1-1 By: Truan, Lucio, Wentworth S.B. No. 89
1-2 Rosson, Zaffirini
1-3 (In the Senate - Filed January 8, 1993; January 14, 1993,
1-4 read first time and referred to Committee on Health and Human
1-5 Services; March 9, 1993, reported adversely, with favorable
1-6 Committee Substitute by the following vote: Yeas 9, Nays 0;
1-7 March 9, 1993, sent to printer.)
1-8 COMMITTEE VOTE
1-9 Yea Nay PNV Absent
1-10 Zaffirini x
1-11 Ellis x
1-12 Madla x
1-13 Moncrief x
1-14 Nelson x
1-15 Patterson x
1-16 Shelley x
1-17 Truan x
1-18 Wentworth x
1-19 COMMITTEE SUBSTITUTE FOR S.B. No. 89 By: Truan
1-20 A BILL TO BE ENTITLED
1-21 AN ACT
1-22 relating to establishing a birth defects registry.
1-23 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-24 SECTION 1. Subtitle D, Title 2, Health and Safety Code, is
1-25 amended by adding Chapter 87 to read as follows:
1-26 CHAPTER 87. BIRTH DEFECTS
1-27 SUBCHAPTER A. GENERAL PROVISIONS
1-28 Sec. 87.001. DEFINITIONS. In this chapter:
1-29 (1) "Birth defect" means a physical or mental
1-30 functional deficit or impairment in a human embryo, fetus, or
1-31 newborn resulting from one or more genetic or environmental causes.
1-32 (2) "Communicable disease" has the meaning assigned by
1-33 Section 81.003.
1-34 (3) "Director" means the executive head of the
1-35 department.
1-36 (4) "Environmental causes" means the sum total of all
1-37 the conditions and elements that make up the surroundings and
1-38 influence the development of an individual.
1-39 (5) "Harmful physical agent" has the meaning assigned
1-40 by Section 503.001.
1-41 (6) "Health professional" means an individual whose:
1-42 (A) vocation or profession is directly or
1-43 indirectly related to the maintenance of health in another
1-44 individual; and
1-45 (B) duties require a specified amount of formal
1-46 education and may require a special examination, certificate, or
1-47 license or membership in a regional or national association.
1-48 (7) "Health facility" includes:
1-49 (A) a general or special hospital licensed by
1-50 the department under Chapter 241;
1-51 (B) a physician-owned or physician-operated
1-52 clinic;
1-53 (C) a publicly or privately funded medical
1-54 school;
1-55 (D) a state hospital or state school maintained
1-56 and managed by the Texas Department of Mental Health and Mental
1-57 Retardation;
1-58 (E) a genetic evaluation and counseling center;
1-59 (F) a public health clinic conducted by a local
1-60 health unit, health department, or public health district organized
1-61 and recognized under Chapter 121;
1-62 (G) a physician peer review organization; and
1-63 (H) another facility specified by board rule.
1-64 (8) "Midwife" has the meaning assigned by Section 1,
1-65 Texas Midwifery Act (Article 4512i, Vernon's Texas Civil Statutes).
1-66 (9) "Local health unit" has the meaning assigned by
1-67 Section 121.004.
1-68 (10) "Toxic substance" has the meaning assigned by
2-1 Section 503.001.
2-2 Sec. 87.002. CONFIDENTIALITY. (a) Except as specifically
2-3 authorized by this chapter, reports, records, and information
2-4 furnished to a department employee or to an authorized agent of the
2-5 department that relate to cases or suspected cases of a health
2-6 condition are confidential and may be used only for the purposes of
2-7 this chapter.
2-8 (b) Reports, records, and information relating to cases or
2-9 suspected cases of health conditions are not public information
2-10 under the open records law, Chapter 424, Acts of the 63rd
2-11 Legislature, Regular Session, 1973 (Article 6252-17a, Vernon's
2-12 Texas Civil Statutes), and may not be released or made public on
2-13 subpoena or otherwise except as provided by this chapter.
2-14 (c) The department may release medical, epidemiological, or
2-15 toxicological information:
2-16 (1) for statistical purposes, if released in a manner
2-17 that prevents the identification of any person;
2-18 (2) with the consent of each person identified in the
2-19 information or, if the person is a minor, the minor's parents,
2-20 managing conservator, guardian, or other person who is legally
2-21 authorized to consent;
2-22 (3) to medical personnel, appropriate state agencies,
2-23 health authorities, regional directors, and public officers of
2-24 counties and municipalities as necessary to comply with this
2-25 chapter and board rules relating to the identification, monitoring,
2-26 and referral of children with birth defects;
2-27 (4) to appropriate federal agencies, such as the
2-28 Centers for Disease Control of the United States Public Health
2-29 Service; or
2-30 (5) to medical personnel to the extent necessary to
2-31 protect the health or life of the child identified in the
2-32 information.
