Frequently Asked Questions: COVID-19 Testing at Skilled Nursing Facilities/ Nursing Homes 1. Who will receive the testing platforms and U.S. Food and Drug Administration (FDA)- authorized antigen diagnostic tests? Nursing homes will receive either a Quidel Sofia 2 Instrument or Becton, Dickinson and Company (BD) Veritor™ Plus System over the coming months along with the associated FDA-authorized antigen diagnostic tests. To be eligible, nursing homes must have a current CLIA Certificate of Waiver AND meet certain epidemiological criteria. The list of nursing homes is posted on the Centers for Medicare & Medicaid Services (CMS) COVID NHSN data page and will be updated as new shipments go out. The U.S. Department of Health and Human Services (HHS) will distribute the testing platforms and FDA-authorized antigen diagnostic tests to all nursing homes with a CLIA Certificate of Waiver over the next few months. Nursing homes mean facilities that are certified as a Medicare Skilled Nursing Facility (SNF) and/or Medicaid Nursing Facility (NF), otherwise referred to a Long Term Care Facility or nursing home. 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? Distribution of instruments and tests are prioritized for facilities based on Centers for Disease Control and Prevention (CDC) epidemiological hotspot data and facilities whose data indicate an elevated risk for COVID-19 transmission. Devices will be sent directly to nursing homes to ensure that nursing homes can begin testing as soon as they receive the devices and complete the requisite training. Shipping schedules are based on the availability of instruments and test kits. Facilities that have been prioritized to receive early shipments (within the first 3 weeks) are located in CDC epidemiological hotspot counties. Most shipments will occur in the first 4 weeks, although it may take up to 14 weeks for all nursing homes to receive their shipment due to supply availability. 3. When will the testing platforms and authorized point-of-care tests be distributed? Instruments and authorized diagnostic antigen tests will begin shipping the week of July 20 and shipments will continue over the course of 14 weeks. Supplies will arrive in a single shipment directly from the manufacturer and/or distributor. 2/8 | Page 4. How many COVID-19 test kits will nursing homes receive? Allotments of instruments and test kits are determined by the estimated volume of tests needed for the facility to test all staff and residents at least once and enable a pathway to conduct ongoing testing according to public health guidelines. This estimated volume is based on the average number of weekly staff, and the average resident census for each facility reported by CMS. All facilities will receive at least one instrument. A second instrument will be allocated to facilities that were identified to receive 900 tests (facilities identified as major outliers). Nursing homes were categorized into 5 groupings based on their estimated testing needs: Ø Small facilities – 150 tests, 1 instrument; Ø Small-medium facilities – 240-250 tests,* 1 instrument; Ø Medium facilities – 325-330 tests,* 1 instrument; Ø Large facilities – 600 tests, 1 instrument; Ø Major outlier facilities – 900+ tests, 2 instruments. *Note: The range accounts for variations in kit size between BD and Quidel. Tests for the BD Veritor™ Plus come in kits of 30 and those for the Quidel Sofia 2 in kits of 25. 5. Who will provide training to nursing home staff? In what format will the training be provided in? Quidel and BD will provide training materials to nursing home staff. Training documentation will be made widely available for all nursing homes that are receiving supplies. Quidel training information can be found at quideltogetheragain.com. BD is offering training services through their Learning Management System (LMS) platform to all BD Veritor System customers at no additional cost. The eLearning training platform is available online. 6. How were nursing homes prioritized to receive a testing platform and FDA-authorized antigen diagnostic tests? The prioritization is based on CDC epidemiological hotspot data, as well as nursing homes that reported the following information to the CDC by July 5th: Ø Current CLIA Certificate of Waiver; Ø Three or more confirmed or suspected new cases of COVID-19 in the last 7 days; Ø At least one new COVID-19 case in the last 7 days after having zero previous COVID-19 cases; Ø Inadequate access to testing in the last 7 days; Ø At least one new resident death due to COVID-19 in the last 7 days; Ø At least one new confirmed or suspected COVID-19 case among staff in the last 7 days. 3/8 | Page 7. Will HHS be providing more tests after the initial shipment? No. After the initial shipment of instruments and tests, nursing homes will be responsible for procuring their own tests directly from the manufacturer or medical device distributor. 8. What safety precautions are required when performing these tests? CDC Interim Laboratory Biosafety Guidelines for Handling