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Illinois Compiled Statutes

Information maintained by the Legislative Reference Bureau
Updating the database of the Illinois Compiled Statutes (ILCS) is an ongoing process. Recent laws may not yet be included in the ILCS database, but they are found on this site as Public Acts soon after they become law. For information concerning the relationship between statutes and Public Acts, refer to the Guide.

Because the statute database is maintained primarily for legislative drafting purposes, statutory changes are sometimes included in the statute database before they take effect. If the source note at the end of a Section of the statutes includes a Public Act that has not yet taken effect, the version of the law that is currently in effect may have already been removed from the database and you should refer to that Public Act to see the changes made to the current law.

PUBLIC HEALTH
(410 ILCS 240/) Newborn Metabolic Screening Act.

410 ILCS 240/0.01

    (410 ILCS 240/0.01) (from Ch. 111 1/2, par. 4902.9)
    Sec. 0.01. Short title. This Act may be cited as the Newborn Metabolic Screening Act.
(Source: P.A. 95-695, eff. 11-5-07.)

410 ILCS 240/1

    (410 ILCS 240/1) (from Ch. 111 1/2, par. 4903)
    Sec. 1. The Illinois Department of Public Health shall promulgate and enforce rules and regulations requiring that every newborn be subjected to tests for genetic, metabolic, and congenital anomalies as the Department may deem necessary. The Department is empowered to promulgate such additional rules and regulations as are found necessary for the administration of this Act, including mandatory reporting of the results of all tests for these conditions to the Illinois Department of Public Health.
(Source: P.A. 98-440, eff. 8-16-13.)

410 ILCS 240/1.5

    (410 ILCS 240/1.5)
    Sec. 1.5. Definitions. In this Act:
    "Accredited laboratory" means any laboratory that holds a valid certificate issued under the Clinical Laboratory Improvement Amendments of 1988, 102 Stat. 2903, 42 U.S.C. 263a, as amended, and that reports its screening results by using normal pediatric reference ranges.
    "Department" means the Department of Public Health.
(Source: P.A. 98-440, eff. 8-16-13.)

410 ILCS 240/1.10

    (410 ILCS 240/1.10)
    Sec. 1.10. Critical congenital heart disease.
    (a) The General Assembly finds as follows:
        (1) According to the United States Secretary of
    
Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children, congenital heart disease affects approximately 7 to 9 of every 1,000 live births in the United States and Europe. The federal Centers for Disease Control and Prevention state that critical congenital heart disease is the leading cause of infant death due to birth defects.
        (2) Many newborn lives could potentially be saved by
    
earlier detection and treatment of critical congenital heart disease if health care facilities in the State were required to perform a simple, non-invasive newborn screening in conjunction with current screening methods.
    (b) The Department shall require that screening tests for critical congenital heart defects be performed at birthing hospitals and birth centers in accordance with a testing protocol adopted by the Department, by rule, in line with current standards of care, such as pulse oximetry screening, and may authorize screening tests for additional congenital anomalies to be performed at birthing hospitals and birth centers in accordance with a testing protocol adopted by the Department, by rule.
    (c) The Department may authorize health care facilities to report screening test results and follow-up information.
(Source: P.A. 98-440, eff. 8-16-13.)

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) The Department may develop a reasonable fee
    
structure and may levy 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. 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) The Department shall 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. 97-227, eff. 1-1-12; 97-532, eff. 8-23-11; 97-813, eff. 7-13-12; 98-440, eff. 8-16-13.)

410 ILCS 240/3

    (410 ILCS 240/3) (from Ch. 111 1/2, par. 4905)
    Sec. 3. The provisions of this Act shall not apply when parent or guardian of the child objects thereto on the grounds that such test conflicts with his religious tenets and practices. A written statement of such objection shall be presented to the physician or other person whose duty it is to administer and report such tests under the provisions of this Act.
(Source: Laws 1965, p. 284.)

410 ILCS 240/3.1

    (410 ILCS 240/3.1)
    Sec. 3.1. Lysosomal storage disorders. In accordance with the timetable specified in this Section, the Department shall provide all newborns with screening tests for the presence of certain lysosomal storage disorders known as Krabbe, Pompe, Gaucher, Fabry, and Niemann-Pick. The testing shall begin within 6 months following the occurrence of all of 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 Federal 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 these processes;
        (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 Section 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 Section.
    It was the goal of Public Act 97-532 that the screening for the specified lysosomal storage disorders begins within 2 years after August 23, 2011 (the effective date of Public Act 97-532). The Department is authorized to implement an additional fee for the screening prior to beginning the testing in order to accumulate the resources for start-up and other costs associated with implementation of the screening and thereafter to support the costs associated with screening and follow-up programs for the specified lysosomal storage disorders.
(Source: P.A. 98-440, eff. 8-16-13.)

410 ILCS 240/3.2

    (410 ILCS 240/3.2)
    Sec. 3.2. Severe combined immunodeficiency disease. In accordance with the timetable specified in this Section, the Department shall provide all newborns with screening tests for the presence of severe combined immunodeficiency disease (SCID). The testing shall begin within 12 months following the occurrence of all of 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 Federal 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 and
    
comparative threshold values for SCID;
        (3) the acquisition and installment by the Department
    
of the equipment necessary to implement the initial pilot and statewide volume of screening tests for SCID;
        (4) the establishment of precise threshold values
    
ensuring defined disorder identification for SCID;
        (5) the authentication of pilot testing achieving
    
each milestone described in items (1) through (4) of this Section for SCID; and
        (6) the authentication of achieving the potential of
    
high throughput standards for statewide volume of the SCID screening test concomitant with each milestone described in items (1) through (4) of this Section.
    It was the goal of Public Act 97-532 that the screening for severe combined immunodeficiency disease begins within 2 years after August 23, 2011 (the effective date of Public Act 97-532). The Department is authorized to implement an additional fee for the screening prior to beginning the testing in order to accumulate the resources for start-up and other costs associated with implementation of the screening and thereafter to support the costs associated with screening and follow-up programs for severe combined immunodeficiency disease.
(Source: P.A. 98-440, eff. 8-16-13.)

410 ILCS 240/3.3

    (410 ILCS 240/3.3)
    Sec. 3.3. Mucopolysacchardosis disorders. In accordance with the timetable specified in this Section, the Department shall provide all newborns with screening tests for the presence of certain lysosomal storage disorders known as mucopolysaccharidosis I (Hurlers) and mucopolysaccharidosis II (Hunters). The testing shall begin within 12 months following the occurrence of all of 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 Federal 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 and
    
comparative threshold values for each screening test and accompanying disorder;
        (3) the acquisition and installment by the Department
    
of the equipment necessary to implement the initial pilot and statewide volume of screening tests for each disorder;
        (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 Section 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 Section.
    It was the goal of Public Act 97-532 that the screening for the specified lysosomal storage disorders begins within 3 years after August 23, 2011 (the effective date of Public Act 97-532). The Department is authorized to implement an additional fee for the screening prior to beginning the testing in order to accumulate the resources for start-up and other costs associated with implementation of the screening and thereafter to support the costs associated with screening and follow-up programs for the specified lysosomal storage disorders.
(Source: P.A. 98-440, eff. 8-16-13.)