Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on February 25, 2026. The findings and conclusions of any investigation by the Division of Healthcare Purchasing and Compliance shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 a review of the director approved procedure for comparison of test results, a review of the laboratory records for twice per year verification of accuracy for the Mohs testing, and an interview with the laboratory personnel, the laboratory failed to ensure that twice per year verification of accuracy for two of two years was performed and documented during each year of testing. Findings include: 1. The procedure for comparison of test results stated, "Any test performed in the laboratory for which proficiency testing is not available will be verified at least twice a year, and the results will be reviewed by the Laboratory Director." 2. A review of the twice per year verificaton of accuracy for the Mohs testing revealed that Mohs test patient cases dated March 22, 2024, October 10, 2024, March 6, 2025 and October 23, 2025 were not reviewed and verified by a second board certified dermatologist or a board certified pathologist until February 8, 2026. 3. The findings were confirmed during an interview with the laboratory personnel conducted on February 25, 2026 at approximately 9:45 AM. According to the submitted CMS-116 form, the laboratory performs 240 histopathology tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of