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AN ACT
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relating to newborn screening. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter A, Chapter 33, Health and Safety |
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Code, is amended by adding Section 33.0021 to read as follows: |
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Sec. 33.0021. SICKLE-CELL TRAIT. Notwithstanding any |
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provision of this chapter, the department shall include sickle-cell |
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trait in the detection and treatment program established under this |
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chapter, in the screening for heritable diseases conducted under |
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Subchapter B, and in the newborn screening services provided under |
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Subchapter C. |
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SECTION 2. Subchapter B, Chapter 33, Health and Safety |
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Code, is amended by adding Sections 33.0111 and 33.0112 to read as |
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follows: |
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Sec. 33.0111. DISCLOSURE. (a) The department shall |
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develop a disclosure statement that clearly discloses to the |
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parent, managing conservator, or guardian of a newborn child |
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subjected to screening tests under Section 33.011: |
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(1) that the department or a laboratory established or |
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approved by the department under Section 33.016 may retain for use |
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by the department or laboratory genetic material used to conduct |
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the newborn screening tests and discloses how the material is |
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managed and used; and |
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(2) that the parent, managing conservator, or guardian |
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may limit the use of the genetic material by providing to the |
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department in accordance with Section 33.0112 a written statement |
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prohibiting the department or laboratory from retaining the genetic |
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material or using the genetic material for any purpose other than |
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the conduct of newborn screening tests authorized under this |
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chapter. |
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(b) The disclosure statement required by Subsection (a) |
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must be included on the form developed by the department to inform |
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parents about newborn screening. The disclosure statement must: |
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(1) be on a separate sheet of the form; |
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(2) be presented together with the written statement |
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described by Subsection (a)(2) in a format that allows a parent, |
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managing conservator, or guardian of a newborn child to either: |
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(A) sign, detach, and mail a portion of the form |
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to the department to require the department or laboratory to |
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destroy the genetic material on completion of the newborn screening |
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tests; or |
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(B) check a box and sign next to the box on the |
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form a statement indicating the parent, managing conservator, or |
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guardian is requiring the department or laboratory to destroy the |
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genetic material on completion of the newborn screening tests; |
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(3) include instructions on how to complete the |
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portions of the form described by Subdivisions (2)(A) and (B); |
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(4) include the department's mailing address; and |
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(5) be made available to a parent, managing |
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conservator, or guardian of a newborn child through alternative |
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sources. |
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(c) At the time a newborn child is subjected to screening |
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tests under Section 33.011, the physician attending a newborn child |
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or the person attending the delivery of a newborn child that is not |
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attended by a physician shall provide the parent, managing |
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conservator, or guardian of a newborn child a copy of the written |
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disclosure statement developed by the department under this |
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section. |
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(d) The department shall establish procedures for a |
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physician attending a newborn child or the person attending the |
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delivery of a newborn child to provide verification to the |
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department that the physician or person has provided the parent, |
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managing conservator, or guardian of the newborn child the |
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disclosure required under this section. |
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Sec. 33.0112. STATEMENT PROHIBITING RETENTION OF GENETIC |
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MATERIAL. (a) A parent, managing conservator, or guardian of a |
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newborn child may file with the department a signed written |
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statement prohibiting the department or a laboratory established or |
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approved by the department from retaining any genetic material |
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related to the newborn screening tests conducted under this chapter |
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or using the genetic material for any purpose other than the conduct |
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of the newborn screening tests. A parent, managing conservator, or |
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guardian may file the written statement on a form provided by the |
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department. |
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(b) Not later than the 60th day after the department |
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receives the written statement, the department or laboratory shall |
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destroy the genetic material used in the screening tests. |
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(c) An adult individual may file with the department a |
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written statement instructing the department or a laboratory |
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established or approved by the department to destroy any genetic |
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material of the individual that is retained and used under this |
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chapter. |
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SECTION 3. Subchapter B, Chapter 33, Health and Safety |
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Code, is amended by adding Section 33.017 to read as follows: |
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Sec. 33.017. CONFIDENTIALITY. (a) Reports, records, and |
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information obtained or developed by the department under this |
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chapter are confidential and are not subject to disclosure under |
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Chapter 552, Government Code, are not subject to subpoena, and may |
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not otherwise be released or made public except as provided by this |
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section. |
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(b) Notwithstanding other law, reports, records, and |
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information obtained or developed by the department under this |
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chapter may be disclosed: |
