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 patient test reports, Abbott ID Now instructions for use, and confirmed by the laboratory director, the laboratory failed to follow manufacturer's instructions by indicating the incorrect COVID-19 test method on two of out nine patient test reports from 10/23/2020 - 1/14/2021. The findings include: 1. On 1/6 /2021, patient identifier A had COVID-19 testing performed using the Abbott ID Now test system. 2. On 1/12/2021, patient identifier B had COVID-19 testing performed using the Abbott ID Now test system. 3. The test reports for both patients had "PCR", indicating the laboratory performed the COVID-19 testing using a polymerase chain reaction test system. 4. The Abbott ID Now instructions for use under "Principles of the Procedure" do not state that the test is a polymerase chain reaction test system. 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 --