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 an interview with the Laboratory Director found that the laboratory failed to report all SARS-Co-V-2 test results as required for five out of six patients tested and reviewed from January 27, 2021 through May 10, 2021. Findings Include: 1. Review of the laboratory's "Facility Testing Procedure" policy and procedure, provided for inspection of the SARS-CoV-2 testing and reporting documentation found the following statement: "...11....a. Confirmed test results must be reported to the local health department within 24 hours." 2. The laboratory's SARS- CoV-2 patient testing and result reporting documentation was reviewed from 01/27 /2021 through 05/10/2021 and found 1 positive patient COVID-19 tested and reported to the local and Ohio Department of Health departments. Further review revealed five out of five negative patient COVID-19 test results were not reported. 3. The Inspector requested the laboratory's evidence that the above mentioned negative COVID-19 results were reported to the Ohio Department of Health from the Laboratory Director. The Laboratory Director confirmed on 08/10/2021 at 9:44 AM, that the laboratory did not report five out of five patient COVID-19 negative test results identified during the remote inspection and were unable to provide the requested documentation. 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 --