Nursing Homes Need CLIA Waiver to Receive COVID Testing Equipment

Posted on July 22, 2020 by Jonathan Lips

The U.S. Department of Health & Human Services (HHS) last week announced plans to supply rapid, point-of-care testing instruments and tests to nursing homes throughout the country to aid in the fight against COVID-19.  

Over the next couple of months, HHS will be sending out Quidel Sofia and Sofia 2 and BD Veritor Plus Systems (one or the other), with an initial allocation of associated test kits.  These instruments are for a COVID-19 “antigen” test, a new category of tests for use in the ongoing pandemic.  These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs, according to an FDA emergency use authorization announcement.

We don’t yet know the specific timing of when HHS will distribute the equipment and tests.  CMS is using various data to determine how nursing homes should be prioritized, including CDC epidemiology data on hot spots, National Healthcare Safety Network (NHSN) data on reported cases within nursing homes, and NHSN data on testing access within nursing homes. CMS plans to make public the methodology for prioritizing nursing homes as well as information on when a nursing home might expect to receive its allocated instrument and testing supply.

One thing CMS has stated however, is that nursing homes must have a CLIA certificate of waiver in order to receive and utilize these instruments and tests.

If your facility has a CLIA waiver, check to confirm that it has not expired.  The waivers are valid for two years, then need to be renewed.  If you do not have ready access to the needed file, you should be able to determine the status of your certificate on this CMS CLIA lookup page. Or contact the Minnesota Department of Health CLIA Program: health.clia@state.mn.us or 651-201-4120.

If you don’t have a CLIA waiver, we recommend you begin the application process right away, if you wish to participate in this federal initiative.  Refer to this MDH webpage and this guidance from CMS for information on how to apply.

Several of our hospital-attached members shared that their hospital lab has a CLIA waiver and asked if the nursing home has to get a CLIA waiver itself in order to receive the machine and initial allotment of testing kits. We are looking into this, but don’t have the answer yet.

Finally, a note about data: Last weekend CMS sent the LeadingAge national team a list of facilities that purportedly did not have CLIA waivers. I reached out individually to those providers yesterday, and learned that many of them do have waivers (or are in the hospital-attached category).  Please know that we will work with MDH, LeadingAge and CMS to be sure HHS has accurate data to drive its distribution planning.

We will continue to monitor this situation and provide updates to members as they become available. Meanwhile, this LeadingAge article summarizes some key questions and answers about this promising initiative.