Full Text of HB2661 98th General Assembly
HB2661ham003 98TH GENERAL ASSEMBLY | Rep. Robyn Gabel Filed: 3/19/2013
| | 09800HB2661ham003 | | LRB098 09098 RPM 43021 a |
|
| 1 | | AMENDMENT TO HOUSE BILL 2661
| 2 | | AMENDMENT NO. ______. Amend House Bill 2661 by replacing | 3 | | everything after the enacting clause with the following:
| 4 | | "Section 5. The Newborn Metabolic Screening Act is amended | 5 | | by changing Sections 1, 1.5, and 2 and by adding Sections 1.10, | 6 | | 3.1, 3.2, and 3.3 as follows:
| 7 | | (410 ILCS 240/1) (from Ch. 111 1/2, par. 4903)
| 8 | | Sec. 1.
The Illinois Department of Public Health shall | 9 | | promulgate and
enforce rules and regulations requiring that | 10 | | every newborn be subjected
to tests for genetic, | 11 | | phenylketonuria, hypothyroidism, galactosemia and such
other | 12 | | metabolic , and congenital anomalies diseases as the
Department | 13 | | may deem necessary from time to time . The Department is
| 14 | | empowered to promulgate such additional rules and regulations | 15 | | as are
found necessary for the administration of this Act, | 16 | | including mandatory
reporting of the results of all tests for |
| | | 09800HB2661ham003 | - 2 - | LRB098 09098 RPM 43021 a |
|
| 1 | | these conditions to the
Illinois Department of Public Health.
| 2 | | (Source: P.A. 83-87.)
| 3 | | (410 ILCS 240/1.5)
| 4 | | Sec. 1.5. Definitions. In this Act:
| 5 | | "Accredited laboratory" means any laboratory that holds a | 6 | | valid
certificate issued under the Clinical Laboratory | 7 | | Improvement
Amendments of 1988, 102 Stat. 2903, 42 U.S.C. 263a, | 8 | | as amended,
and that reports its screening results by using | 9 | | normal pediatric reference
ranges.
| 10 | | "Department" means the Department of Public Health. | 11 | | "Expanded screening" means screening for genetic and | 12 | | metabolic disorders,
including but not limited to amino acid | 13 | | disorders, organic acid disorders,
fatty acid oxidation | 14 | | disorders, and other abnormal profiles,
in newborn infants that | 15 | | can be detected through the use of a tandem
mass
spectrometer.
| 16 | | "Tandem mass spectrometer" means an analytical instrument | 17 | | used to detect
numerous genetic and metabolic disorders at one | 18 | | time.
| 19 | | (Source: P.A. 92-701, eff. 7-19-02.)
| 20 | | (410 ILCS 240/1.10 new) | 21 | | Sec. 1.10. Critical congenital heart disease. | 22 | | (a) The General Assembly finds as follows: | 23 | | (1) According to the United States Secretary of Health | 24 | | and Human Services Advisory Committee on Heritable |
| | | 09800HB2661ham003 | - 3 - | LRB098 09098 RPM 43021 a |
|
| 1 | | Disorders in Newborns and Children, congenital heart | 2 | | disease affects approximately 7 to 9 of every 1,000 live | 3 | | births in the United States and Europe. The federal Centers | 4 | | for Disease Control and Prevention state that critical | 5 | | congenital heart disease is the leading cause of infant | 6 | | death due to birth defects. | 7 | | (2) Many newborn lives could potentially be saved by | 8 | | earlier detection and treatment of critical congenital | 9 | | heart disease if health care facilities in the State were | 10 | | required to perform a simple, non-invasive newborn | 11 | | screening in conjunction with current screening methods. | 12 | | (b) The Department may authorize screening tests for | 13 | | congenital anomalies, including, but not limited to, a | 14 | | screening for critical congenital heart defects, to be | 15 | | performed at a health care facility that provides newborn | 16 | | infant care and that complies with the test procedures and the | 17 | | standards of accuracy and precision required by the Department. | 18 | | (c) The Department may authorize health care facilities to | 19 | | report screening test results and follow-up information.
