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 record review and interview, the laboratory failed to report SARS-CoV-2 negative test results from December 2020 through December 2021. Findings include: 1. In an interview with laboratory staff on 12/08/2021 at 8:45 AM, they confirmed that negative SARS-CoV-2 test results were not reported to the state health department. 2. Laboratory procedure failed to include instructions for reporting negative SARS-CoV-2 test results to the state health department. 3. The laboratory performed approximately 50 SARS-CoV-2 tests annually using the Care Start COVID- 19 Antigen test. 4. The laboratory director confirmed the findings on 12/08/2021 at 9: 00 AM. 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 --