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 a lack of records and interview with the Principal, the laboratory failed to report positive and negative SARS-CoV-2 test results as required for 6-7 of 6-7 students that were tested since the laboratory began testing for SARS-CoV-2 on February 10, 2022. Findings include: 1. The surveyor requested documentation of the laboratory's attempts to report positive and negative SARS-CoV-2 results using its BinaxNOW COVID-19 Ag Card test systems to the health department on 9/20/2022 at 10:00 am and it was not made available. 2. An interview on 9/22/2022 at 10:00 am with the Principal confirmed the laboratory had no documentation to show the students that had tested positive and/or negative for SARS-CoV-2 were reported to the health department. 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 --