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 observation of the Leica CM1520 cryostat, serial number 1028, and the Unico and the Nikon microscopes; review of laboratory records from 2021 - 2023, and interview with laboratory administrative personnel, the laboratory failed to verify the accuracy of testing performed by Mohs surgeon-Y in 2022. Findings included: 1. Review of Mohs records dated 1/05/22 and 5/25/22 documented Mohs surgeon-Y as performing the procedures. 2. The laboratory failed to provide for review 2022 records verifying the accuracy of Mohs procedures performed by Mohs surgeon-Y. 3. Laboratory administrative personnel affirmed (9/14/23 at 11:00am) the aforementioned findings. 4. The reliability and quality of procedures performed by Mohs surgeon-Y in 2022 could not be assured in the absence of records at least twice annually verifying the accuracy of testing. . 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 --