Texas Birth Defects Registry Enabling Law and Rules

Law: Texas Health and Safety Code, Title 2, Subtitle D, Chapter 87.  Effective September 1, 1993.

Rules: Texas Administrative Code, Title 25, Part 1, Chapter 37, Subchapter P.  Revised November 4, 2009. 

Passive Reporting of Specific Laboratory Information to the Birth Defects Epidemiology and Surveillance Branch

Important Update:

Changes to the Texas Administrative Code permit the passive reporting of specific laboratory information to the Birth Defects Epidemiology and Surveillance Branch. Beginning in 2010, fetal and infant chromosomal test results for ICD 9-CM codes of 758 (Chromosomal anomalies) and 759 (Other and unspecified congenital anomalies) became a notifiable condition through the National Electronic Disease Surveillance System (NEDSS). The chromosomal results will be used to clarify those genetic conditions of birth defects cases that have not been definitively diagnosed in the Registry.

What to Report:

• Current Procedural Terminology (CPT) codes: 88245, 88248, 88249, 88261-88264, 88267, 88269, 88271, 88272-88275, 88280, 88283, 88285, and 88289.
• Both positive and negative karyotype results among fetuses and infants (less than 1 year of age).
• Both positive and negative Fluorescence In Situ Hybridization (FISH) results among fetuses and infants (less than 1 year of age).
• Please note that microarray testing (Chromosome Microarray Analysis [CMA] and array Comparative Genome Hybridization [aCGH]) results will not be collected at this time.

Selected Excerpts from the Texas Health and Safety Code

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

(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.

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.

Selected Excerpts from the Texas Administrative Code

RULE §37.303 Definitions

(10) Health facility--Any of the following types of facility:

      (A) a general or special hospital licensed by the department under Health and Safety Code,
      Chapter 241;

      (B) a physician-owned or physician-operated clinic;

      (E) a genetic evaluation and counseling center;

      (I) a clinical or medical laboratory.   

(14) Surveillance--The systematic collection, analysis, interpretation, and dissemination of health data on an ongoing basis.

      (A) Active surveillance--program staff regularly contact or visit data sources, or use remote
      electronic access, to find and collect data on cases.

      (B) Passive surveillance--program receives case reports from data sources.

RULE §37.305 Surveillance of Birth Defects: Central Registry

(a) The central registry shall use a birth defects coding scheme used by the Centers for Disease Control and Prevention (CDC) of the United States Public Health Service in their birth defects monitoring programs.

(b) In order for information related to a child to be included in the central registry, the following conditions must be met.

      (1) The county of occurrence of birth or the mother's residence at the time of birth must have
      been in Texas.

      (2) The child must have a structural or genetic birth defect or other specified outcome that can 
      adversely affect his or her health and development as defined in subsection (a) of this section.

      (3) The defect must be diagnosed prenatally or within one year after delivery. In certain
      circumstances (e.g., the diagnosis of fetal alcohol syndrome, special studies and childhood 
      genetic disorders diagnosed after infancy), the upper age limit will be extended to age six.

(c) A reportable defect as defined in subsection (a) of this section occurring in a fetal death or pregnancy termination shall be included in the central registry.

(d) Interaction between department staff and health facility staff is detailed below:

      (2) Potential cases are obtained by department staff through review of medical and health records, 
      logs, indices, appointment rosters, and other records. Cases may also be obtained through passive 
      reporting from health facilities and health professionals.