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 manager, the laboratory failed to report positive SARS-CoV-2 test results as required for 90 of 90 patients that tested positive since the laboratory has been testing patients for SARS-CoV-2 in January 2022. Findings include: 1. An interview on 9/26/22 at 1:25 pm with the manager revealed the laboratory started testing in January 2022 and had a total of 90 patients test positive for SARS-CoV-2 since testing began. 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 9/26/22 at 1: 25 pm and it was not made available. 3. An interview on 9/26/22 at 1:25 pm with the manager confirmed the laboratory had not reported the 90 patients that had tested positive to 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 --