Abstract

The development of a new technology, called tandem mass spectrometry (tandem MS), has challenged governments worldwide to consider expanding universal newborn screening for rare metabolic disorders. In 1997 the Massachusetts Department of Public Health developed a public process to meet this challenge. After addressing significant medical, legal, ethical, and logistical issues raised by tandem MS, Massachusetts incorporated one new disorder into the mandatory newborn screen and developed an optional pilot program for 20 additional disorders. The Massachusetts experience has wide relevance for other nations and states. As screening protocols are contemplated for entire populations-for newborns and others- it will remain essential that the public participate in an open process of reviewing the justification for and logistics of screening.

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