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 the laboratory procedures and interview with the Testing Personnel, the laboratory failed to establish a procedure for reporting positive and negative SARS-CoV-2 testing to the appropriate health agencies as required from January 16, 2021 through the day of survey. Findings include: 1. On the day of survey, 03/24/2021, the laboratory could not provide a procedure for reporting positive and negative SARS-CoV-2 testing to the appropriate health agencies as required from 01/16/2021 to 03/2021. 2. 377 Access Bio CareStart COVID -19 Antigen specimens were analyzed for SARS-CoV-2 from 01/16/2021 to 03/24/2021. 3. The Testing personnel confirmed the findings above on 3/24/2021 around 8:45 a.m. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --