§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 observation and staff interview, it was determined that the facility failed to ensure proper storage and adherence to expiration/use by dates for pharmaceutical products in one of one medication rooms observed.
Findings include:
Observations of the facility's medication room on May 1, 2024, at approximately 10:35 AM revealed 38 Max Zero Needless connectors that expired May, 8, 2023, 11 Max Zero Needless connectors that expired December 10, 2023, one 20 gauge needle safety infusion set that expired March 31, 2024, two 20 gauge needle safety infusion sets that expired November 30, 2023, two 22 gauge Autoguard BC winged IV catheters that expired January 31, 2023, one 24 gauge Autoguard BC winged IV catheter that expired February 8, 2023, two 27 gauge disposable needles that expired July 20, 2023, two 27 gauge disposable needles that expired April 15, 2024, two IV starter kits that expired September 2, 2023, and one IV starter kit that expired March 31, 2024.
An interview with Employee 1 LPN (license practical nurse) on May 1, 2024, at 10:44 AM confirmed the pharmacy supplies had expired and should have been discarded.
During an interview with the Nursing Home Administrator on May 1, 2024 at approximately 12:45 PM confirmed expired pharmacy products should have been removed from the medication room and discarded.
28 Pa. Code 211.9 (k) Pharmacy services
| | Plan of Correction - To be completed: 06/03/2024
1. All expired pharmaceutical products in the medication room were immediately disposed of.
2. An audit has been completed to ensure all currently stocked pharmaceutical products in the medication room were not expired or beyond their use by dates.
3. All stock department staff, whom are responsible for stocking the medication room, will be educated on the adequate and timely review of use by or expiration dates of stocked pharmaceutical products in the medication room and disposal or use of pharmaceutical products before their use by or expiration dates.
4. The DON, or designee, will audit three times per week that all pharmaceutical products in the medication room are not beyond their use by dates and are not expired. Audit will continue until substantial compliance is received. Results from this audit will be reviewed weekly, reported to the quality assurance committee, and then re-evaluated.
5. The anticipated date of completion of the corrective action is 06/03/2024.
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