Compilation of Rules and Regulations of the State of Georgia › Department 511 - RULES OF GEORGIA DEPARTMENT OF PUBLIC HEALTH › Chapter 511-5 - HEALTH PROMOTION › Subject 511-5-5 - TESTING FOR INHERITED DISORDERS IN THE NEWBORN › Rule 511-5-5-.02 - Definitions

Current through Rules and Regulations filed through June 27, 2024
(a) "Abnormal test
				result" is a test result from blood testing or physiologic monitoring that is
				outside the screening limits set forth in the current edition of the
				Department's "Georgia Newborn Screening Program Policy and Procedure
				Manual";
(b) "Adequate specimen" is
				a dried blood spot specimen that is properly collected in accordance with the
				current edition of the Department's "Georgia Newborn Screening Program Policy
				and Procedure Manual";
(c)
				"Approved laboratory" is a laboratory which has been specifically approved by
				the Department to conduct laboratory analysis of dried blood spot specimens for
				the disorders specified in the Georgia Newborn Screening Policy and Procedure
				Manual;
(d) "Automated auditory
				brainstem response" or "aABR" is a specific test method that measures the
				brainstem's response to acoustic stimulation of the ear, using equipment that
				automatically provides a pass/refer outcome;
(e) "Automated Otoacoustic Emissions Testing"
				or "aOAE" is a specific test method that elicits a physiologic response from
				the outer hair cells in the cochlea, using equipment that automatically
				provides a pass/refer outcome;
(f)
				"Birthing center" means any facility that is licensed by the Georgia Department
				of Community Health as a birthing center;
(g) "Critical Congenital Heart Disease" or
				CCHD refers to a group of serious heart defects that are present from birth,
				including coarctation of the aorta, double-outlet right ventricle,
				D-transposition of the great arteries, Ebstein anomaly, hypoplastic left heart
				syndrome, interrupted aortic arch, pulmonary atresia, single ventricle, total
				anomalous pulmonary venous connection, tetralogy of Fallot, tricuspid atresia,
				and truncus arteriosus;
(h)
				"Department" means the Georgia Department of Public Health;
(i) "Hospital" means any facility that is
				licensed by the Georgia Department of Community Health as a hospital;
(j) "Newborn Screening Specimen Card" or "NBS
				Card" means the current version of DPH Form 3491 used to collect information
				and blood specimen from a newborn baby;
(k) "Newborn Hearing Screening Test" means
				the completion of an objective, physiological test or battery of tests
				administered to determine the infant's hearing status and the need for further
				diagnostic testing by an audiologist or physician in accordance with the
				Georgia Newborn Screening Program Policy and Procedure Manual's approved
				instrumentation, protocols and pass/refer criteria;
(l) "Newborn Screening and Genetics Advisory
				Committee (NBSAC)" is a multi-disciplinary group of professional and consumer
				representatives with knowledge and expertise in newborn screening programs
				appointed by the Commissioner of Public Health;
(m) "Submitter" means any person or entity
				submitting a Newborn Screening Specimen Card for analysis;
(n) "Unsatisfactory Specimen" is a dried
				blood spot specimen that is rejected by the laboratory because the quality of
				the specimen does not allow accurate testing, or because critical information
				is missing from the NBS Card which inhibits the laboratory's ability to
				accurately identify the baby or interpret the test results.
O.C.G.A. §§
											31-2A-6;
				  31-12-5 through  -7; 31-22-2.