Failure to Date Opened Insulin Pen and PPD Vials per Manufacturer Guidelines
Penalty
Summary
Surveyors identified that medications and biologicals were not stored and labeled according to manufacturer recommendations and facility policy. During a review of the C Hall medication cart with an RN, an in-use insulin pen was found that had been opened but was not dated, and the RN stated she did not know when the pen had been placed into service, despite acknowledging that the device has a shortened use life once opened. In a subsequent review of the wet medication room and medication refrigerator with the same RN, two opened vials of Purified Protein Derivative (PPD) solution were found without dates indicating when they had been placed into service, and the RN reported these should have been dated by nursing. Manufacturer product information for PPD specified that a vial entered and in use for 30 days should be discarded, requiring staff to know the date of first use to calculate an appropriate discard date. The facility’s written Medication Storage policy stated that all medications housed on the premises would be stored according to manufacturer recommendations, including appropriate conditions and security, but the undated opened insulin pen and PPD vials showed this was not followed. No specific residents, their medical histories, or conditions at the time of the deficiency were described in the report.
