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 Testing Personnel, the laboratory failed to report SARS-CoV-2 test results as required for 34 of 34 patient tests performed since the laboratory has been in operation. Findings include: 1. A review of the laboratory's "COVID-19 Policy & Procedure" revealed a section stating, "All test results, positive or negative shall be reported to the Michigan Department of Health and Human Services (MDHHS)." 2. An interview with the Testing Personnel on 4/28 /21 at 12:56 pm during a phone call revealed the laboratory did not report all patient test results for SARS-CoV-2 to the health department. 3. An interview with the Testing Personnel on 5/5/21 at 2:34 pm revealed the laboratory had tested 34 patients since beginning testing on 12/18/20. 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 --