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May 25, 1994

Coping With CLIA

Author Affiliations

From the Commission on Office Laboratory Accreditation, Longmont, Colo.

JAMA. 1994;271(20):1621-1622. doi:10.1001/jama.1994.03510440081039

Although most physicians support Congress' intent to improve the reliability of laboratory testing at all testing sites, they are frustrated and confused about what they must do to comply with the Clinical Laboratory Improvement Amendments (CLIA) of 1988.1 And it is no wonder. The CLIA regulations have proliferated since the first rule was published on May 2,1990.2 Extremely controversial, this proposed rule significantly restructured the approach to federal laboratory regulation by introducing rules that are based on the complexity of performing and evaluating tests. It provoked an unprecedented 60 000 written comments from physicians and laboratory professionals and forced the Health Care Financing Administration (HCFA) to seek input from the regulated community. A second proposed rule responding to this input was published by HCFA on February 28, 1992.3 Additional rules have been published describing fees,4 sanctions and enforcement procedures,5 categories of tests classified by complexity,

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