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 interview with Laboratory director (LD) and review of laboratory's Proficiency Testing (PT) records on October 21, 2024, it was determined that the Laboratory failed to ensure that the accuracy of the Mohs test was verified at least twice annually for the years 2022, 2023 and 2024. The findings include: 1. It was the practice of the laboratory to perform Mohs Micrographic Surgery, which is not listed in the subpart I of the 42 CFR part 493. For the test procedure not listed in subpart I the laboratory must verify the accuracy of the test procedure twice annually. 2. On October 21, 2024, at approximately 12:30 pm, the laboratory director affirmed that the laboratory maintained no documentation to show it verified the accuracy of Mohs procedure at least twice annually for the years 2022, 2023 and 2024. 3. The laboratory's testing declaration form, signed by the laboratory director on October 15, 2024, stated that the laboratory had performed 200 Mohs procedures annually. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases 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 2 -- This STANDARD is not met as evidenced by: Based on interview with Laboratory director (LD) and review of laboratory's Proficiency Testing (PT) records on October 21, 2024, it was determined that the Laboratory director failed to ensure that testing systems developed and used for Mohs procedure provides quality laboratory services for all aspects of test performance. See D5217 -- 2 of 2 --