16 Del. Admin. Code § 4107-2.0
"Blood Specimen for Metabolic, Hematologic and Endocrinologic Disorders" means a dried blood spot on a special filter paper utilized for screening (not diagnostic) tests to establish the likely presence of metabolic, hematologic or endocrinologic disorders.
"Certain Structural Disorders" includes critical congenital heart defects and other structural disorders.
"Designated Laboratory" is the laboratory or laboratories, which have been selected by the Division of Public Health to perform these services.
"Endocrinologic Disorder" means the absence or deficiency of a hormone resulting in interference with normal health, growth or development. These disorders include Congenital Hypothyroidism (CH) and Congenital Adrenal Hyperplasia (CAH).
"Hematologic Disorder" means, in these regulations, a condition in which a variation in one or more of the hemoglobin structural genes or in one or more of the genes involved in hemoglobin synthesis produces a variation in hemoglobin structure or synthesis, which results in variation in hemoglobin function. The term "hemoglobinopathies" includes sickle cell anemia, sickle cell hemoglobin C disease (SC disease), sickle beta thalassemia, beta thalassemia, alpha thalassemia, hemoglobin C disease and other clinically important variations in hemoglobin structure or synthesis.
"Kit" means any or all parts of the combined materials, laboratory filter paper, specimen forms, Newborn Screening Program brochure, and/or other components provided by the State Newborn Screening Program for the purposes of collection of the blood spot specimen and for submission of the blood spot specimen for laboratory screening.
"Metabolic Disorder" means a disorder caused by a genetic alteration, which results in a defect in the structure or function of a specific enzyme or other protein. These disorders include, but are not limited to, Phenylketonuria (PKU), Galactosemia, Maple Syrup Urine Disease (MSUD), and Medium Chain Acyl-CoA Dehydrogenase (MCAD) Deficiency.
"Newborn Infant" means any infant born in the state who is under 4 weeks of age.
"Pulse Oximetry Screening" is non-evasive test allowing for determination of the oxygen saturation of a patient's hemoglobin to screen for a critical congenital heart defect.
"Satisfactory Specimen" means a blood spot specimen on which an accurate laboratory analysis for the various disorders can be performed.
"The Newborn Screening Advisory Committee" means a committee, established through the Division of Public Health Newborn Screening Program, convened to provide advice and guidance to the Program. Members are appointed by the Governor and include: three individuals or parents of individuals affected by disorders identified by the screening panel; an ethicist; an attorney not employed by the State; three pediatric physicians; the Medical Director for the Division of Public Health, or their designee; the Laboratory Director for the Division of Public Health, or their designee; a representative from the Department of Services for Children, Youth, and Their Families; the Chair of the Midwifery Advisory Council, or their designee; and a member of the public. The Committee will meet at least semi-annually.
"Unsatisfactory Specimen" means a blood spot specimen that is of insufficient quantity; or a blood spot specimen on which an accurate analysis for the various disorders cannot be performed.
16 Del. Admin. Code § 4107-2.0
23 DE Reg. 378( 11/1/2019) (Final)