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 reviews of the Bi-Annual Peer Review (PR) Accuracy Verification (AV) records, the MOHS Micrographic Surgery Laboratory Control Slides Forms (MMSLCS), and an interview with the Laboratory Manager (LM), the laboratory failed to document resolutions of discrepancies in accuracy verifications. The surveyor noted one of the ten submissions on June 13, 2025, and two of the ten submissions on December 22, 2025, had discrepancies in diagnoses by the Mohs Surgeon (MS) and the Pathologist (P). The findings include: 1. A review of the Bi- Annual PR AV records revealed failure to document resolutions of the discrepancies on returned PR AV results. 2. A review of the MMSLCS form revealed the Mohs surgeon review did include under comment the final determination regarding the two different diagnoses between the MOHS surgeon and the Pathologist for the following submissions. A) June 13, 2025, Case 25X0021, MS Diagnosis-Negative, P Diagnosis- Positive C1S B) December 22, 2025, Case 25X0192, MS Diagnosis-Negative, P Diagnosis-Positive SCIS C) December 22, 2025, Case 25X0181, MS Diagnosis- Negative, P Diagnosis-Positive SCIS 3. LM confirmed the above findings during the exit conference on 07-08-2026 at 1PM. 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 --