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:
To receive notification of changes to this site please subscribe to the Compliance Monitoring Division Information Bulletin Index. Click on the link at the top of the Information Bulletin page to subscribe to the Information Bulletin Index. 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 web addresses weekly for updates.
- http://www.cms.gov/SurveyCertificationGeninfo
See: Policy and Memos to States and Regions
- http://www.cms.gov/manuals/downloads/som107_Appendicestoc.pdf
- CMS Satellite Broadcast/Webcast Educational Programs - http://surveyortraining.cms.hhs.gov/index.aspx
CMS CLIA website: http://www.cms.gov/clia/01_overview.asp
Centers for Disease Control CLIA website: http://www.cdc.gov/clia/
CMS CLIA brochures: http://www.cms.gov/clia/05_clia_Brochures.asp#TopOfPage
Test Categories:
- http://www.cms.gov/clia/10_Categorization_of_Tests.asp
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/search.cfm
CMS 116 Form: http://www.cms.gov/cmforms/downloads/cms116.pdf
Contact CLIA:
Telephone Hotline: 651-201-4120E-mail: health.clia@state.mn.us
Mail:
Minnesota Department of Health
PO Box 64900
St.Paul, MN 55164-0900
