hydroxyzine for the "...indication: anxiety/agitation..." and sertraline for the "...indication: Depression...." Patient #22's medical record did not contain a consent form for psychotherapeutic medications.

Patient #23's medical record contained a note titled "Discharge Summary," dated 02/03/2023, which revealed: "...Patient was restarted on [her] medications...." The medical record also revealed Patient #23 received olanzapine and fluoxetine. Patient #23's medical record contained documentation of a guardian. There was no consent form for psychotherapeutic medications in Patient #23's medical record.

Employee #6 confirmed during an interview on 10/05/2023, that Patient #22 and #23 both received psychotherapeutic medications and had no consent form for these medications in the medical record, as required by policy and procedure.

Employee #1 confirmed during an interview on 10/05/2023 that Patient #22 and Patient #23 did not have consent forms for psychotherapeutic medications in the medical record.

Based on a review of hospital record and interview, it was determined the hospital failed to follow policy and procedure and appropriately monitor a patient who received a chemical restraint and was later found unresponsive and declared dead. This failure poses the risk of injury or death to the patient.

Findings Include:

Policy titled "Proper Use and Monitoring of Physical/Chemical Restraints and Seclusion," revealed: "...The patient's rights, dignity, privacy, safety, and well-being will be supported and maintained...Patients in restraints/seclusion will be closely monitored and evaluated and immediately assisted if a potentially dangerous situation exists, i.e. choking, seizure, etc...Chemical (Medication) Restraint: The administration of a medication for the purpose of controlling an acute episodic behavior, with the intent to restrict the patient's functioning or movement and/or to bring about sedation...Documents the alternatives attempted or the rationale for not using alternatives as well as the patient's response to those measures...The physician's order for use of restraint or seclusion will be recorded in the medical record and include the following...Reason for using restraint/seclusion, including specific behaviors and safety issues...Within one hour of the initiation of restraint or seclusion, the patient shall be evaluated in person by a physician or trained RN...The evaluation will be documented in the medical record to include the following: 5.1 The date and time of the evaluation 5.2 An assessment of the patient's immediate situation 5.3 An evaluation of the patient's reaction to the intervention 5.4 An assessment of the patient's medical and behavioral condition, to include a complete review of systems assessment...If the evaluation is conducted by a trained RN, he/she must consult with the attending physician responsible for the patient's care as soon as possible (within 30 minutes) after the evaluation...The use of restraint/seclusion will be thoroughly documented in the patient's medical record. Documentation related to restraint/seclusion includes: The initial in-person and subsequent evaluations of the patient...Continuous monitoring of patient and care provided...."

Review of CMS report revealed: "...Patient had been sleeping in his assigned bed since September 28, 2023 at 0012. Q15 patient observations were consistently performed. Patient was found unresponsive by Behavioral Health Technician (BHT) at 0335. BHT asked for a peer to take a second look at 0404. After both BHT assessed, they asked a RN to assess at 0405. RN active emergency response by asking BHT's to announce a Code Blue. A Code Blue was called at 0407 by BHT through radio. Resuscitative attempt was initiated by administering external cardiac massage following the American Heart Association algorithm by the unit RN at 0405. The Crash Cart was brought to the room at 0407 and Valley Code responders followed. Bag mask valve ventilation at 0409 and an AED was applied at 0410. No shockable rhythms were detected during the duration of the code; analyzed 3 times. Narcan was administered at 0415 with no response noted. Emergency services were contacted 0411. Fire department arrived at 0416, assessed patient, and obtained patient history, and last known patient's sensorium activity and response. An advanced airway, Laryngeal Mask Airway (LMA) and a right tibia Intraosseous (IO) was insert by EMS. EMS took over resuscitative efforts at 0416 which lasted approximately 19 minutes. EMS notified nursing time of deceased at 0435...."

A review of Patient #24's medical record was conducted on 10/05/2023, which revealed the following entries:

Review of the medical record revealed the following Daily Nurse Progress Note entries:
09/27/2023 at 1800: "... (Patient #24) is pleasant and cooperative. A&Ox4. Able to make [his] needs known. Visible in the milieu and social with staff and peers. Denies SI, HI and auditory/visual hallucinations. Denies any depression or anxiety this shift. Compliant with his medications...Denies any changes or concerns this shift...(Patient #24) denies any medical concerns this shift ...."

09/28/2023 at 0405: "...The BHT staff notified the writer of patient (Patient #24's) unusual presentation in [his] bed during their Q15 rounding. The writer immediately proceed {sic} to the Patient's room. The writer turned on the lights and visualized the patient laying on [his] right side presenting with noticeable edema throughout the face, hands, and legs. Further the pt appeared to be cyanotic specifically in the lips and fingertips. 0407: The writer instructed the BHT staff to initiate a code blue and alert Emergency Services that emergent medical assistance was needed. The writer at that time initiated chest compressions...Oxygen was administered to the patient and the AED was applied to the patient's chest. Chest compression continued...0418: EMS arrived on scene and took over chest compressions. 0435: EMS notified the writer that time of death had been called for 0435 and attempts to resuscitate the patient had ended...."

Review of Medication Administration Record (MAR) revealed 10 mg of Haldol, 50 mg of Benadryl, and 2 mg Ativan were documented as being given intramuscularly at 22:50 on 09/27/2023.

Further review of the Daily Nurse Progress Note revealed no evidence of documentation between the note written at 1800 to 0405.

The medical record was reviewed on 10/05/2023, with Employee #1. Employee #1 confirmed that Patient #24 was acting out the night of 09/27/2023, and was moved to a different unit and received a chemical restraint on the new unit, but there was no documentation of these events. Employee #1 confirmed there was no seclusion or restraint packet, with orders in the medical record, a face to face evaluation one hour after the restraint, nor was there a note or assessment performed on Patient #24 after the day shift left. Employee #1 confirmed there was no documentation in the medical record about the events that happened between 1800 and 0405, or of behavior indicating a need to be moved to another unit or the need for a chemical restraint. Employee #1 confirmed Patient #24 was discovered unresponsive at 0405 and pronounced dead at the hospital by EMS on 9/28/2023.