| 20 | | (410 ILCS 240/2) (from Ch. 111 1/2, par. 4904)
| 21 | | Sec. 2. General provisions. The Department of Public Health | 22 | | shall administer the
provisions of this Act and shall:
| 23 | | (a) Institute and carry on an intensive educational program | 24 | | among
physicians, hospitals, public health nurses and the | 25 | | public concerning disorders included in newborn screening
the |
| | | 09800HB2661ham003 | - 4 - | LRB098 09098 RPM 43021 a |
|
| 1 | | diseases phenylketonuria, hypothyroidism, galactosemia and | 2 | | other
metabolic diseases . This
educational program shall | 3 | | include information about the nature of the
diseases and | 4 | | examinations for the detection of the diseases in early
infancy | 5 | | in order that measures may be taken to prevent the intellectual | 6 | | disabilities resulting from the diseases.
| 7 | | (a-5) Require that Beginning July 1, 2002, provide all | 8 | | newborns be screened
with expanded screening tests for the | 9 | | presence of genetic, metabolic, and congenital anomalies. | 10 | | (a-5.1) Require that all blood and biological specimens | 11 | | collected pursuant to this Act or the rules adopted under this | 12 | | Act be submitted for testing to the nearest Department | 13 | | laboratory designated to perform such tests. The following | 14 | | provisions shall apply concerning testing: | 15 | | (1) The Department may develop a reasonable fee | 16 | | structure and may levy fees according to such structure to | 17 | | cover the cost of providing this testing service and for | 18 | | the follow-up of infants with an abnormal screening test. | 19 | | Fees collected from the provision of this testing service | 20 | | shall be placed in the Metabolic Screening and Treatment | 21 | | Fund. Other State and federal funds for expenses related to | 22 | | metabolic screening, follow-up, and treatment programs may | 23 | | also be placed in the Fund. | 24 | | (2) Moneys shall be appropriated from the Fund to the | 25 | | Department solely for the purposes of providing newborn | 26 | | screening, follow-up, and treatment programs. Nothing in |
| | | 09800HB2661ham003 | - 5 - | LRB098 09098 RPM 43021 a |
|
| 1 | | this Act shall be construed to prohibit any licensed | 2 | | medical facility from collecting additional specimens for | 3 | | testing for metabolic or neonatal diseases or any other | 4 | | diseases or conditions, as it deems fit. Any person | 5 | | violating the provisions of this subsection (a-5.1) is | 6 | | guilty of a petty offense. endocrine, or
other metabolic | 7 | | disorders, including phenylketonuria, galactosemia,
| 8 | | hypothyroidism, congenital adrenal hyperplasia, | 9 | | biotinidase deficiency,
and sickling disorders, as well as | 10 | | other amino acid disorders, organic
acid disorders, fatty | 11 | | acid oxidation disorders, and other abnormalities
| 12 | | detectable through the use of a tandem mass spectrometer. | 13 | | (3) If by July 1,
2002, the Department is unable to | 14 | | provide the expanded screening using the
State Laboratory, | 15 | | it shall temporarily provide such screening
through an | 16 | | accredited laboratory selected by the Department until the
| 17 | | Department has the capacity to provide screening through | 18 | | the State
Laboratory. If expanded screening is provided on | 19 | | a temporary basis
through an accredited laboratory, the | 20 | | Department shall substitute the fee
charged by the | 21 | | accredited laboratory, plus a 5% surcharge for
| 22 | | documentation and handling, for the fee authorized in this | 23 | | subsection (a-5.1) (e) of
this Section . | 24 | | (a-5.2) Maintain a registry of cases, including | 25 | | information of importance for the purpose of follow-up services | 26 | | to assess long-term outcomes. |
| | | 09800HB2661ham003 | - 6 - | LRB098 09098 RPM 43021 a |
|
| 1 | | (a-5.3) Supply the necessary metabolic treatment formulas | 2 | | where practicable for diagnosed cases of amino acid metabolism | 3 | | disorders, including phenylketonuria, organic acid disorders, | 4 | | and fatty acid oxidation disorders for as long as medically | 5 | | indicated, when the product is not available through other | 6 | | State agencies. | 7 | | (a-5.4) Arrange for or provide public health nursing, | 8 | | nutrition, and social services and clinical consultation as | 9 | | indicated. | 10 | | (a-5.5) The Director shall appoint a Genetic and Metabolic | 11 | | Diseases Advisory Committee to provide guidance and | 12 | | recommendations to the Department's newborn screening program. | 13 | | The Genetic and Metabolic Diseases Advisory Committee shall | 14 | | review the feasibility of including additional metabolic, | 15 | | genetic, and congenital disorders in the newborn screening | 16 | | panel. The Genetic and Metabolic Diseases Advisory Committee | 17 | | shall be comprised of health and medical experts and consumer | 18 | | representatives. The Department shall consider the | 19 | | recommendations of the Genetic and Metabolic Diseases Advisory | 20 | | Committee in determining whether to include an additional | 21 | | disorder in the screening panel prior to adopting | 22 | | administrative rules. Members of the Genetic and Metabolic | 23 | | Diseases Advisory Committee may receive compensation for | 24 | | necessary expenses incurred in the performance of their duties.
