Failure to Date Opened Insulin Pen per Policy and Manufacturer Instructions
Penalty
Summary
Surveyors identified a deficiency in medication labeling and dating practices when, during observation in the Cottonwood cottage, an opened and partially used Insulin Glargine 100 unit/mL pen was found without a date indicating when it had been first used. At the time of observation, an RN confirmed that the insulin pen had been used and acknowledged that insulin pens were expected to be labeled with the date they were opened. The DON later confirmed that staff were expected to label multi-dose insulin with the date of opening. Review of the facility’s policy titled “Multidose Vial Use” dated August 2024 showed that all multi-dose vials must be dated with a 28‑day expiration date and labeled with the expiration date at the time of original opening by the person initially accessing the vial. Additionally, review of the insulin manufacturer’s prescribing information, last revised in 2025, indicated that the pen should only be used for up to 28 days after first use, further underscoring that the undated, opened insulin pen was not in compliance with established labeling requirements. No specific resident, medical history, or clinical condition was described in relation to the use of this insulin pen; the deficiency centered on the facility’s failure to label a multi-dose insulin pen with the date it was opened, contrary to facility policy and manufacturer instructions.
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