Approximately two hours after the medical record review with Employee #1, a nursing note dated 09/27/2023, timed 2130, was provided by Employee #1 which described the events leading to the unit change for Patient #24. Employee #1 then confirmed the "note was just found on the unit."

A document titled "Seclusion/Personal Restraint (Physical Hold) Packet," was provided on 10/06/2023, dated 09/27/2023, by Employee #22, with orders signed by Provider #5 on 10/06/2023.

Employee #22 confirmed in an interview on 10/12/2023, that the seclusion and restraint packet was filled out as a late entry, when it was signed by the provider.

Based on a review of policies and procedures, medical records and interview, it was determined the Hospital allowed patients to be placed in restraints without a physician order in place for the chemical restraint. This deficient practice poses a risk to the health and safety of patients if patients are chemically restrained unnecessarily.

Findings Include:

Policy titled "Proper Use and Monitoring of Physical/Chemical Restraints and Seclusion", revealed: " ....IV. DEFINITIONS: ...Chemical (Medication)Restraint: The administration of a medication for the purpose of controlling an acute episodic behavior, with the intent to restrict the patient's functioning or movement and/or to bring about sedation. Medication/chemical restraint occurs when a patient is given a medication or combination of medications to control the patient's acute episodic behavior or restrict the patient's freedom of movement and/or which is not the standard treatment or dosage prescribed for the patient's condition. Whether an order for medication is ONE TIME, PRN or STAT does not determine whether the use of that medication is considered a restraint; if the specific purpose of administering that medication, at that dose, via that route, and at that time, is to impact acute episodic behavior it qualifies as a chemical restraint ...V. PROCEDURE: ...3.0 Physician Orders, Consultation, and Evaluation 3.1 Restraint or seclusion shall be used in emergency situation only and requires an order from a physician ...3.1.2 In the absence of a physician, the registered nurse may authorized the initiation of restraint or seclusion in an emergency. Medication orders must be provided by the physician ...."

Policy titled "Medication Administration", revealed: " ....III. PROCEDURE: Labeling and Dispensing: 1. All mediation are to be dispensed by a licensed Pharmacist when ordered by a licensed independent practitioner with privileges to do so at Valley Hospital ...."

Document titled, "Valley Hospital Medical Staff Rules and Regulations, revealed: " ....5.4 Member Orders ...5.4.4 Only Physicians, Nurse Practitioners and Pas with privileges may write orders for: ...5.4.4.3 Medication ...."

Nineteen (19) patient charts were reviewed with a total of twenty-four (24) restraints episodes, fourteen (14) restraints episodes did not have chemical restraint orders.

Employee #1 and Employee #13 confirmed during an interview conducted on 10/11/2023 that a physician order is required to place a patient in a chemical restraint.

Based on review of hospital policies/procedures and staff interviews, it was determined that the Hospital failed to ensure that trained registered nurses perform one-hour face to face patient evaluations after a restraint or seclusion. This deficient practice poses a risk to the health and safety of patients, when a registered nurse is not trained proper in evaluating the patient reaction to the restraint or seclusion.

Findings Include:

Policy titled, "Proper Use and Monitoring of Physical/Chemical Restraints and Seclusion", revealed: " ...V. PROCEDURE: ...14.0 Staff Training and Competence Assessment: Medical staff, direct care staff, and RNs are oriented to the standards for the use of restraint/seclusion. Direct care staff and Pas are required to attend a nationally recognized physical/aggression management training program and show evidence of competency related to participating in a code situation, application of restraints, or the monitoring, assessment and care of a patient in restraints or seclusion ...Nurses and PAs authorized to conduct the 1-hour face-to-face evaluation will receive additional training and demonstrate competency to conduct both a physical and behavioral assessment of the patient. All records documenting completion of training and competency demonstration will be maintained in staff personnel files or credentials files ...14.3 Training requirements for Registered Nurses: A registered nurse, in the absence of a physician is authorized to initiate restraint or seclusion use and perform evaluations/reevaluations of individuals who are in restraint/seclusion to assess their readiness for discontinuation or establish the need to secure a new order ...14.4 Training Requirement for RNs conducting one hour evaluation: As allowed by CMS, Joint Commission, and state regulations, RNs who have received training and demonstrate competency in this requirement may conduct the one hour evaluation. Training will include: ...14.4.2 Evaluation of the patient's immediate situation. 14.4.3 Evaluation of the patient's reaction to the intervention. 14.4.4 Assessment of the patient's medical and behavioral condition 14.4.5 Assessing the need to continue or terminate the restraint/seclusion ...."

During an employee record review on 10/11/2023 it was revealed the two (2) out of four (4) registered nurses (Employee #23 and Employee #26) did not have the additional face to face training.

A review of seven (7) seclusion and restraint packets, revealed two (2) of the patients had a face to face evaluation performed by Employee #23, and one (1) was performed by Employee #26.

Employee #1 and Employee #13 confirmed during an employee record review that Employee #23 and Employee #26 did not have the training required to perform face to face evaluations, but were currently doing them.

Based on review of hospital policies/procedures and staff interviews, it was determined that the Hospital failed to ensure that patients that were placed in restraint/seclusions had a face to face examination by a physician or trained RN. This deficient practice poses a risk to the health and safety of patients when changes in medical or psychological condition of the patients are not assessed.

