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AN ACT
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relating to certain newborn and infant screening and follow-up |
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services. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. The heading to Section 33.0111, Health and |
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Safety Code, is amended to read as follows: |
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Sec. 33.0111. DISCLOSURE STATEMENT AND CONSENT. |
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SECTION 2. Section 33.0111, Health and Safety Code, is |
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amended by amending Subsections (a), (b), and (d) and adding |
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Subsections (e), (f), and (g) to read as follows: |
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(a) The department shall develop a disclosure statement |
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that clearly discloses to the parent, managing conservator, or |
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guardian of a newborn child subjected to screening tests under |
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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 subject to this section and Sections 33.0112 and |
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33.017; and |
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(2) that reports, records, and information obtained by |
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the department under this chapter that do not identify a child or |
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the family of a child will not be released for public health |
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research purposes under Section 33.017(c-1) unless a parent, |
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managing conservator, or guardian of the child consents to |
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disclosure; and |
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(3) that newborn screening blood spots and associated |
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data are confidential under law and may only be used as described by |
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Section 33.017 [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
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statement described by Subsection (a)(2)] in a format that allows a |
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parent, managing conservator, or guardian of a newborn child to |
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consent to disclosure under Section 33.017(c-1) [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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(2) [(3)] include instructions on how to complete the |
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portions of the form described by Subdivision (1) [Subdivisions
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(2)(A) and (B)]; |
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(3) [(4)] include the department's mailing address; |
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and |
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(4) describe how [(5) be made available to] a parent, |
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managing conservator, or guardian of a newborn child may obtain |
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information regarding consent through alternative sources. |
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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 statement required under this section. |
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(e) The physician attending a newborn child or the person |
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attending the delivery of a newborn child that is not attended by a |
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physician shall submit any document required by the department. |
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(f) This section does not supersede the requirements |
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imposed by Section 33.017. |
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(g) A reference in this section to Section 33.017 means |
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Section 33.017 as added by Chapter 179 (H.B. 1672), Acts of the 81st |
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Legislature, Regular Session, 2009. |
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SECTION 3. Section 33.0112, Health and Safety Code, is |
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amended to read as follows: |
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Sec. 33.0112. DESTRUCTION [STATEMENT PROHIBITING
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RETENTION] OF GENETIC MATERIAL. (a) The department shall destroy |
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any genetic material obtained from a child under this chapter not |
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later than the second anniversary of the date the department |
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receives the genetic material unless a parent, managing |
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conservator, or guardian of the child consents to disclosure under |
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Section 33.017(c-1) [A parent, managing conservator, or guardian of
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a 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) The department shall destroy any genetic material |
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obtained from a child under this chapter not later than the second |
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anniversary of the date the department receives the genetic |
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material if: |
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(1) a parent, managing conservator, or guardian of the |
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child consents to disclosure under Section 33.017(c-1); |
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(2) the parent, managing conservator, or guardian who |
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consented to the disclosure revokes the consent under Section |
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33.017(i); and |
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(3) the department receives the written revocation of |
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consent under Section 33.017(i) not later than the second |
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anniversary of the date the department received the genetic |
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material [Not later than the 60th day after the department receives
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the written statement, the department or laboratory shall destroy
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the genetic material used in the screening tests]. |
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(c) The department shall destroy any genetic material |
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obtained from a child under this chapter not later than the 60th day |
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after the date the department receives a written revocation of |
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consent under Section 33.017(i) if: |
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(1) a parent, managing conservator, or guardian of the |
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child consented to disclosure under Section 33.017(c-1); |
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(2) the parent, managing conservator, or guardian who |
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consented to the disclosure or the child revokes the consent under |
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Section 33.017(i); and |
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(3) the department receives the written revocation of |
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consent later than the second anniversary of the date the |
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department received the genetic material [An adult individual may
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file with the department a written statement instructing the
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department or a laboratory established or approved by the
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department to destroy any genetic material of the individual that
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is retained and used under this chapter]. |
