The Department of Health and Human Services (HHS) is sending 540,000 COVID-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, Those buildings will receive test kits through December, at which time it has been reported that you will need to pay for additional test kits privately.
Washington State has a separate and distinct CLIA waiver application called a Certificate of Waiver Medical Test Site (MTS) that is managed by the Department of Health. When you obtain this licensure, your facility is exempt from the CLIA requirement. Your MTS license will contain both your MTS license number and your CLIA number.
As a licensed MTS, your facility must comply with WAC 246-338; some requirements in this section include policies and procedures, quality control measures, and recordkeeping.
Once the MTS/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). Please note that each waived test conducted, regardless of negative or positive result, must then be reported to the Department of Health as part of your MTS/CLIA license.
There is currently no requirement to use the Abbott test kits, nor is there a current state mandate to routinely test residents and/or staff in assisted living communities.
If an assisted living community is not able or willing to secure a MTS/CLIA waiver, you might consider partnering with a retail pharmacy for the Abbott testing or check with a commercial pharmacy in your area. You may also continue using a local laboratory for PCR testing purposes, as these tests are more sensitive and have a higher accuracy rating.
Retail Pharmacy Contacts Click on any name below to initiate an email.
Health Mart Pharmacy
Good Neighbor Pharmacy
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 via email
Abbot BinaxNOW shipment assistance via email
CDC: online or via telephone at (800) 232-4636