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 staff interview, the laboratory failed to report 872 SARS- CoV-2 patient test results, as required, from 5/26/21 through 8/12/21. The findings were: 1. Review of the laboratory's documentation showed 872 SARS-CoV-2 tests were performed using the Abbott ID Now test system; 143 positive patient test results and 729 negative patient test results. The laboratory was unable to verify the patient test results had been reported to the State Public Health Laboratory. 2. Review of the laboratory's procedures showed no evidence the laboratory had developed a policy and procedure for reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. 3. Interview with the laboratory director on 8/18/21 at 10:07 AM confirmed the laboratory was unable to verify the SARS-CoV-2 positive and negative patient test results had been reported to the State Public Health Laboratory and the laboratory did not have a written procedure for reporting SARS-CoV-2 test results. 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 --