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 Laboratory Director (LD), Six (6) random patient sampling, and review of laboratory's Proficiency Testing (PT) records on October 16, 2025, it was determined that the Laboratory failed to ensure that the accuracy of the Histopathology test was verified at least twice annually for the years 2023, 2024 and 2025. 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 October 16, 2025, at approximately 1:30 p.m., the LD affirmed that the laboratory maintained no documentation to show it verified the accuracy of Histopathology test at least twice annually for 3 of 3 years. 3. The laboratory's testing declaration form, signed by the laboratory director on October 09, 2025, stated that the laboratory had performed 750 histopathology tests 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 --