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Based on observation, interview and record review, the facility failed to ensure the Condition of Participation for Patient Rights was met, as evidenced by:

1.The facility failed to ensure there was a safe transportation process for its Behavioral Health Unit (BHU, inpatient unit that provide treatment and therapy for people who have mental, emotional and behavioral disorders)patients on involuntary hold (involuntary detention at the facility to receive psychiatric [a branch of medicine focused on the diagnosis, treatment, and prevention of mental, emotion, and behavioral disorders] evaluation and treatment) outside the facility when a BHU staff (Certified Nursing Assistant [CNA])1 escorted one of 30 sampled patients (Patient 1) using the route outside of the facility's building to the transportation vehicle during pick up and allowing Patient 1 to step out of the transportation vehicle before her (CNA 1) upon returning to the facility from a conservatorship (a judge appoints a responsible person to care for another adult who cannot care for themselves or manage their own finances due to physical or mental limitations) court hearing.

This deficient practice had resulted in Patient 1 eloping (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave) from the facility by walking one (1) mile away from the facility and had the potential to result in Patient 1 running into traffic, and accidents leading to injury and death.

This deficient practice also had the potential to place all future BHU patients who require going out of the facility for appointments, including the conservatorship court hearing, at risk of eloping and getting injured.

This deficient practice resulted in the facility's inability to provide quality healthcare in a safe environment.

Based on observation, interview and record review, the facility failed to ensure the Condition of Participation for Quality Assurance and Performance Improvement was met, as evidenced by:

1. The facility failed to ensure that its Quality Assurance and Performance Improvement (QAPI, the hospital's program that identifies problems, investigates causes, and make improvements to ensure protection of patients and provide safe care) program was working as required.

The facility's QAPI program did not investigate or respond to problems in how controlled substance (drugs such as morphine [a strong pain medication] and fentanyl, a very strong pain medicine regulated by law because they can be abused) were stored, wasted (discard with a witness), or monitored. Instead, QAPI left the investigation to the Drug Diversion Prevention (DDP) team and expected to hear the result from the DDP team.

Because QAPI did not act, unsafe practices continued:

-Nurses were allowed to keep unused narcotics (very strong pain medicines such as morphine and fentanyl) for up to 12 hours without a secure place to store them.

-lock boxes used to store controlled substances on all units were easily accessible for multiple controlled substances without a witness.

- ControlCheck (formally known as Brightsight, the facility's monitoring system) flagged unsafe handling by Registered Nurse (RN 1), but QAPI did not review or act on the data.

-RN 1 was later found unresponsive in the ICU locker room with narcotics and a syringe, while two patients (Patient 11 and Patient 12) were under RN 1's care.

These deficient practices had the potential to jeopardize Patient 11 and Patient 12's safety due to care provided by Registered Nurse (RN 1) who was under the influence (impairment, to any degree, of an individual's ability to safely perform work because of drug use), and unaccounted controlled substances, and also placed other patients at risk for harm. (Refer to A-0283)

2. The facility's Governing Body (GB, responsible for guiding the hospital's long-term goals and policies, and assists with strategic planning and decision-making) failed to ensure oversight on the Quality Assurance and Performance Improvement (QAPI, the hospital's program that identifies problems, investigates causes, and make improvements to ensure protect patients and provide safe care) committee to ensure there was a thorough analysis of the causes of a patient safety event and identify and implement an effective action plan, when one of 30 sampled patients (Patient 1), from Behavioral Health Unit (BHU, inpatient unit that provide treatment and therapy for people who have mental, emotional and behavioral disorders) eloped (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave) from the facility on 7/30/2025.

This deficient practice resulted in the facility not having a safe transportation process in place to prevent future occurrence of elopement. (Refer to A-0286)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment.

Based on observation, interview and record review, the facility failed to ensure the Condition of Participation for Nursing Services was met, as evidenced by:

1. The facility failed to ensure its nursing staff performed reassessment and checked vital signs (measurements of the body's most basic function including body temperature, heart rate, blood pressure, respirations and pain level) for two of 30 sampled patients (Patient 1 and Patient 5), in accordance with the facility's policy regarding "Medication Use to Manage a Psychiatric Emergency," after receiving one-time emergency medication (EM, administering antipsychotic [class of drugs primarily used to manage psychosis, a mental state characterized by a disconnection from reality] medications or intramuscular medications to a patient without the patients' consent to maintain safety for the patient and other people on the unit) intramuscular (IM, into the muscles) injections when:

1.a. Nursing staff did not reassess and take vital signs for Patient 1 after giving Benadryl (antihistamine [medication that treat allergy symptoms] that can have a calming or sedative [a substance that calms and promotes sleep] effect) 50 milligrams (mg, a unit of measurement), Haldol (medication to treat schizophrenia [mental illness affecting how someone behaves, feels, and thinks] and acute [new onset] agitation [being upset, annoyed, angry and physically disturbed]) 5 mg, and Valium (medication used to treat anxiety [a feeling of unease, worry, or fear] and produce drowsiness (a feeling of sleepiness) and has sedation [a state of calmness or drowsiness induced by drugs] effect)10 mg on 7/30/2025 at 11:25 a.m.

This deficient practice had the potential to result in Patient 1 not getting proper evaluation of the effect of the medications and put Patient 1 at risk for respiratory distress (a condition that occurs when the body needs more oxygen, and can be caused by a number of factors, including infections, chronic illness, or a blocked airway) and oversedation (too much sleepiness and/or drowsiness). (Refer to A-0395)

1.b. Nursing staff did not take vital signs for Patient 5 after giving Valium 5 mg on 6/11/2025 at 7:44 p.m., and injections of Haldol 10 mg, Benadryl 50 mg and Valium 5mg IM on 6/11/2025 at 8:31 p.m.

These deficient practices had the potential to result in Patient 5 not getting proper evaluation of the effect of the medications and put Patient 5 at risk for respiratory distress (a condition that occurs when the body needs more oxygen, and can be caused by a number of factors, including infections, chronic illness, or a blocked airway) and oversedation (too much sleepiness and/or drowsiness). (Refer to A-0395)

2. The facility failed to ensure nurses followed the hospital policy on medication administration documentation, for one (1) of 31 sampled patients (Patient 27), when there was a delay in wasting or returning a bag of Fentanyl which was removed from the Pyxis (an automated medication dispensing system) on 7/09/2025.

This deficient practice had the potential for inaccurate medication administration, medication errors, and/or issues with unaccounted controlled substances (a drug or chemical that is regulated by the government due to potential for abuse or addiction, for example opioids and narcotics). (Refer to A-0398)

3. The facility failed to ensure that nurses measured and documented the amount of controlled substances (medication like morphine or fentanyl that are regulated by law due to their high risk for abuse or addiction) remaining in patient -controlled analgesia (PCA, a pain -management method that allows patients to self-administer small doses of pain medicine through a pump) tubing when discontinuing PCA therapy affecting approximately two (orthopedic patients per month) of 31 sampled patients, who are placed on PCA therapy (Director of Medical Surgical confirmed this information on 8/8/2025 at 12:45 p.m.).

This deficient practice placed approximately two orthopedic patients per month at risk for inaccurate medication documentation and unaccounted controlled substances. In addition, this failure resulted in unaccounted narcotics (a drug or other substance that affects mood or behavior and is consumed for nonmedical purposes) being discarded into unsecured bins without measurement or witness verification. This created a risk for diversion (when drugs are used for purposes other than a patient's prescribed treatment) by staff, which could result in impaired staff providing unsafe care, thereby placing all patients on the orthopedics unit at risk. (Refer to A-0405)

4. The facility failed to ensure that a patient had pain medication orders that addressed the full range of pain on a numeric pain scale utilized by the facility to address patients' pain (0: No pain,1-3: Mild pain, 4-6: Moderate pain,7-10: Severe pain, and 10: The worst pain imaginable), in accordance with the facility's policy regarding pain management. For one (1) of 31 sampled patients (Patient 17), the medical record showed that the patient had no medication ordered for mild to moderate pain (1-6).

This deficient practice placed Patient 17 at risk for experiencing unnecessary suffering from untreated mild to moderate pain (levels 1-6), which had the potential to cause prolonged discomfort, increased stress on the body, and delay recovery. (Refer to A-0405)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment.

Based on observation, interview, and record review, the facility failed to ensure that the Condition of Participation for Pharmaceutical Services was met, as evidenced by:

1. The facility failed to develop policies and procedures for the control and storage of medications, which may negatively impact 31 of 31 sampled patients, as evidenced by:

1.a. Failure to develop a policy and procedure for a contracted vendor software, ControlCheck (formerly called Bluesight, a program that utilizes artificial intelligence and machine learning to monitor and analyze medication transactions, identify unusual patterns, and flags potential drug diversion [unauthorized or illegal transfer of prescription medications from their intended recipients to others, or their use for purposes not intended by the prescriber] events to ensure accountability of medications) that has been in use since 9/12/2018.

This deficient practice had the potential for wrong medication, drug diversion, and/or pilferage (stealing medication) that may affect patient safety. (Refer to A-0491)

1.b. Failure to develop a policy and procedure that indicated an acceptable time frame for nurses to return or waste a medication, and the interim secure storage of such medications in the event that the return or the disposal could not happen within the approved period.

This deficient practice had the potential for wrong medication, drug diversion, and/or pilferage (stealing medication) that may affect patient safety. (Refer to A-0491)

2. The facility failed to ensure that a record system was properly in place to maintain current and accurate records of the receipt and disposition of scheduled drugs by failing to develop and implement policies and procedures to:

- Secure controlled substances (drugs such as morphine [strong opioid pain medication] and fentanyl [a very strong opioid pain medication] that are regulated by law because they can be abused or cause dependence).

-Monitor medication handling.

- Prevent diversion (when medication is used for reason other than prescribed treatment).

This deficient practice involved two (2) of 31 sampled patients (Patient 11 and Patient 12), who were under the care of Registered Nurse (RN) 1, a nurse later confirmed by toxicology testing (laboratory analysis to detect drugs or poisons) to be under the influence (impairment, to any degree, of an individual's ability to safely perform work because of drug use) of fentanyl (a strong opioid pain medication) and opioids (a drug class includes fentanyl and morphine) while on duty.

This deficient practice resulted in Patient 11 and Patient 12 being at immediate risk for harm due to care previously provided by a nurse under the influence of controlled substances. In addition, because the facility continued to allow unsecured storage and inadequate monitoring of controlled substances, other patients in the facility remained at risk for harm from potential diversion, delayed pain treatment, or medication errors. (Refer to A-0494)

3. The facility failed to ensure pharmacy oversight of controlled substances (a drug or chemical that is regulated by the government due to potential for abuse or addiction, for example opioids and narcotics), which may negatively impact 31 of 31 sampled patients, as evidenced by:

3.a. Failure to ensure the pharmacy department manually reviewed the Control Check (formerly called Bluesight, a program that utilizes artificial intelligence and machine learning to monitor and analyze medication transactions, identify unusual patterns, and flags potential drug diversion [unauthorized or illegal transfer of prescription medications from their intended recipients to others, or their use for purposes not intended by the prescriber] events to ensure accountability of medications) alerts for potential diversion of Controlled drugs substances instead of just relying on the Control Check program to identify.

This deficient practice placed patients at risk for harm from diversion (when medications are taken or used for purposes other than prescribed), delayed pain treatment (such as when medication was diverted, thus patient did not receive pain medication on time or as prescribed), or medication errors (such as when medication had been tampered with or inaccurate amount of pain medication was administered not following prescription). (Refer to A-0500)

3.b. Failure to investigate an alert for a long lapse (close to 2 hours) between the time of removal from Pyxis (an automated dispensing system that included a secure computerized cabinet that stores and dispenses medication and integrate with the hospital's electronic medical record system) and the time of administration for a fentanyl (narcotic that is used in anesthesia and pain management) infusion (drip, the process of delivering medication directly into the bloodstream through a needle, typically through a vein, or intravenously/IV) bag on 7/11/2025, for one of 30 sampled patients (Patient 11).

This deficient practice placed patients at risk for harm from diversion (when medications are taken or used for purposes other than prescribed), delayed pain treatment (such as when medication was diverted, thus patient did not receive pain medication on time or as prescribed), or medication errors (such as when medication had been tampered with or inaccurate amount of pain medication was administered not following prescription). (Refer to A-0500)

3.c. Failure to ensure that substances (medications regulated by law due to risk of abuse or dependence, such as fentanyl and morphine) stored in medication lock boxes located throughout all units in the facility were secured and protected from unauthorized access, in accordance with the facility's policy regarding "Distribution, Administration and Accountability of controlled drugs." Once the lock box was opened by a nurse, that nurse had access to all other controlled substances inside, and there was no requirement for a witness when placing or removing medications.

This deficient practice placed patients at risk for harm from diversion (when medications are taken or used for purposes other than prescribed), delayed pain treatment (such as when medication was diverted, thus patient did not receive pain medication on time or as prescribed), or medication errors (such as when medication had been tampered with or inaccurate amount of pain medication was administered not following prescription). (Refer to A-0500)

4. The hospital failed to ensure its sterile (germ-free) compounding process (a process of making sterile intravenous [IV, administered through the vein] medications), was performed in a safe and consistent manner, as evidenced by:

4.a. Failure to ensure the "sterile product preparation tray (a tray that provide surface area for sterile compounding or IV medication preparation)" in one (1) of two (2) sampled medication rooms in the Intensive Care Unit (ICU) was free of stains.

This deficient practice had the potential for all patients requiring IV medications to be exposed to preventable contamination leading to infection that may affect patients' health and safety. (Refer to A-0501)

4.b. Failure to ensure the anteroom (a room serves as a transition area that separates the dirty area from the clean area or room where IV medications are prepared) of the sterile compounding suite (IV room) was clean and free of debris, residues, and/or stains, that could accumulate contaminants and/or microorganisms.

This deficient practice had the potential for all patients requiring IV medications to be exposed to preventable contamination leading to infection that may affect patients' health and safety. (Refer to A-0501)

4.c. Failure to ensure the sterile compounding environment viable sampling plan (a map of sampling locations) used by the vendor that certifies the facility's IV room was included in the hospital's procedure of environmental media testing.

This deficient practice had the potential for all patients requiring IV medications to be exposed to preventable contamination leading to infection that may affect patients' health and safety. (Refer to A-0501)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment.

