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 review of 2021 laboratory records for Mohs surgical procedures, the lack of documents for verifying accuracy of testing, and interview with the Laboratory Director/Technical Supervisor-1/Testing Person-1, it was revealed that the laboratory failed to verify the accuracy of Mohs procedures performed by one out of three testing persons. Findings included: 1. Review of 2021 Mohs Log revealed procedures were performed by three testing persons: VR, AZ, and AK. Testing person-AK performed Mohs in 2021, as follows: Date Number of cases --------------------------------- 3/10/21 5 4/14/21 6 5/05/21 5 2. Laboratory records documented peer review of 2021 Mohs slides to at least twice annually verify the accuracy of the final stages, but failed to include slides from procedures performed by AK. 3. The Laboratory Director /Technical Supervisor-1/Testing Person-1 affirmed (8/29/22 at 11:30AM) the aforementioned findings; and thus, the failure to at least twice annually verify the accuracy of all testing. 4. The reliability and quality of Mohs procedures performed by 1 out of 3 testing persons in 2021 could not be assured when peer review was not done. 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 --