§ 3.3. Mucopolysacchardosis disorders. 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 mucopolysaccharidosis I (Hurlers) and mucopolysaccharidosis II
(Hunters). The testing shall begin within 12 months following the occurrence of all of the
(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 and comparative threshold values
for each screening test and accompanying disorder;
(3) the acquisition and installment by the Department of the equipment necessary to
implement the initial pilot and statewide volume of screening tests for each disorder;
(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 3 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
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