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