Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was conducted on October 21, 2021. Advanced Dermatology and Cosmetic Surgery clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain Quality Control (QC) records documenting the Hematoxylin and Eosin (H&E) stain quality for 2 (2019, 2020) of 3 (2019, 2020, 2021) years reviewed. Findings: Review of the laboratory's QC records showed the log titled, "Daily Quality Control Slide" for recording the H&E stain quality was not available for review for 2019 and 2020. The Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 10/21/2021, noted the laboratory had an estimated annual test volume of 168 histopathology tests per year. On 10/21/2021 at 10:26 AM, the Manager stated she did not know were the logs were located. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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 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 -- 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)