By Jonathan Johnson, MD, FAAP, Department of Pediatrics/Division of Pediatric Cardiology, Mayo Clinic; Kara Fine, MD, FAAP, Department of Pediatrics, Mayo Clinic; and Amy Gaviglio, MS, LCGC, Minnesota Department of Health.
The year 2018 was marked by two incredible milestones for pulse oximetry screening for critical congenital heart disease (CCHD) in neonates. First, this was the anniversary of mandatory screening in the state of Minnesota. Additionally, with the approval of laws in Idaho, all 50 states now have some form of legislation or regulatory action in place to provide pulse oximetry screening for all neonates. This screening has also begun to become accepted and adopted in numerous countries around the world.
Many of us remember when this screening was first rolled out and the objections that took place. Providers and hospital staff were worried about the potential complications of such a policy – too many false positive screens requiring referrals, echocardiograms, and increased cost, the medicolegal concerns related to false negative studies, and the interruptions to established workflows in nurseries around the state. Most importantly, many were worried that screening would simply not be effective.
Years later, it is clear that most of these worries were unfounded. Cardiology practices have not noted an overflow of positive pulse oximetry screens that have overwhelmed the medical system. Screening has been incorporated into most nurseries as part of usual day-to-day practice, similar to newborn bloodspot screening, hearing testing, and the Hepatitis B vaccine.
The worries about efficacy of screening were effectively removed with the paper by Abouk et al in JAMA in 2017. In this landmark paper, a team of researchers examined birth and death rates for neonates, stratifying patients based on the presence or absence of a mandatory CCHD screening policy in that state. The results were striking, showing a marked decrease in infant death in locations where CCHD screening was mandatory compared to those where it was not mandatory.
Despite this demonstration of efficacy, considerable challenges remain. In many states, screening was mandated without any funding mechanism attached. There remain inconsistencies in recommendations for patients in special situations. This includes babies admitted to neonatal intensive care units, and babies born outside of the hospital setting, at home or in communities who historically avoid modern medical settings.
There are also inconsistencies for the so-called “border babies”, who are born in one state but whose parents reside in another state (due to differing laws and criteria in different states). To try to address outcomes, programs such as NewSTEPs have attempted to collect data from screening in a large registry-style format, but have struggled from low participation nationally (with only 10 states currently reporting complete data).
The State of Minnesota has one of the most robust quality mechanisms in the country to ensure compliance and adherence to the established state protocol. However, this requires significant efforts and resources from the team at the Department of Health. It is estimated that every month, around 150-200 babies’ screens are not reported to the state, requiring the Department of Health to spend time and resources to contact these institutions to get the data and ensure compliance with screening.
Around 5-10 times per month across the state, the data is reported, but the care team does not follow the recommendations regarding screening and follow-up, again requiring clarification from the Department of Health team.
Moving forward, teams from the American Academy of Pediatrics, American College of Cardiology, and American Heart Association, along with representatives from State Health Departments, Patient and Family organizations, and researchers will be meeting to study and ultimately update/improve the protocol.
We have much to be proud of in Minnesota, from the incredible involvement of patient and family organizations from our state to the nationally recognized teams at our Department of Health. Without a doubt, 2018 is a year for celebration.