Failure to Label Multi-Dose Insulin Pen with Open and Expiration Dates
Penalty
Summary
A multi-dose insulin pen used for a resident with diabetes was found to be unlabeled with the date it was opened and its expiration date. The resident, who had a history of diabetes mellitus and fluctuating capacity to make medical decisions, was admitted to the facility and had an order for Insulin Glargine. During an observation, a nurse confirmed that the insulin pen in use for this resident was not labeled as required. Multiple staff interviews confirmed that the pen should have been labeled with both the open and expiration dates, in accordance with facility policy and the manufacturer's instructions, which specify that the pen should not be used more than 28 days after opening. Further review of the facility's policy and the insulin manufacturer's guidelines confirmed the requirement for labeling multi-dose vials and pens with the date opened and expiration date. The Director of Nursing acknowledged that the facility's policy was not followed in this instance. The lack of labeling meant that staff could not determine when the insulin pen was first used or when it should be discarded, as confirmed by interviews with nursing staff and the pharmacist.