HB5420 103RD GENERAL ASSEMBLY

LRB103 37927 CES 68059 b

103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
HB5420

Introduced 2/9/2024, by Rep. Kimberly Du Buclet

SYNOPSIS AS INTRODUCED:

410 ILCS 240/3.6 new

Amends the Newborn Metabolic Screening Act. Provides for the screening and testing of all newborns for Guanidinoacetate Methyltransferase (GAMT) deficiency. Sets forth requirements that must be met before the screening and testing begin. Authorizes the Department of Public Health to implement an additional fee for the screening prior to beginning testing in order to accumulate resources to implement the amendatory Act.

A BILL FOR

AN ACT concerning health.

Be it enacted by the People of the State of Illinois, represented in the General Assembly:

Section 5. The Newborn Metabolic Screening Act is amended by adding Section 3.6 as follows:

(410 ILCS 240/3.6 new)

Sec. 3.6. Guanidinoacetate Methyltransferase (GAMT) deficiency.

(a) In accordance with the timetable specified in this Section, the Department shall provide all newborns with screening tests for the presence of Guanidinoacetate Methyltransferase (GAMT) deficiency. The testing shall begin within 12 months after 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 GAMT;

(3) the acquisition and installment by the Department of the equipment necessary to implement the initial pilot and statewide volume of screening tests for GAMT;

(4) the establishment of precise threshold values ensuring defined disorder identification for GAMT;

(5) the authentication of pilot testing achieving each milestone described in items (a) through (d) of this Section for GAMT; and

(6) the authentication of achieving the potential of high throughput standards for statewide volume of the GAMT screening test concomitant with each milestone described in items (1) through (4) of this Section.

(b) The Department may 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 GAMT.