The Trump Administration has announced a large-scale procurement of U.S. Food and Drug Administration (FDA) authorized rapid point-of-care diagnostic test instruments and tests to be distributed to every nursing home in the country.
In a statement, the U.S. Department of Health and Human Services said the initiative is a one-time procurement of devices and tests. This action will facilitate the on-site testing of nursing home residents and staff.
Nursing homes will be able to augment their current capacity for coronavirus testing, bolstering their response and helping to prevent the spread of SARS-CoV-2, the virus that causes COVID-19.
More Testing - Faster
“Access to rapid point-of-care testing in nursing homes will further protect our Nation’s most vulnerable patients,” said Assistant Secretary for Health, Admiral Brett P. Giroir, M.D. “With the recent FDA Emergency Use Authorization of the BD Veritor system, combined with the earlier authorization of the Quidel Sofia and Sofia 2 systems, we now have the ability to provide more testing faster. This could not have been possible without the scientific investments made by these companies, advanced regulatory science from the FDA and other investments by the Federal government.”
Centers for Medicare & Medicaid Services (CMS) will start distributing the test within a week by using a priority list. Each nursing home will receive one diagnostic test instrument and associated tests. Following the initial distribution, nursing homes can procure additional tests directly from the respective manufacturers. Nursing homes must have the capability to screen and test residents and test staff weekly or according to specific guidance by the state and local health departments. This procurement will also enable the testing of visitors if appropriate for that facility.
Protecting the Vulnerable
“This new testing initiative is critical for keeping vulnerable older adults safe while delivering the quality of life they deserve,” said CMS Administrator Seema Verma.
“It gives nursing homes the ability to swiftly identify residents that need to be isolated and mitigate the spread of the virus. As one more tool in the toolbox, it represents an important step toward the long-awaited reunion of residents with their loved ones,” she said.
According to CMS, there are more than 200,000 confirmed or suspected cases of COVID-19 and more than 35,000 COVID-19 deaths among nursing home residents as of July 9, 2020.
Admiral Giroir said this is a very historic moment which will save thousands of lives. He calls it a culmination of about two months of work as they developed the technology working with the FDA to get it done as quickly as possible.