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 Staff Manager, the laboratory failed to report all positive SARS-CoV-2 test results as required for 37 of 37 patients that tested positive since the laboratory started testing for SARS-CoV-2 in February 2022. Findings include: 1. An interview on 10/17/22 at 1:09 pm with the Staff Manager revealed the laboratory started testing in February 2022 and a total of 37 patients had tested positive for SARS-CoV-2 using their Sienna Rapid COVID-19 test kit. The Staff Manager confirmed no positive results had been sent to the health department. 2. The surveyor requested documentation of the laboratory's attempts to report the 37 positive SARS-CoV-2 results using its SARS-CoV-2 antigen test systems to the health department on 10/17/22 at 1:09 pm and it was not made available. 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 --