H.B. No. 411 AN ACT relating to certain newborn and infant screening and follow-up services. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: SECTION 1. The heading to Section 33.0111, Health and Safety Code, is amended to read as follows: Sec. 33.0111. DISCLOSURE STATEMENT AND CONSENT. SECTION 2. Section 33.0111, Health and Safety Code, is amended by amending Subsections (a), (b), and (d) and adding Subsections (e), (f), and (g) to read as follows: (a) The department shall develop a disclosure statement that clearly discloses to the parent, managing conservator, or guardian of a newborn child subjected to screening tests under Section 33.011: (1) that the department or a laboratory established or approved by the department under Section 33.016 may retain for use by the department or laboratory genetic material used to conduct the newborn screening tests and discloses how the material is managed and used subject to this section and Sections 33.0112 and 33.017; and (2) that reports, records, and information obtained by the department under this chapter that do not identify a child or the family of a child will not be released for public health research purposes under Section 33.017(c-1) unless a parent, managing conservator, or guardian of the child consents to disclosure; and (3) that newborn screening blood spots and associated data are confidential under law and may only be used as described by Section 33.017 [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 consent to disclosure under Section 33.017(c-1) [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]; (2) [(3)] include instructions on how to complete the portions of the form described by Subdivision (1) [Subdivisions (2)(A) and (B)]; (3) [(4)] include the department's mailing address; and (4) describe how [(5) be made available to] a parent, managing conservator, or guardian of a newborn child may obtain information regarding consent through alternative sources. (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 statement required under this section. (e) The physician attending a newborn child or the person attending the delivery of a newborn child that is not attended by a physician shall submit any document required by the department. (f) This section does not supersede the requirements imposed by Section 33.017. (g) A reference in this section to Section 33.017 means Section 33.017 as added by Chapter 179 (H.B. 1672), Acts of the 81st Legislature, Regular Session, 2009. SECTION 3. Section 33.0112, Health and Safety Code, is amended to read as follows: Sec. 33.0112. DESTRUCTION [STATEMENT PROHIBITING RETENTION] OF GENETIC MATERIAL. (a) The department shall destroy any genetic material obtained from a child under this chapter not later than the second anniversary of the date the department receives the genetic material unless a parent, managing conservator, or guardian of the child consents to disclosure under Section 33.017(c-1) [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) The department shall destroy any genetic material obtained from a child under this chapter not later than the second anniversary of the date the department receives the genetic material if: (1) a parent, managing conservator, or guardian of the child consents to disclosure under Section 33.017(c-1); (2) the parent, managing conservator, or guardian who consented to the disclosure revokes the consent under Section 33.017(i); and (3) the department receives the written revocation of consent under Section 33.017(i) not later than the second anniversary of the date the department received the genetic material [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) The department shall destroy any genetic material obtained from a child under this chapter not later than the 60th day after the date the department receives a written revocation of consent under Section 33.017(i) if: (1) a parent, managing conservator, or guardian of the child consented to disclosure under Section 33.017(c-1); (2) the parent, managing conservator, or guardian who consented to the disclosure or the child revokes the consent under Section 33.017(i); and (3) the department receives the written revocation of consent later than the second anniversary of the date the department received the genetic material [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]. (d) A reference in this section to Section 33.017 means Section 33.017 as added by Chapter 179 (H.B. 1672), Acts of the 81st Legislature, Regular Session, 2009. SECTION 4. Section 33.017, Health and Safety Code, as added by Chapter 179 (H.B. 1672), Acts of the 81st Legislature, Regular Session, 2009, is amended by amending Subsections (a), (b), and (c) and adding Subsections (a-1), (c-1), (e), (f), (g), (h), (i), and (j) to read as follows: (a) In this section: (1) "Affiliated with a health agency" means a person who is an employee or former employee of a health agency. (2) "Commission" means the Health and Human Services Commission. (3) "Commissioner" means the commissioner of state health services. (4) "Health agency" means the commission and the health and human services agencies listed in Section 531.001, Government Code. (5) "Public health purpose" means a purpose that relates to cancer, a birth defect, an infectious disease, a chronic disease, environmental exposure, or newborn screening. (a-1) 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: (A) the commissioner or the commissioner's designee; and (B) 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; (6) for purposes relating to review or quality assurance of the department's newborn screening under this chapter or the department's newborn screening program services under Subchapter C, provided that no disclosure occurs outside of the department's newborn screening program; (7) for purposes related to obtaining or maintaining federal certification, including related quality assurance, for the department's laboratory, provided that no disclosure occurs outside of the department's newborn screening program; or (8) for purposes relating to improvement of the department's newborn screening under this chapter or the department's newborn screening program services under Subchapter C, provided that the disclosure is approved by the commissioner or the commissioner's designee. (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 federal certification, including related review and [approval, or] quality assurance: (A) for the department's laboratory that require disclosure outside of the department's newborn screening program; or (B) for a public or private