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F0761
D

Improper Storage and Labeling of Multi-Dose Vaccine Vial

Erie, Pennsylvania Survey Completed on 02-04-2025

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

The facility failed to adhere to proper medication storage protocols as evidenced by the observation of a multi-dose vial of Flucelvax in the East Wing medication room. The vial was found to be opened without an accompanying open date, which is a requirement according to the facility's policy on multi-dose vials. This policy mandates that opened vials must be labeled with the date they are opened and discarded according to manufacturer guidelines. The absence of an open date on the vial meant that staff were unable to determine when the vaccine should be discarded, potentially leading to the use of expired medication. During an interview, the Assistant Director of Nursing confirmed the lack of an open date on the vial and acknowledged the inability of staff to ascertain the discard date for the vaccine. Further review of CDC guidelines and information from the dispensing pharmacy indicated that the multi-dose vial should be discarded 28 days after opening. This oversight in labeling and storage practices represents a failure to comply with both federal and state regulations regarding the safe storage and management of medications in the facility.

Plan Of Correction

The Vial was discarded at the time of finding. All medication areas were checked at the time of survey. All licensed staff were educated by the Director of Nursing/designee on multidose vial policy. An audit will be conducted weekly to ensure vaccine vials are dated with date open for 4 weeks then monthly ongoing by the Director of Nursing/designee on all units including med room and carts. Findings will be reported to the Quality Assurance Performance Improvement committee for review and recommendations.

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