How to Become a CLIA-Certified Assisted Living Facility & Receive Abbott Test Kits
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).
If an assisted living community is not able or willing to secure a CLIA waiver, you can partner with the following retail pharmacy contacts for the Abbott testing or check with the commercial pharmacy in your area. AHCA/NCAL is exploring what other CLIA partners might be available to come into your community to perform the tests.
Retail Pharmacy Contacts:
Ryan Koo: KooRyan@cvshealth.com
Emmanuel Kolady: Emmanuel.Kolady@cvshealth.com
Leanne Gassaway: Leanne.Gassaway@cvshealth.com
Amanda Jenkins: Amanda.firstname.lastname@example.org
Casey Cesnovar: Casey.email@example.com
Troy Trygstad: firstname.lastname@example.org
Health Mart Pharmacy:
Nancy Lyons: Nancy.lyons@McKesson.com
Good Neighbor Pharmacy:
Jennifer Zilka: email@example.com
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: firstname.lastname@example.org
Abbot BinaxNOW shipment assistance: ARDxUSGovernmentSupport@abbott.com
CDC: cdv.gov/cdc-info/index.html or 1-800-232-4636
For more information contact Linda Lawther at email@example.com.
Sept. 19, 2020