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Genet Med. 2014 Feb;16(2):183-7. doi: 10.1038/gim.2013.98. Epub 2013 Aug 1.

Decision-making process for conditions nominated to the recommended uniform screening panel: statement of the US Department of Health and Human Services Secretary's Advisory Committee on Heritable Disorders in Newborns and Children.

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Duke Clinical Research Institute, Durham, North Carolina, USA.
Department of Pediatrics, Columbia University Medical Center, New York, New York, USA.
The Colorado Trust, Denver, Colorado, USA.
New England Newborn Screening Program and Department of Pediatrics, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
Department of Bioethics, Case Western Reserve University, Cleveland, Ohio, USA.
Department of Newborn Screening and Genetics, Association of Public Health Laboratories, Silver Spring, Maryland, USA.
Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, Michigan, USA.
Laboratory Services Section, Texas Department of State Health Services, Austin, Texas, USA.
Department of Pediatrics, Louisiana State University Health Sciences Center, Shreveport, Louisiana, USA.



The US Secretary of Health and Human Services provides guidance to state newborn screening programs about which conditions should be included in screening (i.e., the "Recommended Uniform Screening Panel"). This guidance is informed by evidence-based recommendations from the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children. This report describes the Advisory Committee's revised decision-making process for considering conditions nominated to the panel.


An expert panel meeting was held in April 2012 to revise the decision matrix, which helps to guide the recommendation process. In January 2013, the Advisory Committee voted to adopt the revised decision matrix.


The revised decision matrix clarifies the approach to rating magnitude and certainty of the net benefit of screening to the population of screened newborns for nominated conditions, and now includes the consideration of the capability of state newborn screening programs for population-wide implementation by evaluating the feasibility and readiness of states to adopt screening for nominated conditions.


The revised decision matrix will bring increased quality, transparency, and consistency to the process of modifying the recommended uniform screening panel and will now allow formal evaluation of the challenges that state newborn screening programs face in adopting screening for new conditions.

[Indexed for MEDLINE]

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