Findings Include:

Policy titled "Proper Use and Monitoring of Physical/Chemical Restraints and Seclusion", revealed: " ...PROCEDURE: ...5.0 Face to Face Evaluation by the Physician, or trained RN: Within one hour of the initiation of restraint or seclusion, the patient shall be evaluated in person by a physician, or trained RN. A telephone call or telemedicine methodology is not allowed for these evaluations. The evaluation will be documented in the medial record to include the following: 5.1 The date and time of the evaluation 5.2 An assessment of the patient's immediate situation 5.3 An evaluation of the patient's reaction to the intervention 5.4 An assessment of the patient's medical and behavioral condition, to include a complete review of systems assessment, behavioral assessment as well as a review of assessment of the patient's history, drugs and medications, most recent labs work, etc. 5.5 An assessment of the need to continue or terminate the restraint/seclusion. At the time of the in-person evaluation, the individual conducting the evaluation work with the patient and staff to identify ways to help the patient regain control, make necessary revisions to the patient's treatment plan, and if necessary, provide a new order. If the evaluation is conducted by a trained RN, he/she must consult with the attending physician responsible for the patient's care as soon as possible (within 30 minutes) after the evaluation. This consultation should include a discussion of the findings of the 1-hour evaluation, the need for other interventions or treatments, and the need continue or discontinue the use of restraint/seclusion. The consultation must always be conducted prior to a renewal of the order...."

A review of medical charts of patients who were placed in restraint/seclusion was conducted on 10/11/2023. Fifteen (15) out of twenty-seven (27) medical charts that were reviewed, revealed no documentation of a face to face evaluation being performed in person by a physician or a trained registered nurse within one hour of the initiation of a restraint/seclusion episode.

Employee #1 and Employee#13 confirmed during an interview on 10/11/2023 that a face to face evaluation should be performed by a medical provider or trained RN for patients that are placed in restraints/seclusions.

Based on review of hospital policies/procedures and staff interviews, it was determined that the Hospital failed to ensure that trained registered nurses, who conducted the face to face evaluation after a restraint/seclusion episode, consulted with the attending physician as soon as possible. This deficient practice poses a risk to the health and safety of patients, when the attending physician is not notified of the patient's medical and behavioral condition after the restraint and/or seclusion episode.

Cross reference A-0347

Findings Include:

Policy titled, "Proper Use and Monitoring of Physical/Chemical Restraints and Seclusion", revealed: " ...V. PROCEDURE: ...5.0 Face to Face Evaluation by the Physician, or trained RN: Within one hour of the initiation of restraint or seclusion, the patient shall be evaluated in person by a physician or trained RN. A telephone call or telemedicine methodology is not allowed for these evaluations ...If the evaluation is conducted by a trained RN, he/she must consult with the attending physician responsible for the patient's care as soon as possible (within 30 minutes) after the evaluation. This consultation should be included a discussion of the finding of the 1-hour evaluation, the need for other interventions or treatments, and the need continue or discontinue the use of restraint/seclusion. The consultation must always be conducted prior to a renewal of the order ...."

A review of patient medical charts with restraint/seclusion episodes was conducted on 10/11/2023. Nineteen (19) out of twenty-two (22) restraint episodes reviewed revealed that the physician ordering the restraint did not receive the results of a face to face evaluation.

An interview was conducted on 10/12/2023 with Provider #2 confirmed that they do not remember receiving a call from a trained register nurse to review the finding of a face to face that was performed on a patient after a restraint/seclusion episode.

Employee #1 and Employee #13 confirmed during a interview on 10/11/2023 that trained registered nurses should consult with the attending physician within 30 minutes of a face to face evaluation.

Based on a review of hospital record and interview, it was determined the hospital failed to ensure that a patient's behavior leading up to the use of a chemical restraint was documented. This failure poses the risk of a patient receiving unnecessary restraints and an inability to track and evaluate the appropriate use of chemical restraints within the facility.

Findings Include:
Policy titled "Proper Use and Monitoring of Physical/Chemical Restraints and Seclusion," revealed: "...The patient's rights, dignity, privacy, safety, and well-being will be supported and maintained...Patients in restraints/seclusion will be closely monitored and evaluated and immediately assisted if a potentially dangerous situation exists, i.e. choking, seizure, etc...Chemical (Medication) Restraint: The administration of a medication for the purpose of controlling an acute episodic behavior, with the intent to restrict the patient's functioning or movement and/or to bring about sedation...Documents the alternatives attempted or the rationale for not using alternatives as well as the patient's response to those measures...The physician's order for use of restraint or seclusion will be recorded in the medical record and include the following...Reason for using restraint/seclusion, including specific behaviors and safety issues...Within one hour of the initiation of restraint or seclusion, the patient shall be evaluated in person by a physician or trained RN...The evaluation will be documented in the medical record to include the following: 5.1 The date and time of the evaluation 5.2 An assessment of the patient's immediate situation 5.3 An evaluation of the patient's reaction to the intervention 5.4 An assessment of the patient's medical and behavioral condition, to include a complete review of systems assessment...If the evaluation is conducted by a trained RN, he/she must consult with the attending physician responsible for the patient's care as soon as possible (within 30 minutes) after the evaluation...The use of restraint/seclusion will be thoroughly documented in the patient's medical record. Documentation related to restraint/seclusion includes: The initial in-person and subsequent evaluations of the patient...Continuous monitoring of patient and care provided...."

A review of Patient #24's medical record was conducted on 10/05/2023, which revealed the following entries:

Review of the medical record revealed the following Daily Nurse Progress Note entries:
09/27/2023 at 1800: "... (Patient #24) is pleasant and cooperative. A&Ox4. Able to make [his] needs known. Visible in the milieu and social with staff and peers. Denies SI, HI and auditory/visual hallucinations. Denies any depression or anxiety this shift. Compliant with his medications...Denies any changes or concerns this shift...(Patient #24) denies any medical concerns this shift ...."
09/28/2023 at 0405: "...The BHT staff notified the writer of patient (Patient #24's) unusual presentation in [his] bed during their Q15 rounding. The writer immediately proceed {sic} to the Patient's room. The writer turned on the lights and visualized the patient laying on [his] right side presenting with noticeable edema throughout the face, hands, and legs. Further the pt appeared to be cyanotic specifically in the lips and fingertips. 0407: The writer instructed the BHT staff to initiate a code blue and alert Emergency Services that emergent medical assistance was needed. The writer at that time initiated chest compressions...Oxygen was administered to the patient and the AED was applied to the patient's chest. Chest compression continued...0418: EMS arrived on scene and took over chest compressions. 0435: EMS notified the writer that time of death had been called for 0435 and attempts to resuscitate the patient had ended...."

