Illinois General Assembly - Full Text of HB2790
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Full Text of HB2790  99th General Assembly

HB2790 99TH GENERAL ASSEMBLY

  
  

 


 
99TH GENERAL ASSEMBLY
State of Illinois
2015 and 2016
HB2790

 

Introduced , by Rep. Laura Fine

 

SYNOPSIS AS INTRODUCED:
 
410 ILCS 240/3.4 new

    Amends the Newborn Metabolic Screening Act. Requires the Department of Public Health to provide all newborns with screening tests for the presence of adrenoleukodystrophy (ALD). Provides that testing shall begin within 12 months following the occurrence of various events, including: (1) the development and validation of a reliable methodology; (2) the availability of any necessary reagents; (3) the establishment and verification of relevant and appropriate performance specifications; (4) the availability of quality assurance testing; (5) the acquisition and installment of necessary equipment; (6) the establishment of precise threshold values ensuring defined disorder identification for ALD; (7) the authentication of pilot testing; and (8) the authentication of achieving the potential of high throughput standards. Allows the Department 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 adrenoleukodystrophy.


LRB099 03689 JLK 23700 b

 

 

A BILL FOR

 

HB2790LRB099 03689 JLK 23700 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 3.4 as follows:
 
6    (410 ILCS 240/3.4 new)
7    Sec. 3.4. Adrenoleukodystrophy. In accordance with the
8timetable specified in this Section, the Department shall
9provide all newborns with screening tests for the presence of
10adrenoleukodystrophy (ALD). The testing shall begin within 12
11months following the occurrence of all of the following:
12        (1) the development and validation of a reliable
13    methodology for screening newborns for ALD using dried
14    blood spots and quality assurance testing methodology for
15    such test or the approval of a test for ALD using dried
16    blood spots by the federal Food and Drug Administration;
17        (2) the availability of any necessary reagents for such
18    test;
19        (3) the establishment and verification of relevant and
20    appropriate performance specifications as defined under
21    the federal Clinical Laboratory Improvement Amendments and
22    regulations thereunder for Federal Drug
23    Administration-cleared or in-house developed methods,

 

 

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1    performed under an institutional review board approved
2    protocol, if required;
3        (4) the availability of quality assurance testing and
4    comparative threshold values for ALD;
5        (5) the acquisition and installment by the Department
6    of the equipment necessary to implement the initial pilot
7    and statewide volume of screening tests for ALD;
8        (6) the establishment of precise threshold values
9    ensuring defined disorder identification for ALD;
10        (7) the authentication of pilot testing achieving each
11    milestone described in items (1) through (6) of this
12    Section for ALD; and
13        (8) the authentication of achieving the potential of
14    high throughput standards for statewide volume of ALD
15    concomitant with each milestone described in items (1)
16    through (6) of this Section.
17    The Department is authorized to implement an additional fee
18for the screening prior to beginning the testing in order to
19accumulate the resources for start-up and other costs
20associated with implementation of the screening and thereafter
21to support the costs associated with screening and follow-up
22programs for adrenoleukodystrophy.