093_SB1198sam002

 










                                     LRB093 10969 LRD 13095 a

 1                    AMENDMENT TO SENATE BILL 1198

 2        AMENDMENT NO.     .  Amend Senate Bill 1198 by  replacing
 3    everything after the enacting clause with the following:

 4        "Section  1.  Short  title.  This Act may be cited as the
 5    Newborn Screening Act.

 6        Section 5. Rules.   The  Illinois  Department  of  Public
 7    Health  shall  promulgate  and  enforce  rules requiring that
 8    every newborn be  subjected  to  tests  for  phenylketonuria,
 9    hypothyroidism, galactosemia, and other metabolic diseases as
10    the  Department  may  deem  necessary  from  time to time. In
11    addition, every newborn whose mother's Human Immunodeficiency
12    Virus ("HIV") status  is  unknown  must  be  tested  for  HIV
13    antibodies as a routine component of newborn care, subject to
14    parental  or  guardian  right  of  refusal. The Department is
15    empowered  to  promulgate  such  additional  rules   as   are
16    necessary  for  the  administration  of  this  Act, including
17    mandatory reporting of the results of  all  tests  for  these
18    conditions  to  the  Illinois Department of Public Health. To
19    protect the confidentiality of test results, all HIV-positive
20    results shall be reported in accordance with state  laws  and
21    rules,  including  Section 4 of the AIDS Registry Act and  77
22    Ill. Admin. Code Section 697.210  and  77  Ill.  Admin.  Code
 
                            -2-      LRB093 10969 LRD 13095 a
 1    Section 693.30.

 2        Section 10. Definitions. In this Act:
 3        "Accredited laboratory" means any laboratory that holds a
 4    valid   certificate  issued  under  the  Clinical  Laboratory
 5    Improvement Amendments of 1988, 102  Stat.  2903,  42  U.S.C.
 6    263a,  as  amended, and that reports its screening results by
 7    using normal pediatric reference ranges.
 8        "Expanded screening"  means  screening  for  genetic  and
 9    metabolic  disorders, including but not limited to amino acid
10    disorders,  organic  acid  disorders,  fatty  acid  oxidation
11    disorders, and other abnormal  profiles  in  newborn  infants
12    that  can  be  detected  through  the  use  of  a tandem mass
13    spectrometer.
14        "HIV-related test" means a test that detects the presence
15    of HIV antibodies.
16        "Tandem mass spectrometer" means an analytical instrument
17    used to detect numerous genetic and  metabolic  disorders  at
18    one time.

19        Section 15. Powers and duties of Department; tests; fees;
20    Metabolic   Screening   and  Treatment  Fund;  penalty.   The
21    Department of Public Health shall administer  the  provisions
22    of this Act and shall:
23             (1)  Institute and carry on an intensive educational
24        program   among   physicians,  hospitals,  public  health
25        nurses,  and   the   public   concerning   the   diseases
26        phenylketonuria,  hypothyroidism, galactosemia, and other
27        metabolic  diseases.  This  educational   program   shall
28        include  information about the nature of the diseases and
29        examinations for the detection of the diseases  in  early
30        infancy  so  that  measures  may  be taken to prevent the
31        mental retardation resulting from the diseases.
32             (2)  Beginning July 1, 2003,  provide  all  newborns
 
                            -3-      LRB093 10969 LRD 13095 a
 1        with   expanded  screening  tests  for  the  presence  of
 2        genetic,  endocrine,  or   other   metabolic   disorders,
 3        including  phenylketonuria, galactosemia, hypothyroidism,
 4        congenital adrenal hyperplasia,  biotinidase  deficiency,
 5        and  sickling  disorders, and other amino acid disorders,
 6        organic acid disorders, fatty acid  oxidation  disorders,
 7        and  other  abnormalities detectable through the use of a
 8        tandem mass  spectrometer.  If,  by  July  1,  2003,  the
 9        Department  is unable to provide expanded screening using
10        the State Laboratory, it shall temporarily  provide  such
11        screening  through  an  accredited laboratory selected by
12        the Department until the Department has the  capacity  to
13        provide   screening  through  the  State  Laboratory.  If
14        expanded screening  is  provided  on  a  temporary  basis
15        through  an  accredited  laboratory, the Department shall
16        substitute the fee charged by the accredited  laboratory,
17        plus  a  5% surcharge for documentation and handling, for
18        the fee authorized in item (6) of this Section.
19             (3)  Maintain  a   registry   of   cases   including
20        information  of  importance  for the purpose of follow-up
21        services to prevent mental retardation.
22             (4)  Supply the necessary  treatment  product  where
23        practicable  for diagnosed cases for as long as medically
24        indicated when the product is not available through other
25        State agencies.
26             (5)  Arrange for or provide public  health  nursing,
27        nutrition  and social services, and clinical consultation
28        as indicated.
29             (6)  Require that all specimens  collected  pursuant
30        to  this  Act  or the rules promulgated under this Act be
31        submitted for testing to the nearest Department of Public
32        Health laboratory designated to perform such  tests.  The
33        Department may develop a reasonable fee structure and may
34        levy  fees  according to such structure to cover the cost
 