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(d) A reference in this section to Section 33.017 means |
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Section 33.017 as added by Chapter 179 (H.B. 1672), Acts of the 81st |
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Legislature, Regular Session, 2009. |
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SECTION 4. Section 33.017, Health and Safety Code, as added |
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by Chapter 179 (H.B. 1672), Acts of the 81st Legislature, Regular |
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Session, 2009, is amended by amending Subsections (a), (b), and (c) |
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and adding Subsections (a-1), (c-1), (e), (f), (g), (h), (i), and |
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(j) to read as follows: |
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(a) In this section: |
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(1) "Affiliated with a health agency" means a person |
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who is an employee or former employee of a health agency. |
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(2) "Commission" means the Health and Human Services |
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Commission. |
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(3) "Commissioner" means the commissioner of state |
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health services. |
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(4) "Health agency" means the commission and the |
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health and human services agencies listed in Section 531.001, |
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Government Code. |
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(5) "Public health purpose" means a purpose that |
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relates to cancer, a birth defect, an infectious disease, a chronic |
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disease, environmental exposure, or newborn screening. |
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(a-1) Reports, records, and information obtained or |
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developed by the department under this chapter are confidential and |
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are not subject to disclosure under Chapter 552, Government Code, |
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are not subject to subpoena, and may not otherwise be released or |
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made public except as provided by this 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: |
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(A) the commissioner or the commissioner's |
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designee; and |
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(B) an institutional review board or privacy |
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board of the department as authorized by the federal privacy |
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requirements adopted under the Health Insurance Portability and |
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Accountability Act of 1996 (Pub. L. No. 104-191) contained in 45 |
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C.F.R. Part 160 and 45 C.F.R. Part 164, Subparts A and E; |
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(6) for purposes relating to review or quality |
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assurance of the department's newborn screening under this chapter |
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or the department's newborn screening program services under |
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Subchapter C, provided that no disclosure occurs outside of the |
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department's newborn screening program; |
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(7) for purposes related to obtaining or maintaining |
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federal certification, including related quality assurance, for |
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the department's laboratory, provided that no disclosure occurs |
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outside of the department's newborn screening program; or |
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(8) for purposes relating to improvement of the |
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department's newborn screening under this chapter or the |
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department's newborn screening program services under Subchapter |
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C, provided that the disclosure is approved by the commissioner or |
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the commissioner's designee. |
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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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federal certification, including related review and [approval, or] |
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quality assurance: |
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(A) for the department's laboratory that require |
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disclosure outside of the department's newborn screening program; |
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or |
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(B) for a public or private laboratory to perform |
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newborn screening tests that are not part of inter-laboratory |
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exchanges required for federal certification of the department's |
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laboratory, provided that the disclosure is approved by the |
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commissioner or the commissioner's designee; or |
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(3) other [purposes relating to review, quality
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assurance, or improvement of the department's newborn screening
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under this chapter or the department's newborn screening program
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services under Subchapter C;
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[(4)
research purposes, provided that the disclosure
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is approved by an institutional review board or privacy board of the
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department; or
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[(5)] quality assurance purposes related to public |
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health testing equipment and supplies, provided that the disclosure |
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is approved by: |
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(A) the commissioner or the commissioner's |
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designee [assessment is performed by a person who is not a
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laboratory]; and |
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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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(c-1) 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 for public health research purposes not described |
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by Subsection (b)(5) if: |
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(1) a parent, managing conservator, or guardian of the |
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child consents to the disclosure; and |
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(2) the disclosure is approved by: |
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(A) an institutional review board or privacy |
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board of the department; and |
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(B) the commissioner or the commissioner's |
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designee. |
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(e) If disclosure is approved by the commissioner or the |
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commissioner's designee under Subsection (c)(3) or (c-1), the |
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department shall post notice on the newborn screening web page on |
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the department's Internet website that disclosure has been |
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approved. The commissioner shall determine the form and content of |
