Virginia Regulatory Town Hall
Agency
Virginia Department of Health
 
Board
State Board of Health
 
chapter
Regulations Governing Virginia Newborn Screening Services [12 VAC 5 ‑ 71]
Action Add Critical Congenital Heart Disease to the Virginia Newborn Screening System
Stage Emergency/NOIRA
Comment Period Ended on 2/25/2015
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2/23/15  8:56 am
Commenter: Amy Hewett, American Heart Association

Support for the addition of CCHD testing to the Virginia Newborn Screening System
 

The American Heart Association strongly supports the Department’s new regulations that add critical congenital heart disease (CCHD) screening using pulse oximetry testing in the Commonwealth’s Newborn Screening System.

With this new regulation, Virginia joins dozens of other states that have taken the important steps to require this life-saving screening for newborns.  The simple pulse oximetry test can detect CCHD in more than 90 percent of afflicted newborns. Moreover, pulse oximetry screening is a low-cost, non-invasive bedside diagnostic test that can be completed in as little as 45 seconds. 

We appreciate the Department’s efforts to move quickly in developing these important regulations that will help some of Virginia’s most-vulnerable citizens.

CommentID: 39190
 

2/23/15  3:38 pm
Commenter: Robert Shor, MD, FACC, VA Chapter American College of Cardiology

Support of Newborn Screening Services
 

The Virginia Chapter of the American College of Cardiology (the Chapter) supports the Emergency Regulation Governing Virginia Newborn Screening Services published in the Virginia Register of Regulations, January 26, 2015, pages 942-946. This regulation would implement critical congenital heart disease (CCHD) screening for all babies born in Virginia hospitals with newborn nurseries. Newborn screening for CCHD is strongly supported by the Chapter and the American College of Cardiology Foundation.

This Emergency Regulation enhances the quality of life for children born in Virginia hospitals. Pulse oximetry screening is a simple, effective, inexpensive, and noninvasive test. Newborn screening for CCHD can identify congenital heart defects early and save lives. CCHD is the number one birth defect in the United States and the number one killer of infants with birth defects. While most Virginia hospitals with birthing facilities have already implemented pulse oximetry screening for CCHD, this Emergency Regulation will ensure that no infant leaves a Virginia hospital before being screened for life-threatening conditions.

The Chapter is particularly pleased with the definition of screening technology which “means pulse oximetry testing in the right hand and either foot”. The Chapter strongly approves that the definition allows for future contingencies. “Screening technology shall also include alternate medically accepted tests that measure the percentage of blood oxygen saturation, follow medical guideline consensus and recommendations issued by the American Academy of Pediatrics and are approved by the State Board of Health.”

The screening is to be “performed on every newborn in the birth hospital between 24 and 48 hours of life, or if the newborn is discharged from the hospital before reaching 24 hours of life, the CCHD screening shall be performed as late as practical before discharge.”

The Emergency Regulation states that “all CCHD screening results shall be recorded in the newborn’s medical record.” In addition, “all CCHD results shall be entered into the electronic birth certificate system” stating that CCHD screening was completed together with the result.

The Chapter is pleased that the Emergency Regulation permits the Virginia Department of Health (VDH) to collect information via the Virginia Congenital Anomalies Reporting and Education System so that infants identified with CCHD can be referred to the Care Connection for Children network to obtain care coordination services.

The Chapter supports the requirement that a refusal of CCHD screening based on religious grounds by a parent or guardian “shall be documented on a refusal form provided by the VDH and made a part of the newborn’s medical record.” The Chapter also supports requiring the hospital to notify the VDH of a screening refusal within five days of the newborn’s birth.

CommentID: 39195