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 email correspondence with the Laboratory Director, the laboratory failed to report SARS-CoV-2 test results as required for 520 of 520 SARS- CoV-2 tests administered since the laboratory has been in operation. Findings include: 1. The surveyor requested documentation of the laboratory's attempts to report SARS- CoV-2 testing results using its Abbott BinaxNOW antigen testing system on 1/6/22 at 10:03 am. 2. Email correspondence with the Laboratory Director on 1/13/22 revealed the SARS-CoV-2 testing results had not been reported to the health department. 3. A review of the laboratory's "2021 GLIAC Tournament COVID-19 Testing Dates" revealed a total of 520 SARS-CoV-2 tests were administered by the laboratory and had not been 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 --