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 199 out of 199 patients tested from 08/15/2021 through 08/21/2021. Findings Include: 1. Review of the laboratory's "HealthSource of Ohio General Laboratory Policy", provided for inspection of the SARS-CoV-2 testing and reporting documentation found the following statements: "In-house laboratory services are provided under the direction of the Medical Leader and shall consist of CLIA waived tests and will conform to CLIA regulations." "Reporting requirements: The center ' s personnel will comply with federal, state and local requirements regarding official reporting of public health concerns such as reportable infectious diseases, ...Reports will be made to the county in which the patient resides, regardless of the HSO office location." 2. The laboratory's SARS-CoV-2 patient result reporting documentation was reviewed from 08/15/2021 through 08/21/2021 and found 199 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 199 COVID-19 test results were reported to the Ohio Department of Health from the Laboratory Director. The Laboratory Director confirmed via electronic mail, on 09/20/2021 at 12:27 PM, "...we have not been reporting results to the state..." 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 --