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, the laboratory failed to report all SARS-Co-V-2 test results as required for 14 out of 14 patients tested from 12/03/2020 through 08/30/2021. Findings Include: 1. Review of the laboratory's "Tylersville Dental" policy, provided for inspection of the SARS-CoV-2 testing and reporting documentation found the following statement: "All testing results are reported to the person being tested. If a positive test is received, the staff member is told, then told to contact their primary care physician and to quarantine for the current recommendations of the CDC." 2. The laboratory's SARS-CoV-2 patient result reporting documentation was reviewed from 12/03/2020 through 08/30/2021 and found 14 COVID-19 individuals tested that were not reported to the Ohio Department of Health. 3. The Inspector requested the laboratory's evidence that the above mentioned 14 COVID-19 test results were reported to the Ohio Department of Health from the Laboratory Director. The Laboratory Director confirmed via electronic mail, on 09/09/2021 at 3:18 PM, that the laboratory only reported the two positive COVID test results to the Warren County Health Department. The 12 negative COVID test results were not reported. The Laboratory Director further confirmed the laboratory did not report any results to the Ohio Department of Health, not even the two positives as they were not provided that guidance from the Warren County Health Department and was 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 --