CLIA Waiver Program - Primary Health
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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.

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Key Features

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

Data sources
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 participant/parental consent

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

Sign up for interest

Our CLIA-waived expertise has supported hundreds of California school districts

  • 8M+

    Tests under CDPH

  • 4K+

    Testing sites under CDPH

  • 700+

    School districts under CDPH

Interested in Enrolling?
Already enrolled and need assistance?
Contact us or call 1-855-970-3223.
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 they say about us

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!
Primary Health
  • Nicholas Meyerson
  • CEO
  • Darwin Biosciences

Public Programs

Primary.Health’s platform simplified our emergency diversion efforts at a critical moment. With little time to learn a new system, it was easy to use and quick to implement…allowing us to rapidly adapt during our flooding event.
  • Kristina Hsieh
  • Lab Director
  • San Mateo Public Health Lab

Public Programs

Primary.Health helps us streamline patient registration, lab results, and even travel letters. Our clients love Primary.Health’s user-friendly platform, which frees us up to focus on processing COVID tests for employers, professional sports teams, and community members. As a queer-owned and -operated public benefit lab, renegade.bio is tackling this crisis head-on, and Primary.Health is a critical component in our success.
Primary Health
  • Craig Rouskey
  • CEO
  • Renegade.bio

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.
Primary Health
  • Don Geddis
  • Governing Member of the Board of Trustees
  • Hillsborough City 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.
Primary Health
  • 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.

Sign up for interest
FAQ

Frequently Asked Questions

Frequently Asked Questions

Still have questions? Contact us