published Thursday, February 6th, 2014

Time crucial in screening newborns for disease; Tennessee's timing record unclear

Andrew Jace Gaconnet, 1 day old, waits to be taken back to his mother in the Well Baby Nursery at the Baroness Campus at Erlanger Health System. Newborns go through genetic screening tests administered shortly after birth to test for diseases that may not have been previously detected.
Andrew Jace Gaconnet, 1 day old, waits to be taken back to his mother in the Well Baby Nursery at the Baroness Campus at Erlanger Health System. Newborns go through genetic screening tests administered shortly after birth to test for diseases that may not have been previously detected.
Photo by Erin O. Smith.

Every hour counts when it comes to testing newborns for serious illness.

A quick prick of the tiny heel, a few drops of blood on a sheet of filter paper, and a lab test can help reveal what doctors may not be able to detect: Genetic diseases like cystic fibrosis and sickle cell anemia.

Without such tests -- and without quick turnaround times for results -- some such disorders may remain undetected until it's too late to prevent disability, brain damage, even death. One in 800 babies is born with such illnesses.

"These diseases can cause some very damaging consequences, sometimes within a few weeks [after birth]," said Dr. Michael Warren, director of maternal and child health for the Tennessee Department of Health.

"That's why it's so important to get a sample on every baby, and that the testing on that screening be done in a timely manner. You want to be able to act on these quickly."

But it is unclear how Tennessee hospitals or the state's laboratory perform on timing.

Tennessee and Alabama are two of just 14 states that have not made public how long it takes samples to get to their state labs for testing, meaning the public can't track whether hospitals are performing up to standards.

Georgia, which has made its delivery times public, performs in the midrange of states evaluated in this category.

In December, Tennessee officials began flagging delays in its individual reports to hospitals, after an investigative report by the Milwaukee Journal Sentinel revealed the scope and effect of delays around the nation.

In 2012, at least 160,000 blood samples from newborns nationwide arrived late at state labs, the Journal Sentinel's analysis found.

The report also revealed that many hospitals across the county do not face consequences for the delays.

Recommendations made by the U.S. Department of Health and Human Services call for the samples to be shipped to labs 24 hours after the babies are tested, and to arrive in three days.

In Georgia, where the tests' transit times have been made public, 7,033 samples out of 148,480 tested in 2012 -- or 4.7 percent -- took six or more days to reach the lab. By comparison, just 0.19 percent of Iowa's samples were delayed, while 33.75 percent of South Carolina's tests didn't meet the mark.

In Georgia, 44 facilities had more than 5 percent of samples reach a lab six or more days after collection.

Statistics for Hutcheson Medical Center in Fort Oglethorpe were available through the Journal-Sentinel's database, though the hospital suspended its labor and delivery services in December as a part of its strategic plan.

It showed that 46 samples, or 7.37 percent, of its 665 tests that year were six or more days late.

•••

Newborn screening programs began in the 1960s, and hospitals now test for more than two dozen illnesses.

Tennessee Health Department rules call for the baby to be tested within 24 hours of birth and to have the samples shipped within 24 hours after that.

But it's unclear how many hospitals actually meet this deadline.

Since 1999, Tennessee health officials tracked and publicly made available reports of whether hospitals are conducting tests properly. That includes ensuring the baby has been tested after it is at least 24 hours old, and that the blood is being collected in a way that it can be correctly tested.

But transit times were not included in those reports until December.

Now Tennessee hospitals are flagged for delays if it has taken more than 10 days for the tests to reach the lab -- twice the turnaround rate recommended by HHS.

While the state has begun communicating that information to hospitals, the number of delays is not publicly available.

Tennessee officials cite patient privacy as the reason, since hospitals receive patient-identifiable information. But names and patient outcomes are not factors in the other statistics the state already provides.

Officials with Tennessee's Division of Laboratory Services stated they monitor the transit time of specimens and that "procedures are being developed" to help hospitals improve.

The agency did not respond to questions by Wednesday evening requesting more details on the procedures, whether transit times were monitored closely prior to December, and what the state's average transit times are.

Warren said the department is working closely with hospitals that are dealing with delays and other problems with specimen collection.

"I think that all the stakeholders involved in the screening process, from collection to testing to reporting, are focused on doing what is best for babies," he said last month. "Just this morning, we have had four inquiries from hospitals across Tennessee asking for technical assistance in their specimen collection process."

Tennessee is also one of 10 states that do not have specific requirements for how hospitals deliver their samples to the lab.

Erlanger Health System sends its samples daily via U.S. Postal Service, and Parkridge East Hospital sends its tests daily via FedEx.

Once the samples reach the labs, screenings are normally complete in 48 hours, said Shelley Walker, a spokeswoman for the Tennessee Department of Health.

In Georgia, the rules are somewhat more stringent. While those hospitals also are required to send samples within 24 hours of collection, their samples must be sent to the Georgia Public Health Laboratory in Decatur by courier, overnight delivery, or express mail, the Journal Sentinel report found.

Georgia's state lab pays for one UPS shipment each day from each hospital.

In Tennessee, Georgia and Alabama, testing labs are not open on weekends or holidays, meaning babies born later in the week could have results delayed further.

Warren said it is possible that changes in tracking and reporting times may come up at the meeting of the department's genetic advisory committee this spring.

"The committee and our follow-up program want to do everything we can do to reduce the rate of unsatisfactory specimens," Warren said. "There is interest now in transit time, and I think there will be a look at that."

•••

Dr. Joani Jack has seen firsthand what a difference newborn screenings can make in a family's life.

Jack, the medical director of the well newborn nursery at T.C. Thompson Children's Hospital at Erlanger, says most parents are willing to have their babies tested.

But others take more coaxing. Jack recalls one family last year that was adamant about not wanting their newborn tested.

After some long conversations, they finally relented, only to find the child had hypothyroidism -- a condition that can lead to intellectual disabilities, growth and heart problems if not treated early.

With treatment, the child has developed normally.

"The thing about hypothyroidism and other conditions like it is that the symptoms may not reveal themselves until the damage is already done," Jack said. "That's why the tests are so important."

Erlanger's system for collection is set up like clockwork, Erlanger Laboratory Support Services manager Mary Hooper explains. The collection is taken 24 hours after the baby is born, and most tests are typically shipped the next day, unless it is a weekend.

The staff has a log of pending tests. If the results do not come in within the next week or so, the staff will follow up with the state or request a new test.

If the staff is worried about something while the baby is still in the hospital, they may order an in-house test in addition to what they send to the state lab, Jack said.

While Jack said she is confident in Erlanger's screening system, she is "all for" upping oversight over transit times to improve that state's performance.

At Parkridge East Hospital, the collection process occurs within the same time frame.

The hospital has implemented a new tracking system to follow the specimen from collection to reporting, "to verify that no infant goes untested," said Misty Prock, lab manager for the hospital.

"The goal is for no specimen to arrive at the state lab any later than five days after collection. We therefore send them daily via FedEx," Prock said.

Prock said her staff is aware of the state's new monitoring of the 10-day time limit. So far, the hospital has seen no outliers with the new system, she said.

Contact staff writer Kate Harrison at kharrison@timesfreepress.com or 423-757-6673.

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