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 records selected at random for this Survey, the lack of laboratory records, and interview with laboratory personnel, it was determined that the laboratory failed to at least twice annually in 2022, 2023, and 2024 verify the accuracy of pathology reported for biopsy specimen and the accuracy of clearing tumor in Mohs procedures. Findings included: 1. Pathology of biopsy specimen were reported by the Testing Person/Laboratory Director, as follows Mohs Date Case # Biopsy Pathology ---------------------------------------------------------------- 2/09/22 T22- 129 1/26/22 12/07/22 T22-784 12/05/22 3/22/23 T23-184 2/27/23 6/14/23 T23-356 6 /07/23 4/16/24 T24-136 3/18/24 2. Other Mohs procedures were performed by the Testing Person/Laboratory Director, as follows: Mohs Date Mohs Case # ----------------------------------- 7/27/22 T22-466 11/28/23 T23-689 10/01/24 T24-268 12 /10/24 T24-320 3. The laboratory failed to have records verifying the accuracy of biopsy Pathology reports and the accuracy of Mohs procedures at least twice each year for 2022, 2023, and 2024. 4. The Laboratory Director and laboratory administrator affirmed (8/06/25 at 3:30 PM) the aforementioned findings; and thus, the failure to verify the accuracy of Pathology reports and the accuracy of Mohs procedures at least twice each year for 2022 - 2024. . D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks 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 -- may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on review of laboratory records and interview with the Laboratory Director, it was determined that the laboratory failed to have a laboratory manual of written policies and procedures approved by the Laboratory Director for personnel to use as their reference. Findings included: 1. The record titled, CMS116 CLIA Application (8 /06/25), documented laboratory testing in Histopathology, specifically Mohs procedures to clear tumor. 2. The laboratory failed to provide it's Laboratory Manual for this Survey. 3. The Laboratory Director affirmed (8/06/25 at 3:30 PM) the lack of a Laboratory Manual; and thus, the failure to have written policies and procedures for the staff to follow to ensure compliance. 4. Laboratory records documented the staff assisted with the collection and handling of biopsy specimen and Mohs specimen and managing laboratory records as the Laboratory Director/Testing Person reported Biopsy Pathology reports and performed Mohs procedures since 2022. . 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 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)