Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions for the BD Veritor System SARS- CoV-2 test and interview with laboratory director (LD) 7/14/22, the laboratory failed to provide fact sheets to patients and providers. Findings: Review of manufacturer's instructions, page 14, revealed "CONDITIONS OF AUTHORIZATION FOR THE LABORATORY...Authorized laboratories using your product must include with test result reports, all authorized Fact Sheets.". Interview with LD at approximately 9:45 a. m. confirmed fact sheets were not included with test result reports for the SARS-CoV- 2 testing performed. She stated she was unaware it was required. 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 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)