Licensure/Registration Index Page

Clinical Laboratory Improvement Amendment (CLIA)

The Centers for Medicare and Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The objective of the CLIA program is to ensure quality laboratory testing.

Notification of Updates and Changes from MDH

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Federal Centers for Medicare and Medicaid Services Guidelines and Program Letters (CMS)

Please check these websites weekly for updates:

Relevant Sites

CMS CLIA website

Centers for Disease Control CLIA website

CMS CLIA brochures

Test Categories

CMS - CLIA - Categorization of Tests

FDA - CLIA - Clinical Laboratory Improvement Amendments

CMS 116 Form

Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (PDF)


Frequently Asked Questions

Contact CLIA

Telephone Hotline: 651-201-4120
Fax: 320-223-7350

Minnesota Department of Health
CLIA Program
3333 West Division Street, Suite 212
St. Cloud, MN 56301-4557

Updated Thursday, October 16, 2014 at 02:19PM