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Blood sample screening dispute awaits hearing

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Kim McKibben, a phlebotomist at Olmsted Medical Center, holds a blood-sample card for newborn screening.

A long-running spat over archived newborn blood samples continues to rile the Citizens' Council for Health Freedom, a Minnesota-based patient-rights group.

Proponents say the screenings for medical anomalies help newborns get treated early, preventing complications that can occur if treatment isn't given and, in some cases, actually saving lives.

But the Citizens' Council worries parents often don't know that the tests are done — and don't know data from the tests gets warehoused.

The group has expressed concern about genetic data and blood samples containing DNA being kept by the state, especially because of the potential that whole-genome screens soon will be possible.

Hospitals use blood-spot screening of newborns to look for conditions such as phenylketonuria or "PKU," for example. Babies with that condition are genetically unable to metabolize the amino acid phenylalanine. Left untreated, they can experience severe developmental and physical complications.


Destruction delayed

The Citizens' Council sent out an announcement Monday saying data from samples taken from the heal pricks of newborns was being destroyed by the Minnesota Department of Health because of a Minnesota Supreme Court ruling.

But later in the day, the group sent an update, saying, "destruction of newborn genetic test results still has not begun."

Two sample-destruction issues remain.

One is destruction of archived data indicating how many blood samples tests positive (and for which medical abnormalities they test positive).

The other is destruction of the archived blood samples themselves.

Twila Brase, co-founder of the Citizens' Council, views the Minnesota Supreme Court decision to mean that the Department of Health's collection of samples, and retention of data gleaned from them, was illegal.

Mark McCann, newborn-screening program manager at the Minnesota Department Health's Public Health Laboratory, said blood-spot samples obtained after the Nov. 16, 2011, Supreme Court ruling are now, by recently enacted law, allowed to be collected.


But they must be destroyed after 71 days — if they test negative for medical anomalies.

If they test positive, they can be kept for two years for followups and rechecks.

Awaiting hearing

Archived blood samples from before the Supreme Court decision "are on a litigation hold," said Department of Health spokesman Doug Schultz. A Januaryhearing is intended to assess damages related to claims made against the state, both the Citizens' Council and the Department of Heath say.

"So MDH will not destroy those (archived) blood spots until a district court judge issues an order permitting the destruction," Schultz said. The same is true for data gathered from the samples, he said.

McCann said blood samples are placed on multi-layered sample-collection cards that include five layers. Three are kept by the Department of Health and two go to Mayo Clinic in Rochester — meaning a sample from every newborn screening bloodspot collected in Minnesota goes to Mayo.

Mayo analyzes the samples to check for more than 40 medical anomalies, McCann said.

Mayo spokesman Bryan Anderson said when it's time for sample destruction, newborn screening cards get torn into two pieces at Mayo.


"The part that contains the blood spot is placed in biohazard containers and is incinerated," he said. "The part containing private health information is shredded at the Mayo recycling center."

The Department of Health destroys new samples after 71 days in keeping with standard laboratory protocols for destruction of biohazardous materials, McCann said.

Anderson declined to specify whether most parents continue to allow the newborn screenings to occur. The new law allows parents to "opt out" and decline such screening.

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