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 staff interview, the laboratory failed to report 2 negative SARS-CoV-2 patient test results, as required, for 1 month of testing (August 2021). The findings were: 1. Review of the laboratory's documentation showed 2 SARS-CoV- 2 tests were performed using the Quidel Sofia SARS Antigen test system in August 2021. There was no evidence the 2 negative SARS-CoV-2 patient results had been reported to the State Public Health Laboratory. 2. Review of a patient information document showed "...In the event that you are positive, Teton County Public Health will automatically be notified." 2. Interview with laboratory manager on 9/13/21 at 9 AM confirmed the negative SARS-CoV-2 patient test results had not been reported to the County or State Public Health Laboratory. 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 --