Caroselli, Beachler & Coleman, L.L.C.

HHS Issues New Recommendations for Infant Heart Screening

For centuries, doctors have struggled to treat children with congenital heart defects. Unfortunately, CHDs account for nearly a quarter of birth-defect related infant deaths in the United States. Approximately 4,800 babies are born each year with critical congenital heart defects (CCHD).

In September 2011, a United States Department of Health and Human Services (HHS) advisory committee recommended that all newborns be screened for CCHD; however, the HHS has not approved a final protocol. In the interim, the medical community has moved forward to tackle the issue, as delayed diagnosis of such defects can prove fatal for the patient.

In a report entitled "Strategies for Implementing Screening for Critical Congenital Heart Disease," researchers recommend pulse oximetry monitoring to detect CCHD in well-baby and intermediate-care nurseries. The report, set to be published in the November issue of "Pediatrics," addresses large population clinical studies covering a broad range of newborn delivery systems as well as work group discussions.

The protocol workgroups included pediatric cardiologists, neonatologists, and representatives from a number of organizations including the March of Dimes, the American Academy of Pediatrics (AAP), the American Heart Association (AHA) and the federal government. Presently, the protocol is endorsed by the AHA, AAP and the American College of Cardiology Foundation.

The proposed protocol for screening newborns outlines timeframes and rationales for testing that reduce the risk of false positives. The recommendations include screenings after the first day of life, follow-up prior to discharge, and public education and outreach. This is all important given the fact that some babies who appear healthy at first are sent home with heart defects. It's estimated that nearly 280 babies are discharged each year with undetected CCHD.

Presently, the HHS recommends that 30 core conditions be screened in newborns. Most of these evaluations can be performed through the standard blood spot or heel prick blood test. Including blood oximetry in the screening panel would simply add one test to the screening routine. The medical community understands that using pulse oximetry monitoring to detect CCHD has its limitations, but evidence does show that it can help in early detection.

CCHD remains the leading cause of death in children under the age of one year. Time will tell if this newly endorsed protocol will dramatically increase the early detection and prevention of heart defect related infant deaths. In the meantime, physicians must remain vigilant about screening, in order to protect the safety of their patients and avoid medical malpractice liability.

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