NEWBORN METABOLIC SCREENING

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Full Text of SB3049

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SB3049 - 104th General Assembly

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SB3049 Enrolled
LRB104 16764 BDA 32796 b
1

AN ACT concerning health.

2

Be it enacted by the People of the State of Illinois,
3
represented in the General Assembly:

4

Section 5.
The Newborn Metabolic Screening Act is amended
5
by changing Section 2 as follows:

6

(410 ILCS 240/2)

(from Ch. 111 1/2, par. 4904)
7

Sec. 2.
General provisions.
The Department of Public
8
Health shall administer the provisions of this Act and shall:
9

(a) Institute and carry on an intensive educational
10
program among physicians, hospitals, public health nurses
,
and
11
the public concerning disorders included in newborn screening.
12
This educational program shall include information about the
13
nature of the diseases and examinations for the detection of
14
the diseases in early infancy in order that measures may be
15
taken to prevent the disabilities resulting from the diseases.
16

(a-5) Require that all newborns be screened for the
17
presence of certain genetic, metabolic, and congenital
18
anomalies as determined by the Department, by rule.
19

(a-5.1) Require that all blood and biological specimens
20
collected pursuant to this Act or the rules adopted under this
21
Act be submitted for testing to the nearest Department
22
laboratory designated to perform such tests. The following
23
provisions shall apply concerning testing:

SB3049 Enrolled
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LRB104 16764 BDA 32796 b
1

(1) Beginning July 1, 2015, the base fee for newborn
2

screening services shall be $118. The Department may
3

develop a reasonable fee structure and may levy additional
4

fees according to such structure to cover the cost of
5

providing this testing service and for the follow-up of
6

infants with an abnormal screening test; however,
7

additional fees may be levied no sooner than 6 months
8

prior to the beginning of testing for a new genetic,
9

metabolic, or congenital disorder. Fees collected from the
10

provision of this testing service shall be placed in the
11

Metabolic Screening and Treatment Fund. Other State and
12

federal funds for expenses related to metabolic screening,
13

follow-up, and treatment programs may also be placed in
14

the Fund.
15

(2) Moneys shall be appropriated from the Fund to the
16

Department solely for the purposes of providing newborn
17

screening, follow-up, and treatment programs. Nothing in
18

this Act shall be construed to prohibit any licensed
19

medical facility from collecting additional specimens for
20

testing for metabolic or neonatal diseases or any other
21

diseases or conditions, as it deems fit. Any person
22

violating the provisions of this subsection (a-5.1) is
23

guilty of a petty offense.
24

(3) If the Department is unable to provide the
25

screening using the State Laboratory, it shall temporarily
26

provide such screening through an accredited laboratory

SB3049 Enrolled
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LRB104 16764 BDA 32796 b
1

selected by the Department until the Department has the
2

capacity to provide screening through the State
3

Laboratory. If screening is provided on a temporary basis
4

through an accredited laboratory, the Department shall
5

substitute the fee charged by the accredited laboratory,
6

plus a 5% surcharge for documentation and handling, for
7

the fee authorized in this subsection (a-5.1).
8

(a-5.2) Maintain a registry of cases, including
9
information of importance for the purpose of follow-up
10
services to assess long-term outcomes.
11

(a-5.3) Supply the necessary metabolic treatment formulas
12
where practicable for diagnosed cases of amino acid metabolism
13
disorders, including phenylketonuria, organic acid disorders,
14
and fatty acid oxidation disorders for as long as medically
15
indicated, when the product is not available through other
16
State agencies.
17

(a-5.4) Arrange for or provide public health nursing,
18
nutrition, and social services and clinical consultation as
19
indicated.
20

(a-5.5) Utilize the
Universal Newborn Screening

Genetic
21
and Metabolic Diseases
Advisory Committee established under
22
the Genetic and Metabolic Diseases Advisory Committee Act to
23
provide guidance and recommendations to the Department's
24
newborn screening program. The
Universal Newborn Screening

25
Genetic and Metabolic Diseases
Advisory Committee shall review
26
the feasibility and advisability of including additional

SB3049 Enrolled
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LRB104 16764 BDA 32796 b
1
metabolic, genetic, and congenital disorders in the newborn
2
screening panel, according to a review protocol applied to
3
each suggested addition to the screening panel.
Beginning
4
January 1, 2027, the Universal Newborn Screening Advisory
5
Committee shall review all new conditions added to the federal
6
Recommended Uniform Screening Panel within 12 months of the
7
condition being added to the Recommended Uniform Screening
8
Panel, as long as the condition meets the requirements of this
9
Section. If the Recommended Uniform Screening Panel includes
10
conditions not screened by the State on the effective date of
11
this amendatory Act of the 104th General Assembly, the
12
Universal Newborn Screening Advisory Committee shall begin
13
review of the condition no later than one year after the
14
effective date of this amendatory Act of the 104th General
15
Assembly. Nothing in this Section shall be construed to
16
prevent the review and recommendation of additional conditions
17
not on the Recommended Uniform Screening Panel on the
18
effective date of this amendatory Act of the 104th General
19
Assembly, as long as they meet the requirements for review.