Review of Medication Administration Record (MAR) revealed 10 mg of Haldol, 50 mg of Benadryl, and 2 mg Ativan were documented as being given intramuscularly at 22:50 on 09/27/2023.

Further review of the Daily Nurse Progress Note revealed no evidence of documentation between the note written at 1800 to 0405.

The medical record was reviewed on 10/05/2023, with Employee #1. Employee #1 confirmed that Patient #24 was acting out the night of 09/27/2023, and was moved to a different unit and received a chemical restraint on the new unit, but there was no documentation of these events. Employee #1 confirmed there was no seclusion or restraint packet, with orders in the medical record, a face to face evaluation one hour after the restraint, nor was there a note or assessment performed on Patient #24 after the day shift left. Employee #1 confirmed there was no documentation in the medical record about the events that happened between 1800 and 0405, or of behavior indicating a need to be moved to another unit or the need for a chemical restraint. Employee #1 confirmed Patient #24 was discovered unresponsive at 0405 and pronounced dead at the hospital by EMS on 9/28/2023.

Approximately two hours after the medical record review with Employee #1, a nursing note dated 09/27/2023, timed 2130, was provided by Employee #1 which described the events leading to the unit change for Patient #24.
Employee #1 then confirmed the "note was just found on the unit."

A document titled "Seclusion/Personal Restraint (Physical Hold) Packet," was provided on 10/06/2023, dated 09/27/2023, by Employee #22, with orders signed by Provider #5 on 10/06/2023.

Employee #22 confirmed in an interview on 10/12/2023, that the seclusion and restraint packet was filled out as a late entry, when it was signed by the provider.

Based on a review of hospital record, it was determined the hospital failed to report a death associated with a chemical restraint within 24 hours. This failure poses the risk of an incomplete evaluation as to contributory factors in the death due to passage of time.

Hospital policy titled "Proper Use and Monitoring of Physical/Chemical Restraints and Seclusion," revealed: "...Notification of CMS and Corporate Risk Management: The hospital must report to CMS, and Corporate Risk Management...Any death that occurs within 24 hours after the patient has been removed from restraint or seclusion...The report to CMS should be made by the next business day following knowledge of the patient's death...."

Hospital document titled "CMS Report of a Hospital Death Associated With the Use of Restraint or Seclusion," revealed: "...Patient Death Details...Date of Death 09/28/2023 Time of Death 0435...The staff must document in the patient's medical record the date and time the death was reported to CMS for deaths described in 42 CFR 482.13(g)(1)...Date 10/02/2023 Time 1030...."

A review of Patient #24's medical record revealed no documentation of CMS notification time.

Based on a review of medical records and interview, it was determined the hospital failed to ensure medical staff was held accountable when:
1. Patients seeking emergency psychiatric medical care did not receive a medical screening exam by a Qualified Medical Professional (QMP);
2. Physicians did not review the results of a one hour face to face evaluation when it was performed by a trained RN, after a patient received a chemical restraint on physician order.
This failure poses the risk of a patient suffering poor outcomes, with an increased risk of morbidity and mortality, due to not having an appropriate evaluation by a QMP.

Cross reference A-0049, A-0182

Findings Include:
1. Hospital document titled "Valley Hospital Medical Staff Bylaws," revealed: "...The responsibilities of the Medical Staff are to account to the Board for the patient care processes and outcomes rendered by all Members, Residents, Interns, and Allied Health Professionals authorized to practice in the Facility through the following means...a procedure for monitoring patient care practices, including intake, assessment...analysis of patient care processes and outcomes...obtain appropriate informed consent...The Governing Body of Valley Hospital, having final authority for the provision of the quality of care of patients, has delegated the authority and responsibility for such provision of high quality care to the medical staff...."

Hospital policy titled "Patient Transfers to Another Facility From Intake," revealed: "...Providing an Emergency Medical Screen 1. All individuals presenting for examination or treatment for an Emergency Medical Condition (EMC) at Valley Hospital will receive a Medical Screening Examination (MSE)...2. The Medical Screening Examination is composed of two parts: a. The Initial Medical Screen, Part 1 is performed by a Qualified Medical Professional (QMP), who is defined by the Medical Staff Bylaws as being an RN or Physician. B. The Medical Screening Examination, Part 2 (Level of Care Assessment) is performed by a Qualified Mental Health Professional (QMHP), who is defined by the Med Staff Bylaws as a RN, Physician or clinicians with a master's degree in counseling or mental health. 3. At the conclusion of the two-part screening examination, a physician is consulted and a determination is made as to whether an Emergency Medical Condition exists...."

Hospital document titled "Valley Hospital Medical Staff Rules and Regulations," revealed: "...Licensed Independent Practitioner/Qualified Medical Provider" is defined as, for the purposes of these Rules and Regulations, any individual permitted by law and by the Hospital, in accordance with limits established by the Governing Board and the Medical Staff, to provide patient care and services at the Hospital without direction or supervision, but with the scope of the individual's license and consistent with individually granted Clinical Privileges, including without limitation the following: (a) Physician's; (b) Nurse Practitioners; (c) Physician's Assistant...."

Hospital document titled "Standardized Intake Assessment," revealed: "...Level of Care Determination: The level of care recommendation was made by the clinician examining the patient and the physician...."
A review of 20 patient medical records from the Intake Department revealed four patients (Patients #25, #26, #27, #28), were not seen or consulted by a physician and had the Level of Care determination of "Outpatient-Referred to Community."

