S.B. No. 89
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 (d) The scientific advisory committee shall:
5-14 (1) review and advise the department on all proposed
5-15 projects and programs prior to and during implementation;
5-16 (2) monitor the birth defects registry and related
5-17 programs; and
5-18 (3) make recommendations to the department or the
5-19 legislature, as appropriate.
5-20 (Sections 87.007 to 87.020 reserved for expansion
5-21 SUBCHAPTER B. BIRTH DEFECTS MONITORING PROGRAM
5-22 Sec. 87.021. SURVEILLANCE PROGRAM; REGISTRY ESTABLISHED.
5-23 (a) The board may establish in the department a program to:
5-24 (1) identify and investigate certain birth defects in
5-25 children; and
5-26 (2) maintain a central registry of cases of birth
5-27 defects.
6-1 (b) The board may authorize the department to implement a
6-2 statewide program or to limit the program to a part or all of one
6-3 or more public health regions, depending on the funding available
6-4 to the department. In establishing the program, the board shall
6-5 consider:
6-6 (1) the number and geographic distribution of births
6-7 in the state;
6-8 (2) the trained personnel and other departmental
6-9 resources that may be assigned to the program activities; and
6-10 (3) the occurrence or probable occurrence of an urgent
6-11 situation that requires or will require an unusual commitment of
6-12 the department's personnel and other resources.
6-13 (c) The board and the department shall design the program so
6-14 that the program will:
6-15 (1) provide information to identify risk factors and
6-16 causes of birth defects;
6-17 (2) provide information on other possible causes of
6-18 birth defects;
6-19 (3) provide for the development of strategies to
6-20 prevent birth defects;
6-21 (4) provide for interview studies about the causes of
6-22 birth defects;
6-23 (5) together with other departmental programs,
6-24 contribute birth defects data to a central registry;
6-25 (6) provide for the appointment of authorized agents
6-26 to collect birth defects information; and
6-27 (7) provide for the active, not passive, collection of
7-1 birth defects information.
7-2 (d) The board shall adopt rules to govern the operation of
7-3 the program and carry out the intent of this chapter. At a
7-4 minimum, the rules shall:
7-5 (1) use a medically recognized system to specify the
7-6 birth defects to be identified and investigated;
7-7 (2) select a system for classifying the birth defects
7-8 according to the public health significance of each defect to
7-9 prioritize the use of resources;
7-10 (3) develop a system to select and specify the cases
7-11 to be investigated;
7-12 (4) specify a system for selecting the demographic
7-13 areas in which the department may undertake investigations; and
7-14 (5) prescribe the training and experience a person
7-15 must have for appointment as an authorized agent of the department.
7-16 (e) In adopting the rules required by Subsection (d), the
7-17 board shall consider at least:
7-18 (1) the known incidence and prevalence rates of a
7-19 birth defect in the state or portions of the state;
7-20 (2) the known incidence and prevalence rates of a
7-21 particular birth defect in specific population groups who live in
7-22 the state or portions of the state;
7-23 (3) the morbidity and mortality resulting from the
7-24 birth defect; and
7-25 (4) the existence, cost, and availability of a
7-26 strategy to prevent and treat the birth defect.
7-27 Sec. 87.022. DATA COLLECTION. (a) To ensure an accurate
8-1 source of data necessary to investigate the incidence, prevalence,
8-2 and trends of birth defects, the board may require a health
8-3 facility, health professional, or midwife to make available for
8-4 review by the department or by an authorized agent medical records
8-5 or other information that is in the facility's, professional's, or
8-6 midwife's custody or control and that relates to the occurrence of
8-7 a birth defect specified by the board.
8-8 (b) The board by rule shall prescribe the manner in which
8-9 records and other information are made available to the department.
8-10 (c) The board shall adopt procedural rules to facilitate
8-11 cooperation between the health care facility, health professional,
8-12 or midwife and a department employee or authorized agent, including
8-13 rules for notice, requests for medical records, times for record
8-14 reviews, and record management during review.
8-15 Sec. 87.023. REFERRAL FOR SERVICES. A child who meets the
8-16 medical criteria prescribed by board rule, and the child's family,
8-17 shall be referred to the department's case management program for
8-18 guidance in applying for financial or medical assistance available
8-19 through existing state and federal programs.
8-20 (Sections 87.024 to 87.040 reserved for expansion
8-21 SUBCHAPTER C. INVESTIGATIONS AND INSPECTIONS
8-22 Sec. 87.041. INVESTIGATIONS. (a) The department may
8-23 conduct investigations, including epidemiological or toxicological
8-24 investigations, of cases of specified birth defects.
8-25 (b) The department may conduct these investigations to
8-26 determine the nature and extent of the disease or the known or
8-27 suspected cause of the birth defect and to formulate and evaluate
9-1 control measures to protect the public health. The department's
9-2 investigation is not limited to geographic, temporal, or
9-3 occupational associations and may include investigation of past
9-4 exposures.
9-5 (c) A person shall provide medical, demographic,
9-6 epidemiological, toxicological, and environmental information to
9-7 the department under this chapter.
9-8 (d) A person is not liable in damages or other relief for
9-9 providing medical or other confidential information to the
9-10 department during an epidemiological or toxicological
9-11 investigation.
