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 representative (LR), the laboratory failed to evaluate results of bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for eight of eight events in 2023 through the date of survey 09/23/2025. Findings include: 1) Review of laboratory policies and procedures revealed the policy, "Proficiency Testing for Dermatology", which stated, under "Policy", "Upon receipt of completed review, the physician receives a critique with the intended diagnosis, diagnostic criteria and references." 2) Review of laboratory records revealed a lack of documentation of evaluations of results upon receipt of peer reviewed histopathology interpretations for eight of eight reviewed bi- annual method accuracy events. Year: Event: 2023 Q3 2023 Q4 2024 Q1 2024 Q2 2024 Q3 2024 Q4 2025 Q1 2025 Q2 3) Interview with the LR on 09/23/2025, at 1:37 pm, confirmed laboratory failed to evaluate results of bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for eight of eight events in 2023 through the date of survey 09/23/2025. 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 --