83R5840 AED-F
By: Crownover H.B. No. 740
A BILL TO BE ENTITLED
AN ACT
relating to newborn screening for congenital heart defects.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 33.001, Health and Safety Code, is
amended by amending Subdivision (1) and adding Subdivision (1-a) to
read as follows:
(1) "Congenital heart defect" means an abnormality in
the structure and function of the heart that exists at birth.
(1-a) "Heritable disease" means an inherited disease
that may result in mental or physical retardation or death.
SECTION 2. Section 33.011, Health and Safety Code, is
amended by amending Subsections (a-1) and (c) and adding Subsection
(d) to read as follows:
(a-1) Except as provided by this subsection and to the
extent funding is available for the screening, the department shall
require newborn screening tests to screen for disorders listed as
core and secondary conditions in the December 2011 Recommended
Uniform Screening Panel of the Secretary's Advisory Committee on
Heritable Disorders in Newborns and Children [core panel and in the
secondary targets of the uniform newborn screening panel
recommended in the 2005 report by the American College of Medical
Genetics entitled "Newborn Screening: Toward a Uniform Screening
Panel and System"] or other recommendation [another report]
determined by the department to provide more stringent newborn
screening guidelines to protect the health and welfare of this
state's newborns. The department, with the advice of the Newborn
Screening Advisory Committee, may require additional newborn
screening tests under this subsection to screen for other disorders
or conditions. The department may exclude from the newborn
screening tests required under this subsection screenings for
galactose epimerase and galactokinase.
(c) Except as provided by Subsection (d), the [The]
screening tests required by this section must be performed by the
laboratory established by the department or by a laboratory
approved by the department under Section 33.016.
(d) The department may authorize a screening test,
including a screening for congenital heart defects, to be performed
at a health care facility that provides newborn infant care and that
complies with the test procedures and the standards of accuracy and
precision required by the department for each screening test.
SECTION 3. Sections 33.0111(a), (b), and (f), Health and
Safety Code, are amended to read as follows:
(a) The department shall develop a disclosure statement
that clearly discloses to the parent, managing conservator, or
guardian of a newborn child subjected to screening tests under
Section 33.011:
(1) that the department, any health care facility
authorized to perform the tests, or a laboratory established or
approved by the department under Section 33.016 may retain for use
by the department, health care facility, or laboratory genetic
material used to conduct the newborn screening tests and discloses
how the material is managed and used subject to this section and
Sections 33.0112 and 33.018 [33.017]; [and]
(2) that reports, records, and information obtained by
the department under this chapter that do not identify a child or
the family of a child will not be released for public health
research purposes under Section 33.018(c-1) [33.017(c-1)] unless a
parent, managing conservator, or guardian of the child consents to
disclosure; and
(3) that newborn screening blood spots and associated
data are confidential under law and may only be used as described by
Section 33.018 [33.017].
(b) The disclosure statement required by Subsection (a)
must be included on the form developed by the department to inform
parents about newborn screening. The disclosure statement must:
(1) be in a format that allows a parent, managing
conservator, or guardian of a newborn child to consent to
disclosure under Section 33.018(c-1) [33.017(c-1)];
(2) include instructions on how to complete the
portions of the form described by Subdivision (1);
(3) include the department's mailing address; and
(4) describe how a parent, managing conservator, or
guardian of a newborn child may obtain information regarding
consent through alternative sources.
(f) This section does not supersede the requirements
imposed by Section 33.018 [33.017].
SECTION 4. Section 33.014(a), Health and Safety Code, is
amended to read as follows:
(a) If, because of an analysis of a specimen submitted under
Section 33.011, the department reasonably suspects that a newborn
child may have phenylketonuria, another heritable disease,
hypothyroidism, or another disorder for which the screening tests
are required, the department shall notify the person who submits
the specimen that the results are abnormal and provide the test
results to that person. The department may notify one or more of
the following that the results of the analysis or of a screening
test reported to the department under Section 33.015 are abnormal
and recommend further testing when necessary:
(1) the physician attending the newborn child or the
physician's designee;
(2) the person attending the delivery of the newborn
child that was not attended by a physician;
(3) the parents of the newborn child;
(4) the health authority of the jurisdiction in which
the newborn child was born or in which the child resides, if known;
or
(5) physicians who are cooperating pediatric
specialists for the program.
SECTION 5. Section 33.017(c), Health and Safety Code, is
amended to read as follows:
(c) The advisory committee shall advise the department
regarding strategic planning, policy, rules, and services related
to newborn screening and additional newborn screening tests for
each disorder included in the list described by Section
33.011(a-1).
SECTION 6. Section 33.0111(g), Health and Safety Code, is
repealed.
SECTION 7. As soon as practicable after the effective date
of this Act, the Department of State Health Services shall
implement the changes in law made by this Act to the newborn
screening program under Chapter 33, Health and Safety Code.
SECTION 8. This Act takes effect September 1, 2013.