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 Laboratory Director, the laboratory failed to report positive SARS-CoV-2 test results as required for one patient that tested positive since the laboratory has been testing patients for SARS-CoV-2 in May 2022. Findings include: 1. An interview on 9/12/22 at 10:15 am with the Laboratory Director revealed the laboratory started testing in May 2022 and had one patient test positive for SARS-CoV-2. 2. The surveyor requested documentation of the laboratory's attempt to report positive SARS-CoV-2 results using its SARS-CoV-2 antigen test systems to the health department on 9/12/22 at 10:15 am and it was not made available. 3. An interview on 9/12/22 at 10:15 am with the Laboratory Director confirmed the laboratory had no documentation showing the one patient that had tested positive was 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 --