KRS 214.155: Screening and tests for heritable disorders for newborns and infants --

Screening for critical congenital heart disease -- Information provided to

parent or guardian -- Application for federal grants -- Short title.

(1) The Cabinet for He alth and Family Services shall operate a newborn screening

program for heritable and congenital disorders that includes but is not limited to

procedures for conducting initial newborn screening tests on infants twenty -eight

(28) days or less of age and def initive diagnostic evaluations provided by a state

university-based specialty clinic for infants whose initial screening tests resulted in

a positive test. The secretary of the cabinet shall, by administrative regulation

promulgated pursuant to KRS Chapter 13A:

(a) Prescribe the times and manner of obtaining a specimen and transferring a

specimen for testing;

(b) Prescribe the manner of procedures, testing specimens, and recording and

reporting the results of newborn screening tests; and

(c) Establish and collect fees to support the newborn screening program.

(2) The administrative officer or other person in charge of each health facility caring

for infants twenty -eight (28) days or less of age and the person required in

pursuance of the provisions of KRS 21 3.046 shall register the birth of a child and

cause to have administered to every such infant or child in his, her, or the facility's

care tests for heritable disorders, including but not limited to phenylketonuria

(PKU), sickle cell disease, congenital hypothyroidism, galactosemia, medium-chain

acyl-CoA dehydrogenase deficiency (MCAD), very long -chain acyl -CoA

deficiency (VLCAD), short -chain acyl -CoA dehydrogenase deficiency (SCAD),

maple syrup urine disease (MSUD), congenital adrenal hyperplasia (CAH),

biotinidase disorder, cystic fibrosis (CF), 3 -methylcrotonyl-CoA carboxylase

deficiency (3MCC), 3 -OH 3 -CH3 glutaric aciduria (HMG), argininosuccinic

acidemia (ASA), beta -ketothiolase deficiency (BKT), carnitine uptake defect

(CUD), citrullinemia (CIT), gluta ric acidemia type I (GA I), Hb S/beta -thalassemia

(Hb S/Th), Hb S/C disease (Hb S/C), homocystinuria (HCY), isovaleric acidemia

(IVA), long -chain L -3-OH acyl -CoA dehydrogenase deficiency (LCAD),

methylmalonic acidemia (Cbl A,B), methylmalonic acidemia muta se deficiency

(MUT), multiple carboxylase deficiency (MCD), propionic acidemia (PA),

trifunctional protein deficiency (TFP), tyrosinemia type I (TYR I), spinal muscular

atrophy (SMA), and krabbe disease. The listing of tests for heritable disorders to be

performed shall include all conditions consistent with the recommendations of the

American College of Medical Genetics.

(3) The administrative officer or other person in charge of each health facility caring

for infants twenty -eight (28) days or less of age and the person required in

pursuance of the provisions of KRS 213.046 shall register the birth of a child and

cause to have administered to every such infant or child in his, her, or the facility's

care a screening for critical congenital heart disease (C CHD) prior to discharge

unless CCHD has been ruled out or diagnosed with prior echocardiogram or

prenatal diagnosis of CCHD.

(4) Each health care provider of newborn care shall provide an infant's parent or

guardian with information about the newborn scree ning tests required under

subsections (2) and (3) of this section. The health facility or health care provider

shall arrange for appropriate and timely follow -ups to the newborn screening tests,

including but not limited to additional diagnoses, evaluation , and treatment when

indicated.

(5) Nothing in this section shall be construed to require the testing of any child whose

parents are members of a nationally recognized and established church or religious

denomination, the teachings of which are opposed to medical tests, and who object

in writing to the testing of his or her child on that ground.

(6) The cabinet shall make available the names and addresses of health care providers,

including but not limited to physicians, nurses, and nutritionists, who may provide

postpartum home visits to any family whose infant or child has tested positive for a

newborn screening test.

(7) A parent or guardian shall be provided information by the health facility or health

care provider of newborn care about the availability and costs of screening tests not

specified in subsections (2) and (3) of this section. The pare nt or guardian shall be

responsible for costs relating to additional screening tests performed under this

subsection, and these costs shall not be included in the fees established for the

cabinet's newborn screening program under subsection (1) of this sec tion. All

positive results of additional screening of these tests shall be reported to the cabinet

by the health facility or health care provider.

(8) (a) For the purposes of this subsection, a qualified laboratory means a clinical

laboratory not operated by the cabinet that is accredited pursuant to 42 U.S.C.

sec. 263a, licensed to perform newborn screening testing in any state, and

reports its screening results using normal pediatric reference ranges.

(b) The cabinet shall enter into agreements with publi c or private qualified

laboratories to perform newborn screening tests if the laboratory operated by

the cabinet is unable to screen for a condition specified in subsection (2) of

this section.

(c) The cabinet may enter into agreements with public or priva te qualified

laboratories to perform testing for conditions not specified in subsection (2) of

this section. Any agreement entered into under this paragraph shall not

preclude a health facility or health care provider from conducting newborn

screening tests for conditions not specified in subsections (2) and (3) of this

section by utilizing other public or private qualified laboratories.

(9) The secretary for health and family services or his or her designee shall apply for

any federal funds or grants avail able through the Public Health Service Act and

may solicit and accept private funds to expand, improve, or evaluate programs to

provide screening, counseling, testing, or specialty services for newborns or

children at risk for heritable disorders.

(10) As used in this section, "health facility" has the same meaning as in KRS 216B.015.

(11) This section shall be cited as the James William Lazzaro and Madison Leigh Heflin

Newborn Screening Act.