Annual Report - Annual Report 2015
Counting Hours to Save a Baby’s Life
Nancy Maddox 2016-03-21 11:50:52
Counting Hours to Save a Baby’s Life Newborn screening is all about quality and speed — a race to accurately identify infants with congenital disorders before the onset of irreparable damage — or even death. For the healthcare workers who collect newborn bloodspot specimens and the laboratory scientists who conduct the screens, it is a high-stakes race that is repeated more than four million times a year, once for each baby born in the United States. In 2015, much of APHL’s newborn screening work was geared toward shaving hours off the clock. Aurora, Colorado 39.6880° N, 104.6897° W Since 2012, APHL has teamed up with the Colorado School of Public Health (Colorado SPH) in Aurora to provide a valuable resource to newborn screening stakeholders, the Newborn Screening Technical assistance and Evaluation Program or NewSTEPs. In September 2015, the Colorado SPH, in collaboration with APHL, was awarded $5.4 million — $1.8 million/year for three years — to support at least 20 states seeking to make initial newborn screening system processes more efficient. This funding — from the US Department of Health and Human Services, Maternal and Child Health Bureau — will be used for a 360-degree review of the newborn screening system, leading to a range of solutions to improve timeliness, such as courier services to hand-deliver newborn specimens to laboratories and health information technology for faster results reporting. The project — dubbed NewSTEPs 360 — has already created one of the nation’s largest collaborations of newborn screening stakeholders, including the March of Dimes, Association of Maternal and Child Health Programs, National Institute for Children’s Healthcare Quality and many others. Washington, DC 38.9047° N, 77.0164° W While APHL’s Newborn Screening and Genetics Program hosted a number of meetings throughout 2015, perhaps the most momentous was a June gathering in Washington, DC, involving officials from every state newborn screening program, attorneys general or other legal advisors for every state newborn screening program and officials from the federal Office of Human Research Protections. The purpose? To discuss the impact of the Newborn Screening Saves Lives Act, Section 12, which Congress added when the act was reauthorized in late 2014. In short, Section 12 lays out new requirements for the use of the infant bloodspots remaining after newborn screening is complete. Historically, these so-called residual dried bloodspots (DBSs) have been de-identified and made available for qualified medical research and for core newborn screening activities, such as calibrating laboratory instruments and developing tests for newly treatable congenital disorders. The revised law requires states to obtain informed consent before residual DBSs can be used in any federally funded research, and this requirement remains in effect until the Federal Policy for the Protection of Human Subjects (aka the Common Rule) is updated. Although APHL, and newborn screening scientists generally, support informed consent, they also recognize that the current, vaguely worded law can be construed so as to hinder vital public health activities. Thus, meeting participants identified issues related to broad consent for future use of residual DBSs, as well as strategies to educate the public about newborn screening and opportunities to participate in newborn screening research. APHL and its members are also providing information to the US Department of Health and Human Services as it weighs changes to the Common Rule. What happens when there is no commercial laboratory test? When newborn screening programs want to add a new disorder to their test panels, often they have to develop it themselves, because there are no commercial test kits for most extremely rare disorders. The first states to screen for severe combined immunodeficiency (SCID), for example, began in 2010; the first commercial, FDA-approved SCID test wasn’t available until 2015. Similarly, when emerging diseases arise — such as chikungunya and Ebola — CDC and governmental public health laboratories are virtually always the first to bring diagnostic tests online. Again, there are no pre-existing FDA-approved commercial test kits. Even today, there is no FDA-approved molecular assay for measles. This ability to create laboratory-developed tests (LDTs) has been crucial to meet emerging public health needs. Yet, FDA is considering changing the rules to make the process more costly and burdensome, and public health laboratories less nimble. In response, APHL called upon its members to speak at a public FDA forum in January 2015 and submitted written comments to the agency. The association remains hopeful that any new FDA LDT guidance will not obstruct potentially life-saving public health laboratory work.
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