Bill Text: IL SB1761 | 2011-2012 | 97th General Assembly | Chaptered
Bill Title: Amends the Newborn Metabolic Screening Act. Provides that the Department of Public Health shall provide newborns with expanded screening tests for the presence of Mucopolysaccharidosis I (Hurler disease), Mucopolysaccharidosis II (Hunters disease), and Severe Combined Immunodeficiency Syndrome (SCIDS). Provides that if the Department is unable to provide expanded screening for SCIDS using the State Laboratory within 180 days after the effective date of the amendatory Act, then the Department shall temporarily provide the screening through an accredited laboratory selected by the Department until the Department has the capacity to provide screening through the State Laboratory. Permits the Department to substitute the fee charged by the accredited laboratory, plus a 5% surcharge for documentation and handling for the fee authorized if expanded screening is provided on a temporary basis through an accredited laboratory. Effective immediately.
Spectrum: Bipartisan Bill
Status: (Passed) 2011-08-23 - Public Act . . . . . . . . . 97-0532 [SB1761 Detail]
Download: Illinois-2011-SB1761-Chaptered.html
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Public Act 097-0532 | ||||
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AN ACT concerning public health.
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Be it enacted by the People of the State of Illinois,
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represented in the General Assembly:
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Section 5. The Newborn Metabolic Screening Act is amended | ||||
by changing Section 2 as follows:
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(410 ILCS 240/2) (from Ch. 111 1/2, par. 4904)
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Sec. 2. The Department of Public Health shall administer | ||||
the
provisions of this Act and shall:
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(a) Institute and carry on an intensive educational program | ||||
among
physicians, hospitals, public health nurses and the | ||||
public concerning
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 mental
retardation resulting from the | ||||
diseases.
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(a-5) Beginning July 1, 2002, provide all newborns
with | ||||
expanded screening tests for the presence of genetic, | ||||
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. If by July 1,
2002, the Department is unable to | ||
provide 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 | ||
subsection (e) of
this Section.
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(a-6) 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 the registration with the federal | ||
Food and Drug Administration of the necessary reagents ; |
(ii) the availability of the necessary reagents from | ||
the Centers for Disease Control and Prevention; | ||
(ii) (iii) the availability of quality assurance | ||
testing methodology for these processes; and | ||
(iii) (iv) 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 this amendatory Act of the 97th 95th | ||
General Assembly that the expanded screening for the specified | ||
Lysosomal Storage Disorders begins within 2 3 years after the | ||
effective date of this amendatory Act of the 97th General | ||
Assembly . 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.
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(a-7) In accordance with the timetable specified in this
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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 this amendatory Act of the 97th General
| ||
Assembly that the expanded screening for Severe Combined | ||
Immunodeficiency Disease begins within 2 years after the | ||
effective date of this amendatory Act of the 97th General | ||
Assembly. 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) 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 this amendatory Act of the 97th General | ||
Assembly that the expanded screening for the specified
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Lysosomal Storage Disorders begins within 3 years after the | ||
effective date of this amendatory Act of the 97th General | ||
Assembly. 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) Maintain a registry of cases including information of | ||
importance
for the purpose of follow-up services to prevent | ||
mental retardation.
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(c) Supply the necessary metabolic treatment formulas
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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.
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(d) Arrange for or provide public health nursing, nutrition | ||
and
social services and clinical consultation as indicated.
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(e) 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
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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.
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(Source: P.A. 95-695, eff. 11-5-07.)
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Section 99. Effective date. This Act takes effect upon | ||
becoming law.
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