9-12 Sec. 87.042. DEPARTMENTAL INVESTIGATORY POWERS. To conduct
9-13 an investigation under this chapter, the director or the director's
9-14 designee has the same authority to enter, inspect, investigate, and
9-15 take samples and to do so in the same manner as is provided for
9-16 communicable diseases under Sections 81.061, 81.063, 81.064, and
9-17 81.065.
9-18 (Sections 87.043 to 87.060 reserved for expansion
9-19 SUBCHAPTER D. CENTRAL REGISTRY
9-20 Sec. 87.061. REGISTRY; CONFIDENTIALITY. (a) Information
9-21 collected and analyzed by the department or an authorized agent
9-22 under this chapter may be placed in a central registry to
9-23 facilitate research and to maintain security. The department may
9-24 also store information available from other departmental programs
9-25 and information from other reporting systems and health care
9-26 providers.
9-27 (b) The department shall use the registry to:
10-1 (1) investigate the causes of birth defects and other
10-2 health conditions as authorized by Texas statutes;
10-3 (2) design and evaluate measures to prevent the
10-4 occurrence of birth defects and other health conditions; and
10-5 (3) conduct other investigations and activities
10-6 necessary for the board and department to fulfill their obligation
10-7 to protect the health of the public.
10-8 (c) The department may store in the central registry
10-9 information that is obtained from the section of the birth
10-10 certificate entitled "For Medical and Health Use Only." This
10-11 information may be used only as provided by Section 191.002(b),
10-12 relating to the form and contents of the birth certificate.
10-13 Sec. 87.062. ACCESS TO INFORMATION. (a) Access to the
10-14 central registry information is limited to authorized department
10-15 employees and other persons with a valid scientific interest who
10-16 are engaged in demographic, epidemiological, or other studies
10-17 related to health and who agree in writing to maintain
10-18 confidentiality.
10-19 (b) The department shall maintain a listing of each person
10-20 who is given access to the information in the central registry.
10-21 The listing shall include:
10-22 (1) the name of the person authorizing access;
10-23 (2) the name, title, and organizational affiliation of
10-24 each person given access;
10-25 (3) the dates of access; and
10-26 (4) the specific purpose for which the information was
10-27 used.
11-1 (c) The listing is public information, is open to the public
11-2 under the open records law, Chapter 424, Acts of the 63rd
11-3 Legislature, Regular Session, 1973 (Article 6252-17a, Vernon's
11-4 Texas Civil Statutes), and may be inspected during the department's
11-5 normal hours of operation.
11-6 Sec. 87.063. RESEARCH; REVIEW AND APPROVAL. (a) The
11-7 director and the department's committee for the protection of human
11-8 subjects shall review each research proposal that requests the use
11-9 of information in the central registry. The board shall adopt
11-10 rules establishing criteria to be used in deciding if the research
11-11 design should be approved. A proposal that meets the approval
11-12 criteria is considered to establish a valid interest as required by
11-13 Section 87.062(a), and the director and the committee shall
11-14 authorize the researcher to review the records relevant to the
11-15 research proposal and to contact cases and controls.
11-16 (b) If an investigator using central registry data under a
11-17 research design approved under this section believes it is
11-18 necessary to contact case subjects and controls, the investigator
11-19 must submit a protocol describing the purpose and method to the
11-20 director and the department's committee for the protection of human
11-21 subjects. If the contact protocol is approved, the investigator is
11-22 considered to have established a bona fide research, development,
11-23 or planning purpose and is entitled to carry out the contacts
11-24 without securing additional approvals or waivers from any entity.
11-25 Sec. 87.064. REPORT OF CENTRAL REGISTRY ACTIVITIES AND
11-26 FINDINGS. (a) The department shall publish an annual report of
11-27 activities using data contained in the central registry. The
12-1 report shall include:
12-2 (1) a description of research projects in progress
12-3 since the last report and the sponsors and principal investigators
12-4 directing each project;
12-5 (2) results of the completed research projects either
12-6 as an abstract or a complete scientific paper that has been
12-7 reviewed and approved by an appropriate jury;
12-8 (3) a summary of the statistical information compiled
12-9 in the registry, including a specific discussion of any clusters,
12-10 high or low incidences, or prevalences or trends encountered;
12-11 (4) any policy, research, educational, or other
12-12 recommendations the department considers appropriate; and
12-13 (5) such other information the editors of the report
12-14 find is appropriate.
12-15 (b) The department may publish periodic reports in addition
12-16 to the annual report.
12-17 Sec. 87.065. COORDINATION WITH MEXICO. In developing the
12-18 central registry and conducting research in areas of this state
12-19 that border Mexico, the department shall make every effort to
12-20 coordinate its efforts with similar efforts and research programs
12-21 in Mexico.
12-22 SECTION 2. (a) This Act takes effect September 1, 1993.
12-23 (b) The Texas Board of Health shall adopt rules as required
12-24 by Chapter 87, Health and Safety Code, as added by this Act, not
12-25 later than October 15, 1993.
12-26 (c) The Texas Department of Health shall begin to collect
12-27 information as required by Chapter 87, Health and Safety Code, as
13-1 added by this Act, not later than January 1, 1994.
13-2 SECTION 3. The importance of this legislation and the
13-3 crowded condition of the calendars in both houses create an
13-4 emergency and an imperative public necessity that the
13-5 constitutional rule requiring bills to be read on three several
13-6 days in each house be suspended, and this rule is hereby suspended.