| 25 | | (a-6) (Blank). In accordance with the timetable specified | 26 | | in this subsection, provide all newborns with expanded |
| | | 09800HB2661ham003 | - 7 - | LRB098 09098 RPM 43021 a |
|
| 1 | | screening tests for the presence of certain Lysosomal Storage | 2 | | Disorders known as Krabbe, Pompe, Gaucher, Fabry, and | 3 | | Niemann-Pick. The testing shall begin within 6 months following | 4 | | the occurrence of all of the following: | 5 | | (i) the establishment and verification of relevant and | 6 | | appropriate performance specifications as defined under | 7 | | the federal Clinical Laboratory Improvement Amendments and | 8 | | regulations thereunder for Federal Drug | 9 | | Administration-cleared or in-house developed methods, | 10 | | performed under an institutional review board approved | 11 | | protocol, if required; | 12 | | (ii) the availability of quality assurance testing | 13 | | methodology for these processes; | 14 | | (iii) the acquisition and installment by the | 15 | | Department of the equipment necessary to implement the | 16 | | expanded screening tests; | 17 | | (iv) establishment of precise threshold values | 18 | | ensuring defined disorder identification for each | 19 | | screening test; | 20 | | (v) authentication of pilot testing achieving each | 21 | | milestone described in items (i) through (iv) of this | 22 | | subsection (a-6) for each disorder screening test; and | 23 | | (vi)
authentication achieving potentiality of high | 24 | | throughput standards for statewide volume of each disorder | 25 | | screening test concomitant with each milestone described | 26 | | in items (i) through (iv) of this subsection (a-6). |
| | | 09800HB2661ham003 | - 8 - | LRB098 09098 RPM 43021 a |
|
| 1 | | It is the goal of Public Act 97-532 that the expanded | 2 | | screening for the specified Lysosomal Storage Disorders begins | 3 | | within 2 years after August 23, 2011 (the effective date of | 4 | | Public Act 97-532). The Department is authorized to implement | 5 | | an additional fee for the screening prior to beginning the | 6 | | testing in order to accumulate the resources for start-up and | 7 | | other costs associated with implementation of the screening and | 8 | | thereafter to support the costs associated with screening and | 9 | | follow-up programs for the specified Lysosomal Storage | 10 | | Disorders.