2-33 (d) A board member, the director, another employee of the
2-34 department, or an authorized agent may not be examined in a civil,
2-35 criminal, special, or other proceeding as to the existence or
2-36 contents of pertinent records of or reports or information about a
2-37 child identified or monitored for a birth defect by the department
2-38 without the consent of the child's parents, managing conservator,
2-39 guardian, or other person authorized by law of this state or
2-40 another state or by a court order to give consent.
2-41 Sec. 87.003. CONTRACTS. The department may enter into
2-42 contracts or agreements with persons as necessary to implement this
2-43 chapter. The contracts or agreements may provide for payment by
2-44 the state for supplies, equipment, data, and data collection and
2-45 other services.
2-46 Sec. 87.004. LIMITATION OF LIABILITY. A health
2-47 professional, a health facility, or an administrator, officer, or
2-48 employee of a health facility subject to this chapter is not
2-49 civilly or criminally liable for divulging information required to
2-50 be released under this chapter, except in a case of gross
2-51 negligence or wilful misconduct.
2-52 Sec. 87.005. COOPERATION OF GOVERNMENTAL ENTITIES. Another
2-53 state board, commission, agency, or governmental entity capable of
2-54 assisting the department in carrying out the intent of this chapter
2-55 shall cooperate with the department and furnish expertise,
2-56 services, and facilities to the program.
2-57 Sec. 87.006. SCIENTIFIC ADVISORY COMMITTEE. (a) The
2-58 director shall establish a scientific advisory committee to provide
2-59 practical and scientific advice to the department in implementing
2-60 an effective birth defects registry and related research, referral,
2-61 and educational activities.
2-62 (b) The committee may be composed of not more than 11
2-63 members and must include scientific experts in the fields of birth
2-64 defects, genetics, epidemiology, and medicine. At least one member
2-65 must be from the general public.
2-66 (c) If the department implements a pilot birth defects
2-67 registry in selected regions of the state, membership of the
2-68 scientific advisory committee must include persons who work or live
2-69 in the areas where the pilot birth defects registry activity is
2-70 implemented.
3-1 (Sections 87.007 to 87.020 reserved for expansion
3-2 SUBCHAPTER B. BIRTH DEFECTS MONITORING PROGRAM
3-3 Sec. 87.021. SURVEILLANCE PROGRAM; REGISTRY ESTABLISHED.
3-4 (a) The board may establish in the department a program to:
3-5 (1) identify and investigate certain birth defects in
3-6 children; and
3-7 (2) maintain a central registry of cases of birth
3-8 defects.
3-9 (b) The board may authorize the department to implement a
3-10 statewide program or to limit the program to a part or all of one
3-11 or more public health regions, depending on the funding available
3-12 to the department. In establishing the program, the board shall
3-13 consider:
3-14 (1) the number and geographic distribution of births
3-15 in the state;
3-16 (2) the trained personnel and other departmental
3-17 resources that may be assigned to the program activities; and
3-18 (3) the occurrence or probable occurrence of an urgent
3-19 situation that requires or will require an unusual commitment of
3-20 the department's personnel and other resources.
3-21 (c) The board and the department shall design the program so
3-22 that the program will:
3-23 (1) provide information to identify risk factors and
3-24 causes of birth defects;
3-25 (2) provide information on other possible causes of
3-26 birth defects;
3-27 (3) provide for the development of strategies to
3-28 prevent birth defects;
3-29 (4) provide for interview studies about the causes of
3-30 birth defects;
3-31 (5) together with other departmental programs,
3-32 contribute birth defects data to a central registry;
3-33 (6) provide for the appointment of authorized agents
3-34 to collect birth defects information; and
3-35 (7) provide for the active, not passive, collection of
3-36 birth defects information.
3-37 (d) The board shall adopt rules to govern the operation of
3-38 the program and carry out the intent of this chapter. At a
3-39 minimum, the rules shall:
3-40 (1) use a medically recognized system to specify the
3-41 birth defects to be identified and investigated;
3-42 (2) select a system for classifying the birth defects
3-43 according to the public health significance of each defect to
3-44 prioritize the use of resources;
3-45 (3) develop a system to select and specify the cases
3-46 to be investigated;
3-47 (4) specify a system for selecting the demographic
3-48 areas in which the department may undertake investigations; and
3-49 (5) prescribe the training and experience a person
3-50 must have for appointment as an authorized agent of the department.