laboratory to perform newborn screening tests that are not part of inter-laboratory exchanges required for federal certification of the department's laboratory, provided that the disclosure is approved by the commissioner or the commissioner's designee; or (3) other [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 purposes related to public health testing equipment and supplies, provided that the disclosure is approved by: (A) the commissioner or the commissioner's designee [assessment is performed by a person who is not a laboratory]; and (B) [only newborn screening specimens are disclosed; and [(C) the disclosure is approved by] an institutional review board or privacy board of the department. (c-1) Notwithstanding other law, reports, records, and information that do not identify a child or the family of a child may be released for public health research purposes not described by Subsection (b)(5) if: (1) a parent, managing conservator, or guardian of the child consents to the disclosure; and (2) the disclosure is approved by: (A) an institutional review board or privacy board of the department; and (B) the commissioner or the commissioner's designee. (e) If disclosure is approved by the commissioner or the commissioner's designee under Subsection (c)(3) or (c-1), the department shall post notice on the newborn screening web page on the department's Internet website that disclosure has been approved. The commissioner shall determine the form and content of the notice. (f) In accordance with this section, the commissioner or the commissioner's designee: (1) may approve disclosure of reports, records, or information obtained or developed under this chapter only for a public health purpose; and (2) may not approve disclosure of reports, records, or information obtained or developed under this chapter for purposes related to forensic science or health insurance underwriting. (g) An institutional review board or privacy board of the department that reviews a potential disclosure under this section must include at least three persons who are not affiliated with a health agency, one of whom must be a member of the public. (h) Nothing in this section affects the requirement that screening tests be performed under Section 33.011. (i) If a parent, managing conservator, or guardian of a child consents to disclosure under this section: (1) the parent, managing conservator, or guardian who consented to the disclosure may revoke the consent, in writing, at any time by using a form designated by the department; and (2) the child may revoke the consent, in writing, at any time on or after the date the child attains the age of majority by using a form designated by the department. (j) If a person revokes consent under Subsection (i), the department shall destroy any genetic material obtained from the child as provided by Section 33.0112. SECTION 5. Section 47.001(2), Health and Safety Code, is amended to read as follows: (2) "Birthing facility" means: (A) a hospital licensed under Chapter 241 that offers obstetrical services [and is located in a county with a population of more than 50,000]; [or] (B) a birthing center licensed under Chapter 244; (C) a children's hospital; or (D) a facility, maintained or operated by this state or an agency of this state, that provides obstetrical services [that is located in a county with a population of more than 50,000 and that has 100 or more births per year]. SECTION 6. Section 47.003, Health and Safety Code, is amended by amending Subsections (a), (c), (d), and (e) and adding Subsections (a-1) and (f) to read as follows: (a) A birthing facility, through a program certified by the department under Section 47.004, shall perform, either directly or through a transfer agreement, [offer the parents of a newborn] a hearing screening [for the newborn] for the identification of hearing loss on each newborn or infant born at the facility before the newborn or infant is discharged from the facility unless: (1) the parent declines the screening; (2) the newborn or infant is transferred to another facility before the screening is performed; or (3) the screening has previously been completed. (a-1) The birthing facility [screening] shall inform the parents [be offered] during [the birth] admission that: (1) the facility is required by law to screen a newborn or infant for hearing loss; and (2) the parents may decline the screening[, and the parents shall be informed that information may be provided to the department upon their written consent]. (c) Subject to Section 47.008, the [The] department shall [may] maintain data and information on each newborn or infant who receives a hearing screening under Subsection (a) [services under a program]. (d) The department shall ensure that intervention is available to families for a newborn or infant identified as having hearing loss and that the intervention is managed by state programs operating under the Individuals with Disabilities Education Act (20 U.S.C. Section 1400 et seq.). (e) The department shall ensure that the intervention described by Subsection (d) is available for a newborn or infant identified as having hearing loss not later than the sixth month after the newborn's or infant's birth and through the time the child is an infant unless the infant has been hospitalized since birth. (f) If a newborn or an infant receives medical intervention services, including a hearing aid or cochlear implant, the intervention specialist shall report the results of the intervention to the department. SECTION 7. Chapter 47, Health and Safety Code, is amended by adding Section 47.0031 to read as follows: Sec. 47.0031. FOLLOW-UP SCREENING. (a) The program that performed the hearing screening under Section 47.003 shall provide the newborn's or infant's parents with the screening results. A birthing facility, through the program, shall offer a follow-up hearing screening to the parents of a newborn or infant who does not pass the screening, or refer the parents to another program for the follow-up hearing screening. The follow-up hearing screening should be performed not later than the 30th day after the date the newborn or infant is discharged from the facility. (b) If a newborn or an infant does not pass the screening in a follow-up hearing screening, the program that performed the follow-up hearing screening on the newborn or infant shall: (1) provide the newborn's or infant's parents with the screening results; (2) assist in scheduling a diagnostic audiological evaluation for the newborn or infant, consistent with the most current guidelines in the