Newborn screening for critical congenital heart defects (CCHD) utilizing pulse oximetry

The North Carolina State Legislature passed Session Law 2013-15 to expand the Newborn Screening program established by the Department of Health and Human Services to include newborn screening for critical congenital heart defects (CCHD) utilizing pulse oximetry.  As a result, of this legislation, public health rules requiring CCHD screening of every neonate and required reporting of data related to CCHD screening went into effect on July 25, 2014. 

The rules for Newborn Screening for CCHD were developed using an expert panel and multiple other stakeholders from North Carolina.  Representatives from a wide variety of stakeholders participated in face to face meetings, conference calls, and email communications. Participants engaged in the development of the rules included families of children with CCHD, pediatricians, neonatologists, nurse practitioners, nurse midwives, and representative from the NC Hospital Association, the NC Chapter of American Heart Association, the NC Chapter of the March of Dimes, the Perinatal Quality Collaborative of NC, the NC Board of Nursing, the NC Academy of Family Physicians, and the NC Academy of Physician Assistants. These rules can be found at:\Title 10A - Health and Human Services\Chapter 43 - Personal Health

CCHD screening has been recommended since 2011 as part of the Routine Uniform Screening Panel and endorsed by the American Heart Association (AHA), the American Academy of Pediatrics (AAP), and the American College of Cardiology.  As a result, many North Carolina birthing hospitals and health care providers have already initiated routine pulse oximetry screening for CCHD in neonates as the standard of care.

Screening for CCHD utilizing pulse oximetry is now required for every neonate delivered in hospitals, birthing centers, homes or other locations by 24 to 48 hours of age in NC.  FDA approved pulse oximetry machines are recommended for CCHD screening and more information can be found at: Parents or guardians may object to the CCHD screening of a neonate or infant in NC at any time before the screening is performed in accordance with G.S. 130A-125. The NC rules also state that screening for CCHD does not have to be performed if a diagnostic neonatal echocardiogram is performed on the neonate or infant after birth and prior to discharge from care.

The NC rules state that CCHD screening must follow a protocol based on the national AAP/AHA recommendations. In addition, all hospitals, birthing centers and attending health care providers of the neonate and infant are required to have and implement a plan for timely evaluation and follow up of neonates with positive CCHD screenings before discharge from care and in accordance with the most current published recommendations from the AAP/AHA. This requirement applies to health care providers of neonates who are involved with births which occur in birthing facilities, homes or other locations in NC. A protocol for screening for CCHD and a process for evaluation of neonates and infants is also required for neonatal intensive care units in NC. The national recommendations can be found at:  

In addition, reporting requirements about CCHD screening are now in effect in order to allow for mandated data collection for public health surveillance of CCHD through the NC Birth Defects Monitoring Program.  All medical facilities and health care providers who perform CCHD screenings on neonates and infants will be required to electronically report specific data elements about those neonates and infants with positive or failed screenings.  These medical facilities and health care providers will also be required to report aggregate data elements related to CCHD screening of neonates and infants.  Specific information about the types of required data to be reported can be found at:\Title 10A - Health and Human Services\Chapter 43 - Personal Health.   To start the process to be able to report data go to:

It is important that attending health care providers of the neonates and infants communicate with families about the CCHD results before discharge from care and especially how a negative screening result does not exclude the possibility of CCHD. The AAP/AHA recommendations emphasize the role of the newborn’s or infant’s ongoing outpatient primary care provider or medical home and the need for CCHD screening results to be shared with the medical home.  In addition the recommendations state, “during the first outpatient visit primary care providers should ensure that all newborns were appropriately screened and received any necessary follow up….Primary care providers play a central role in ensuring long term follow up for those infants diagnosed with CCHD through newborn screening and coordinating their care with a pediatric cardiologist.”