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