Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the Hematoxylin reagent log sheet, and staff interview, the laboratory failed to ensure that it did not use three of three lots of tissue marking dyes and one of one lot of Hematoxylin stain beyond their expiration in Mohs histopathology patient testing in 2025. The findings include: 1. Observation of the Mohs laboratory on 06/24/2025 at 1:20 p.m. revealed one opened bottle of: Avantik Gill 3 Hematoxylin stain- Lot 184042, Expiration date 4/30/2025 And the following opened Avantik tissue marking dyes: Green- Lot 165667, Expiration date 1 /31/2025 Yellow- Lot 166232, Expiration date 2/28/2025 Black- Lot 167158, Expiration date 2/28/2025 2. A review of the Hematoxylin Reagent Log Sheet revealed that the stain had been placed in use on 1/6/2025 and expired on 4/30/2025. 3. An interview with the Mohs lab technician on 06/24/2025 at 1:20 p.m. confirmed that the laboratory used the observed tissue marking dyes and hematoxylin stain for patient testing after expiration. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --