In accordance with the timetable specified in this Section, the Department shall provide all newborns with screening tests for the presence of certain lysosomal storage disorders known as Krabbe, Pompe, Gaucher, Fabry, and Niemann-Pick. The testing shall begin within 6 months following the occurrence of all of the following: (1) 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; (2) the availability of quality assurance testing methodology for these processes; (3) the acquisition and installment by the Department of the equipment necessary to implement the screening tests; (4) the establishment of precise threshold values ensuring defined disorder identification for each screening test; (5) the authentication of pilot testing achieving each milestone described in items (1) through (4) of this Section for each disorder screening test; and (6) the authentication of achieving the potential of high throughput standards for statewide volume of each disorder screening test concomitant with each milestone described in items (1) through (4) of this Section. It was the goal of Public Act 97-532 that the screening for the specified lysosomal storage disorders begins within 2 years after August 23, 2011 (the effective date of Public Act 97-532). The Department is authorized to implement an additional fee for the screening 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 the specified lysosomal storage disorders. 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; methodology for these processes; of the equipment necessary to implement the screening tests; ensuring defined disorder identification for each screening test; each milestone described in items (1) through (4) of this Section for each disorder screening test; and high throughput standards for statewide volume of each disorder screening test concomitant with each milestone described in items (1) through (4) of this Section.
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