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 2023 - 2026 laboratory records for Mohs procedures, the lack of laboratory records, and interview with laboratory personnel, it was determined the laboratory failed to verify the accuracy of Mohs procedures performed in 2023. Findings included: 1. Laboratory records documented Mohs procedures performed in 2023 by different Mohs Surgeons/Testing Personnel. Several cases selected for this Survey were, as follows: Date Mohs Case # Mohs Surgeon ---------------------------------------------------------------- 5/24/23 23PT340 Dr. P T 7/28 /23 23PT493 Dr. P T 10/06/23 23SL002 Dr. S L 10/27/23 23SL027 Dr. S L 10/25/23 23HZ001 Dr. H Z 10/25/23 23HZ005 Dr. H Z 10/30/23 23KB003 Dr. K B 12/04/23 23KB029 Dr. K B 12/18/23 23ME001 Dr. M E 12/18/23 23ME010 Dr. M E 2. To meet the requirement of this regulation to at least twice each calendar year, verify the accuracy of procedures performed by each Mohs Surgeon, the laboratory had a policy and practice of selecting Mohs slides for review by another qualified Mohs surgeon, dermatologist, dermatopathologist, or pathologist to verify the tumor was cleared in the final stage. 3. The laboratory was unable to provide such records of peer review for any of the Mohs procedures performed in 2023. 4. Laboratory personnel affirmed (1/29/26 at 1:00 PM) the aforementioned findings and lack of peer review records for 2023. 5. And thus, the reliability, accuracy, and quality of Mohs procedures performed in 2023 were not assured during this Survey. The laboratory's CMS116 CLIA Application (dated 1/22/26) stated 530 Mohs procedures performed 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 --