Summary:
Summary Statement of Deficiencies D0000 A Validation survey was performed at Ochsner Northshore Dermatology Mohs Surgery, CLIA ID 19D2090898, on August 11, 2026. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the CMS 209 form, laboratory's policies, and interview with personnel, the laboratory failed to establish a complete written competency assessment policy for Testing Personnel. Findings: 1. Review of the laboratory's CMS 209 (Laboratory Personnel Report) form revealed the Laboratory Director serves as the Testing Personnel. 2. Review of the laboratory's policies revealed the laboratory did not include a competency assessment policy for personnel serving as Testing Personnel. 3. In interview on August 11, 2026 at the Histotechnican confirmed the laboratory did not include written competency assessment policies for Testing Personnel. 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 may supplement but not replace the laboratory's written procedures for testing or examining specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and interview with personnel, the laboratory failed to establish a complete policy and procedures manual. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not include the following: Complete twice a year verification procedure: to include frequency of performance of audits with another dermatopathologist to verify the accuracy of the Mohs test performance. 2. In interview on August 11, 2026 at 11:19 am, the Hisotechnician confirmed the laboratory did not include the frequency of test performance of audits to verify the accuracy of Mohs testing. 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)