Residual dried blood spot specimens are retained by the New York State Department of Health NBS program because they are an invaluable resource for a variety of functions. They are used internally in the NBS program as well as externally by approved public health researchers and health care professionals.
NBS Program Use
Residual blood spots are vital to our quality control program, helping us to ensure the accuracy of our results. By periodically re-testing specimens that have known positive and negative results, we are able to confirm our ability to reproduce the original results. We also routinely use residual blood spots to ensure that new shipments of testing materials give results that are consistent with results obtained from materials currently in use.
Residual dried blood spot specimens are also a critical component in the program’s ability to expand and enhance our testing capabilities. Specimens are required to test new products, improve existing testing methods and develop new screening tests, all with the goal of enhancing the level of protection that we can provide to babies in NYS. For example from 2002 to 2014, we have been able to add 37 disorders to our screening panel by using residual blood spot specimens to develop these new methods. As a result, the health of babies who have one of these additional disorders has been greatly enhanced.
Public Health Research
Residual blood spots are also a valuable resource for researchers who are looking to further their understanding of diseases in children. Most importantly the specimens help us develop accurate newborn screening tests. Residual blood spot specimens have also been used to study exposure to environmental chemicals and organic pollutants.
The use of residual specimens beyond routine NBS screening purposes is strictly controlled. All proposed research projects must be reviewed and approved by the NYSDOH Institutional Review Board. The Institutional Review Board ensures that researchers follow all applicable laws and ethical guidelines. Typically, specimens used for these approved research projects are stripped of any information that may identify the specimen as belonging to a specific baby. Some proposed projects may require information that might allow identification of the baby to whom a specimen belongs. In these cases, the researcher must provide a consent form signed by the parents or legal guardians of the babies involved. This ensures that parents are informed of the proposed use of their baby’s residual specimen(s) and agree that such use is acceptable. Your baby’s identity will not be made available to any researcher unless you specifically give your consent in writing. Some parents request samples because they want to enroll their babies in a research project. We review the request and will need a copy of the protocol and informed consent form to be held on record here.
Health care providers, medical examiners and the courts may also request or subpoena dried blood specimens as part of an official investigation such as to determine the cause of death. In these cases, the residual specimens may be used to establish identity or to test for inherited disorders that may have caused a child’s death. Parents may not request specimens for these purposes. Parents or the baby’s legal guardian will have to sign a consent form if their baby’s specimen is being requested by a healthcare professional.
Specimen Retention and Security Policies
Upon completion of newborn screening testing, some of the dried blood spot specimen remains unused. This is referred to as a residual blood spot specimen. The Newborn Screening (NBS) Program stores residual dried blood spot specimens for up to 27 years under secure conditions where access is strictly controlled. Prior to storage, your baby’s identifying information is separated from the actual specimen, leaving only a randomly assigned 9-digit Lab ID number to link the specimen to our demographic database. This is the database with more specific information about each newborn such as name and hospital of birth. Specimen identification and retrieval can only be accomplished by Wadsworth Center NBS staff who have special password access to the NBS laboratory information management system (LIMS). This LIMS is not connected to the Internet. Without approved LIMS access, the specimen with the Lab ID number cannot be linked to information about your baby.