http://www.chron.com/disp/story.mpl/metropolitan/6782897.html

AUSTIN — The state will destroy an estimated 5.3 million blood samples legally collected from newborns but kept without parental consent under a federal lawsuit settlement announced Tuesday.

The number of newborns involved is unclear because multiple samples are received from each by the Texas Department of State Health Services, department spokeswoman Allison Lowery said.

Typically, two samples are taken from each child, but there could be more, she said. The disputed samples cover a period of about seven years starting in 2002. The state conducts newborn screening to detect disorders or illnesses.

“This is about consent,” said lawyer Jim Harrington of the Texas Civil Rights Project. The group, after discovering the agency had been keeping the samples without permission, sued on behalf of parents in federal district court in San Antonio.

The Health Department said in a statement it would destroy the samples — retained as blood spot cards — that it received and stored before legislation took effect last May allowing their retention. The legislation allows parents, guardians or managing conservators to opt out of having the blood retained.

Lowery said the agency is seeking permission from fewer than 400 parents to preserve their babies' samples because the children tested positive for rare disorders.
Collected before lawsuit

She said samples have been securely stored at the Texas A&M Health Science Center School of Rural Public Health.

That institution said in a statement that all the blood spots at the center were collected before the lawsuit and are subject to a joint resolution between the center and the agency to destroy them.

Andrea Beleno, an Austin mother who was one of the plaintiffs in the lawsuit, said she was pleased with the settlement.

“There's no financial gain for any of the plaintiffs,” Beleno said. “Basically, what we wanted to do was to make sure that our children's privacy was being protected and that the state is respecting our rights, because if we don't stand up and make the government do that, nobody's going to do it for us.”

Parents from San Antonio and Houston also were part of the lawsuit, which was filed against Commissioner David Lakey of the Department of State Health Services and Dr. Nancy Dickey, president of the Texas A&M Health Science Center and vice chancellor for health affairs of the Texas A&M System.

“The Texas A&M Health Science Center is glad that we have reached agreement in order to settle the lawsuit,” Dickey's office said in a statement. “We are saddened, however, that a superb database has been lost. This database could have continued to shed light on causes of congenital birth defects and potentially led to preventive measures saving thousands of infants and their families the distress these defects cause.”

The parents' lawsuit said there was no legal authority to keep the blood indefinitely without consent.

Harrington said his group became aware the blood samples were being stored after being called by a reporter from the Austin American-Statesman. Beleno said she first read about it in the newspaper.
Detailed conditions

Under the settlement, Harrington said, all blood specimens must be destroyed unless the state gets written permission to retain and use them. The destruction must occur within 120 days of the lawsuit being dismissed with the settlement, which occurred Dec. 14.

The agency also must post information on its newborn screening Web site, including a list of all research projects for which it has provided newborn-screening blood specimens.

In addition, the agency must inform the parents who sued how their children's blood was used and any financial transactions involving the specimens, Harrington said.
Pledges compliance

The Texas Department of Health said in its statement that it is complying with the new law and “will continue to be very sensitive to the privacy concerns of parents and the confidentiality of all medical information.”

“If parents don't object, the department saves the samples for uses allowed under the new legislation — primarily quality assurance and control purposes to ensure accuracy in lab testing and because the samples could provide an invaluable resource in researching new or more effective ways to prevent, diagnose and treat serious medical conditions that affect Texas children, including leukemia and birth defects,” the agency said in its statement.

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