Section 661.15  Definitions

            "Act" means the Phenylketonuria Testing Act [410 ILCS 240].

            "Advisory Committee" means the Genetic and Metabolic Diseases Advisory Committee appointed by the Director.

            "CF" means cystic fibrosis.

            "CLSI" means Clinical and Laboratory Standards Institute.

            "Department" or "DPH" means the Department of Public Health.

            "Director" means the Director of the Department of Public Health.

"Formula" means a medically prescribed treatment substance that has been designed to treat a specific metabolic disorder.

"Newborn screening" or "testing" means the testing of a blood sample for classical phenylketonuria (PKU) and certain other amino acid, organic acid, and fatty acid oxidation disorders, primary hypothyroidism, classical galactosemia, congenital adrenal hyperplasia due to 21-hydroxylase deficiency, biotinidase deficiency, sickle cell disease/trait and cystic fibrosis.  At times, variant forms of some disorders, or related conditions, may also be identified.

            "PKU" means classical phenylketonuria.

            "Tandem mass spectrometry" means use of a tandem mass spectrometer and associated software to test a newborn screening sample.

            "MS/MS" means Tandem Mass Spectrometry.

            "Using accepted statistical techniques" means using techniques that have been published in peer reviewed scientific literature.

(Source:  Amended at 31 Ill. Reg. 13203, effective August 28, 2007)