HospitalInspections.org

Based on observation, review of the CFR (Code of Federal Regulations) 1301.12(a) and 1304.21(a) and interview, it was determined the facility:
1. Failed to use their own DEA (Drug Enforcement Administration) registration to order and procure controlled substances for their patients.
2. Failed to complete the official paper order form, DEA Form 222, when controlled substances were transferred from the main hospital to the hospital being surveyed.
3. Failed to maintain complete and accurate records for each controlled substance dispensed in the hospital.

The failed practices could not assure they were meeting DEA Regulations, nor could they assure they maintained a closed system to reduce the potential for diversion. The failed practice had the likelihood to affect all controlled substances in the hospital. Findings follow:

A. During a tour of the facility on 03/08/22 from 9:30 to 10:50 AM, observation revealed an employee filling an ADM (Automated Dispensing Machine) with medications from a brown paper sack. This surveyor asked Pharmacist #1 where the medications came from. Pharmacist #1 responded the main hospital campus, not the hospital we were surveying. This surveyor asked Pharmacist #1 if the controlled substances also came from the main hospital campus, and they responded yes. This surveyor asked Pharmacist #1 if the controlled substances brought to the hospital were transferred on a DEA Form 222, and the answer was no.
B. Review of CFR Separate Registrations for Separate Locations showed a separate registration was required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person. This separate registration was to be used to order their own controlled substances, that were to be delivered to the hospital's address that was registered with the DEA.
C. Review of CFR 1304.21(a) General Requirements for Continuing Records showed every pharmacy must have maintained complete and accurate records on a current basis for every controlled substance received, sold, delivered, or otherwise disposed of.
D. During an interview on 03/09/22 at 9:50 AM, the Main Hospital Pharmacy Supervisor verified the main hospital ordered all the controlled substances for the main hospital and the hospital that was being surveyed under the DEA registration of the main hospital and filled the ADM for both hospitals. They verified the controlled substances were not ordered using the surveyed hospital's DEA Registration. They also verified there was not a process to transfer all the controlled substances brought over and placed in the ADMs by using the DEA Form 222.