Based on interview and record review, the facility's Governing Body (GB, responsible for guiding the hospital's long-term goals and policies, and assists with strategic planning and decision-making) failed to ensure policies and procedures were established to ensure proper accounting of dispensed controlled substances to provide safe and quality care for three of 31 sampled Patients (Patients 1, 11, 12) when there was a failure to:

1. -Secure controlled substances (drugs as morphine [a strong pain medication] and fentanyl [a powerful drug used in the treatment of severe pain] that are regulated by law because they can be abused or cause dependence).

This deficient practice had the potential to jeopardize Patient 11 and Patient 12's safety due to care provided by Registered Nurse (RN 1) who was under the influence (impairment, to any degree, of an individual's ability to safely perform work because of drug use). This deficient practice also had the potential to impact other patients in the ICU (Intensive Care Unit), where controlled substances are unsecured.

-Monitor medication handling and prevent diversion (when medication is taken or used for purposes other than what was prescribed for a patient).

This deficient practice had the potential to result in unsafe medication handling, diversion (when medication is taken or used for purpose other than what was prescribed for a patient), and unaccounted controlled substances. This failure placed patients at risk for delayed treatment, untreated pain, or receiving unsafe care from staff who may be impaired by diverted drugs.

-Ensure the Quality Assurance and Performance Improvement (QAPI, the facility's program for identifying problems, investigating causes, and making improvements) program investigated and corrected unsafe practices.

This deficient practice jeopardized Patient 11 and Patient 12's safety due to care provided by Registered Nurse (RN 1) under the influence (impairment, to any degree, of an individual's ability to safely perform work because of drug use), and unaccounted controlled substances, placing patients at risk for harm.

2. Ensure there was a safe process to transport Behavioral Health Unit (BHU, inpatient unit that provide treatment and therapy for people who have mental, emotional and behavioral disorders) patients outside the facility for appointments including conservative (a judge appoints a responsible person to care for another adult who cannot care for themselves or manage their own finances due to physical or mental limitations) court hearings.

This deficient practice resulted in Patient 1 eloping (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave) from the facility and which had the potential for Patient 1 running into traffic, accident, getting injured and/or death. This deficient practice also had the potential to put other BHU patients requiring transportation outside the facility at risk for elopements.

Findings:

1.a. During an interview with the Director of the Intensive Care Unit (DICU) on 8/5/2025 at 3:42 p.m., DICU confirmed RN 1 was found unresponsive (not awake not reacting) in the ICU (Intensive Care Unit, area in hospital that care for the critically ill patients) locker restroom while on duty on 7/26/2025. DICU confirmed that RN 1 was assigned the care of Patient 11 and Patient 12 on the night (7 p.m. to 7 a.m. shift) RN 1 was found unresponsive.

During an interview on 8/6/2025 at 2:45 p.m. with the Chief Medical Officer (CMO), the CMO confirmed that RN 1 was in possession of a morphine vial (a small glass container holding a strong pain medicine), used syringe (a device for injecting fluids), uncapped needle (needle without its safety cover), and tourniquet (a tight band used to slow blood flow, often applied before injecting) at the time RN 1 was found unresponsive. The CMO also confirmed toxicology testing (laboratory analysis to detect drugs or poisons) in the Emergency Department (ED, a hospital unit for urgent medical care) was positive for fentanyl (a very strong opioid pain medication) and opioids (a group of drugs that includes morphine [a strong opioid medication] and fentanyl [a very strong opioid medication]).

During a review of Patient 11's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 7/21/2025 , the "H&P" indicated, Patient 11 had past medical history which included pancreatic cancer (a type of cancer that develops in the pancreas, an organ located behind the stomach that plays a crucial role in digestion and blood sugar regulation), on chemotherapy (the treatment of disease by the use of chemical substances). Patient 11 was admitted for worsening abdominal pain, with a care plan including pain control.

During a review of Patient 11's "Medication Administration Record (MAR)," dated 7/26/2025, the MAR indicated Patient 11 had a physician's order for fentanyl (a very strong opioid pain medication) infusion intravenously (medication administered into the vein).

During a concurrent interview and record review on 8/7/2025 at 4:00 p.m. with the Medication Safety Officer (MSO), Patient 11's "Medication Administration Record (MAR)," dated 7/24/2025, was reviewed. The MAR indicated that RN 1 administered a new bag of fentanyl (a very strong opioid pain medication) 100 milliliters (ml, a unit of measurement) intravenously (IV, administer medication into the vein) infusing for 8 hours. MSO stated the total volume infused was 75 ml when a new bag was changed. MSO confirmed that approximately 25 ml was unaccounted for. MSO stated pharmacy did not know where the unaccounted fentanyl went.

During a review of Patient 12's "History and Physical (H&P)," dated 7/21/2025, the "H&P" indicated, Patient 12 was transferred to this facility due to having an aneurysm (part of an artery wall weakens, allowing it to abnormally balloon out or widen).

During a review of Patient 12's medication dispensing report date 7/25/2025, the report indicated RN 1 removed Morphine (strong opioid pain medication) 3 times in one day (7 a.m. - 7:00 p.m.): at 8:32 p.m., 10:22 p.m., and 3:22 a.m.

During a concurrent interview and record review on 8/7/2025 at 12:32 p.m. with the Pharmacy Manager (MP) and the Medication Safety Officer (MSO), RN 1's audit record in "Control Check (a drug diversion monitoring software, formerly called Bluesight) for period of 7/5/2025 - 8/4/2025, was reviewed. The MSO stated the system flagged alerts for fentanyl infusions given more than 60 minutes after removal from the Pyxis (an automated medication dispensing system). However, RN 1's IRIS score (individual Risk Identification Score, a risk score for diversion) was 2/5, below the facility's threshold of 5. Therefore, no investigation occurred.

During a concurrent interview and record review on 8/7/2025 at 12:40 p.m. with the Manager of Pharmacy (MP), RN 1's ControlCheck audit report was reviewed. MP stated the report was run after the incident on 7/26/2025 for the last 30 days (6/27/2025 -7/27/2025). MP stated they did not look into why RN 1's score was 2.5 because this score was below 5, which was the threshold that the facility would start an investigation. The report indicated the score of 2.5 meant the following:

- "RN 1 has a highly unusual number of variances (discrepancies or differences between expected and actual quantities of controlled substances, such as medications, during handling and dispensing), including 4 variances with a status of Closed Reconcile (MP stated the Nurse Manager closed this variance that was flagged by the system)." 2 Variances in Reconcile - Missing either administration, waste, or return, and 2 variances in reconciled - Missing administration."
-"RN 1 logged 5 actions with the time between events exceeding the threshold (60 minutes): 1 action with first dispense (when RN removed the controlled substance) and first administration (when RN 1 gave the medication) for a patient greater than 60 minutes (hospital threshold). 4 actions with first and last touch for a patient greater than 41 minutes (Nursing Average)."

During an interview on 8/7/2025 at 12:54 p.m. with the Director of Pharmacy (DOP), the DOP stated the policy titled "Automatic Dispensing Cabinet (a computerized medicine storage and tracking system)," dated 1/3/2024, allowed nurses to keep controlled substances that required wasting (throwing away leftover drugs with witness) for up to 12 hours without defining a secure storage location (locked cabinet or other secure space). DOP confirmed that RNs "keep the medication in their possession until they can waste it with a witness," and there was no policy on how or where to store the medication securely during this time.

During an interview on 8/5/2025 at 10:30 a.m. with the Director of Quality and Accreditation (DQA), the DQA stated "There is no official root cause analysis (RCA, a structured was to find the underlying reason for a problem). The Drug Diversion Response (DDR) team responded and started the investigation on 7/28/2025. QAPI has not had any activity, as this occurred on 7/26/2025 (10 days prior to today)." The Director confirmed that QAPI relied on the DDP (Drug Diversion Prevention) team to complete the investigation and communicate back to QAPI.

During an interview on 8/5/2025 at 3:42 p.m. with the Director of Critical Care (DICU), the DICU stated RN 1, the nurse who overdosed (a toxic amount of a drug, or combination of drugs overwhelms the body), had no prior issues. The DICU stated, "After the event, we planned to have a bag or case over the narcotics (a drug or other substance that affects mood or behavior), but it has not been implemented." The DICU also stated the hospital used ControlCheck (a computer program that scores staff medication handling to detect possible drug diversion). RN 1's score was 2.5, which was below the hospital's investigation threshold of 5, thus "we did not look into it." The DICU also stated the lock boxes on the units could be opened by any nurse, giving access to multiple narcotics, without a witness.

During an interview on 8/6/2025 at 12:54 p.m. with the Director of Pharmacy (DOP), the DOP confirmed there was no secure location for staff to hold controlled substances awaiting waste and that nurses carried them until a witness was available. There was no policy or procedure to provide guidance on where the controlled substance should be stored while waiting to be wasted (discard with a witness) or administered.

During an interview on 8/8/2025 at 6:26 p.m. with the Chief Medical Officer (CMO), the CMO stated they attend Governing Body (GB) board meetings and was a member of the board. CMO stated they had the responsibility for reporting all clinical matters and resolutions, as well as progress to GB. CMO stated they meet every month to discuss progress of any pending project. The CMO stated, "GB has the ultimate decision of all operations. They are responsible for all activities, facility wide."

During a review of the facility's "Bylaws of the Community Board of (Name of the facility)," dated 4/25/2024, the Bylaws indicated, "Community Board Role and Responsibility: he Corporation, which owns and operates the Hospital, is controlled and managed by the Corporate Board. All powers and functions with respect to the management and governance of the Hospital are vested in the Corporate Board as set forth in the bylaws of the Corporation (the "Corporate Bylaws") and the Nonprofit Code. Subject to its own oversight and ultimate authority as required by the Nonprofit Code, the Corporate Board has delegated (a) certain responsibilities and functions to the Community Board as set forth in the Corporate Bylaws and these bylaws of the Community Board (the "Community Board Bylaws" and (b) certain powers and functions to the Corporation's president for the day- to-day management of the Hospital's business ... to-day management of the Hospital's business. The Corporation's president and the Community ... Providing institutional planning to meet the health care needs of the community the Hospital serves."

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment and Performance Improvement (QAPI) Program Plan," dated 5/28/2025, the P&P indicated, "The Community Board (CB) = Governing Body (GB) is responsible and accountable for assuring oversight of an ongoing quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services. The CB is responsible for evaluating QAPI through periodic review and establishment of clear expectations for quality of care and patient safety. The CB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually. The CB will delegate the development, implementation, and evaluation of QAPI to respective AHGL committees/teams ..."

1.b. During a review of Patient 1's "Behavioral Health History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 7/16/2025, the H&P indicated, Patient 1 was readmitted to the facility's Behavioral Health Unit (BHU, inpatient unit that provide treatment and therapy for people who have mental, emotional and behavioral disorders) with diagnosis of acute (new onset) exacerbation (worsening) of chronic (long-term) schizophrenia (a severe mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

During a review of Patient 1's physician order dated 7/15/2025, the physician order indicated Patient 1 was placed on suicidal (harming self, ending own's life), elopement (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave) and fall (an unexpected event where a patient unintentionally comes to rest on the floor or another lower level, such as a bed or chair) precaution.

During a review of Patient 1's legal conservatorship (a judge appoints a responsible person to care for another adult who cannot care for themselves or manage their own finances due to physical or mental limitations) document titled, "Petition for appointment of conservator of the person and estate (and temporary conservatorship of the person)," dated 7/3/2025, the legal conservatorship document indicated, Patient 1 was placed on temporary conservatorship since 6/23/2025.

During a review of Patient 1's letter from Department of Mental Health, dated 7/29/2025, the letter indicated, Patient 1 was scheduled for an in-person conservatorship court hearing in [a city] on 7/30/2025 at 8:30 a.m.

During a concurrent observation and interview on 8/7/2025 at 9:40 a.m. with the Director (DIR 2) of BHU and Director (DIR 3) of Security, facility's security video footage dated 7/30/2025, was reviewed. The following was observed through the security video footage with no audio (video footage showing the time when Patient 1 was picked up from the facility):
-7:12:45 a.m.: Patient 1, CNA 1, and the ambulance driver were at the facility's BHU (Unit 1) waiting area next to nursing station
-7:13:55 a.m.: Patient 1, CNA 1 and the ambulance driver left the unit using Unit 1's side door on foot
-7:15:40 a.m.: Patient 1, CNA 1 and the ambulance driver got into the ambulance van
-DIR 2 stated Patient 1, CNA 1 and the ambulance driver walked outside of the facility's building to get to the ambulance van.

During a concurrent observation and interview on 8/7/2025 at 9:56 a.m. with DIR 2 and DIR 3, DIR 3 walked 174 steps following the same route Patient 1, CNA and the ambulance driver took from BHU to the ambulance van on 7/30/2025. DIR 2 stated the route was not safe because it was outside of the facility. DIR 2 further stated Patient 1 was exposed to the outside environment and put Patient 1 at risk for elopement (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave).

During a concurrent observation and interview on 8/6/2025 at 10:28 a.m. with DIR 2 and DIR 3, the facility's security video footage dated 7/30/2025 was reviewed. The following was observed through the security video footage with no audio (video footage showing the time when Patient 1 was returned to the facility from conservatorship hearing):
-10:32:58 a.m.: An ambulance van pulled up to main entrance
-10:33:10 a.m.: ambulance driver stepped out from the vehicle and opened the sliding door
-10:33:17 a.m.: Patient 1 stepped out from the vehicle ahead of CNA 1 from the vehicle, walked away from the main entrance toward east side of the facility. CNA 1 stepped out after Patient 1 and followed Patient 1 while ambulance driver stayed by the van
-10:34:09 a.m.: the ambulance van left the facility
-DIR 3 stated CNA 1 stepped out from the vehicle six (6) seconds after Patient 1 had gotten out from the vehicle. DIR 2 stated Patient 1 left the facility's premises for about twenty (20) minutes then brought back by local police department.

During an interview on 8/6/2025 at 11:17 a.m. with the BHU Registered Nurse (RN) 4, RN 4 stated the following: the BHU would send patients out for conservatorship court hearing. The unit would arrange transportation for the patient. Patients would be on one on one (1:1, a patient safety strategy where a designated staff member continuously observes a single patient, remaining in close proximity and able to intervene immediately if needed) monitoring during transportation until return to the unit. There was no elopement risk assessment tool to assess a patient's elopement risk. RN 4 also stated there were no guidelines or protocols from the facility regarding transporting patients for court hearing.

