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Minn. Senate Passes Bill to Restore Newborn Screening Bloodspot, Data Retention Policy

NEW YORK (GenomeWeb) – The Minnesota Senate has passed a bill that would enable the state's Department of Health (MDH) to retain newborn bloodspot samples and related data indefinitely, a change that would restore a state policy that was overturned by a state court three years ago.

The Newborn Screening Program Modifications bill (SF 2047), which passed on a 41 to 22 vote, has strong support of screening advocacy groups, but it has drawn fire from others who worry that it will undercut genetic privacy and take choice from parents and give it to the state.

Minnesota had been retaining blood spots indefinitely for use in screening research, follow-up care, and other research programs until 2011, when the Minnesota Supreme Court ruled that the MDH was against the law in holding blood spots indefinitely. To comply with the court, the state was eventually forced to destroy the blood spots for 1 million children who were born before 2011.

Under the current policy, MDH retains normal blood spots (those testing negative) for 71 days before they are destroyed. Samples with abnormal results and the test results for all babies are kept for 24 months before being destroyed.

During these retention periods, MDH may only use blood spots for basic program operations, and not for research, public health studies, or to develop new screening tests without the written consent of a parent or guardian.

The new bill would enable the state to retain these spots indefinitely again, and to use them and test results in research related to newborn screening and to develop new tests, although parents would be able to choose if they do not want their child's samples and results stored.

The bill would require more education for parents about newborn screening, and would allow the samples and results to be used in public health studies not related to newborn testing if the parents or guardians provide their written consent. If a parent or guardian chooses against storage, or has a change of mind and revokes consent they had given previously, the test results must be destroyed within one week of such a request.

Under the proposal, individuals also may revoke the approval for bloodspot and test results storage once they are 18 years old or older.

The Minnesota Chapter of the American Academy of Pediatrics said recently that the current policy needs to be changed. If screening test results are destroyed when a child is two years old that information is no longer available for them for future tests or analyses, and the 71 days rule is too soon, MNAAP said, because it can take up to six months for doctors to confirm diagnoses in some cases.

"After all, there shouldn't be an expiration date on important medical information. The ability to access and reference newborn blood spots is critical in cases of missed or delayed diagnoses and helpful in cases of unexplained death," Robert Jacobsen, President of MNAAP, wrote in an op-ed in the Rochester Post-Bulletin yesterday.

Jacobsen also argued that there are already many safeguards in place to protect individual privacy, and parents with privacy concerns may choose to use private screening, refuse testing altogether, or choose not to have their blood spots stored.

The Council for Responsible Genetics' President Jeremy Gruber opposes the change, saying it would be a strike against privacy rights, that the opt-out model the bill proposes is faulty, and that there is little transparency in how newborn samples and data are handled and managed.

In testimony opposing HF 2526, (SF 2047's twin bill, currently in the Minnesota House), Gruber wrote that the opt-out model "is not a true model of consent because it does not require any actual form of consent." The opt-out model also requires that parents be "well informed about the screening programs and their consent options," but the reality is that many parents are not well informed about these programs and the related issues, Gruber argued.

The bill also has spurred reaction from a group that opposes government involvement in healthcare in general, the Citizen's Council for Health Freedom. In a statement reacting to the vote, CCHF said the Senate "just awarded state government ownership of the genetic information of every newborn baby in Minnesota. It just voted to repeal genetic privacy rights at birth."

CCHF said in its 2011 ruling that the Minnesota Supreme Court "spoke very clearly in upholding the right of parents and a parental consent requirement before newborn DNA could be warehoused by the state. Yesterday's vote undermines the court's ruling as well as the privacy and property rights of newborn babies."