The Centers for Medicare & Medicaid Services (CMS) on July 22 released the list of the first skilled nursing facilities to receive point-of-care COVID-19 testing devices under an initiative announced last week.
The nursing homes identified by CMS will be receiving Quidel Sofia and Sofia 2 Instruments and BD Veritor Plus Systems, along with the respective antigen diagnostic tests that go with each device. Priority is being given to nursing homes in COVID-19 hotspots, as determined by data from the Centers for Disease Control and Prevention (CDC), and to facilities “whose data indicate an elevated risk for COVID-19 transmission,” according to an FAQ document on the initiative.
Facilities must have a current Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver to receive the test devices and associated kits.
Roughly 600 homes are slated to receive the first round of kits, though CMS has prioritized more than 3,900 nursing homes to receive devices and tests in the coming weeks, according to the document.
“Shipping schedules are based on the availability of instruments and test kits,” the FAQ document said. “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.”
Quidel and BD will provide training materials for nursing home staff, and the documentation for that training “will be made widely available” for all nursing homes receiving supplies.
Nursing homes were prioritized to receive the test kits based on both the CDC data and nursing homes that reported the following information to the CDC by July 5, according to the document:
- Current CLIA Certificate of Waiver
- Three or more confirmed or suspected new cases of COVID-19 in the last seven days
- At least one new COVID-19 case in the last seven days after having zero previous COVID-19 cases
- Inadequate access to testing in the last seven days
- At least one new resident death due to COVID-19 in the last seven days
- At least one new confirmed or suspected COVID-19 case among staff in the last seven days
In terms of safety precautions, providers need to follow the “CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019,” though their states could have more strict requirements, the document said.
- Using the instrument in a location associated with a current CLIA certificate
- Training staff on the proper use of the instrument and the ways to minimize risk exposures
- Changing gloves after adding patient specimens to the instrument
- Decontaminating the instrument after each test run
According to the CMS data, the states with COVID-19 hotspot counties include: Alabama, Arizona, California, Florida, Georgia, Idaho, Louisiana, Mississippi, North Carolina, Nevada, South Carolina, Tennessee, Texas and Utah.
Florida has the most such counties, with 24, while South Carolina was second, with 13.