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 an interview with the Laboratory Manager, the laboratory failed to report positive SARS-CoV-2 test results as required for 17 of 17 patients that tested positive since the laboratory has been testing patients for SARS- CoV-2 on October 24, 2022. Findings include: 1. An interview on 4/12/23 at 11:00 am with the Laboratory Manager revealed the laboratory started testing October 24, 2022, and had a total of 17 patients test positive for SARS-CoV-2 using the BD Veritor test system. 2. 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 4/12/23 at 11:16 am and it was not made available. 3. An interview on 4/12/23 at 11:30 am the Laboratory Manager confirmed the laboratory had a lack of documentation showing 17 patients that had tested positive were reported the health department as required. 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 --