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the notice. |
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(f) In accordance with this section, the commissioner or the |
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commissioner's designee: |
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(1) may approve disclosure of reports, records, or |
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information obtained or developed under this chapter only for a |
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public health purpose; and |
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(2) may not approve disclosure of reports, records, or |
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information obtained or developed under this chapter for purposes |
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related to forensic science or health insurance underwriting. |
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(g) An institutional review board or privacy board of the |
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department that reviews a potential disclosure under this section |
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must include at least three persons who are not affiliated with a |
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health agency, one of whom must be a member of the public. |
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(h) Nothing in this section affects the requirement that |
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screening tests be performed under Section 33.011. |
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(i) If a parent, managing conservator, or guardian of a |
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child consents to disclosure under this section: |
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(1) the parent, managing conservator, or guardian who |
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consented to the disclosure may revoke the consent, in writing, at |
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any time by using a form designated by the department; and |
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(2) the child may revoke the consent, in writing, at |
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any time on or after the date the child attains the age of majority |
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by using a form designated by the department. |
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(j) If a person revokes consent under Subsection (i), the |
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department shall destroy any genetic material obtained from the |
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child as provided by Section 33.0112. |
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SECTION 5. Section 47.001(2), Health and Safety Code, is |
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amended to read as follows: |
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(2) "Birthing facility" means: |
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(A) a hospital licensed under Chapter 241 that |
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offers obstetrical services [and is located in a county with a
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population of more than 50,000]; [or] |
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(B) a birthing center licensed under Chapter 244; |
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(C) a children's hospital; or |
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(D) a facility, maintained or operated by this |
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state or an agency of this state, that provides obstetrical |
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services [that is located in a county with a population of more than
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50,000 and that has 100 or more births per year]. |
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SECTION 6. Section 47.003, Health and Safety Code, is |
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amended by amending Subsections (a), (c), (d), and (e) and adding |
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Subsections (a-1) and (f) to read as follows: |
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(a) A birthing facility, through a program certified by the |
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department under Section 47.004, shall perform, either directly or |
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through a transfer agreement, [offer the parents of a newborn] a |
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hearing screening [for the newborn] for the identification of |
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hearing loss on each newborn or infant born at the facility before |
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the newborn or infant is discharged from the facility unless: |
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(1) the parent declines the screening; |
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(2) the newborn or infant is transferred to another |
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facility before the screening is performed; or |
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(3) the screening has previously been completed. |
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(a-1) The birthing facility [screening] shall inform the |
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parents [be offered] during [the birth] admission that: |
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(1) the facility is required by law to screen a newborn |
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or infant for hearing loss; and |
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(2) the parents may decline the screening[, and the
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parents shall be informed that information may be provided to the
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department upon their written consent]. |
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(c) Subject to Section 47.008, the [The] department shall |
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[may] maintain data and information on each newborn or infant who |
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receives a hearing screening under Subsection (a) [services under a
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program]. |
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(d) The department shall ensure that intervention is |
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available to families for a newborn or infant identified as having |
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hearing loss and that the intervention is managed by state programs |
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operating under the Individuals with Disabilities Education Act (20 |
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U.S.C. Section 1400 et seq.). |
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(e) The department shall ensure that the intervention |
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described by Subsection (d) is available for a newborn or infant |
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identified as having hearing loss not later than the sixth month |
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after the newborn's or infant's birth and through the time the child |
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is an infant unless the infant has been hospitalized since birth. |
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(f) If a newborn or an infant receives medical intervention |
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services, including a hearing aid or cochlear implant, the |
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intervention specialist shall report the results of the |
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intervention to the department. |
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SECTION 7. Chapter 47, Health and Safety Code, is amended by |
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adding Section 47.0031 to read as follows: |
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Sec. 47.0031. FOLLOW-UP SCREENING. (a) The program that |
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performed the hearing screening under Section 47.003 shall provide |
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the newborn's or infant's parents with the screening results. A |
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birthing facility, through the program, shall offer a follow-up |
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hearing screening to the parents of a newborn or infant who does not |
