214.155 Screening and tests for heritable disorders for newborns and infants --
952 words·~4 min read·
/ky/214-155A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Screening for critical congenital heart disease -- Information provided to
parent or guardian -- Application for federal grants -- Short title.
(1)The Cabinet for Health 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 definitive 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 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 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), glutaric 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 mutase 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
(CCHD)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 screening 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 parent 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 section. All
positive results of additional screening of these tests shall be reported to the cabinet
by the health facility or health care provider.
(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 public 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 private 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 available 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.