Committee Report: Considerations and Recommendatio... [Genet Med. 2011] - PubMed result

Genet Med. 2011 May 19. [Epub ahead of print]
Committee Report: Considerations and Recommendations for National Guidance Regarding the Retention and Use of Residual Dried Blood Spot Specimens After Newborn Screening.
Therrell BL Jr, Hannon WH, Bailey DB Jr, Goldman EB, Monaco J, Norgaard-Pedersen B, Terry SF, Harris A, Vasquez LM, Johnson A, Lloyd-Puryear MA, Howell RR.

Source
From the 1National Newborn Screening and Genetics Resource Center, Austin, Texas; 2Department of Pediatrics, University of Texas Health Science Center at San Antonio, San Antonio, Texas; 3RTI International, Research Triangle Park, North Carolina; 4Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan; 5SACHDNC; 6Department of Clinical Biochemistry and Immunology, Statens Serum Institut, Denmark; 7Genetic Alliance, Washington D.C.; 8Health Resources and Services Administration, Rockville, Maryland; and 9Johnson Policy Consulting, Annandale, Virginia.


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.

PMID:21602691[PubMed - as supplied by publisher]
Committee Report: Considerations and Recommendatio... [Genet Med. 2011] - PubMed result