Evaluation and accreditation

There is a pressing need to develop methods to make comparative evaluations of decision support systems and to provide procedures for professional accreditation, quality assurance (QA) and licensing. Given a modular approach, laboratories are likely to be provided with a choice of which decision system to adopt for a particular biomarker evaluation, entirely analogous to the freedom to choose the best instrument for an analytical method. Of the alternative decision support aids, some will clearly be better engineered and will produce superior results. Robust methods of comparison will be needed, akin to those for analytical methods, in order to select those best suited to a particular purpose. For critical decision systems, a requirement for them to be accredited through a body such as the US Food and Drug Administration can be envisaged. Similarly, ongoing QA of system performance will be needed, especially where local customization or calibration is undertaken. The French Agency of Medicine recently embarked on a national scheme of screening for trisomy-21 and far-sightedly undertook a programme of accreditation of the calculators used in the risk assessment process. At present, many agencies lack the expertise to undertake this function, but the French approach could be an important indication of what the future might hold.

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