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, lack of documentation, and interview with the Laboratory Director, the laboratory failed to report SARS-CoV-2 test results as required for 5 of 5 testing dates since the laboratory has been in operation. Findings include: 1. The surveyor requested documentation showing the laboratory had reported SARS-CoV-2 testing results on 8/30/21 at 10:00 am and it was not made available 2. A review of the laboratory's testing records revealed the laboratory had performed 24 SARS-CoV- 2 tests since the laboratory started testing. 3. An interview with the Laboratory Director on 8/30/21 at 10:00 am revealed the laboratory did not report patient test results for SARS-CoV-2 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 --