Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the laboratory failed to follow their policy and procedure regarding COVID-19 result reporting of 23 out of 23 COVID-19 tests conducted from 12/02/2020 through 01/07/2021. Findings Include: 1. Review of the laboratory's "Diseases Reportable to the State" policy, provided for inspection of the SARS-CoV-2 testing and reporting documentation found the following statement: "The Infection Control Nurse or Designee will report all cases or suspected cases of reportable diseases as defined by the Ohio Administrative Code." 2. The laboratory's SARS-CoV-2 patient result reporting documentation was reviewed from 12/02/2020 through 01/07/2021 and found 23 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 23 COVID-19 test results were reported to the Ohio Department of Health from the Laboratory Director. The Laboratory Director confirmed over a phone conversation on 09/07/2021 at 11:52 AM that the laboratory sent out rapid COVID positive test samples to a reference laboratory for confirmation. The reference laboratory reported all confirmed positives. The Laboratory Director further confirmed the laboratory did not report any results to the Ohio Department of Health, not even the positives as they did not want to double report and was unable to provide the requested documentation. D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 23 out of 23 patients tested from 12/02/2020 through 01/07/2021. Findings Include: 1. Review of the laboratory's "Diseases Reportable to the State" policy, provided for inspection of the SARS-CoV-2 testing and reporting documentation found the following statement: "The Infection Control Nurse or Designee will report all cases or suspected cases of reportable diseases as defined by the Ohio Administrative Code." 2. The laboratory's SARS-CoV-2 patient result reporting documentation was reviewed from 12/02/2020 through 01/07/2021 and found 23 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 23 COVID-19 test results were reported to the Ohio Department of Health from the Laboratory Director. The Laboratory Director confirmed over a phone conversation on 09/07/2021 at 11:52 AM that the laboratory sent out rapid COVID positive test samples to a reference laboratory for confirmation. The reference laboratory reported all confirmed positives. The Laboratory Director further confirmed the laboratory did not report any results to the Ohio Department of Health, not even the positives as they did not want to double report and was unable to provide the requested documentation. -- 2 of 2 --