CLIA-Exempt States: What CLIA-Exempt Means and Which States Qualify
A CLIA-exempt lab is licensed by a state whose licensure program CMS has approved as equal to or more stringent than CLIA (42 CFR 493.2). CMS currently lists two exempt states: Washington (Medical Test Site Program) and New York (Clinical Laboratory Evaluation Program). New York's exemption is partial, so some New York labs still need a CLIA certificate.
Sound Lab Consultants (SLC) works with labs nationwide on CLIA certification and state licensure. This page is based on official CMS, CDC, and eCFR sources. It is not legal advice.
What "CLIA-exempt" means
42 CFR 493.2 defines a CLIA-exempt laboratory as one licensed or approved by a state where CMS has found that:
the state's laboratory laws are equal to or more stringent than CLIA, and
the state licensure program has been approved by CMS under Subpart E.
Under 42 CFR 493.3, a lab must either hold a current CLIA certificate or be CLIA-exempt. Exemption is therefore an alternative to a CLIA certificate. It is not an exemption from quality standards. The state program enforces standards at least as strict as CLIA.
Exemption applies to a laboratory, not a test. CDC's test complexity page warns against confusing "CLIA-exempt" with "CLIA-waived." A waived test is a test category. "CLIA-exempt" describes a lab's regulatory status in an approved state.
How a state gets CLIA exemption
Under 42 CFR 493.551, CMS may exempt all state-licensed or approved labs in a state that has a state licensure program established by law, if:
the state's requirements are equal to or more stringent than CLIA condition-level requirements, and
the program meets Subpart E and is approved by CMS.
Subpart E also covers approval, validation inspections, continuing federal oversight, and removal of an exemption (§§ 493.553–493.575).
Which states are CLIA-exempt
The CMS List of Exempt States (August 2025) names two programs:
Washington: Washington State Department of Health, Medical Test Site Program.
New York: New York State Department of Health, Clinical Laboratory Evaluation Program.
New York's exemption is partial. CMS's brochure How to Obtain a CLIA Certificate of Waiver says New York has a partial exemption. It tells labs located there to contact the New York State Agency about whether they need a CLIA certificate.
Every other state, including Arizona, follows the standard federal process. You file Form CMS-116 with the State Agency and get a CLIA certificate. Many of these states also have their own lab or personnel licensing. See CLIA laboratory state licensing.
What labs in exempt states still need to do
Get the state license from the state program. In an exempt state, the state program takes the place of the CLIA certificate.
Meet the state's standards, which CMS has found equal to or more stringent than CLIA.
Check the scope in New York, because the exemption is partial.
See SLC's New York CLIA laboratory license and Washington CLIA laboratory license pages.
CLIA-exempt checklist
☐ Confirm the state where each testing site is physically located.
☐ Check the current CMS List of Exempt States.
☐ In Washington, apply through the Medical Test Site Program.
☐ In New York, contact the state program to confirm whether you also need a CLIA certificate.
☐ In all other states, file Form CMS-116 with the State Agency for the right certificate.
☐ Check your state's separate licensure rules for labs and personnel.
☐ Recheck exemption status when you add sites or test specimens from other states.
FAQs
What are the CLIA-exempt states?
CMS lists Washington and New York. New York's exemption is partial.
Does CLIA-exempt mean a lab has no quality standards?
No. The state program must be equal to or more stringent than CLIA, and CMS keeps federal oversight of approved programs.
Is "CLIA-exempt" the same as "CLIA-waived"?
No. Waived is a category of simple, low-risk tests. CLIA-exempt describes a lab licensed under a CMS-approved state program.
Do labs in exempt states fill out Form CMS-116?
Labs in fully exempt programs work through the state program instead. New York labs should ask the New York State Agency, because the exemption is partial.
Is Arizona CLIA-exempt?
No. Arizona is not on the CMS exempt-states list, so Arizona labs need a CLIA certificate.
Can a state lose its CLIA exemption?
Yes. Subpart E includes procedures for CMS to remove a CLIA exemption (§ 493.575).
Get help with CLIA or state licensure
SLC helps labs nationwide with CLIA certificates, state licenses, and multistate setups. Learn more in What is CLIA? and how to start a clinical laboratory.
Sound Lab Consultants Mailing address: PO Box 2135, Chandler, AZ 85244