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Full Text of SB1761  97th General Assembly

SB1761enr 97TH GENERAL ASSEMBLY

  
  
  

 


 
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1    AN ACT concerning public health.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Newborn Metabolic Screening Act is amended
5by changing Section 2 as follows:
 
6    (410 ILCS 240/2)  (from Ch. 111 1/2, par. 4904)
7    Sec. 2. The Department of Public Health shall administer
8the provisions of this Act and shall:
9    (a) Institute and carry on an intensive educational program
10among physicians, hospitals, public health nurses and the
11public concerning the diseases phenylketonuria,
12hypothyroidism, galactosemia and other metabolic diseases.
13This educational program shall include information about the
14nature of the diseases and examinations for the detection of
15the diseases in early infancy in order that measures may be
16taken to prevent the mental retardation resulting from the
17diseases.
18    (a-5) Beginning July 1, 2002, provide all newborns with
19expanded screening tests for the presence of genetic,
20endocrine, or other metabolic disorders, including
21phenylketonuria, galactosemia, hypothyroidism, congenital
22adrenal hyperplasia, biotinidase deficiency, and sickling
23disorders, as well as other amino acid disorders, organic acid

 

 

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1disorders, fatty acid oxidation disorders, and other
2abnormalities detectable through the use of a tandem mass
3spectrometer. If by July 1, 2002, the Department is unable to
4provide expanded screening using the State Laboratory, it shall
5temporarily provide such screening through an accredited
6laboratory selected by the Department until the Department has
7the capacity to provide screening through the State Laboratory.
8If expanded screening is provided on a temporary basis through
9an accredited laboratory, the Department shall substitute the
10fee charged by the accredited laboratory, plus a 5% surcharge
11for documentation and handling, for the fee authorized in
12subsection (e) of this Section.
13    (a-6) In accordance with the timetable specified in this
14subsection, provide all newborns with expanded screening tests
15for the presence of certain Lysosomal Storage Disorders known
16as Krabbe, Pompe, Gaucher, Fabry, and Niemann-Pick. The testing
17shall begin within 6 months following the occurrence of all of
18the following:
19        (i) the establishment and verification of relevant and
20    appropriate performance specifications as defined under
21    the federal Clinical Laboratory Improvement Amendments and
22    regulations thereunder for Federal Drug
23    Administration-cleared or in-house developed methods,
24    performed under an institutional review board approved
25    protocol, if required the registration with the federal
26    Food and Drug Administration of the necessary reagents;

 

 

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1        (ii) the availability of the necessary reagents from
2    the Centers for Disease Control and Prevention;
3        (ii) (iii) the availability of quality assurance
4    testing methodology for these processes; and
5        (iii) (iv) the acquisition and installment by the
6    Department of the equipment necessary to implement the
7    expanded screening tests; .
8        (iv) establishment of precise threshold values
9    ensuring defined disorder identification for each
10    screening test;
11        (v) authentication of pilot testing achieving each
12    milestone described in items (i) through (iv) of this
13    subsection (a-6) for each disorder screening test; and
14        (vi) authentication achieving potentiality of high
15    throughput standards for statewide volume of each disorder
16    screening test concomitant with each milestone described
17    in items (i) through (iv) of this subsection (a-6).
18    It is the goal of this amendatory Act of the 97th 95th
19General Assembly that the expanded screening for the specified
20Lysosomal Storage Disorders begins within 2 3 years after the
21effective date of this amendatory Act of the 97th General
22Assembly. The Department is authorized to implement an
23additional fee for the screening prior to beginning the testing
24in order to accumulate the resources for start-up and other
25costs associated with implementation of the screening and
26thereafter to support the costs associated with screening and

 

 

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1follow-up programs for the specified Lysosomal Storage
2Disorders.
3    (a-7) In accordance with the timetable specified in this
4subsection (a-7), provide all newborns with expanded screening
5tests for the presence of Severe Combined Immunodeficiency
6Disease (SCID). The testing shall begin within 12 months
7following the occurrence of all of the following:
8        (i) the establishment and verification of relevant and
9    appropriate performance specifications as defined under
10    the federal Clinical Laboratory Improvement Amendments and
11    regulations thereunder for Federal Drug
12    Administration-cleared or in-house developed methods,
13    performed under an institutional review board approved
14    protocol, if required;
15        (ii) the availability of quality assurance testing and
16    comparative threshold values for SCID;
17        (iii) the acquisition and installment by the
18    Department of the equipment necessary to implement the
19    initial pilot and expanded statewide volume of screening
20    tests for SCID;
21        (iv) establishment of precise threshold values
22    ensuring defined disorder identification for SCID;
23        (v) authentication of pilot testing achieving each
24    milestone described in items (i) through (iv) of this
25    subsection (a-7) for SCID; and
26        (vi) authentication achieving potentiality of high

