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 surveyor review of Wisconsin Electronic Disease Surveillance System (WEDSS) reports, and interview with testing personnel, staff A, the laboratory failed to supply documentation of result reporting and failed to report as required negative and positive SARS-CoV-2 (COVID-19) antigen test results for this site to local, state and federal authorities for all days of test performance for thiry-four of thirty-four days. Findings include: 1. Interview with staff A on April 6, 2022 at 3:25 PM confirmed the laboratory performs COVID-19 rapid antigen testing onsite at 625 Linn Street, Baraboo, WI. 2. Interview with staff A revealed the laboratory started COVID- 19 antigen testing and PCR collections on February 18, 2022. Further interview confirmed the laboratory, CLIA# 52D2256352 failed to supply documentation of result reporting and failed to report as required negative and positive SARS-CoV-2 (COVID-19) antigen test results for this site to local, state and federal authorities for all days of test performance for thiry-four of thirty-four days. A WEDSS report was obtained on April 12, 2022 from the Wisconsin State Laboratory of Hygiene. This report confirmed that no COVID-19 results were reported to the state reporting system from February 18, 2022 through April 6, 2022 from CLIA# 52D2256352. 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 --