By:  Truan, et al.                                      S.B. No. 89
                                 A BILL TO BE ENTITLED
                                        AN ACT
    1-1  relating to establishing a birth defects registry.
    1-2        BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
    1-3        SECTION 1.  Subtitle D, Title 2, Health and Safety Code, is
    1-4  amended by adding Chapter 87 to read as follows:
    1-5                      CHAPTER 87.  BIRTH DEFECTS
    1-6                   SUBCHAPTER A.  GENERAL PROVISIONS
    1-7        Sec. 87.001.  DEFINITIONS.  In this chapter:
    1-8              (1)  "Birth defect" means a physical or mental
    1-9  functional deficit or impairment in a human embryo, fetus, or
   1-10  newborn resulting from one or more genetic or environmental causes.
   1-11              (2)  "Communicable disease" has the meaning assigned by
   1-12  Section 81.003.
   1-13              (3)  "Director" means the executive head of the
   1-14  department.
   1-15              (4)  "Environmental causes" means the sum total of all
   1-16  the conditions and elements that make up the surroundings and
   1-17  influence the development of an individual.
   1-18              (5)  "Harmful physical agent" has the meaning assigned
   1-19  by Section 503.001.
   1-20              (6)  "Health professional" means an individual whose:
   1-21                    (A)  vocation or profession is directly or
   1-22  indirectly related to the maintenance of health in another
   1-23  individual; and
   1-24                    (B)  duties require a specified amount of formal
    2-1  education and may require a special examination, certificate, or
    2-2  license or membership in a regional or national association.
    2-3              (7)  "Health facility" includes:
    2-4                    (A)  a general or special hospital licensed by
    2-5  the department under Chapter 241;
    2-6                    (B)  a physician-owned or physician-operated
    2-7  clinic;
    2-8                    (C)  a publicly or privately funded medical
    2-9  school;
   2-10                    (D)  a state hospital or state school maintained
   2-11  and managed by the Texas Department of Mental Health and Mental
   2-12  Retardation;
   2-13                    (E)  a genetic evaluation and counseling center;
   2-14                    (F)  a public health clinic conducted by a local
   2-15  health unit, health department, or public health district organized
   2-16  and recognized under Chapter 121;
   2-17                    (G)  a physician peer review organization; and
   2-18                    (H)  another facility specified by board rule.
   2-19              (8)  "Midwife" has the meaning assigned by Section 1,
   2-20  Texas Midwifery Act (Article 4512i, Vernon's Texas Civil Statutes).
   2-21              (9)  "Local health unit" has the meaning assigned by
   2-22  Section 121.004.
   2-23              (10)  "Toxic substance" has the meaning assigned by
   2-24  Section 503.001.
   2-25        Sec. 87.002.  CONFIDENTIALITY.  (a)  Except as specifically
   2-26  authorized by this chapter, reports, records, and information
   2-27  furnished to a department employee or to an authorized agent of the
    3-1  department that relate to cases or suspected cases of a health
    3-2  condition are confidential and may be used only for the purposes of
    3-3  this chapter.
    3-4        (b)  Reports, records, and information relating to cases or
    3-5  suspected cases of health conditions are not public information
    3-6  under the open records law, Chapter 424, Acts of the 63rd
    3-7  Legislature, Regular Session, 1973 (Article 6252-17a, Vernon's
    3-8  Texas Civil Statutes), and may not be released or made public on
    3-9  subpoena or otherwise except as provided by this chapter.
   3-10        (c)  The department may release medical, epidemiological, or
   3-11  toxicological information:
   3-12              (1)  for statistical purposes, if released in a manner
   3-13  that prevents the identification of any person;
   3-14              (2)  with the consent of each person identified in the
   3-15  information or, if the person is a minor, the minor's parents,
   3-16  managing conservator, guardian, or other person who is legally
   3-17  authorized to consent;
   3-18              (3)  to medical personnel, appropriate state agencies,
   3-19  health authorities, regional directors, and public officers of
   3-20  counties and municipalities as necessary to comply with this
   3-21  chapter and board rules relating to the identification, monitoring,
   3-22  and referral of children with birth defects;
   3-23              (4)  to appropriate federal agencies, such as the
   3-24  Centers for Disease Control of the United States Public Health
   3-25  Service; or
   3-26              (5)  to medical personnel to the extent necessary to
   3-27  protect the health or life of the child identified in the
    4-1  information.
