HEALTH & SAFETY CODE
CHAPTER 87. BIRTH DEFECTS
SUBCHAPTER A. GENERAL PROVISIONS
§ 87.001. DEFINITIONS. In this chapter:
(1) "Birth defect" means a physical or mental
functional deficit or impairment in a human embryo, fetus, or
newborn resulting from one or more genetic or environmental causes.
(2) "Communicable disease" has the meaning assigned by
Section 81.003.
(3) Repealed by Acts 1995, 74th Leg., ch. 76, §
8.134, eff. Sept. 1, 1995.
(4) "Environmental causes" means the sum total of all
the conditions and elements that make up the surroundings and
influence the development of an individual.
(5) "Harmful physical agent" has the meaning assigned
by Section 503.001.
(6) "Health professional" means an individual whose:
(A) vocation or profession is directly or
indirectly related to the maintenance of health in another
individual; and
(B) duties require a specified amount of formal
education and may require a special examination, certificate, or
license or membership in a regional or national association.
(7) "Health facility" includes:
(A) a general or special hospital licensed by the
department under Chapter 241;
(B) a physician-owned or physician-operated
clinic;
(C) a publicly or privately funded medical
school;
(D) a state hospital or state school maintained
and managed by the Texas Department of Mental Health and Mental
Retardation;
(E) a genetic evaluation and counseling center;
(F) a public health clinic conducted by a local
health unit, health department, or public health district organized
and recognized under Chapter 121;
(G) a physician peer review organization; and
(H) another facility specified by board rule.
(8) "Midwife" has the meaning assigned by Section
203.002, Occupations Code.
(9) "Local health unit" has the meaning assigned by
Section 121.004.
(10) "Toxic substance" has the meaning assigned by
Section 503.001.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
Amended by Acts 1995, 74th Leg., ch. 76, § 8.134, eff. Sept. 1,
1995; Acts 2001, 77th Leg., ch. 1420, § 14.774, eff. Sept. 1,
2001.
§ 87.002. CONFIDENTIALITY. (a) Except as specifically
authorized by this chapter, reports, records, and information
furnished to a department employee or to an authorized agent of the
department that relate to cases or suspected cases of a health
condition are confidential and may be used only for the purposes of
this chapter.
(b) Reports, records, and information relating to cases or
suspected cases of health conditions are not public information
under Chapter 552, Government Code, and may not be released or made
public on subpoena or otherwise except as provided by this chapter.
(c) The department may release medical, epidemiological, or
toxicological information:
(1) for statistical purposes, if released in a manner
that prevents the identification of any person;
(2) with the consent of each person identified in the
information or, if the person is a minor, the minor's parents,
managing conservator, guardian, or other person who is legally
authorized to consent;
(3) to medical personnel, appropriate state agencies,
health authorities, regional directors, and public officers of
counties and municipalities as necessary to comply with this
chapter and board rules relating to the identification, monitoring,
and referral of children with birth defects;
(4) to appropriate federal agencies, such as the
Centers for Disease Control of the United States Public Health
Service; or
(5) to medical personnel to the extent necessary to
protect the health or life of the child identified in the
information.
(d) A board member, the commissioner, another employee of
the department, or an authorized agent may not be examined in a
civil, criminal, special, or other proceeding as to the existence
or contents of pertinent records of or reports or information about
a child identified or monitored for a birth defect by the department
without the consent of the child's parents, managing conservator,
guardian, or other person authorized by law of this state or another
state or by a court order to give consent.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
Amended by Acts 1995, 74th Leg., ch. 76, § 5.95(88), 8.130, eff.
Sept. 1, 1995.
§ 87.003. CONTRACTS. The department may enter into
contracts or agreements with persons as necessary to implement this
chapter. The contracts or agreements may provide for payment by the
state for supplies, equipment, data, and data collection and other
services.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
§ 87.004. LIMITATION OF LIABILITY. A health
professional, a health facility, or an administrator, officer, or
employee of a health facility subject to this chapter is not civilly
or criminally liable for divulging information required to be
released under this chapter, except in a case of gross negligence or
wilful misconduct.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
§ 87.005. COOPERATION OF GOVERNMENTAL
ENTITIES. Another state board, commission, agency, or
governmental entity capable of assisting the department in carrying
out the intent of this chapter shall cooperate with the department
and furnish expertise, services, and facilities to the program.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
SUBCHAPTER B. BIRTH DEFECTS MONITORING PROGRAM
§ 87.021. SURVEILLANCE PROGRAM; REGISTRY
ESTABLISHED. (a) The board shall establish in the department a
program to:
(1) identify and investigate certain birth defects in
children; and
(2) maintain a central registry of cases of birth
defects.
