1. (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, which is titled "Birth Defects and Genetic Branch 6-Digit Code for Reportable Congenital Anomalies" dated June 1993.
2. (b) The central registry will cover only the pilot project area until resources necessary to expand statewide are allocated.

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

   1. (1) The county of occurrence of birth or the mother's residence at the time of birth must have been in a Texas county covered by the central registry.
   2. (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. (3) The defect must be diagnosed or its signs and symptoms must be recognized within the first year of life. In certain circumstances (e.g., the surveillance of fetal alcohol syndrome, special studies and childhood genetic disorders diagnosed after infancy), the upper age limit will be extended to age six.
4. (d) 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.

5. (e) Each health care facility midwife's office, birthing center, pregnancy termination center and physician likely to have knowledge of a birth defect case and located in a county covered by the registry shall receive an introductory letter from the Texas Department of Health's director of the Texas Birth Defects Monitoring Division, providing materials about Chapter 87 of the Health and Safety Code, relating to birth defects and the rules in this section relating to their participation in the surveillance system. Additional information shall be available upon request.

   1. (1) The chief operating officer, administrator, manager, director, and/or person in charge of each facility or office shall appoint one staff member as the contact person for the central registry surveillance activities. That staff member will coordinate scheduled visits by central registry staff to review logs, discharge indices and other case-finding sources, and will be responsible for arranging medical records review visits and record management.
   2. (2) Potential cases are obtained through review of medical and health records, logs, indices, appointment rosters, and other records.
   3. (3) Central registry staff and the contact individual shall establish a general schedule of case-finding and record review visits. This schedule shall take into account the capabilities of the health care facility in responding to requests, as well as the expected needs of the central registry workload.
6. (f) The medical records and other materials provided by the health care facility shall not be removed from that facility. If copies are made, central registry staff must abide by procedures regarding copier use agreed upon with each health care facility. All information, either on paper or in electronic form, which is removed from the health care facility shall be transported by secure means at all times. Forms, notes, and other information will be carried in locked brief cases and will be stored in locked offices or lockable file cabinets.

7. (g) The following general skills and qualifications shall be required for employment in the Texas Birth Defects Monitoring Division.

   1. (1) The Director of the Texas Birth Defects Monitoring Division shall possess doctoral level training in the medical or public health sciences and experience in public health surveillance or birth defects. He/she shall conduct himself/herself in a professional manner and shall have signed an agreement to actively protect the confidentiality of patient information.
   2. (2) Persons who will conduct case-finding and data abstraction shall possess knowledge of basic medical terminology, be able to interpret complex medical record information, conduct themselves in a professional manner, and shall have signed an agreement to actively protect the confidentiality of the patient information they collect and process.
   3. (3) All other employees shall conduct themselves in a professional manner, and shall have signed an agreement to actively protect the confidentiality of all patient information.

Source Note:The provisions of this §37.305 adopted to be effective October 20, 1994, 19 TexReg 8032.