Summary:
Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to report SARS-Co-V-2 test results as required for 3 of 3 tests performed since the laboratory has been in operation. Findings include: 1. The surveyor requested the facility's SARS-CoV-2 testing and reporting policy via email correspondence on 2/23 /21 at 9:00 am and it was not made available. 2. An interview with the Laboratory Director on 2/24/21 at 3:00 pm revealed the laboratory had performed a total of three patient tests with the BD Veritor Plus SARS-CoV-2 antigen test system and it did not report those results to the health department. 3. The Laboratory Director confirmed the findings on 2/24/21 at 3:00 pm. 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 --