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Public Act 098-0440


 

Public Act 0440 98TH GENERAL ASSEMBLY

  
  
  

 


 
Public Act 098-0440
 
HB2661 EnrolledLRB098 09098 RPM 39235 b

    AN ACT concerning health facilities.
 
    Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
 
    Section 5. The Newborn Metabolic Screening Act is amended
by changing Sections 1, 1.5, and 2 and by adding Sections 1.10,
3.1, 3.2, and 3.3 as follows:
 
    (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,
phenylketonuria, hypothyroidism, galactosemia and such other
metabolic, and congenital anomalies diseases as the Department
may deem necessary from time to time. 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. 83-87.)
 
    (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.
    "Expanded screening" means screening for genetic and
metabolic disorders, including but not limited to amino acid
disorders, organic acid disorders, fatty acid oxidation
disorders, and other abnormal profiles, in newborn infants that
can be detected through the use of a tandem mass spectrometer.
    "Tandem mass spectrometer" means an analytical instrument
used to detect numerous genetic and metabolic disorders at one
time.
(Source: P.A. 92-701, eff. 7-19-02.)
 
    (410 ILCS 240/1.10 new)
    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.
 
    (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 the
diseases phenylketonuria, hypothyroidism, galactosemia and
other metabolic diseases. 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 intellectual
disabilities resulting from the diseases.
    (a-5) Require that Beginning July 1, 2002, provide all
newborns be screened with expanded screening tests 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. endocrine, or other metabolic
    disorders, including phenylketonuria, galactosemia,
    hypothyroidism, congenital adrenal hyperplasia,
    biotinidase deficiency, and sickling disorders, as well as
    other amino acid disorders, organic acid disorders, fatty
    acid oxidation disorders, and other abnormalities
    detectable through the use of a tandem mass spectrometer.
        (3) If by July 1, 2002, the Department is unable to
    provide the expanded 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 expanded 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) (e) of this Section.
    (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). In accordance with the timetable specified
in this subsection, provide all newborns with expanded
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:
        (i) 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;
        (ii) the availability of quality assurance testing
    methodology for these processes;
        (iii) the acquisition and installment by the
    Department of the equipment necessary to implement the
    expanded screening tests;
        (iv) establishment of precise threshold values
    ensuring defined disorder identification for each
    screening test;
        (v) authentication of pilot testing achieving each
    milestone described in items (i) through (iv) of this
    subsection (a-6) for each disorder screening test; and
        (vi) authentication achieving potentiality of high
    throughput standards for statewide volume of each disorder
    screening test concomitant with each milestone described
    in items (i) through (iv) of this subsection (a-6).
    It is the goal of Public Act 97-532 that the expanded
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.
    (a-7) (Blank). In accordance with the timetable specified
in this subsection (a-7), provide all newborns with expanded
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:
        (i) 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;
        (ii) the availability of quality assurance testing and
    comparative threshold values for SCID;
        (iii) the acquisition and installment by the
    Department of the equipment necessary to implement the
    initial pilot and expanded statewide volume of screening
    tests for SCID;
        (iv) establishment of precise threshold values
    ensuring defined disorder identification for SCID;
        (v) authentication of pilot testing achieving each
    milestone described in items (i) through (iv) of this
    subsection (a-7) for SCID; and
        (vi) authentication achieving potentiality of high
    throughput standards for statewide volume of the SCID
    screening test concomitant with each milestone described
    in items (i) through (iv) of this subsection (a-7).
    It is the goal of Public Act 97-532 that the expanded
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.
    (a-8) (Blank). In accordance with the timetable specified
in this subsection (a-8), provide all newborns with expanded
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:
        (i) 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;
        (ii) the availability of quality assurance testing and
    comparative threshold values for each screening test and
    accompanying disorder;
        (iii) the acquisition and installment by the
    Department of the equipment necessary to implement the
    initial pilot and expanded statewide volume of screening
    tests for each disorder;
        (iv) establishment of precise threshold values
    ensuring defined disorder identification for each
    screening test;
        (v) authentication of pilot testing achieving each
    milestone described in items (i) through (iv) of this
    subsection (a-8) for each disorder screening test; and
        (vi) authentication achieving potentiality of high
    throughput standards for statewide volume of each disorder
    screening test concomitant with each milestone described
    in items (i) through (iv) of this subsection (a-8).
    It is the goal of Public Act 97-532 that the expanded
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.
    (b) (Blank). Maintain a registry of cases including
information of importance for the purpose of follow-up services
to prevent intellectual disabilities.
    (c) (Blank). 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.
    (d) (Blank). Arrange for or provide public health nursing,
nutrition and social services and clinical consultation as
indicated.
    (e) (Blank). Require that all specimens collected pursuant
to this Act or the rules and regulations promulgated hereunder
be submitted for testing to the nearest Department of Public
Health laboratory designated to perform such tests. 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. Fees collected from the provision of this
testing service shall be placed in a special fund in the State
Treasury, hereafter known as 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 such Fund. Moneys shall be
appropriated from such Fund to the Department of Public Health
solely for the purposes of providing metabolic 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 (e) is guilty of a petty offense.
(Source: P.A. 97-227, eff. 1-1-12; 97-532, eff. 8-23-11;
97-813, eff. 7-13-12.)
 
    (410 ILCS 240/3.1 new)
    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.
 
    (410 ILCS 240/3.2 new)
    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.
 
    (410 ILCS 240/3.3 new)
    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.
 
    Section 10. The Genetic and Metabolic Diseases Advisory
Committee Act is amended by changing Section 5 as follows:
 
    (410 ILCS 265/5)
    Sec. 5. Genetic and Metabolic Diseases Advisory Committee.
    (a) The Director of Public Health shall create the Genetic
and Metabolic Diseases Advisory Committee to advise the
Department of Public Health regarding issues relevant to
newborn screenings of metabolic diseases.
    (b) The purposes of Metabolic Diseases Advisory Committee
are all of the following:
        (1) Advise the Department regarding issues relevant to
    its Genetics Program.
        (2) Advise the Department regarding optimal laboratory
    methodologies for screening of the targeted conditions.
        (3) Recommend to the Department consultants who are
    qualified to diagnose a condition detected by screening,
    provide management of care, and genetic counseling for the
    family.
        (4) Monitor the incidence of each condition for which
    newborn screening is done, evaluate the effects of
    treatment and genetic counseling, and provide advice on
    disorders to be included in newborn screening panel.
        (5) Advise the Department on educational programs for
    professionals and the general public.
        (6) Advise the Department on new developments and areas
    of interest in relation to the Genetics Program.
        (7) Any other matter deemed appropriate by the
    Committee and the Director.
    (c) The Committee shall consist of 20 members appointed by
the Director of Public Health. Membership shall include
physicians, geneticists, nurses, nutritionists, and other
allied health professionals, as well as patients and parents.
Ex-officio members may be appointed, but shall not have voting
privileges.
    (d) Members of the Committee may receive compensation for
necessary expenses incurred in the performance of their duties.
(Source: P.A. 95-695, eff. 11-5-07.)
 
    Section 99. Effective date. This Act takes effect upon
becoming law.

Effective Date: 8/16/2013