The Trump Administration announced HHS would embark on a one-time procurement of rapid point-of-care testing devices and tests to be distributed to nursing homes in COVID-19 hotspot areas of the United States.
Each nursing home will receive one diagnostic instrument – either the Quidel Sofia 2 Instrument or the BD Veritor Plus system – along with the associated tests. Following the initial distribution, nursing homes can procure additional tests directly from the respective manufacturer. All nursing homes must have the capability to screen and test residents at baseline, and test staff on a weekly basis or according to specific guidance by the state and local health departments. This procurement will also enable testing of visitors if appropriate for that facility.
Distribution will begin with nursing homes prioritized by CMS. The prioritization is based on CDC epidemiological hotspot data, as well as nursing homes that have reported the following information to the CDC by July 5th:
- Three or more confirmed or suspected new cases of COVID-19 within the last 7 days.
- At least one new COVID-19 case in the last 7 days after having zero previous COVID-19 cases.
- Inadequate access to testing within the last 7 days.
- At least one new resident death due to COVID-19 within the last 7 days.
- At least one new confirmed or suspected COVID-19 case among staff within the last 7 days.
Both the Quidel Sofia 2 and BD Veritor Plus analyzers use antigen tests that can quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs, providing results in minutes. These unique tools adds to the spectrum of diagnostic test types available for COVID-19 response, and will assist the federal government in scaling up to test millions of Americans per day.
Facilities that do not have a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver to administer the tests will not receive a testing instrument. Each state has facilities that do not have a waiver, and the following states did not have any facilities that met the criteria for receiving an instrument while also having a CLIA waiver: Alaska, Hawaii, Washington and West Virginia. Facilities in these states will receive allocations when HHS sends the remaining nursing homes instruments and tests, and they obtain a CLIA waiver. Nursing homes can follow the CMS guidance to obtain a CLIA Certificate of Waiver.
It is critically important we all do our part to raise awareness about how to use point-of-care diagnostic technology and we implore you to join HHS and device manufacturers in getting nursing home staff trained to operate devices and tests so utilization will be maximized. Help us to protect the elderly by sharing this message and the effort to ensure awareness and access to training.
Please see the full press release here.