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 the lack of the laboratory's Mohs reports peer review, review of five (6) randomly chosen Mohs patient's reports, and interviews with the laboratory's technical consultant (TC) on December 5, 2024; it was determined that the laboratory failed to verify, at least twice annually, the accuracy of its Mohs histopathology tests for the years 2022 and 2023. The findings included: 1. The laboratory did not have any documentation showing that it had verified its histopathology Mohs tests' accuracy for the years 2022 and 2023 for the dermatopathologists performing slide reading and providing patients' diagnosis. Therefore, the accuracy of the laboratory's test results for patients' Mohs histopathology procedures, cannot be assured. 2. The TC confirmed at approximately 11:00 a.m., that the laboratory did not have any record to verify its Mohs test accuracy for the years 2022 and 2023. 3. The laboratory's testing declaration form signed by the laboratory director, stated that the laboratory performs approximately 500 Mohs tests annually. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on the deficiency cited (See D5217), the laboratory director is herein cited for 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 -- deficient practice in overall administration to ensure the laboratory is enrolled in proficiency testing (peer review) for Mohs surgery samples tested and results reported. -- 2 of 2 --