83R18173 AED-F
By: Crownover, Thompson of Harris, Keffer, H.B. No. 740
et al.
Substitute the following for H.B. No. 740:
By: Kolkhorst C.S.H.B. No. 740
A BILL TO BE ENTITLED
AN ACT
relating to newborn screening for critical congenital heart disease
and other disorders.
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 Subdivisions (1-a)
and (1-b) to read as follows:
(1) "Birthing facility" means an inpatient or
ambulatory health care facility that offers obstetrical or newborn
care services. The term includes:
(A) a hospital licensed under Chapter 241 that
offers obstetrical services;
(B) a birthing center licensed under Chapter 244;
(C) a children's hospital; or
(D) a facility that provides obstetrical
services and is maintained and operated by this state or an agency
of this state.
(1-a) "Critical congenital heart disease" means an
abnormality in the structure or function of the heart that exists at
birth, causes severe, life-threatening symptoms, and requires
medical intervention within the first few hours, days, or months of
life.
(1-b) "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), (a-1), and (c) and adding
Subsections (d), (e), and (f) to read as follows:
(a) The physician attending a newborn child or the person
attending the delivery of a newborn child that is not attended by a
physician shall cause the child to be subjected [subject the child]
to screening tests approved by the department for phenylketonuria,
other heritable diseases, hypothyroidism, and other disorders for
which screening is required by the department.
(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 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, with the advice of the Newborn Screening
Advisory Committee, shall authorize a screening test for critical
congenital heart disease to be performed at a birthing facility
that provides care to newborn patients and that complies with the
test procedures and the standards of accuracy and precision
required by the department for each screening test.
(e) If the department under Subsection (d) authorizes the
performance at a birthing facility of a screening test for critical
congenital heart disease, a birthing facility must perform the
screening test on each newborn who is a patient of the facility
before the newborn is discharged from the facility unless:
(1) the parent declines the screening;
(2) the newborn is transferred to another facility
before the screening test is performed;
(3) the screening test has previously been completed;
or
(4) the newborn is discharged from the birthing
facility not more than 10 hours after birth and a referral for the
newborn was made to another birthing facility, physician, or health
care provider.
(f) Before requiring any additional screening test for
critical congenital heart disease, the department must review the
necessity of the additional screening test, including an assessment
of the test implementation costs to the department, birthing
facilities, and other health care providers.
SECTION 3. Section 33.0111, Health and Safety Code, is
amended by amending Subsections (a), (b), and (f) and adding
Subsection (h) 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 or a laboratory established or
approved by the department under Section 33.016 may retain for use
by the department 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].
(h) Nothing in this section prohibits a physician attending
a newborn child from delegating the physician's responsibilities
under this section to any qualified and properly trained person
acting under the physician's supervision.
SECTION 4. Section 33.015(a), Health and Safety Code, is
amended to read as follows:
(a) Each physician, health authority, birthing facility, or
other individual who has the information of a confirmed case of a
disorder for which a screening test is required that has been
detected by a mechanism other than identification through a
screening of a specimen by the department's diagnostic laboratory
shall report the confirmed case to the department.
SECTION 5. Sections 33.017(b) and (c), Health and Safety
Code, are amended to read as follows:
(b) The advisory committee consists of members appointed by
the commissioner of state health services. The advisory committee
must include the following members:
(1) at least four physicians licensed to practice
medicine in this state, including at least two physicians
specializing in neonatal-perinatal medicine [health care
providers];
(2) at least two [a] hospital representatives
[representative];
(3) at least two persons who have family members
affected by a condition for which newborn screening is or may be
required under this subchapter; and
(4) at least two health care providers [persons] who
are involved in the delivery of newborn screening services,
follow-up, or treatment in this state.
(c) The advisory committee shall:
(1) 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); and
(2) review the necessity of requiring additional
screening tests, including an assessment of the test implementation
costs to the department, birthing facilities, and other health care
providers.
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. (a) The change in law made by this Act in
amending Section 33.017, Health and Safety Code, regarding the
qualifications of members of the Newborn Screening Advisory
Committee does not affect the entitlement of a member serving on the
committee immediately before the effective date of this Act to
continue to serve as a member of the committee for the remainder of
the member's term. The change in law applies only to a member
appointed on or after the effective date of this Act.
(b) As soon as practicable after the effective date of this
Act, the commissioner of state health services shall appoint the
additional committee members required by Section 33.017, Health and
Safety Code, as amended by this Act.
SECTION 9. This Act takes effect September 1, 2013.