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-Co-V-2 test results as required for 684 of 706 tests performed since the laboratory has been in operation. Findings include: 1. A review of the laboratory's "COVID-19 Testing Policy" revealed a lack of process for reporting the patient results negative for SARS-CoV-2 to the health department. 2. A review of the laboratory's testing records revealed the laboratory had performed 684 SARS-CoV-2 tests with a negative result since the laboratory started testing 9/18/20. 3. An interview with the Laboratory Director on 4/22/21 at 9:58 am during a phone call 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 --