    4-2        (d)  A board member, the director, another employee of the
    4-3  department, or an authorized agent may not be examined in a civil,
    4-4  criminal, special, or other proceeding as to the existence or
    4-5  contents of pertinent records of or reports or information about a
    4-6  child identified or monitored for a birth defect by the department
    4-7  without the consent of the child's parents, managing conservator,
    4-8  guardian, or other person authorized by law of this state or
    4-9  another state or by a court order to give consent.
   4-10        Sec. 87.003.  CONTRACTS.  The department may enter into
   4-11  contracts or agreements with persons as necessary to implement this
   4-12  chapter.  The contracts or agreements may provide for payment by
   4-13  the state for supplies, equipment, data, and data collection and
   4-14  other services.
   4-15        Sec. 87.004.  LIMITATION OF LIABILITY.  A health
   4-16  professional, a health facility, or an administrator, officer, or
   4-17  employee of a health facility subject to this chapter is not
   4-18  civilly or criminally liable for divulging information required to
   4-19  be released under this chapter, except in a case of gross
   4-20  negligence or wilful misconduct.
   4-21        Sec. 87.005.  COOPERATION OF GOVERNMENTAL ENTITIES.  Another
   4-22  state board, commission, agency, or governmental entity capable of
   4-23  assisting the department in carrying out the intent of this chapter
   4-24  shall cooperate with the department and furnish expertise,
   4-25  services, and facilities to the program.
   4-26        Sec. 87.006.  SCIENTIFIC ADVISORY COMMITTEE.  (a)  The
   4-27  director shall establish a scientific advisory committee to provide
    5-1  practical and scientific advice to the department in implementing
    5-2  an effective birth defects registry and related research, referral,
    5-3  and educational activities.
    5-4        (b)  The committee may be composed of not more than 11
    5-5  members and must include scientific experts in the fields of birth
    5-6  defects, genetics, epidemiology, and medicine.  At least one member
    5-7  must be from the general public.
    5-8        (c)  If the department implements a pilot birth defects
    5-9  registry in selected regions of the state, membership of the
   5-10  scientific advisory committee must include persons who work or live
   5-11  in the areas where the pilot birth defects registry activity is
   5-12  implemented.
   5-13          (Sections 87.007 to 87.020 reserved for expansion
   5-14            SUBCHAPTER B.  BIRTH DEFECTS MONITORING PROGRAM
   5-15        Sec. 87.021.  SURVEILLANCE PROGRAM; REGISTRY ESTABLISHED.
   5-16  (a)  The board may establish in the department a program to:
   5-17              (1)  identify and investigate certain birth defects in
   5-18  children; and
   5-19              (2)  maintain a central registry of cases of birth
   5-20  defects.
   5-21        (b)  The board may authorize the department to implement a
   5-22  statewide program or to limit the program to a part or all of one
   5-23  or more public health regions, depending on the funding available
   5-24  to the department.  In establishing the program, the board shall
   5-25  consider:
   5-26              (1)  the number and geographic distribution of births
   5-27  in the state;
    6-1              (2)  the trained personnel and other departmental
    6-2  resources that may be assigned to the program activities; and
    6-3              (3)  the occurrence or probable occurrence of an urgent
    6-4  situation that requires or will require an unusual commitment of
    6-5  the department's personnel and other resources.
    6-6        (c)  The board and the department shall design the program so
    6-7  that the program will:
    6-8              (1)  provide information to identify risk factors and
    6-9  causes of birth defects;
   6-10              (2)  provide information on other possible causes of
   6-11  birth defects;
   6-12              (3)  provide for the development of strategies to
   6-13  prevent birth defects;
   6-14              (4)  provide for interview studies about the causes of
   6-15  birth defects;
   6-16              (5)  together with other departmental programs,
   6-17  contribute birth defects data to a central registry;
   6-18              (6)  provide for the appointment of authorized agents
   6-19  to collect birth defects information; and
   6-20              (7)  provide for the active, not passive, collection of
   6-21  birth defects information.
   6-22        (d)  The board shall adopt rules to govern the operation of
   6-23  the program and carry out the intent of this chapter.  At a
   6-24  minimum, the rules shall:
   6-25              (1)  use a medically recognized system to specify the
   6-26  birth defects to be identified and investigated;
   6-27              (2)  select a system for classifying the birth defects
    7-1  according to the public health significance of each defect to
    7-2  prioritize the use of resources;
    7-3              (3)  develop a system to select and specify the cases
    7-4  to be investigated;
    7-5              (4)  specify a system for selecting the demographic
    7-6  areas in which the department may undertake investigations; and
    7-7              (5)  prescribe the training and experience a person
    7-8  must have for appointment as an authorized agent of the department.
