Summary:
Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) 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 Supervisor (LS) found that the laboratory failed to report all SARS-Co-V-2 test results as required for three out of three patients tested and reviewed from February 15, 2021 through June 10, 2021. Findings Include: 1. Review of the laboratory's "Rapid COVID-19 Antigen Testing" policy and procedure, provided for inspection of the SARS-CoV-2 testing and reporting documentation found the following statement: "8) Results I. Positive Antigen Reports must be reported to Ohio Department of Health by reporting the results on the Ohio Confidential Reportable Disease form (HEA 3334 Rev.5/14) to the patients County of Residence." 2. The laboratory's SARS-CoV-2 patient testing and result reporting documentation was reviewed from 02/15/2021 through 06/10/2021 and found the following three out of three tested and unreported patient COVID-19 test results: 02/15/2021 1 patient result - negative 02/25/2021 1 patient result - negative 03/01/2021 1 patient result - negative 3. The Inspector requested the laboratory's evidence that the above mentioned COVID-19 results were reported to the health department from the LS. The LS confirmed on 06/21/2021 at 4:05 PM, the laboratory did not report, to the health department, the three out of three patient 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 -- COVID test results identified during the remote inspection and was unable to provide the requested documentation. -- 2 of 2 --