Illinois § 3.35

§ 3.35.

Spinal muscular atrophy. In accordance with the timetable specified in this Section, the Department shall provide all newborns with a screening test for spinal muscular atrophy using a method that determines the presence or absence of the intact or normal SMN1 gene, beginning on the earlier of the following: (1) July 1, 2020; or (2) within 6 months following the occurrence of all of the following: (A) the establishment and verification of relevant and appropriate performance specifications as defined under the federal Clinical Laboratory Improvement Amendments and regulations thereunder for federal Food and Drug Administration-cleared or in-house developed methods, performed under an institutional review board approved protocol, if required; (B) the availability of quality assurance materials and comparative threshold values to determine the presence or absence of the intact or normal SMN1 gene; (C) the procurement and installation by the Department of the equipment necessary to implement the initial pilot and statewide volume of screening tests for spinal muscular atrophy; (D) the establishment of precise threshold values ensuring defined disorder identification for spinal muscular atrophy; (E) the development and validation of a reliable methodology for screening newborns for spinal muscular atrophy using dried blood spots and quality assurance testing methodology for such test or the approval and procurement of a test for spinal muscular atrophy using dried blood spots by the federal Food and Drug Administration; (F) the authentication of pilot testing achieving each milestone described in subparagraphs (A) through (E) of this paragraph for spinal muscular atrophy; and (G) the authentication of achieving the potential of high throughput standards for statewide volume of spinal muscular atrophy concomitant with each milestone described in subparagraphs (A) through (E) of this paragraph. The Department is authorized to implement an additional fee for the screening upon the effective date of this amendatory Act of the 100th General Assembly in order to accumulate the resources for start-up and other costs associated with the implementation of the screening and thereafter to support the costs associated with screening. If the Department has not implemented statewide screening for spinal muscular atrophy under this Section within 36 months after the effective date of this amendatory Act of the 100th General Assembly, then the Department shall cease collecting any additional fees related to the screening. The Department may adopt emergency rules in accordance with Section 5-45 of the Illinois Administrative Procedure Act to implement this Section. (Source: P.A. 100-864, eff. 8-14-18.)