Employee #1 confirmed in an interview on 10/05/2023, that the physician does not have to see the patients that come into the intake department if they do not have a medical issue. Employee #1 also confirmed that the RN or the clinicians staffed in the intake department, none of which are nurse practitioners, physician's assistants, or physicians, are able to determine if the patient can be discharged from the intake department, without consulting with a physician. Employee #1 further confirmed the current policy of the hospital stated a Qualified Mental Health Provider could determine if an emergency medical condition existed and if a patient was stabilized from an emergency medical condition.

2. Policy titled, "Proper Use and Monitoring of Physical/Chemical Restraints and Seclusion", revealed: " ...V. PROCEDURE: ...5.0 Face to Face Evaluation by the Physician, or trained RN: Within one hour of the initiation of restraint or seclusion, the patient shall be evaluated in person by a physician or trained RN. A telephone call or telemedicine methodology is not allowed for these evaluations ...If the evaluation is conducted by a trained RN, he/she must consult with the attending physician responsible for the patient's care as soon as possible (within 30 minutes) after the evaluation. This consultation should be included a discussion of the finding of the 1-hour evaluation, the need for other interventions or treatments, and the need continue or discontinue the use of restraint/seclusion. The consultation must always be conducted prior to a renewal of the order ...."

A review of patient medical charts with restraint/seclusion episodes was conducted on 10/11/2023. Nineteen (19) out of twenty-two (22) restraint episodes reviewed revealed that the physician ordering the restraint did not receive the results of a face to face evaluation or perform the one hour face to face evaluation.

An interview conducted on 10/12/2023, with Provider #2 confirmed that they do not remember receiving a call from a trained register nurse to review the finding of a face to face that was performed on a patient after a restraint/seclusion episode.

Employee #1 and Employee #13 confirmed during a interview on 10/11/2023 that trained registered nurses should consult with the attending physician within 30 minutes of a face to face evaluation.

Based on review of hospital records and staff interviews, it was determined the hospital failed to provide organized nursing services 24-hours per day to assess the individual needs of each patient and deliver and supervise the care required in accordance with physician orders, policies and procedures and nursing standards of care as evidenced by:

Cross reference A-0168: Physician orders were not received to place a patient in chemical restraints.

Cross reference A-0179: RNs performing face to face evaluations did not have the required training;

Cross reference A-0179: Patients failed to receive a face to face evaluation by a physician or trained RN;

Cross reference A-0182: Physicians were not notified of a face to face evaluation when a patient received a chemical restraint;

Cross reference A-0185: There was no documentation of a patient's behavior to indicate a chemical restraint was needed;

Cross reference A-0386: Ensure the CNO was responsible for the quality of care provided by nursing services;

Cross reference A-0395: 1. Ensure patients seeking emergency psychiatric care receive an RN assessment; 2. Patients receiving chemical restraints were appropriately monitored.

Cross reference A-0405: Ensure medications are only given in compliance with an order;

The cumulative effect of these systemic deficient practices resulted in the facility's failure to meet the requirement for Condition of Participation in Nursing Services.

Based on the review of policies and procedures, hospital documents, medical records, observations, and staff interviews, it was determined the Chief Nursing Officer failed to manage the overall operations of the nursing services of the facility. This deficient practice poses a potential risk to the health and safety of patients if a lack of continuous nursing supervision in the provision of quality patient care to meet the needs of patients is provided in a timely manner, ensuring staffing was adequate to address the needs of the patient population, and establishing of policies and procedures for nursing staff adherence and proper surveillance of its implementation to preserve, maintain, and support the patient's physical and mental well-being.

Finding Include:

Policy titled, "Role of the Nurse Executive", revealed: " ...The Chief Nursing Officer is responsible for the development, organization and management of all nursing activities ...Patient care standards and Nursing Practice/Professional Standards are established and implemented with the continuous guidance and scrutinized approval of the Chief Nursing Officer as a mechanism for operationalizing authority in the planning, direction and evaluation of Nursing Services activities. The Chief Nursing Officer collaborates with other leadership on all matters relevant to the delivery of quality patient care and continually assesses utilization of the collaborative process among all clinical staff at all levels and other disciplines/departments to ensure organized, comprehensive, efficient, and effective patient care. The Nurse Executive maintains the following areas of responsibility: TO NURSING STAFF ...2. Guides formulation and implementation of nursing policies and procedures which facilitate efficient and effective patient care ...4. Guides development, implementation and evaluation of programs for continued education and professional growth of nursing staff members. 5. Directs Performance Improvement activities to include the analysis of data, action steps and estimated timeframes for completion. 6. Guides development, implementation, and evaluation of programs for continued education and professional growth of nursing staff members ...10. Collaborates with the Intake Department to provide clinical advisement regarding the assignment of admissions with consideration ...11. Plans for delivery of nursing care, evaluation of patient care, improvement in the health-care delivery systems, and staffing/scheduling of personnel to meet patient needs ...."

Hospital document titled, "Chief Nursing Officer, Job Description", revealed: " ...JOB DESCRIPTION: The CNO develops department guidelines ...This position directs the implementation and ensures compliance with the Standard of Nursing Practice that promotes optimum health care delivery. This position will oversee the activities of infection control and staff education ...PRIMARY CRITERIA/RESPONSIBILITIES: ...5. Plans, delivers and monitors quality nursing care services. 6. Assesses the quality of care rendered by the nursing department through quality assurance monitoring ...15. Assures compliance with all standards and policies of the Facility ...22. Develops, implements and evaluates education programs designed to meet the competency needs of nursing and clinical staff ...37. Assumes responsibility for professional development and ongoing education ...."

