Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory policy and procedure, Quality Assurance records, and staff interviews, the laboratory failed to verify the accuracy of Mohs micrographic surgery (Mohs) histopathology testing at least twice annually in 2023 and 2024. The findings include: 1. An observation of the laboratory on 03/04/2025 at 08:30 a.m. revealed equipment and stains used for preparing slides from tissue removed during Mohs surgical procedures. 2. A review of the Proficiency Testing section of the Quality Assurance policy revealed a requirement for random selections of Mohs surgical cases to be chosen biannually for proficiency testing. 3. A review of the Quality Assurance Proficiency Testing records revealed that cases had been reviewed on 07/24/2023, 12/16/2024, and 02/04/2025. 4. An interview with the Laboratory Director and the Clinic Supervisor on 03/04/2025 at 11:30 a.m. confirmed that the laboratory failed to verify accuracy of Mohs testing at least twice annually in 2023 and 2024. 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 --