(b) The board may authorize the department to implement a
statewide program or to limit the program to a part or all of one or
more public health regions, depending on the funding available to
the department. In establishing the program, the board shall
consider:
(1) the number and geographic distribution of births
in the state;
(2) the trained personnel and other departmental
resources that may be assigned to the program activities; and
(3) the occurrence or probable occurrence of an urgent
situation that requires or will require an unusual commitment of
the department's personnel and other resources.
(c) The board and the department shall design the program so
that the program will:
(1) provide information to identify risk factors and
causes of birth defects;
(2) provide information on other possible causes of
birth defects;
(3) provide for the development of strategies to
prevent birth defects;
(4) provide for interview studies about the causes of
birth defects;
(5) together with other departmental programs,
contribute birth defects data to a central registry;
(6) provide for the appointment of authorized agents
to collect birth defects information; and
(7) provide for the active collection of birth defects
information.
(d) The board shall adopt rules to govern the operation of
the program and carry out the intent of this chapter. At a minimum,
the rules shall:
(1) use a medically recognized system to specify the
birth defects to be identified and investigated;
(2) select a system for classifying the birth defects
according to the public health significance of each defect to
prioritize the use of resources;
(3) develop a system to select and specify the cases to
be investigated;
(4) specify a system for selecting the demographic
areas in which the department may undertake investigations; and
(5) prescribe the training and experience a person
must have for appointment as an authorized agent of the department.
(e) In adopting the rules required by Subsection (d), the
board shall consider at least:
(1) the known incidence and prevalence rates of a
birth defect in the state or portions of the state;
(2) the known incidence and prevalence rates of a
particular birth defect in specific population groups who live in
the state or portions of the state;
(3) the morbidity and mortality resulting from the
birth defect; and
(4) the existence, cost, and availability of a
strategy to prevent and treat the birth defect.
(f) In addition to providing for the active collection of
birth defects information under Subsection (c)(7), the board and
the department may design the program to also provide for the
passive collection of that information.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
Amended by Acts 2003, 78th Leg., ch. 1042, § 1, eff. June 20,
2003.
§ 87.022. DATA COLLECTION. (a) To ensure an accurate
source of data necessary to investigate the incidence, prevalence,
and trends of birth defects, the board may require a health
facility, health professional, or midwife to make available for
review by the department or by an authorized agent medical records
or other information that is in the facility's, professional's, or
midwife's custody or control and that relates to the occurrence of a
birth defect specified by the board.
(b) The board by rule shall prescribe the manner in which
records and other information are made available to the department.
(c) The board shall adopt procedural rules to facilitate
cooperation between the health care facility, health professional,
or midwife and a department employee or authorized agent, including
rules for notice, requests for medical records, times for record
reviews, and record management during review.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
§ 87.023. REFERRAL FOR SERVICES. A child who meets the
medical criteria prescribed by board rule, and the child's family,
shall be referred to the department's case management program for
guidance in applying for financial or medical assistance available
through existing state and federal programs.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
SUBCHAPTER C. INVESTIGATIONS AND INSPECTIONS
§ 87.041. INVESTIGATIONS. (a) The department may
conduct investigations, including epidemiological or toxicological
investigations, of cases of specified birth defects.
(b) The department may conduct these investigations to
determine the nature and extent of the disease or the known or
suspected cause of the birth defect and to formulate and evaluate
control measures to protect the public health. The department's
investigation is not limited to geographic, temporal, or
occupational associations and may include investigation of past
exposures.
(c) A person shall provide medical, demographic,
epidemiological, toxicological, and environmental information to
the department under this chapter.
