States fail to protect newborns
Federal standards on disease screening not met, GAO report says
Most states have not met federal benchmarks to screen newborns in a timely manner for serious yet treatable genetic disorders, according to a report released by the U.S. Government Accountability Office.
Although progress has been made, no states met a goal to have 95% of results reported to pediatricians within five days of birth for babies with the most time-sensitive conditions. No states had 95% of samples reach their lab within 24 hours of collection.
As part of a bill signed by President Obama in 2014, the report was required in response to a Milwaukee Journal Sentinel investigation that found infants have died and suffered permanent disabilities because of screening delays by hospitals and state labs. The investigation was triggered by a Wisconsin baby who nearly died and was left brain damaged because of a delayed screening in 2012.
The bill authorized nearly $20 million in spending for programs that support the country’s staterun newborn screening system. The GAO is an independent, nonpartisan agency that works for Congress to investigate how the federal government spends taxpayer dollars. Nearly every baby in the country is tested for genetic disorders shortly after birth. Blood is collected on a card that is sent to state public health labs for testing. In 2013, the Journal Sentinel found that thousands of hospitals sent babies’ blood samples late to state labs, more than half of which were closed on weekends. In Colorado, a baby with a treatable disorder died before his newborn screening test was completed because the state lab was closed over the weekend.
Though the GAO highlighted many changes states made to improve timeliness, the agency said its analysis indicates “substantial work remains for the majority of states to achieve the recommended benchmark by 2017.”
The benchmark was set by a federal advisory committee that advises the U.S. secretary of Health and Human Services. In 2015, the committee set goals for three stages of newborn screening and said states should have at least 95% of babies’ blood samples meet these marks:
to collection: A baby’s blood should be collected within 48 hours of birth.
to arrival at lab: The blood sample should arrive at the lab within 24 hours of collection.
arrival to reporting results: Results for the most timesensitive conditions should be reported to doctors within five days of birth, and all conditions should be reported within seven days of birth.
The GAO did its analysis by reviewing data collected by the Association of Public Health Laboratories, which represents state labs across the country and has received about $9 million in federal grants to help states improve newborn screening. One of the government-funded programs is a data repository to better track states’ progress.
The GAO reported 37 states and Puerto Rico had submitted data, so the agency could not assess the entire country. The Journal Sentinel had the same problem with its investigation, as only 31 states initially released newborn screening data.
Participation in the data repository is voluntary, although the lab association says it hopes all states will join by April. The following had not submitted data: Connecticut, District of Columbia, Guam, Idaho, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nevada, Oklahoma, Utah and West Virginia. The GAO listed several challenges states face to improve timeliness, many of which were identified by the Journal Sentinel in 2013: limited lab hours, staff turnover, nursing protocol, limited courier availability, lack of feedback to hospitals on performance and relying on the mail to communicate results.
Dozens of states and thousands of hospitals throughout the country significantly changed how they approach newborn screening. They opened labs on weekends, required couriers for rural areas and provided hospitals with monthly performance reports. The changes weren’t enough to meet the benchmarks laid out by the federal advisory committee.
“We are making progress, but we are certainly not where we want to be, ” said Cynthia Pellegrini, senior vice president of public policy and government affairs for the national March of Dimes, which advocates for newborn screening. “Even though this system looks relatively straightforward on the surface, once you start digging into it, it becomes unexpectedly complex.”
The Association of Public Health Laboratories said it works with state lab officials to make improvements and doesn’t think enough time has passed to evaluate states’ progress.
Some states have met individual goals: In 2015, 10 out of 35 states had 95% of blood samples collected within 48 hours of birth.
It is unclear which states have made progress because data submitted in the repository are not public. In response to the Journal Sentinel’s investigation, some states began posting hospitals’ performance online. The information is not always easy to find or kept up to date. Many states keep the numbers secret, leaving parents in the dark over newborn screening performance that could affect their baby.
The lab association said keeping data private provides incentive to participate.
“Bottom line: If we revealed state data, they wouldn’t contribute,” according to Jelili Ojodu, director of newborn screening and genetics for the lab association.
Sen. Tammy Baldwin, D-Wis., who supported the newborn screening bill in 2014, is a member of a Senate committee that received the GAO report.
“This new report shows that we still have more work to do,” Baldwin said in a statement. “I stand ready to continue my work to ensure that critical newborn screenings are completed quickly and accurately and to improve consistency in newborn testing across the country.”
The GAO noted that although newborn screening has largely been the responsibility of state health departments, the federal government plays an influential role in providing grants, and the federal advisory committee was charted to recommend improvements to states and provide advice to the secretary of Health and Human Services.
A Journal Sentinel investigation this month revealed that newborn screening lab policies and protocols vary widely from state to state, and many states ignore scientific advances. As a result, children can suffer catastrophic harm.