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10A NCAC 43K .0101, .0102, .0103 – Newborn Screening for Critical Congenital Heart Defects

The Commission for Public Health intends to adopt the rules cited as 10A NCAC 43K .0101, .0102 and .0103 with a proposed effective date of April 1, 2015.

S.L. 2013-45 (S98) required that Public Health adopt temporary and permanent rules to include pulse oximetry screening for critical congenital heart defects (CCHD) in the Newborn Screening Program so that newborns in North Carolina are screened at 24 to 48 hours of age for this defect. CCHD potentially affects up to 200 newborns each year in North Carolina. Timely diagnosis can prevent major disease complications and death which are possible outcomes if critical congenital heart defects are not detected. The proposed permanent rules replace the temporary rules, which expire April 21, 2015. The permanent rules assure that all medical facilities and attending providers of neonates and infants in NC (as defined in the rules) are using a consistent screening protocol based on national standards. The rules also assure that all medical facilities and attending providers of neonates and infants have a consistent and standardized written plan for evaluation and follow up of positive critical congenital heart defect screenings. Further, the rules provide for data collection, reporting and monitoring of screening for critical congenital heart defects.

A public hearing was held on January 5, 2015 at 10:00 a.m. in the Cardinal Room, located at: 5605 Six Forks Road, Raleigh, NC 27609 External link.

Proposed Permanent Rules: 10A NCAC 43K .0101, 10A NCAC 43K .0102, 10A NCAC 43K .0103
Fiscal Note: Fiscal Note: Screening for Congenital Heart Defects (PDF, 378 KB)
Federal Certification: N/A
Adopted Rule: N/A

Public Comments

The public comment period was from December 2, 2014 through January 30, 2015. Comments for this rule will not be accepted after 01/30/15.



Additional Links

Procedure for Subjecting a Proposed Rule to Legislative Review