3-51 (e) In adopting the rules required by Subsection (d), the
3-52 board shall consider at least:
3-53 (1) the known incidence and prevalence rates of a
3-54 birth defect in the state or portions of the state;
3-55 (2) the known incidence and prevalence rates of a
3-56 particular birth defect in specific population groups who live in
3-57 the state or portions of the state;
3-58 (3) the morbidity and mortality resulting from the
3-59 birth defect; and
3-60 (4) the existence, cost, and availability of a
3-61 strategy to prevent and treat the birth defect.
3-62 Sec. 87.022. DATA COLLECTION. (a) To ensure an accurate
3-63 source of data necessary to investigate the incidence, prevalence,
3-64 and trends of birth defects, the board may require a health
3-65 facility, health professional, or midwife to make available for
3-66 review by the department or by an authorized agent medical records
3-67 or other information that is in the facility's, professional's, or
3-68 midwife's custody or control and that relates to the occurrence of
3-69 a birth defect specified by the board.
3-70 (b) The board by rule shall prescribe the manner in which
4-1 records and other information are made available to the department.
4-2 (c) The board shall adopt procedural rules to facilitate
4-3 cooperation between the health care facility, health professional,
4-4 or midwife and a department employee or authorized agent, including
4-5 rules for notice, requests for medical records, times for record
4-6 reviews, and record management during review.
4-7 Sec. 87.023. REFERRAL FOR SERVICES. A child who meets the
4-8 medical criteria prescribed by board rule, and the child's family,
4-9 shall be referred to the department's case management program for
4-10 guidance in applying for financial or medical assistance available
4-11 through existing state and federal programs.
4-12 (Sections 87.024 to 87.040 reserved for expansion
4-13 SUBCHAPTER C. INVESTIGATIONS AND INSPECTIONS
4-14 Sec. 87.041. INVESTIGATIONS. (a) The department may
4-15 conduct investigations, including epidemiological or toxicological
4-16 investigations, of cases of specified birth defects.
4-17 (b) The department may conduct these investigations to
4-18 determine the nature and extent of the disease or the known or
4-19 suspected cause of the birth defect and to formulate and evaluate
4-20 control measures to protect the public health. The department's
4-21 investigation is not limited to geographic, temporal, or
4-22 occupational associations and may include investigation of past
4-23 exposures.
4-24 (c) A person shall provide medical, demographic,
4-25 epidemiological, toxicological, and environmental information to
4-26 the department under this chapter.
4-27 (d) A person is not liable in damages or other relief for
4-28 providing medical or other confidential information to the
4-29 department during an epidemiological or toxicological
4-30 investigation.
4-31 Sec. 87.042. DEPARTMENTAL INVESTIGATORY POWERS. To conduct
4-32 an investigation under this chapter, the director or the director's
4-33 designee has the same authority to enter, inspect, investigate, and
4-34 take samples and to do so in the same manner as is provided for
4-35 communicable diseases under Sections 81.061, 81.063, 81.064, and
4-36 81.065.
4-37 (Sections 87.043 to 87.060 reserved for expansion
4-38 SUBCHAPTER D. CENTRAL REGISTRY
4-39 Sec. 87.061. REGISTRY; CONFIDENTIALITY. (a) Information
4-40 collected and analyzed by the department or an authorized agent
4-41 under this chapter may be placed in a central registry to
4-42 facilitate research and to maintain security. The department may
4-43 also store information available from other departmental programs
4-44 and information from other reporting systems and healthcare
4-45 providers.
4-46 (b) The department shall use the registry to:
4-47 (1) investigate the causes of birth defects and other
4-48 health conditions;
4-49 (2) design and evaluate measures to prevent the
4-50 occurrence of birth defects and other health conditions; and
4-51 (3) conduct other investigations and activities
4-52 necessary for the board and department to fulfill their obligation
4-53 to protect the health of the public.
4-54 (c) The department may store in the central registry
4-55 information that is obtained from the section of the birth
4-56 certificate entitled "For Medical and Health Use Only." This
4-57 information may be used only as provided by Section 191.002(b),
4-58 relating to the form and contents of the birth certificate.
4-59 Sec. 87.062. ACCESS TO INFORMATION. (a) Access to the
4-60 central registry information is limited to authorized department
4-61 employees and other persons with a valid scientific interest who
4-62 are engaged in demographic, epidemiological, or other studies
4-63 related to health and who agree in writing to maintain
4-64 confidentiality.
