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 the laboratory director (LD); the laboratory failed to correlate and evaluate results of Mohs bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for five of five events from the beginning of 2023 to the date of survey, 07/08/2025. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled, "Part 1: Quality Assessment Procedures", which stated, under "3. Ongoing Assessment:", "The programs and methods used for Proficiency Testing ...and results of this testing will be evaluated by the Laboratory Director or an appropriate, designated staff member ever six months." 2. Review of laboratory records revealed a lack of documentation of correlation and evaluations of results upon receipt of peer reviewed Mohs histopathology interpretations for five of five reviewed bi-annual method accuracy events. 3. Interview with the LD at 1:20 pm, on 07/08/2025, 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 the beginning of 2023 to the date of survey, 07/08/2025. 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 --