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.
This program supports a variety of organization types:
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.
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.
We’re here to help you navigate the CLIA Waiver application process and support your program.
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