About CLIA-Waived Testing - Primary Health

Do lab testing with Primary CLIA waiver coverage

The Primary platform now offers the coverage you need to administer professional point-of-care tests––without the usual testing headaches.

offer more testing

CLIA waivers make point-of-care testing possible

With a CLIA waiver you can offer:

  • Flu, RSV, COVID and Strep tests

  • Hemoglobin A1C tests

  • Rapid HIV tests

  • Cholesterol monitoring

  • Urine pregnancy tests

LEARN MORE

Webinar: From Illness to Action: Test to Treat in Real Time

Discover the power of point-of-care testing to transform care in residential settings by enabling faster diagnostics and immediate treatment decisions during our LIVE webinar:

From Illness to Action – Test to Treat in Real Time

Date: Wednesday, February 28
Time: 1 pm PST / 4 pm EST

Don’t miss this exclusive discussion designed for residential care facility administrators, clinicians, and administrative staff!

Test to treat CLIA testing
Photo of getting CLIA-waived care at an unsheltered clinic
HELP MORE PEOPLE

Expand your testing program with a Primary CLIA waiver

With a CLIA waiver you can do more than over-the-counter testing. The CLIA waiver allows your program to offer certain professional tests that are not available over the counter.

With CLIA-waived testing, you can screen your community for more, keeping people safer.

DO MORE FOR YOUR COMMUNITY

Point-of-care tests help keep all communities safe

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Schools

Keep students healthy and protected by offering point-of-care flu and RSV tests at the nurse’s office, thereby improving academic performance and reducing absences.

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Residential care facilities

Stay compliant and keep your residents safe with on-site point-of-care testing made possible by Primary’s CLIA waiver.

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Community organizations

Meet compliance requirements and keep your residents safe with on-site point-of-care testing made possible by Primary’s CLIA certification.

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Employers

Uphold OSHA compliance and protect your workforce by implementing professional testing protocols.

State & government

From fire departments to Veterans Affairs, support your community with point-of-care tests to keep them safe and healthy.

Our CLIA program handles compliance for you

We take care of CLIA training, paperwork, and reporting so you can focus on keeping your community safe.

digital health results for CLIA waived tests

We’ve supported hundreds of CLIA-waived testing programs in California

  • 8M+

    Tests Administered

  • 4K+

    Testing Sites

  • 700+

    School Districts Supported

Already have CLIA coverage? Learn how Primary’s clinic management solution can power your community health efforts.

  • Automated reporting

  • Simplified workflows

  • Data & dashboards

  • Digital registration

  • Treatment

FAQ

Frequently Asked Questions

Transitioning from CDPH? Read our CDPH FAQs.

How long does it take to complete and receive a new CLIA certificate?

Once you fill out the initial form with your information and sign the 90-day free contract, we will have all the information we need to submit the CLIA application. 

After applying, it typically takes 4-6 weeks to receive the CLIA certificate. Applications are processed in the order received, and we’ll apply for the CLIA certificate for you.

Can we test while we wait for our CLIA waiver?

While waiting for CLIA approval, Primary can enable an over-the-counter (OTC) test service option for your organization to allow participants to record their OTC results on the platform. We encourage all organizations to continue testing with OTC tests. All POC and professional testing will be paused until the application is approved.

Can I perform additional tests other than COVID?

Your CLIA application will include COVID, Flu, RSV, and Strep CLIA-waived tests. But CLIA-waived testing goes beyond that to include STI testing, women’s health testing, men’s health testing and lots of other preventive and chronic management testing options. If you are interested in a test outside of these standard services, please contact providerops@primary.health

How much will the tests cost? What does it cost to get the Flu/Strep/other tests, and can we order tests through Primary?

We are putting together test kit procurement options to meet the diverse needs of the populations you serve. For cost inquiries, you can contact us at providerops@primary.health

I finished filling out the CLIA waiver interest form. What are the next steps?

Great! After you submit the form, Primary will reach out to you to set a zero-dollar contract for 90 days. This will allow you to continue using the Primary platform for OTC while waiting for CLIA coverage. Primary will apply to add you to our CLIA during this time. We will contact you once the waiver has been approved. At that time you may resume professional testing services. Please note that it can take up to 6 weeks before the CLIA waiver is approved.

Which professional tests can I offer with a CLIA waiver?

Some professional tests that can be offered with a CLIA waiver include Rapid strep tests, Rapid flu tests, Urine pregnancy tests, Blood glucose monitoring, Cholesterol monitoring tests, Hemoglobin tests, and Rapid HIV tests.

What if I’m not operating in California?

Currently, we offer CLIA waivers in several states. We would like to hear from you if you’re interested in a CLIA waiver and can have a dedicated team member assist you with your program needs. Contact us at providerops@primary.health to learn more about our program and offering.

Will Primary or the site have to cover the cost of supplies?

The site is responsible for securing its own testing supplies and can do so by purchasing through vendors. We recommend that you reach out to your state and local public health agencies to inquire if free tests are available to you. We are putting together test kit procurement options to meet the diverse needs of the populations you serve. For cost inquiries, contact us at providerops@primary.health

What are my compliance obligations under Primary’s CLIA program?

Primary will provide a lab director, training, policies/procedures, and supervision for the program.  Your participating staff must undergo training before they can administer or access test results in the Primary platform.  Staff must comply with Primary’s policies and the lab director’s directives at all times.  Lastly, as with any licensed lab, you should be prepared for a CDPH representative to conduct an inspection with little to no notice.

What if I already have my own CLIA waiver? Can I still use Primary’s software?

Primary software is designed to empower point-of-care testing, whether you’re using your own CLIA waiver or are part of the Primary CLIA program. Our streamlined interface allows you to record test results as they are run and distribute results to participants in real time. Additionally, our account team will work with you to ensure your compliance needs are met, from notating your requisitioning provider to logging staff member training.

Still have questions about Primary’s CLIA program?

About Primary.Health

Our mission is to end the spread of diseases and reduce the severity of all illnesses by providing simple, affordable diagnostics, immunizations, and preventative care at scale.