If your facility runs even a simple drug screen on site, this is the certificate that makes it legal. Here's what it is, who needs one, and how to get it.
A CLIA waiver — formally a Certificate of Waiver — is a federal certificate, issued under the Clinical Laboratory Improvement Amendments (CLIA), that lets a facility perform simple, low-risk lab tests classified as "waived," such as urine drug screens and rapid point-of-care tests. Any facility that tests samples on site — including behavioral health and addiction treatment programs — needs one to do so legally.
The FDA sorts lab tests by complexity. "Waived" tests are the simplest category — tests with such a low risk of error that they're exempt from the more intensive requirements that apply to complex lab work. A Certificate of Waiver covers exactly these tests. The most common one in behavioral health is the on-site urine drug screen.
| What it is | A federal Certificate of Waiver under CLIA |
|---|---|
| What it covers | Simple, low-risk "waived" tests — urine drug screens, rapid tests, basic point-of-care tests |
| Who needs it | Any facility performing waived tests on site (treatment centers, clinics, behavioral health programs) |
| How to apply | CMS Form 116, submitted to the state, plus the certificate fee |
| Valid for | Two years, then renewed |
The test is simple: do you test samples on your own premises? If a urine sample is read at your facility — even with a simple dip cup — rather than shipped to an outside lab, you're operating a laboratory in the eyes of CMS and need at least a Certificate of Waiver. Behavioral health programs, addiction treatment facilities, and clinics running their own screens all fall under this.
Verify the specific tests you'll run are in the waived category. Anything more complex needs a higher certificate level.
The CLIA application. Accuracy here is what determines whether you're approved in weeks or stuck in correction loops.
File with the appropriate state agency (in California, Laboratory Field Services) and pay the certificate fee.
Once approved, CMS issues a Certificate of Waiver valid for two years, after which you renew.
A Certificate of Waiver is a federal certificate under the Clinical Laboratory Improvement Amendments that permits a facility to perform simple, low-risk "waived" tests — like urine drug screens and rapid point-of-care tests — legally on site.
Tests the FDA categorizes as waived — simple tests with a low risk of incorrect results. Common examples include urine drug screens, rapid tests, and basic point-of-care tests. More complex testing needs a higher certificate level.
Any facility performing waived tests on site — behavioral health programs, addiction treatment facilities, and clinics running their own urine drug screens. If samples are tested on premises rather than sent out, a CLIA certificate is required.
Complete CMS Form 116, submit it to the appropriate state agency, and pay the certificate fee. In California it's processed with Laboratory Field Services. Once approved, CMS issues a Certificate of Waiver valid for two years.
DHCS licensing vs. certification, explained.
The full sequence from level of care to opening.
How to get in-network and reimbursed.
We confirm what you need, prepare the application, and get your certificate issued — no guesswork.