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 observation of the CLIA Certificate of Registration, review of laboratory records for Mohs Micrographic Skin Cancer Surgeries, the lack of laboratory documents, and interview with the Laboratory Director/Testing Person, it was determined the laboratory failed to verify the accuracy of Mohs surgeries to clear tumor at final stages of the procedures. Findings included: 1. The laboratory posted the CLIA Certificate of Registration which had the effective date of 10/09/23. 2. The Laboratory Director/Testing Person affirmed (10/22/24 at 11:40 AM) that Mohs surgeries were performed when the laboratory CLIA Certificate type was PPMP in 2022. 3. The Log Book for Mohs surgeries documented procedures performed from 10 /28/22 to October 2024. A total of 11 procedures were performed in 2022 and a total of 297 procedures were performed in 2023. A few selected for this survey were, as follows: Date ID -------------------------- 10/28/22 M22-002 12/02/22 M22-011 6/30/23 M23-124 9/29/23 M23-207 12/22/23 M23-296 1/12/24 M24-006 5/31/24 M24-222 10 /11/24 M24-420 4. The laboratory failed to provide any records for 2022 and 2023 that verified the accuracy of Mohs surgeries to clear tumor at the final stages of the procedures. 5. The Laboratory Director/Testing Person/Mohs Surgeon affirmed (10/22 /24 at 11:40 AM) the aforementioned findings, and thus, the failure to verify the accuracy of the Mohs surgeries. 6. The reliability and quality of Mohs surgeries performed in 2022 and 2023 could not be assured during this CLIA survey for reviewing test records. . D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 -- The laboratory director must ensure that the quality assessment programs are established 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 the lack of laboratory records and deficiency cited (see D5217), the Laboratory Director is herein cited for deficient practice in providing oversite of the laboratory to ensure that quality assessment processes are established and maintained to assure the quality and accuracy of services provided. . -- 2 of 2 --