Chapter 3701-54 | Critical Congenital Heart Disease

Rule 3701-54-01 | Definitions.

• Effective: October 16, 2025
• Promulgated Under: 119.03

(A) "Attending physician" means the physician treating the newborn or infant while the newborn or infant is in the hospital.

(B) "CCHD Coordinator" means a member of the clinical team at the facility that is responsible for the coordination, implementation, and follow-up procedures for the facility's CCHD screening program.

(C) "Clinical Team" means a team of health professionals from different disciplines (e.g., nursing, cardiology, neonatology, or primary care) who coordinate and convene to discuss management of a particular condition in a particular patient.

(D) "Critical congenital heart disease" also known as CCHD, means a group of serious heart defects that are present from birth.

(E) "Critical congenital heart defects screening" means the identification of a newborn or infant that may have a critical congenital heart defect, using a physiologic test.

(F) "Custodian" means a government agency, or an individual, other than a parent or guardian, with legal or permanent custody of a child as defined in section 2151.011 of the Revised Code.

(G) "Director" means the director of health or authorized designee.

(H) "Discharge" means the release of a patient from a hospital or freestanding birthing center to a non-institutional setting.

(I) "Freestanding birthing center" means any facility in which deliveries routinely occur, regardless of whether the facility is located on the campus of another health care facility.

(J) "Guardian" has the same meaning as the term is defined in section 2111.01 of the Revised Code.

(K) "Hospital" means a hospital that has a maternity unit or newborn nursery.

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

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

(N) "Newborn care nursery" means a distinct portion of a hospital in which inpatient care is provided to newborns and infants. Newborn care nursery also includes a distinct portion of a hospital in which intensive care is provided to newborns and infants.

(O) "Objection" means parent, guardian, or custodian of the newborn or infant who opposes a critical congenital heart disease screening on the grounds that the screening conflicts with the parent's, guardian's, or custodian's religious tenets and practices.

(P) "Oxygen saturation" means the oxygen bound to hemoglobin in red blood cells, measured with a pulse oximeter.

(Q) "Parent" means either parent, unless the parents are separated or divorced or their marriage has been dissolved or annulled, in which case "parent" means the parent who is the residential parent and legal custodian.

(R) "Pediatric echocardiogram" means ultrasonography used to evaluate the anatomical structure and function of the heart.

(S) "Primary care physician" means the physician who will provide care for the newborn or infant after discharge.

(T) "Pulse oximetry" means a non-invasive test that estimates the percentage of hemoglobin in blood that is saturated with oxygen.

(U) "Transfer" means the release of a patient from a hospital or freestanding birth center to another healthcare facility, which undertakes responsibility for the patient.

Last updated October 16, 2025 at 7:27 AM

Supplemental Information

Authorized By: 3701.5010
Amplifies: 3701.5010
Five Year Review Date: 10/16/2030

Rule 3701-54-02 | Facility screening obligations.

• Effective: October 16, 2025
• Promulgated Under: 119.03

All hospitals, freestanding birthing centers, and newborn care nurseries will:

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

(B) Provide the Ohio department of health the name and contact information of the individual designated as the CCHD newborn screening coordinator and notify the Ohio department of health whenever the designated individual changes;

(C) Ensure each newborn or infant's parent, guardian, or custodian is given notice of the critical congenital heart disease screening prior to it being conducted and if necessary, report the refusal to consent in accordance with rule 3701-54-05 of the Administrative Code;

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

(E) Communicate the results of the critical congenital heart disease screening to the newborn or infant's parent, guardian, or custodian;

(F) Communicate the results of the critical congenital heart disease screening or the reason the screening was not completed to the newborn or infant's attending physician and primary care physician;

(G) Report the results of the newborn or infant's critical congenital heart disease screening or the reason not screened to the Ohio department of health in accordance with rule 3701-54-04 of the Administrative Code;

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

(I) Have a protocol in place for immediately evaluating, referring, and/or transferring babies that fail the screening.

Last updated October 16, 2025 at 7:27 AM

Supplemental Information

Authorized By: 3701.5010
Amplifies: 3701.5010
Five Year Review Date: 10/16/2030
Prior Effective Dates: 12/26/2019

Rule 3701-54-03 | Screening procedures and equipment.

• Effective: October 16, 2025
• Promulgated Under: 119.03

(A) Each hospital, freestanding birthing center, and newborn care nursery will conduct a critical congenital heart disease screening using pulse oximetry, on each newborn or infant born in, admitted to, or transferred into its facility, prior to discharge, and when the newborn or infant is at least twenty-four hours of age or shortly before discharge if less than twenty-four hours of age unless one of the following applies:

(1) The newborn or infant has a known prenatal diagnosis of critical congenital heart disease;

(2) The newborn or infant had a pediatric echocardiogram;

(3) The newborn or infant's parent, guardian, or custodian objects in accordance with rule 3701-54-05 of the Administrative Code; or

(4) The newborn or infant is transferred to another hospital or facility before screening can be done.

