HospitalInspections.org

Based on facility document review and staff interviews, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address the disposition of Controlled Dangerous Substances (CDS) in accordance with acceptable standards of practice and Federal regulations.

Findings include:

Reference: Drug Enforcement Administration (DEA) regulation 21 CFR 1317.90 Methods of destruction, https://www.deadiversion.usdoj.gov/21cfr/cfr/1317/subpart_c.htm, states, "(a) All controlled substances to be destroyed by a registrant, or caused to be destroyed by a registrant, pursuant to 1317.95(c), shall be destroyed in compliance with applicable Federal, State, tribal, and local laws and regulations and shall be rendered non-retrievable."

Reference: The DEA (Drug Enforcement Administration) Drug Disposal Regulations: Registrant Fact Sheet, https://www.deadiversion.usdoj.gov/drug_disposal/fact_sheets/disposal_registrant.pdf, states, " ...The new regulations do not require a particular method of destruction, so long as the desired result is achieved. Pharmaceutical controlled substances must be rendered "non-retrievable" in compliance with all applicable Federal, State, tribal and local laws. This standard is intended to allow public and private entities to develop a variety of destruction methods that are secure, convenient, and responsible, consistent with preventing the diversion of such substances. "Non-retrievable" means the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance's physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes. A controlled substance is considered "non-retrievable" when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue."

Reference: Facility policy titled, "Controlled Substance Procurement, Storage, and Distribution" dated 12/21,states, "... 32. Partial doses or waste of controlled substances shall be disposed of in an approved controlled substance disposal container..."

During a facility tour of the Intensive Care Unit (ICU) on 5/4/23, four staff members were interviewed about the method used to dispose of CDS. At 12:00 PM, Staff #7 (S7), a Registered Nurse (RN), stated that partial doses of injectable CDS would be disposed of by pouring the medication onto an absorbent chux pad, and then thrown into the trash. At 12:05 PM, Staff #5 (S5), an ICU Nurse Manager, and Staff #6 (S6), an ICU RN, also stated that they would dispose of injectable CDS in an absorbent chux pad and then the trash. At 12:06 PM, Staff # 4 (S4), the Pharmacy Director, stated that small volumes of CDS should be discarded in a container such as an RxDestroyer, however larger volumes of CDS could be discarded in the trash after pouring onto a chux pad. Discarding CDS into an absorbent chux pad is not in accordance with the facility policy and does not render the medication "irretrievable" as defined by the DEA, both referenced above.

On 5/4/23, the facility policy that addresses the disposition of CDS was requested. The policy titled "Controlled Substance Procurement, Storage, and Distribution" dated 12/21 was reviewed. The policy states, "...21. Pharmacy manufactured items (i.e. Fentanyl drips, Midazolam drips, etc.) are returned to stock and issued to wastage. These items are wasted in a sink by two pharmacists..." This policy is not in accordance to the DEA requirements for CDS disposal referenced above.

These findings were confirmed by S4, the Pharmacy Director, on 5/4/23 at 12:50 PM.

Based on facility document review and staff interviews, it was determined that the facility failed to ensure that policies and procedures that address the monitoring of Controlled Dangerous Substances (CDS) administration and disposition for discrepancies are developed and implemented to ensure accountability.

Findings include:

During an interview on 5/4/23 at 1:30 PM, S11, a Pharmacist, explained the processes in place to ensure the accountability for CDS that involves the monitoring of CDS administration, disposition, and documentation discrepancies. S11 explained that one of the computer programs utilized is called Blue Site. S11 and S4, the Pharmacy Director, stated that the reports should be reviewed by pharmacy staff and nursing management daily, to monitor for discrepancies in CDS usage and documentation. Any issues identified in the "open events" dashboard should be researched and resolved. If the issues can't be resolved, an incident report should be filed and an investigation initiated.

During the facility tour of the Intensive Care Unit (ICU) on 5/4/23 at 11:45 AM in the presence of S4, Staff #5 (S5), an ICU Nurse Manager, stated that they review Blue Site reports on a weekly basis to monitor for CDS discrepancies. On 5/4/23 at 1:35 PM, S4 confirmed this finding and stated that S5 should be reviewing reports daily, not weekly.

On 5/4/23 at 1:45 PM, the Blue Site dashboard was reviewed in the presence of S4 and S11. The unresolved discrepancies for the date range of 4/1/23 through 4/30/23 were included in the report. Thirty-three "open events" were identified on the report. S11 stated that the open events were potential CDS discrepancies identified by the software that were not yet resolved. S11 and S4 confirmed that these open events should have been reviewed and resolved on a daily basis. S11 stated that the thirty-three open events should have been either investigated or under investigation by the survey date, 5/4/23 at 1:53 PM.

On 5/4/23, a policy that addressed the facility's use of computer software for the monitoring and resolution of CDS discrepancies was requested. On 5/4/23 at 1:42 PM, S4 stated that a policy was in the process of being developed, however an approved policy was not in place on the survey date. The facility failed to develop a policy that addressed the monitoring of CDS administration and disposition discrepancies to ensure the accountability of CDS.

These findings were confirmed by S4 on 5/4/23 at 2:07 PM.

Based on facility document review, facility policy review, and staff interviews, it was determined that the facility failed to ensure that discrepancies in Controlled Dangerous Substance (CDS) inventory counts are reported to pharmacy management, in accordance with facility policy.

Findings include:

Facility policy titled "Controlled Substance Procurement, Storage, and Distribution" dated 12/21, states, "...Discrepancies... Nursing supervisors will report any discrepancies occurring on the patient care areas to the pharmacy manager..."

On 5/4/23, Pyxis (automated medication dispensing system) CDS inventory discrepancy reports for the Intensive Care Unit (ICU) dated 3/20/23 to 3/31/23, were reviewed in the presence of Staff #4 (S4), the Pharmacy Director. One of two of the Fentanyl 500 mcg (micrograms)/100 ml (milliliter) inventory discrepancies, dated 3/30/23, was reported to pharmacy management and the facility investigation and incident reports were reviewed.
The facility investigation identified that the Pyxis report dated 3/22/23 at 18:57 (6:57 PM) identified a discrepancy in the number of Fentanyl 500 mcg /100 ml containers present. The report indicated that one container was missing. The facility was unable to provide an incident report for this discrepancy upon request. On 5/4/23, S4 stated that the discrepancy was marked "resolved" by nursing staff and not reported to pharmacy management.

During an interview on 5/4/23 at 11:25 AM, S4 confirmed this CDS discrepancy and confirmed that the discrepancy was not reported to the pharmacy management as required by facility policy.