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 the laboratory's procedures, review of 2019, 2020, and 2021 laboratory records, the absence of records, and interview with the laboratory manager 3/22/22, the laboratory failed to verify accuracy of Mohs testing at least twice a year in 2021. Findings: The laboratory policy, "Biannual Proficiency Testing" states, "Scope/Purpose...The quality assurance program for verifying the accuracy and reliability of the testing results in the Mohs laboratory. Four cases will be randomly selected twice a year for review..." Review of proficiency testing records revealed the verification of accuracy was completed in 2019 and 2020 but there was no documentation that the laboratory had verified accuracy of Mohs testing performed by the two Mohs surgeons in 2021. At approximately 3 p.m, the laboratory manager confirmed the proficiency testing had not been completed in 2021. Deficiency previously cited 7/26/19. 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 --