Summary:
Summary Statement of Deficiencies D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) (a)(3)(i) Records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on review of 2025 and 2026 laboratory records, the absence of validation records, and interview with the laboratory director 3/4/26, the laboratory failed to retain validation documentation for the hematoxylin and eosin (H&E) staining performed. Review of 2025 and 2026 laboratory records revealed the laboratory did not have validation records for the H&E stains performed, including a summary /timeline of the steps taken to validate the H&E stain, the date patient testing began, and the laboratory director's signature and date of approval. During interview at approximately 11:05 a.m., the laboratory director stated the validation was done prior to the start of patient testing, but they could not locate it. He stated Mohs patient testing began 9/9/25. 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- 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 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 -- 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)