Sec. 3.5. Metachromatic leukodystrophy.
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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.
(2)The availability of any necessary reagent for a metachromatic leukodystrophy
screening test.
(3)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.
(4)The availability of quality assurance testing and comparative threshold values for
metachromatic leukodystrophy screening tests.
(5)The acquisition and installation by the Department of equipment necessary to
implement metachromatic leukodystrophy screening tests.
(6)The establishment of precise threshold values ensuring defined disorder
identification of metachromatic leukodystrophy.
(7)The authentication of pilot testing indicating that each milestone described in
paragraphs
(1)through
(6)has been achieved.
(8)The authentication of achieving the potential of high throughput standards for
statewide volume of each metachromatic leukodystrophy screening test concomitant with each milestone described in paragraphs
(1)through (4).
(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.