State of Illinois
2023 and 2024


Introduced 1/20/2023, by Sen. Laura Fine


410 ILCS 240/3.5 new

    Amends the Newborn Metabolic Screening Act. Requires the Department of Public Health to provide all newborns with screening tests for the presence of metachromatic leukodystrophy. Requires the testing to begin within 6 months following the occurrence of specified milestones. Allows the Department to require payment of an additional fee for the provision of metachromatic leukodystrophy screening tests. Contains other provisions.

LRB103 04485 CPF 49491 b





SB0067LRB103 04485 CPF 49491 b

1    AN ACT concerning health.
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4    Section 5. The Newborn Metabolic Screening Act is amended
5by adding Section 3.5 as follows:
6    (410 ILCS 240/3.5 new)
7    Sec. 3.5. Metachromatic leukodystrophy.
8    (a) The Department shall provide all newborns with
9screening tests for the presence of metachromatic
10leukodystrophy. The testing shall begin within 6 months after
11the occurrence of all of the following milestones:
12        (1) Unless the federal Food and Drug Administration
13    approves a screening test for metachromatic leukodystrophy
14    using dried blood spots, the development and validation of
15    a reliable methodology for screening newborns for
16    metachromatic leukodystrophy using dried blood spots and a
17    methodology for conducting quality assurance testing of
18    the screening test.
19        (2) The availability of any necessary reagent for a
20    metachromatic leukodystrophy screening test.
21        (3) The establishment and verification of relevant and
22    appropriate performance specifications as defined under
23    the federal Clinical Laboratory Improvement Amendments and



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1    regulations thereunder for Federal Drug
2    Administration-cleared or in-house developed methods,
3    performed under an institutional review board approved
4    protocol, if required.
5        (4) The availability of quality assurance testing and
6    comparative threshold values for metachromatic
7    leukodystrophy screening tests.
8        (5) The acquisition and installation by the Department
9    of equipment necessary to implement metachromatic
10    leukodystrophy screening tests.
11        (6) The establishment of precise threshold values
12    ensuring defined disorder identification of metachromatic
13    leukodystrophy.
14        (7) The authentication of pilot testing indicating
15    that each milestone described in paragraphs (1) through
16    (6) has been achieved.
17        (8) The authentication of achieving the potential of
18    high throughput standards for statewide volume of each
19    metachromatic leukodystrophy screening test concomitant
20    with each milestone described in paragraphs (1) through
21    (4).
22    (b) To accumulate the resources for the costs, including
23start-up costs, associated with metachromatic leukodystrophy
24screening tests and any follow-up programs, the Department may
25require payment of an additional fee for administering a
26metachromatic leukodystrophy screening test under this



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1Section. The Department may not require the payment of the
2additional fee prior to 6 months before the Department
3administers metachromatic leukodystrophy screening tests under
4this Section.