Getting Started with CLIA

If your facility performs laboratory testing on human specimens (e.g. blood, tissue, or bodily fluid) to assess health or to diagnose, prevent, or treat disease, you need to apply for a CLIA certificate. 

Exceptions where a CLIA certificate may not be required, include:

• Forensic testing
• Research laboratories (if you don’t report patient-specific results or the result isn’t used to change treatment)
• Specimen collection facilities, i.e., blood collection
• Drug testing for pre-employment screening or laboratories certified by SAMHSA 
• Laboratories under the jurisdiction of the Department of Veteran Affairs

Facilities only collecting or preparing specimens (or both) or only serving as a mailing service aren't considered laboratories. 

Find step-by-step information to apply for a CLIA Certificate and more details about CLIA certification, accreditation & test complexity.