Nearly two decades ago, Congress passed the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88), which created uniform federal standards for regulating laboratory testing.  This legislation unified the disparate federal and state standards regulating clinical laboraories, as well as extended government oversight to all testing facilities, including physicians' office laboratories.

The rules implementing CLIA'88 were published in 1992 and fully effective starting in 1995.  The government agencies responsible for overseeing the laboratory standards--CMS, CDC and FDA--have periodically updated the standards to reflect scientific and technological improvements.  This site directs you to the information you need to know to remain in compliance with these standards, as well as garner insight into previous and ongoing discussions involving the regulations. 

If you have questions about CLIA'88 or this site, please contact AACC Government Affairs at (800) 892-1400.