Laboratories - Clinical

CLIA Program
Clinical Laboratory Improvement Amendments

The federal government requires that 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.

For assistance with answering your questions or completing your CLIA Application contact our office:

Information on the CLIA Program is available on the internet.  The web address is: www.cms.hhs.gov/clia/

SCROLL DOWN TO FIND:

1. Regulations are titled "CLIA Regulations Part 493--Most current – Includes all changes through 1/24/03 (CDC Site)
2. Interpretive Guidelines are titled "New Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services

FDA CLIA Home Page http://www.fda.gov/cdrh/clia/index.html

WAIVED TESTING

A current listing of the FDA CLIA Waived Test List is available from the internet at the following websites:

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

If you want to check a test’s complexity, go to this website:

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

CLIA CHANGE FORM

To request changes to your CLIA Certificate - CLIA Change form

To request CLIA Ownership Information Form

STATE LICENSURE

Requirements: None

 

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