During an interview on 8/6/2025 at 11:54 a.m. with CNA 1, CNA 1 stated the following: she (CNA 1) accompanied Patient 1 to the court on 7/30/2025. Upon return to the facility, the ambulance driver opened the door, Patient 1 stepped out first then she (CNA 1) came after Patient 1. Patient 1 looked around and stated to CNA 1 that she (Patient 1) did not want to go back inside (the facility). Patient 1 started to walk away. CNA 1 used her (CNA 1's) personal phone to notify the BHU and followed Patient 1. CNA 1 followed Patient 1 all the way across the street. Patient 1 walked in between traffic. CNA 1 had to block the traffic so Patient 1 could cross the street. Patient 1 continued to walk away and hide at the gas station. CNA 1 stated she (CNA 1) did not know where security was. She found out from the facility's security guard later that they did not follow the patient once the patient had left the facility's premises.

During an interview on 8/6/2025 at 12:15 p.m. with CNA 1, CNA 1 stated the following: it was her (CNA 1's) first time accompanying a patient to the court. CNA 1 did not remember if she (CNA 1) had received any training before going with Patient 1. CNA 1 further stated, "there are many risks (when patient was outside of the unit). We should get a class or have an orientation."

During an interview on 8/6/2025 at 12:24 p.m. with CNA 2, CNA 2 stated the following: she (CNA 2) had experience of accompanying BHU patients to the court but there was no training or guidelines given to her (CNA 2) regarding transporting patients to court. She (CNA 2) would stay close with the patients because she (CNA 2) liked to be responsible.

During a concurrent interview and record review on 8/6/2025 at 3:10 p.m. with RN Educator (EDU 1) of BHU, Patient 1's physician order dated 7/15/2025, was reviewed. The physician order indicated "Precaution for suicide, elopement and fall." EDU 1 stated BHU patients on elopement precaution were to remain in the locked unit. EDU 1 further stated if the patient needed to go out of the unit, a staff member would escort the patient to make sure the patient did not elope or run away."

During an interview on 8/6/2025 at 3:15 p.m. with EDU 1, EDU 1 stated the following: the Basic Life Support (BLS) ambulance would drop off and pick up BHU patients next to the BHU nursing station with a gurney. He (EDU 1) never experienced BLS ambulance dropping off a BHU patient at the facility's lobby. EDU 1 also stated it was unsafe to drop off BHU patients at the facility's front lobby because there were many risks outside. EDU stated patients could run away, run into traffic and get hurt.

During an interview on 8/7/2025 at 10 a.m. with DIR 3, DIR 3 stated Patient 1 walked about one (1) mile away from the facility when Patient 1 eloped on 7/30/2025.

During an interview on 8/7/2025 at 10:49 a.m. with DIR 2, DIR 2 stated when the ambulance with Patient 1 returned to the facility, CNA 1 should have stepped out of the vehicle before Patient 1 to prevent Patient 1 from eloping. DIR 2 also stated all BHU patients were at risk for elopement.

During a concurrent interview and record review on 8/7/2025 at 10:52 a.m. with DIR 2, the facility's policy and procedure (P&P) titled, "Transportation," dated 9/2023, was reviewed. The P&P indicated, "The purpose of this policy is to establish guidelines for transportation of patients to appointment outside [the facility]." DIR 2 stated the P&P did not indicate any staff responsibilities when accompanying patients outside the facility and did not indicate any procedure of how to send out the patient from the BHU unit to the vehicle and how to receive the patient upon ambulance arrival.

During an interview on 8/8/2025 at 6 p.m. with the Program Manager of Performance Improvement, the Program Manager of Performance Improvement stated the GB (Governing Body) had oversight for all the policies and procedures.

During a concurrent interview and record review on 8/8/2025 at 6:17 p.m. with the Senior Director of Risk Management (SDRM), the facility's "Apparent Cause Analysis (ACA report)," dated 7/30/2025, was reviewed. The ACA report indicated there were corrective actions implemented in response to Patient 1's elopement incident on 7/30/2025 including improving communication between transport team and facility upon return to the facility, re-educating on response to patient's elopement, and offering web-based option for court hearing. The ACA report did not indicate any transport route or steps staff should follow when transporting patient. SDRM stated the following: the ACA meeting was held the same day after Patient 1 eloped from the facility. The ACA did not identify any issue with CNA 1 taking Patient 1 outside of the facility to walk to the ambulance van and CNA 1 letting Patient 1 step out of the vehicle before her (CNA 1).

During an interview on 8/8/2025 at 6:26 p.m. with the Chief Medical Officer (CMO), CMO stated there was no patient eloping during transport before and the facility did not transport too often, recently there were more due to the added programs. CMO also stated the GB had the ultimate decision for all hospital operations.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment and Performance Improvement (QAPI) Program Plan," dated 5/2025, the P&P indicated, "The Quality Assessment & Performance Improvement (QAPI) Program is a proactive, interdisciplinary, systematic approach to designing or redesigning patient-centered systems to improve quality of care and patient safety, in alignment with regulatory standards ... Structure and Accountability ... The Community Board (CB) = Governing Body (GB) is responsible and accountable for assuring oversight of an ongoing quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services. The GB is responsible for evaluating QAPI through periodic review and establishment of clear expectations for quality of care and patient safety ... [the facility] leadership is responsible for identifying priorities, supporting change management, and allocating resources for [facility] QAPI program. Leadership is responsible for improving quality of care, safety, and serv ices provided by [facility] staff through established structures and processes ... Patient Safety Program... Patient safety integrates with all quality assessment and performance improvement activities. Cause Analysis and Proactive Risk Assessments ... will be utilized to assess actual and potential risk, failure, points of vulnerability, and prioritized areas for improvement based on impact patient care outcomes."

During a review of the facility's GB Bylaws titled, "Bylaws of the Community Board of [the facility]," dated 4/25/2024, the GB Bylaws indicated, "Community Board Role and Responsibility ... Subject to the oversight and ultimate authority of the Corporate Board, the Corporate Board delegates to the Community Board, and the Community Board shall be responsible to the Corporate Board for, the following responsibilities and functions ... Ensuring a safe environment within the Hospital for employees, medical staff, patients, and visitors."

Based on observation, interview and record review, the facility failed to ensure there was a safe transportation process for its Behavioral Health Unit (BHU, inpatient unit that provide treatment and therapy for people who have mental, emotional and behavioral disorders)patients on involuntary hold (involuntary detention at the facility to receive psychiatric [a branch of medicine focused on the diagnosis, treatment, and prevention of mental, emotion, and behavioral disorders] evaluation and treatment) outside the facility when a BHU staff (Certified Nursing Assistant [CNA])1 escorted one of 30 sampled patients (Patient 1) using the route outside of the facility's building to the transportation vehicle during pick up and allowing Patient 1 to step out of the transportation vehicle before her (CNA 1) upon returning to the facility from a conservatorship (a judge appoints a responsible person to care for another adult who cannot care for themselves or manage their own finances due to physical or mental limitations) court hearing.

This deficient practice had resulted in Patient 1 eloping (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave) from the facility by walking one (1) mile away from the facility and had the potential to result in Patient 1 running into traffic, and accidents leading to injury and death. This deficient practice also had the potential to place all future BHU patients who require going out of the facility for appointments, including the conservatorship court hearing, at risk of eloping and getting injured.

On 8/7/2025 at 4:29 p.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements have caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient), in the presence of the Chief Medical Officer (CMO), Patient Care Executive/Chief Nursing Officer (CNO), Director of Quality (DQ), Administrative Director of Cardiovascular, Peri-Operative, Imaging (AD 1), and the System Director for Accreditation and Licensing (SDAL) who attended via telephone. The facility failed to ensure there was a safe process when clinical staff escorted a Behavioral Health Unit (BHU, inpatient unit that provide treatment and therapy for people who have mental, emotional and behavioral disorders) patient to conservatorship (a judge appoints a responsible person to care for another adult who cannot care for themselves or manage their own finances due to physical or mental limitations) court hearing outside the facility. A review of the facility's security footage indicated the following: on 7/30/2025, a BHU patient (Patient 1), on involuntary hold (involuntary detention at the facility to receive psychiatric [a branch of medicine focused on the diagnosis, treatment, and prevention of mental, emotional, and behavioral disorders] evaluation and treatment), was escorted by a BHU staff (Certified Nursing Assistant [CNA] 1) and walked outside of the facility building to get to an ambulance van to go to a conservatorship court hearing. Upon returning to the facility, Patient 1 stepped out of the ambulance van ahead of CNA 1. This resulted in Patient 1 eloping (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave) in the presence of CNA 1. During an interview on 8/7/2025 at 10 a.m. with the Director (DIR) 3 of Security, DIR 3 stated Patient 1 walked through the traffic and walked about one (1) mile away from the facility. During an interview on 8/7/2025 at 10:49 a.m. with the Director (DIR) 2 of BHU, DIR 2 stated CNA 1 should have stepped out of the vehicle before Patient 1 to prevent Patient 1 from eloping. DIR 2 also stated all BHU patients were at risk for elopement. This deficient practice placed Patient 1's safety at risk of being exposed to traffic, accidents, injury and/or death.

On 8/8/2025 at 8:40 p.m. the IJ was removed in the presence of the CMO, CNO, DQ, AD 1, Director (DIR 2) of Behavioral Health Unit, Nurse Manager (NM 2) of BHU, and the SDAL who attended via telephone, after the facility submitted an acceptable IJ Removal Plan (interventions to correct the deficient practice). The elements of the IJ Removal Plan were verified and confirmed by the survey team while onsite through observation, interview, and record review. The IJ Removal Plan indicated that immediate action taken by the facility were as follows: starting 8/8/2025, BHU staff would complete an elopement risk quick screen on all BHU patients a minimum of every shift and prior to departure to court. Nursing staff would contact physicians for any high elopement risk patients to determine if the patients would be appropriate to go to court hearing in person. A new process for safe and secure BHU patients' transportation outside facility was developed. A minimum of one BHU staff, two (2) staff for high elopement risk patients, would be assigned as escort for BHU patient transportation to and from a court hearing. When ambulance staff arrive at the facility, the BHU charge nurse would provide a copy of the contracted ambulance staff education material to the ambulance staff for review and have the ambulance staff to sign the "Safe and Secure Transport to Court Hearings" log acknowledging receipt. The BHU charge nurse or designee would contact security to accompany the escort(s) and patient to the facility's East Tower main lobby. There would be a designated internal hospital route (exit and entry) to and from the transportation vehicle using only the facility's East Tower main lobby exit. No other hospital exits were permitted. Escort(s) would always enter the transportation vehicle after the patient and would always exit the transportation vehicle prior to patient exit. Upon returning, BHU staff and security would be present at the transportation drop-off location in front of the East Tower main lobby to receive the patient then escort the patient back to BHU. Education on the new transportation process started on 8/8/2025 for all BHU staff and the security team members at the start of shift, and would continue until 100% of staff were trained. BHU director, nurse manager or designee would conduct direct observations and audits to ensure staff understanding and compliance with the newly developed transportation process.

Findings:

During a review of Patient 1's "Behavioral Health History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 7/16/2025, the H&P indicated, Patient 1 was readmitted to the facility's Behavioral Health Unit (BHU, inpatient unit that provide treatment and therapy for people who have mental, emotional and behavioral disorders) with diagnosis of acute (new onset) exacerbation (worsening) of chronic (long-term) schizophrenia (a severe mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

During a review of Patient 1's physician order dated 7/15/2025, the physician order indicated Patient 1 was placed on suicidal (harming self, ending own's life), elopement (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave) and fall (an unexpected event where a patient unintentionally comes to rest on the floor or another lower level, such as a bed or chair) precaution.

During a review of Patient 1's legal conservatorship (a judge appoints a responsible person to care for another adult who cannot care for themselves or manage their own finances due to physical or mental limitations) document titled, "Petition for appointment of conservator of the person and estate (and temporary conservatorship of the person)," dated 7/3/2025, the legal conservatorship document indicated, Patient 1 was placed on temporary conservatorship since 6/23/2025.

During a review of Patient 1's letter from the Department of Mental Health dated 7/29/2025, the letter indicated, Patient 1 was scheduled for an in-person conservatorship court hearing in [a city] on 7/30/2025 at 8:30 a.m.

During a concurrent observation and interview on 8/7/2025 at 9:40 a.m. with the Director (DIR 2) of BHU and the Director (DIR 3) of Security, the facility's security video footage dated 7/30/2025, was reviewed. The following was observed through the security video footage with no audio (when Patient 1 was picked up to attend a conservatorship hearing):
-7:12:45 a.m.: Patient 1, CNA 1, and the ambulance driver were at the facility's BHU (Unit 1) waiting area next to nursing station
-7:13:55 a.m.: Patient 1, CNA 1 and the ambulance driver left the unit using Unit 1's side door on foot
-7:15:40 a.m.: Patient 1, CNA 1 and the ambulance driver got into the ambulance van

During the same concurrent observation and interview on 8/7/2025 at 9:40 a.m. with the Director (DIR 2) of BHU and the Director (DIR 3) of Security, DIR 2 stated Patient 1, CNA 1 and the ambulance driver walked outside of the facility's building to get to the ambulance van.

During a concurrent observation and interview on 8/7/2025 at 9:56 a.m. with DIR 2 and DIR 3, DIR 3 walked 174 steps following the same route, taken by Patient 1, CNA and the ambulance driver, from BHU to the ambulance van on 7/30/2025. DIR 2 stated the route was not safe because it was outside the facility. DIR 2 further stated Patient 1 was exposed to the outside environment and put Patient 1 at risk for elopement (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave).During a concurrent observation and interview on 8/6/2025 at 10:28 a.m. with DIR 2 and DIR 3, the facility's security video footage dated 7/30/2025 was reviewed. The following was observed through the security video footage with no audio (when Patient 1 returned from conservatorship hearing and was dropped off by the ambulance van):
-10:32:58 a.m.: An ambulance van pulled up to main entrance
-10:33:10 a.m.: ambulance driver stepped out from the vehicle and opened the sliding door
-10:33:17 a.m.: Patient 1 stepped out from the vehicle ahead of CNA 1 from the vehicle, walked away from the main entrance toward east side of the facility. CNA 1 stepped out after Patient 1 and followed Patient 1 while ambulance driver stayed by the van
-10:34:09 a.m.: the ambulance van left the facility

During the same concurrent observation and interview on 8/6/2025 at 10:28 a.m. with DIR 2 and DIR 3, DIR 3 stated CNA 1 stepped out from the vehicle six (6) seconds after Patient 1 had gotten out from the vehicle. DIR 2 stated Patient 1 left the facility's premises for about twenty (20) minutes then brought back to the facility by local police department.

