Sec. 3.2. Severe combined immunodeficiency disease.

275 words·~1 min read·/il/chapter-410/act-240/3-2

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Sec. 3.2. Severe combined immunodeficiency disease. In accordance with the timetable specified in this Section, the Department shall provide all newborns with screening tests for the presence of severe combined immunodeficiency disease (SCID). The testing shall begin within 12 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 and comparative threshold values for

SCID;

(3)the acquisition and installment by the Department of the equipment necessary to

implement the initial pilot and statewide volume of screening tests for SCID;

(4)the establishment of precise threshold values ensuring defined disorder

identification for SCID;

(5)the authentication of pilot testing achieving each milestone described in items

through

(4)of this Section for SCID; and

(6)the authentication of achieving the potential of high throughput standards for

statewide volume of the SCID 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 severe combined immunodeficiency disease 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 severe combined immunodeficiency disease.