By: Brady H.B. No. 1801
73R635 LGF-D
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to establishing a birth defects registry.
1-3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-4 SECTION 1. Subtitle D, Title 2, Health and Safety Code, is
1-5 amended by adding Chapter 87 to read as follows:
1-6 CHAPTER 87. BIRTH DEFECTS
1-7 SUBCHAPTER A. GENERAL PROVISIONS
1-8 Sec. 87.001. DEFINITIONS. In this chapter:
1-9 (1) "Birth defect" means a physical or mental
1-10 functional deficit or impairment in a human embryo, fetus, or
1-11 newborn resulting from one or more genetic or environmental causes.
1-12 (2) "Communicable disease" has the meaning assigned by
1-13 Section 81.003.
1-14 (3) "Environmental causes" means the sum total of all
1-15 the conditions and elements that make up the surroundings and
1-16 influence the development of an individual, including communicable
1-17 diseases, toxic substances, and harmful physical agents.
1-18 (4) "Harmful physical agent" has the meaning assigned
1-19 by Section 503.001.
1-20 (5) "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 (6) "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 (7) "Midwife" has the meaning assigned by Section 1,
2-20 Texas Midwifery Act (Article 4512i, Vernon's Texas Civil Statutes).
2-21 (8) "Local health unit" has the meaning assigned by
2-22 Section 121.004.
2-23 (9) "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 and
3-22 monitoring 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 in a
3-27 medical emergency to protect the health or life of the child
4-1 identified in the information.
4-2 (d) A board member, the commissioner, another employee of
4-3 the department or an authorized agent may not be examined in a
4-4 civil, criminal, special, or other proceeding as to the existence
4-5 or contents of pertinent records of, or reports or information
4-6 about, a child identified or monitored for a birth defect by the
4-7 department without the consent of the child's parents, managing
4-8 conservator, guardian, or other person authorized by law of another
4-9 state or 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 (Sections 87.006-87.020 reserved for expansion
4-27 SUBCHAPTER B. BIRTH DEFECTS MONITORING PROGRAM
5-1 Sec. 87.021. SURVEILLANCE PROGRAM; REGISTRY ESTABLISHED.
5-2 (a) The board may establish in the department a program to:
5-3 (1) identify and investigate certain birth defects in
5-4 children; and
5-5 (2) maintain a central registry of cases of birth
5-6 defects.
5-7 (b) The board may authorize the department to implement a
5-8 statewide program or to limit the program to a part or all of one
5-9 or more public health regions, depending on the funding available
5-10 to the department. In establishing the program, the board shall
5-11 consider:
5-12 (1) the number and geographic distribution of births
5-13 in the state;
5-14 (2) the trained personnel and other departmental
5-15 resources that may be assigned to the program activities; and
5-16 (3) the occurrence or probable occurrence of an urgent
5-17 situation that requires or will require an unusual commitment of
5-18 the department's personnel and other resources.
5-19 (c) The board and the department shall design the program so
5-20 that the program will:
5-21 (1) provide information on the incidence, prevalence,
5-22 and trends in the occurrence of birth defects in the state;
5-23 (2) provide information to determine if environmental
5-24 hazards are associated with birth defects and to identify those
5-25 environmental hazards;
5-26 (3) provide information on other possible causes of
5-27 birth defects;
6-1 (4) provide for the development of strategies to
6-2 prevent birth defects;
6-3 (5) provide for interview studies about the causes of
6-4 birth defects;
6-5 (6) together with other departmental programs,
6-6 contribute birth defects data to a central registry; and
6-7 (7) provide for the appointment of authorized agents
6-8 to collect birth defect information.
6-9 (d) The board shall adopt rules to govern the operation of
6-10 the program and carry out the intent of this chapter. At a
6-11 minimum, the rules shall:
6-12 (1) use a medically recognized system to specify the
6-13 birth defects to be identified and investigated;
6-14 (2) select a system for classifying the birth defects
6-15 according to the public health significance of each defect to
6-16 prioritize the use of resources;
6-17 (3) develop a system to select and specify the cases
6-18 to be investigated;
6-19 (4) specify a system for selecting the demographic
6-20 areas in which the department may undertake investigations; and
6-21 (5) prescribe the training and experience a person
6-22 must have for appointment as an authorized agent of the department.
