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