Failure to Label and Monitor Expiration of Tuberculin Vial
Penalty
Summary
The facility failed to ensure that drugs and biologicals were labeled in accordance with currently accepted professional principles, specifically regarding the expiration date. During an observation of the medication storage room and a medication cart, it was found that a Tuberculin vial stored in the medication storage room refrigerator was opened but not labeled with a date to calculate its discard date. The facility's policy, reviewed in October 2020, required that multi-dose vials be dated upon opening and discarded within 28 days unless otherwise specified by the manufacturer. However, the Tuberculin vial was not dated, which was against both the facility's policy and the manufacturer's guidelines. Interviews with staff, including an LPN and the Interim Director of Nursing/Regional Quality Manager, confirmed that the expectation was for vials to be dated immediately upon opening and monitored for the appropriate discard date. The LPN acknowledged that the undated vial should be discarded as it may not be effective if used. The Interim Director of Nursing expressed concerns about the potential ineffectiveness of the drug and the risk of infections due to improper labeling. The Administrator also stated that staff were expected to follow the facility's policy to ensure compliance with the manufacturer's guidance.