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 Office Manager, the laboratory failed to report positive SARS-CoV-2 test results as required for 13 of 13 individuals that tested positive since the laboratory has been testing patients for SARS-CoV-2 in June 2022. Findings include: 1. The surveyor requested documentation of the laboratory's attempts to report positive SARS-CoV-2 results using its SARS-CoV-2 antigen test systems to the health department on 9/12/22 at 1:23 pm and it was not made available. 2. An interview on 9/12/22 at 1:23 pm with the Office Manager confirmed the laboratory had no documentation showing the individuals that had tested positive for SARS-CoV-2 were reported to the health department. 3. Email correspondence on 9/13/22 with the Office Manager revealed the laboratory started testing 6/6/22 and had a total of 13 patients test positive for SARS-CoV-2. 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 --