 

 

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1    throughput standards for statewide volume of the SCID
2    screening test concomitant with each milestone described
3    in items (i) through (iv) of this subsection (a-7).
4    It is the goal of this amendatory Act of the 97th General
5Assembly that the expanded screening for Severe Combined
6Immunodeficiency Disease begins within 2 years after the
7effective date of this amendatory Act of the 97th General
8Assembly. The Department is authorized to implement an
9additional fee for the screening prior to beginning the testing
10in order to accumulate the resources for start-up and other
11costs associated with implementation of the screening and
12thereafter to support the costs associated with screening and
13follow-up programs for Severe Combined Immunodeficiency
14Disease.
15    (a-8) In accordance with the timetable specified in this
16subsection (a-8), provide all newborns with expanded screening
17tests for the presence of certain Lysosomal Storage Disorders
18known as Mucopolysaccharidosis I (Hurlers) and
19Mucopolysaccharidosis II (Hunters). The testing shall begin
20within 12 months following the occurrence of all of the
21following:
22        (i) the establishment and verification of relevant and
23    appropriate performance specifications as defined under
24    the federal Clinical Laboratory Improvement Amendments and
25    regulations thereunder for Federal Drug
26    Administration-cleared or in-house developed methods,

 

 

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1    performed under an institutional review board approved
2    protocol, if required;
3        (ii) the availability of quality assurance testing and
4    comparative threshold values for each screening test and
5    accompanying disorder;
6        (iii) the acquisition and installment by the
7    Department of the equipment necessary to implement the
8    initial pilot and expanded statewide volume of screening
9    tests for each disorder;
10        (iv) establishment of precise threshold values
11    ensuring defined disorder identification for each
12    screening test;
13        (v) authentication of pilot testing achieving each
14    milestone described in items (i) through (iv) of this
15    subsection (a-8) for each disorder screening test; and
16        (vi) authentication achieving potentiality of high
17    throughput standards for statewide volume of each disorder
18    screening test concomitant with each milestone described
19    in items (i) through (iv) of this subsection (a-8).
20    It is the goal of this amendatory Act of the 97th General
21Assembly that the expanded screening for the specified
22Lysosomal Storage Disorders begins within 3 years after the
23effective date of this amendatory Act of the 97th General
24Assembly. The Department is authorized to implement an
25additional fee for the screening prior to beginning the testing
26in order to accumulate the resources for start-up and other

 

 

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1costs associated with implementation of the screening and
2thereafter to support the costs associated with screening and
3follow-up programs for the specified Lysosomal Storage
4Disorders.
5    (b) Maintain a registry of cases including information of
6importance for the purpose of follow-up services to prevent
7mental retardation.
8    (c) Supply the necessary metabolic treatment formulas
9where practicable for diagnosed cases of amino acid metabolism
10disorders, including phenylketonuria, organic acid disorders,
11and fatty acid oxidation disorders for as long as medically
12indicated, when the product is not available through other
13State agencies.
14    (d) Arrange for or provide public health nursing, nutrition
15and social services and clinical consultation as indicated.
16    (e) Require that all specimens collected pursuant to this
17Act or the rules and regulations promulgated hereunder be
18submitted for testing to the nearest Department of Public
19Health laboratory designated to perform such tests. The
20Department may develop a reasonable fee structure and may levy
21fees according to such structure to cover the cost of providing
22this testing service. Fees collected from the provision of this
23testing service shall be placed in a special fund in the State
24Treasury, hereafter known as the Metabolic Screening and
25Treatment Fund. Other State and federal funds for expenses
26related to metabolic screening, follow-up and treatment

 

 

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1programs may also be placed in such Fund. Moneys shall be
2appropriated from such Fund to the Department of Public Health
3solely for the purposes of providing metabolic screening,
4follow-up and treatment programs. Nothing in this Act shall be
5construed to prohibit any licensed medical facility from
6collecting additional specimens for testing for metabolic or
7neonatal diseases or any other diseases or conditions, as it
8deems fit. Any person violating the provisions of this
9subsection (e) is guilty of a petty offense.
10(Source: P.A. 95-695, eff. 11-5-07.)
 
11    Section 99. Effective date. This Act takes effect upon
12becoming law.