6-23 (e) In adopting the rules required by Subsection (d), the
6-24 board shall consider at least:
6-25 (1) the known incidence and prevalence rates of a
6-26 particular birth defect in specific population groups who live in
6-27 the state or portions of the state;
7-1 (2) the known incidence and prevalence rates of a
7-2 particular birth defect in specific population groups who live in
7-3 the state or portions of the state;
7-4 (3) the morbidity and mortality resulting from the
7-5 birth defect; and
7-6 (4) the existence, cost, and availability of a
7-7 strategy to prevent and treat the birth defect.
7-8 Sec. 87.022. DATA COLLECTION. (a) To ensure an accurate
7-9 source of data necessary to investigate the incidence, prevalence,
7-10 and trends of birth defects, the board may require a health
7-11 facility, health professional, or midwife to make available for
7-12 review by the department or by an authorized agent medical records
7-13 or other information that is in the facility's, professional's, or
7-14 midwife's custody or control and that relates to the occurrence of
7-15 a birth defect specified by the board.
7-16 (b) The board by rule shall prescribe the manner in which
7-17 records and other information are made available to the department.
7-18 The rules may require that the following sources be made available
7-19 to the department or an authorized agent:
7-20 (1) the medical records of a child reported as having
7-21 a specified birth defect;
7-22 (2) the medical records of that child's natural
7-23 parents and other appropriate collateral relatives;
7-24 (3) the medical records of a mother suspected of or
7-25 diagnosed as having a fetal death, miscarriage, or pregnancy
7-26 termination, if the embryo or fetus was suspected or diagnosed as
7-27 having a specified birth defect; and
8-1 (4) the records of another person who has agreed to
8-2 serve as a control for interview studies about the causes of birth
8-3 defects.
8-4 (c) The board shall adopt procedural rules to facilitate
8-5 cooperation between the health care facility, health professional,
8-6 or midwife and a department employee or authorized agent, including
8-7 rules for notice, requests for medical records, times for record
8-8 reviews, and record management during review.
8-9 Sec. 87.023. REFERRAL FOR SERVICES. A child who meets the
8-10 medical criteria prescribed by board rule, and the child's family,
8-11 may be referred to the department's case management program for
8-12 guidance in applying for financial or medical assistance available
8-13 through existing state and federal programs.
8-14 (Sections 87.024-87.040 reserved for expansion
8-15 SUBCHAPTER C. INVESTIGATIONS AND INSPECTIONS
8-16 Sec. 87.041. INVESTIGATIONS. (a) The department may
8-17 conduct investigations, including epidemiological or toxicological
8-18 investigations, of cases of specified birth defects.
8-19 (b) The department may conduct these investigations to
8-20 determine the nature and extent of the disease or environmental
8-21 exposure believed or suspected to have resulted in the birth defect
8-22 and to formulate and evaluate control measures to protect the
8-23 public health. The department's investigation is not limited to
8-24 geographic, temporal, or occupational associations and may include
8-25 investigation of past exposures.
8-26 (c) A person shall provide medical, demographic,
8-27 epidemiological, toxicological, and environmental information to
9-1 the department under this chapter.
9-2 (d) A person is not liable in damages or other relief for
9-3 providing medical or other confidential information to the
9-4 department during an epidemiological or toxicological
9-5 investigation.
9-6 Sec. 87.042. DEPARTMENTAL INVESTIGATORY POWERS. To conduct
9-7 an investigation under this chapter, the commissioner or the
9-8 commissioner's designee has the same authority to enter, inspect,
9-9 investigate, and take samples and to do so in the same manner as is
9-10 provided for communicable diseases under Sections 81.061, 81.063,
9-11 81.064, and 81.065.
9-12 (Sections 87.043-87.060 reserved for expansion
9-13 SUBCHAPTER D. CENTRAL REGISTRY
9-14 Sec. 87.061. REGISTRY; CONFIDENTIALITY. (a) Information
9-15 collected and analyzed by the department or an authorized agent
9-16 under this chapter may be placed in a central registry to
9-17 facilitate research and to maintain security. The department may
9-18 also store information available from other departmental programs
9-19 and information from other reporting systems and healthcare
9-20 providers.