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pass the screening, or refer the parents to another program for the |
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follow-up hearing screening. The follow-up hearing screening |
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should be performed not later than the 30th day after the date the |
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newborn or infant is discharged from the facility. |
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(b) If a newborn or an infant does not pass the screening in |
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a follow-up hearing screening, the program that performed the |
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follow-up hearing screening on the newborn or infant shall: |
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(1) provide the newborn's or infant's parents with the |
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screening results; |
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(2) assist in scheduling a diagnostic audiological |
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evaluation for the newborn or infant, consistent with the most |
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current guidelines in the Joint Committee on Infant Hearing |
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Position Statement, or refer the newborn or infant to a licensed |
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audiologist who provides diagnostic audiological evaluations for |
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newborns or infants that are consistent with the most current |
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guidelines in the Joint Committee on Infant Hearing Position |
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Statement; and |
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(3) refer the newborn or infant to early childhood |
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intervention services. |
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SECTION 8. Sections 47.004(b) and (d), Health and Safety |
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Code, are amended to read as follows: |
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(b) In order to be certified, the program must: |
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(1) provide hearing screening using equipment |
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recommended by the department; |
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(2) use appropriate staff to provide the screening; |
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(3) maintain and report data electronically as |
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required by the department; |
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(4) distribute family, health care provider, and |
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physician educational materials standardized by the department; |
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[and] |
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(5) provide information, as recommended by the |
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department, to the parents on follow-up services for newborns and |
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infants who do not pass the [with abnormal] screening; and |
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(6) be supervised by: |
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(A) a physician; |
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(B) an audiologist; |
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(C) a registered nurse; or |
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(D) a physician assistant [results]. |
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(d) The department may renew the certification of a program |
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on a periodic basis as established by board rule in order to ensure |
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quality services to newborns, infants, and families. |
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SECTION 9. Section 47.005, Health and Safety Code, is |
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amended by amending Subsections (a) and (b) and adding Subsections |
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(d) and (e) to read as follows: |
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(a) A birthing facility that operates a program shall |
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distribute to the parents of each newborn or infant who is screened |
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educational materials that are standardized by the department |
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regarding screening results and follow-up care. |
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(b) A birthing facility that operates a program shall report |
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screening results to: |
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(1) the parents; |
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(2) [,] the newborn's or infant's attending |
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physician, primary care physician, or other applicable health care |
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provider; [,] and |
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(3) the department. |
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(d) The department may coordinate the diagnostic |
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audiological evaluation required under Section 47.0031(b)(2). A |
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diagnostic audiological evaluation must be completed on the newborn |
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or infant: |
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(1) not later than the third month after the newborn's |
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or infant's birth unless the newborn or infant has been |
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hospitalized since birth; or |
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(2) upon referral by the newborn's or infant's primary |
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care physician or other applicable health care provider. |
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(e) An audiologist who performs a diagnostic audiological |
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evaluation under this chapter shall report the results of the |
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evaluation to: |
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(1) the parents; |
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(2) the newborn's or infant's primary care physician |
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or other applicable health care provider; and |
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(3) the department under Section 47.007(b). |
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SECTION 10. Section 47.007, Health and Safety Code, is |
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amended by amending Subsection (b) and adding Subsections (d) |
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through (h) to read as follows: |
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(b) Subject to Section 47.008, a [A] qualified hearing |
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screening provider, hospital, health care provider, physician, |
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audiologist, or intervention specialist shall [may] access the |
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information management, reporting, and tracking system to provide |
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information[, where available,] to the department and may obtain |
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information from the department[, including information] relating |
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to: |
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(1) the results of each hearing screening performed |
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under Section 47.003(a) or 47.0031(a); |
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(2) the results of each diagnostic audiological |
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evaluation required under Section 47.0031(b)(2); |
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(3) [(1)] infants who receive follow-up care; |
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(4) [(2)] infants identified with hearing loss; |
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(5) [(3)] infants who are referred for intervention |
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services; and |
