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.


LRB103 37927 CES 68059 b

 
 
A BILL FOR
 
HB5420LRB103 37927 CES 68059 b

1    AN ACT concerning health.
 
2    Be it enacted by the People of the State of Illinois, 
3represented in the General Assembly:
 
4    Section 5. The Newborn Metabolic Screening Act is amended 
5by adding Section 3.6 as follows:
 
6    (410 ILCS 240/3.6 new)
7    Sec. 3.6. Guanidinoacetate Methyltransferase (GAMT) 
8deficiency. 
9    (a) In accordance with the timetable specified in this 
10Section, the Department shall provide all newborns with 
11screening tests for the presence of Guanidinoacetate 
12Methyltransferase (GAMT) deficiency. The testing shall begin 
13within 12 months after the occurrence of all of the following:
14        (1) the establishment and verification of relevant and 
15    appropriate performance specifications as defined under 
16    the federal Clinical Laboratory Improvement Amendments and 
17    regulations thereunder for Federal Drug 
18    Administration-cleared or in-house developed methods, 
19    performed under an institutional review board approved 
20    protocol, if required;
21        (2) the availability of quality assurance testing and 
22    comparative threshold values for GAMT;
23        (3) the acquisition and installment by the Department 
 
 
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1    of the equipment necessary to implement the initial pilot 
2    and statewide volume of screening tests for GAMT;
3        (4) the establishment of precise threshold values 
4    ensuring defined disorder identification for GAMT;
5        (5) the authentication of pilot testing achieving each 
6    milestone described in items (a) through (d) of this 
7    Section for GAMT; and
8        (6) the authentication of achieving the potential of 
9    high throughput standards for statewide volume of the GAMT 
10    screening test concomitant with each milestone described 
11    in items (1) through (4) of this Section. 
12    (b) The Department may implement an additional fee for the 
13screening prior to beginning the testing in order to 
14accumulate the resources for start-up and other costs 
15associated with implementation of the screening and thereafter 
16to support the costs associated with screening and follow-up 
17programs for GAMT.