William P Baugh, Md Inc

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 observation of the Cryostat and Microscope, review of 2022-2024 laboratory records for Mohs procedures, the lack of laboratory records, and interview with laboratory personnel, it was determined the laboratory failed to verify the accuracy of Mohs procedures to remove/clear tumor. Findings included: a. A few laboratory records selected for this Survey documented Mohs procedures were performed during the timeframe 2022-2024, as follows: Date Mohs # ------------------------- 3/07/22 #26 -- B,R 9/19/22 #96 -- B,J 11/28/22 #120--S,A 3/06 /23 #38 -- B,C 10/23/23 #137--A,J 1/05/24 #07 -- H,R 7/08/24 #95 -- K,J 9/09/24 #123 --C,R b. The laboratory failed to have records of peer review verifying the accuracy of Mohs procedures to clear tumor, at least twice each calendar year for 2022, 2023, and 2024. c. The office manager affirmed (9/25/25 at 1:30 PM) the aforementioned findings, that the laboratory lacked the practice of peer review of Mohs slides to verify tumor was cleared; and that the laboratory lacked a written policy and procedure to do so. d. And thus, the reliability and quality of Mohs procedures to clear tumor could not be assured during this Survey. The laboratory reported 2,795 Histopathology tests annually including Mohs procedures. . 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 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 -- 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)

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory's patient testing result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to follow written policies and procedures effectively for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. The findings included: a. The laboratory has been certificated for histopathology and test performed including the biopsy diagnosis and Mohs surgery procedures tissue slide readings. b. Review of 8 patient testing result reports covering 2018 and 2019 for accuracy of the histopathology testing result reports. c. One of the 8 reports, a Pathology Report identified by Patient ID #109399, Accession #HS19-339, and Date Collected on 07/17 /19 with Date Reported on 08/30/19 was noted to have discrepancy and incorrect specimen information of the site of the tissue collected. d. The site on the Pathology Report indicated "Right Superior Eyelid" while the site indicated on the slide label is "RLAUPREYELID" which translated by the laboratory personnel as "Right Lateral Eyelid". e. The laboratory personnel stated (01/10/2020 @ 12:30 PM) that the laboratory currently newly installed electronic medical record (EMR) system, EMA, and was told by the vendor that no correction can be made once incorrect. f. The EMA system prevent the laboratory personnel to make