| 11 | | (a-7) (Blank). In accordance with the timetable specified | 12 | | in this
subsection (a-7), provide all newborns with expanded | 13 | | screening tests
for the presence of Severe Combined | 14 | | Immunodeficiency Disease (SCID). The testing shall begin | 15 | | within 12 months following the occurrence of all of the | 16 | | following: | 17 | | (i) the establishment and verification of relevant and | 18 | | appropriate performance specifications as defined under | 19 | | the federal Clinical Laboratory Improvement Amendments and | 20 | | regulations thereunder for Federal Drug | 21 | | Administration-cleared or in-house developed methods, | 22 | | performed under an institutional review board approved | 23 | | protocol, if required; | 24 | | (ii) the availability of quality assurance testing and | 25 | | comparative threshold values for SCID; | 26 | | (iii) the acquisition and installment by the |
| | | 09800HB2661ham003 | - 9 - | LRB098 09098 RPM 43021 a |
|
| 1 | | Department of the equipment necessary to implement the | 2 | | initial pilot and expanded statewide volume of screening | 3 | | tests for SCID; | 4 | | (iv) establishment of precise threshold values | 5 | | ensuring defined disorder identification for SCID; | 6 | | (v) authentication of pilot testing achieving each | 7 | | milestone described in items (i) through (iv) of this | 8 | | subsection (a-7) for SCID; and | 9 | | (vi) authentication achieving potentiality of high | 10 | | throughput standards for statewide volume of the SCID | 11 | | screening test concomitant with each milestone described | 12 | | in items (i) through (iv) of this subsection (a-7). | 13 | | It is the goal of Public Act 97-532 that the expanded | 14 | | screening for Severe Combined Immunodeficiency Disease begins | 15 | | within 2 years after August 23, 2011 (the effective date of | 16 | | Public Act 97-532). The Department is authorized to
implement | 17 | | an additional fee for the screening prior to
beginning the | 18 | | testing in order to accumulate the resources for
start-up and | 19 | | other costs associated with implementation of the
screening and | 20 | | thereafter to support the costs associated with
screening and | 21 | | follow-up programs for Severe Combined Immunodeficiency | 22 | | Disease. | 23 | | (a-8) (Blank). In accordance with the timetable specified | 24 | | in this subsection (a-8), provide all newborns with expanded | 25 | | screening tests
for the presence of certain Lysosomal Storage | 26 | | Disorders known as Mucopolysaccharidosis I (Hurlers) and |
| | | 09800HB2661ham003 | - 10 - | LRB098 09098 RPM 43021 a |
|
| 1 | | Mucopolysaccharidosis II (Hunters). The testing shall begin | 2 | | within 12 months following the occurrence of all of the | 3 | | following: | 4 | | (i) the establishment and verification of relevant and | 5 | | appropriate performance specifications as defined under | 6 | | the federal Clinical Laboratory Improvement Amendments and | 7 | | regulations thereunder for Federal Drug | 8 | | Administration-cleared or in-house developed methods, | 9 | | performed under an institutional review board approved | 10 | | protocol, if required; | 11 | | (ii) the availability of quality assurance testing and | 12 | | comparative threshold values for each screening test and | 13 | | accompanying disorder; | 14 | | (iii) the acquisition and installment by the | 15 | | Department of the equipment necessary to implement the | 16 | | initial pilot and expanded statewide volume of screening | 17 | | tests for each disorder; | 18 | | (iv) establishment of precise threshold values | 19 | | ensuring defined disorder identification for each | 20 | | screening test; | 21 | | (v) authentication of pilot testing achieving each | 22 | | milestone described in items (i) through (iv) of this | 23 | | subsection (a-8) for each disorder screening test; and | 24 | | (vi) authentication achieving potentiality of high | 25 | | throughput standards for statewide volume of each disorder | 26 | | screening test concomitant with each milestone described |
| | | 09800HB2661ham003 | - 11 - | LRB098 09098 RPM 43021 a |
|
| 1 | | in items (i) through (iv) of this subsection (a-8). | 2 | | It is the goal of Public Act 97-532 that the expanded | 3 | | screening for the specified
Lysosomal Storage Disorders begins | 4 | | within 3 years after August 23, 2011 (the effective date of | 5 | | Public Act 97-532). The Department is authorized to
implement | 6 | | an additional fee for the screening prior to beginning the | 7 | | testing in order to accumulate the resources for
start-up and | 8 | | other costs associated with implementation of the screening and | 9 | | thereafter to support the costs associated with
screening and | 10 | | follow-up programs for the specified Lysosomal Storage | 11 | | Disorders. | 12 | | (b) (Blank). Maintain a registry of cases including | 13 | | information of importance
for the purpose of follow-up services | 14 | | to prevent intellectual disabilities.
| 15 | | (c) (Blank). Supply the necessary metabolic treatment | 16 | | formulas
where practicable for
diagnosed cases of amino acid | 17 | | metabolism disorders, including phenylketonuria, organic acid | 18 | | disorders, and fatty acid oxidation disorders for as long as | 19 | | medically indicated, when the product is
not available through | 20 | | other State agencies.
| 21 | | (d) (Blank). Arrange for or provide public health nursing, | 22 | | nutrition and
social services and clinical consultation as | 23 | | indicated.
| 24 | | (e) (Blank). Require that all specimens collected pursuant | 25 | | to this Act or the rules
and regulations promulgated hereunder | 26 | | be submitted for testing to the nearest
Department of Public |
| | | 09800HB2661ham003 | - 12 - | LRB098 09098 RPM 43021 a |
|
| 1 | | Health laboratory designated to perform such tests.
