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  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