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AN ACT relating to newborn and infant screenings. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
Section 1. KRS 214.155 is amended to read as follows: 3
(1) The Cabinet for Health and Family Services shall operate a newborn screening 4
program for heritable and congenital disorders that includes but is not limited to 5
procedures for conducting initial newborn screening tests on infants twenty-eight 6
(28) days or less of age and definitive diagnostic evaluations provided by a state 7
university-based specialty clinic for infants whose initial screening tests resulted in 8
a positive test. The secretary of the cabinet shall, by administrative regulation 9
promulgated pursuant to KRS Chapter 13A: 10
(a) Prescribe the times and manner of obtaining a specimen and transferring a 11
specimen for testing; 12
(b) Prescribe the manner of procedures, testing specimens, and recording and 13
reporting the results of newborn screening tests; and 14
(c) Establish and collect fees to support the newborn screening program. 15
(2) The administrative officer or other person in charge of each institution caring for 16
infants twenty-eight (28) days or less of age and the person required in pursuance of 17
the provisions of KRS 213.046 shall register the birth of a child and cause to have 18
administered to every such infant or child in its or his care tests for heritable 19
disorders, including but not limited to phenylketonuria (PKU), sickle cell disease, 20
congenital hypothyroidism, galactosemia, medium-chain acyl-CoA dehydrogenase 21
deficiency (MCAD), very long-chain acyl-CoA deficiency (VLCAD), short-chain 22
acyl-CoA dehydrogenase deficiency (SCAD), maple syrup urine disease (MSUD), 23
congenital adrenal hyperplasia (CAH), biotinidase disorder, cystic fibrosis (CF), 3-24
methylcrotonyl-CoA carboxylase deficiency (3MCC), 3-OH 3-CH3 glutaric 25
aciduria (HMG), argininosuccinic acidemia (ASA), beta-ketothiolase deficiency 26
(BKT), carnitine uptake defect (CUD), citrullinemia (CIT), glutaric acidemia type I 27 UNOFFICIAL COPY 22 RS BR 1631
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(GA I), Hb S/beta-thalassemia (Hb S/Th), Hb S/C disease (Hb S/C), homocystinuria 1
(HCY), isovaleric acidemia (IVA), long-chain L-3-OH acyl-CoA dehydrogenase 2
deficiency (LCAD), methylmalonic acidemia (Cbl A,B), methylmalonic acidemia 3
mutase deficiency (MUT), multiple carboxylase deficiency (MCD), propionic 4
acidemia (PA), trifunctional protein deficiency (TFP), tyrosinemia type I (TYR I), 5
spinal muscular atrophy (SMA), [and ]krabbe disease, and cytomegalovirus 6
(CMV). The listing of tests for heritable disorders to be performed shall include all 7
conditions consistent with the recommendations of the American College of 8
Medical Genetics. 9
(3) The administrative officer or other person in charge of each institution caring for 10
infants twenty-eight (28) days or less of age and the person required in pursuance of 11
the provisions of KRS 213.046 shall register the birth of a child and cause to have 12
administered to every such infant or child in its or his care a screening for critical 13
congenital heart disease (CCHD) prior to discharge unless CCHD has been ruled 14
out or diagnosed with prior echocardiogram or prenatal diagnosis of CCHD. 15
(4) Each health care provider of newborn care shall provide an infant's parent or 16
guardian with information about the newborn screening tests required under 17
subsections (2) and (3) of this section. The institution or health care provider shall 18
arrange for appropriate and timely follow-ups to the newborn screening tests, 19
including but not limited to additional diagnoses, evaluation, and treatment when 20
indicated. 21
(5) Nothing in this section shall be construed to require the testing of any child whose 22
parents are members of a nationally recognized and established church or religious 23
denomination, the teachings of which are opposed to medical tests, and who object 24
in writing to the testing of his or her child on that ground. 25
(6) The cabinet shall make available the names and addresses of health care providers, 26
including but not limited to physicians, nurses, and nutritionists, who may provide 27 UNOFFICIAL COPY 22 RS BR 1631
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postpartum home visits to any family whose infant or child has tested positive for a 1
newborn screening test. 2
(7) A parent or guardian shall be provided information by the institution or health care 3
provider of newborn care about the availability and costs of screening tests not 4
specified in subsections (2) and (3) of this section. The parent or guardian shall be 5
responsible for costs relating to additional screening tests performed under this 6
subsection, and these costs shall not be included in the fees established for the 7
cabinet's newborn screening program under subsection (1) of this section. All 8
positive results of additional screening of these tests shall be reported to the cabinet 9
by the institution or health care provider. 10
(8) (a) For the purposes of this subsection, a qualified laboratory means a clinical 11
laboratory not operated by the cabinet that is accredited pursuant to 42 U.S.C. 12
sec. 263a, licensed to perform newborn screening testing in any state, and 13
reports its screening results using normal pediatric reference ranges. 14
(b) The cabinet shall enter into agreements with public or private qualified 15
laboratories to perform newborn screening tests if the laboratory operated by 16
the cabinet is unable to screen for a condition specified in subsection (2) of 17
this section. 18
(c) The cabinet may enter into agreements with public or private qualified 19
laboratories to perform testing for conditions not specified in subsection (2) of 20
this section. Any agreement entered into under this paragraph shall not 21
preclude an institution or health care provider from conducting newborn 22
screening tests for conditions not specified in subsections (2) and (3) of this 23
section by utilizing other public or private qualified laboratories. 24
(9) The secretary for health and family services or his or her designee shall apply for 25
any federal funds or grants available through the Public Health Service Act and may 26
solicit and accept private funds to expand, improve, or evaluate programs to provide 27 UNOFFICIAL COPY 22 RS BR 1631
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screening, counseling, testing, or specialty services for newborns or children at risk 1
for heritable disorders. 2
(10) This section shall be cited as the James William Lazzaro and Madison Leigh Heflin 3
Newborn Screening Act. 4
SECTION 2. A NEW SECTION OF KRS CHAPTER 214 IS CREATED TO 5
READ AS FOLLOWS: 6
(1) For the purposes of this section, "department" means the Department for Public 7
Health in the Cabinet for Health and Family Services. 8
(2) The department shall provide pregnant women and women who may become 9
pregnant with educational resources and information regarding the incidence of 10
cytomegalovirus, the transmission of cytomegalovirus before and during 11
pregnancy, birth defects caused by congenital cytomegalovirus, methods of 12
diagnosing congenital cytomegalovirus, available preventive measures, and 13
resources for the family of an infant born with congenital cytomegalovirus. The 14
department may solicit and accept the assistance of relevant medical associations 15
or community resources to develop, promote, and distribute the public 16
educational resources. 17
Section 3. This Act may be cited as the Bella Dawn Streeval Law. 18