During the survey it was determined the Chief Nursing Officer failed to perform the core functions of the position as demonstrated by the following:

A-0092 The hospital failed to ensure patients seeking emergency medical psychiatric are received:
1. A medical screening exam by a qualified medical practitioner (QMP)
2. An assessment performed by a registered nurse (RN)

A-0130 The hospital failed to discuss a discharge plan with the court appointed guardian of an adult patient.

A-0131 The hospital failed to ensure informed consent was obtained from patients before administering psychotherapeutic medications.

A-0168 The hospital failed to ensure that orders for a chemical restraint were order by a physician.

A-0178 The hospital failed to ensure that trained registered nurses perform one-hour face to face evaluation after a restraint or seclusion.

A-0179 The hospital failed to ensure that patient that were placed in restraint/seclusions had a face to face examination by a physician or trained RN.

A-0182 The hospital failed to ensure that trained registered nurses, who conducted the face to face evaluation after a restraint/seclusion episode, consulted with the attending physician as soon as possible.

A-0185 The hospital failed to ensure that a patient's behavior leading up to the use of chemical restraint was documents.

A-0395 The hospital failed to ensure that patients presenting to the Intake Department for evaluation received an assessment performed by a registered nurse (RN).

A-0405 The hospital failed to ensure that medications were administered to patients in compliance with a physician's order.

Employee #1 confirmed on 10/11/2023 the CNO was responsible for the operation of nursing services.

Based on a review of hospital records and interview, it was determined the hospital failed to ensure

1. Patients presenting to the Intake Department for evaluation received an assessment performed by a registered nurse (RN).
2. A patient receiving a chemical restraint was monitored appropriately.

This failure poses the risk of patients not receiving an assessment to determine clinical condition, leading to injury or death.

Cross reference A-0092

Findings Include:

1. Hospital policy titled "Patient Transfers to Another Facility From Intake," revealed: "...Providing an Emergency Medical Screen 1. All individuals presenting for examination or treatment for an Emergency Medical Condition (EMC) at Valley Hospital will receive a Medical Screening Examination (MSE)...2. The Medical Screening Examination is composed of two parts: a. The Initial Medical Screen, Part 1 is performed by a Qualified Medical Professional (QMP), who is defined by the Medical Staff Bylaws as being an RN or Physician. B. The Medical Screening Examination, Part 2 (Level of Care Assessment) is performed by a Qualified Mental Health Professional (QMHP), who is defined by the Med Staff Bylaws as a RN, Physician or clinicians with a master's degree in counseling or mental health...."

A review of 20 medical records from the Intake Department revealed four patients (Patient #26, #27, #29, and #30) did not have documentation of an RN assessment performed in the Intake Assessment.

Employee #1 confirmed in an interview conducted on 10/05/2023, there was no RN assessment documented in these medical records.

2. Policy titled "Proper Use and Monitoring of Physical/Chemical Restraints and Seclusion," revealed: "...The patient's rights, dignity, privacy, safety, and well-being will be supported and maintained...Patients in restraints/seclusion will be closely monitored and evaluated and immediately assisted if a potentially dangerous situation exists, i.e. choking, seizure, etc...Chemical (Medication) Restraint: The administration of a medication for the purpose of controlling an acute episodic behavior, with the intent to restrict the patient's functioning or movement and/or to bring about sedation...Documents the alternatives attempted or the rationale for not using alternatives as well as the patient's response to those measures...The physician's order for use of restraint or seclusion will be recorded in the medical record and include the following...Reason for using restraint/seclusion, including specific behaviors and safety issues...Within one hour of the initiation of restraint or seclusion, the patient shall be evaluated in person by a physician or trained RN...The evaluation will be documented in the medical record to include the following: 5.1 The date and time of the evaluation 5.2 An assessment of the patient's immediate situation 5.3 An evaluation of the patient's reaction to the intervention 5.4 An assessment of the patient's medical and behavioral condition, to include a complete review of systems assessment...If the evaluation is conducted by a trained RN, he/she must consult with the attending physician responsible for the patient's care as soon as possible (within 30 minutes) after the evaluation...The use of restraint/seclusion will be thoroughly documented in the patient's medical record. Documentation related to restraint/seclusion includes: The initial in-person and subsequent evaluations of the patient...Continuous monitoring of patient and care provided...."

Review of CMS report revealed: "...Patient had been sleeping in his assigned bed since September 28, 2023 at 0012. Q15 patient observations were consistently performed. Patient was found unresponsive by Behavioral Health Technician (BHT) at 0335. BHT asked for a peer to take a second look at 0404. After both BHT assessed, they asked a RN to assess at 0405. RN active emergency response by asking BHT's to announce a Code Blue. A Code Blue was called at 0407 by BHT through radio. Resuscitative attempt was initiated by administering external cardiac massage following the American Heart Association algorithm by the unit RN at 0405. The Crash Cart was brought to the room at 0407 and Valley Code responders followed. Bag mask valve ventilation at 0409 and an AED was applied at 0410. No shockable rhythms were detected during the duration of the code; analyzed 3 times. Narcan was administered at 0415 with no response noted. Emergency services were contacted 0411. Fire department arrived at 0416, assessed patient, and obtained patient history, and last known patient's sensorium activity and response. An advanced airway, Laryngeal Mask Airway (LMA) and a right tibia Intraosseous (IO) was insert by EMS. EMS took over resuscitative efforts at 0416 which lasted approximately 19 minutes. EMS notified nursing time of deceased at 0435...."

