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CLIA Waiver Program: CLIA-waived testing and other testing options with Primary.Health

About

What is CLIA-waived testing?

CLIA (Clinical Laboratory Improvement Amendments of 1988)

Generally, facilities that test and result samples in the United States for health assessments, diagnosis, prevention, or treatment are regulated under CLIA.

Waived tests are those cleared by the FDA for home use or approved for waiver under CLIA criteria.

Eligibility

Who is eligible to enroll in this program?

This program supports a variety of organization types:

K-12 schools and districts

K-12 schools and districts, public, private, charter

Residential care facilities

Residential care facilities for the elderly (adult day care centers, retirement homes, skilled nursing, etc.)

Community sites

Including but not limited to community sites, daycare/preschool centers, employers, colleges, faith-based organizations, local health departments, sports clubs, non-profits

Organizations with their own CLIA

Organizations that have their own CLIA and do not need the CLIA certification from CDPH

Eligibility

How can you use CLIA-waived tests?

A new CLIA certificate is required. We’re ready to assist you in securing this.
Our platform will simplify your compliance management if you obtain the certificate independently.

Key Features

How can Primary.Health support your CLIA-waived testing?

Automated reporting

Eliminate paperwork and reduce errors by automating state reporting and participant notifications.

On-site workflow management

We help you test participants quickly and efficiently to minimize organizational disruptions.

Data analytics & dashboards

Monitor program metrics to identify outbreaks quickly and track cases over time at a district level.

Digital consent for participants and parents

Easily capture digital signatures and consent of all participants.

Automated result notifications & communication

We provide digital proof of test result/vaccination. Communication via the Primary.Health platform is easy, fast, and able to send automated result notifications to participants.

Fully HIPAA-compliant system

Millions of users have registered. Available in 24+ languages. HIPAA-compliant.

Device-agnostic app

The easiest way to record at-home tests! Works on any browser.

Access digital records wherever you are

We provide digital proof of test result/vaccination.

Additional services

  • Registration, consent, resulting, and reporting software

  • Real-time data and dashboards customized for your organization

  • Account management

  • CLIA-waiver certificate

  • The knowledge you are helping to keep your community safe by providing these testing services!

  • Access to a call center to support participants

Primary.Health’s Mission

Create and scale access to simple and streamlined healthcare experiences.

Primary.Health is working to eliminate long-standing health and social inequities and disparities by empowering inclusivity and illuminating social determinants of health through not only our software, but on providing services where they are needed most, including communities of color, unhoused populations, institutional settings–wherever people are.

Testimonials

What our partners say

Public Programs

While our students are back to focusing on learning, credit is due to the district’s ongoing commitment to testing and responding proactively to the data with the measures and care our educators and health experts have at their disposal. Testing contributed to where we are today: a reduction of in-school transmission to almost zero.

Don Geddis
Governing Member of the Board of Trustees
Hillsborough City School District

Public Programs

With Primary.Health’s software, we were able to integrate our testing technology and deploy school-based surveillance programs in a matter of days. Working with their team really was a great experience and we could not have accomplished what we did without them!

Nicholas Meyerson
CEO
Darwin Biosciences

Public Programs

Primary.Health’s platform helped us create a safer in-person learning environment for all of our staff, especially our teachers and students.

Roy Mendiola, Ed.D
Superintendent
McSwain Union Elementary School District

Public Programs

We began using antigen testing following extended breaks. After Winter Break, we were able to significantly decrease exposure due to a staggered school day start and antigen testing. This program has kept our school in-person through the Omicron surge and we are very grateful for it.

Tanya Spishak
Director of Communications
Woodland School

Ready to apply or learn more?

We’re here to help you navigate the CLIA Waiver application process and support your program.

FAQ

Frequently Asked Questions

How long does the CLIA Waiver take?

Less than 10 minutes to complete.

Generally 6 week minimum to approval.

What does Primary.Health support?

The Primary.Health software platform supports the general testing program. We help you set up accounts, register participants, report results, and other software tasks.

What test types does this program cover?

Currently, this program only supports rapid antigen tests.

Must my entire staff attend training?

Yes! All staff with access to the Primary.Health platform MUST attend a CDPH hands-on training and complete the quiz. The system is reconciled weekly and administrators who do not meet training requirements will be disabled.

Do I need to import my participant list?

No, this is optional. Most organizations email the registration link to their distribution list and have participants register that way. If you prefer to have your roster imported, submit the Primary.Health Support Request Form and select Data.

Is using Primary.Health required?

Testing is no longer required by CDPH. However, if you do enroll in this optional program, you will use Primary.Health.

My account says it is “In development.” How do I activate it?

Email CDPH for account information: CommunityRapidTesting@cdph.ca.gov

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.

offer more testing

CLIA waivers make point-of-care testing possible

A CLIA waiver allows trained community members to perform low-complexity testing outside of a regulated facility.

You can offer professional point-of-care testing with the proper training and a CLIA waiver. Primary can help.

With a CLIA waiver you can offer:

  • Flu, RSV, COVID and Strep tests

  • Hemoglobin A1C tests

  • Rapid HIV tests

  • Cholesterol monitoring

  • Urine pregnancy tests

…and more!

LEARN MORE

On-Demand 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 recorded webinar:

From Illness to Action: Test to Treat in Real Time

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

Watch the on-demand webinar
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.

Get CLIA coverage

DO MORE FOR YOUR COMMUNITY

Point-of-care tests help keep all communities safe

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.

Residential care facilities

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

Community organizations

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

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.

digital health results for CLIA waived tests

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.

Join the CLIA program

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

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.

Address

Primary.Health
595 Pacific Ave, Floor 4
San Francisco, CA 94133

Phone Number

1-855-970-3223

Email Addresses

sales@primary.health

support@primary.health

Contact us

Let’s start talking

Tell us about your organization and how we can help.

Testing anywhere, done by the book.

We handle the CLIA waiver so your sites can run point-of-care testing with confidence.

Talk to our team Explore the Health platform