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Waived and Nonwaived Tests: The Clinical Laboratory Improvement Act

I. Bruce Rosenzweig, PhD
JAMA. 1993;269(5):587-588. doi:10.1001/jama.1993.03500050065017.
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To the Editor.  —Drs Ferris and Fischer1 make a good point when they write that the clinical laboratory industry is making great strides in developing methodologies and instrumentation to make laboratory testing easier. It is true that almost anyone can perform many of the assays in a clinical laboratory with just a modicum of training. Their article implies that it requires very little training to perform laboratory testing and that the rules according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for waived and nonwaived tests appear to be arbitrary, partly because of a lack of criteria for establishing test complexity. However, the ease of performing tests was really not the issue or the reason for CLIA in the first place. The purpose of the act was to ensure the reliability of results obtained from a clinical laboratory. How is this purpose achieved if any test can be


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