CHAPTER 87. BIRTH DEFECTS - Texas Statutes

HEALTH AND SAFETY CODE

TITLE 2. HEALTH

SUBTITLE D. PREVENTION, CONTROL, AND REPORTS OF DISEASES

CHAPTER 87. BIRTH DEFECTS

SUBCHAPTER A. GENERAL PROVISIONS

Sec. 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(3) Repealed by Acts 1995, 74th Leg., ch. 76, Sec. 8.134, eff.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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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

Sec. 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.

Sec. 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.

Sec. 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

Sec. 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.

Sec. 87.042. DEPARTMENTAL INVESTIGATORY POWERS. To conduct an

investigation 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

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.

Sec. 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.