Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bay Area Skin Cancer Surgery and Dermatology LLC on 06/17/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 observation, record review, and interview, the laboratory used an expired reagent for patient testing for the subspecialty of Histopathology. Findings included: A tour of the lab was conducted on 06/17/2025 at 9:40 a.m. A 4 oz bottle of Mounting Medium was observed being used. The expiration date on the bottle was 11/2024. The bottle was not labeled with an open date. Review of records failed to reveal a reagent log. Interview with the Mohs Technician on 06/17/2025 at 9:52 a.m. confirmed the above. 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 --