During an interview on 8/6/2025 at 11:17 a.m. with the BHU Registered Nurse (RN) 4, RN 4 stated the following: the BHU would send patients out for conservatorship court hearing. The unit would arrange transportation for the patient. Patients would be on one on one (1:1, a patient safety strategy where a designated staff member continuously observes a single patient, remaining in close proximity and able to intervene immediately if needed) monitoring during transportation until their return to the unit. There was no elopement risk assessment tool to assess a patient's elopement risk. RN 4 also stated there were no guidelines or protocols from the facility regarding transporting patients for court hearing.

During an interview on 8/6/2025 at 11:54 a.m. with CNA 1, CNA 1 stated the following: she (CNA 1) accompanied Patient 1 to the court on 7/30/2025. Upon return to the facility, the ambulance driver opened the door, Patient 1 stepped out first then she (CNA 1) came after Patient 1. Patient 1 looked around and stated to CNA 1 that she (Patient 1) did not want to go back inside (the facility). Patient 1 started to walk away. CNA 1 used her (CNA 1's) personal phone to notify the BHU and followed Patient 1. CNA 1 followed Patient 1 all the way across the street. Patient 1 walked in between traffic. CNA 1 had to block the traffic so Patient 1 could cross the street. Patient 1 continued to walk away and hide at the gas station. CNA 1 stated she (CNA 1) did not know where security was. She found out from the facility's security guard later that they did not follow the patient once the patient had left the facility's premises.

During an interview on 8/6/2025 at 12:15 p.m. with CNA 1, CNA 1 stated the following: it was her (CNA 1's) first time accompanying a patient to the court. CNA 1 did not remember if she (CNA 1) had received any training before going with Patient 1. CNA 1 further stated, "there are many risks (when patient was outside of the unit). We should get a class or have an orientation."

During an interview on 8/6/2025 at 12:24 p.m. with CNA 2, CNA 2 stated the following: she (CNA 2) had experience of accompanying BHU patients to the court but there was no training or guidelines given to her (CNA 2) regarding transporting patients to court. She (CNA 2) would stay close with the patients because she (CNA 2) liked to be responsible.

During a concurrent interview and record review on 8/6/2025 at 3:10 p.m. with RN Educator (EDU 1) of BHU, Patient 1's physician order dated 7/15/2025, was reviewed. The physician order indicated "Precaution for suicide, elopement and fall." EDU 1 stated BHU patients on elopement precaution were to remain in the locked unit. EDU 1 further stated if the patient needed to go out of the unit, a staff member would escort the patient to make sure the patient did not elope or run away."

During an interview on 8/6/2025 at 3:15 p.m. with EDU 1, EDU 1 stated the following: the Basic Life Support (BLS) ambulance would drop off and pick up BHU patients next to the BHU nursing station with a gurney. He (EDU 1) never experienced BLS ambulance dropping off a BHU patient at the facility's lobby. EDU 1 also stated it was unsafe to drop off BHU patients at the facility's front lobby because there were many risks outside. EDU stated patients could run away, run into traffic and get hurt.

During an interview on 8/7/2025 at 10 a.m. with DIR 3, DIR 3 stated Patient 1 walked about one (1) mile away from the facility when Patient 1 eloped on 7/30/2025.

During an interview on 8/7/2025 at 10:49 a.m. with DIR 2, DIR 2 stated when the ambulance with Patient 1 returned to the facility on 7/30/2025, CNA 1 should have stepped out of the vehicle before Patient 1 to prevent Patient 1 from eloping. DIR 2 also stated all BHU patients were at risk for elopement.

During a concurrent interview and record review on 8/7/2025 at 10:52 a.m. with DIR 2, the facility's policy and procedure (P&P) titled, "Transportation," dated 9/2023, was reviewed. The P&P indicated, "The purpose of this policy is to establish guidelines for transportation of patients to appointment outside [the facility]." DIR 2 stated the P&P did not indicate any staff responsibilities when accompanying patients outside the facility and did not indicate any procedure of how to send out the patient from the BHU unit to the vehicle and how to receive the patient upon ambulance arrival.

Based on interview and record review, the facility failed to ensure that its Quality Assurance and Performance Improvement (QAPI, the hospital's program that identifies problems, investigates causes, and make improvements to ensure protection of patients and provide safe care) program was working as required.

The facility's QAPI program did not investigate or respond to problems in how controlled substance (drugs such as morphine [a strong pain medication] and fentanyl, a very strong pain medicine regulated by law because they can be abused) were stored, wasted (discard with a witness), or monitored. Instead, QAPI left the investigation to the Drug Diversion Prevention (DDP) team and expected to hear the result from the DDP team.

Because QAPI did not act, unsafe practices continued:
-Nurses were allowed to keep unused narcotics (very strong pain medicines such as morphine and fentanyl) for up to 12 hours without a secure place to store them.
-lock boxes used to store controlled substances on all units were easily accessible for multiple controlled substances without a witness.
- ControlCheck (formally known as Brightsight, the facility's monitoring system) flagged unsafe handling by Registered Nurse (RN 1), but QAPI did not review or act on the data.
-RN 1 was later found unresponsive in the ICU locker room with narcotics and a syringe, while two patients (Patient 11 and Patient 12) were under RN 1's care.

These deficient practices had the potential to jeopardize Patient 11 and Patient 12's safety due to care provided by Registered Nurse (RN 1) who was under the influence (impairment, to any degree, of an individual's ability to safely perform work because of drug use), and unaccounted controlled substances, and also placed other patients at risk for harm.

Findings:

During an interview on 8/5/2025 at 10:30 a.m. with the Director of Quality and Accreditation (DQA), the DQA, stated "There is no official root cause analysis (RCA, a structured was to find the underlying reason for a problem). The Drug Diversion Response team responded and started the investigation on 7/28/2025. QAPI has not had any activity, as this occurred on 7/26/2025 (10 days prior to today). The Director confirmed that QAPI relied on the DDP (Drug Diversion Prevention) team to complete the investigation and communicate back to QAPI.

During an interview on 8/5/2025 at 3:42 p.m. with the Director of Critical Care (DICU), DICU stated RN 1, the nurse who overdosed (a toxic amount of a drug, or combination of drugs overwhelms the body), had no prior issues. The DICU stated, "After the event, we planned to have a bag or case over the narcotics (a drug or other substance that affects mood or behavior), but it has not been implemented." The DICU also stated the hospital used Controlcheck (a computer program that scores staff medication handling to detect possible drug diversion). RN 1's IRIS score (a tool used by Bluesight's Control Check to monitor and detect potential drug diversion by healthcare staff) was 2.5, which was below the hospital's investigation threshold of 5, thus "we did not look into it." The DICU also stated the lock boxes on the units could be opened by any nurse, giving access to multiple narcotics, without a witness.

During a concurrent interview and record review on 8/7/2025 at 12:40 p.m. with the Manager of Pharmacy (MP), RN 1's ControlCheck audit report, was reviewed. MP stated the report was run after the incident on 7/26/2025 for the last 30 days (6/27/2025 -7/27/2025). MP stated they did not look into why RN 1's score was 2.5 because this score was below 5, which was the threshold that the facility would start an investigation. The report indicated the score of 2.5 meant the following:
- "(Name of RN 1) has a highly unusual number of variances (discrepancies or differences between expected and actual quantities of controlled substances, such as medications, during handling and dispensing), including 4 variances with a status of Closed Reconcile (MP stated the Nurse Manager closed this variance that was flagged by the system)." 2 Variances in Reconcile - Missing either administration, waste, or return, and 2 variances in reconciled - Missing administration."
-"(Name of RN 1) logged 5 actions with the time between events exceeding the threshold (60 minutes): 1 action with first dispense (when RN removed the controlled substance) and first administration (when RN 1 gave the medication) for a patient greater than 60 minutes (hospital threshold). 4 actions with first and last touch for a patient greater than 41 minutes (Nursing Average)."

During an interview on 8/6/2025 at 12:54 p.m. with the Director of Pharmacy (DOP), the DOP stated that audit of RN 1's handling of controlled substances was only reviewed after the overdose. The Director stated that nurses were allowed to hold onto narcotics that needed to be wasted (discard) with a witness for up to 12 hours, and there was no secure place to store them during that time. The Director confirmed QAPI did not address this policy gap.

During an interview on 8/6/2025 at 2:45 p.m. with the Chief Medical Officer (CMO), the CMO confirmed that RN 1 was in possession of narcotic (a drug or other substance that affects mood or behavior) medication (morphine vial, a small glass container holding a strong pain medicine), a used syringe (a device for injecting fluids), an uncapped needle (needle without its safety cover), and a tourniquet (a tight band used to slow blood flow, often applied before injecting). The CMO also confirmed that toxicology testing (laboratory test of blood or urine for drugs or poisons) done in the Emergency Department (ED, hospital unit for urgent care) was positive for fentanyl (a very strong opioid pain medication) and opioids (a group of drugs that includes morphine and fentanyl).

During an interview with Intensive Care Unit (ICU, area in hospital that care for the critically ill patients) Nurse Manager (NM)1, NM1 stated NM1 did not look into the 2.5 IRIS score in the ControlCheck system for RN 1, and did not know the details of the 2.5 IRIS score as it was below 5.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment and Performance Improvement (QAPI) Program Plan," dated 5/28/2025, the P&P indicated, "Process improvement indicators will focus on improvement of health outcomes and prevention/reduction of medical errors and will include: Measurement and tracking of medical errors/adverse patient events with analysis of causes ...Data will be intensively assessed when the organization detects or suspects a significant undesirable performance outcome or variation. Intensive analysis is conducted, as follows: Levels of performance, patterns, or trends vary significantly and undesirably from expected, or as compared to peers/recognized standards ... At minimum, the organization will collect data in the following areas ...Adverse Events, including (not limited to): Significant medication errors; adverse drug reactions; medical errors..."

During a review of the facility provided user manual titled, "ControlCheck: Learner's Guide," dated 2023, the guide indicated, "IRIS (a tool used by Bluesight's Control Check to monitor and detect potential drug diversion by healthcare staff) The next section on the card is "IRIS." This will allow you to see your user's IRIS score or "Individual Risk Identification Score" This score uses our metrics to calculate a score of how anomalous this user is compared to their peers. Each of these variances should be thoroughly reviewed before closing ..."

Based on observation, interview and record review, the facility's Governing Body (GB, responsible for guiding the hospital's long-term goals and policies, and assists with strategic planning and decision-making) failed to ensure oversight on the Quality Assurance and Performance Improvement (QAPI, the hospital's program that identifies problems, investigates causes, and make improvements to ensure protect patients and provide safe care) committee to ensure there was a thorough analysis of the causes of a patient safety event and identify and implement an effective action plan, when one of 30 sampled patients (Patient 1), from Behavioral Health Unit (BHU, inpatient unit that provide treatment and therapy for people who have mental, emotional and behavioral disorders) eloped (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave) from the facility on 7/30/2025.

This deficient practice resulted in the facility not having a safe transportation process in place to prevent future occurrence of elopement.

Findings:

During a review of Patient 1's "Behavioral Health History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 7/16/2025, the H&P indicated, Patient 1 was readmitted to the facility's Behavioral Health Unit (BHU, inpatient unit that provide treatment and therapy for people who have mental, emotional and behavioral disorders) with diagnosis of acute (new onset) exacerbation (worsening) of chronic (long-term) schizophrenia (a severe mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

During a review of Patient 1's physician order, dated 7/15/2025, the physician order indicated Patient 1 was placed on suicidal (harming self, ending own's life), elopement (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave) and fall (an unexpected event where a patient unintentionally comes to rest on the floor or another lower level, such as a bed or chair) precaution.

During a review of Patient 1's legal conservatorship (a judge appoints a responsible person to care for another adult who cannot care for themselves or manage their own finances due to physical or mental limitations) document titled, "Petition for appointment of conservator of the person and estate (and temporary conservatorship of the person)," dated 7/3/2025, the legal conservatorship document indicated, Patient 1 was placed on temporary conservatorship since 6/23/2025.

During a review of Patient 1's letter from Department of Mental Health, dated 7/29/2025, the letter indicated, Patient 1 was scheduled for an in-person conservatorship court hearing in [a city] on 7/30/2025 at 8:30 a.m.

During a concurrent observation and interview on 8/7/2025 at 9:40 a.m. with the Director (DIR 2) of BHU and Director (DIR 3) of Security, the facility's security video footage dated 7/30/2025, was reviewed. The following was observed through the security video footage with no audio (video footage that showed when Patient 1 was picked up by the ambulance):
-7:12:45 a.m.: Patient 1, CNA 1, and the ambulance driver were at the facility's BHU (Unit 1) waiting area next to nursing station
-7:13:55 a.m.: Patient 1, CNA 1 and the ambulance driver left the unit using Unit 1's side door on foot
-7:15:40 a.m.: Patient 1, CNA 1 and the ambulance driver got into the ambulance van
-DIR 2 stated Patient 1, CNA 1 and the ambulance driver walked outside of the facility's building to get to the ambulance van.

During a concurrent observation and interview on 8/7/2025 at 9:56 a.m. with DIR 2 and DIR 3, DIR 3 walked 174 steps following the same route Patient 1, CNA 1 and the ambulance driver took from BHU to the ambulance van on 7/30/2025. DIR 2 stated the route was not safe because it was outside of the facility. DIR 2 further stated Patient 1 was exposed to the outside environment and put Patient 1 at risk for elopement (leaving the facility without physician's permission when doing so may present an imminent threat to the person's health or safety as they have been deemed too ill or impaired to make a reasoned decision to leave).

During a concurrent observation and interview on 8/6/2025 at 10:28 a.m. with DIR 2 and DIR 3, the facility's security video footage, dated 7/30/2025, was reviewed. The following was observed through the security video footage with no audio (Video footage that showed when Patient 1 was dropped off at the facility after a conservatorship hearing):
-10:32:58 a.m.: An ambulance van pulled up to the main entrance
-10:33:10 a.m.: ambulance driver stepped out from the vehicle and opened the sliding door
-10:33:17 a.m.: Patient 1 stepped out from the vehicle ahead of CNA 1 from the vehicle, walked away from the main entrance toward east side of the facility. CNA 1 stepped out after Patient 1 and followed Patient 1 while ambulance driver stayed by the van
-10:34:09 a.m.: the ambulance van left the facility
-DIR 3 stated CNA 1 stepped out from the vehicle six (6) seconds after Patient 1 had gotten out from the vehicle. DIR 2 stated Patient 1 left the facility's premises for about twenty (20) minutes then Patient 1 was brought back by local police department.

