Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 surveyor observations, patient MOHs maps, and confirmed in staff interview, the laboratory failed to ensure two of four tissue marking dyes did not exceed their expiration dates prior to patient testing on 03/05/2025. Findings included: 1. During a tour of the histopathology laboratory on 03/05/2025 at 11:21 a.m., the surveyor observed the following expired tissue marking dyes located on the counter: Yellow Tissue Marking Dye - lot #166702; Expiration date: 02/28/2025 Red Tissue Marking Dye - lot #168108; Expiration date: 02/28/2025 2. Review of patient MOHs maps revealed one of one patient whose tissue was stained with the expired yellow tissue marking dye in the preparation of histopathology slides on 03/05/2025: MOHs accession # 25-154 3. During an interview 03/05/2025 at 11:23 a.m. in the laboratory, the Laboratory Manager and Histotechnician confirmed the tissue marking dyes had exceeded their expiration dates and the yellow dye used in patient testing. 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 --