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F0761
D

Failure to Properly Label and Store Insulin Pen

Byrdstown, Tennessee Survey Completed on 04-09-2025

Penalty

No penalty information released
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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 related to the labeling and storage of a prefilled Semaglutide insulin pen for a resident with Type 2 Diabetes, Anxiety, Major Depressive Disorder, and PTSD. The insulin pen, which was ordered to be administered weekly, was found on a medication cart with its packaging opened and the pen appearing full and unused. The insulin pen was not labeled with the date it was opened or the date it was removed from refrigeration, as required by both facility policy and the product's boxed warning. According to the product labeling, unopened insulin pens should be refrigerated, and once opened, they should be stored at room temperature with the date of opening clearly marked. During interviews, the RN responsible for the cart was unable to confirm how long the insulin pen had been out of refrigeration and acknowledged that it was not labeled or stored correctly. The DON also confirmed that the insulin pen was available for resident use and was not labeled or stored in accordance with policy or manufacturer instructions. These findings demonstrate a failure to ensure drugs and biologicals were labeled and stored in accordance with accepted professional principles and facility policy.

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