Committee report

Considerations and recommendations for national guidance regarding the retention and use of residual dried blood spot specimens after newborn screening

Bradford L. Therrell, W. Harry Hannon, Donald B. Bailey, Edward B. Goldman, Jana Monaco, Bent Norgaard-Pedersen, Sharon F. Terry, Alissa Johnson, R. Howell

Research output: Contribution to journalArticle

48 Citations (Scopus)

Abstract

Newborn screening programs are state based with variable policies. Guidance regarding the retention, storage, and use of portions of newborn screening dried blood spots that remain after screening (residual specimens) was first published in 1996. Since then, newborn screening programs have paid increased attention to specimen storage and usage issues. Standard residual specimen uses include quality assurance and program evaluation, treatment efficacy, test refinement, and result verification. In all cases, privacy and security are primary concerns. In general, two distinct state practices regarding the storage and use of residual newborn screening specimens exist: (1) short-term storage (<3 years), primarily for standard program uses and (2) long-term storage (>18 years), for standard program uses and possible important public health research uses. Recently, there have been concerns in some consumer communities regarding both the potential uses of residual specimens and patient (newborn and family) privacy. To assist in policy improvements that can protect the individual's privacy and allow for important public health uses of residual newborn screening specimens, the Secretary of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children has developed recommendations (with requested action by the Secretary where applicable). This report presents the Committee's recommendations and reviews the pertinent associated issues.

Original languageEnglish
Pages (from-to)621-624
Number of pages4
JournalGenetics in Medicine
Volume13
Issue number7
DOIs
StatePublished - Jul 1 2011
Externally publishedYes

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Keywords

  • blood spots
  • newborn
  • policy
  • screening
  • specimen repositories

ASJC Scopus subject areas

  • Genetics(clinical)

Cite this

Committee report : Considerations and recommendations for national guidance regarding the retention and use of residual dried blood spot specimens after newborn screening. / Therrell, Bradford L.; Hannon, W. Harry; Bailey, Donald B.; Goldman, Edward B.; Monaco, Jana; Norgaard-Pedersen, Bent; Terry, Sharon F.; Johnson, Alissa; Howell, R.

In: Genetics in Medicine, Vol. 13, No. 7, 01.07.2011, p. 621-624.

Research output: Contribution to journalArticle

Therrell, Bradford L. ; Hannon, W. Harry ; Bailey, Donald B. ; Goldman, Edward B. ; Monaco, Jana ; Norgaard-Pedersen, Bent ; Terry, Sharon F. ; Johnson, Alissa ; Howell, R. / Committee report : Considerations and recommendations for national guidance regarding the retention and use of residual dried blood spot specimens after newborn screening. In: Genetics in Medicine. 2011 ; Vol. 13, No. 7. pp. 621-624.
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