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.

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 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

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

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

The Primary family has made me feel at home from the day I interviewed. My managers help me strive for excellence and gave me the opportunity to hone my skills as a software engineer. You can reach out to anyone on the team if you’re blocked and they’ll be more than happy to guide you in the right direction. Every person at Primary is down to earth and in the business of making a difference!
Primary Health
  • Damon Sawyer
  • Software Engineer

Public Programs

Our findings helped us communicate with community residents how widespread COVID-19 infection rates were in the early days of this pandemic aiding in crushing the curve and saving lives.
Primary Health
  • Rachel J. Keith, Ph.D., APRN, ANP-C
  • Assistant Professor of Medicine
  • University of Louisville

Public Programs

Primary.Health has been a courageous and innovative partner — willing to create and iterate product offerings through every step of our partnership. Their system has allowed thousands of Coloradans to easily schedule both testing and vaccination appointments.
Primary Health
  • Nina Safane
  • Executive Director
  • COVIDCheck Colorado, a Gary Community Venture

Public Programs

Parents and students are eager for schools to reopen in San Diego. Primary.Health’s automated technology is giving us the tools we need to register, streamline and organize testing so that we can get life back to normal for our kids, while ensuring teachers and parents feel healthy and safe.
donnie
  • Donnie Salamanca
  • Deputy Superintendent
  • Coronado Unified School District

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

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

Frequently Asked Questions

Still have questions? Contact us