    7-9        (e)  In adopting the rules required by Subsection (d), the
   7-10  board shall consider at least:
   7-11              (1)  the known incidence and prevalence rates of a
   7-12  birth defect in the state or portions of the state;
   7-13              (2)  the known incidence and prevalence rates of a
   7-14  particular birth defect in specific population groups who live in
   7-15  the state or portions of the state;
   7-16              (3)  the morbidity and mortality resulting from the
   7-17  birth defect; and
   7-18              (4)  the existence, cost, and availability of a
   7-19  strategy to prevent and treat the birth defect.
   7-20        Sec. 87.022.  DATA COLLECTION.  (a)  To ensure an accurate
   7-21  source of data necessary to investigate the incidence, prevalence,
   7-22  and trends of birth defects, the board may require a health
   7-23  facility, health professional, or midwife to make available for
   7-24  review by the department or by an authorized agent medical records
   7-25  or other information that is in the facility's, professional's, or
   7-26  midwife's custody or control and that relates to the occurrence of
   7-27  a birth defect specified by the board.
    8-1        (b)  The board by rule shall prescribe the manner in which
    8-2  records and other information are made available to the department.
    8-3        (c)  The board shall adopt procedural rules to facilitate
    8-4  cooperation between the health care facility, health professional,
    8-5  or midwife and a department employee or authorized agent, including
    8-6  rules for notice, requests for medical records, times for record
    8-7  reviews, and record management during review.
    8-8        Sec. 87.023.  REFERRAL FOR SERVICES.  A child who meets the
    8-9  medical criteria prescribed by board rule, and the child's family,
   8-10  shall be referred to the department's case management program for
   8-11  guidance in applying for financial or medical assistance available
   8-12  through existing state and federal programs.
   8-13          (Sections 87.024 to 87.040 reserved for expansion
   8-14             SUBCHAPTER C.  INVESTIGATIONS AND INSPECTIONS
   8-15        Sec. 87.041.  INVESTIGATIONS.  (a)  The department may
   8-16  conduct investigations, including epidemiological or toxicological
   8-17  investigations, of cases of specified birth defects.
   8-18        (b)  The department may conduct these investigations to
   8-19  determine the nature and extent of the disease or the known or
   8-20  suspected cause of the birth defect and to formulate and evaluate
   8-21  control measures to protect the public health.  The department's
   8-22  investigation is not limited to geographic, temporal, or
   8-23  occupational associations and may include investigation of past
   8-24  exposures.
   8-25        (c)  A person shall provide medical, demographic,
   8-26  epidemiological, toxicological, and environmental information to
   8-27  the department under this chapter.
    9-1        (d)  A person is not liable in damages or other relief for
    9-2  providing medical or other confidential information to the
    9-3  department during an epidemiological or toxicological
    9-4  investigation.
    9-5        Sec. 87.042.  DEPARTMENTAL INVESTIGATORY POWERS.  To conduct
    9-6  an investigation under this chapter, the director or the director's
    9-7  designee has the same authority to enter, inspect, investigate, and
    9-8  take samples and to do so in the same manner as is provided for
    9-9  communicable diseases under Sections 81.061, 81.063, 81.064, and
   9-10  81.065.
   9-11          (Sections 87.043 to 87.060 reserved for expansion
   9-12                    SUBCHAPTER D.  CENTRAL REGISTRY
   9-13        Sec. 87.061.  REGISTRY; CONFIDENTIALITY.  (a)  Information
   9-14  collected and analyzed by the department or an authorized agent
   9-15  under this chapter may be placed in a central registry to
   9-16  facilitate research and to maintain security.  The department may
   9-17  also store information available from other departmental programs
   9-18  and information from other reporting systems and healthcare
   9-19  providers.
   9-20        (b)  The department shall use the registry to:
   9-21              (1)  investigate the causes of birth defects and other
   9-22  health conditions;
   9-23              (2)  design and evaluate measures to prevent the
   9-24  occurrence of birth defects and other health conditions; and
   9-25              (3)  conduct other investigations and activities
   9-26  necessary for the board and department to fulfill their obligation
   9-27  to protect the health of the public.
