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 laboratory records and manufacturer's IFU(instructions for use) and interview with testing personnel 3/10/22, the laboratory failed to follow manufacturer's instructions for the SARS-CoV-2 rapid antigen testing performed to ensure authorized Fact Sheets for patients and providers were included with the SARS- CoV 2 test result reports. Findings: Review of laboratory records revealed the laboratory began testing the BD Veritor system for Rapid Detection of SARS-CoV-2 and Flu A&B in August 2021. 1. The laboratory failed to ensure authorized Fact Sheets for patients and providers were included with SARS Cov-2 test result reports. Review of the IFU for the BD Veritor System for Rapid Detection of SARS-CoV-2 and Flu A&B revealed on page 15, "Conditions of Authorization for the Laboratory... Authorized laboratories using your product must include with test result reports, all authorized fact sheets..." During interview at approximately 12:30 p.m, testing personnel #1 confirmed the laboratory does not provide the fact sheets with test result reports. 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 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 -- 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)