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

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

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 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

Working for a mission oriented company like Primary makes going to work very rewarding, day in and day out. Being able to make a difference in the health equity and health tech space is incredibly motivating. Everyone at Primary is committed to collaboration! In addition, Primary’s benefits are very focused on self and professional development, and offers its employees opportunities to learn and explore new areas in the tech space.
Primary Health
  • Tyler Martins
  • Product Manager

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

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

Still have questions? Contact us