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1 | AN ACT concerning health.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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4 | Section 5. The Newborn Metabolic Screening Act is amended | ||||||
5 | by changing Section 2 and by adding Section 3.4 as follows:
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6 | (410 ILCS 240/2) (from Ch. 111 1/2, par. 4904)
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7 | Sec. 2. General provisions. The Department of Public Health | ||||||
8 | shall administer the
provisions of this Act and shall:
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9 | (a) Institute and carry on an intensive educational program | ||||||
10 | among
physicians, hospitals, public health nurses and the | ||||||
11 | public concerning disorders included in newborn screening. | ||||||
12 | This
educational program shall include information about the | ||||||
13 | nature of the
diseases and examinations for the detection of | ||||||
14 | the diseases in early
infancy in order that measures may be | ||||||
15 | taken to prevent the disabilities resulting from the diseases.
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16 | (a-5) Require that all newborns be screened
for the | ||||||
17 | presence of certain genetic, metabolic, and congenital | ||||||
18 | anomalies as determined by the Department, by rule. | ||||||
19 | (a-5.1) Require that all blood and biological specimens | ||||||
20 | collected pursuant to this Act or the rules adopted under this | ||||||
21 | Act be submitted for testing to the nearest Department | ||||||
22 | laboratory designated to perform such tests. The following | ||||||
23 | provisions shall apply concerning testing: |
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1 | (1) Beginning July 1, 2015, the base fee for newborn | ||||||
2 | screening services shall be $118. The Department may | ||||||
3 | develop a reasonable fee structure and may levy additional | ||||||
4 | fees according to such structure to cover the cost of | ||||||
5 | providing this testing service and for the follow-up of | ||||||
6 | infants with an abnormal screening test. Fees collected | ||||||
7 | from the provision of this testing service shall be placed | ||||||
8 | in the Metabolic Screening and Treatment Fund. Other State | ||||||
9 | and federal funds for expenses related to metabolic | ||||||
10 | screening, follow-up, and treatment programs may also be | ||||||
11 | placed in the Fund. | ||||||
12 | (2) Moneys shall be appropriated from the Fund to the | ||||||
13 | Department solely for the purposes of providing newborn | ||||||
14 | screening, follow-up, and treatment programs. Nothing in | ||||||
15 | this Act shall be construed to prohibit any licensed | ||||||
16 | medical facility from collecting additional specimens for | ||||||
17 | testing for metabolic or neonatal diseases or any other | ||||||
18 | diseases or conditions, as it deems fit. Any person | ||||||
19 | violating the provisions of this subsection (a-5.1) is | ||||||
20 | guilty of a petty offense. | ||||||
21 | (3) If the Department is unable to provide the | ||||||
22 | screening using the
State Laboratory, it shall temporarily | ||||||
23 | provide such screening
through an accredited laboratory | ||||||
24 | selected by the Department until the
Department has the | ||||||
25 | capacity to provide screening through the State
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26 | Laboratory. If screening is provided on a temporary basis
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1 | through an accredited laboratory, the Department shall | ||||||
2 | substitute the fee
charged by the accredited laboratory, | ||||||
3 | plus a 5% surcharge for
documentation and handling, for the | ||||||
4 | fee authorized in this subsection (a-5.1). | ||||||
5 | (a-5.2) Maintain a registry of cases, including | ||||||
6 | information of importance for the purpose of follow-up services | ||||||
7 | to assess long-term outcomes. | ||||||
8 | (a-5.3) 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 | (a-5.4) Arrange for or provide public health nursing, | ||||||
15 | nutrition, and social services and clinical consultation as | ||||||
16 | indicated. | ||||||
17 | (a-5.5) Utilize the Genetic and Metabolic Diseases | ||||||
18 | Advisory Committee established under the Genetic and Metabolic | ||||||
19 | Diseases Advisory Committee Act to provide guidance and | ||||||
20 | recommendations to the Department's newborn screening program. | ||||||
21 | The Genetic and Metabolic Diseases Advisory Committee shall | ||||||
22 | review the feasibility and advisability of including | ||||||
23 | additional metabolic, genetic, and congenital disorders in the | ||||||
24 | newborn screening panel, according to a review protocol applied | ||||||
25 | to each suggested addition to the screening panel. The | ||||||
26 | Department shall consider the recommendations of the Genetic |
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1 | and Metabolic Diseases Advisory Committee in determining | ||||||
2 | whether to include an additional disorder in the screening | ||||||
3 | panel prior to proposing an administrative rule concerning | ||||||
4 | inclusion of an additional disorder in the newborn screening | ||||||
5 | panel. Notwithstanding any other provision of law, no new | ||||||
