P.L. 2011, c.074 (A3744)

An Act concerning newborn screening and supplementing Title 26 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. The Legislature finds and declares that:

a. Congenital heart defects (CHDs) are structural abnormalities of the heart that are present at birth; CHDs range in severity from simple problems such as holes between chambers of the heart, to severe malformations, such as the complete absence of one or more chambers or valves; some critical CHDs can cause severe and life-threatening symptoms which require intervention within the first days of life;

b. According to the United States Secretary of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children, congenital heart disease affects approximately seven to nine of every 1,000 live births in the United States and Europe; the federal Centers for Disease Control and Prevention states that CHD is the leading cause of infant death due to birth defects;

c. Current methods for detecting CHDs generally include prenatal ultrasound screening and repeated clinical examinations; while prenatal ultrasound screenings can detect some major congenital heart defects, these screenings, alone, identify less than half of all CHD cases, and critical CHD cases are often missed during routine clinical exams performed prior to a newborn’s discharge from a birthing facility;

d. Pulse oximetry is a non-invasive test that estimates the percentage of hemoglobin in blood that is saturated with oxygen; when performed on a newborn a minimum of 24 hours after birth, pulse oximetry screening is often more effective at detecting critical, life-threatening CHDs which otherwise go undetected by current screening methods; newborns with abnormal pulse oximetry results require immediate confirmatory testing and intervention; and

e. Many newborn lives could potentially be saved by earlier detection and treatment of CHDs if birthing facilities in the State were required to perform this simple, non-invasive newborn screening in conjunction with current CHD screening methods.

2. a. The Commissioner of Health and Senior Services shall require each birthing facility licensed by the Department of Health and Senior Services to perform a pulse oximetry screening, a minimum of 24 hours after birth, on every newborn in its care.

b. As used in this section, “birthing facility” means an inpatient or ambulatory health care facility licensed by the Department of Health and Senior Services that provides birthing and newborn care services.

c. The commissioner shall adopt rules and regulations, pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), necessary to carry out the purposes of this act.

3. This act shall take effect on the 90th day after enactment, but the commissioner may take such anticipatory administrative action in advance thereof as shall be necessary for the implementation of this act.

STATEMENT

This bill requires each birthing facility licensed by the Department of Health and Senior Services to perform a pulse oximetry screening for congenital birth defects (CHDs), a minimum of 24 hours after birth, on every newborn in its care.

For newborns, pulse oximetry screening involves taping a small sensor to a newborn’s foot while the sensor beams red light through the foot to measure how much oxygen is in the blood. Pulse oximetry screening is effective at detecting CHDs that may otherwise go undetected by current screening methods. Pulse oximetry screenings are non-invasive, painless, and take approximately one minute to perform.

According to the United States Secretary of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children, congenital heart disease affects approximately seven to nine of every 1,000 live births in the United States and Europe; the federal Centers for Disease Control and Prevention states that CHD is the leading cause of infant death due to birth defects.

Current methods used to detect CHDs include prenatal ultrasound screening and repeated clinical examinations; however, prenatal ultrasound screenings, alone, identify less than half of all CHD cases. Many newborn lives could potentially be saved by requiring birthing facilities to incorporate pulse oximetry screening as a method for early detection of CHDs in conjunction with current CHD screening methods.

The bill takes effect on the 90th day after enactment, but the Commissioner of Health and Senior Services may take such anticipatory administrative action in advance as is necessary to implement the provisions of the bill.

Requires birthing facilities to screen newborns for congenital heart defects prior to discharge.