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F0761
E

Failure to Properly Date and Store Insulin Pen-Injectors

Milford, Ohio Survey Completed on 04-09-2025

Penalty

Fine: $53,370
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The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.

Summary

Surveyors identified a deficiency in the facility’s handling of insulin medications, specifically regarding the labeling and storage of insulin pen-injectors. During observations of medication carts across multiple nursing units, it was found that insulin pens for several residents were not dated when removed from refrigerated storage and placed in the medication carts. This practice was confirmed through interviews with LPNs responsible for medication administration, who acknowledged that the insulin pens lacked the required dating. Additionally, some insulin pens remained in use beyond the manufacturer-recommended 28-day period after removal from refrigeration, and in one case, an insulin pen was still present in the cart after the physician’s order for its use had been discontinued. The residents affected by this deficiency had complex medical histories, including diagnoses such as diabetes mellitus type II, end-stage renal disease, congestive heart failure, cerebrovascular accident, malignant neoplasm of the brain, and other significant comorbidities. Many of these residents required extensive assistance with activities of daily living, and some were dependent on enteral feeding tubes or had tracheostomies. The improper labeling and storage of insulin affected a total of ten residents who were identified as receiving insulin therapy at the time of the survey. Interviews with the consulting pharmacist and the Director of Nursing confirmed that facility policy and manufacturer guidelines require insulin vials and pen-injectors to be dated when first used and to be discarded 28 days after removal from refrigerated storage. The facility’s policy on medication storage also specifies that medications and biologicals must be stored according to manufacturer or pharmacy recommendations to maintain their integrity. Despite these requirements, the survey found multiple instances where insulin pens were not properly dated or discarded, resulting in noncompliance with accepted professional standards for medication management.

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