During an interview on 8/6/2025 at 11:17 a.m. with the BHU Registered Nurse (RN) 4, RN 4 stated the following: the BHU would send patients out for conservatorship court hearing. The unit would arrange transportation for the patient. Patients would be on one on one (1:1, a patient safety strategy where a designated staff member continuously observes a single patient, remaining in close proximity and able to intervene immediately if needed) monitoring during transportation until return to the unit. There was no elopement risk assessment tool to assess a patient's elopement risk. RN 4 also stated there were no guidelines or protocols from the facility regarding transporting patients for court hearing.

During an interview on 8/6/2025 at 11:54 a.m. with CNA 1, CNA 1 stated the following: she (CNA 1) accompanied Patient 1 to the court on 7/30/2025. Upon return to the facility, the ambulance driver opened the door, Patient 1 stepped out first then she (CNA 1) came after Patient 1. Patient 1 looked around and stated to CNA 1 that she (Patient 1) did not want to go back inside (the facility). Patient 1 started to walk away. CNA 1 used her (CNA 1's) personal phone to notify the BHU and followed Patient 1. CNA 1 followed Patient 1 all the way across the street. Patient 1 walked in between traffic. CNA 1 had to block the traffic so Patient 1 could cross the street. Patient 1 continued to walk away and hide at the gas station. CNA 1 stated she (CNA 1) did not know where security was. She found out from the facility's security guard later that they did not follow the patient once the patient had left the facility's premises.

During an interview on 8/6/2025 at 12:15 p.m. with CNA 1, CNA 1 stated the following: it was her (CNA 1's) first time accompanying a patient to the court. CNA 1 did not remember if she (CNA 1) had received any training before going with Patient 1. CNA 1 further stated, "there are many risks (when patient was outside of the unit). We should get a class or have an orientation."

During an interview on 8/6/2025 at 12:24 p.m. with CNA 2, CNA 2 stated the following: she (CNA 2) had experience of accompanying BHU patients to the court but there was no training or guidelines given to her (CNA 2) regarding transporting patients to court. She (CNA 2) would stay close with the patients because she (CNA 2) liked to be responsible.

During a concurrent interview and record review on 8/6/2025 at 3:10 p.m. with RN Educator (EDU 1) of BHU, Patient 1's physician order, dated 7/15/2025, was reviewed. The physician order indicated "Precaution for suicide, elopement and fall." EDU 1 stated BHU patients on elopement precaution were to remain in the locked unit. EDU further stated if the patient needed to go out of the unit, a staff member would escort the patient to make sure the patient did not elope or run away."

During an interview on 8/6/2025 at 3:15 p.m. with EDU 1, EDU 1 stated the following: the Basic Life Support (BLS) ambulance would drop off and pick up BHU patients next to the BHU nursing station with a gurney. He (EDU 1) never experienced BLS ambulance dropping off a BHU patient at the facility's lobby. EDU 1 also stated it was unsafe to drop off BHU patients at the facility's front lobby because there were many risks outside. EDU stated patients could run away, run into traffic and get hurt.

During an interview on 8/7/2025 at 10 a.m. with DIR 3, DIR 3 stated Patient 1 walked about one (1) mile away from the facility when Patient 1 eloped on 7/30/2025.

During an interview on 8/7/2025 at 10:49 a.m. with DIR 2, DIR 2 stated when the ambulance with Patient 1 returned to the facility, CNA 1 should have stepped out of the vehicle before Patient 1 to prevent Patient 1 from eloping. DIR 2 also stated all BHU patients were at risk for elopement.

During a concurrent interview and record review on 8/7/2025 at 10:52 a.m. with DIR 2, the facility's policy and procedure (P&P) titled, "Transportation," dated 9/2023, was reviewed. The P&P indicated, "The purpose of this policy is to establish guidelines for transportation of patients to appointment outside [the facility]." DIR 2 stated the P&P did not indicate any staff responsibilities when accompanying patients outside the facility and did not indicate any procedure of how to send out the patient from the BHU unit to the vehicle and how to receive the patient upon ambulance arrival.

During a concurrent interview and record review on 8/8/2025 at 6:17 p.m. with the Senior Director of Risk Management (SDRM), the facility's "Apparent Cause Analysis (ACA report)," dated 7/30/2025, was reviewed. The ACA report indicated there were corrective actions implemented in response to Patient 1's elopement incident on 7/30/2025 including improving communication between transport team and facility upon return to the facility, re-educating on response to patient's elopement, and offering web-based option for court hearing. The ACA report did not indicate any transport route or steps staff should follow when transporting patient. SDRM stated the following: the ACA meeting was held the same day after Patient 1 eloped from the facility. The ACA did not identify any issue with CNA 1 taking Patient 1 outside of the facility to walk to the ambulance van and CNA 1 letting Patient 1 step out of the vehicle before her (CNA 1).

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment and Performance Improvement (QAPI) Program Plan," dated 5/2025, the P&P indicated, "The Quality Assessment & Performance Improvement (QAPI) Program is a proactive, interdisciplinary, systematic approach to designing or redesigning patient-centered systems to improve quality of care and patient safety, in alignment with regulatory standards ... Structure and Accountability ... [the facility] leadership is responsible for identifying priorities, supporting change management, and allocating resources for [facility] QAPI program. Leadership is responsible for improving quality of care, safety, and serv ices provided by [facility] staff through established structures and processes ... Patient Safety Program... Patient safety integrates with all quality assessment and performance improvement activities. Cause Analysis and Proactive Risk Assessments ... will be utilized to assess actual and potential risk, failure, points of vulnerability, and prioritized areas for improvement based on impact patient care outcomes."

Based on interview and record review, the facility failed to ensure its nursing staff performed reassessment and checked vital signs (measurements of the body's most basic function including body temperature, heart rate, blood pressure, respirations and pain level) for two of 30 sampled patients (Patient 1 and Patient 5), in accordance with the facility's policy regarding "Medication Use to Manage a Psychiatric Emergency," after receiving one-time emergency medication (EM, administering antipsychotic [class of drugs primarily used to manage psychosis, a mental state characterized by a disconnection from reality] medications or intramuscular medications to a patient without the patients' consent to maintain safety for the patient and other people on the unit) intramuscular (IM, into the muscles) injections when:

1. Nursing staff did not reassess and take vital signs for Patient 1 after giving Benadryl (antihistamine [medication that treat allergy symptoms] that can have a calming or sedative [a substance that calms and promotes sleep] effect) 50 milligrams (mg, a unit of measurement), Haldol (medication to treat schizophrenia [mental illness affecting how someone behaves, feels, and thinks] and acute [new onset] agitation [being upset, annoyed, angry and physically disturbed]) 5 mg, and Valium (medication used to treat anxiety [a feeling of unease, worry, or fear] and produce drowsiness (a feeling of sleepiness) and has sedation [a state of calmness or drowsiness induced by drugs] effect)10 mg on 7/30/2025 at 11:25 a.m.

2. Nursing staff did not take vital signs for Patient 5 after giving Valium 5 mg on 6/11/2025 at 7:44 p.m., and injections of Haldol 10 mg, Benadryl 50 mg and Valium 5mg IM on 6/11/2025 at 8:31 p.m.

These deficient practices had the potential to result in Patient 1 and Patient 5 not getting proper evaluation of the effect of the medications and put Patient 1 and Patient 5 at risk for respiratory distress (a condition that occurs when the body needs more oxygen, and can be caused by a number of factors, including infections, chronic illness, or a blocked airway) and oversedation (too much sleepiness and/or drowsiness).

Findings:

1. During an interview on 8/6/2025 at 3:57 p.m. with the Registered Nurse (RN) Educator (EDU 1) of Behavioral Health Unit (inpatient unit that provide treatment and therapy for people who have mental, emotional and behavioral disorders), EDU 1 stated the following: a one-time injection of emergency medication (EM, administering antipsychotic [class of drugs primarily used to manage psychosis, a mental state characterized by a disconnection from reality] medications or intramuscular medications to a patient without his consent to maintain safety for the patient and other people on the unit) intramuscular (IM, into the muscles) injections would be given per physician order when a BHU patient presented behavior that was an immediate danger to self or others. EDU 1 said there should be reassessment including checking vital signs (measurements of the body's most basic function including body temperature, heart rate, blood pressure, respirations and pain level) and behavior assessments performed by the RN after the injections were given.

During a review of Patient 1's "Behavioral Health History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 7/16/2025, the H&P indicated, Patient 1 was readmitted to the facility's BHU with diagnosis of acute (new onset) exacerbation (worsening) of chronic (long-term) schizophrenia (a severe mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

During a review of Patient 1's "Clinical Note Nursing (nurse notes)," dated 7/30/2025, the nurse notes indicated, at 11:30 a.m., "Patient (Patient 1) is agitated (being upset, annoyed, angry, and physically disturbed), tearful and angry for being in the hospital. Question her (Patient 1) admission and does not follow directions. [MD] was notified and emergency IM medication ordered ..."

During a concurrent interview and record review on 8/6/2025 at 4 p.m. with EDU 1, Patient 1's Medication Administration Record (MAR, record of medications given to patients), was reviewed. The MAR indicated Patient 1 received the following medications via intramuscular (IM) on 7/30/2025 at 11:25 a.m.: Benadryl (antihistamine [medication that treat allergy symptoms] that can have a calming or sedative effect) 50 milligrams (mg, a unit of measurement), Haldol (medication to treat schizophrenia [mental illness affecting how someone behaves, feels, and thinks] and acute [new onset] agitation [being upset, annoyed, angry and physically disturbed]) 5 mg, and Valium (medication used to treat anxiety [a feeling of unease, worry, or fear] and produce drowsiness (a feeling of sleepiness) and has sedation [a state of calmness or drowsiness induced by drugs] effect) 10 mg. EDU stated a RN should perform reassessment after the injections.

During an interview on 8/6/2025 at 4:09 p.m. with EDU 1, EDU 1 stated there were no vital signs or reassessment completed for Patient 1 after receiving the emergency medications on 7/30/2025.

During an interview on 8/7/2025 at 12:41 p.m. with the Nurse Manager (NM 2) of BHU, NM 2 stated RN should take vital signs and re-assess patient's behavior, mental status and response to the medications within an hour after emergency medication administration, to make sure there was no adverse effects (unintended, harmful, or unpleasant outcomes that occur during or after treatment with a drug, therapy, or other intervention) from the medications including respiratory distress (a condition that occurs when the body needs more oxygen, and can be caused by a number of factors, including infections, chronic illness, or a blocked airway) and oversedation (too much sleepiness and/or drowsiness).

During an interview on 8/8/2025 at 3:44 p.m. with the Director (DIR 2) of BHU, DIR 2 stated Valium had sedation side effects. DIR 2 further stated Registered Nurses needed to observe and perform reassessment after giving emergency medication injections to the patients to check for patient's response to medications and possible side effects.

During a review of the facility's policy and procedure (P&P) titled, "Medication Use to Manage a Psychiatric Emergency," dated 12/2022, the P&P indicated, "Documentation of Psychiatric Emergency Medication Use ... In admission to the e-MAR documentation, a Nursing Note is to be included in the patient record that describes: i. Reason for the emergency administration ii. Patient understanding of the intervention and patient behaviors during the actual administration iii. Route of administration iv. Observed patient response to the emergency medication."

2. During a review of Patient 5's "Psychiatric History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 6/7/2025, the H&P indicated, Patient 5 was admitted to the facility's Behavioral Health Unit with diagnoses of schizoaffective (a mental illness that affects mood and has symptoms of hallucinations [a false perception that can involve any of the five senses: sight, hearing, touch, smell, or taste] and/or delusions [a belief that is not based in reality and is held with absolute certainty despite evidence to the contrary]) disorder bipolar (a mental illness that causes unusual shifts in mood, energy, and concentration) type and autistic spectrum disorder (ASD, a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave).

During a review of Patient 5's "Clinical Note Nursing," dated 6/11/2025, the nurse notes indicated, "At 7:45 p.m. a code gray (an emergency code that signifies a situation involving a combative or aggressive patient) was called due to patient hitting head on the wall, attempting to hit staff, severe agitation, and being non-redirectable. MD notified and ordered Valium 5 (mg) IM STAT (at once). Medication administered..." The nurse notes also indicated, "at 8:33 p.m. a code gray was called due to patient (Patient 5) starting to hit head on the wall again in addition to swinging arms and legs towards staff. Patient (Patient 5) was highly agitated and combative. MD notified and ordered Haldol 10 mg, Valium 5 mg and Benadryl 50 mg IM STAT. Medication administered ..."

During a review of Patient 5's Medication Administration Record (MAR), dated 6/11/2025, the MAR indicated Patient 5 received an injection of Valium 5 mg at 7:44 p.m., and injections of Haldol 10 mg, Benadryl 50 mg and Valium 5mg IM at 8:31 p.m.

During an interview on 8/6/2025 at 3:57 p.m. with the Registered Nurse (RN) Educator (EDU 1) of BHU, EDU 1 stated the following: a one-time injection of emergency medication would be given per physician order when a BHU patient presented behavior that was an immediate danger to self or others. There should be reassessment including checking vital signs and behavior assessments, performed by the RN after the injections were given.

During an interview on 8/7/2025 at 12:41 p.m. with the Nurse Manager (NM 2) of BHU, NM 2 stated the RN should take vital signs and re-assess patient's behavior, mental status and response to the medications within an hour after emergency medication administration, to make sure there was no adverse effects from the medications including respiratory distress and oversedation.

During a concurrent interview and record review on 8/8/2025 at 3:35 p.m. with Nurse Manager (NM 2) of BHU, Patient 5's vital signs record titled, "Vital Signs," dated 6/11/2025, was reviewed. The vital signs record indicated there was only one set of vital signs taken on 6/11/2025 at 7:31 p.m. The vital signs record indicated there were no other vital signs taken on 6/11/2025. NM 2 stated there were no vital signs checked after Patient 5 received emergency medication injections at 7:44 p.m. and at 8:31 p.m. NM 2 stated the reassessment was incomplete.

During an interview on 8/8/2025 at 3:44 p.m. with the Director (DIR 2) of BHU, DIR 2 stated Valium had sedation side effects. DIR 2 further stated Registered Nurses needed to observe and perform reassessment after giving emergency medication injections to the patients to check for patient's response to medications and possible side effects.

