103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
SB0067
 
Introduced 1/20/2023, by Sen. Laura Fine
 
SYNOPSIS AS INTRODUCED:
 

 
410 ILCS 240/3.5 new

     Amends the Newborn Metabolic Screening Act. Requires the Department of Public Health to provide all newborns with screening tests for the presence of metachromatic leukodystrophy. Requires the testing to begin within 6 months following the occurrence of specified milestones. Allows the Department to require payment of an additional fee for the provision of metachromatic leukodystrophy screening tests. Contains other provisions.
  


LRB103 04485 CPF 49491 b

 
 
A BILL FOR
 

  
SB0067LRB103 04485 CPF 49491 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 3.5 as follows:
 
6    (410 ILCS 240/3.5 new)
7    Sec. 3.5. Metachromatic leukodystrophy.
8    (a)   The Department shall provide all newborns with 
9screening tests for the presence of metachromatic 
10leukodystrophy. The testing shall begin within 6 months after 
11the occurrence of all of the following milestones:
12        (1)   Unless the federal Food and Drug Administration 
13    approves a screening test for metachromatic leukodystrophy 
14    using dried blood spots, the development and validation of 
15    a reliable methodology for screening newborns for 
16    metachromatic leukodystrophy using dried blood spots and a 
17    methodology for conducting quality assurance testing of 
18    the screening test.
19        (2)   The availability of any necessary reagent for a 
20    metachromatic leukodystrophy screening test.
21        (3)   The establishment and verification of relevant

and 
22    appropriate performance specifications as defined under 
23    the federal Clinical Laboratory Improvement Amendments and 
 
 
SB0067- 2 -LRB103 04485 CPF 49491 b

1    regulations thereunder for Federal Drug 
2    Administration-cleared or in-house developed methods, 
3    performed under an institutional review board approved 
4    protocol, if required.
5        (4)   The availability of quality assurance testing and 
6    comparative threshold values for metachromatic 
7    leukodystrophy screening tests.
8        (5)   The acquisition and installation by the Department 
9    of equipment necessary to implement metachromatic 
10    leukodystrophy screening tests.
11        (6)   The establishment of precise threshold values 
12    ensuring defined disorder identification of metachromatic 
13    leukodystrophy.
14        (7)   The authentication of pilot testing indicating 
15    that each milestone described in paragraphs (1) through 
16    (6) has been achieved.
17        (8)   The authentication of achieving the potential of 
18    high throughput standards for statewide volume of each 
19    metachromatic leukodystrophy screening test concomitant 
20    with each milestone described in paragraphs (1) through 
21    (4).
22    (b)   To accumulate the resources for the costs, including 
23start-up costs, associated with metachromatic leukodystrophy 
24screening tests and any follow-up programs, the Department may 
25require payment of an additional fee for administering a 
26metachromatic leukodystrophy screening test under this 
 
 
SB0067- 3 -LRB103 04485 CPF 49491 b

1Section. The Department may not require the payment of the 
2additional fee prior to 6 months before the Department 
3administers metachromatic leukodystrophy screening tests under 
4this Section.