Chapter 3701-54 | Critical Congenital Heart Disease

Rule 3701-54-01 | Definitions.

• Effective: December 26, 2019
• Promulgated Under: 119.03

(A) Critical congenital heart disease (also known as CCHD) means structural heart defects usually associated with hypoxia in the newborn period that could have significant morbidity or mortality early in life with the closing of the ductus arteriosus or other physiologic changes early in life. Seven specific lesions targeted for critical congenital heart disease screening are: hypoplastic left heart syndrome; pulmonary atresia; tetralogy of Fallot; total anomalous pulmonary venous return; transposition of the great arteries; tricuspid atresia and truncus arteriosus.

(B) Critical congenital heart disease screening means the identification of a newborn or infant that may have a critical congenital heart defect, through the use of a physiologic test.

(C) Director means the director of the Ohio department of health or his or her designee.

(D) Freestanding birthing center means a facility other than a hospital perinatal unit providing obstetrical delivery services registered under section 3702.30 of the Revised Code.

(E) Infant means a child who is at least thirty days but less than one year of age.

(F) Hospital has the same meaning as in section 3701.503 of the Revised Code.

(G) Newborn means a child who is less than thirty days old.

(H) For purposes of these rules, "Newborn care nursery" means a distinct portion of a hospital in which inpatient care is provided to newborns and infants. It also includes a distinct portion of a children's hospital in which intensive care is provided to newborns and infants.

(I) Pulse oximetry means a non-invasive procedure used to measure the oxygen level (or oxygen saturation percentage) in the blood.

Supplemental Information

Authorized By: 3701.5010
Amplifies: 3701.5010
Five Year Review Date: 6/24/2025
Prior Effective Dates: 10/1/2014

Rule 3701-54-02 | Required screening; facility requirements.

• Effective: December 26, 2019
• Promulgated Under: 119.03

(A) Each newborn or infant shall be screened before discharge, in accordance with procedures set forth in this chapter for the presence of critical congenital heart disease, unless the newborn or infant has had a pediatric echocardiogram or is being discharged home on oxygen.

(B) All hospitals, freestanding birthing centers, and newborn care nurseries that are required by this chapter to conduct critical congenital heart disease screening shall:

(1) Designate a CCHD newborn screening coordinator responsible for the coordination, implementation and follow-up procedures for the facility's CCHD screening; and

(2) Notify the Ohio department of health, children and specialty health section of the name and contact information of the individual designated as the CCHD newborn screening coordinator whenever the designated individual changes.

(3) Prior to conducting the critical congenital heart disease screening, the person designated in the applicable provision of this rule shall oversee or ensure that each newborn or infant's parent, legal guardian, or legal custodian, is given notice of the screening to be conducted.

(a) When a birth occurs in a hospital, the hospital shall provide the information; or

(b) When a birth occurs in a freestanding birth center, the freestanding birthing center shall provide the information.

(4) Conduct the critical congenital heart disease screening in accordance with specifications in rule 3701-54-03 of the Administrative Code.

(5) Communicate the results of the critical congenital heart disease screening to the newborn's or infant's parent, guardian, or custodian, and attending physician.

(6) Report the results of the newborn's or infant's critical congenital heart disease screening to the Ohio department of health through the vital statistics electronic birth certificate system or an alternative electronic system approved by the director.

(7) Refer newborns or infants that receive abnormal screening results to providers for appropriate pediatric follow-up services.

(8) If a newborn is transferred to another hospital before screening can take place, the receiving hospital shall conduct the screening when it is determined to be medically appropriate.

(9) Hospitals without access to the Ohio department of health vital statistics electronic birth certificate system or an alternative electronic system approved by the director shall report screening results to the Ohio department of health on a form provided by the department.

Supplemental Information

Authorized By: 3701.5010
Amplifies: 3701.5010
Five Year Review Date: 6/24/2025
Prior Effective Dates: 10/1/2014

Rule 3701-54-03 | Critical congenital heart disease screening procedures, equipment.

• Effective: December 26, 2019
• Promulgated Under: 119.03

(A) Each hospital and freestanding birthing center shall conduct a critical congenital heart disease screening using pulse oximetry, prior to discharge, and when the newborn or infant is at least twenty-four hours of age.

(1) If the first pulse oximetry saturation percentage is ninety-five per cent or greater in either the right hand or either foot and the difference between the right hand and either foot is three per cent or less, the newborn or infant has passed.

(2) If any pulse oximetry saturation percentage is less than ninety per cent in the right hand or either foot, the newborn or infant has failed and should receive immediate pediatrician evaluation and/or referral to pediatric cardiology for a pediatric echocardiogram.

(3) If the first pulse oximetry saturation is greater than or equal to ninety per cent but less than ninety-five per cent in both right hand and either foot or has a difference of greater than three per cent between the right hand and either foot, the pulse oximetry screening should be repeated in approximately one hour.

(4) If the second pulse oximetry reading is greater than or equal to ninety per cent but less than ninety-five per cent in both right hand and either foot or has a difference of greater than three per cent between the right hand and either foot, the pulse oximetry screening should be repeated again in approximately one hour.

(5) If the third pulse oximetry reading is greater than or equal to ninety per cent but less than ninety-five per cent in both right hand and either foot or has a difference of greater than three per cent between the right hand and either foot, the newborn or infant should receive immediate pediatrician evaluation and/or referral to pediatric cardiology for a pediatric echocardiogram.

(B) The pulse oximetry screening should be performed with a motion-tolerant pulse oximeter that reports functional oxygen saturation, has been validated in low-perfusion conditions, has been cleared by the food and drug administration for use in newborns, and has a two per cent root-mean-square accuracy.

Supplemental Information

Authorized By: 3701.5010
Amplifies: 3701.5010
Five Year Review Date: 6/24/2025
Prior Effective Dates: 10/1/2014

Rule 3701-54-04 | Religious exception.

• Effective: May 26, 2020
• Promulgated Under: 119.03

The provisions of this chapter requiring critical congenital heart disease screening of newborns and infants do not apply if the parents, guardian or custodian of the child object thereto on the grounds that such screening conflicts with their religious tenets and practices. Refusal to consent to the critical congenital heart disease screening must be documented in the newborn or infant's medical record and reported to the director.

Supplemental Information

Authorized By: 3701.5010
Amplifies: 3701.5010
Five Year Review Date: 6/24/2025
Prior Effective Dates: 10/1/2014