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(6) [(4)] case level information necessary to report |
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required statistics to: |
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(A) the Maternal and Child Health Bureau on an |
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annual basis; and |
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(B) the federal Centers for Disease Control and |
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Prevention. |
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(d) A birthing facility described by Subsection (a) shall |
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report the resulting information in the format and within the time |
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frame specified by the department. |
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(e) A qualified hearing screening provider, audiologist, |
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intervention specialist, educator, or other person who receives a |
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referral from a program under this chapter shall: |
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(1) provide the services needed by the newborn or |
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infant or refer the newborn or infant to a person who provides the |
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services needed by the newborn or infant; and |
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(2) provide, with the consent of the newborn's or |
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infant's parent, the following information to the department or the |
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department's designee: |
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(A) results of follow-up care; |
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(B) results of audiologic testing of an infant |
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identified with hearing loss; and |
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(C) reports on the initiation of intervention |
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services. |
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(f) A qualified hearing screening provider, audiologist, |
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intervention specialist, educator, or other person who provides |
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services to an infant who is diagnosed with hearing loss shall |
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provide, with the consent of the infant's parent, the following |
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information to the department or the department's designee: |
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(1) results of follow-up care; |
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(2) results of audiologic testing; and |
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(3) reports on the initiation of intervention |
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services. |
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(g) A hospital that provides services under this chapter |
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shall use the information management, reporting, and tracking |
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system described by this section, access to which has been provided |
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to the hospital by the department, to report, with the consent of |
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the infant's parent, the following information to the department or |
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the department's designee: |
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(1) results of all follow-up services for an infant |
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who does not pass the screening described by Section 47.003(a) if |
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the hospital provides the follow-up services; or |
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(2) the name of the provider or facility to which the |
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hospital refers an infant who does not pass the screening described |
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by Section 47.003(a) for follow-up services. |
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(h) Subject to Section 47.008, a qualified hearing |
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screening provider, hospital, health care provider, physician, |
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audiologist, or intervention specialist may obtain information |
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from the department relating to: |
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(1) the results of each hearing screening performed |
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under Section 47.003(a) or 47.0031(a); |
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(2) the results of each diagnostic audiological |
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evaluation required under Section 47.0031(b)(2); |
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(3) infants who receive follow-up care; |
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(4) infants identified with hearing loss; and |
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(5) infants who are referred for intervention |
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services. |
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SECTION 11. Chapter 47, Health and Safety Code, is amended |
|
by adding Sections 47.010 and 47.011 to read as follows: |
|
Sec. 47.010. RULEMAKING. (a) The executive commissioner |
|
of the Health and Human Services Commission may adopt rules for the |
|
department to implement this chapter. |
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(b) If the executive commissioner adopts rules, the |
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executive commissioner shall consider the most current guidelines |
|
established by the Joint Committee on Infant Hearing. |
|
Sec. 47.011. DUTIES OF MIDWIFE. (a) In this section, |
|
"midwife" has the meaning assigned by Section 203.002, Occupations |
|
Code, and includes a nurse midwife described by Section 301.152, |
|
Occupations Code. |
|
(b) A midwife who attends the birth of a newborn: |
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(1) is not required to offer the parents of the newborn |
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a hearing screening for the newborn for the identification of |
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hearing loss; and |
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(2) shall refer the parents of the newborn to a |
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birthing facility or a provider that participates in the program |
|
and make a record of the referral. |
|
SECTION 12. Section 47.002, Health and Safety Code, is |
|
repealed. |
|
SECTION 13. (a) Not later than January 1, 2012, the |
|
executive commissioner of the Health and Human Services Commission |
|
shall prescribe a form to document a parent's decision to decline |
|
screening under Section 47.003(a)(1), Health and Safety Code, as |
|
added by this Act, in consultation with persons and organizations |
|
interested in newborn hearing screening. |
|
(b) The Department of State Health Services may post the |
|
form prescribed under Subsection (a) of this section on the |
|
department's Internet website. |
|
(c) A person or facility is not required to comply with the |
|
changes in law made by this Act to Chapter 47, Health and Safety |
|
Code, until January 1, 2012. |
|
SECTION 14. (a) Except as provided by Subsection (b) of |
|
this section, 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, 2011. |
|
(b) The changes made to Sections 33.0111 and 33.0112, Health |
|
and Safety Code, as amended by this Act, and Section 33.017(c-1), as |
|
added by this Act, take effect June 1, 2012. |
|
|
|
______________________________ |
______________________________ |
|
President of the Senate |
Speaker of the House |
|
|
|
I certify that H.B. No. 411 was passed by the House on April |
|
11, 2011, by the following vote: Yeas 147, Nays 0, 1 present, not |
|
voting; and that the House concurred in Senate amendments to H.B. |
|
No. 411 on May 27, 2011, by the following vote: Yeas 134, Nays 4, 2 |
|
present, not voting. |
|
|
|
______________________________ |
|
Chief Clerk of the House |
|
|
I certify that H.B. No. 411 was passed by the Senate, with |
|
amendments, on May 23, 2011, by the following vote: Yeas 29, Nays |
|
1. |
|
|
|
______________________________ |
|
Secretary of the Senate |
|
APPROVED: __________________ |
|
Date |
|
|
|
__________________ |
|
Governor |