During a review of the facility's policy and procedure (P&P) titled, "Medication Use to Manage a Psychiatric Emergency," dated 12/2022, the P&P indicated, "Documentation of Psychiatric Emergency Medication Use ... In admission to the e-MAR documentation, a Nursing Note is to be included in the patient record that describes: i. Reason for the emergency administration ii. Patient understanding of the intervention and patient behaviors during the actual administration iii. Route of administration iv. Observed patient response to the emergency medication."

Based on interview and record review, the facility failed to ensure nurses followed the hospital policy on medication administration documentation, for one (1) of 31 sampled patients (Patient 27), when there was a delay in wasting or returning a bag of Fentanyl which was removed from the Pyxis (an automated medication dispensing system) on 7/09/2025.

This deficient practice had the potential for inaccurate medication administration, medication errors, and/or issues with unaccounted controlled substances (a drug or chemical that is regulated by the government due to potential for abuse or addiction, for example opioids and narcotics).

Findings:

During an interview on 8/7/2025 at 12:50 p.m. with the director of Intensive Care Unit (DICU), the DICU stated medication administration was expected to happen soon after medication removal from the Pyxis (an automated dispensing system that included a secure computerized cabinet that stores and dispenses medication at nursing unit and integrate with the hospital's electronic medical record system) or dispensed by Pharmacy.

During a review of the Pyxis activity report, the pharmacy manager (MP) confirmed there was a premixed bag of fentanyl (narcotic, controlled substances, and a potent opioid to treat pain and used in anesthesia) 1000 micrograms (mcg, unit to measure mass) per 100 milliliter (ml, unit to measure volume) in 100 ml bag was removed on 7/9/2025 at 8:08 a.m. for Patient 27 and returned at 10:58 a.m., two hours and 50 minutes later, on the same date.

During a concurrent interview on 8/8/2025 at 4:22 p.m. with the director of pharmacy (DOP), the DOP stated there were 2 hours and 50 mins of unknown activity and/or storage of the fentanyl, which had the potential for diversion, theft, and pilferage. DOP stated nurses should return or waste medication as soon as possible.

During an interview on 8/8/2025 at 5:45 p.m., DICU stated, on 7/9/2025 between 9 a.m. to 11 a.m., there was no emergency event documented that might cause a delay in the medication return process, and no documented reason for the delay.

During a review of the facility's policy and procedure (P&P) titled, Medication Administration (revised 12/6/2024), the policy indicated " ... Documentation ... If medication was not given, document a reason and state ... document reason ..."

Based on observation, interview, and record review, the facility failed to:

1. Ensure that nurses measured and documented the amount of controlled substances (medication like morphine or fentanyl that are regulated by law due to their high risk for abuse or addiction) remaining in patient -controlled analgesia (PCA, a pain -management method that allows patients to self-administer small doses of pain medicine through a pump) tubing when discontinuing PCA therapy affecting approximately two (orthopedic patients per month) of 31 sampled patients, who are placed on PCA therapy (Director of Medical Surgical confirmed this information on 8/8/2025 at 12:45 p.m.).

This deficient practice placed approximately two orthopedic patients per month at risk for inaccurate medication documentation and unaccounted controlled substances. In addition, this failure resulted in unaccounted narcotics (a drug or other substance that affects mood or behavior and is consumed for nonmedical purposes) being discarded into unsecured bins without measurement or witness verification. This created a risk for diversion (when drugs are used for purposes other than a patient's prescribed treatment) by staff, which could result in impaired staff providing unsafe care, thereby placing all patients on the orthopedics unit at risk.

2. Ensure that a patient had pain medication orders that addressed the full range of pain on a numeric pain scale utilized by the facility to address patients' pain (0: No pain,1-3: Mild pain, 4-6: Moderate pain,7-10: Severe pain, and 10: The worst pain imaginable), in accordance with the facility's policy regarding pain management. For one (1) of 31 sampled patients (Patient 17), the medical record showed that the patient had no medication ordered for mild to moderate pain (1-6).

This deficient practice placed Patient 17 at risk for experiencing unnecessary suffering from untreated mild to moderate pain (levels 1-6), which had the potential to cause prolonged discomfort, increased stress on the body, and delay recovery.

Findings:

1. During an interview on 8/8/2025 with RN 15 and the Director of Medical Surgical (DIR) 1, RN 15 demonstrated PCA (patient -controlled analgesia, a pain -management method that allows patients to self-administer small doses of pain medicine through a pump) discontinuation in the medication room. RN 15 showed how the morphine syringe removed from the PCA would be discarded into the blue bins (non-hazardous medication waste and sharps container). The tubing attached to the syringe, which contained residual medication, was also discarded into the blue bin without measurement of the liquid inside. RN 15 stated, "The liquid in the tubing goes into the blue bin, we don't measure it." The DIR 1 confirmed the blue bin had an open lid and can be accessed by anyone having access to the medication room, which included RNs, computer technician, maintenance service, and EVS (environmental services, responsible for maintaining the cleanliness, hygiene, and safety of the hospital premises).

During an interview with RN 19 and DIR 1 on 8/8/2025 at 12:19 p.m., RN 19 explained the PCA discontinuation process: obtaining a witness nurse, removing the syringe fluid into a white container, documenting the waste in the MAR (Medication Administration Record), and discarding the syringe with tubing attached into the sharp's container. However, RN 19 did not mention measuring the amount of medication remaining in the tubing. The Director confirmed that tubing containing controlled substances was also discarded into the blue bin without measurement of the remaining amount so it can be accounted for.

During an interview with RN 20 and DIR 1 on 8/8/2025 at 12:37 p.m., RN 20 stated that PCA syringes were emptied into white bins containing solutions designed to cause break down of the controlled substance (disintegration). Tubing was discarded into the blue bin without measuring the residual fluid inside the tubing. DIR 1 confirmed that approximately one to two patients on the orthopedics unit may be placed on PCA therapy in a given month.

During an interview with the Clinical Nurse educator (CNE) on 8/8/2025 at 12:55 p.m., the CNE confirmed that during staff training, nurses were taught that both the syringe and the tubing from PCA pumps must be measured for residual controlled substances. The CNE stated, "It is important to account for the medication in the tubing, because it contains controlled substances, and throwing it (tubing with controlled substance residual) away without measurement creates a diversion risk since the bins were accessible. CNE stated the facility did not have written educational material or protocol on measurement of PCA syringe and tubing residual; however, the education department will add this to the training materials.

During a concurrent interview and record review on 8/7/2025 at 12:32 p.m. with the Pharmacy Manager (MP), the facility's policy and procedure (P&P) titled, "Controlled Substance Waste Disposal," dated 5/28/2025, was reviewed. The P&P indicated, the policy affected departments/services which included Pharmcy Services, Nursing Services, Anesthesia Services, and Environmental Services (EVS), "Unused controlled medications are wasted in a designated controlled substance waste container in accordance with established procedure and documentation requirements." MP confirmed that the facility did not have a policy and procedure on wasting controlled substances from the PCA with syringe and tubing attached; however, MP stated all of the remaining unused controlled substances should be accounted for and documented during the wasting process.

2. During a review of Patient 17's History and Physical (H&P, the initial document describing a patient's medical history and condition), dated 8/1/2025, the H&P indicated that Patient 17 was admitted for possible stroke (a condition where blood supply to part of the brain is interrupted, causing brain tissue damage). The H&P further indicated that Patient 17 reported headaches, right-and left-sided numbness, and an inability to walk.

During a concurrent observation, interview, and record review on 8/1/2025 with RN 21, who was assigned to Patient 17's care, Patient 17 was observed sleeping, but face appeared reddened with a slight elevation of respiration (number of breaths per minute) at 22. In Patient 17's electronic medical record (EMR, the digital record of a patient's health information), in the section titled "Orders," RN 21 confirmed that there were no pain medication orders for pain levels 1-6 on the numeric pain scale (a tool used by healthcare providers where 0: No pain,1-3: Mild pain, 4-6: Moderate pain,7-10: Severe pain, and 10: the worst pain imaginable). RN 21 stated that the only order present was for Morphine (a strong pain medication) 1 milligram (mg, a unit of measurement) every 4 hours for severe pain (level 7-10).

During an interview on 8/1/2025 at 12:35 p.m. with the Intensive Care Unit (ICU, area in hospital caring for the critically ill patients) Nurse Manger (NM) 1, NM 1 stated that the standard process was for nurses to contact the physician if a patient did not have pain medications ordered to cover all levels of pain on the numeric scale. NM 1 stated that this process was important because patients may experience varying levels of pain, and the care team must be able to address pain at every level from 1-10.

During a review of the facility's policy and procedure (P&P) titled, "Nursing Pain Management of Patients," dated 5/28/2024, the P&P indicated, "The purpose of this policy is to promote prompt and effective assessment, diagnosis, and treatment of pain using a collaborative, multidisciplinary approach to pain management with participation of the patient and the patient's family/significant other... The goals of pain management include Maximum pain relief. Preservation or restoration of function. Achieving the highest possible quality of life based on the patient's unique needs and condition ...responsivities, Registered Nurse: Collaborates with the patient and providers to establish the effective plan of care and goals for pain management ... To aid in avoiding pain recurrence, analgesics should be scheduled in a manner to maximize comfort and promote level of pain at or below tolerable level ..."

Based on interview and record review, the facility failed to develop policies and procedures for the control and storage of medications, which may negatively impact 31 of 31 sampled patients, as evidenced by:

1. Failure to develop a policy and procedure for a contracted vendor software, ControlCheck (formerly called Bluesight, a program that utilizes artificial intelligence and machine learning to monitor and analyze medication transactions, identify unusual patterns, and flags potential drug diversion [unauthorized or illegal transfer of prescription medications from their intended recipients to others, or their use for purposes not intended by the prescriber] events to ensure accountability of medications) that has been in use since 9/12/2018.

2. Failure to develop a policy and procedure that indicated an acceptable time frame for nurses to return or waste a medication, and the interim secure storage of such medications in the event that the return or the disposal could not happen within the approved period.

These deficient practices had the potential for wrong medication, drug diversion, and/or pilferage (stealing medication) that may affect patient safety.

Findings:

1. During an interview on 8/5/2025 at 12:11 p.m. with the director of pharmacy (DOP), the DOP stated the hospital used a program called Bluesight (now renamed ControlCheck, a program that utilizes artificial intelligence and machine learning to monitor and analyze medication transactions, identify unusual patterns, and flags potential drug diversion [unauthorized or illegal transfer of prescription medications from their intended recipients to others, or their use for purposes not intended by the prescriber] events to ensure accountability of medications) to monitor controlled substances (a drug or chemical that is regulated by the government due to potential for abuse or addiction, for example opioids (a group of drugs that includes morphine [a strong pain medication] and fentanyl [a very strong pain medication]) and narcotics [a drug or other substance that affects mood or behavior]).

During a concurrent interview and record review on 8/7/2025 at around 4:18 p.m. with the Director of Quality Accreditation (DQA), the DQA presented the contract for the use of ControlCheck (or Bluesight) and was reviewed. The contract indicated it was effective on 9/12/2018.

During an interview on 8/8/2025 at 9:59 a.m. with the Director of Pharmacy (DOP), the DOP stated the hospital did not have a policy and procedure regarding the process of using Blue Sight or Control Check.

2. During a concurrent interview and record review on 8/6/2025 12:44 p.m. with the Director of Pharmacy (DOP), the hospital policy titled, Automated Dispensing Cabinets (ADC, controlled substances: distribution, administration, and accountability, and automated dispensing cabinets), revised 1/3/2024, was reviewed. DOP stated the ADC policy did not indicate where the nurses should keep the unused portion of narcotic medications to be wasted, if waiting to find a witness for the disposition process. DOP stated per policy, nurses had until the end of the shift (each shift is typically 12 hours long), or 4 hours within patient discharge out of the hospital, to enter the wastage in the pyxis (an automated dispensing system that included a secure computerized cabinet that stores and dispenses medication and integrate with the hospital's electronic medical record system).

During an interview on 8/6/2025 at 1:30 p.m., the chief medical officer (CMO) stated nurses could keep used vials or medication in their pockets until they could find a witness to document the wastage.

During a review of the Pyxis (an automated dispensing system that included a secure computerized cabinet that stores and dispenses medication and integrate with the hospital's electronic medical record system) activity report, dated 7/9/2025, the pharmacy manager (MP) confirmed there was a premixed bag of fentanyl (narcotic, controlled substances, and a potent opioid to treat pain and used in anesthesia) 1000 micrograms (mcg, unit to measure mass) per 100 milliliter (ml, unit to measure volume) (in 100 ml bag) removed on 7/9/2025 at 8:08 a.m. for Patient 27 and returned at 10:58 a.m., two hours and 50 minutes later on the same date.

During an interview on 8/8/2025 at 4:22 p.m. with the director of pharmacy (DOP), the DOP stated there were two (2) hours and 50 mins of unknown activity and/or storage of the fentanyl, which had the potential for diversion, theft, and pilferage. DOP stated nurses should return or waste medication as soon as possible.

During a review of the hospital's policy and procedure (P&P) titled, Drug Storage (revised 9/29/2022), the P&P indicated " ... The medication storage areas in the pharmacy and throughout the hospital are under the supervision of the director of pharmacy or designee. ... All medications are stored in locked areas ... Drug storage in patient care areas ... Controlled drugs stored on the unit ... in a locked cabinet in a secured area to prevent diversion ..."

Based on observation, interview, and record review, the facility failed ensure that a record system was properly in place to maintain current and accurate records of the receipt and disposition of scheduled drugs by failing to develop and implement policies and procedures to:

- Secure controlled substances (drugs such as morphine [strong opioid pain medication] and fentanyl [(a very strong opioid pain medication]) that are regulated by law because they can be abused or cause dependence).

-Monitor medication handling.

- Prevent diversion (when medication is used for reason other than prescribed treatment).

This deficient practice involved two (2) of 31 sampled patients (Patient 11 and Patient 12), who were under the care of Registered Nurse (RN) 1, a nurse later confirmed by toxicology testing (laboratory analysis to detect drugs or poisons) to be under the influence (impairment, to any degree, of an individual's ability to safely perform work because of drug use) of fentanyl (a strong opioid pain medication) and opioids (a drug class includes fentanyl and morphine) while on duty.

