(a) All newborns in Delaware shall have a satisfactory blood specimen taken prior to 72 hours of age and shall been screened for metabolic, hematologic, endocrinologic, immunologic and certain structural disorders. Parents may elect not to participate in any of the following:
(1) Screening to be performed;
(2) The blood spot to be stored following testing; and/or
(3) The results of the screen to be securely shared electronically through a health information exchange so that health-care providers can appropriately access information.
(b) The informed consent process shall assure that the parent or guardian who elects that a newborn shall not be tested understands the consequences of such a decision, including the inability to prevent developmental delay and death. Language conveying such information shall be recommended by the Committee for approval by the Division Director.
(c) There will be no research utilizing the stored blood specimens or the stored data without parental consent, except for population-based studies in which all identifying information is removed; the blood spots may be used within the Division of Public Health for quality assurance or performance improvement activities including pilot studies when a new disorder is being considered for addition to the panel, or may be used by Division of Public Health for any other purpose authorized by law.
80 Del. Laws, c. 96, § 1.
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