§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, review of drug manufacturer instructions, and staff interviews, it was determined that the facility failed to appropriately date and store medications on one of two nursing units (North medication room) and one of five medication carts (South medication cart).
Findings include:
Observation on 2/14/2024, at 9:45 a.m. in the North medication room, revealed an opened vial of Tubersol Purified Protein Derivative (PPD-a skin testing agent for tuberculosis) without an open date marked on the vial.
A review of the drug manufacturer leaflet indicated a vial of Tubersol which has been entered and in use for 30 days should be discarded.
At the time of the observation, the Registered Nurse Supervisor Employee E1 confirmed the PPD vial was opened, undated and not dated to indicate when the medication should be discarded. The Director of Nursing (DON) confirmed on 2/15/2024, at 9:45 a.m. the PPD vial should have been identified with an open date to indicate after 30 days of use, the vial would be discarded.
Observation on 2/14/2024, at 3:10 p.m. of the South medication cart, revealed an opened Humalog insulin pen without an open date marked on the pen.
A review of the drug manufacturer leaflet indicated a Humalog insulin pen which has been entered and in use for 28 days should be discarded.
At the time of the observation, the Licensed Practical Nurse Employee E2 confirmed the insulin pen was opened, undated and not dated to indicate when the medication should be discarded. The DON confirmed on 2/15/2024, at 9:45 a.m. the insulin pen should have been identified with an open date to indicate after 28 days of use, the insulin pen would be discarded.
28 Pa. Code 211.9(a)(1) Pharmacy services
28 Pa. Code 211.12(d)(1)(5) Nursing services
| | Plan of Correction - To be completed: 03/17/2024
The open vial of Tubersol Purified Protein Derivative that was opened and not dated was immediately discarded. The Humalog insulin pen that was not dated when opened was discarded. All multidose vials and insulin pens will be dated when they are opened.
All medication carts and medication rooms will be audited to ensure all open multidose vials and insulin pens are dated. Open multidose vials and insulin pens that are not dated will be discarded.
All nurses will be trained by the Director of Nursing/designee on dating multidose vials and insulin pens when they are opened. The Nursing Home Administrator/designee will monitor to ensure training is completed.
The Director of Nursing/designee will audit medication rooms and medication carts Five (5) times a week times two (2) weeks, weekly times two (2) weeks and then monthly times two (2) months.
Director of Nursing has developed and implemented a Medication Room and Medication Cart Audit to ckeck for expired medications, opened multidose vials for date opened and insulin pens for date opened. Audit and checklist is completed nightly. Medications are discarded and reordered as needed.
Results of the audits will be discussed at the Quality Assurance Process Improvement.
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