The | 2 | | Department may develop a reasonable fee structure and may levy | 3 | | fees
according to such structure to cover the cost of providing | 4 | | this testing
service. Fees collected from the provision of this | 5 | | testing service shall
be placed in a special fund in the State | 6 | | Treasury, hereafter known as the
Metabolic Screening and | 7 | | Treatment Fund. Other State and federal funds for
expenses | 8 | | related to metabolic screening, follow-up and treatment | 9 | | programs
may also be placed in such Fund. Moneys shall be | 10 | | appropriated from such
Fund to the Department of Public Health | 11 | | solely for the purposes of providing
metabolic screening, | 12 | | follow-up and treatment programs. Nothing in this
Act shall be | 13 | | construed to prohibit any licensed medical facility from
| 14 | | collecting
additional specimens for testing for metabolic or | 15 | | neonatal diseases or any
other diseases or conditions, as it | 16 | | deems fit. Any person
violating the provisions of this | 17 | | subsection (e) is guilty of a petty offense.
| 18 | | (Source: P.A. 97-227, eff. 1-1-12; 97-532, eff. 8-23-11; | 19 | | 97-813, eff. 7-13-12.)
| 20 | | (410 ILCS 240/3.1 new) | 21 | | Sec. 3.1. Lysosomal storage disorders. In accordance with | 22 | | the timetable specified in this Section, the Department shall | 23 | | provide all newborns with screening tests for the presence of | 24 | | certain lysosomal storage disorders known as Krabbe, Pompe, | 25 | | Gaucher, Fabry, and Niemann-Pick. The testing shall begin |
| | | 09800HB2661ham003 | - 13 - | LRB098 09098 RPM 43021 a |
|
| 1 | | within 6 months following the occurrence of all of the | 2 | | following: | 3 | | (1) the establishment and verification of relevant
and | 4 | | appropriate performance specifications as defined under | 5 | | the federal Clinical Laboratory Improvement Amendments and | 6 | | regulations thereunder for Federal Drug | 7 | | Administration-cleared or in-house developed methods, | 8 | | performed under an institutional review board approved | 9 | | protocol, if required; | 10 | | (2) the availability of quality assurance testing | 11 | | methodology for these processes; | 12 | | (3) the acquisition and installment by the Department | 13 | | of the equipment necessary to implement the screening | 14 | | tests; | 15 | | (4) establishment of precise threshold values ensuring | 16 | | defined disorder identification for each screening test; | 17 | | (5) authentication of pilot testing achieving each | 18 | | milestone described in items (1) through (4) of this | 19 | | Section for each disorder screening test; and | 20 | | (6) authentication achieving potentiality of high
| 21 | | throughput standards for statewide volume of each disorder | 22 | | screening test concomitant with each milestone described | 23 | | in items (1) through (4) of this Section. | 24 | | It is the goal of Public Act 97-532 that the screening for | 25 | | the specified lysosomal storage disorders begins within 2 years | 26 | | after August 23, 2011 (the effective date of Public Act |
| | | 09800HB2661ham003 | - 14 - | LRB098 09098 RPM 43021 a |
|
| 1 | | 97-532). The Department is authorized to implement an | 2 | | additional fee for the screening prior to beginning the testing | 3 | | in order to accumulate the resources for start-up and other | 4 | | costs associated with implementation of the screening and | 5 | | thereafter to support the costs associated with screening and | 6 | | follow-up programs for the specified lysosomal storage | 7 | | disorders. | 8 | | (410 ILCS 240/3.2 new) | 9 | | Sec. 3.2. Severe combined immunodeficiency disease. In | 10 | | accordance with the timetable specified in this Section, the | 11 | | Department shall provide all newborns with screening tests for | 12 | | the presence of severe combined immunodeficiency
disease | 13 | | (SCID). The testing shall begin within 12 months following the | 14 | | occurrence of all of the following: | 15 | | (1) the establishment and verification of relevant and
| 16 | | appropriate performance specifications as defined under
| 17 | | the federal Clinical Laboratory Improvement Amendments and
| 18 | | regulations thereunder for Federal Drug
