Is your district interested in rapid antigen testing?
While the SOS piloti itself is full, the project can share information, resources and training to help you get started. Contact us so that we can connect you to others and share our learning process.
To use rapid antigen tests in the school setting you will need a Clinical Laboratory Improvement Amendment (CLIA) Waiver. A CLIA waiver allows you to carry out a low complexity test like Binax Now 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. To obtain a CLIA waiver for a California school district you have two options:
Use the California Department of Public Health Waiver. To do this you will need to carry out a two-step enrollment process, obtain training, and certify competency of your trainees.
- Initial enrollment link
- Follow-up enrollment
- Submit a Competency Quiz for all trained personnel (link forthcoming)
Identify a physician who will act as your CLIA Director.
Clinical laboratory directors are also eligible. This is not a demanding or time consuming thing to do. You can for example ask a community or parent physician to play that role. A school-based health center physician may be able to play this role. In some cases your local health department may be able to provide the medical oversight or a medical director for a county office of education. A CLIA waiver director can oversee multiple district waivers.
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 school district.
- A full list of the school sites where you plan to do the testing
Note: For the purposes of these documents the “Lab” is the school district name and address, the “owner” is the school authority, the “test” is Abbott Binax Now or whatever rapid test you are using, the setting is school, and CLIA number and State ID can be left blank. At present, in California, each school district needs to apply for a separate CLIA waiver, but not each school, if you are not using the CDPH waiver.
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 school 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 schools. 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. ideally an automated data upload should be feasible
- Collecting consent from staff and parents
- Scheduling tests if needed
- Appropriate language options for your community
- Entering test results and associating a test kit with the individual
- 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 a handful of such platforms, including:
- Primary.Health is the platform selected for this project which provides all the functions above. They have been very supportive with developing and providing training and tools across California
- Project Beacon was created for Massachusetts and is being used in other states
- Color is currently supporting PCR including the Perkins Elmer lab in Valencia and developing a rapid antigen testing interface
- Microsoft is developing an integrated COVID app for schools, starting with Los Angeles Unified School District but it is not yet more broadly available
In general such systems require an on-boarding fee and a per test processing fee which declines with volume. Some platforms can provide integrated for rapid antigen testing and PCR testing support. Primary.Health can also provide vaccination support. PCR fees may be folded into insurance billing.