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 the surveyor's review of Proficiency Testing (PT) records and an interview with the Laboratory Director (LD) on July 31, 2025, it was determined that the Laboratory did not verify the accuracy of the Histopathology test at least twice annually for the years 2024 and 2025.The findings include: 1. It was the practice of the laboratory to perform Mohs Micrographic Surgery, which is not listed in subpart I of the 42 CFR part 493. For test procedures not listed in subpart I, the laboratory must verify the accuracy of the test procedure twice annually. 2. On 07/31/2025 at approximately 10:30 am, the LD confirmed that the laboratory did not verify the accuracy of the Histopathology testing in 2024 and 2025. 3. The laboratory's testing declaration form, signed by the laboratory director on July 31, 2025, stated that the laboratory performed approximately 50 tests annually. Therefore, the accuracy of the laboratory's test results cannot be assured and may have potential to harm patients. 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 --