10A NCAC 43K .0102       screening requirements

(a)  All medical facilities and attending providers of a neonate or infant shall assure the following:

(1)           Screening of every neonate for critical congenital heart defects (CCHD) using pulse oximetry shall be performed at 24 to 48 hours of age using a written protocol developed by the provider based upon and in accordance with the most current recommendations from the American Academy of Pediatrics and American Heart Association (AAP/AHA) which are incorporated by reference including subsequent amendments and editions, unless a diagnostic neonatal echocardiogram has been performed. A copy of the recommendations is available for inspection at the NC Division of Public Health, Women's and Children's Health Section, Children and Youth Branch, 5601 Six Forks Road, Raleigh, NC 27609. In addition, the recommendations can be accessed at the American Academy of Pediatrics website at:

http://pediatrics.aappublications.org/content/128/5/e1259.full.pdf+html?sid=85e81711-f9b8-43d1-a352-479168895a72.

(2)           Screening of a neonate for CCHD who is born in a free-standing birthing center or home may occur as early as 6 hours of age but shall not occur later than 48 hours of age using the AAP/AHA recommendations. 

(3)           Screening of neonates and infants in neonatal intensive care units for critical congenital heart defects using pulse oximetry screening shall be performed using a written protocol based on the AAP/AHA recommendations as soon as the neonate or infant is stable, as determined by the attending provider, and off oxygen and before discharge unless a diagnostic echocardiogram is performed on the neonate or infant after birth and prior to discharge from the medical facility.

(4)           Only U.S. Food and Drug Administration approved pulse oximetry equipment is used and maintained to screen the neonate or infant for the presence of critical congenital heart defects.

(b)  Parents or guardians may object to the critical congenital heart defects screening at any time before the screening is performed in accordance with G.S. 130A-125.

(c)  All medical facilities and attending providers of the neonate or infant shall have and implement a written protocol developed by the provider for evaluation and follow up of positive critical congenital heart defect screenings.

(1)           Evaluation and follow up of a positive screening for all neonates shall occur as soon as possible but no later than 24 hours of obtaining a positive screening result.  Evaluation and follow-up shall be in accordance with the most current published recommendations from the American Academy of Pediatrics and American Heart Association (AAP/AHA) which is incorporated by reference including subsequent amendments and editions.  A copy of the recommendations is available for inspection at the NC Division of Public Health, Women's and Children's Health Section, Children and Youth Branch, 5601 Six Forks Road, Raleigh, NC 27609. In addition, the recommendations can be accessed at the American Academy of Pediatrics website at:

http://pediatrics.aappublications.org/content/128/5/e1259.full.pdf+html?sid=85e81711-f9b8-43d1-a352-479168895a72.

(2)           Attending providers of neonates and infants in neonatal intensive care units must have a written protocol developed by the provider for evaluation and follow up of positive screenings in place at their medical facility.

(3)           Options for neonatal or infant echocardiograms may include on-site, telemedicine, or by transfer or referral to an appropriate medical facility with the capacity to perform and interpret a neonatal or infant echocardiogram. Echocardiograms must be interpreted as recommended by the most current recommendations from the AAP/AHA, which are incorporated by reference including subsequent amendments and editions.  A copy of the recommendations is available for inspection at the NC Division of Public Health, Women's and Children's Health Section, Children and Youth Branch, 5601 Six Forks Road, Raleigh, NC 27609.  In addition, the recommendations can be accessed at the American Academy of Pediatrics website at:

http://pediatrics.aappublications.org/content/128/5/e1259.full.pdf+html?sid=85e81711-f9b8-43d1-a352-479168895a72.

History Note:        Authority G.S. 130A-125;

Temporary Adoption Eff. July 25, 2014;

Eff. April 1, 2015.