   10-1        (c)  The department may store in the central registry
   10-2  information that is obtained from the section of the birth
   10-3  certificate entitled "For Medical and Health Use Only."  This
   10-4  information may be used only as provided by Section 191.002(b),
   10-5  relating to the form and contents of the birth certificate.
   10-6        Sec. 87.062.  ACCESS TO INFORMATION.  (a)  Access to the
   10-7  central registry information is limited to authorized department
   10-8  employees and other persons with a valid scientific interest who
   10-9  are engaged in demographic, epidemiological, or other studies
  10-10  related to health and who agree in writing to maintain
  10-11  confidentiality.
  10-12        (b)  The department shall maintain a listing of each person
  10-13  who is given access to the information in the central registry.
  10-14  The listing shall include:
  10-15              (1)  the name of the person authorizing access;
  10-16              (2)  the name, title, and organizational affiliation of
  10-17  each person given access;
  10-18              (3)  the dates of access; and
  10-19              (4)  the specific purpose for which the information was
  10-20  used.
  10-21        (c)  The listing is public information, is open to the public
  10-22  under the open records law, Chapter 424, Acts of the 63rd
  10-23  Legislature, Regular Session, 1973 (Article 6252-17a, Vernon's
  10-24  Texas Civil Statutes), and may be inspected during the department's
  10-25  normal hours of operation.
  10-26        Sec. 87.063.  RESEARCH; REVIEW AND APPROVAL.  (a)  The
  10-27  director and the department's committee for the protection of human
   11-1  subjects shall review each research proposal that requests the use
   11-2  of information in the central registry.  The board shall adopt
   11-3  rules establishing criteria to be used in deciding if the research
   11-4  design should be approved.  A proposal that meets the approval
   11-5  criteria is considered to establish a valid interest as required by
   11-6  Section 87.062(a), and the director and the committee shall
   11-7  authorize the researcher to review the records relevant to the
   11-8  research proposal and to contact cases and controls.
   11-9        (b)  If an investigator using central registry data under a
  11-10  research design approved under this section believes it is
  11-11  necessary to contact case subjects and controls, the investigator
  11-12  must submit a protocol describing the purpose and method to the
  11-13  director and the department's committee for the protection of human
  11-14  subjects.  If the contact protocol is approved, the investigator is
  11-15  considered to have established a bona fide research, development,
  11-16  or planning purpose and is entitled to carry out the contacts
  11-17  without securing additional approvals or waivers from any entity.
  11-18        Sec. 87.064.  REPORT OF CENTRAL REGISTRY ACTIVITIES AND
  11-19  FINDINGS.  (a)  The department shall publish an annual report of
  11-20  activities using data contained in the central registry.  The
  11-21  report shall include:
  11-22              (1)  a description of research projects in progress
  11-23  since the last report and the sponsors and principal investigators
  11-24  directing each project;
  11-25              (2)  results of the completed research projects either
  11-26  as an abstract or a complete scientific paper that has been
  11-27  reviewed and approved by an appropriate jury;
   12-1              (3)  a summary of the statistical information compiled
   12-2  in the registry, including a specific discussion of any clusters,
   12-3  high or low incidences, or prevalences or trends encountered;
   12-4              (4)  any policy, research, educational, or other
   12-5  recommendations the department considers appropriate; and
   12-6              (5)  such other information the editors of the report
   12-7  find is appropriate.
   12-8        (b)  The department may publish periodic reports in addition
   12-9  to the annual report.
  12-10        Sec. 87.065.  COORDINATION WITH MEXICO.  In developing the
  12-11  central registry and conducting research in areas of this state
  12-12  that border Mexico, the department shall make every effort to
  12-13  coordinate its efforts with similar efforts and research programs
  12-14  in Mexico.
  12-15        SECTION 2.  (a)  This Act takes effect September 1, 1993.
  12-16        (b)  The Texas Board of Health shall adopt rules as required
  12-17  by Chapter 87, Health and Safety Code, as added by this Act, not
  12-18  later than October 15, 1993.
  12-19        (c)  The Texas Department of Health shall begin to collect
  12-20  information as required by Chapter 87, Health and Safety Code, as
  12-21  added by this Act, not later than January 1, 1994.
  12-22        SECTION 3.  The importance of this legislation and the
  12-23  crowded condition of the calendars in both houses create an
  12-24  emergency and an imperative public necessity that the
  12-25  constitutional rule requiring bills to be read on three several
  12-26  days in each house be suspended, and this rule is hereby suspended.