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 the surveyor's review of Proficiency Testing (PT) records, random selection of seven (7) patient reports, and interviews on August 11, 2026, it was determined that the laboratory did not verify the accuracy of high complexity Histopathology test at least twice annually for the years 2023, 2024, and 2025. The findings included: 1. The laboratory conducted Histopathology testing for Mohs Micrographic Surgery, which in not listed in subpart I of the 42 CFR part 493. For test procedures not listed in subpart I, the laboratory must verify the accuracy of the test procedures at least twice annually. 2. On August 11, 2026, at approximately 1:00 p.m., the laboratory director confirmed that all peer review cases for the years 2023, 2024, 2025, and 2026 were collectively submitted for peer review on July 30, 2026. The laboratory did not maintain records for accuracy verification of tests at least twice annually during 2023, 2024, and 2025. 3. The laboratory's testing declaration form, signed by the laboratory director on July 30, 2026, stated that the laboratory performed approximately 500 tests annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)