|§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 surveyor observation, manufacturer information, facility documentation, and staff interview, it was determined that the facility failed to discard expired medications for one of five medication carts observed (D hall medication cart).
Observation of the D hall medication cart on January 7, 2020 at 1:10 PM revealed one Novolog insulin pen with a label indicating that the medication was opened on November 26, 2019 (42 days earlier).
Review of the manufacturer's package insert for the Novolog insulin pen indicated that once the medication is open it should be stored at room temperature and discarded after 28 days even if it still has insulin left in it.
Review of facility provided document regarding insulin storage states Novolog should be, "Refrigerate until opened, then may be stored at room temperature. Expires 28 days after first use even if some drug remains. (same for vials/cartridges/pens)"
Interview with the Director of Nursing on January 9, 2020 at 11:10 AM, revealed that she would have expected the Novolog insulin pen would have been discarded after 28 days.
28 Pa. Code 201.18(b)(1) Management
28 Pa. Code 211.9(a)(1)(i) Pharmacy services.
28 Pa. Code 211.12(d)(1)(2)(5) Nursing services.
| ||Plan of Correction - To be completed: 02/27/2020|
F 0761 483.45 Label/Store Drugs and Biologicals
No resident was injured with this finding. Was immediately corrected by discarding the expired insulin pen and using new insulin pen for medication administration, dated to be discarded 28 days after opening.
Medications are labeled with the proper information - Date of Open, Date of Expiration, Nurse's Initials. Expired medications will be discarded immediately and replaced.
Re-education will be provided to Licensed Staff Nurses on proper labeling of medications with expiration guidelines. Nurse's will perform daily med cart audit for expired medications on 11-7 shift. 11-7 Nurse performing daily audit will sign that med cart audit was completed for their shift. Expired medications will be discarded immediately and replaced.
Clinical Managers will perform random audits on their assigned neighborhood of med cart to ensure all expired meds were identified and discarded during 11-7 audit. Audit schedule will be completed weekly for 4 weeks, then biweekly for 1 month. The audits will observe for accuracy overall. Results of the audits will be reported to the QAPI committee.
Date of completion 2/27/20.