Frequently Asked Questions: COVID-19 Testing at Skilled Nursing Facilities/ Nursing Homes includes 27 FAQs:
1. Who will receive the testing platforms and U.S. Food and Drug Administration (FDA)- authorized antigen diagnostic tests?
2. How is distribution of the testing platforms and FDA-authorized antigen diagnostic tests being determined? Will these devices be sent directly to the nursing homes or to states for distribution?
3. When will the testing platforms and authorized point-of-care tests be distributed?
4. How many COVID-19 test kits will nursing homes receive?
5. Who will provide training to nursing home staff? In what format will the training be provided in?
6. How were nursing homes prioritized to receive a testing platform and FDA-authorized antigen diagnostic tests?
7. Will HHS be providing more tests after the initial shipment?
8. What safety precautions are required when performing these tests?
9. Will every nursing home receive a point-of-care instrument and associated tests?
10. Which nursing homes will receive instruments and tests in the first wave of shipments?
11. When will my nursing home receive the shipment of testing platforms and FDAauthorized antigen diagnostic tests?
12. How will states be made aware that nursing homes within their states will receive instruments and supplies?
13. What are antigen tests? Is it required to retest negative results with a PCR test?
14. How many tests can be conducted with the Quidel Sofia 2 Instrument and the BD Veritor™ Plus System testing platforms?
15. Why is the federal government sending antigen testing supplies to nursing homes if they cannot be used to rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment?
16. Are nursing homes required to report results of any COVID-19 tests?
17. Can nursing homes keep the testing platforms?
18. How should facilities handle indeterminate results?
19. Do facilities need a provider order to conduct the test?
20. How should the materials be stored when they arrive?
21. Does a Skilled Nursing Facility/ Nursing Facilities need a CLIA (Clinical Laboratory Improvement Amendments of 1988) Certificate of Waiver in order to perform testing of specimens for COVID-19?
22. I understand that HHS will be distributing tests and test systems to Skilled Nursing Facilities/ Nursing Facilities. What type of CLIA certificate would my facility need in order to perform this testing?
23. How do I apply for a CLIA Certificate of Waiver so that my Skilled Nursing Facility/ Nursing Facility can perform COVID-19 testing?
24. If my Skilled Nursing Facility/ Nursing Facility already holds a CLIA Certificate of Waiver, can we begin performing COVID-19 testing?
25. If my Skilled Nursing Facility/ Nursing Facility already holds a CLIA Certificate of Waiver, am I required to update my test menu with CMS?
26. How does my Skilled Nursing Facility/ Nursing Facility obtain the instrument, test kits and disposables?
27. My Skilled Nursing Facility/ Nursing Facility is located in a CLIA Exempt State (Washington or New York). Will we be able to get one of the new test systems?