20
The Department shall consider the recommendations of the
21
Universal Newborn Screening

Genetic and Metabolic Diseases

22
Advisory Committee in determining whether to include an
23
additional disorder in the screening panel prior to proposing
24
an administrative rule concerning inclusion of an additional
25
disorder in the newborn screening panel. Notwithstanding any
26
other provision of law, no new screening may begin prior to the

SB3049 Enrolled
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LRB104 16764 BDA 32796 b
1
occurrence of all the following:
2

(1) the establishment and verification of relevant and
3

appropriate performance specifications as defined under
4

the federal Clinical Laboratory Improvement Amendments and
5

regulations thereunder for U.S. Food and Drug
6

Administration-cleared or in-house developed methods,
7

performed under an institutional review board-approved
8

protocol, if required;
9

(2) the availability of quality assurance testing
10

methodology for the processes set forth in item (1) of
11

this subsection (a-5.5);
12

(3) the acquisition and installment by the Department
13

of the equipment necessary to implement the screening
14

tests;
15

(4) the establishment of precise threshold values
16

ensuring defined disorder identification for each
17

screening test;
18

(5) the authentication of pilot testing achieving each
19

milestone described in items (1) through (4) of this
20

subsection (a-5.5) for each disorder screening test; and
21

(6) the authentication of achieving the potential of
22

high throughput standards for statewide volume of each
23

disorder screening test concomitant with each milestone
24

described in items (1) through (4) of this subsection
25

(a-5.5).
26

(a-6) (Blank).

SB3049 Enrolled
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LRB104 16764 BDA 32796 b
1

(a-7) (Blank).
2

(a-8) (Blank).
3

(b) (Blank).
4

(c) (Blank).
5

(d) (Blank).
6

(e) (Blank).
7
(Source: P.A. 98-440, eff. 8-16-13; 98-756, eff. 7-16-14;
8
99-403, eff. 8-19-15.)

9

Section 10.
The Genetic and Metabolic Diseases Advisory
10
Committee Act is amended by changing Section 5 as follows:

11

(410 ILCS 265/5)
12

Sec. 5.
Universal Newborn Screening

Genetic and Metabolic
13
Diseases
Advisory Committee.
14

(a) The Director of Public Health shall create the
15
Universal Newborn Screening

Genetic and Metabolic Diseases

16
Advisory Committee to advise the Department of Public Health
17
regarding issues relevant to newborn screenings of metabolic
18
diseases.
19

(b) The
Universal Newborn Screening Advisory Committee
20
shall

purposes of Metabolic Diseases Advisory Committee are
21
all of the following
:
22

(1) Conduct reviews of any condition added to the
23

federal Recommended Uniform Screening Panel pursuant to
24

Section 2 of the Newborn Metabolic Screening Act within

SB3049 Enrolled
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LRB104 16764 BDA 32796 b
1

one year of addition to the Recommended Uniform Screening
2

Panel.
3

(2) Conduct reviews within one year of any condition
4

that meets the following criteria once both criteria have
5

been met:
6

(A) there is a newborn screening assay available
7

for the condition; and
8

(B) there is a therapeutic intervention or
9

treatment approved by the United States Food and Drug
10

Administration for the condition.
11

(3) Following review of each condition, make a formal
12

recommendation to the Department of Public Health on
13

whether to add the condition to the newborn screening
14

panel. If the Department approves the addition of the
15

condition, the Department must inform the State Laboratory
16

within 60 days of receiving the recommendation. The State
17

Laboratory shall implement newborn screening for the
18

approved conditions within 2 years. If the Department does
19

not approve the condition, the Department must provide
20

information as to why the decision was made and what gaps
21

of information are needed for reconsideration.
22

(4) Submit to the Governor's Office and the General
23

Assembly by December 31, 2027 and each year thereafter, a
24

list of the conditions the Committee reviewed, the
25

Committee's recommendations, the Department of Public
26

Health's decisions, and the status of implementation in

SB3049 Enrolled
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LRB104 16764 BDA 32796 b
1

the lab. Any recommendations not to add a condition shall
2

include information from the Committee as to why the
3

decision was made, what gaps of information need to be met
4

for reconsideration along with processes to initiate
5

reconsideration.
6

(5)

(1)
Advise the Department regarding issues
7

relevant to its Genetics Program.
8

(6)

(2)
Advise the Department regarding optimal
9

laboratory methodologies for screening of the targeted
10

conditions.
11

(7)

(3)
Recommend to the Department consultants who
12

are qualified to diagnose a condition detected by
13

screening, provide management of care, and genetic
14

counseling for the family.
15

(8)

(4)
Monitor the incidence of each condition for
16

which newborn screening is done, evaluate the effects of
17

treatment and genetic counseling, and provide advice on
18

disorders to be included in newborn screening panel.
19

(9)

(5)
Advise the Department on educational programs
20

for professionals and the general public.
21

(10)

(6)
Advise the Department on new developments and
22

areas of interest in relation to the Genetics Program.
23

(11)

(7)

Address any other matters

Any other matter

24

deemed appropriate by the Committee and the Director.
25

(b-5) Nothing in this Section shall be construed to
26
prevent the review and recommendation of additional conditions

SB3049 Enrolled
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LRB104 16764 BDA 32796 b
1
not currently on the Recommended Uniform Screening Panel.

2

(c) The Committee shall consist of 20 members appointed by
3
the Director of Public Health. Membership shall include
4
physicians, geneticists, nurses, nutritionists, and other
5
allied health professionals, as well as patients and parents.
6
Ex officio

Ex-officio
members may be appointed, but shall not
7
have voting privileges.
8

(d) Members of the Committee may receive compensation for
9
necessary expenses incurred in the performance of their
10
duties.
11
(Source: P.A. 98-440, eff. 8-16-13.)

12

Section 99.
Effective date.
This Act takes effect upon
13
becoming law.

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