Clinical Laboratory Improvement Amendments Finally May Go Into Effect September 1

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Abstract
This article is only available in the PDF format. Download the PDF to view the article, as well as its associated figures and tables. FEDERAL INSPECTION and regulation of physicians' office laboratories are moving nearer. Regulations for implementing the Clinical Laboratory Improvement Amendments have just been published in the Federal Register. The amendments, often referred to by their acronym (CLIA), were passed by Congress 4 years ago in the wake of widely publicized allegations of clinical laboratory errors, especially involving Papanicolaou testing (JAMA. 1989;262:2355-2356). Barring challenges, implementation begins in 24 weeks. However, the American Society for Microbiology already is charging that the newly published regulations "threaten to undermine the integrity of laboratory testing." Cynthia Graham, PhD, Lahey Clinic Medical Center, Burlington, Mass, secretary of the society (which represents some 39 000 laboratory personnel from physicians and other doctorate-level medical scientists through medical technologists), charges that these regulations "understate and misclassify the level of complexity of many tests, consequently lowering the personnel standards required for conducting and supervising these tests." The American Medical Association (AMA)

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