Clinical Chemistry
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Clinical Chemistry 33: 328-336, 1987;
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Clinical Chemistry, Vol 33, 328-336, Copyright © 1987 by American Association for Clinical Chemistry

Quality assurance in changing times: proposals for reform and research in the clinical laboratory field

ML Kenney

The U.S. Department of Health and Human Services recently commissioned a comprehensive analysis of the effectiveness and appropriateness of federal clinical regulations. The analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS- funded analysis are: the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; a single, uniform set of federal regulations should be developed that covers all civilian laboratories receiving federal reimbursement or operating in interstate commerce; a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and clinical laboratory regulations should be based upon objective data to the maximum extent possible.


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M. J. Bloch, G. S. Cembrowski, and G. J. Lembesis
Longitudinal Study of Error Prevalence in Pennsylvania Physicians' Office Laboratories
JAMA, July 8, 1988; 260(2): 230 - 235.
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Copyright © 1987 by the American Association for Clinical Chemistry.