Save Babies Through Screening Foundation (SBTS), the only national volunteer-run nonprofit organization devoted exclusively to the advocacy of newborn screening (NBS), reaffirmed its commitment to the public health value of retention and appropriate use of residual dried blood spot specimens.
SBTS will increase its efforts to raise awareness and disseminate vital information in order to better educate the public on this issue of growing visibility and importance. ”Recent litigation efforts in Texas and Minnesota dried blood spot specimens make clear the abundance of misinformation in circulation regarding the privacy and protection related to the use of newborn blood spots,” said Jill Levy-Fisch, SBTS President.
“Now more than ever, a public education campaign is needed to provide greater clarity about the benefits of retaining these samples as well as the privacy protections already in place in all states and afforded by the Genetics Information Nondiscrimination Act of 2008.”
Many components in a properly stored blood spot can last for decades, enabling doctors to make use of samples for health-related testing of patients, long after the NBS process has concluded. In addition, the retention of de-identified samples allows researchers to develop new and more refined screening tests as well as conduct quality control assessments of screening methods already in use.
Currently, laws regulating the retention and use of blood spot specimens differ from state to state. All states, however, have patient privacy protections in place. Strict state and federal rules and regulations govern the use of these specimens for research. Specimens can only be used for research without patient consent if all identifying information has been removed.
Researchers must work through an Institutional Review Board (IRB) and state health institutions. Once approval is granted, researchers receive de-identified samples in order to ensure that privacy is protected.
“Newborn screening is one of the most successful public health efforts of the last 50 years,” notes Dr. Jerry Vockley, Professor of Pediatrics and Human Genetics at the University of Pittsburgh School and Chief of Medical Genetics at the Children’s Hospital of Pittsburgh of UPMC.
“The blood spots represent a valuable resource that provide us with the ability not only to quality control screening programs but also to develop new tests that play a crucial role in helping diagnose disorders that can lead to death or severe mental disabilities. They enable us to do this early enough to allow therapy and treatment to work before these diseases are able to take their course.”
“These dried spots are invaluable for the development of new life-saving newborn screening tests and increased understanding of the conditions that will lead to better treatments,” added Dr. R. Rodney Howell, Professor of Pediatrics and Chairman Emeritus, Miller School of Medicine at the University of Miami.
“These blood spots must be stored and used under conditions that will maintain the public confidence in the programs. The Secretary’s Advisory Committee on Hereditary Disorders in Newborns and Children (SACHDNC), of which I was the Founding Chairman, has published a report outlining the ideal storage and use of these spots, and I strongly recommend that states follow these suggestions.”
SBTS recognizes the need for state public health departments to address public concerns about privacy and consent while at the same time clearly articulating the importance of NBS and the possible public health benefits of research using dried blood spots. To this end, SBTS supports the recent SACHDNC report and recommendations to the Secretary of Health and Human Services on this subject (see the July 2011 issue of Genetics in Medicine ).
This report clearly reaffirms the need to “improve efforts to educate the public and healthcare providers about NBS and the retention and use of specimens.” It does not encourage the destruction of this very valuable national resource.