and Processing Specimens Associated with Coronavirus Disease 2019 are outlined below. States may have more stringent requirements, so you may need to consult with your State Agency (SA Contacts) for further guidance. Ø For providers collecting specimens or within 6 feet of patients suspected to be infected with SARS-CoV-2, maintain proper infection control and use recommended personal protective equipment (PPE), which includes an N95 or higher-level respirator (or facemask if a respirator is not available), eye protection, gloves, and a gown, when collecting specimens. Ø Use the instrument in a location associated with a current CLIA certificate. Ø Perform a site-specific and activity-specific risk assessment to identify and mitigate safety risks. Ø Train staff on the proper use of the instrument and ways to minimize the risk of exposures. Follow manufacturer recommended procedures for decontamination after use. Ø Follow Standard Precautions when handling clinical specimens, including hand hygiene and the use of PPE, such as laboratory coats or gowns, gloves, and eye protection. If needed, additional precautions can be used, such as a surgical mask or face shield, or other physical barriers, such as a splash shield to work behind. Ø When using patient swabs, minimize contamination of the swab stick and wrapper by widely opening the wrapper prior to placing the swab back into the wrapper. Ø Change gloves after adding patient specimens to the instrument. Ø Decontaminate the instrument after each run by using an EPA-approved disinfectant for SARS-CoV-2. Following the manufacturer’s recommendations for use, such as dilution, contact time, and safe handling. 9. Will every nursing home receive a point-of-care instrument and associated tests? CMS has prioritized > 3,900 nursing homes to receive instruments and tests in the coming weeks. Once those shipments are complete, HHS will continue a phased distribution of 4/8 | Page antigen testing supplies to nursing homes with a current CLIA Certificate of Waiver and based on updated epidemiological data. 10. Which nursing homes will receive instruments and tests in the first wave of shipments? The list of nursing homes receiving instruments and tests in the first wave is available on the CMS COVID NHSN data page. This list will be updated as the phased distribution progresses. 11. When will my nursing home receive the shipment of testing platforms and FDAauthorized antigen diagnostic tests? Instruments and tests will be shipped on a weekly basis directly to CMS-prioritized nursing homes. Instruments and tests will begin shipping the week of July 20 and shipments will continue over the course of 14 weeks. Each nursing home will receive one shipment that includes supplies to facilitate baseline testing among nursing home residents and staff, and enable a pathway to conduct ongoing testing according to public health guidelines. 12. How will states be made aware that nursing homes within their states will receive instruments and supplies? Facilities will be made aware of shipments directly from the manufacturers. States can refer to the CMS COVID NHSN data page to see which nursing homes in your state is receiving supplies. 13. What are antigen tests? Is it required to retest negative results with a PCR test? Antigen diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. Negative results should generally be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. If necessary, confirmation with a molecular assay for patient management may be performed. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. 14. How many tests can be conducted with the Quidel Sofia 2 Instrument and the BD Veritor™ Plus System testing platforms? Each test takes about 20 minutes to perform from start to finish. However, it is possible to run tests in an assembly line fashion to test 20 – 30 samples per hour. To use this strategy, the start time for each test is staggered by a few minutes. Next, at the end of the test incubation period, each test is read one by one every few minutes. Instructions for using batch mode are included with the Instructions for Use and vendor training. 5/8 | Page 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? Fighting this global pandemic requires an array of different technologies, including antigen testing. In areas of high prevalence or for patients with known risk factors, positive results from an antigen test can be considered confirmatory and used for diagnostic purposes. In areas of high prevalence, confirming negative results using an alternate form of testing is recommended. In low-prevalence areas where the patient is asymptomatic, results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and