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 and interview with the Laboratory Director, the laboratory failed to report SARS-CoV-2 test results as required for 57 of 57 testing dates since the laboratory has been in operation. Findings include: 1. An email from the Laboratory Director on 8/9/21 at 5:56 pm revealed the laboratory has been testing for 57 days. 2. A review of the laboratory's testing records revealed the laboratory had performed 51 SARS-CoV-2 tests with a negative result since the laboratory started testing 6/13/21. 3. An interview with the Laboratory Director on 8/11/21 at 10:00 am revealed the laboratory did not report patient test results negative 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 --