| 19 | | Administration-cleared or in-house developed methods,
| 20 | | performed under an institutional review board approved
| 21 | | protocol, if required; | 22 | | (2) the availability of quality assurance testing and
| 23 | | comparative threshold values for SCID; | 24 | | (3) the acquisition and installment by the
Department | 25 | | of the equipment necessary to implement the
initial pilot |
| | | 09800HB2661ham003 | - 15 - | LRB098 09098 RPM 43021 a |
|
| 1 | | and statewide volume of screening
tests for SCID; | 2 | | (4) establishment of precise threshold values
ensuring | 3 | | defined disorder identification for SCID; | 4 | | (5) authentication of pilot testing achieving each
| 5 | | milestone described in items (1) through (4) of this
| 6 | | Section for SCID; and | 7 | | (6) authentication achieving potentiality of high
| 8 | | throughput standards for statewide volume of the SCID
| 9 | | screening test concomitant with each milestone described
| 10 | | in items (1) through (4) of this Section. | 11 | | It is the goal of Public Act 97-532 that the screening for | 12 | | severe combined immunodeficiency disease begins within 2 years | 13 | | after August 23, 2011 (the effective date of Public Act | 14 | | 97-532). The Department is authorized to implement an | 15 | | additional fee for the screening prior to beginning the testing | 16 | | in order to accumulate the resources for start-up and other | 17 | | costs associated with implementation of the screening and | 18 | | thereafter to support the costs associated with screening and | 19 | | follow-up programs for severe combined immunodeficiency | 20 | | disease. | 21 | | (410 ILCS 240/3.3 new) | 22 | | Sec. 3.3. Mucopolysacchardosis disorders. In accordance | 23 | | with the timetable specified in this Section, the Department | 24 | | shall provide all newborns with screening tests for the | 25 | | presence of certain lysosomal storage disorders
known as |
| | | 09800HB2661ham003 | - 16 - | LRB098 09098 RPM 43021 a |
|
| 1 | | mucopolysaccharidosis I (Hurlers) and mucopolysaccharidosis II | 2 | | (Hunters). The testing shall begin within 12 months following | 3 | | the occurrence of all of the following: | 4 | | (1) the establishment and verification of relevant and
| 5 | | appropriate performance specifications as defined under
| 6 | | the federal Clinical Laboratory Improvement Amendments and
| 7 | | regulations thereunder for Federal Drug | 8 | | Administration-cleared or in-house developed methods, | 9 | | performed under an institutional review board approved | 10 | | protocol, if required; | 11 | | (2) the availability of quality assurance testing and | 12 | | comparative threshold values for each screening test and | 13 | | accompanying disorder; | 14 | | (3) the acquisition and installment by the Department | 15 | | of the equipment necessary to implement the initial pilot | 16 | | and statewide volume of screening tests for each disorder; | 17 | | (4) establishment of precise threshold values ensuring | 18 | | defined disorder identification for each screening test; | 19 | | (5) authentication of pilot testing achieving each | 20 | | milestone described in items (1) through (4) of this | 21 | | Section for each disorder screening test; and | 22 | | (6) authentication achieving potentiality of high | 23 | | throughput standards for statewide volume of each disorder | 24 | | screening test concomitant with each milestone described | 25 | | in items (1) through (4) of this Section. | 26 | | It is the goal of Public Act 97-532 that the screening for |
| | | 09800HB2661ham003 | - 17 - | LRB098 09098 RPM 43021 a |
|
| 1 | | the specified lysosomal storage disorders begins within 3 years | 2 | | after August 23, 2011 (the effective date of Public Act | 3 | | 97-532). The Department is authorized to implement an | 4 | | additional fee for the screening prior to beginning the testing | 5 | | in order to accumulate the resources for start-up and other | 6 | | costs associated with implementation of the screening and | 7 | | thereafter to support the costs associated with screening and | 8 | | follow-up programs for the specified lysosomal storage
| 9 | | disorders.
| 10 | | Section 99. Effective date. This Act takes effect upon | 11 | | becoming law.".
|
|