New federal rules for proficiency testing, personnel, and waived tests worry scientists in clinical laboratories
WASHINGTON -- When the 90th annual meeting of the American Society for Microbiology convenes this week in Anaheim, Calif., the talk in the halls will almost certainly be about new federal regulations for clinical laboratories. Those proposed regulations, which implement the Clinical Laboratory Improvement Amendments of 1988, will affect tens of thousands of micro- biologists.

The 1988 law, known as CLIA 88, remains one of the more hotly contested regulatory issues in the microbiology community. This law revises standards set more than 20 years ago for clinical laboratories. At that time, a complex, book-length set of regulations was developed to assess and maintain those standards, which were based primarily according to whether the laboratories were located in a hospital or here. CLIA 88 shifts the basis for regulation so that the rules are determined by...

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