Tenn. Code Ann. § 68-5-506 - Creation of Birth Defects Registry

Creation of Birth Defects Registry

In the interest of learning about and preventing the occurrence of birth defects, the general assembly enacted this statute. A birth defect is defined as a structural or biochemical abnormality that is diagnosed at the time of birth and that requires medical or surgical attention or that interferes with normal growth and development. The goals of this statute is to create an ongoing program that monitors birth defects and that provides information on the incidence, prevalence, and trends relating to it. In addition, the assembly hopes to provide insight on possible causes and hopes to provide referrals and information to families with child born with birth defects.

This statute also creates the birth defects registry in the Department of Health. The commissioner of health and an advisory committee shall help the Department establish and maintain this registry. The advisory committee shall include members from various disciplines including gynecology, pediatrics, genetics, epidemiology, biostatistics, hospital administration, state agency service providers, parents who have children with birth defects, members of nonprofit organizations, and members of the general public. This committee shall annually evaluate the adequacy of the registry, and they shall report their findings to the appropriate committees of the general assembly.

The Department will also maintain a system for collecting information needed to carry out the duties of this section. In order to do so, the Department shall have access to any medical records pertaining to birth defects including the mother's records. Anyone who provides information for the purpose of this section shall not be liable for releasing confidential medical records. The Department will be responsible for disseminating information about this registry to participating perinatal centers. This includes an explanation and description about the purpose of the registry and also about how information will be kept confidential.

The registry shall collect information on birth defects, regardless if they occur as live births, still births, or fetal deaths. Information will be collected from children up to five years of age. This registry shall be created as a pilot project and shall include reporting of any of the five designated perinatal centers that choose to be involved in the project. If they are participating, they shall report to the registry as required by the commissioner. 

The Department, with the help of the advisory committee, shall also establish a program that refers families to state resources. In order for a family to participate in this referral program, the child's parents or legal guardian must contact the department and request to be included.

The staff of the registry shall use information that is collected and that is available from other reporting systems to study the causes and prevention measures of birth defects. This will not be limited to geographic, temporal, or occupational associations.

Any information collected pursuant this section shall be confidential. The identity of the individual patient shall only be used for the purposes provided here. The commissioner, with approval of the advisory committee, shall give access to scientists who perform the studies. These scientists must agree in writing, to be identified and coded and to maintain confidentiality with their work. This also applies to the Centers for Disease Control for inclusion in the National Birth Defects registry.

The Department shall maintain an accurate record of all persons who give access to information that is included in the registry. This includes the name of the person who authorized access; the name, title, and organization that person is affiliated with; the dates of the access; the purpose for which information was used; and the result of the independent research. Nothing in this section shall prohibit statistical compilations of this information from being published as long as it does not identify individual sources of information. Anyone who willfully or negligently discloses information that is deemed confidential will be liable of a class A misdemeanor.