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 18 out of 18 COVID-19 tests conducted from 06/01/2021 through 08/25/2021. Findings Include: 1. Review of the laboratory's "Hospice of Guernsey Rapid COVID Testing Policy", provided for inspection of the SARS-CoV-2 testing and reporting documentation found the following statement: "All positive tests will result in outpatient lab testing for verification. The outpatient Jab will notify appropriate authorities per reporting policies." 2. The laboratory's SARS-CoV-2 patient testing and result reporting documentation was reviewed from 06/01/2021 through 08/25 /2021 and found 18 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 negative COVID-19 results were reported to the Ohio Department of Health from the Laboratory Director. The Laboratory Director confirmed on 08/30/2021 at 1:13 PM, the laboratory did not report any COVID-19 test results 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 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 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 -- 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 the laboratory failed to report all SARS-Co-V-2 test results as required for 18 out of 18 patients tested from 06/01/2021 through August 25, 2021. Findings Include: 1. Review of the laboratory's "Hospice of Guernsey Rapid COVID Testing Policy", provided for inspection of the SARS-CoV-2 testing and reporting documentation found the following statement: "All positive tests will result in outpatient lab testing for verification. The outpatient Jab will notify appropriate authorities per reporting policies." 2. The laboratory's SARS-CoV-2 patient result reporting documentation was reviewed from 06/01/2021 through 08/25/2021 and found 18 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 negative COVID-19 results were reported to the Ohio Department of Health from the Laboratory Director. The Laboratory Director confirmed on 08/30/2021 at 1:13 PM, the laboratory did not report any COVID-19 test results and was unable to provide the requested documentation. -- 2 of 2 --