In accordance with the timetable specified in this Section, the Department shall provide all newborns with screening tests for the presence of adrenoleukodystrophy (ALD). The testing shall begin within 18 months following the occurrence of all of the following: (1) the development and validation of a reliable methodology for screening newborns for ALD using dried blood spots and quality assurance testing methodology for such test or the approval of a test for ALD using dried blood spots by the federal Food and Drug Administration; (2) the availability of any necessary reagents for such 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 ALD; (5) the acquisition and installment by the Department of the equipment necessary to implement the initial pilot and statewide volume of screening tests for ALD; (6) the establishment of precise threshold values ensuring defined disorder identification for ALD; (7) the authentication of pilot testing achieving each milestone described in items (1) through (6) of this Section for ALD; and (8) the authentication of achieving the potential of high throughput standards for statewide volume of ALD concomitant with each milestone described in items (1) through (6) of this Section. The Department is authorized to implement an additional fee for the screening no sooner than 6 months prior to beginning the testing in order to accumulate the resources for start-up and other costs associated with implementation of the screening and thereafter to support the costs associated with screening and follow-up programs for adrenoleukodystrophy. methodology for screening newborns for ALD using dried blood spots and quality assurance testing methodology for such test or the approval of a test for ALD using dried blood spots by the federal Food and Drug Administration; such test; 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; comparative threshold values for ALD; of the equipment necessary to implement the initial pilot and statewide volume of screening tests for ALD; ensuring defined disorder identification for ALD; each milestone described in items (1) through (6) of this Section for ALD; and high throughput standards for statewide volume of ALD concomitant with each milestone described in items (1) through (6) of this Section.
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