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 interviews with the Laboratory Director and Laboratory Manager, the laboratory failed to report all SARS-Co-V-2 test results as required for 247 out of 247 patients tested from 07/01/2021 through 08/26/2021. Findings Include: 1. Review of the laboratory's "BinaxNow COVID-19 Ag Card Point of Care Testing for Compassus Colleagues/Associates" policy and procedure, provided for inspection of the SARS-CoV-2 testing and reporting documentation found the following statements: "1. Per local health department direction or CDC information requests, colleague test results may be provided to health department officials for public health data collection. 2. The use of information collected during this procedure is for screening purposes only and negative results may be shared with Compassus ' contracted partners as part of normal public health disclosures related to the management of communicable diseases." 2. The laboratory's SARS-CoV-2 patient result reporting documentation was reviewed from 07/01/2021 through 08/26/2021 and found 247 negative 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 247 negative COVID-19 test results were reported to the Ohio Department of Health from the Laboratory Director and the Laboratory Manager. The Laboratory Director confirmed in an electronic mail sent on 09/01/2021 at 4:47 PM, "We were only aware that we had to report positive test results. We had not had any to report." 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 --