H.B. No. 1672
AN ACT
relating to newborn screening.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subchapter A, Chapter 33, Health and Safety
Code, is amended by adding Section 33.0021 to read as follows:
Sec. 33.0021. SICKLE-CELL TRAIT. Notwithstanding any
provision of this chapter, the department shall include sickle-cell
trait in the detection and treatment program established under this
chapter, in the screening for heritable diseases conducted under
Subchapter B, and in the newborn screening services provided under
Subchapter C.
SECTION 2. Subchapter B, Chapter 33, Health and Safety
Code, is amended by adding Sections 33.0111 and 33.0112 to read as
follows:
Sec. 33.0111. DISCLOSURE. (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; and
(2) that the parent, managing conservator, or guardian
may limit the use of the genetic material by providing to the
department in accordance with Section 33.0112 a written statement
prohibiting the department or laboratory from retaining the genetic
material or using the genetic material for any purpose other than
the conduct of newborn screening tests authorized under this
chapter.
(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 on a separate sheet of the form;
(2) be presented together with the written statement
described by Subsection (a)(2) in a format that allows a parent,
managing conservator, or guardian of a newborn child to either:
(A) sign, detach, and mail a portion of the form
to the department to require the department or laboratory to
destroy the genetic material on completion of the newborn screening
tests; or
(B) check a box and sign next to the box on the
form a statement indicating the parent, managing conservator, or
guardian is requiring the department or laboratory to destroy the
genetic material on completion of the newborn screening tests;
(3) include instructions on how to complete the
portions of the form described by Subdivisions (2)(A) and (B);
(4) include the department's mailing address; and
(5) be made available to a parent, managing
conservator, or guardian of a newborn child through alternative
sources.
(c) At the time a newborn child is subjected to screening
tests under Section 33.011, the physician attending a newborn child
or the person attending the delivery of a newborn child that is not
attended by a physician shall provide the parent, managing
conservator, or guardian of a newborn child a copy of the written
disclosure statement developed by the department under this
section.
(d) The department shall establish procedures for a
physician attending a newborn child or the person attending the
delivery of a newborn child to provide verification to the
department that the physician or person has provided the parent,
managing conservator, or guardian of the newborn child the
disclosure required under this section.
Sec. 33.0112. STATEMENT PROHIBITING RETENTION OF GENETIC
MATERIAL. (a) A parent, managing conservator, or guardian of a
newborn child may file with the department a signed written
statement prohibiting the department or a laboratory established or
approved by the department from retaining any genetic material
related to the newborn screening tests conducted under this chapter
or using the genetic material for any purpose other than the conduct
of the newborn screening tests. A parent, managing conservator, or
guardian may file the written statement on a form provided by the
department.
(b) Not later than the 60th day after the department
receives the written statement, the department or laboratory shall
destroy the genetic material used in the screening tests.
(c) An adult individual may file with the department a
written statement instructing the department or a laboratory
established or approved by the department to destroy any genetic
material of the individual that is retained and used under this
chapter.
SECTION 3. Subchapter B, Chapter 33, Health and Safety
Code, is amended by adding Section 33.017 to read as follows:
Sec. 33.017. CONFIDENTIALITY. (a) Reports, records, and
information obtained or developed by the department under this
chapter are confidential and are not subject to disclosure under
Chapter 552, Government Code, are not subject to subpoena, and may
not otherwise be released or made public except as provided by this
section.
(b) Notwithstanding other law, reports, records, and
information obtained or developed by the department under this
chapter may be disclosed:
(1) for purposes of diagnosis or follow-up authorized
under Section 33.014;
(2) with the consent of each identified individual or
an individual authorized to consent on behalf of an identified
child;
(3) as authorized by court order;
(4) to a medical examiner authorized to conduct an
autopsy on a child or an inquest on the death of a child; or
(5) to public health programs of the department for
public health research purposes provided that the disclosure is
approved by an institutional review board or privacy board of the
department as authorized by the federal privacy requirements
adopted under the Health Insurance Portability and Accountability
Act of 1996 (Pub. L. No. 104-191) contained in 45 C.F.R. Part 160
and 45 C.F.R. Part 164, Subparts A and E.
(c) Notwithstanding other law, reports, records, and
information that do not identify a child or the family of a child
may be released without consent if the disclosure is for:
(1) statistical purposes;
(2) purposes related to obtaining or maintaining
certification, approval, or quality assurance for the department's
laboratory or a public or private laboratory to perform newborn
screening tests;
(3) purposes relating to review, quality assurance, or
improvement of the department's newborn screening under this
chapter or the department's newborn screening program services
under Subchapter C;
(4) research purposes, provided that the disclosure is
approved by an institutional review board or privacy board of the
department; or
(5) quality assurance related to equipment and
supplies, provided that:
(A) the assessment is performed by a person who
is not a laboratory;
(B) only newborn screening specimens are
disclosed; and
(C) the disclosure is approved by an
institutional review board or privacy board of the department.
(d) A state officer or employee, a department contractor, or
a department contractor's employee, officer, director, or
subcontractor may not be examined in a civil, criminal, special, or
other judicial or administrative proceeding as to the existence or
contents of records, reports, or information made confidential by
this section unless disclosure is authorized by this section.
SECTION 4. (a) The speaker of the house of representatives
shall charge a committee of members selected by the speaker or a
house standing committee to conduct an interim study on newborn
screening in this state.
(b) The committee designated under Subsection (a) of this
section shall:
(1) study the time frame and procedures for the
disclosure required by Chapter 33, Health and Safety Code, to the
parent, managing conservator, or guardian of a newborn child;
(2) analyze whether procedures should be developed by
the Department of State Health Services to provide confirmation to
a parent, managing conservator, or guardian of a newborn child that
a stored specimen has been destroyed as required by a written
statement submitted by the parent, managing conservator, or
guardian; and
(3) study standardization of the disclosure process
for health care facilities in this state.
(c) Not later than December 15, 2010, the committee
designated under Subsection (a) of this section shall file a report
on the results of the interim study conducted under this section
with both houses of the legislature.
SECTION 5. As soon as practicable after the effective date
of this Act, the Department of State Health Services shall
implement Section 33.0021, Health and Safety Code, as added by this
Act.
SECTION 6. As soon as practicable after the effective date
of this Act, the Department of State Health Services shall develop
the disclosure statement required by Section 33.0111, Health and
Safety Code, as added by this Act. The department shall modify an
existing form for use for purposes of that section.
SECTION 7. This Act takes effect immediately if it receives
a vote of two-thirds of all the members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect September 1, 2009.
______________________________ ______________________________
President of the Senate Speaker of the House
I certify that H.B. No. 1672 was passed by the House on April
8, 2009, by the following vote: Yeas 141, Nays 4, 1 present, not
voting; and that the House concurred in Senate amendments to H.B.
No. 1672 on May 18, 2009, by the following vote: Yeas 143, Nays 0,
2 present, not voting.
______________________________
Chief Clerk of the House
I certify that H.B. No. 1672 was passed by the Senate, with
amendments, on May 15, 2009, by the following vote: Yeas 29, Nays
1.
______________________________
Secretary of the Senate
APPROVED: __________________
Date
__________________
Governor