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 evaluate results of bi-annual method accuracy (proficiency testing/peer reviewed Mohs histopathology interpretations) for 24 of 24 events in 2024 and 2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Proficiency Testing and Assessment of Personnel's Competency", which stated, "Mohs surgeon will submit on average, 1 slide per week worked, to Dr. [B], a Board Certified Dermatopathologist .... Once reviewed, Dr. [B] will submit, in return to the Mohs surgeon, a sheet that documents his findings on these slides so that they can be reviewed by the Mohs surgeon." 2. Review of laboratory records revealed the laboratory lacked documentation of correlation and evaluations of results upon receipt of peer reviewed Mohs histopathology interpretations for 24 of 24 events in 2024 and 2025. 3. Interview with the LD on 01/13/2026, at 1:07 pm, confirmed the laboratory failed to evaluate results of bi-annual method accuracy (proficiency testing/peer reviewed Mohs histopathology interpretations) for 24 of 24 events in 2024 and 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 --