A review of Patient #24's medical record was conducted on 10/05/2023, which revealed the following entries:
Review of the medical record revealed the following Daily Nurse Progress Note entries:
09/27/2023 at 1800: "... (Patient #24) is pleasant and cooperative. A&Ox4. Able to make [his] needs known. Visible in the milieu and social with staff and peers. Denies SI, HI and auditory/visual hallucinations. Denies any depression or anxiety this shift. Compliant with his medications...Denies any changes or concerns this shift...(Patient #24) denies any medical concerns this shift ...."
09/28/2023 at 0405: "...The BHT staff notified the writer of patient (Patient #24's) unusual presentation in [his] bed during their Q15 rounding. The writer immediately proceed {sic} to the Patient's room. The writer turned on the lights and visualized the patient laying on [his] right side presenting with noticeable edema throughout the face, hands, and legs. Further the pt appeared to be cyanotic specifically in the lips and fingertips. 0407: The writer instructed the BHT staff to initiate a code blue and alert Emergency Services that emergent medical assistance was needed. The writer at that time initiated chest compressions...Oxygen was administered to the patient and the AED was applied to the patient's chest. Chest compression continued...0418: EMS arrived on scene and took over chest compressions. 0435: EMS notified the writer that time of death had been called for 0435 and attempts to resuscitate the patient had ended...."

Review of Medication Administration Record (MAR) revealed 10 mg of Haldol, 50 mg of Benadryl, and 2 mg Ativan were documented as being given intramuscularly at 22:50 on 09/27/2023.
Further review of the Daily Nurse Progress Note revealed no evidence of documentation between the note written at 1800 to 0405.

The medical record was reviewed on 10/05/2023, with Employee #1. Employee #1 confirmed that Patient #24 was acting out the night of 09/27/2023, and was moved to a different unit and received a chemical restraint on the new unit, but there was no documentation of these events. Employee #1 confirmed there was no seclusion or restraint packet, with orders in the medical record, a face to face evaluation one hour after the restraint, nor was there a note or assessment performed on Patient #24 after the day shift left. Employee #1 confirmed there was no documentation in the medical record about the events that happened between 1800 and 0405, or of behavior indicating a need to be moved to another unit or the need for a chemical restraint. Employee #1 confirmed Patient #24 was discovered unresponsive at 0405 and pronounced dead at the hospital by EMS on 9/28/2023.

Approximately two hours after the medical record review with Employee #1, a nursing note dated 09/27/2023, timed 2130, was provided by Employee #1 which described the events leading to the unit change for Patient #24.
Employee #1 then confirmed the "note was just found on the unit."

A document titled "Seclusion/Personal Restraint (Physical Hold) Packet," was provided on 10/06/2023, dated 09/27/2023, by Employee #22, with orders signed by Provider #5 on 10/06/2023.

Employee #22 confirmed in an interview on 10/12/2023, that the seclusion and restraint packet was filled out as a late entry, when it was signed by the provider.

A review of medical charts of patients who were placed in restraint/seclusion was conducted on 10/11/2023. Fifteen (15) out of twenty-seven (27) restraint episodes that were reviewed, revealed no documentation of a face to face evaluation or further monitoring performed after receiving a chemical restraint.

Employee #1 and Employee#13 confirmed during an interview on 10/11/2023 that a face to face evaluation should be performed by a medical provider or trained RN for patients that are placed in restraints/seclusions.

Further review revealed the RN failed to supervise or evaluate care as demonstrated by the following:

A-0168: Physician orders were not received to place a patient in chemical restraints.

A-0178: RNs performing face to face evaluations did not have the required training;

A-0179: Patients failed to receive a face to face evaluation by a physician or trained RN;

A-0182: Physicians were not notified of a face to face evaluation when a patient received a chemical restraint;

A-0185: There was no documentation of a patient's behavior to indicate a chemical restraint was needed.

Based on review of hospital policies/procedures and staff interviews, it was determined that the Hospital failed to ensure that medications were administered to patients in compliance with a physician's order. This deficient practice poses a risk to the health and safety of patients, when medications are administered without a written physician's order to reference and confirm the validity of the order.

Findings Include:

Policy titled "Proper Use and Monitoring of Physical/Chemical Restraints and Seclusion", revealed: " ....IV. DEFINITIONS: ...Chemical (Medication)Restraint: The administration of a medication for the purpose of controlling an acute episodic behavior, with the intent to restrict the patient's functioning or movement and/or to bring about sedation. Medication/chemical restraint occurs when a patient is given a medication or combination of medications to control the patient's acute episodic behavior or restrict the patient's freedom of movement and/or which is not the standard treatment or dosage prescribed for the patient's condition. Whether an order for medication is ONE TIME, PRN or STAT does not determine whether the use of that medication is considered a restraint; if the specific purpose of administering that medication, at that dose, via that route, and at that time, is to impact acute episodic behavior it qualifies as a chemical restraint ...V. PROCEDURE: ...3.0 Physician Orders, Consultation, and Evaluation 3.1 Restraint or seclusion shall be used in emergency situation only and requires an order from a physician ...3.1.2 In the absence of a physician, the registered nurse may authorized the initiation of restraint or seclusion in an emergency. Medication orders must be provided by the physician ...."

Policy titled "Medication Administration", revealed: " ....III. PROCEDURE: Labeling and Dispensing: 1. All mediation are to be dispensed by a licensed Pharmacist when ordered by a licensed independent practitioner with privileges to do so at Valley Hospital ...."

Document titled, "Valley Hospital Medical Staff Rules and Regulations, revealed: " ....5.4 Member Orders ...5.4.4 Only Physicians, Nurse Practitioners and Pas with privileges may write orders for: ...5.4.4.3 Medication ...."

Patient #8's Physician Medication Orders dated 04/12/2023 identified "...Lorazepam Injectable 2mg/ml SOLN...2mg INJEC NOW...Start: 04/12/23 03:01...esigned...04/12/223 09:22...haloperidol Injectable 5mg/ml SOLN...10mg IM NOW...Start: 04/12/23 03:03...esigned...04/12/23 09:22...diphenhydramine Injectable 50mg/ml SOLN...50mg IM NOW...Start: 04/12/23 03:04....esigned...04/12/23 09:22...."

