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Full Text of SB1761  97th General Assembly

SB1761ham001 97TH GENERAL ASSEMBLY

Rep. JoAnn D. Osmond

Filed: 5/17/2011

 

 


 

 


 
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1
AMENDMENT TO SENATE BILL 1761

2    AMENDMENT NO. ______. Amend Senate Bill 1761 by replacing
3everything after the enacting clause with the following:
 
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

 

 

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1diseases.
2    (a-5) Beginning July 1, 2002, provide all newborns with
3expanded screening tests for the presence of genetic,
4endocrine, or other metabolic disorders, including
5phenylketonuria, galactosemia, hypothyroidism, congenital
6adrenal hyperplasia, biotinidase deficiency, and sickling
7disorders, as well as other amino acid disorders, organic acid
8disorders, fatty acid oxidation disorders, and other
9abnormalities detectable through the use of a tandem mass
10spectrometer. If by July 1, 2002, the Department is unable to
11provide expanded screening using the State Laboratory, it shall
12temporarily provide such screening through an accredited
13laboratory selected by the Department until the Department has
14the capacity to provide screening through the State Laboratory.
15If expanded screening is provided on a temporary basis through
16an accredited laboratory, the Department shall substitute the
17fee charged by the accredited laboratory, plus a 5% surcharge
18for documentation and handling, for the fee authorized in
19subsection (e) of this Section.
20    (a-6) In accordance with the timetable specified in this
21subsection, provide all newborns with expanded screening tests
22for the presence of certain Lysosomal Storage Disorders known
23as Krabbe, Pompe, Gaucher, Fabry, and Niemann-Pick. The testing
24shall begin within 6 months following the occurrence of all of
25the following:
26        (i) the establishment and verification of relevant and

 

 

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1    appropriate performance specifications as defined under
2    the federal Clinical Laboratory Improvement Amendments and
3    regulations thereunder for Federal Drug
4    Administration-cleared or in-house developed methods,
5    performed under an institutional review board approved
6    protocol, if required the registration with the federal
7    Food and Drug Administration of the necessary reagents;
8        (ii) the availability of the necessary reagents from
9    the Centers for Disease Control and Prevention;
10        (ii) (iii) the availability of quality assurance
11    testing methodology for these processes; and
12        (iii) (iv) the acquisition and installment by the
13    Department of the equipment necessary to implement the
14    expanded screening tests; .
15        (iv) establishment of precise threshold values
16    ensuring defined disorder identification for each
17    screening test;
18        (v) authentication of pilot testing achieving each
19    milestone described in items (i) through (iv) of this
20    subsection (a-6) for each disorder screening test; and
21        (vi) authentication achieving potentiality of high
22    throughput standards for statewide volume of each disorder
23    screening test concomitant with each milestone described
24    in items (i) through (iv) of the subsection (a-6).
25    It is the goal of this amendatory Act of the 97th 95th
26General Assembly that the expanded screening for the specified

 

 

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1Lysosomal Storage Disorders begins within 2 3 years after the
2effective date of this amendatory Act of the 97th General
3Assembly. The Department is authorized to implement an
4additional fee for the screening prior to beginning the testing
5in order to accumulate the resources for start-up and other
6costs associated with implementation of the screening and
7thereafter to support the costs associated with screening and
8follow-up programs for the specified Lysosomal Storage
9Disorders.
10    (a-7) In accordance with the timetable specified in this
11subsection (a-7), provide all newborns with expanded screening
12tests for the presence of Severe Combined Immunodeficiency
13Disease (SCID). The testing shall begin within 12 months
14following the occurrence of all of the following:
15        (i) the establishment and verification of relevant and
16    appropriate performance specifications as defined under
17    the federal Clinical Laboratory Improvement Amendments and
18    regulations thereunder for Federal Drug
19    Administration-cleared or in-house developed methods,
20    performed under an institutional review board approved
21    protocol, if required;
22        (ii) the availability of quality assurance testing and
23    comparative threshold values for SCID;
24        (iii) the acquisition and installment by the
25    Department of the equipment necessary to implement the
26    initial pilot and expanded statewide volume of screening

 

 

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1    tests for SCID;
2        (iv) establishment of precise threshold values
3    ensuring defined disorder identification for SCID;
4        (v) authentication of pilot testing achieving each
5    milestone described in items (i) through (iv) of this
6    subsection (a-7) for SCID; and
7        (vi) authentication achieving potentiality of high
8    throughput standards for statewide volume of the SCID
9    screening test concomitant with each milestone described
10    in items (i) through (iv) of this subsection (a-7).
11    It is the goal of this amendatory Act of the 97th General
12Assembly that the expanded screening for Severe Combined
13Immunodeficiency Disease begins within 2 years after the
14effective date of this amendatory Act of the 97th General
15Assembly. The Department is authorized to implement an
16additional fee for the screening prior to beginning the testing
17in order to accumulate the resources for start-up and other
18costs associated with implementation of the screening and
19thereafter to support the costs associated with screening and
20follow-up programs for Severe Combined Immunodeficiency
21Disease.
22    (a-8) In accordance with the timetable specified in this
23subsection (a-8), provide all newborns with expanded screening
24tests for the presence of certain Lysosomal Storage Disorders
25known as Mucopolysaccharidosis I (Hurlers) and
26Mucopolysaccharidosis II (Hunters). The testing shall begin

 

 

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

 

 

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1    (a-8).
2    It is the goal of this amendatory Act of the 97th General
3Assembly that the expanded screening for the specified
4Lysosomal Storage Disorders begins within 3 years after the
5effective date of this amendatory Act of the 97th General
6Assembly. The Department is authorized to implement an
7additional fee for the screening prior to beginning the testing
8in order to accumulate the resources for start-up and other
9costs associated with implementation of the screening and
10thereafter to support the costs associated with screening and
11follow-up programs for the specified Lysosomal Storage
12Disorders.
13    (b) Maintain a registry of cases including information of
14importance for the purpose of follow-up services to prevent
15mental retardation.
16    (c) Supply the necessary metabolic treatment formulas
17where practicable for diagnosed cases of amino acid metabolism
18disorders, including phenylketonuria, organic acid disorders,
19and fatty acid oxidation disorders for as long as medically
20indicated, when the product is not available through other
21State agencies.
22    (d) Arrange for or provide public health nursing, nutrition
23and social services and clinical consultation as indicated.
24    (e) Require that all specimens collected pursuant to this
25Act or the rules and regulations promulgated hereunder be
26submitted for testing to the nearest Department of Public

 

 

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1Health laboratory designated to perform such tests. The
2Department may develop a reasonable fee structure and may levy
3fees according to such structure to cover the cost of providing
4this testing service. Fees collected from the provision of this
5testing service shall be placed in a special fund in the State
6Treasury, hereafter known as the Metabolic Screening and
7Treatment Fund. Other State and federal funds for expenses
8related to metabolic screening, follow-up and treatment
9programs may also be placed in such Fund. Moneys shall be
10appropriated from such Fund to the Department of Public Health
11solely for the purposes of providing metabolic screening,
12follow-up and treatment programs. Nothing in this Act shall be
13construed to prohibit any licensed medical facility from
14collecting additional specimens for testing for metabolic or
15neonatal diseases or any other diseases or conditions, as it
16deems fit. Any person violating the provisions of this
17subsection (e) is guilty of a petty offense.
18(Source: P.A. 95-695, eff. 11-5-07.)
 
19    Section 99. Effective date. This Act takes effect upon
20becoming law.".