CLIA Waivers for other Sites
To use rapid antigen tests in many settings you will need a Clinical Laboratory Improvement Amendment (CLIA) Waiver. A CLIA waiver allows you to carry out a low complexity test like Abbott’s BinaxNOW rapid antigen test outside of the traditional clinical laboratory setting but with some professional oversight. This is required by the FDA for use of most rapid antigen tests. The waiver process varies from state to state. The California Department of Public Health is offering an umbrella CLIA waiver for other types of facilities such as Homeless Shelters or Daycare Centers, see the Testing Taskforce website for more information. Locations can also apply for their own CLIA waiver, however, we recommend using the state’s CLIA if you are are eligible.
To apply for your own waiver, you will need to follow the steps below:
- Identify a physician or clinical laboratory director who will act as your CLIA Director.
- Complete and submit the paperwork. Forms are all available on the CDPH website here. They are submitted as uploaded attachments to the online application. You will need:
- The new online waiver application
- The Federal CMS 116 completed by the CLIA Director
- The state LAB 183 form an attestation completed by the CLIA Director and the
- The state LAB182 attestation completed by the organization that will be testing.
- A full list of the sites where you plan to do the testing
- Pay the fees
- The state fee to submit the CLIA application is $113 payable plus $26 per testing site payable to CDPH at the time of application.
- The Federal fee is approximately $150 and will be invoiced later.
- Note: The site can start testing once the waiver request is submitted!
- Issue a standing order for testing: Have your CLIA Director or another physician issue a standing order for testing with the selected test at your institution. See an example here.
A data platform is essential to support large scale screening. Key functions for a data platform, include:
- Registering students, staff and teachers
- Collecting consent from staff and parents
- Scheduling tests if needed
- Providing appropriate language options for your community
- Recording test results linked to the individuals tested
- Carrying out mandatory public health reporting
- Notifying individuals or their parents of results
- Providing the district with a useful dashboard with which to understand findings and manage the process
- Connecting to PCR providers who can also carry out insurance billing
We are aware of these platforms:
- Primary.Health which is the SOS partner.
- Project Beacon which was created for Massachusetts and is being used in other states
- Abbott is offering the Navica App which is free but has fewer functions.
In general platforms require an onboarding fee and a per test processing fee based on testing volume.
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Safely Opening Schools is a project of the Public Health Institute, (PHI) PHI has been a leader in public health and development for over 50 years. PHI is a 501(c)(3) non-profit organization with a vision of creating healthy communities where individuals reach their highest potential. Safely Opening Schools is part of PHIs Prevention Policy Group, which works on policy approaches involved in safely opening public schools after Covid-19.