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 interview with Office Manager (OM) and review of laboratory's Proficiency Testing (PT) records on January 8, 2025, it was determined that the Laboratory failed to ensure that the accuracy of the Mohs test was verified at least twice annually for the years 2022, 2023 and 2024. The findings include: 1. It was the practice of the laboratory to perform Mohs Micrographic Surgery, which is not listed in the subpart I of the 42 CFR part 493. For the test procedure not listed in subpart I the laboratory must verify the accuracy of the test procedure twice annually. 2. On January 8, 2025, at approximately 10:00 am, the Office Manager affirmed that the laboratory maintained no documentation to show it verified the accuracy of Mohs procedure at least twice annually for 3 of 3 years. 3. The laboratory's testing declaration form, signed by the laboratory director on January 8, 2025, stated that the laboratory had performed 300 Mohs procedures annually. 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 --