Get Started

 

 

Is your district interested in rapid antigen testing?

Contact Admin@safelyopeningschools.org or SchoolBinax@cdph.ca.gov to learn more about rapid antigen testing in CA school districts.

Key steps for starting in your district

If you are a California School: 

  • All California Schools whether public or private can now use the California K-12 School Rapid Testing Program  
  • Step 1: Fill out the Interest Form
  • Step 2: Join introductory call and FAQ session with CDPH and receive a copy of the Playbook and other materials
  • Step 3: Complete MOU with CDPH and send to CDPH at SchoolBinax@cdph.ca.gov
  • Step 4: CDPH will enroll you in the Primary.Health data platform, then you create an account/profile and upload rosters
  • Step 5: Order materials, including kits from CDPH and other materials for testing
  • Step 6: Identify BinaxNOW Leads and trainees and begin training
  • Do online pre-trainings listed in CDPH playbook or use our SOS Rise online-training platform (training@safelyopeningschools.org)
  • Receive remote 1-hour CDPH hands on training on performing the BinaxNOW test; complete the BinaxNOW Quiz following the training
  • Receive remote training on Primary platform
  • If you are a district in a high-needs area, reach out training@safelyopeningschools.org to receive SOS support
    • Offer an online platform for additional BinaxNOW training and a test site workflow overview
    • Share resource documents created through our pilot program such as tools of communication for parents and staff
    • Provide first day testing launch support
    • Continuing to be a readily available resource after testing has begun
  • Step 7: Communicate
    • Inform parents/guardians and strongly encourage request consent, see attached sample letters in English and Spanish
    • Inform staff and invite consent, see attached sample letters in English and Spanish
    • Get creative! Consider events, prizes, stickers, raffles, or other incentives to encourage participation. Check out Planada Elementary School District’s example here
  • Identify your plan for follow-up PCR testing when needed. You can do this through the Primary.Health data platform but you will need a separate contract with a PCR provider. Alternatively you can use the CUE Molecular Test on-site.  

If you are not a California School:

  • Check with your state or local health department for applicable requirements in your state
  • You will need to operate under a Clinical Laboratory Improvement Amendment (CLIA) Waiver signed by a licensed physician or other eligible professional as your CLIA Director. This waiver allows rapid antigen tests to be performed outside of a laboratory, and under the supervision of the CLIA Director. The CLIA process varies from state-to-state.
  • Identify staff to coordinate and administer screening at each testing site. Verify local requirements with who can screen in your state.
  • Communicate formally with your staff and parent community about your anticipated testing program.
  • Select a data platform to manage registration and consent, schedule testing, record and report results, and track your outcomes.
  • Undertake appropriate training for your team
  • Identify your plan for follow-up PCR testing when needed – either in partnership with your selected data platform provider or with other community partners.

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.

    Training

    SOS participants complete comprehensive on-site and virtual training.  

    Who can be trained? 

    Trainees do not need to be health professionals to implement this test. The California Department of Public Health has determined that school personnel “who are caring for students under their responsibility” are authorized to carry out this test.  However, school nurses or other health professionals provide valuable oversight and are encouraged to participate. 

    Use our Rise online-training platform by contacting training@safelyopeningschools.org

    Rise is an online training platform that contains the resources below as well as a series of simple and accessible lessons for people who are being trained to implement rapid testing. Rise can also allow a site administrator track who has completed their training. 

    Video trainings available online

    • Abbot BinaxNOW Training modules 1 – 4 (11 minutes)
    • Training for reading equivocal tests for all participants who will be reading or registering test results (8 minutes)
    • HIPAA training (15 minutes) – only for those without certification
    • For screening and test administrators who do not have a HIPAA certificate, you can receive one online after going through the online training course. There are a number of resources for HIPAA Training, for example this training with Accountable.
    •  If you already have your certificate, you will not need additional HIPAA training. Primary will collect the certificate during the intake process. Keenan School Resources also offers HIPAA training for subscribing schools.

    Video of children self-swabbing for rapid antigen testing

    Other key training materials 

    • Quality Control Log for BinaxNOW testing. Sites are required to perform the quality control tests once for each new shipment or lot received (not each box). Results should be logged.
    • Training Log: sites should keep careful records of training of staff implementing rapid antigen testing.  

    To use the SOS online training platform contact training@safelyopeningschools.org   

    Data Platforms

    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. 

    Other Resources

    California recommendations 

    National reports 

    Scientific articles

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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.