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 records for Mohs procedures, the lack of laboratory records, and interview with laboratory personnel, it was determined that for each calendar year in 2023, the laboratory failed to at least twice annually verify the accuracy of Mohs procedures to clear tumor by Testing Person-2; and in 2024, the laboratory failed to at least twice annually verify the accuracy of pathology reported for Frozen Biopsy specimen. Findings included: 1. The laboratory chose to establish a process for Peer Review of it's testing in Histopathology as the means to fulfill the requirement to at least twice within the calendar year verify the accuracy of testing. 2. Laboratory records selected at random from 2023 for this Survey included Mohs procedures performed by Testing Person-2, as follows: Date Case ----------------------------- 10/19/23 CM-488 11/29/23 CM-499 3. Laboratory records selected at random from 2024 for this Survey included Frozen Biopsy specimen for reporting pathology during Mohs surgeries, as follows: Date ID, FBX Pathology reported ------------------------------------------------------------ 3/07/24 R, P; Left Hand SCC 8/22/24 W, K; Lower Back BCC SCC = Squamous Cell Carcinoma BCC = Basal Cell Carcinoma 4. The laboratory failed to have records at least twice in 2023 for verifying the accuracy of Mohs procedures to clear tumor by Testing Person-2; and at least twice in 2024 for verifying the accuracy of pathology reported for Frozen Biopsy specimen during Mohs procedures. 5. Laboratory/Medical Assistant-1 affirmed (8/21/25 at 4:30 PM) the aforementioned findings; and thus, the laboratory's failure to have written policy/procedure and practice to include all Testing Persons performing Mohs procedures, as well as pathology reported for Frozen Biopsy, when verifying accuracy of tests performed. . 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 --