4-65 (b) The department shall maintain a listing of each person
4-66 who is given access to the information in the central registry.
4-67 The listing shall include:
4-68 (1) the name of the person authorizing access;
4-69 (2) the name, title, and organizational affiliation of
4-70 each person given access;
5-1 (3) the dates of access; and
5-2 (4) the specific purpose for which the information was
5-3 used.
5-4 (c) The listing is public information, is open to the public
5-5 under the open records law, Chapter 424, Acts of the 63rd
5-6 Legislature, Regular Session, 1973 (Article 6252-17a, Vernon's
5-7 Texas Civil Statutes), and may be inspected during the department's
5-8 normal hours of operation.
5-9 Sec. 87.063. RESEARCH; REVIEW AND APPROVAL. (a) The
5-10 director and the department's committee for the protection of human
5-11 subjects shall review each research proposal that requests the use
5-12 of information in the central registry. The board shall adopt
5-13 rules establishing criteria to be used in deciding if the research
5-14 design should be approved. A proposal that meets the approval
5-15 criteria is considered to establish a valid interest as required by
5-16 Section 87.062(a), and the director and the committee shall
5-17 authorize the researcher to review the records relevant to the
5-18 research proposal and to contact cases and controls.
5-19 (b) If an investigator using central registry data under a
5-20 research design approved under this section believes it is
5-21 necessary to contact case subjects and controls, the investigator
5-22 must submit a protocol describing the purpose and method to the
5-23 director and the department's committee for the protection of human
5-24 subjects. If the contact protocol is approved, the investigator is
5-25 considered to have established a bona fide research, development,
5-26 or planning purpose and is entitled to carry out the contacts
5-27 without securing additional approvals or waivers from any entity.
5-28 Sec. 87.064. REPORT OF CENTRAL REGISTRY ACTIVITIES AND
5-29 FINDINGS. (a) The department shall publish an annual report of
5-30 activities using data contained in the central registry. The
5-31 report shall include:
5-32 (1) a description of research projects in progress
5-33 since the last report and the sponsors and principal investigators
5-34 directing each project;
5-35 (2) results of the completed research projects either
5-36 as an abstract or a complete scientific paper that has been
5-37 reviewed and approved by an appropriate jury;
5-38 (3) a summary of the statistical information compiled
5-39 in the registry, including a specific discussion of any clusters,
5-40 high or low incidences, or prevalences or trends encountered;
5-41 (4) any policy, research, educational, or other
5-42 recommendations the department considers appropriate; and
5-43 (5) such other information the editors of the report
5-44 find is appropriate.
5-45 (b) The department may publish periodic reports in addition
5-46 to the annual report.
5-47 Sec. 87.065. COORDINATION WITH MEXICO. In developing the
5-48 central registry and conducting research in areas of this state
5-49 that border Mexico, the department shall make every effort to
5-50 coordinate its efforts with similar efforts and research programs
5-51 in Mexico.
5-52 SECTION 2. (a) This Act takes effect September 1, 1993.
5-53 (b) The Texas Board of Health shall adopt rules as required
5-54 by Chapter 87, Health and Safety Code, as added by this Act, not
5-55 later than October 15, 1993.
5-56 (c) The Texas Department of Health shall begin to collect
5-57 information as required by Chapter 87, Health and Safety Code, as
5-58 added by this Act, not later than January 1, 1994.
5-59 SECTION 3. The importance of this legislation and the
5-60 crowded condition of the calendars in both houses create an
5-61 emergency and an imperative public necessity that the
5-62 constitutional rule requiring bills to be read on three several
5-63 days in each house be suspended, and this rule is hereby suspended.
5-64 * * * * *
5-65 Austin,
5-66 Texas
5-67 March 9, 1993
5-68 Hon. Bob Bullock
5-69 President of the Senate
5-70 Sir:
6-1 We, your Committee on Health and Human Services to which was
6-2 referred S.B. No. 89, have had the same under consideration, and I
6-3 am instructed to report it back to the Senate with the
6-4 recommendation that it do not pass, but that the Committee
6-5 Substitute adopted in lieu thereof do pass and be printed.
6-6 Zaffirini,
6-7 Chair
6-8 * * * * *
6-9 WITNESSES
6-10 FOR AGAINST ON
6-11 ___________________________________________________________________
6-12 Name: Michele Trepagnier x
6-13 Representing: March of Dimes
6-14 City: Austin
6-15 -------------------------------------------------------------------
6-16 Name: Joyce Gates x
6-17 Representing: March of Dimes
6-18 City: Austin
6-19 -------------------------------------------------------------------