9-21 (b) The department shall use the registry to:
9-22 (1) investigate the causes of birth defects and other
9-23 health conditions;
9-24 (2) design and evaluate measures to prevent the
9-25 occurrence of birth defects and other health conditions; and
9-26 (3) conduct other investigations and activities
9-27 necessary for the board and department to fulfill their obligation
10-1 to protect the health of the public.
10-2 (c) The department may store in the central registry
10-3 information that is obtained from the section of the birth
10-4 certificate entitled "For Medical and Health Use Only." This
10-5 information may be used only as provided by Section 191.002(b),
10-6 relating to the form and contents of the birth certificate.
10-7 Sec. 87.062. ACCESS TO INFORMATION. (a) Access to the
10-8 central registry information is limited to authorized department
10-9 employees and other persons with a valid scientific interest who
10-10 are engaged in demographic, epidemiological, or other studies
10-11 related to health and who agree in writing to maintain
10-12 confidentiality.
10-13 (b) The department shall maintain a listing of each person
10-14 who is given access to the information in the central registry.
10-15 The listing shall include:
10-16 (1) the name of the person authorizing access;
10-17 (2) the name, title, and organizational affiliation of
10-18 each person given access;
10-19 (3) the dates of access; and
10-20 (4) the specific purpose for which the information was
10-21 used.
10-22 (c) The listing is public information, is open to the public
10-23 under the open records law, Chapter 424, Acts of the 63rd
10-24 Legislature, Regular Session, 1973 (Article 6252-17a, Vernon's
10-25 Texas Civil Statutes), and may be inspected during the department's
10-26 normal hours of operation.
10-27 Sec. 87.063. RESEARCH; REVIEW AND APPROVAL. (a) The
11-1 commissioner and the department's committee for the protection of
11-2 human subjects shall review each research proposal that requests
11-3 the use of information in the central registry. The board shall
11-4 adopt rules establishing criteria to be used in deciding if the
11-5 research design should be approved. A proposal that meets the
11-6 approval criteria is considered to establish a valid interest as
11-7 required by Section 87.062(a), and the commissioner and the
11-8 committee shall authorize the researcher to review the records
11-9 relevant to the research proposal and to contact cases and
11-10 controls.
11-11 (b) If an investigator using central registry data under a
11-12 research design approved under this section believes it is
11-13 necessary to contact case subjects and controls, the investigator
11-14 must submit a protocol describing the purpose and method to the
11-15 commissioner and the department's committee for the protection of
11-16 human subjects. If the contact protocol is approved, the
11-17 investigator is considered to have established a bona fide
11-18 research, development, or planning purpose and is entitled to carry
11-19 out the contacts without securing additional approvals or waivers
11-20 from any entity.
11-21 Sec. 87.064. REPORT OF CENTRAL REGISTRY ACTIVITIES AND
11-22 FINDINGS. The department may publish a periodic report of
11-23 activities using data contained in the central registry. The
11-24 report may include:
11-25 (1) a description of research projects in progress
11-26 since the last report and the sponsors and principal investigators
11-27 directing each project;
12-1 (2) results of the completed research projects either
12-2 as an abstract or a complete scientific paper that has been
12-3 reviewed and approved by an appropriate jury; and
12-4 (3) such other information as the editors of the
12-5 report find is appropriate.
12-6 SECTION 2. (a) This Act takes effect September 1, 1993.
12-7 (b) The Texas Board of Health shall adopt rules as required
12-8 by Chapter 87, Health and Safety Code, as added by this Act, not
12-9 later than October 15, 1993.
12-10 (c) The Texas Department of Health shall begin to collect
12-11 information as required by Chapter 87, Health and Safety Code, as
12-12 added by this Act, not later than January 1, 1994.
12-13 SECTION 3. The importance of this legislation and the
12-14 crowded condition of the calendars in both houses create an
12-15 emergency and an imperative public necessity that the
12-16 constitutional rule requiring bills to be read on three several
12-17 days in each house be suspended, and this rule is hereby suspended.