Grosse and R . Rodney Howell

BACKGROUND: Although newborn screening for critical congenital heart disease (CCHD) was recommended by the US Health and Human Services Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children to promote early detection, it was deemed by the Secretary of the HHS as not ready for adoption pending an implementation plan from HHS agencies. OBJECTIVE: To develop strategies for the implementation of safe, effective, and efficient screening. METHODS: A work group was convened with members selected by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children, the American Academy of Pediatrics, the American College of Cardiology Foundation, and the American Heart Association. RESULTS: On the basis of published and unpublished data, the work groupmade recommendations for a standardized approach to screening and diagnostic follow-up. Key issues for future research and evaluation were identified. CONCLUSIONS: The work-group members found sufficient evidence to begin screening for low blood oxygen saturation through the use of pulse-oximetry monitoring to detect CCHD in well-infant and intermediate care nurseries. Research is needed regarding screening in special populations (eg, at high altitude) and to evaluate service infrastructure and delivery strategies (eg, telemedicine) for nurseries without on-site echocardiography. Public health agencies will have an important role in quality assurance and surveillance. Central to the effectiveness of screening will be the development of a national technical assistance center to coordinate implementation and evaluation of newborn screening for CCHD. Pediatrics 2011;128:e1259–e1267 AUTHORS: Alex R. Kemper, MD, MPH, MS,a William T. Mahle, MD,b Gerard R. Martin, MD,c W. Carl Cooley, MD,d Praveen Kumar, MBBS, DCH, MD,e W. Robert Morrow, MDf Kellie Kelm, PhD,g Gail D. Pearson, MD, ScD,h Jill Glidewell, RN, MSN, MPH,i Scott D. Grosse, PhD,i and R. Rodney Howell, MDj aDuke Clinical Research Institute and Department of Pediatrics, Duke University, Durham, North Carolina; bDepartment of Pediatrics, Emory University School of Medicine, Atlanta, Georgia; cDivision of Cardiology, Children’s National Medical Center, Washington, DC; dCenter for Medical Home Improvement, Concord, New Hampshire; eDepartment of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois; fDepartment of Pediatrics, University of Arkansas for Medical Sciences School of Medicine, Little Rock, Arkansas; gFood and Drug Administration, US Department of Health and Human Services, Silver Spring, Maryland; hNational Heart, Lung, and Blood Institute, National Institutes of Health, US Department of Health and Human Services, Bethesda, Maryland; iCenters for Disease Control and Prevention, US Department of Health and Human Services, Atlanta, Georgia; and jDepartment of Pediatrics, Miller School of Medicine, University of Miami, Miami, Florida