Literature review of research related to the Clinical Laboratory Improvement Amendments of 1988

In conjunction with a 1990 Report to Congress on the studies required by the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), the Centers for Disease Control, Atlanta, Ga, prepared a summary of the existing scientific literature related to the five studies listed in Section 4 of the Act. Over 800 articles were identified that, by title, seemed to deal with subjects that have been assumed to be associated with the quality of clinical laboratory testing. Although our search was not exhaustive, we believe that the articles included in our search are representative of the scientific evidence that exists. Most of the articles collected in our initial search were later eliminated from additional review because they were determined to be evaluations of laboratory analytic methods, contained only anecdotal evidence, were primarily descriptions of methods or programs, or were opinion articles without specific scientific data to support the opinions. This review reports the conclusions drawn by the research investigators of the 90 referenced articles; it does not analyze each article to assess the scientific validity of the research nor does it critique each article that is included. The review points to the need for additional research to answer questions raised by CLIA '88.