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 the laboratory failed to report SARS-Co-V-2 negative test results from January 2021 through August 2021. Findings include: 1. Email response to survey request received 9/14/2021 from laboratory director indicated only positive SARS-CoV-2 test results were reported to Southwest Utah Public 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 30 SARS-CoV-2 tests using the Abbott BinaxNOW COVID-19 Antigen test annually. 4. The laboratory director confirmed the findings by phone call on 09/14/2021 at 10:30 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 --