(B) If a newborn or infant is transferred to another hospital or facility before screening can take place, the receiving hospital or facility will conduct and report the screening when it is determined to be medically appropriate.

(C) Screening will be conducted by individuals who:

(1) Have pulse oximetry testing within their scope of practice;

(2) Are trained in the use of pulse oximetry;

(3) Are trained in the CCHD algorithm; and

(4) Regularly use pulse oximetry for other purposes.

(D) Screening will be done while the newborn or infant is alert, breathing room air, and at least twenty-four hours of age or shortly before discharge if less than twenty-four hours of age to avoid false positive screens.

(E) The pulse oximetry screening will 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 no worse than a two per cent root-mean-square accuracy.

Last updated October 16, 2025 at 7:27 AM

Supplemental Information

Authorized By: 3701.5010
Amplifies: 3701.5010
Five Year Review Date: 10/16/2030
Prior Effective Dates: 10/1/2014

Rule 3701-54-04 | Results and reporting.

• Effective: October 16, 2025
• Promulgated Under: 119.03

(A) A pulse oximetry sensor will be placed on the right hand and another sensor on either foot to establish oxygen saturation percentage in each extremity.

(B) A screening is considered passed if:

Any of two screenings, each separated by one hour, has an oxygen saturation measure that is greater than or equal to ninety-five per cent in the right hand and either foot with a less than or equal to three per cent absolute difference between the right hand and foot.

(C) A screening is considered failed, and the newborn or infant should receive immediate pediatric evaluation and/or referral to pediatric cardiology for a pediatric echocardiogram if:

(1) Any oxygen saturation measure is less than ninety per cent; or,

(2) Oxygen saturation is greater than or equal to ninety per cent but less than ninety-five per cent in the right hand or foot on two measures, each separated by one hour; or,

(3) A greater than three per cent absolute difference exists in oxygen saturation between the right hand and foot on two measures, each separated by one hour.

(D) Results of the newborn or infant's critical congenital heart disease screening or the reason the newborn or infant was not screened, in accordance with rule 3701-54-03 of the Administrative Code, are reported by the birthing hospital to the Ohio department of health using a system approved by the director.

(E) If a newborn or infant is transferred to another hospital or facility before screening can take place, the birthing hospital will report the reason why the screen was not completed, and the receiving hospital or facility will conduct the screening when it is medically appropriate and report the results to the Ohio department of health using a form provided by the department.

Last updated October 16, 2025 at 7:27 AM

Supplemental Information

Authorized By: 3701.5010
Amplifies: 3701.5010
Five Year Review Date: 10/16/2030

Rule 3701-54-05 | Objections to screening.

• Effective: October 16, 2025
• Promulgated Under: 119.03

(A) The parent, guardian, or custodian of a newborn or infant may object to critical congenital heart disease screening on the grounds that the screening conflicts with the parent's, guardian's, or custodian's religious tenets and practices.

(B) A parent's, guardian's, or custodian's refusal to consent to a critical congenital heart disease screening will be documented on a form provided by the department or in a written statement signed by the parent, guardian, or custodian. The written statement will include the following:

(1) The parent, guardian, or custodian is fully informed and understands the possible consequences to their child's health resulting from undetected critical congenital heart disease;

(2) The parent, guardian, or custodian has received critical congenital heart disease screening information;

(3) The parent, guardian, or custodian is objecting on the grounds that the screening conflicts with their religious tenets and practices; and

(4) The parent, guardian, or custodian releases and holds harmless the director, the hospital, newborn care nursery or freestanding birthing center, the person responsible for conducting the critical congenital heart disease screening, for any injury, illness, and/or consequences which may result from refusal.

(C) Except as provided in paragraph (D) of this rule, a completed copy of the objection form or written statement will be sent to the Ohio department of health within ten days of completion.

(D) If the parent, guardian, or custodian of a newborn or infant objects to a critical congenital heart disease screening and refuses to sign the form or written statement, the hospital or freestanding birthing center will document the parent's, guardian's, or custodian's refusal to sign the objection form or written statement.

(E) Each hospital, freestanding birthing center, and newborn care nursery will report the refusal to consent to the critical congenital heart disease screening in accordance with rule 3701-54-04 of the Administrative Code.

Last updated October 16, 2025 at 7:27 AM

Supplemental Information

Authorized By: 3701.5010
Amplifies: 3701.5010
Five Year Review Date: 10/16/2030
Prior Effective Dates: 10/1/2014