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 review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to perform bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for Mohs Micrographic surgery testing in 2024 and 2025. Findings include: 1. Review of laboratory policies and procedures revealed the document titled, "Proficiency Testing", which stated, under "Mohs Micrographic surgery skin specimens ", "Semi-annually, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it out for a microscopic examination by a board certified dermatopathologist." 2. Review of laboratory records revealed that the laboratory failed to send out proficiency cases semi-annually since starting Mohs Micrographic surgery testing in August of 2024. Date range: Date of PT review: 08/2024 - 08/2025 01/09/2026 08 /2025 - 08/2026 07/06/2026 3. Interview with the LD on 08/20/2026, at 11:40 am, confirmed the laboratory failed to perform bi-annual method accuracy (proficiency testing/peer reviewed interpretations) for Mohs micrographic surgery testing semi- annually as required starting in August of 2024 through the date of survey 08/20/2026. 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 --