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 accuracy verification policies and procedures for the microscopic interpretation of Mohs specimens and interview with the facility personnel on 7/14/26 at 12:00 PM, the laboratory failed to verify the accuracy of Mohs testing performed under the subspecialty of histopathology at least twice annually during the timeframe of August 23, 2025 through July 14, 2026. Findings include: 1. The laboratory performs the microscopic interpretation of Mohs specimens in the subspecialty of histopathology. The laboratory began patient testing on August 23, 2025 and reports 1,800 tests annually. 2. No documentation was presented for review to indicate the laboratory verified the accuracy of the microscopic interpretation of Mohs specimens at least twice annually from August 23, 2025 through July 14, 2026. 3. The laboratory's established policy titled "Quality Assessment" states, "At least every 6 months slides from Mohs Surgery will be sent to an outside Dermatopathology Lab to confirm the surgeon's findings." 4. The facility personnel interviewed on 7/14/26 at 12: 00 PM confirmed the laboratory failed to verify the accuracy of histopathology testing at least twice annually from August 25, 2025 through July 14, 2026. 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 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 -- examination, including the detection of inadequately prepared slides. (b)(3) Step-by- 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)