6 | screening may begin prior to the occurrence of all the | ||||||
7 | following: | ||||||
8 | (1) the establishment and verification of relevant and
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9 | appropriate performance specifications as defined under
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10 | the federal Clinical Laboratory Improvement Amendments and
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11 | regulations thereunder for U.S. Food and Drug
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12 | Administration-cleared or in-house developed methods,
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13 | performed under an institutional review board-approved
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14 | protocol, if required; | ||||||
15 | (2) the availability of quality assurance testing
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16 | methodology for the processes set forth in item (1) of this | ||||||
17 | subsection (a-5.5); | ||||||
18 | (3) the acquisition and installment by the Department
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19 | of the equipment necessary to implement the screening
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20 | tests; | ||||||
21 | (4) the establishment of precise threshold values | ||||||
22 | ensuring
defined disorder identification for each | ||||||
23 | screening test; | ||||||
24 | (5) the authentication of pilot testing achieving each
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25 | milestone described in items (1) through (4) of this
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26 | subsection (a-5.5) for each disorder screening test; and |
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1 | (6) the authentication of achieving the potential of | ||||||
2 | high
throughput standards for statewide volume of each | ||||||
3 | disorder
screening test concomitant with each milestone | ||||||
4 | described
in items (1) through (4) of this subsection | ||||||
5 | (a-5.5).
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6 | (a-6) (Blank). | ||||||
7 | (a-7) (Blank). | ||||||
8 | (a-8) (Blank). | ||||||
9 | (b) (Blank).
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10 | (c) (Blank).
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11 | (d) (Blank).
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12 | (e) (Blank).
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13 | (Source: P.A. 97-227, eff. 1-1-12; 97-532, eff. 8-23-11; | ||||||
14 | 97-813, eff. 7-13-12; 98-440, eff. 8-16-13; 98-756, eff. | ||||||
15 | 7-16-14.)
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16 | (410 ILCS 240/3.4 new) | ||||||
17 | Sec. 3.4. Adrenoleukodystrophy. In accordance with the | ||||||
18 | timetable specified in this Section, the Department shall | ||||||
19 | provide all newborns with screening tests for the presence of | ||||||
20 | adrenoleukodystrophy (ALD). The testing shall begin within 18 | ||||||
21 | months following the occurrence of all of the following: | ||||||
22 | (1) the development and validation of a reliable | ||||||
23 | methodology for screening newborns for ALD using dried | ||||||
24 | blood spots and quality assurance testing methodology for | ||||||
25 | such test or the approval of a test for ALD using dried |
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1 | blood spots by the federal Food and Drug Administration; | ||||||
2 | (2) the availability of any necessary reagents for such | ||||||
3 | test; | ||||||
4 | (3) the establishment and verification of relevant and | ||||||
5 | appropriate performance specifications as defined under | ||||||
6 | the federal Clinical Laboratory Improvement Amendments and | ||||||
7 | regulations thereunder for Federal Drug | ||||||
8 | Administration-cleared or in-house developed methods, | ||||||
9 | performed under an institutional review board approved | ||||||
10 | protocol, if required; | ||||||
11 | (4) the availability of quality assurance testing and | ||||||
12 | comparative threshold values for ALD; | ||||||
13 | (5) the acquisition and installment by the Department | ||||||
14 | of the equipment necessary to implement the initial pilot | ||||||
15 | and statewide volume of screening tests for ALD; | ||||||
16 | (6) the establishment of precise threshold values | ||||||
17 | ensuring defined disorder identification for ALD; | ||||||
18 | (7) the authentication of pilot testing achieving each | ||||||
19 | milestone described in items (1) through (6) of this | ||||||
20 | Section for ALD; and | ||||||
21 | (8) the authentication of achieving the potential of | ||||||
22 | high throughput standards for statewide volume of ALD | ||||||
23 | concomitant with each milestone described in items (1) | ||||||
24 | through (6) of this Section. | ||||||
25 | The Department is authorized to implement an additional fee | ||||||
26 | for the screening prior to beginning the testing in order to |
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1 | accumulate the resources for start-up and other costs | ||||||
2 | associated with implementation of the screening and thereafter | ||||||
3 | to support the costs associated with screening and follow-up | ||||||
4 | programs for adrenoleukodystrophy.
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5 | Section 99. Effective date. This Act takes effect July 1, | ||||||
6 | 2015.
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