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Based on medical record review, review of the facility complaint and grievance log, policy review, facility investigative documentation and pharmacy documentation, the facility failed to ensure current and accurate records were kept of the receipt and distribution of all scheduled drugs (A494).

Based on medical record review, review of the facility complaint and grievance log, policy review, facility investigative documentation and pharmacy documentation, the facility failed to ensure current and accurate records were kept of the receipt and distribution of all scheduled drugs for two of six patients reviewed as receiving narcotics/controlled substances (Patient #6 and #13). The total sample was 13. This could affect all patients receiving services from the facility. The facility had a current census of 1030.

Findings include:

1. Review of the medical record for Patient #6 revealed the patient was admitted on 02/13/23 with diagnoses which included status epilepticus, global developmental disorder, and monoallelic genetic mutation. The medical record revealed on 02/13/22 at 9:56 AM Staff F ordered Fentanyl citrate (narcotic used for pain and sedation) 16 micrograms (mcg) 1.6 milliliters (ml). The documentation revealed Staff E removed two vials of Fentanyl 50 mcg per ml in a two ml vial (100 micrograms total) from the pyxis. One vial was removed at 9:56 AM and the second vial was removed at 10:00 AM in preparation for Patient #6's intubation (breathing tube). The intubation was cancelled.

The facility received a grievance which expressed concerns regarding Fentanyl ordered for Patient #6 but was not administered. There was an allegation that the medication was pulled and stolen by a caregiver as the family of Patient #6 received a bill and were charged for this Fentanyl. Review of the facility's investigative documentation revealed the facility reviewed the medical record for the Patient #6, interviewed pharmacy department leadership, the Nursing Unit Director Staff G and Assistant Nursing Director Staff J for further review and investigation.

A separate complaint was received by the the facility's police department which involved Patient #6 and alleged diverted Fentanyl. Review of Police Inspector I's diversion investigative report revealed the facility had received a complaint which alleged a theft of Fentanyl. The report revealed the facility was unable to find documentation of administration of Fentanyl to Patient #6. The facility's pharmacy was notified in August 2022 and initiated an investigation and determined the Fentanyl was improperly wasted.

Interview on 03/28/23 at 10:45 AM with Staff H revealed all routinely scheduled controlled medications (controlled medications were those medications tightly controlled because of potential risk for abuse or addiction) were reconciled each day by the pharmacy. These scheduled medications were connected in the pharmacy's electronic medication tracking software to a physician order. Staff H explained that the pharmacy provided certain hospital departments with authorizations for "pharmacy cabinet over-rides" which permitted immediate access for both controlled and non-controlled medications on an as needed basis. The departments that were granted cabinet over-ride privileges were traditionally in departments such as the emergency department, intensive care units, behavioral health, labor and delivery or operating rooms where medications were needed immediately. During the interview, a request was made to the pharmacy team to provide documentation of the reconciliation of the Fentanyl ordered for Patient #6. Staff H provided documentation that on 02/13/22, Staff E removed two vials of Fentanyl 50 mcg per ml in a two ml vial (100 micrograms total) from the Pediatric Intensive Care Unit's (PICU) pyxis. One vial was removed at 9:56 AM and the second vial was removed at 10:00 AM in preparation for intubation. The intubation was cancelled. The interview revealed the pharmacy was unable to provide documentation that the unused medication was either wasted per facility policy and procedure or was returned to the pyxis. The team was further questioned why there was no reconciliation documentation for the disposition of the Fentanyl pulled for Patient's #6. The team responded it was not done for pharmacy cabinet over-rides. These cabinet over-rides were not connected to a physician order and the medications were often pulled in anticipation of need prior to the physician ordering the medications. The facility's pharmacy electronic tracking system had no way to track the over-rides if they were not attached to a physician order in real time. Pharmacy staff reviewed the cabinet over-ride report monthly not to reconcile individual medications but rather to identify high volume over-rides per staff and to identify trends or patterns of individual staff. The facility's over-ride volumes were so high that the facility pharmacy monitored staff for patterns or trends of high-volume overrides. Staff H verbalized that if specific staff had a few numbers of over-rides, they would not meet the threshold and would not be flagged for high volumes and further investigation. The pharmacy team determined that Staff E fell below the pattern or trend threshold and no further investigation was required. The pharmacy determined the Fentanyl pulled for Patient #6 was most likely wasted but that nursing staff failed to complete the wasted medication documentation. Interview with Staff H confirmed the facility was unable to provide fentanyl citrate medication reconciliation for Patients #6 and Patient #13. Staff H stated reconciliation of medication cabinet over-rides were not reconciled daily, and this was a hazard of the pharmacy's medication cabinet over-ride process.

2. Review of the pharmacy's medication cabinet over-ride report for 02/03/22 revealed PICU Staff K removed two vials of Fentanyl citrate (50 mcg/milligram; 2mL vial) for Patient #13 on 02/03/22 at 2:49 AM. The medical record revealed the medication was not administered. The pharmacy was unable to provide controlled medication reconciliation documentation that the medication was either returned or wasted.

Interview with Staff H on 03/29/23 at 12:14 PM confirmed the facility was unable to provide reconciliation of this medication. Staff H verbalized this medication was pulled from the PICU medication cabinet via the medication over-ride process and had no physician order connected to it.

Review of the facility's policy titled, Utilizing Compare Report for Reconciling Controlled Drug Transactions Standard Operating Procedure, with a most recent approved/reviewed date of 04/13/22, revealed that the controlled substance reconciliation report will be run and reviewed at least daily for all ADC's (Automated Dispensing Cabinet) to ensure security of all controlled substances, minimize risk for diversion, and limit the time to detection in the event diversion occurs. Pharmacy personnel will comply with completing the reconciliation report for drug distribution and return transactions. Reconciliation reports will be reviewed by the designee at least daily.

This deficiency represents noncompliance investigated under Substantial Allegation OH00140214.