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F0761
F

Failure to Label Opened Multi-Use Tuberculin Vials

Heath, Ohio Survey Completed on 09-15-2025

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 multi-use vials of Tuberculin (TB) solution (Tubersol) stored in medication refrigerators across three separate medication storage rooms were opened but not labeled with the date they were first accessed. In each instance, the vials were found without any indication on the vial or packaging to reflect when they had been opened, despite the manufacturer’s guidelines requiring that opened vials be discarded after 30 days of use. The expiration date on all vials was noted to be 04/2026, but there was no way to determine how long the vials had been in use. Interviews with staff, including a medication technician and two unit managers, confirmed the absence of open dates on the vials and acknowledged that the vials should not have been in use without proper labeling. The staff members removed and discarded the vials upon discovery. The facility’s practice of not labeling opened multi-use vials of Tuberculin solution had the potential to affect all 112 residents, as all new admissions receive a two-step TB test upon admission.

An unhandled error has occurred. Reload 🗙