This deficient practice resulted in Patient 11 and Patient 12 being at immediate risk for harm due to care previously provided by a nurse under the influence of controlled substances. In addition, because the facility continued to allow unsecured storage and inadequate monitoring of controlled substances, other patients in the facility remained at risk for harm from potential diversion, delayed pain treatment, or medication errors.

On 8/7/2025 at 4:30 p.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements have caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient), in the presence of the Chief Medical Officer (CMO), Patient Care Executive/Chief Nursing Officer (CNO), Director of Quality (DQ), Administrative Director of Cardiovascular, Peri-Operative, Imaging (AD 1), and the System Director for Accreditation and Licensing (SDAL) who attended via telephone. The facility failed to develop and carry out effective policies and procedures to:
-Secure controlled substances (medication like morphine or fentanyl that are regulated by law due to their high risk for abuse or addiction).
- Monitor medication handling.
-Prevent diversion (when drugs are used for purposes other than a patient's prescribed treatment).

During an interview with the Director (DICU) of Intensive Care Unit (ICU, area in the hospital that cares for critical ill patients) on 8/5/2025 at 3:42 p.m., DICU stated Registered Nurse (RN) 1 was found unresponsive (not awake and not reacting) in the ICU locker room while on duty.

During an interview on 8/6/2025 at 2:45 p.m. with the Chief Medical Officer (CMO), the CMO confirmed that RN 1 was in possession of narcotic (a drug or other substance that affects mood or behavior) medication (morphine vial, a small glass container holding a strong pain medicine), a used syringe (a device for injecting fluids), an uncapped needle (needle without its safety cover), and a tourniquet (a tight band used to slow blood flow, often applied before injecting). The CMO also confirmed that toxicology testing (laboratory test of blood or urine for drugs or poisons) done in the Emergency Department (ED, hospital unit for urgent care) was positive for fentanyl (a very strong opioid pain medication) and opioids (a group of drugs that includes morphine and fentanyl).

During a concurrent interview and record review with the Medication Safety Officer (MSO) on 8/7/2025 at 4:00 p.m., Patient 11's "Medication Administration Record (MAR)," dated 7/24/2025, was reviewed. The MAR indicated that RN 1 started an intravenous (IV, administer medication into the vein) infusion of 100 milliliters (ml, a unit of measurement) intended to run for 10 hours at a rate of 10 ml per hour. The medication was stopped after 8 hours of infusion. MSO confirmed that only 75 ml were documented as infused, and approximately 25 ml were unaccounted for.

During a record review of Patient 12's medication dispensing report indicated that RN 1 removed morphine three times in one day (a 12-hour shift; from 7:00 p.m. through 7 a.m. at 8:32 p.m., 10:22 p.m., and at 3:22 a.m.).

During an interview with the Director of Pharmcy (DOP) on 8/7/2025 at 12:54 p.m., the DOP confirmed that the facility's policy, "Automated Dispensing Cabinet," dated 1/3/2024, allowed licensed nurses to retain (keep) controlled substances pending waste (leftover medication to be discarded with a witness) for up to 12 hours, but did not require secure interim storage (locked area).

During a concurrent interview and record review on 8/7/2025 at 12:32 p.m. with the Pharmacy Manager (MP) and the Medication Safety Officer (MSO), RN 1's audit record dated from 7/5/2025 through 8/4/2025 from the system called "Control Check (formally known as Blue Sight, a drug diversion detection software). MSO confirmed that the system flagged an alert when a fentanyl drip was administered more than 60 minutes after removal from the dispensing system. However, because RN 1's IRIS score (Individual Risk Identification Score, a diversion risk score) was 2.5 (below the facility's investigation threshold of 5), no investigation occurred.
This resulted in Patient 11 and Patient 12, and potential other patients being at immediate risk for harm due to care previously provided by a nurse under the influence of controlled substances and the unsecured handling of narcotic medication.

On 8/8/2025 at 8:41 p.m. the IJ was removed in the presence of the CMO, CNO, DQ, AD 1, Director (DIR 2) of Behavioral Health Unit, Nurse Manager (NM 2) of BHU, and SDAL who attended via telephone, after the facility submitted an acceptable IJ Removal Plan (interventions to correct the deficient practice). The elements of the IJ Removal Plan were verified and confirmed by the survey team while onsite through observation, interview, and record review. The IJ Removal Plan indicated immediate corrective actions which included: Audits (an official inspection) all controlled substance (a drug or chemical whose manufacture, possession, and use are regulated by a government because it may be abused or cause addiction) removed, plan to revise policies, education on new policies process to pharmacy manager and ICU RNs, and immediate monitoring by ICU Charge RN, will monitor the distribution, administration and accountability of controlled drugs and automated dispensing cabinet (ADC, controlled substances: distribution, administration, and accountability, and automated dispensing cabinets) activity report twice a shift.

On 8/7/2025 p.m., the ICU Charge RN immediately audited all controlled substances. Starting on 8/7/2025, the Pharmacy Director educated the Pharmacy Manager, Medication Safety Officer, and Pharmacy Supervisor on revised policies and processes for safe and secure monitoring and handling of dispensed controlled substances. Policies will be revised: Distribution, Administration and Accountability of Controlled Drugs and Automated Dispensing Cabinet (ADC) policy. Revision to the ADC Policy regarding partial waste, which will indicate, immediate waste of partial doses (excluding drips, PCAs, compounds) at the time of removal from ADC, must be witnessed by 2 licensed healthcare professionals and recorded in the ADC. This will replace the process of allowing waste by the end of the shift or within 4 hours of patient discharge. If immediate waste is not possible due to urgent patient care (i.e. rapid sequence intubation, code blue), the remaining portion of the medication must be immediately wasted or returned back to pyxis (if unopened). The justification of the delay must be documented during waste transaction at the ADC. Documentation of controlled substances withdrawn from ADC and subsequent waste, must occur with 2 licensed healthcare professionals at times of medications dispensed, except for life threatening emergencies and procedure/procedural areas. Education: Controlled Substances removed from pyxis must be administered immediately (immediate is defined as 15 minutes). Documentation of waste must occur at the time of medication removal from Pyxis by two licensed healthcare professionals. In cases such as procedures & emergencies, the waste will be documented at the completion of the procedure/emergency. The ICU Director met with ICU RNs on shift to provide education on the revised process for the safe and secure handling of controlled substances. Incoming staff will receive training prior to beginning their shift, until 100% active ICU RNs are trained. ICU RNs on leave will be trained upon return to shift. Immediate Monitoring: Starting 8/7/2025, the ICU Charge RN will monitor the ADC activity report twice a shift every 6 hours. Audit includes review of dispensed controlled substances drawn, wasted, administered and reconciled with the MAR. Audit will be conducted for 7 days by the ICU Charge RN and unresolved discrepancies will be escalated to ICU Director or Manager. After 7 days, audit will become integrated into ICU daily operations for 7 days. Any fallout will be immediately addressed and corrective action taken according to just culture algorithm. Unresolved discrepancies will be immediately escalated by the ICU Director or Manager to the Director of Pharmacy who would activate the DDRT if further investigation is required.


Findings:

During an interview with the Director of the Intensive Care Unit (DICU) on 8/5/2025 at 3:42 p.m., DICU confirmed RN 1 was found unresponsive (not awake not reacting) in the ICU locker restroom while on duty. DICU confirmed that RN 1 was assigned the care of Patient 11 and Patient 12 on the night RN 1 was found unresponsive (a person is not reacting or able to react in a normal way to stimuli like touch, sound, or commands).

During an interview on 8/6/2025 at 2:45 p.m. with the Chief Medical Officer (CMO), the CMO confirmed that RN 1 was in possession of a morphine vial (a small glass container holding a strong pain medicine), used syringe (a device for injecting fluids), uncapped needle (needle without its safety cover), and tourniquet (a tight band used to slow blood flow, often applied before injecting) at the time RN 1 was found unresponsive (7/26/2025). The CMO also confirmed toxicology testing (laboratory analysis to detect drugs or poisons) in the Emergency Department (ED, a hospital unit for urgent medical care) was positive for fentanyl (a very strong opioid pain medication) and opioids (a group of drugs that includes morphine and fentanyl).

During a review of Patient 11's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 7/21/2025 , the "H&P" indicated, Patient 11 had past medical history which included pancreatic cancer (a type of cancer that develops in the pancreas, an organ located behind the stomach that plays a crucial role in digestion and blood sugar regulation), on chemotherapy (the treatment of disease by the use of chemical substances). Patient 11 was admitted for worsening abdominal pain, with a care plan including pain control.

During a review of Patient 11 's "Medication Administration Record (MAR)," dated 7/26/2025, the MAR indicated Patient 11 had a physician's order for fentanyl (a very strong opioid pain medication) infusion intravenously (medication administered into the vein).

During a concurrent interview and record review on 8/7/2025 at 4:00 p.m. with the Medication Safety Officer (MSO), Patient 11's "Medication Administration Record (MAR)," dated 7/24/2025, was reviewed. The MAR indicated that RN 1 administered a new bag of fentanyl (a very strong opioid pain medication) 100 milliliters (ml, a unit of measurement) intravenously (IV, administer medication into the vein) infusing for eight (8) hours. MSO stated the total volume infused was 75 ml when a new bag was changed. MSO confirmed that approximately 25 ml was unaccounted for. MSO stated pharmacy did not know where the unaccounted fentanyl went.

During a review of Patient 12's "History and Physical (H&P)," dated 7/21/2025, the "H&P" indicated, Patient 12 was transferred to the facility due to having an aneurysm (part of an artery wall weakens, allowing it to abnormally balloon out or widen).

During a review of Patient 12's medication dispensing report dated, 7/25/2025, the report indicated RN 1 removed Morphine (strong opioid pain medication) three (3) times in one day (7 a.m. - 7:00 p.m.): at 8:32 p.m.,10:22 p.m., and 3:22 a.m.

During a concurrent interview and record review on 8/7/2025 at 12:32 p.m. with the Pharmacy Manager (MP) and the Medication Safety Officer (MSO), RN 1's audit record in "Control Check (a drug diversion monitoring software, formerly called Bluesight) for period of 7/5/2025 - 8/4/2025, was reviewed. The MSO stated the system flagged alerts for fentanyl infusions given more than 60 minutes after removal from the Pyxis (an automated medication dispensing system). However, RN 1's IRS score (individual Risk Identification Score, a risk score for diversion) was 2.5, below the facility's threshold of 5. Therefore, no investigation occurred.

During a concurrent interview and record review on 8/7/2025 at 12:40 p.m. with the Manager of Pharmacy (MP), RN 1's ControlCheck audit report, was reviewed. MP stated the report was run after the incident on 7/26/2025 for the last 30 days (6/27/2025 -7/27/2025). MP stated they did not look into why RN 1's score was 2.5 because this score was below 5, which was the threshold that the facility would start an investigation. The report indicated the score of 2.5 meant the following:

- "(Name of RN 1) has a highly unusual number of variances (discrepancies or differences between expected and actual quantities of controlled substances, such as medications, during handling and dispensing), including 4 variances with a status of Closed Reconcile (MP stated the Nurse Manager closed this variance that was flagged by the system)." Two (2) Variances in Reconcile - Missing either administration, waste, or return, and 2 variances in reconciled - Missing administration."

-"Name of RN 1) logged 5 actions with the time between events exceeding the threshold (60 minutes): 1 action with first dispense (when RN removed the controlled substance) and first administration (when RN 1 gave the medication) for a patient greater than 60 minutes (hospital threshold). Four (4) actions with first and last touch for a patient greater than 41 minutes (Nursing Average)."

During an interview on 8/7/2025 at 12:54 p.m. with the Director of Pharmacy (DOP), the DOP stated the policy titled, "Automatic Dispensing Cabinet (a computerized medicine storage and tracking system)," dated 1/3/2024 allowed nurses to keep controlled substances that required wasting (throwing away leftover drugs with witness) for up to 12 hours without defining a secure storage location (locked cabinet or other secure space). DOP confirmed that RNs "keep the medication in their possession until they can waste it with a witness," and there was no policy on how or where to store the medication securely during this time.

During an interview on 8/6/2025 at 2:22 p.m. with the Compliance Officer (CO), the CO stated the diversion response team (a group of professionals who focus on diversion prevention and response) was only activated after RN's overdose (a toxic amount of a drug, or combination of drugs overwhelms the body).

During an interview on 8/6/2025 at 3:10 p.m. with the Director (DICU) of Intensive Care Unit (area in hospital that care for the critical ill patients), DICU stated that to waste a medication, two RNs must be present to enter the amount being wasted into the Medication Administration Record (MAR, the electronic log of medications given). Both nurses' names must be documented. If unable to waste right away, the RN will keep the medication until a witness was available. DICU stated if there were multiple pending wastes, the Pyxis (an automated medication dispensing system) would display them, and ControlCheck will alert the manager that waste required witnessing at the beginning of the next shift.

During an interview on 8/7/2025 at 9:48 a.m. with ICU RN, (RN 17), RN 17 stated that if an emergency prevented wasting immediately, the unused narcotic (a drug or other substance that affects mood or behavior) may be placed in a medication lock box. RN 17 stated that "everyone can get the key; anyone can get it with access to Pyxis," and there was no witness requirement when placing medications in the lock box. RN 17 further stated that all controlled substances placed in the box were accessible to any RN with the key.

During an interview on 8/7/2025 at 10:07 a.m. with ICU RN (RN 18), RN 18 confirmed that if waste could not be completed right away, nurses either carried the medication until a witness was available or placed it in the medication lock box. RN 18 confirmed there was no witness requirement for lock box use.

During a concurrent observation and interview on 8/7/2025 at 11:51 a.m. with the ICU Nurse Manager (NM) 1 in the ICU's medication room, on the wall was a mounted transparent medication box. NM 1 confirmed multiple controlled substances could be placed inside and accessed by any nurse with Pyxis access, without a witness.

During an interview on 8/8/2025 at 5:00 p.m. with the DOP, DOP confirmed lock boxes existed on all units and that any nurse with Pyxis access could retrieve the key. The DOP stated there was no written policy or protocol for lock box use.

During a review of the facility's policy and procedure (P&P) titled, "Automated Dispensing Cabinet (ADC)," dated 1/3/2024, the P&P indicated, "Wasting a medication: Documentation of waste must occur at the time of medication removal from ADC. Within 4 hours of patient discharge time or by the end of the shift ..."

During a review of the facility's policy and procedure (P&P) titled, "Distribution, Administration and Accountability of controlled drugs," dated 12/6/2024, the P&P indicated, "The pharmacy department will comply with all applicable State & Federal laws pertaining to control, distribution and accountability of Controlled Substances."

