TY - JOUR
T1 - Committee report
T2 - Considerations and recommendations for national guidance regarding the retention and use of residual dried blood spot specimens after newborn screening
AU - Therrell, Bradford L.
AU - Hannon, W. Harry
AU - Bailey, Donald B.
AU - Goldman, Edward B.
AU - Monaco, Jana
AU - Norgaard-Pedersen, Bent
AU - Terry, Sharon F.
AU - Johnson, Alissa
AU - Howell, R. Rodney
N1 - Copyright:
Copyright 2013 Elsevier B.V., All rights reserved.
PY - 2011/7
Y1 - 2011/7
N2 - 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.
AB - 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.
KW - blood spots
KW - newborn
KW - policy
KW - screening
KW - specimen repositories
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U2 - 10.1097/GIM.0b013e3182147639
DO - 10.1097/GIM.0b013e3182147639
M3 - Article
C2 - 21602691
AN - SCOPUS:79960841778
VL - 13
SP - 621
EP - 624
JO - Genetics in Medicine
JF - Genetics in Medicine
SN - 1098-3600
IS - 7
ER -