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 COVID 19 Abbott ID Now and BD Veritor Test, Patient Results and interview with the Site Manager (SM), the laboratory failed to follow the Information for Use (IFU) when performing COVID tests from January 2020 to the date of the survey. The findings include: The laboratory did not follow the IFU as below: 1. The Laboratory did not report all COVID 19 results to the State of New Jersey. 2. The Laboratory performs approximately 80 COVID 19 tests per day. 3. The SM confirmed at 10:30 am on 1/25/2021 that the laboratory did not follow the IFU. 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 --