Illinois Statutes Chapter 410. Public Health § 240/3.3. Mucopolysacchardosis disorders

(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.