California 2012 Law for Critical Congenital Heart Defects — applies ONLY to hospitals

https://www.aap.org/en-us/advocacy-and-policy/state-advocacy/Documents/2013%20CCHD%20Newborn%20Screening%20Bills,%20Regulations,%20and%20Executive%20Orders%20-%20AAP%20Division%20of%20State%20Govt%20Affairs.pdf

Assembly Bill No. 1731

CHAPTER 336

An act to add Article 6.6 (commencing with Section 124121) to Chapter 3 of Part 2 of Division 106 of the Health and Safety Code, relating to public health.

[Approved by Governor September 15, 2012. Filed with Secretary of State September 15, 2012.]

legislative counsel’s digest

AB 1731, Block. Newborn screening program: critical congenital heart disease.

Existing law provides for the Newborn and Infant Hearing Screening, Tracking, and Intervention program, under which general acute care hospitals with licensed perinatal services, as specified, are required to administer to newborns a hearing screening test for the identification of hearing loss, as prescribed, using protocols developed by the State Department of Health Care Services, or its designee.

This bill would, beginning July 1, 2013, require a general acute care hospital that has a licensed perinatal service to offer to parents of a newborn, prior to discharge, a pulse oximetry test for the identification of critical congenital heart disease (CCHD), and would require the department to issue guidance stating that hospitals perform this test in a manner consistent with the federal Centers for Disease Control and Prevention guidelines for CCHD screening. This bill would require these hospitals to develop a CCHD screening program, as prescribed.

The people of the State of California do enact as follows:

SECTION 1. The Legislature finds and declares the following:

(a) Congenital heart disease affects about seven to nine of every 1,000 live births in the United States and is the most common cause of death in the first year of life, with defects accounting for 3 percent of all infant deaths and more than 40 percent of all deaths due to congenital malformations.

(b) Critical congenital heart disease (CCHD) is a group of defects that cause severe and life-threatening symptoms and require intervention within the first days or first year of life.

(c) Current methods for detecting CCHD generally include prenatal ultrasound screening and careful and repeated clinical examinations.

(d) CCHD is often missed during the routine clinical exam that generally is scheduled prior to a newborn’s discharge, and many cases of CCHD are also missed during discharge and postdischarge clinical exams.

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(e) Fetal ultrasound screening programs improve detection of major congenital heart defects. However, prenatal diagnosis alone picks up less than one-half of all cases.

(f) Pulse oximetry is a noninvasive test that estimates the percentage of hemoglobin in blood that is saturated with oxygen.

(g) Virtuallyallhospitals,includingsmallhospitals,frequentlyusepulse oximetry as a standard of care in their newborn nurseries.

(h) Many newborn lives could potentially be saved by earlier detection and treatment of CCHD if hospitals were required to perform this simple, noninvasive newborn screening method.

SEC. 2. Article 6.6 (commencing with Section 124121) is added to Chapter 3 of Part 2 of Division 106 of the Health and Safety Code, to read:

Article 6.6. Newborn Critical Congenital Heart Disease Screening Program

124121. For purposes of this article, “CCHD” means critical congenital heart disease.

124122. (a) (1) Beginning July 1, 2013, a general acute care hospital that has a licensed perinatal service shall offer to parents of a newborn, prior to discharge, a pulse oximetry test for the identification of CCHD.

(2) The State Department of Health Care Services shall issue guidance stating that hospitals perform this test in a manner consistent with the federal Centers for Disease Control and Prevention guidelines for CCHD screening.

(3) A hospital described in paragraph (1) shall be responsible for developing a screening program that provides competent CCHD screening, utilizes appropriate staff and equipment for administering the testing, completes the testing prior to the newborn’s discharge from a newborn nursery unit, refers infants with abnormal screening results for appropriate care, maintains and reports data as required by the department, and provides physician and family-parent education.

(b) A pulse oximetry test provided for pursuant to subdivision (a) shall be performed by a licensed physician, licensed registered nurse, or an appropriately trained individual who is supervised in the performance of the test by a licensed health care professional.

(c) This section shall not apply to a newborn whose parent or guardian objects to the test on the grounds that the test is in violation of his or her beliefs.

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