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RULE §37.305Surveillance 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.

  (4) In addition, reports of Fetal Alcohol Spectrum Disorders (FASD), regardless of the affected person's age, will be collected under Health and Safety Code, §87.021(f), of the statute providing for passive data collection.

(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:

  (1) The chief operating officer, administrator, manager, director, and/or person in charge of each facility or office or center shall appoint one staff member as the contact person for the central registry surveillance activities. That staff member will coordinate scheduled visits and/or remote electronic access by central registry staff to review logs, discharge indices and other case-finding sources, and will be responsible for arranging visits and/or remote electronic access for medical records review and providing the needed records at the time scheduled.

  (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.

  (3) Central registry staff and the contact individual shall establish a general schedule of visits and/or remote electronic access for case-finding and record review. 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.

(e) The medical records and other materials provided by the health care facility shall not be removed from that facility. If copies are made, 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 locked file cabinets.

Source Note: The provisions of this §37.305 adopted to be effective October 20, 1994, 19 TexReg 8032; amended to be effective August 28, 2003, 28 TexReg 6854; amended to be effective December 12, 2005, 30 TexReg 8291; amended to be effective November 4, 2009, 34 TexReg 7649

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