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(1) for purposes of diagnosis or follow-up authorized |
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under Section 33.014; |
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(2) with the consent of each identified individual or |
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an individual authorized to consent on behalf of an identified |
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child; |
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(3) as authorized by court order; |
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(4) to a medical examiner authorized to conduct an |
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autopsy on a child or an inquest on the death of a child; or |
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(5) to public health programs of the department for |
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public health research purposes provided that the disclosure is |
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approved by an institutional review board or privacy board of the |
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department as authorized by the federal privacy requirements |
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adopted under the Health Insurance Portability and Accountability |
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Act of 1996 (Pub. L. No. 104-191) contained in 45 C.F.R. Part 160 |
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and 45 C.F.R. Part 164, Subparts A and E. |
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(c) Notwithstanding other law, reports, records, and |
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information that do not identify a child or the family of a child |
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may be released without consent if the disclosure is for: |
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(1) statistical purposes; |
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(2) purposes related to obtaining or maintaining |
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certification, approval, or quality assurance for the department's |
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laboratory or a public or private laboratory to perform newborn |
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screening tests; |
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(3) purposes relating to review, quality assurance, or |
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improvement of the department's newborn screening under this |
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chapter or the department's newborn screening program services |
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under Subchapter C; |
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(4) research purposes, provided that the disclosure is |
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approved by an institutional review board or privacy board of the |
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department; or |
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(5) quality assurance related to equipment and |
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supplies, provided that: |
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(A) the assessment is performed by a person who |
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is not a laboratory; |
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(B) only newborn screening specimens are |
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disclosed; and |
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(C) the disclosure is approved by an |
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institutional review board or privacy board of the department. |
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(d) A state officer or employee, a department contractor, or |
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a department contractor's employee, officer, director, or |
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subcontractor may not be examined in a civil, criminal, special, or |
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other judicial or administrative proceeding as to the existence or |
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contents of records, reports, or information made confidential by |
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this section unless disclosure is authorized by this section. |
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SECTION 4. (a) The speaker of the house of representatives |
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shall charge a committee of members selected by the speaker or a |
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house standing committee to conduct an interim study on newborn |
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screening in this state. |
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(b) The committee designated under Subsection (a) of this |
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section shall: |
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(1) study the time frame and procedures for the |
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disclosure required by Chapter 33, Health and Safety Code, to the |
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parent, managing conservator, or guardian of a newborn child; |
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(2) analyze whether procedures should be developed by |
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the Department of State Health Services to provide confirmation to |
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a parent, managing conservator, or guardian of a newborn child that |
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a stored specimen has been destroyed as required by a written |
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statement submitted by the parent, managing conservator, or |
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guardian; and |
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(3) study standardization of the disclosure process |
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for health care facilities in this state. |
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(c) Not later than December 15, 2010, the committee |
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designated under Subsection (a) of this section shall file a report |
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on the results of the interim study conducted under this section |
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with both houses of the legislature. |
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SECTION 5. As soon as practicable after the effective date |
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of this Act, the Department of State Health Services shall |
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implement Section 33.0021, Health and Safety Code, as added by this |
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Act. |
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SECTION 6. As soon as practicable after the effective date |
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of this Act, the Department of State Health Services shall develop |
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the disclosure statement required by Section 33.0111, Health and |
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Safety Code, as added by this Act. The department shall modify an |
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existing form for use for purposes of that section. |
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SECTION 7. This Act takes effect immediately if it receives |
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a vote of two-thirds of all the members elected to each house, as |
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provided by Section 39, Article III, Texas Constitution. If this |
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Act does not receive the vote necessary for immediate effect, this |
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Act takes effect September 1, 2009. |
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______________________________ |
______________________________ |
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President of the Senate |
Speaker of the House |
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I certify that H.B. No. 1672 was passed by the House on April |
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8, 2009, by the following vote: Yeas 141, Nays 4, 1 present, not |
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voting; and that the House concurred in Senate amendments to H.B. |
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No. 1672 on May 18, 2009, by the following vote: Yeas 143, Nays 0, |
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2 present, not voting. |
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______________________________ |
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Chief Clerk of the House |
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I certify that H.B. No. 1672 was passed by the Senate, with |
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amendments, on May 15, 2009, by the following vote: Yeas 29, Nays |
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1. |
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______________________________ |
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Secretary of the Senate |
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APPROVED: __________________ |
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Date |
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__________________ |
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Governor |