During a review of the facility's policy and procedure (P&P) titled, "Reasonable Suspicion Drug and Alcohol Guide," dated August 2024, the P&P indicated, "(Name of the Facility) is committed to the safe and secure workplace for all employees. The philosophy of a drug-free workplace is grounded in the belief that a safe, healthy, and productive work environment is essential for the well-being of employees, patients and the organization ... Ensuring a safe workplace is paramount. Illegal drug use and alcohol misuse can impair judgment, coordination, and reaction times, increasing the risk of accidents and injuries. A drug and alcohol-free workplace policy aims to mitigate these risks and protect employees and patients. Illegal drug use and alcohol misuse negatively affects employee performance, leading to errors, decreased efficiency, and poor decision-making. Maintaining a drug and alcohol-free workplace helps ensure that employees are operating at their highest capacity, contributing to overall organizational success ..."

During a review of the facility provided user manual titled, "ControlCheck: Learner's Guide," dated 2023, the guide indicated, "IRIS (a tool used by Bluesight's Control Check to monitor and detect potential drug diversion by healthcare staff) The next section on the card is 'IRIS.' This will allow you to see your user's IRIS score or 'Individual Risk Identification Score' This score uses our metrics to calculate a score of how anomalous this user is compared to their peers. When viewing the audit ... Each of these variances should be thoroughly reviewed before closing ..."

Based on observation, interview and record review, the facility failed to ensure pharmacy oversight of controlled substances (a drug or chemical that is regulated by the government due to potential for abuse or addiction, for example opioids and narcotics), which may negatively impact 31 of 31 sampled patients, as evidenced by:

1. Failure to ensure the pharmacy department manually reviewed the Control Check (formerly called Bluesight, a program that utilizes artificial intelligence and machine learning to monitor and analyze medication transactions, identify unusual patterns, and flags potential drug diversion [unauthorized or illegal transfer of prescription medications from their intended recipients to others, or their use for purposes not intended by the prescriber] events to ensure accountability of medications) alerts for potential diversion of Controlled drugs substances instead of just relying on the Control Check program to identify.

2. Failure to investigate an alert for a long lapse (close to 2 hours) between the time of removal from Pyxis (an automated dispensing system that included a secure computerized cabinet that stores and dispenses medication and integrate with the hospital's electronic medical record system) and the time of administration for a fentanyl (narcotic that is used in anesthesia and pain management) infusion (drip, the process of delivering medication directly into the bloodstream through a needle, typically through a vein, or intravenously/IV) bag on 7/11/2025, for one of 30 sampled patients (Patient 11).

3. Failure to ensure that substances (medications regulated by law due to risk of abuse or dependence, such as fentanyl and morphine) stored in medication lock boxes located throughout all units in the facility were secured and protected from unauthorized access, in accordance with the facility's policy regarding "Distribution, Administration and Accountability of controlled drugs." Once the lock box was opened by a nurse, that nurse had access to all other controlled substances inside, and there was no requirement for a witness when placing or removing medications.

These deficient practices placed patients at risk for harm from diversion (when
medications are taken or used for purposes other than prescribed), delayed pain
treatment (such as when medication was diverted, thus patient did not receive pain medication on time or as prescribed), or medication errors (such as when medication had been tampered with or inaccurate amount of pain medication was administered not following prescription).

Findings:

1. During an interview on 8/5/2025 at 12:11 p.m. with the director of pharmacy (DOP), the DOP stated the hospital used a program called Bluesight (now renamed ControlCheck, a program that utilizes artificial intelligence and machine learning to monitor and analyze medication transactions, identify unusual patterns, and flags potential drug diversion [unauthorized or illegal transfer of prescription medications from their intended recipients to others, or their use for purposes not intended by the prescriber] events to ensure accountability of medications) to monitor controlled substances (CS, a drug or chemical that is regulated by the government due to potential for abuse or addiction, for example opioids and narcotics).

During a concurrent interview and record review on 8/7/2025 at 11:29 a.m. with the medical Safety Officer (MSO), the Patient Care Audit function of the ControlCheck program, was reviewed. MSO stated the ControlCheck was not set up to monitor any infusion (or drips, the process of delivering medication directly into the bloodstream through a needle, typically through a vein, or intravenously/IV)) because the program cannot monitor infusion rate, or volume.

During an interview on 8/7/2025 at 11:48 a.m. with the MSO, the MSO stated monitoring the ControlCheck was part of her (MSO) daily duty.

During an interview on 8/7/2025 at 12:42 p.m. with the MSO, the MSO stated that because the ControlCheck program could not monitor controlled substance drips accurately, the program could not close or reconcile drips with the administration record, and the program would just flag those as audit alerts, which would require the Pharmacist or nursing managers to manually clear the alerts.

During a review of the ControlCheck generated Individual Risk Identification Score (IRIS, is a proprietary score the program used to identify and prioritize individuals at higher risk for drug diversion within the healthcare facility) for the registered nurse (RN 1), RN 1's IRIS score was "0.9" for action time and highlighted in color green; however, below the score, there was an action listed: " ... first dispense and first [administration] for a patient happened [more than] 60 [minutes] (which was past the hospital threshold)"

During a review of the action alert listed under RN 1's ControlCheck generated Individual Risk Identification Score, the action alert indicated that RN 1 removed a Fentanyl drip bag for Patient 11 on 7/11/2025 at 10:48 p.m. and the administration time was on 7/12/2025 at 12:59 a.m. (which was 2 hours and 11 minutes after the time of removal).

During an interview on 8/7/2025 at 12:47 p.m. with the medical safety officer (MSO), the MSO stated she (MSO) did not reconcile the action alert because RN 1's IRIS score was low (0.9, which was below the facility's threshold of 5).

During an interview on 8/7/2025 at 12:50 p.m. with the director of Intensive Care Unit (DICU). The DICU stated medication administration was expected to happen soon after medication removal from the Pyxis (an automated dispensing system that included a secure computerized cabinet that stores and dispenses medication at nursing unit and integrate with the hospital's electronic medical record system) or dispensed by Pharmacy.

During an interview on 8/7/2025 at 2:40 p.m. with the DICU, the DICU stated there was no critical/emergency event on 7/11/2025 between 10:48 p.m. to 7/12/2025 at 1 a.m., and there were no additional duties assigned to RN 1 that would justify the delay in administration of the fentanyl drip.

During an interview on 8/8/2025 at 5:56 p.m. with the medical safety officer (MSO) and the DOP, the MSO stated there was no review of any user activity if the user IRIS score was below 5 (RN 1's IRIS score was 0.9). MSO stated she (MSO) would forward the individual user report to the supervising nursing manager if the user's IRIS score was above 5. The DOP said there was no manual pharmacy review of ControlCheck alerts regardless of IRIS scores.

During a review of the facility's policy and procedure (P&P) titled, Controlled and Regulated Substances Stewardship (last revised on 2/15/2024), the P&P indicated the stewardship " ... to improve, monitor, and evaluate the use of controlled and regulated substances ... Members of the Stewardship Committee should include Medical Staff ... Pharmacy ... provide oversight of controlled and regulated substances utilization ..."

During a review of the facility's policy and procedure (P&P) titled, Pharmacy Scope of Services (last revised on 5/28/2024), the P&P indicated " ... To collect data about department function, staff performance, and patient care related to medication use for quality management purposes and continuous quality improvement ... to support nursing care based on nursing process and medication management ... To develop, implement, and evaluate standards utilized in the pharmaceutical services ..."


2. During an observation and interview on 8/5/2025 at 12:04 p.m. with the Intensive Care Unit (ICU, area in hospital caring for the critically ill patients) Nurse Manager (NM) 1, in the ICU's medication room, there was a mounted transparent lock box on the wall, approximately 15 inches by 18 inches, with a key lock. NM 1 stated that medications such as fentanyl (a very strong pain medication) that were sent from pharmacy but not yet administered could be placed in the lock box. NM 1 confirmed that multiple controlled substances could be placed in the same lock box at the same time. NM 1 confirmed that any nurse with Pyxis (an automated medication dispensing system) access could obtain the key to the lock box and open it. Once opened, that nurse could access all medications stored inside, with no witness requirement.

During an interview on 8/7/2025 at 9:48 a.m. with ICU Registered Nurse (RN) 17, RN 17 stated that if an emergency prevented wasting (disposing of left over medication with a witness), the unused narcotic (a drug or other substance that affects mood or behavior) could be placed in the medication lock box. RN 17 explained that:
-"Everyone can get the key; anyone with Pyxis access can open it."
-"There is no witness when placing meds (medications) into the lock box."
-"If there are multiple medications waiting to be wasted, they are placed together in the box."
-RN 17 confirmed that once the lock box was opened, all controlled substances inside were accessible to any nurse with the key.

During an interview on 8/7/2025 at 10:07 a.m. with ICU RN 18, RN 18 confirmed that when the wasting of controlled substances (a drug or chemical whose manufacture, possession, and use are regulated by a government because it may be abused or cause addiction) could not be completed right away, the medication was either "kept on the nurse until a witness was available or placed in the narcotics lock box" and that once accessed, all controlled substances stored in the box could be removed by anyone.

During an interview on 8/8/2025 at 5:00 p.m. with the Director of Pharmacy (DOP), the DOP confirmed that lock boxes were installed in all unit medication rooms. DOP confirmed that:
-Any nurse could log into the Pyxis, obtain the key, and open the lock box.
-Once opened, the nurse had access to all controlled substances inside.
-There was no policy or protocol governing the use of the lock box for controlled substances.

During a review of the facility's policy and procedure (P&P) titled, "Drug Storage," dated 9/29/2022, the P&P indicated, "The medication storage areas in the pharmacy and throughout the hospital are under the supervision of the director of pharmacy or designee ... Drugs are stored under proper conditions of temperature, light, humidity, sanitation, ventilation, and segregation per manufacturer recommendations. In the absence of such recommendations, drugs are stored according to a pharmacist's instructions. Storage areas are secure and accessible only to designated and authorized personnel ... If there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the organization will evaluate its current medication control policies and procedures and implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained ..."

During a review of the facility's policy and procedure (P&P) titled, "Distribution, Administration and Accountability of controlled drugs," dated 12/6/2024, the P&P indicated, "The pharmacy department will comply with all applicable State & Federal laws pertaining to control, distribution and accountability of Controlled Substances."

Based on observation, interview, and record review, the hospital failed to ensure its sterile (germ-free) compounding process (a process of making sterile intravenous [IV, administered through the vein] medications), was performed in a safe and consistent manner, as evidenced by:

1. Failure to ensure the "sterile product preparation tray (a tray that provide surface area for sterile compounding or IV medication preparation)" in one (1) of two (2) sampled medication rooms in the Intensive Care Unit (ICU) was free of stains.

2. Failure to ensure one of one sampled anteroom (a room serves as a transition area that separates the dirty area from the clean area or room where IV medications are prepared) of the sterile compounding suite (IV room) was clean and free of debris, residues, and/or stains, that could accumulate contaminants and/or microorganisms.

3. Failure to ensure the sterile compounding environment viable sampling plan (a map of sampling locations) used by the vendor that certifies the facility's IV room was included in the hospital's procedure of environmental media testing.

These deficient practices had the potential for all patients requiring IV medications to be exposed to preventable contamination leading to infection that may affect patients' health and safety.

Findings:

1. During an interview on 8/5/2025 at 12:04 p.m. with the ICU nurse manager (NM 1), NM 1 stated there were two (2) medication rooms in the ICU department.

During a concurrent observation and interview on 8/5/2025 at 1:01 p.m. with Nurse Manager (NM) 1, in one (1) of two (2) ICU medication rooms (5 North), there was a white tray labeled "sterile product preparation tray" on top of the refrigerator. NM 1 stated there were stains on top (work area) of the tray. NM 1 said the tray was cleaned with Sani Cloth AF3 (used for disinfecting an equipment or surface) by nurses as needed, not routinely. NM 1 stated the expectation was to clean before and after preparation of a sterile product.

During a review of the facility's policy and procedure (P&P) titled, Safe Admixture of Parenteral Products (revised 6/18/2019), the P&P indicated " ... The intravenous admixture service is provided for good patient care and for safe and sanitary admixture of parenteral products ... Admixtures prepared outside of the IV room (i.e. nursing unit med room) ... Assure cleanliness of work space ..."

2. During an observation on 8/5/2025 at 4:09 p.m. with the pharmacy personnels, in the anteroom of the IV suite, the floors around a bench, a steel table, and a refrigerator had brown stains and debris.

During an interview on 8/5/2025 at 4:15 p.m. with the pharmacy manager (MP 2), the MP 2 stated the area was difficult to clean. MP 2 said the technicians cleaned the floor every day. MP 2 agreed that the technicians did not clean the area well.

During a review of the facility's policy and procedure (P&P) titled, IV Room Cleaning and Disinfecting (revised 12/6/2024), the P&P indicated " ... definitions: ... Cleaning - removing residues, such as debris, microbes and residual drug and chemicals. Disinfection - Destroys fungi, viruses, and bacteria ... The Pharmacy Department is responsible for performing routine cleaning and maintaining sterility of the pharmacy IV clean rooms ..."

3. During a concurrent interview and record review on 8/8/2025 at 4:02 p.m. with the pharmacy manager (MP 2), the "Environmental Sampling locations" in the hospital pharmacy's standard operating procedures (SOP) "Procedure of Environmental Media Testing, was reviewed. MP 2 stated those sampling locations were the in-house monthly viable sampling test locations.

During a concurrent interview and record review on 8/8/2025 at 4:05 p.m. with the director of pharmacy (DOP), the facility's IV room certification reports, were reviewed. The DOP confirmed the sampling plan used by the vendor (who performed their IV rooms' bi-annually [twice a year] certifications) was different from the locations listed in the SOP. The DOP stated that the SOP did not match the environment sample plan map used by the vendor. The DOP said the hospital followed the guidance of US Pharmacopeia (USP, a scientific, non-governmental organization that sets standards for medicines) chapter 797 (USP 797, is a chapter of the United States Pharmacopeia that provides guidelines and standards for compounding sterile preparations [CSPs] in healthcare settings, ensuring patient safety by preventing harm from microbial contamination, endotoxins, and other errors. It covers various aspects of sterile compounding, including personnel training, facility requirements, and quality control procedures).

During a review of the current edition of USP 797, the chapter indicated " ... The microbiological air and surface monitoring program must be clearly described in the facility's SOPs, which must include a diagram of the sampling locations ..."