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(410 ILCS 240/3.5) Sec. 3.5. Metachromatic leukodystrophy. (a) The Department shall provide all newborns with screening tests for the presence of metachromatic leukodystrophy. The testing shall begin within 6 months after the occurrence of all of the following milestones: (1) Unless the federal Food and Drug Administration |
| approves a screening test for metachromatic leukodystrophy using dried blood spots, the development and validation of a reliable methodology for screening newborns for metachromatic leukodystrophy using dried blood spots and a methodology for conducting quality assurance testing of the screening test.
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(2) The availability of any necessary reagent for a
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| metachromatic leukodystrophy screening test.
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(3) The establishment and verification of relevant
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| 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.
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(4) The availability of quality assurance testing and
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| comparative threshold values for metachromatic leukodystrophy screening tests.
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(5) The acquisition and installation by the
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| Department of equipment necessary to implement metachromatic leukodystrophy screening tests.
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(6) The establishment of precise threshold values
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| ensuring defined disorder identification of metachromatic leukodystrophy.
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(7) The authentication of pilot testing indicating
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| that each milestone described in paragraphs (1) through (6) has been achieved.
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(8) The authentication of achieving the potential of
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| high throughput standards for statewide volume of each metachromatic leukodystrophy screening test concomitant with each milestone described in paragraphs (1) through (4).
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(b) To accumulate the resources for the costs, including start-up costs, associated with metachromatic leukodystrophy screening tests and any follow-up programs, the Department may require payment of an additional fee for administering a metachromatic leukodystrophy screening test under this Section. The Department may not require the payment of the additional fee prior to 6 months before the Department administers metachromatic leukodystrophy screening tests under this Section.
(Source: P.A. 103-368, eff. 1-1-24.)
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