How to Become a CLIA-Certified Assisted Living Facility & Receive Abbott Test Kits

COVID-19; Assisted Living
The Department of Health and Human Services (HHS) is sending 540,000 COIVD-19 test kits made by Abbott to assisted living communities this week. To receive a kit from HHS, a community, by law,​ must have a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver to perform testing​.    

Providers who wish to become CLIA certified must apply for a CLIA Certificate. Please view the brochure, How to Apply for CLIA Certificate of Waiver and submit your application form (CMS Form 116) to the state (CLIA State Agency Contacts) where the provider who is applying is located.  

Once the provider has identified a qualified laboratory director and has provided all required information on the CMS-116 application, a CLIA number will be assigned. Once the CLIA number has been assigned, the provider is considered to have a CLIA certified waived laboratory and can begin testing if applicable CLIA requirements have been met (e.g., establishing performance specifications). 

​​Our understanding is that HHS will ship test kits to all ALs with CLIA Certificates of Waiver this week to be used for residents and staff. Replenishment of kits will be sent weekly thereafter with enough kits based on size and varying based on the CMS ratings for COVID-19 test positivity in your county (red, yellow or green). HHS has also provided a training portal here.  

For additional questions on the HHS shipment of Abbot Testing Kits you can contact: 

Abbott BinaxNOW technical assistance: ts.scr@abbott.com 

Abbot BinaxNOW shipment assistance: ARDxUSGovernmentSupport@abbott.com 

CDC: ​​cdv.gov/cdc-info/index.html or 1-800-232-4636