Dermatology Associates

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 laboratory records for Mohs procedures performed in 2020, the lack of records, and interview with the Laboratory Director/Testing Person, the laboratory failed to at least twice within the 2020 calendar year verify the accuracy of Mohs procedures to clear skin cancer. Findings included: 1. The laboratory Mohs Log recorded more than two Mohs procedures were performed in 2020. 2. Laboratory records documented microscope slides from one of the Mohs procedures performed in 2020 had been sent to a reference laboratory for review, as the means to fulfill the requirement to verify the accuracy of testing. 3. The laboratory failed to provide records that documented at least one additional case of 2020 Mohs slides had been reviewed to verify accuracy. 4. The Laboratory Director/ Testing Person affirmed (9 /18/23 at 11am) the aforementioned findings. 5. And thus, the accuracy, reliability and quality of the Mohs precedures performed in 2020 had not been assured. . D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 a review of the laboratory records for evaluation of proficiency testing performance and an interview with the laboratory director (LD), it was determined that the laboratory failed to twice annually document and verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. The findings included: a.The laboratory performs histopathology (Mohs) testing. b. The laboratory director affirmed that the laboratory failed to verify the accuracy of its histopathology Mohs at least twice a year in the 2019 timeframe. This was reviewed during a meeting with the laboratory director on 2/4/2020 at approximately 2 p.m. 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 --