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 laboratory documents, the lack of records, and interview with laboratory personnel, it was determined the laboratory failed to verify the accuracy of Mohs procedures to clear tumor at the final stage. Findings included: 1. The laboratory's CLIA Application (CMS116, 5/08/25) stated Mohs procedures for testing in Histopathology. 2. Mohs records documented procedures performed 2024 to present 2025. Cases randomly selected for this CLIA survey were, as follows: Date Case # ----------------------------------------------- 7/08/24 24-008 9/09/24 24-120 12/03 /24 24-433 1/16/25 25-024 3/18/25 25-258 5/07/25 FS-5-02 Frozen Section. 5/07/25 25-468 3. The laboratory provided records of slides review for assessing the histologic quality of slide preparation and staining; the laboratory failed to have records verifying the accuracy of Mohs procedures to clear tumor in the final stage. The laboratory policy failed to specify verifying the accuracy of pathology reported for Frozen Sections. 4. Two laboratory persons affirmed (5/21/25 at 12:30 pm) the aforementioned findings and that an outdated form had been used. 5. The reliability and accuracy of Mohs procedures to clear tumor was not assured. The reliability and accuracy of pathology reported for Frozen Sections was not assured. 6. The laboratory performed 1000 Mohs procedures annually (CLIA Application, 5/08/25) and did not state the number of Frozen Biopsy performed annually. . D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established 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 -- and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on findings and the deficiency cited at D5217, the Laboratory Director is herein cited for deficient practice in providing overall supervision for establishing and maintaining the program to at least twice annually verify the accuracy of Mohs procedures and Frozen Sections during Mohs. Findings included: 1. The laboratory failed to have records verifying the accuracy of Mohs procedures to clear tumor. 2. The laboratory policy failed to include verifying the accuracy of Frozen Sections obtained during Mohs surgeries. 3. See D5217 . -- 2 of 2 --