In 1965, Congress enacted legislation, which created the Medicare program.  One provision of that law required that health care providers participating in the new health insurance program meet certain quality standards.  This resulted in the development of a laboratory regulation that applied only to Medicare laboratories.

In 1967, Congress passed separate legislation, which created laboratory standards for all laboratories engaging in interstate commerce.  This resulted in differing standards for some laboratories, while subjecting others to both--in addition to any state requirements that existed.

Although periodic legislative efforts to unify the laboratory standards failed in the 1970's, Congress passed the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88), which established uniform federal regulation and usurped  state requirements unless they were more stringent. 

Periodically, over the past two decades there have been congressional efforts to revise the regulations, along with a number of hearings on the implementation of the standards.  The most significant attempt to change the regulation occurred in 1995, when Rep. Bill Archer (R-TX) came within a few votes in the Senate of getting physicians' office laboratories exempted from CLIA'88 (the House had already approved the measure).  

Most recent legislative initiatives involving CLIA'88 have pertained to quality concerns involing Maryland General Hospital in Balitmore.  A series of news articles, which received national attention, reported the hospital had passed inspections although significant quality problems were found to exist.  There were two congressional hearings on this matter, but no legislative action was taken.   

CLIA Statute