Patient #8's Medication Administration Record dated 04/10/2023 identified " ...Lorazepam 2mg Injectable NOW ... Administered 21:15 4/11/23...haloperidol solution 10mg Intramuscular NOW ...Administered 21:15 4/11/23 ...diphenhydramine solution 50mg Intramuscular NOW ...Administered 21:15 4/11/23 ...."

Patient #24's Physician Medication Order dated 09/27/2023 identified "...haloperidol Injectable 5mg/ml SOLN...10mg INJEC NOW...Start: 09/27/23 23:11...esigned by ____...Lorazepam Injectable 2mg/ml SOLN...2mg INJEC NOW...Start: 09/27/23 23:12...esigned by____...diphenhydraamine Injectable 50mg/ml SOLN...50mg INJEC NOW...Start: 09/27/23 23:11...esigned by _____...."

Patient #24's Medication Administration Record dated 09/25/2023 identified " ...haloperidol solution 10mg Injectable NOW ...Administered 22:50 9/27/23...Lorazepam Solution 2mg Injectable NOW...Administered 22:50 9/27/23...diphenhydramine Solution 50mg Injectable NOW...Administered 22:50 9/27/23...."


Employee #1, Employee #12 and Employee #13 confirmed during an interview conducted on 10/11/2023 that the medication administration record for Patient #8 and Patient #24 revealed that haloperidol, Lorazepam and diphenhydramine were administered before the order was documented as being received. Employee #1, Employee #12 and Employee #13 further confirmed that a physician order is needed to administer medication.

Based on review of hospital records and staff interviews, it was determined the hospital failed to meet the emergency needs of patients within acceptable standards of practice as evidenced by:

A-1104: The hospital failed to ensure that patients seeking emergency psychiatric medical care were evaluated by an RN and/or a qualified medical provider.

The cumulative effects of this deficient practice resulted in the hospital failing to meet the condition of participation for emergency services.

Based on a review of medical record and interview, it was determined the hospital failed to ensure patients seeking emergency medical psychiatric care received:
1. A medical screening exam by a qualified medical practitioner (QMP).
2. An assessment performed by an RN.
This failure poses the risk of a licensed staff member working outside their scope of practice, an emergency medical and/or psychiatric condition going undiagnosed, and a patient having an unsafe disposition from the facility if deemed to not have an emergency medical condition by an unqualified staff member.

Cross reference A-0092

Findings Include:

Hospital document titled "Valley Hospital Medical Staff Bylaws," revealed: "...The responsibilities of the Medical Staff are to account to the Board for the patient care processes and outcomes rendered by all Members, Residents, Interns, and Allied Health Professionals authorized to practice in the Facility through the following means...a procedure for monitoring patient care practices, including intake, assessment...analysis of patient care processes and outcomes...obtain appropriate informed consent...The Governing Body of Valley Hospital, having final authority for the provision of the quality of care of patients, has delegated the authority and responsibility for such provision of high quality care to the medical staff...."

Hospital policy titled, "Emergency Services and Patient Transfers-EMTALA," revealed: " ...The governing body of Valley Hospital has adopted the following policy in accord with the rules adopted by the Arizona Department of Health Services and The Centers for Medicare and Medicaid (CMS) regarding the provision of emergency services..."Emergent medical condition" means a condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbance, and symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in: a. Placing the health of the individual...in serious jeopardy...When a patient comes to the hospital requesting examination or treatment, the patient must be evaluated by qualified medical personnel (QMP), or a qualified mental health professional (QMHP) as determined by the Hospital in its bylaws...."

Hospital policy titled "Patient Transfers to Another Facility From Intake," revealed: "...Providing an Emergency Medical Screen 1. All individuals presenting for examination or treatment for an Emergency Medical Condition (EMC) at Valley Hospital will receive a Medical Screening Examination (MSE)...2. The Medical Screening Examination is composed of two parts: a. The Initial Medical Screen, Part 1 is performed by a Qualified Medical Professional (QMP), who is defined by the Medical Staff Bylaws as being an RN or Physician. B. The Medical Screening Examination, Part 2 (Level of Care Assessment) is performed by a Qualified Mental Health Professional (QMHP), who is defined by the Med Staff Bylaws as a RN, Physician or clinicians with a master's degree in counseling or mental health. 3. At the conclusion of the two-part screening examination, a physician is consulted and a determination is made as to whether an Emergency Medical Condition exists...."

Hospital document titled "Valley Hospital Medical Staff Rules and Regulations," revealed: "...Licensed Independent Practitioner/Qualified Medical Provider" is defined as, for the purposes of these Rules and Regulations, any individual permitted by law and by the Hospital, in accordance with limits established by the Governing Board and the Medical Staff, to provide patient care and services at the Hospital without direction or supervision, but with the scope of the individual's license and consistent with individually granted Clinical Privileges, including without limitation the following: (a) Physician's; (b) Nurse Practitioners; (c) Physician's Assistant...."
Hospital document titled "Standardized Intake Assessment," revealed: "...Level of Care Determination: The level of care recommendation was made by the clinician examining the patient and the physician...."
A review of 20 patient medical records from the Intake Department revealed four patients (Patients #25, #26, #27, #28), were not seen or consulted by a physician and had the Level of Care determination of "Outpatient-Referred to Community."

A review of 20 medical records from the Intake Department revealed three (Patient #26, #27, and #30) did not have documentation of an RN assessment performed in the Intake Assessment.

Employee #1 confirmed in an interview on 10/05/2023, that the physician does not have to see the patients that come into the intake department if they do not have a medical issue. Employee #1 also confirmed that the RN or the clinicians staffed in the intake department, none of which are nurse practitioners, physician's assistants, or physicians, are able to determine if the patient can be discharged from the intake department, without consulting with a physician. It was also confirmed that three patients did not have nursing assessments performed. Employee #1 further confirmed the current policy of the hospital stated a Qualified Mental Health Provider could determine if an emergency medical condition existed and if a patient was stabilized from an emergency medical condition.