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F0761
D

Failure to Label and Date Multi-Dose Eye Medications

Framingham, Massachusetts Survey Completed on 07-29-2025

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 observed that the facility failed to ensure proper labeling and storage of multi-dose vials of eye medications on the Front Unit and on one medication cart (Medication Cart A). Specifically, an open multi-dose vial of Timolol Maleate ophthalmic solution was found in the medication storage room refrigerator without an open or use by date. On Medication Cart A, an open multi-dose vial of Natural Tears eye drops was also found without an open or discard date, and two open vials of Timolol Maleate were present—one with only an open date and the other with no date at all. Neither of the Timolol vials had a use by date. Facility policy requires that multi-dose vials be labeled with both the date opened and the discard date, following manufacturer guidelines or USP 797 recommendations. Interviews with the DON and a nurse confirmed that the correct procedure is to label multi-dose vials with both the open and use by dates, and that the observed vials did not meet this requirement. The DON and nurse acknowledged that, without proper labeling, it was not possible to determine if the medications were still viable, and that the affected vials would need to be discarded. The failure to label these medications as required was directly observed and confirmed by staff during the survey.

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