Attn: Community Based Residential Facilities
BinaxNOW COVID-19 Ag Card Diagnostic Antigen Tests
On September 14, 2020, the U.S. Department of Health and Human Services (HHS) began shipping BinaxNOW COVID-19 Ag Card diagnostic antigen tests to a number of Community Based Residential Facilities to conduct rapid testing of staff and residents. Supplies will be sent directly to each facility, and will arrive in a single shipment directly from the manufacturer.
Prior to using these rapid COVID-19 test kits facilities must have the following in place:
- A valid CLIA waiver- laboratories certified under the CLIA, 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests
- A clinician order to perform the test
- Qualified staff who have received training on the use of the test kits
- A mechanism to meet reporting requirements for results to state (DPH) and Federal CDC/HHS (e.g., Web-based Laboratory Reporting (WLR)
- Testing Consent Forms found at COVID-19 Testing: Resident/Patient/Client Consent, F-02658A and COVID-19 Testing: Staff Consent, F-02658
Over the past several days, assisted living facilities have contacted the Department of Health Services regarding invoices they have received along with the testing kit shipments. HHS has confirmed they will be covering the entire cost of these shipments. Copies of invoices should be sent to the HHS Binax Team at: Binax.Team@hhs.gov in order to remedy any outstanding invoices.
The Division of Quality Assurance, Bureau of Assisted Living (BAL) is working with the Division of Public Health to develop further guidance regarding the use of these tests and will share information as it becomes available.
Please join the Assisted Living Forum on Tuesday, September 22, 2020 from 10-11:30 AM for additional information on the BinaxNOW COVID-19 Ag Card diagnostic antigen test and a question and answer session.
To Join:
Join Zoom Meeting
Meeting ID: 726 961 504
Or by Phone: +1 312 626 6799
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