Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 13, 2023. Leavitt Medical Associates of Florida Inc. d/b/a Advanced Dermatology and Cosmetic Surgery clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 the quality control (QC) records, peer review records and interview, the laboratory failed to have documentation to verify accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain at least twice annually for 2022. The findings include: Review of the Daily Quality Control Slide log showed the Laboratory Director evaluated the H&E stain quality for 12 of 12 months (January to December) for Mohs surgical cases performed in 2022. Review of the Mohs Proficiency form for the Laboratory Director dated 12/13/2023 showed the form was signed and dated by the Laboratory Director only. Mohs Proficiency form showed no indication the slides were review by another doctor. No other Mohs Proficiency forms were available for review for the Laboratory Director for 2022. On 09/13/2023 at 4:08 AM, the Area Administrative Manager stated the forms were not completed and they did not know where any other Mohs proficiency for 2022 was located. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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 -- procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)