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House Bill 411 |
House Author: Laubenberg et al. |
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Effective: See below |
Senate Sponsor: Deuell |
House Bill 411 amends provisions of the Health and Safety Code relating to the disclosure of reports, records, and information obtained or developed by the Department of State Health Services (DSHS) through newborn screening tests. Among other provisions, the bill authorizes any such information, rather than only non-identifying information, to be disclosed under certain conditions for purposes relating to review, quality assurance, and improvement of the department's newborn screening program and for purposes related to obtaining or maintaining federal certification for the department's laboratory. Additionally, the bill requires a disclosure of newborn screening information for public health research purposes or for quality assurance purposes related to public health testing equipment and supplies to be approved by the commissioner of state health services or the commissioner's designee. The commissioner is authorized to approve such a disclosure under certain circumstances and DSHS is required to post notice on the department's newborn screening web page if approval is granted. Such notice is not required for information disclosed to a DSHS public health program. The bill authorizes non-identifying newborn screening information to be released to an entity other than a DSHS public health program for public health research purposes only if a parent, managing conservator, or guardian of the child consents to the disclosure and the disclosure is approved by an institutional review board or privacy board of DSHS in addition to the commissioner.
Previous law authorized a parent, managing conservator, or guardian of a newborn child to file with DSHS a statement prohibiting the retention of any genetic material related to newborn screening tests or the use of genetic material for any purpose other than the conduct of those tests and authorized an adult individual to file a statement instructing DSHS or a laboratory established or approved by DSHS to destroy any genetic material of the individual that was retained for newborn screening purposes. The bill removes those authorizations and instead sets deadlines by which DSHS is required to destroy any genetic material obtained from a child through newborn screening tests if consent to disclosure of that information for public health research purposes has not been obtained or has been revoked. A parent, managing conservator, or guardian who consents to disclosure of newborn screening information may revoke the consent at any time and the child who is the subject of the information may revoke the consent at any time after attaining the age of majority. The bill revises the criteria for the disclosure statement that DSHS is required to give to a parent, managing conservator, or guardian of a child subjected to newborn screening tests.
House Bill 411 also amends provisions relating to hearing loss in newborns. Previous law required a birthing facility to offer the parents of a newborn a hearing screening for the newborn for the identification of hearing loss. The bill requires a birthing facility to perform, either directly or through a transfer agreement, a hearing screening for the identification of hearing loss on each newborn or infant born at the facility before the newborn or infant is discharged unless the parent declines the screening, the newborn or infant is transferred to another facility before the screening is performed, or the screening has previously been completed. The bill expands the list of facilities that are considered birthing facilities for such purposes and specifies that a midwife is not required to offer the parents of a newborn a hearing screening for the newborn, but is required to refer the parents to a birthing facility or a provider participating in a certified newborn hearing screening, tracking, and intervention program. The bill expands and establishes reporting requirements for certain providers of newborn hearing services, authorizes those providers to obtain certain newborn hearing information from DSHS, and establishes requirements regarding the provision of follow-up screening, diagnostic audiological evaluation, and intervention services to newborns or infants who do not pass the initial screening. The bill revises the certification criteria for a newborn hearing screening, tracking, and intervention program to require that a program be supervised by a physician, an audiologist, a registered nurse, or a physician assistant.
House Bill 411 takes effect June 17, 2011, except for provisions relating to the newborn screening information disclosure statement, the destruction of genetic material obtained from newborn screening tests, and the requirement to obtain consent from a parent, managing conservator, or guardian before disclosing newborn screening information for certain public health research purposes, which take effect June 1, 2012.