Minnesota 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

Subscribe to the Information Bulletins to receive notification of changes to this site. New bulletins and information will be delivered directly to you by email.

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

Please check these websites weekly for updates:

• CMS - Survey & Certification - General Information
  See: Policy and Memos to States and Regions
  
• Medicare State Operations Manual Appendix (PDF)
  
• CMS Quality, Safety & Education Portal (QSEP)
  CMS satellite broadcast/webcast educational programs.

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)

FAQs

• Frequently Asked Questions

Contact Info

State Agency & Regional Office CLIA Contacts
This page lists CLIA contacts for each state agency. If you have any questions regarding CLIA, contact the appropriate state agency.

Minnesota CLIA contact information:
Minnesota Department of Health
CLIA Program
PO Box 64900
St Paul, MN 55164-0900
health.clia@state.mn.us
Phone: 651-201-4120