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 surveyor review of the Test Report (TR) and interview with the General Supervisor (GS), the laboratory failed to report Covid 19 testing accurately. The findings state: 1. The laboratory performed non Food and Drug Administration (FDA) cleared tests and there was no statement "This test has not been FDA cleared or approved; The test has been authorized by the FDA under an Emergency Use Authorization (EUA)". 2. The GS confirmed on 6/6/23 at 11:00 am that Covid 19 tests were not reported accurately. 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 --