                            -4-      LRB093 10969 LRD 13095 a
 1        of providing this testing service.  Fees  collected  from
 2        the  provision  of  this  testing service shall be placed
 3        into the Metabolic Screening and Treatment Fund, which is
 4        hereby created as a special fund in the  State  treasury.
 5        Other  State  and  federal  funds for expenses related to
 6        metabolic screening, follow-up,  and  treatment  programs
 7        may  also  be  placed  into  that  Fund.  Moneys shall be
 8        appropriated from the Fund to the  Department  of  Public
 9        Health  solely  for  the  purposes of providing metabolic
10        screening, follow-up, and treatment programs. Nothing  in
11        this  Act  shall  be  construed  to prohibit any licensed
12        medical facility from collecting additional specimens for
13        testing for metabolic or neonatal diseases or  any  other
14        diseases  or  conditions  as  it  deems  fit.  Any person
15        violating the provisions of this item (6) is guilty of  a
16        petty offense.

17        Section  20.  Powers  and duties of Department; HIV tests
18    and education; penalty.
19        (a)  The Department of Public Health shall administer the
20    provisions of this Act and shall:
21             (1)  Institute and carry on an intensive educational
22        program  among  physicians,  hospitals,   public   health
23        nurses,  and  the public concerning HIV. This educational
24        program shall include information about the nature of the
25        disease and the diagnostic test for the detection of  the
26        disease  that  should  be  done during pregnancy or for a
27        newborn within 48 hours of birth (if the  HIV  status  of
28        the  mother is unknown), subject to the right of refusal,
29        in order that  measures  may  be  taken  to  prevent  HIV
30        infection.
31             (2)  Establish   a  comprehensive  program  for  the
32        detection of antibodies to the  HIV  virus.  The  program
33        must include instructions on but need not be limited to:
 
                            -5-      LRB093 10969 LRD 13095 a
 1                  (i)  the requirements of this Act;
 2                  (ii)  the  benefits of HIV testing for pregnant
 3             women and the newborns whose mother's HIV status  is
 4             unknown;
 5                  (iii)  the  possible  interventions  to prevent
 6             HIV transmission from a pregnant woman to her  fetus
 7             or newborn;
 8                  (iv)  the side effects of such interventions;
 9                  (v)  the  statutory  confidentiality provisions
10             that relate to HIV and  acquired  immune  deficiency
11             syndrome ("AIDS") testing; and
12                  (vi)  resources available for health care, case
13             management,  counseling,  and  treatment  for people
14             with HIV and AIDS.
15             (3)  Promulgate rules governing  the  implementation
16        of  the  program  required  under item (2), including the
17        administration of counseling, testing,  disclosure  of  a
18        child's  test  results  to  the  child's  mother or other
19        designated guardian,  referral  to  follow-up  care,  and
20        educational activities relating to such testing.
21        If  a  mother  has  had  an  HIV-related test, the person
22    responsible for  testing  under  this  Section  may  omit  an
23    HIV-related test for the mother's newborn.
24        (b)  Any  person violating the provisions of this Section
25    20 is guilty of a petty offense.

26        Section  25.  Administration  of  HIV-related  tests   to
27    newborns.   The  person  in  charge  of each institution that
28    cares for newborn infants shall cause to have administered an
29    HIV-related test to every newborn infant in  its  care  whose
30    mother's  HIV status is unknown. Any health care provider who
31    performs  an  HIV-related  test  on  a  newborn   under   the
32    provisions of this Section 25 shall report the results to the
33    mother  or other designated guardian of the newborn within 48
 
                            -6-      LRB093 10969 LRD 13095 a
 1    hours of the birth of the newborn. The provider  shall  refer
 2    any newborn who tests positive for HIV to an HIV case manager
 3    and  an appropriate health care provider.  The provider shall
 4    also give the mother  a  list  of  support  and  health  care
 5    services  for  people with HIV and AIDS. Any person violating
 6    the provisions of this  Section  25  is  guilty  of  a  petty
 7    offense.

 8        Section 30. Objections of parent or guardian.
 9        (a)  The provisions of this Act related to HIV testing do
10    not apply to a child if his or her parent or guardian objects
11    to  the  HIV  testing  for  any reason. Documentation of such
12    objection shall be written by the physician or  other  person
13    whose duty is to administer such tests under this Act.
14        (b)  This  Act  applies to all screening tests covered by
15    the Act, except HIV when the parent or guardian of the  child
16    objects  thereto on the grounds that such test conflicts with
17    his or her religious tenets and practices.  Documentation  of
18    such  objection  shall  be  written by the physician or other
19    person whose duty is to administer such tests under this Act.

20        Section 75.  The State Finance Act is amended  by  adding
21    Section 5.595 as follows:

22        (30 ILCS 105/5.595 new)
23        Sec. 5.595.  The Metabolic Screening and Treatment Fund.

24        Section  99.  Effective date.  This Act takes effect upon
25    becoming law.".