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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:
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?
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
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8M+
Tests under CDPH
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4K+
Testing sites under CDPH
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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
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.
- 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.
- Rachel J. Keith, Ph.D., APRN, ANP-C
- Assistant Professor of Medicine
- University of Louisville
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
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.
- Craig Rouskey
- CEO
- Renegade.bio
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
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
