CLIA Waiver Program - Primary Health

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 in securing this for you.
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

With our CLIA Waived expertise, we’ve 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

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

It has helped parents trust that we are paying attention, it has taken the pressure off families to find tests, it has helped us keep kids in school.
  • Cory Powers
  • Grade School Administration Coordinator
  • San Francisco Waldorf School

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

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

I’ve always been about seats at the table and the importance of representation where brainstorming sessions and decisions happen. And it’s not only about physical diversity for decisions, but it’s also about inclusion with neurodiversity and realizing our strength in democratizing knowledge. It’s rare to be part of a company culture where there’s so much inherent trust with each other to do the right thing and make the best decisions that help everyone.
Primary Health
  • Jacky So
  • Sr. Director of Technical Platforms and Innovation

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