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INFORMATION FOR

What schools need from labs

Just as labs have never worked with K-12 schools before, schools have never had to communicate with labs or order tests. They’ll need a lot of help from you.

Testing services providers

If you’d prefer to hand the client-services side over to a partner organization, you can do that!

These testing services providers can handle everything from getting consent for testing to supplying schools with test kits, providing customer support, transporting samples, and more.

Basic information: questions schools will start with

The initial list of FAQs you’ll need to be able to answer in order to work in the K-12 space.
  • What is your turnaround time?

    It must be < 48 hours from obtaining a sample to individual result; < 24 hours is preferable.
  • Where is your lab located?

    This has significant repercussions for turnaround time. Note that the Rockefeller Foundation’s K-12 National Testing Action Plan specifically indicates that no specimens should have to get on a plane.
  • Does your lab offer pooling?

    If so, how many are in a pool? Are samples pooled on-site or in the lab?

    Note that when samples are pooled on-site, reflexing puts a significant additional burden on school nurses. This burden is manageable for small- to medium-sized districts, but for large districts and districts with higher prevalence/more positive pools it can impact feasibility.

    In addition, some families may be unwilling to sign up for testing because of the potential burden of bringing a student back for follow-up testing. In some districts, school nurses have even been unwilling to allow members of positive pools into school buildings for reflex testing.

  • What are the sensitivity and specificity of your test?

    Be prepared to explain what sensitivity and specificity are. School representatives may simply ask how “accurate” your test is.
  • What kind of authorization/validation does your test have?

    Most schools will require that your test have Emergency Use Authorization (EUA). If you offer pooling, your pooling strategy should have EUA or internal validation.
  • What type of specimen does your test require?

    Does your lab require anterior nasal swabs, saliva samples, or can you use either? If your lab uses saliva, how much saliva is required? (Nasopharyngeal swabs are unacceptable for schools.)

Legal and regulatory needs

You’ll need to be prepared to help schools fulfill the legal requirements that accompany testing.
  • CLIA waiver

    In some states, the state will provide a blanket CLIA waiver for schools, which typically requires that the school complete an application process. If that is not the case, do you provide a CLIA waiver for the school?

    Templates and examples:

  • Contracts and requests for proposals

    Negotiating contracts with schools and state government bodies is not trivial. Schools are highly individualistic places, and they are unlikely to accept the boilerplate contractual language. In addition, they are often governed by very strict state laws that limit the process by which proposals are submitted, vetted, and accepted.

    Templates and examples:

    • RFP and contract between small public school district in Massachusetts and vendor providing on-site pooled PCR testing for faculty, staff, and students using nasal swabs
    • RFP and contract between medium-sized public school district in Massachusetts and vendor providing in-lab pooled PCR testing for faculty, staff, and students using saliva
    • RFP and contract for weekly testing of athletes and coaches, small school district in Kentucky, test agnostic
    • RFP and contract for onsite testing of faculty and staff, fourth largest school district in Kentucky, test agnostic
    • RFP and contract for onsite testing of faculty and staff, charter school, District of Columbia, test agnostic
  • School liability concerns

    In some cases, schools will be reluctant to test because they are concerned about liability. A good way to manage that concern is to address it in your contract language and consent forms.

    In addition, schools need to know that the Public Readiness and Emergency Preparedness (PREP) Act provides liability coverage for schools doing testing.

Software and customer support

Make it as easy as possible for the schools.
  • Privacy

    All software used for accessioning tests must be compliant with federal privacy laws governing education (FERPA) and health care (HIPAA).
  • Templates and examples

    Concentric by Ginkgo Ginkgo created their own digital platform for pooled testing in schools. Their Instructions for Test Champions includes some screen shots.

    Crush the Curve

  • Customer support

    Schools typically need a lot of support from the two weeks before starting a testing program through the two weeks after the program begins. After that, customer-support needs tend to decrease and become more sporadic.
  • Training

    School staff may require hands-on training with accessioning software. A

    ll staff who will be involved with procuring samples will need to be trained. In most cases, you can train one or two people who will then train others at the school.

  • Ease of use and onboarding

    Software must be user-friendly and onboarding should be simple. School staff are not used to sending tests to a lab, and they’re overwhelmed with COVID-mitigation tasks in addition to their educational duties. Accessioning tests and receiving results needs to be easy.
  • Tracking tests and reporting results

    All software used for accessioning tests must be able to track tests and report results to individuals, the school, and public-health officials. It should include feedback on inconclusive results so that schools can learn how to avoid them. It is highly preferable that software be searchable and able to report results that can easily be depersonalized for research purposes.

Consent

If you are part of a statewide program, the state may provide a boilerplate consent form for you to use. In that situation, make sure that the consent form is identical across all vendors contracted by the state, so that schools can switch vendors with less friction. Remember that you will need separate consent for pooling and for diagnostic testing.

For the consent process, labs should provide:

  • Consent form approved by legal for the relevant state
  • Consent form summaries in plain language
  • Both of the above translated into all of the languages spoken at home in the relevant communities
  • .CSV template for bulk-uploading consent forms into software
  • Option for electronic and paper consent
Templates and examples:

Designing a testing program

Schools have never done this sort of thing before and will need help figuring out the details. The good news is, you don’t have to invent this wheel.

Test kit delivery and sample collection

These questions and issues are likely to come up as part of requests for proposals and other vendor-selection processes.
  • Procurement

    • How will schools order test kits and supplies?
    • What supplies will they receive?
    • Will test kits be pre-packaged, or will school staff have to assemble them?
  • Specimen collection

    Specimen collection must be as frictionless as possible
    for students and staff.

    You may need to provide guidance for schools on how to set up specimen collection sites and what safety protocols should be in place. Some schools do not have adequate staff to collect samples themselves and will need you or a testing services provider to step in.

    Four options for managing specimen collection are described in detail on the CDC’s Open and Safe Schools website.

  • Specimen delivery

    • How are specimens delivered to the lab?
    • If the lab is local to the school, do you provide courier service?
    • Is courier service a required part of the service you provide, or can school staff or volunteers transport the samples themselves?
  • Templates and examples

    Specimen Collecting Procedures
    From Littleton Public Schools in Massachusetts. Includes individual plans for high school, middle school, and elementary schools with time of sample collection, location, staffing, and order of operations.

    Getting Your Pools to the Lab
    Swab-based. Refers to CIC-Health and Project Beacon for the Massachusetts statewide pooled testing program.

    Getting Your Pools to the Lab
    Saliva-based. Refers to Veritas and Mirimus for the Massachusetts statewide pooled testing program.

Important Regulatory Information about SalivaDirect™

SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.