If your facility runs on-site drug screens, you need a CLIA Certificate of Waiver. We prepare and submit the application — CMS Form 116, fees, and California lab registration — so you're testing legally and ready for inspection.
What is a CLIA waiver? 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. Behavioral health, addiction treatment, and sober living facilities need one to legally screen clients on site.
If you perform any testing on site — even a basic urine drug screen cup — the answer is almost always yes. The moment a sample is tested at your facility rather than sent to an outside lab, you are operating a laboratory in the eyes of CMS, and you need at minimum a Certificate of Waiver. Operating without one puts your DHCS license and Joint Commission accreditation at risk, and surveyors check for it.
| What it covers | Waived tests — urine drug screens, rapid tests, basic point-of-care testing |
|---|---|
| Who issues it | CMS (federal), administered with the state — in California, the Department of Public Health Laboratory Field Services |
| Application form | CMS Form 116 (Clinical Laboratory Improvement Amendments Application for Certification) |
| Certificate term | Two years, then renewed |
| Typical fee | Set by CMS (commonly ~$180 for the two-year certificate; we confirm current amounts) |
| Typical timeline | A few weeks after a correctly submitted application |
We review the tests you'll run on site and confirm they fall under the waived category — and flag anything that would require a higher certificate level.
We complete the application accurately, the single biggest factor in avoiding weeks of delay, and align it with your DHCS and accreditation paperwork.
We submit to CMS and complete California lab registration, and track the application through to your Certificate of Waiver being issued.
We set you up with the simple recordkeeping waived labs must maintain, and put the two-year renewal on your calendar so it never lapses.
A Certificate of Waiver is a federal certificate under the Clinical Laboratory Improvement Amendments that allows a facility to perform simple, low-risk "waived" laboratory tests — like urine drug screens and rapid tests. Behavioral health and addiction treatment facilities need one for on-site drug screening.
Yes. If you test samples on site — even simple drug screen cups — you must hold a Certificate of Waiver before testing clients. Without it, on-site testing is non-compliant and can jeopardize your license and accreditation.
The federal Certificate of Waiver fee is set by CMS and paid for a two-year certificate (commonly around $180, subject to CMS updates). California facilities may also need state lab registration. We confirm current fees and handle both.
Once CMS Form 116 is submitted correctly with payment, the certificate is typically issued within a few weeks. Form errors are the most common cause of delay.
A Certificate of Waiver covers only simple, waived tests. If you perform moderate- or high-complexity testing, you need a higher certificate level with more requirements. We confirm which level fits your testing before filing.
The certificate that makes on-site drug screening legal.
DHCS licensing vs. certification, explained.
The full sequence from level of care to opening.
We'll confirm what you need, prepare the application, and get your Certificate of Waiver issued. One conversation gets it moving.