Ga. Comp. R. & Regs. R. 511-5-5-.02 - Definitions

(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.

Notes

Ga. Comp. R. & Regs. R. 511-5-5-.02

O.C.G.A. §§ 31-2A-6; 31-12-5 through -7; 31-22-2.

Original Rule entitled "Provisions" adopted. F. Sep. 20, 2013; eff. Oct. 10, 2013. Repealed: New Rule entitled "Definitions" adopted. F. May 13, 2014; eff. June 2, 2014. Amended: F. Nov. 29, 2021; eff. Dec. 29, 2021, as specified by the Agency.