§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 manufacturer's instructions and observations, as well as staff interviews, it was determined that the facility failed to label multidose vials of tuberculin (solution used to detect tuberculosis infection).
Findings include:
Manufacturer's instructions for Tubersol, dated November 1, 2021, indicated that a multi-dose vial of Tubersol solution should be discarded 30 days after it is opened.
Observations of the facility's medication room on April 23, 2025, at 10:39 a.m. revealed there was one opened and undated bottle of Tubersol Tuberculin injection for Mantoux TB skin test (to test for tuberculosis).
Interview with the Director of Nursing on April 23, 2025, at 3:58 p.m. confirmed that the bottle of Tubersol was not dated when it was opened and that it should have been.
28 Pa. Code 211.9(a)(1) Pharmacy Services.
28 Pa. Code 211.12(d)(1) Nursing Services.
| | Plan of Correction - To be completed: 06/11/2025
The undated vial of Tubersol (multidose tuberculin serum) was immediately discarded and new vials were ordered from the pharmacy. All other vials in the medication storage room were checked, and none were found to be open and undated. In conjunction with the pharmacy, date / expiration stickers will be placed on boxes by the pharmacy so there is a tracking system on the multidose serum. The Director of Nursing or designee will audit the medication room for undated vials of Tubersol daily for 5 days, weekly for three weeks and monthly for one month. The results of these audits will be reviewed by the Quality Assurance Performance Improvement Committee for compliance. Date of compliance: June 11, 2025.
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