(d) A person is not liable in damages or other relief for
providing medical or other confidential information to the
department during an epidemiological or toxicological
investigation.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
§ 87.042. DEPARTMENTAL INVESTIGATORY POWERS. To
conduct an investigation under this chapter, the commissioner or
the commissioner's designee has the same authority to enter,
inspect, investigate, and take samples and to do so in the same
manner as is provided for communicable diseases under Sections
81.061, 81.063, 81.064, and 81.065.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
Amended by Acts 1995, 74th Leg., ch. 76, § 8.132, eff. Sept. 1,
1995.
SUBCHAPTER D. CENTRAL REGISTRY
§ 87.061. REGISTRY; CONFIDENTIALITY. (a) Information
collected and analyzed by the department or an authorized agent
under this chapter may be placed in a central registry to facilitate
research and to maintain security. The department may also store
information available from other departmental programs and
information from other reporting systems and health care providers.
(b) The department shall use the registry to:
(1) investigate the causes of birth defects and other
health conditions as authorized by Texas statutes;
(2) design and evaluate measures to prevent the
occurrence of birth defects and other health conditions; and
(3) conduct other investigations and activities
necessary for the board and department to fulfill their obligation
to protect the health of the public.
(c) The department may store in the central registry
information that is obtained from the section of the birth
certificate entitled "For Medical and Health Use Only." This
information may be used only as provided by Section 191.002(b),
relating to the form and contents of the birth certificate.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
§ 87.062. ACCESS TO INFORMATION. (a) Access to the
central registry information is limited to authorized department
employees and other persons with a valid scientific interest who
are engaged in demographic, epidemiological, or other studies
related to health and who agree in writing to maintain
confidentiality.
(b) The department shall maintain a listing of each person
who is given access to the information in the central registry. The
listing shall include:
(1) the name of the person authorizing access;
(2) the name, title, and organizational affiliation of
each person given access;
(3) the dates of access; and
(4) the specific purpose for which the information was
used.
(c) The listing is public information, is open to the public
under Chapter 552, Government Code, and may be inspected during the
department's normal hours of operation.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
Amended by Acts 1995, 74th Leg., ch. 76, § 5.95(88), eff. Sept.
1, 1995.
§ 87.063. RESEARCH; REVIEW AND APPROVAL. (a) The
commissioner and the department's committee for the protection of
human subjects shall review each research proposal that requests
the use of information in the central registry. The board shall
adopt rules establishing criteria to be used in deciding if the
research design should be approved. A proposal that meets the
approval criteria is considered to establish a valid interest as
required by Section 87.062(a), and the commissioner and the
committee shall authorize the researcher to review the records
relevant to the research proposal and to contact cases and
controls.
(b) If an investigator using central registry data under a
research design approved under this section believes it is
necessary to contact case subjects and controls, the investigator
must submit a protocol describing the purpose and method to the
commissioner and the department's committee for the protection of
human subjects. If the contact protocol is approved, the
investigator is considered to have established a bona fide
research, development, or planning purpose and is entitled to carry
out the contacts without securing additional approvals or waivers
from any entity.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
Amended by Acts 1995, 74th Leg., ch. 76, § 8.133, eff. Sept. 1,
1995.
§ 87.064. REPORT OF CENTRAL REGISTRY ACTIVITIES AND
FINDINGS. (a) The department shall publish an annual report of
activities using data contained in the central registry. The
report shall include:
(1) a description of research projects in progress
since the last report and the sponsors and principal investigators
directing each project;
(2) results of the completed research projects either
as an abstract or a complete scientific paper that has been reviewed
and approved by an appropriate jury;
(3) a summary of the statistical information compiled
in the registry, including a specific discussion of any clusters,
high or low incidences, or prevalences or trends encountered;
(4) any policy, research, educational, or other
recommendations the department considers appropriate; and
(5) such other information the editors of the report
find is appropriate.
(b) The department may publish periodic reports in addition
to the annual report.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
§ 87.065. COORDINATION WITH MEXICO. In developing the
central registry and conducting research in areas of this state
that border Mexico, the department shall make every effort to
coordinate its efforts with similar efforts and research programs
in Mexico.
Added by Acts 1993, 73rd Leg., ch. 602, § 1, eff. Sept. 1, 1993.
