§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.
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Observations:
Based on review of facility policies, observations, and staff interviews, it was determined that the facility failed to properly secure stored medications and/or biologicals in two of three medication rooms (TCU and Harmony Unit Medication Rooms).
Findings include:
Review of facility policy " Medication Storage" dated 10/27/25, indicated that medications and biologicals that the medication supply shall be accessible only to licensed nursing personnel, pharmacy personnel, or staff members lawfully authorized to administer medications. Medication rooms, cabinets and medication supplies should remain locked when not in use or attended by persons with authorized access.
During rounds on 12/22/25, at 10:45 a.m. the Director of Nursing (DON) and surveyor checked the Harmony Unit Medication Room and the TCU Medication Room. The doors were unlocked with medications that were designated to be returned, sitting on the counter. These doors require a key to be locked. Education was completed in November by the facility in response to this event, policy for controlled substances administration, ordering, storage, handling and disposal, confirmed with staff interviews.
During an interview on 12/22/25, at approximately 9:50 a.m. Licensed Practical Nurse Employee E1 confirmed he had a key to the Harmony Unit Medication Room and that the door should be locked.
During an interview on 12/22/25, at approximately 9:55 a.m. Licensed Practical Nurse Employee E2 confirmed she had a key to the Harmony Unit Medication Room and that the door should be locked and proceeded to lock the unlocked door.
During an interview on 12/22/25, at approximately 10:00 a.m. Licensed Practical Nurse Employee E3 confirmed she had a key to the TCU Unit Medication Room and that the door should be locked and proceeded to lock the unlocked door.
During an interview on 12/22/25, at approximately 2:45 p.m. the Nursing Home Administrator and the Director of Nursing confirmed the facility failed to properly secure medications and/or biologicals in one of two medication rooms.
28 Pa. Code: 211.9(a)(1)(j.1)(k) Pharmacy services.
28 Pa. Code: 211.12(d)(1)(2)(3)(5) Nursing services.
| | Plan of Correction - To be completed: 01/28/2026
1. How the corrective action will be accomplished
Immediately upon identification, all medication room doors on the TCU and Harmony Units were secured and locked. Medications awaiting return are now properly stored.
2. How other areas were identified and corrected
A facility-wide audit of all medication rooms, carts, and storage areas was completed to ensure compliance with locking and storage requirements. No additional unsecured areas were identified.
3. Measures to prevent recurrence Don or designee will re-educate licensed staff on Medication storage with emphasis for medication doors being closed and locked.
4. Monitoring system
The DON or designee will conduct random weekly audits x 8, then monthly x 2 of medication rooms to ensure doors are closed and locked. Results will be reported through QAPI.All corrective actions will be reviewed through the facility's Quality Assurance and Performance Improvement (QAPI) program to ensure sustained compliance.
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