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 review of the quality control (QC), patient records for the Sofia Sars COVID-19 Antigen Test (including reporting log) and an interview with the laboratory staff and technical consultant (TC) on 11/11/2020 at10:00 am, the laboratory failed to report after 9/23/2020, all SARS-CoV-2 results including (positives and negatives) to the Secretary of Health and Human Services via the Mississippi State Department of Health (MSDH). Findings Include: 1. Review of the QC and patient result logs and the Positive patient report logs for the Sofia SARS- CoV-2 test, indicated that only positive SARS-CoV-2 patient results had been reported to MSDH since the testing began 8/1/2020. 2. Interview with staff and the laboratory TC on 11/11/2020 at 10:00 am confirmed that only positive SARS-CoV-2 patient test results had been reported to MSDH from 8/1/2020 until the day of survey on 11/11/2020. 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 --