§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 and manufacturer's guidelines, as well as observations and staff interviews, it was determined that the facility failed to monitor medication refrigerator temperatures on one of two nursing units (300/400/500 unit).
Findings include:
The facility's policy regarding medication storage, dated December 1, 2023, indicated that all medications housed on the premises will be stored in the medication room according to manufacturer's recommendations and sufficient to ensure proper sanitation, temperature, light, ventilation, moisture control, segregation and security. All medications requiring refrigeration will be stored within 36-46 degrees Fahrenheit. Charts are kept on each refrigerator, and temperature levels are recorded daily by the charge nurse or other designee.
Observations of the first refrigerator in the 300/400/500 medication room on May 13, 2024, at 1:39 p.m. revealed three vials of Humalog insulin, three vials of Aplisol (tuberculosis skin testing solution), one vial of Lantus insulin, two Ozempic pens (medication used for diabetes), 1 vial of Prevnar (pneumonia vaccination), one bottle of Protonix (liquid), seven Aspart insulin pens, three Trulicity insulin pens, and two Humira pens (medication used for arthritis). Observations of the second refrigerator revealed two tubes of Latanoprost eye drops, one bottle of Protonix (liquid), one Ozempic pen, six Aspart insulin pens, one glargine insulin vial, two Humulin R insulin pens, one Levemir pen, four Basaglar insulin pens, four Lantus insulin pens, one Prolia pen (medication used for bone loss), and two Daptomycin intravenous bags (antibiotic medication). There was no documented evidence that temperatures were monitored daily to ensure the medications were stored within 36 to 46 degrees Fahrenheit per the manufacturer's recommendations for these two refrigerators from July 2022 to May 13, 2024.
Interview with Registered Nurse 1 on May 13, 2024, at 1:39 p.m. confirmed that there was no evidence to indicate that temperatures were monitored daily for the two refrigerators in the 300/400/500 medication room, per manufacturer's recommendations since July 2022.
Interviews with the Director of Nursing on May 13, 2024, a 2:20 p.m. confirmed there was no documentation that the 300/400/500 medication refrigerators were being monitored daily to maintain temperatures between 36 and 46 degrees Fahrenheit.
28 Pa. Code 211.9(a)(1) Pharmacy Services.
28 Pa. Code 211.12(d)(1) Nursing Services.
| | Plan of Correction - To be completed: 06/24/2024
The preparation and/or execution of the plan of correction does not constitute admission of agreement by the provider of truth of the facts or conclusions set forth in the statement of deficiencies. This plan of correction is prepared and/or executed solely because it is required by the provision of federal and state laws.
No residents suffered ill effects as a result of inconsistency in completion of the medication refrigerator temperature log.
Licensed nursing staff educated on completion of the temperature log of the medication refrigerator.
Assistant Director of Nursing or designee observing completion of the medication refrigerator temperature logs five times per week for four weeks and then monthly random checks for three months.
Medication refrigerator temperature logs will be discussed at the monthly Quality Assurance Performance Improvement meeting for six months.
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