Law:Title 2. Health. Subtitle D. Prevention, Control, And Reports Of Diseases from Chapter 87. Birth Defects (Texas)

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Subtitle D. Prevention, Control, And Reports Of Diseases

Contents

Chapter 87. Birth Defects

Subchapter A. General Provisions

Section  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(3)  Repealed by Acts 1995, 74th Leg., ch. 76, Sec. 8.134, eff.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, Sec. 1, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 8.134, eff. Sept. 1, 1995; Acts 2001, 77th Leg., ch. 1420, Sec. 14.774, eff. Sept. 1, 2001.



Section  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, Sec. 1, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(88), 8.130, eff. Sept. 1, 1995.



Section  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, Sec. 1, eff. Sept. 1, 1993.



Section  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, Sec. 1, eff. Sept. 1, 1993.



Section  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, Sec. 1, eff. Sept. 1, 1993.



Subchapter B. Birth Defects Monitoring Program

Section  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, Sec. 1, eff. Sept. 1, 1993. Amended by Acts 2003, 78th Leg., ch. 1042, Sec. 1, eff. June 20, 2003.



Section  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, Sec. 1, eff. Sept. 1, 1993.



Section  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, Sec. 1, eff. Sept. 1, 1993.



Subchapter C. Investigations And Inspections

Section  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, Sec. 1, eff. Sept. 1, 1993.



Section  87.042.  Departmental Investigatory Powers. To Conduct An Inves

tigation 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, Sec. 1, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 8.132, eff. Sept. 1, 1995.



Subchapter D. Central Registry

Section  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, Sec. 1, eff. Sept. 1, 1993.



Section  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, Sec. 1, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(88), eff. Sept. 1, 1995.



Section  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, Sec. 1, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 8.133, eff. Sept. 1, 1995.



Section  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, Sec. 1, eff. Sept. 1, 1993.



Section  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, Sec. 1, eff. Sept. 1, 1993.


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