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410 ILCS 240/2

    (410 ILCS 240/2) (from Ch. 111 1/2, par. 4904)
    Sec. 2. General provisions. The Department of Public Health shall administer the provisions of this Act and shall:
    (a) Institute and carry on an intensive educational program among physicians, hospitals, public health nurses and the public concerning disorders included in newborn screening. This educational program shall include information about the nature of the diseases and examinations for the detection of the diseases in early infancy in order that measures may be taken to prevent the disabilities resulting from the diseases.
    (a-5) Require that all newborns be screened for the presence of certain genetic, metabolic, and congenital anomalies as determined by the Department, by rule.
    (a-5.1) Require that all blood and biological specimens collected pursuant to this Act or the rules adopted under this Act be submitted for testing to the nearest Department laboratory designated to perform such tests. The following provisions shall apply concerning testing:
        (1) Beginning July 1, 2015, the base fee for newborn
screening services shall be $118. The Department may develop a reasonable fee structure and may levy additional fees according to such structure to cover the cost of providing this testing service and for the follow-up of infants with an abnormal screening test; however, additional fees may be levied no sooner than 6 months prior to the beginning of testing for a new genetic, metabolic, or congenital disorder. Fees collected from the provision of this testing service shall be placed in the Metabolic Screening and Treatment Fund. Other State and federal funds for expenses related to metabolic screening, follow-up, and treatment programs may also be placed in the Fund.
        (2) Moneys shall be appropriated from the Fund to the
Department solely for the purposes of providing newborn screening, follow-up, and treatment programs. Nothing in this Act shall be construed to prohibit any licensed medical facility from collecting additional specimens for testing for metabolic or neonatal diseases or any other diseases or conditions, as it deems fit. Any person violating the provisions of this subsection (a-5.1) is guilty of a petty offense.
        (3) If the Department is unable to provide the
screening using the State Laboratory, it shall temporarily provide such screening through an accredited laboratory selected by the Department until the Department has the capacity to provide screening through the State Laboratory. If screening is provided on a temporary basis through an accredited laboratory, the Department shall substitute the fee charged by the accredited laboratory, plus a 5% surcharge for documentation and handling, for the fee authorized in this subsection (a-5.1).
    (a-5.2) Maintain a registry of cases, including information of importance for the purpose of follow-up services to assess long-term outcomes.
    (a-5.3) Supply the necessary metabolic treatment formulas where practicable for diagnosed cases of amino acid metabolism disorders, including phenylketonuria, organic acid disorders, and fatty acid oxidation disorders for as long as medically indicated, when the product is not available through other State agencies.
    (a-5.4) Arrange for or provide public health nursing, nutrition, and social services and clinical consultation as indicated.
    (a-5.5) Utilize the Genetic and Metabolic Diseases Advisory Committee established under the Genetic and Metabolic Diseases Advisory Committee Act to provide guidance and recommendations to the Department's newborn screening program. The Genetic and Metabolic Diseases Advisory Committee shall review the feasibility and advisability of including additional metabolic, genetic, and congenital disorders in the newborn screening panel, according to a review protocol applied to each suggested addition to the screening panel. The Department shall consider the recommendations of the Genetic and Metabolic Diseases Advisory Committee in determining whether to include an additional disorder in the screening panel prior to proposing an administrative rule concerning inclusion of an additional disorder in the newborn screening panel. Notwithstanding any other provision of law, no new screening may begin prior to the occurrence of all the following:
        (1) the establishment and verification of relevant
and appropriate performance specifications as defined under the federal Clinical Laboratory Improvement Amendments and regulations thereunder for U.S. Food and Drug Administration-cleared or in-house developed methods, performed under an institutional review board-approved protocol, if required;
        (2) the availability of quality assurance testing
methodology for the processes set forth in item (1) of this subsection (a-5.5);
        (3) the acquisition and installment by the Department
of the equipment necessary to implement the screening tests;
        (4) the establishment of precise threshold values
ensuring defined disorder identification for each screening test;
        (5) the authentication of pilot testing achieving
each milestone described in items (1) through (4) of this subsection (a-5.5) for each disorder screening test; and
        (6) the authentication of achieving the potential of
high throughput standards for statewide volume of each disorder screening test concomitant with each milestone described in items (1) through (4) of this subsection (a-5.5).
    (a-6) (Blank).
    (a-7) (Blank).
    (a-8) (Blank).
    (b) (Blank).
    (c) (Blank).
    (d) (Blank).
    (e) (Blank).
(Source: P.A. 98-440, eff. 8-16-13; 98-756, eff. 7-16-14; 99-403, eff. 8-19-15.)