§483.45(g) Labeling of Drugs and Biologicals Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable.
§483.45(h) Storage of Drugs and Biologicals
§483.45(h)(1) In accordance with State and Federal laws, the facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys.
§483.45(h)(2) The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.
|
Observations:
Based on review of facility policy, observation, and staff interviews, it was determined that the facility failed to store controlled schedule II-V medications (medications that may be abused or cause addiction that are closely monitored due to high risk of diversion) in a separately locked, permanently affixed compartment in the medication refrigerator.
Findings include:
A facility policy entitled, "Management of Controlled Drugs" dated 8/2024, revealed, "Storage and maintenance of Controlled drugs: Store and maintain controlled drugs properly according to federal, state, or local regulations."
Observation on 9/4/24, at 1:05 p.m. of the medication room refrigerator revealed several vials of controlled scheduled II-V medications in a separately locked container that was attached to a removable shelf, therefore it was not permanently affixed to the refrigerator, this was witnessed and confirmed by the Licensed Practical Nurse Employee E1.
Interview with the Director of Nursing on 9/4/24, at approximately 1:30 p.m. confirmed that the controlled scheduled II-V medications should be stored in a separately locked permanently affixed compartment, and not attached to a removable shelf.
28 Pa. Code 201.14(a) Responsibility of licensee
28 Pa. Code 201.18(b)(1) Management
28 Pa. Code 201.18(e)(1) Management
| | Plan of Correction - To be completed: 10/11/2024
The shelf for the box for the schedule II-V medications in the locked refrigerator in the medication room was secured in the refrigerator so it could not be remove. After secured, it was tested and could not be removed.
This is the only refrigerator for medications in the medication room
The Registered nurses/Licensed Practical nurses will be educated as to why the shelf with the box for the schedule II-V medications needs to be secure and not removable at all times.
The Director of Nursing/designee will audit weekly for 3 months that the shelf for the schedule II-V medications in the medication room refrigerator is unable to be removed. If an issue, will contact maintenance.
This will be reported out at the quarterly Quality Assurance Process Improvement meeting.
|
|