Georgia Newborn Genetic Testing & Surveillance System State GA Statute/ Rule STATUTE: Chapter 1 Chapter 2 Chapter 12 Title 33 Chapter 54 RULE: 290-5-.02 and 290-5- 24 Language Specific to Genetic Testing and Surveillance System 31-1-3.1. Reporting disabled newborn persons; referral to treatment and rehabilitative services. (a) It is the intent of the General Assembly to ensure the registration by the department of disabled newborn persons in order that all such persons might obtain referral and other services provided by existing state agencies, departments, other organizations, and individuals. (b) As used in this Code section, the term "disabled newborn person" means a person less than 12 months old who is deaf, blind, or has a serious congenital defect as defined by the department. Exemption Research Authority Consent Required? Dissent Allowed? 31-12-6: 31-12-1. Power to NO YES - (i) The conduct research and religious requirements of studies The Department this Code section of Public Health and with regard to county boards of health screening, are empowered to retrieval, and conduct studies, diagnosis shall research, and training not apply to any appropriate to the infant whose prevention of diseases parents object in and accidents, the use writing thereto and control of toxic on the grounds materials, and the that such tests prevention of and treatment environmental conflict with conditions which, if their religious permitted to develop or tenets and continue, would likely practices. endanger the health of individuals or communities. Copyright Citizens Council for Health Freedom August 2013 1
31-12-6 System for prevention of serious illness, severe physical or developmental disability, and death resulting from inherited metabolic and genetic disorders (a) The department shall promulgate rules and regulations creating a system for the prevention of serious illness, severe physical or developmental disability, and death caused by genetic conditions, such as phenylketonuria, galactosemia, homocystinuria, maple syrup urine disease, hypothyroidism, congenital adrenal hyperplasia, and such other inherited metabolic and genetic disorders as may be identified in the future to result in serious illness, severe physical or developmental disability, and death if undiagnosed and untreated. The system shall have five components: screening newborns for the disorders; retrieving potentially affected screenees back into the health care system; accomplishing specific diagnoses; initiating and continuing therapy; and assessing the program 31-12-7 Rules and regulations regarding tests for sickle cell anemia, sickle cell trait, and other metabolic and genetic disorders; counseling; fees. (a) provided, however, that this Code section shall not apply to any infant whose parents object thereto on the grounds that such tests and treatment conflict with their religious tenets and practices. Chapter 54, Genetic Testing: 33-54-6. Use of information for scientific research purposes authorized. Notwithstanding the provisions of Code Sections 33-54-3 and 33-54-4, any research facility may conduct genetic testing and may use the information derived from genetic testing for scientific research purposes so long as the identity of any individual tested is not disclosed to any third party, except that the individual's identity may be disclosed to the individual's physician with the consent of the individual. (enacted by Ga. L. 1995) [emphasis added] Copyright Citizens Council for Health Freedom August 2013 2
(c) The department shall be responsible for the screening of all newborns for the disorders enumerated and in a manner determined by the department pursuant to rules and regulations and shall be responsible for assessment of the program. 31-12-7. Rules and regulations regarding tests for sickle cell anemia, sickle cell trait, and other metabolic and genetic disorders; counseling; fees: (a) In coordination and association with the system established by the department for the screening, retrieval, and diagnosis of certain metabolic and genetic disorders pursuant to Code Section 31-12-6, the department, or its successor agency or department, shall adopt and promulgate appropriate rules and regulations governing tests for sickle cell anemia, sickle cell trait, and other metabolic and genetic disorders as enumerated by the department pursuant to rules and regulations so that as nearly as possible all newborn infants who are susceptible or likely to have sickle cell anemia, sickle cell 290-5-24-.02 Provisions. (1) Every live born infant shall have an adequate blood test for all disorders defined in Rule 290-5- 24-.01 unless its parents or legal guardians for religious reasons object in writing to such testing. 31-12-5. State-wide network for medical genetics services (a) The department and appropriate medical centers shall cooperate in the development of a state-wide network for medical genetics. (b) The network shall be available state-wide and will be responsible for training of personnel in genetics, research ing inborn errors of metabolism, and quality control of laboratory services for genetics. This system shall also provide counseling regarding genetically caused disorders. Copyright Citizens Council for Health Freedom August 2013 3
trait, or other metabolic and genetic disorders shall receive a test for sickle cell anemia, sickle cell trait, or other metabolic and genetic disorders or all of such conditions as soon after birth as successful testing and treatment therefor may be initiated; 290-5-24-.02 Provisions. (5) Approved laboratories performing mandated newborn screening tests for the purpose of satisfying the legal requirements for testing newborns shall report all such test results to the attending physician and the hospital where the birth occurred; the results shall be made a part of the clinical record Such laboratories shall report all results to the Genetic Newborn Screening Program of the Department on the day the testing is completed and this report shall include the patient s required information. Copyright Citizens Council for Health Freedom August 2013 4
(10) In determining which disorders are to be added or deleted from the newborn screening panel, the Director, Division of Public Health will seek the advice and guidance of the Newborn Screening Advisory Committee (b) Upon consideration of these criteria, the Director will recommend adding or deleting a specific disorder to the Board. Upon approval by the Board, the disorder will be added to or deleted form the newborn screening panel. [ Board not defined] Copyright Citizens Council for Health Freedom August 2013 5