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,
| 3 | | represented in the General Assembly:
| 4 | | Section 5. The Newborn Metabolic Screening Act is amended | 5 | | by 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 | 8 | | the
provisions of this Act and shall:
| 9 | | (a) Institute and carry on an intensive educational program | 10 | | among
physicians, hospitals, public health nurses and the | 11 | | public concerning
the diseases phenylketonuria, | 12 | | hypothyroidism, galactosemia and other
metabolic diseases. | 13 | | This
educational program shall include information about the | 14 | | nature of the
diseases and examinations for the detection of | 15 | | the diseases in early
infancy in order that measures may be | 16 | | taken to prevent the mental
retardation resulting from the | 17 | | diseases.
| 18 | | (a-5) Beginning July 1, 2002, provide all newborns
with | 19 | | expanded screening tests for the presence of genetic, | 20 | | endocrine, or
other metabolic disorders, including | 21 | | phenylketonuria, galactosemia,
hypothyroidism, congenital | 22 | | adrenal hyperplasia, biotinidase deficiency,
and sickling | 23 | | disorders, as well as other amino acid disorders, organic
acid |
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| 1 | | disorders, fatty acid oxidation disorders, and other | 2 | | abnormalities
detectable through the use of a tandem mass | 3 | | spectrometer. If by July 1,
2002, the Department is unable to | 4 | | provide expanded screening using the
State Laboratory, it shall | 5 | | temporarily provide such screening
through an accredited | 6 | | laboratory selected by the Department until the
Department has | 7 | | the capacity to provide screening through the State
Laboratory. | 8 | | If expanded screening is provided on a temporary basis
through | 9 | | an accredited laboratory, the Department shall substitute the | 10 | | fee
charged by the accredited laboratory, plus a 5% surcharge | 11 | | for
documentation and handling, for the fee authorized in | 12 | | subsection (e) of
this Section.
| 13 | | (a-6) In accordance with the timetable specified in this | 14 | | subsection, provide all newborns with expanded screening tests | 15 | | for the presence of certain Lysosomal Storage Disorders known | 16 | | as Krabbe, Pompe, Gaucher, Fabry, and Niemann-Pick. The testing | 17 | | shall begin within 6 months following the occurrence of all of | 18 | | the 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 | 19 | | General Assembly that the expanded screening for the specified | 20 | | Lysosomal Storage Disorders begins within 2 3 years after the | 21 | | effective date of this amendatory Act of the 97th General | 22 | | Assembly . The Department is authorized to implement an | 23 | | additional fee for the screening prior to beginning the testing | 24 | | in order to accumulate the resources for start-up and other | 25 | | costs associated with implementation of the screening and | 26 | | thereafter to support the costs associated with screening and |
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| 1 | | follow-up programs for the specified Lysosomal Storage | 2 | | Disorders.
| 3 | | (a-7) In accordance with the timetable specified in this
| 4 | | subsection (a-7), provide all newborns with expanded screening | 5 | | tests
for the presence of Severe Combined Immunodeficiency | 6 | | Disease (SCID). The testing shall begin within 12 months | 7 | | following 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
| 5 | | Assembly that the expanded screening for Severe Combined | 6 | | Immunodeficiency Disease begins within 2 years after the | 7 | | effective date of this amendatory Act of the 97th General | 8 | | Assembly. The Department is authorized to
implement an | 9 | | additional fee for the screening prior to
beginning the testing | 10 | | in order to accumulate the resources for
start-up and other | 11 | | costs associated with implementation of the
screening and | 12 | | thereafter to support the costs associated with
screening and | 13 | | follow-up programs for Severe Combined Immunodeficiency | 14 | | Disease. | 15 | | (a-8) In accordance with the timetable specified in this | 16 | | subsection (a-8), provide all newborns with expanded screening | 17 | | tests
for the presence of certain Lysosomal Storage Disorders | 18 | | known as Mucopolysaccharidosis I (Hurlers) and | 19 | | Mucopolysaccharidosis II (Hunters). The testing shall begin | 20 | | within 12 months following the occurrence of all of the | 21 | | following: | 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 | 21 | | Assembly that the expanded screening for the specified
| 22 | | Lysosomal Storage Disorders begins within 3 years after the | 23 | | effective date of this amendatory Act of the 97th General | 24 | | Assembly. The Department is authorized to
implement an | 25 | | additional fee for the screening prior to beginning the testing | 26 | | in order to accumulate the resources for
start-up and other |
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| 1 | | costs associated with implementation of the screening and | 2 | | thereafter to support the costs associated with
screening and | 3 | | follow-up programs for the specified Lysosomal Storage | 4 | | Disorders. | 5 | | (b) Maintain a registry of cases including information of | 6 | | importance
for the purpose of follow-up services to prevent | 7 | | mental retardation.
| 8 | | (c) Supply the necessary metabolic treatment formulas
| 9 | | where practicable for
diagnosed cases of amino acid metabolism | 10 | | disorders, including phenylketonuria, organic acid disorders, | 11 | | and fatty acid oxidation disorders for as long as medically | 12 | | indicated, when the product is
not available through other | 13 | | State agencies.
| 14 | | (d) Arrange for or provide public health nursing, nutrition | 15 | | and
social services and clinical consultation as indicated.
| 16 | | (e) Require that all specimens collected pursuant to this | 17 | | Act or the rules
and regulations promulgated hereunder be | 18 | | submitted for testing to the nearest
Department of Public | 19 | | Health laboratory designated to perform such tests.
The | 20 | | Department may develop a reasonable fee structure and may levy | 21 | | fees
according to such structure to cover the cost of providing | 22 | | this testing
service. Fees collected from the provision of this | 23 | | testing service shall
be placed in a special fund in the State | 24 | | Treasury, hereafter known as the
Metabolic Screening and | 25 | | Treatment Fund. Other State and federal funds for
expenses | 26 | | related to metabolic screening, follow-up and treatment |
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| 1 | | programs
may also be placed in such Fund. Moneys shall be | 2 | | appropriated from such
Fund to the Department of Public Health | 3 | | solely for the purposes of providing
metabolic screening, | 4 | | follow-up and treatment programs. Nothing in this
Act shall be | 5 | | construed to prohibit any licensed medical facility from
| 6 | | collecting
additional specimens for testing for metabolic or | 7 | | neonatal diseases or any
other diseases or conditions, as it | 8 | | deems fit. Any person
violating the provisions of this | 9 | | subsection (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 | 12 | | becoming law.
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