Summary:
Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) 2; the laboratory failed to correlate and evaluate results of Mohs bi-annual method accuracy (proficiency testing /peer reviewed histopathology interpretations) for four of four events from 2023 to the date of survey, 08/19/2025. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled, "Proficiency Testing", which stated, "Upon receipt of the pathology report from the Dermatopathologist or Mohs surgeon, diagnosis of the slide will be matched to the in-house diagnosis by the physician." 2. Review of laboratory records revealed a lack of documentation of correlation and evaluations of results by the Mohs surgeon upon receipt of peer reviewed Mohs histopathology interpretations for four of four bi-annual method accuracy events. Event Date returned Fall 2023 12/11/2023 Spring 2024 06/10/2024 Fall 2024 12/11 /2024 Spring 2025 06/11/2025 3. Interviews with the TP2, at 2:43 pm, on 08/19/2025, confirmed the laboratory failed to correlate and evaluate results of Mohs bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for four of four events from 2023 to the date of survey, 08/19/2025. 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 --