|§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.
Based on facility policy review, observation, and staff interview, it was determined that the facility failed to ensure appropriate storage and timely disposition of expired medications on one of four nursing units. (Aster Avenue)
Review of the facility policy entitled, "Medication Storage in the Facility," revealed that outdated medications were to be immediately removed from inventory, disposed of according to procedures for medication disposal, and reordered from the pharmacy if a current order existed. When the original seal of a manufacturer's container or vial broken, the container or vial would be dated. The nurse should date the "do not use after" sticker on the medication.
Observation of the medication cart on Aster Avenue nursing unit on June 28, 2022, at 10:00 a.m., revealed a container of ipratropium-albuterol solution (a breathing treatment) that was open and not dated and a blister pack of hydrocodone acetaminophen (a pain medication) with an expiration date of April 30, 2022. During the same observation, the medication refrigerator in the medication room on Aster Avenue nursing unit contained a package of lorazepam (an antianxiety medication) that was open and not dated. In an interview during the observation, LPN 1, stated that the ipratropium-albuterol solution should have been dated after opening, the hydrocodone acetaminophen should have been destroyed, and the lorazepam should have been dated after opening.
28 Pa. Code 211.9(h)(i)Pharmacy services.
28 Pa. Code 211.12(d)(1)(2)(3)(5)Nursing services.
| ||Plan of Correction - To be completed: 07/29/2022|
No residents had complications from the observation.
Education to nursing staff regarding medication storage policy by 7/18/22.
Audits will be completed by DON/Designee on all medications to ensure that appropriate storage and timely disposition of expired medications is adhered to. Weekly audits times 4, then monthly times 4.
Results will be presented at the QAPI meetings for further discussion and or follow up.