Joint Committee on Infant Hearing Position Statement, or refer the newborn or infant to a licensed audiologist who provides diagnostic audiological evaluations for newborns or infants that are consistent with the most current guidelines in the Joint Committee on Infant Hearing Position Statement; and (3) refer the newborn or infant to early childhood intervention services. SECTION 8. Sections 47.004(b) and (d), Health and Safety Code, are amended to read as follows: (b) In order to be certified, the program must: (1) provide hearing screening using equipment recommended by the department; (2) use appropriate staff to provide the screening; (3) maintain and report data electronically as required by the department; (4) distribute family, health care provider, and physician educational materials standardized by the department; [and] (5) provide information, as recommended by the department, to the parents on follow-up services for newborns and infants who do not pass the [with abnormal] screening; and (6) be supervised by: (A) a physician; (B) an audiologist; (C) a registered nurse; or (D) a physician assistant [results]. (d) The department may renew the certification of a program on a periodic basis as established by board rule in order to ensure quality services to newborns, infants, and families. SECTION 9. Section 47.005, Health and Safety Code, is amended by amending Subsections (a) and (b) and adding Subsections (d) and (e) to read as follows: (a) A birthing facility that operates a program shall distribute to the parents of each newborn or infant who is screened educational materials that are standardized by the department regarding screening results and follow-up care. (b) A birthing facility that operates a program shall report screening results to: (1) the parents; (2) [,] the newborn's or infant's attending physician, primary care physician, or other applicable health care provider; [,] and (3) the department. (d) The department may coordinate the diagnostic audiological evaluation required under Section 47.0031(b)(2). A diagnostic audiological evaluation must be completed on the newborn or infant: (1) not later than the third month after the newborn's or infant's birth unless the newborn or infant has been hospitalized since birth; or (2) upon referral by the newborn's or infant's primary care physician or other applicable health care provider. (e) An audiologist who performs a diagnostic audiological evaluation under this chapter shall report the results of the evaluation to: (1) the parents; (2) the newborn's or infant's primary care physician or other applicable health care provider; and (3) the department under Section 47.007(b). SECTION 10. Section 47.007, Health and Safety Code, is amended by amending Subsection (b) and adding Subsections (d) through (h) to read as follows: (b) Subject to Section 47.008, a [A] qualified hearing screening provider, hospital, health care provider, physician, audiologist, or intervention specialist shall [may] access the information management, reporting, and tracking system to provide information[, where available,] to the department and may obtain information from the department[, including information] relating to: (1) the results of each hearing screening performed under Section 47.003(a) or 47.0031(a); (2) the results of each diagnostic audiological evaluation required under Section 47.0031(b)(2); (3) [(1)] infants who receive follow-up care; (4) [(2)] infants identified with hearing loss; (5) [(3)] infants who are referred for intervention services; and (6) [(4)] case level information necessary to report required statistics to: (A) the Maternal and Child Health Bureau on an annual basis; and (B) the federal Centers for Disease Control and Prevention. (d) A birthing facility described by Subsection (a) shall report the resulting information in the format and within the time frame specified by the department. (e) A qualified hearing screening provider, audiologist, intervention specialist, educator, or other person who receives a referral from a program under this chapter shall: (1) provide the services needed by the newborn or infant or refer the newborn or infant to a person who provides the services needed by the newborn or infant; and (2) provide, with the consent of the newborn's or infant's parent, the following information to the department or the department's designee: (A) results of follow-up care; (B) results of audiologic testing of an infant identified with hearing loss; and (C) reports on the initiation of intervention services. (f) A qualified hearing screening provider, audiologist, intervention specialist, educator, or other person who provides services to an infant who is diagnosed with hearing loss shall provide, with the consent of the infant's parent, the following information to the department or the department's designee: (1) results of follow-up care; (2) results of audiologic testing; and (3) reports on the initiation of intervention services. (g) A hospital that provides services under this chapter shall use the information management, reporting, and tracking system described by this section, access to which has been provided to the hospital by the department, to report, with the consent of the infant's parent, the following information to the department or the department's designee: (1) results of all follow-up services for an infant who does not pass the screening described by Section 47.003(a) if the hospital provides the follow-up services; or (2) the name of the provider or facility to which the hospital refers an infant who does not pass the screening described by Section 47.003(a) for follow-up services. (h) Subject to Section 47.008, a qualified hearing screening provider, hospital, health care provider, physician, audiologist, or intervention specialist may obtain information from the department relating to: (1) the results of each hearing screening performed under Section 47.003(a) or 47.0031(a); (2) the results of each diagnostic audiological evaluation required under Section 47.0031(b)(2); (3) infants who receive follow-up care; (4) infants identified with hearing loss; and (5) infants who are referred for intervention services. 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. (b) If the executive commissioner adopts rules, the 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: (1) is not required to offer the parents of the newborn a hearing screening for the newborn for the identification of hearing loss; and (2) shall refer the parents of the newborn to a 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