CMS has issued a Q&A on COVID-19 point-of-care (POC) testing and a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver applications. The agency notes it is temporarily exercising enforcement discretion under CLIA for POC testing when a facility has submitted its waiver application but has not yet been assigned a CLIA number. This allows a facility to begin using a testing device including BinaxNOW once it has applied for its CLIA certificate. The enforcement discretion may be especially important to assisted living facilities that did not previously have a CLIA waiver and have applied for one.

Specifically, facilities that have applied for a CLIA Certificate of Waiver to perform SARS-CoV-2 POC testing (as indicated on section VI of the submitted CMS-116) can begin SARS-CoV-2 POC testing and reporting patient-specific results as soon as they have submitted their application to their state agency, which in Virginia is the VDH Office of Licensure and Certification (OLC). A non-certified facility will be treated as operating under CoW while their application is being processed.

Since ALFs are not CMS-certified organizations, VDH OLC requested that VHCA-VCAL relay this information to our assisted living members. ALFs which have not yet submitted an application for a CLIA Certificate of Waiver can review this CMS webpage, How to Apply for a CLIA Certificate, for more information.