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.
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: