Human Services Committee

Filed: 5/16/2007

 

 


 

 


 
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1
AMENDMENT TO SENATE BILL 19

2     AMENDMENT NO. ______. Amend Senate Bill 19 by replacing
3 everything after the enacting clause with the following:
 
4     "Section 5. The Department of Public Health Powers and
5 Duties Law of the Civil Administrative Code of Illinois is
6 amended by adding Section 2310-577 as follows:
 
7     (20 ILCS 2310/2310-577 new)
8     Sec. 2310-577. Cord blood stem cell banks.
9     (a) Subject to appropriation, the Department shall
10 establish a network of human cord blood stem cell banks. The
11 Director shall enter into contracts with qualified cord blood
12 stem cell banks to assist in the establishment, provision, and
13 maintenance of the network.
14     (b) A cord blood stem cell bank is eligible to enter the
15 network and be a donor bank if it satisfies each of the
16 following:

 

 

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1         (1) Has obtained all applicable federal and State
2     licenses, accreditations, certifications, registrations,
3     and other authorizations required to operate and maintain a
4     cord blood stem cell bank.
5         (2) Has implemented donor screening and cord blood
6     collection practices adequate to protect both donors and
7     transplant recipients and to prevent transmission of
8     potentially harmful infections and other diseases.
9         (3) Has established a system of strict confidentiality
10     to protect the identity and privacy of patients and donors
11     in accordance with existing federal and State law and
12     consistent with regulations promulgated under the Health
13     Insurance Portability and Accountability Act of 1996,
14     Public Law 104-191, for the release of the identity of
15     donors, the identity of recipients, or identifiable
16     records.
17         (4) Has established a system for encouraging donation
18     by an ethnically and racially diverse group of donors.
19         (5) Has developed adequate systems for communication
20     with other cord blood stem cell banks, transplant centers,
21     and physicians with respect to the request, release, and
22     distribution of cord blood units nationally and has
23     developed those systems, consistent with the regulations
24     promulgated under the Health Insurance Portability and
25     Accountability Act of 1996, Public Law 104-191, to track
26     recipients' clinical outcomes for distributed units.

 

 

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1         (6) Has developed an objective system for educating the
2     public, including patient advocacy organizations, about
3     the benefits of donating and utilizing cord blood stem
4     cells in appropriate circumstances.
5         (7) Has policies and procedures in place for the
6     procurement of materials for the conduct of stem cell
7     research, including policies and procedures ensuring that
8     persons are empowered to make voluntary and informed
9     decisions to participate or to refuse to participate in the
10     research, and ensuring confidentiality of the decision.
11         (8) Has policies and procedures in place to ensure the
12     bank is following current best practices with respect to
13     medical ethics, including informed consent of patients and
14     the protection of human subjects.
15     (c) A donor bank that enters into the network shall do all
16 of the following:
17         (1) Acquire, tissue-type, test, cryopreserve, and
18     store donated units of human cord blood acquired with the
19     informed consent of the donor, in a manner that complies
20     with applicable federal regulations.
21         (2) Make cord blood units collected under this Section,
22     or otherwise, available to transplant centers for stem cell
23     transplantation.
24         (3) Allocate up to 10% of the cord blood inventory each
25     year for peer-reviewed research. This quota may be met by
26     using cord blood units that did not meet the cell count

 

 

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1     standards necessary for transplantation.
2     (d) An advisory committee shall advise the Department
3 concerning the administration of the cord blood stem cell bank
4 network. The committee shall be appointed by the Director and
5 consist of members who represent each of the following:
6         (1) Cord blood stem cell transplant centers.
7         (2) Physicians from participating birthing hospitals.
8         (3) The cord blood stem cell research community.
9         (4) Recipients of cord blood stem cell transplants.
10         (5) Family members who have made a donation to a
11     statewide cord blood stem cell bank.
12         (6) Individuals with expertise in the social sciences.
13         (7) Members of the general public.
14         (8) Each network donor bank.
15     Except as otherwise provided under this subsection, each
16 member of the committee shall serve for a 3-year term and may
17 be reappointed for one or more additional terms. Appointments
18 for the initial members shall be for terms of 1, 2, and 3
19 years, respectively, so as to provide for the subsequent
20 appointment of an equal number of members each year. The
21 committee shall elect a chairperson.
22     (e) A person has a conflict of interest if any action,
23 advice, or recommendation with respect to a matter may directly
24 or indirectly financially benefit any of the following:
25         (1) That person.
26         (2) That person's spouse, immediate family living with

 

 

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1     that person, or that person's extended family.
2         (3) Any individual or entity required to be disclosed
3     by that person.
4         (4) Any other individual or entity with which that
5     person has a business or professional relationship.
6     An advisory committee member who has a conflict of interest
7 with respect to a matter may not discuss that matter with other
8 committee members and shall not vote upon or otherwise
9 participate in any committee action, advice, or recommendation
10 with respect to that matter. Each recusal occurring during a
11 committee meeting shall be made a part of the minutes or
12 recording of the meeting in accordance with the Open Meetings
13 Act.
14     The Department shall not allow any Department employee to
15 participate in the processing of, or to provide any advice or
16 recommendation concerning, any matter with which the
17 Department employee has a conflict of interest.
18     (f) Each advisory committee member shall file with the
19 Secretary of State a written disclosure of the following with
20 respect to the member, the member's spouse, and any immediate
21 family living with the member:
22         (1) Each source of income.
23         (2) Each entity in which the member, spouse, or
24     immediate family living with the member has an ownership or
25     distributive income share that is not an income source
26     required to be disclosed under item (1) of this subsection

 

 

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1     (f).
2         (3) Each entity in or for which the member, spouse, or
3     immediate family living with the member serves as an
4     executive, officer, director, trustee, or fiduciary.
5         (4) Each entity with which the member, member's spouse,
6     or immediate family living with the member has a contract
7     for future income.
8     Each advisory committee member shall file the disclosure
9 required by this subsection (f) at the time the member is
10 appointed and at the time of any reappointment of that member.
11     Each advisory committee member shall file an updated
12 disclosure with the Secretary of State promptly after any
13 change in the items required to be disclosed under this
14 subsection with respect to the member, the member's spouse, or
15 any immediate family living with the member.
16     The requirements of Section 3A-30 of the Illinois
17 Governmental Ethics Act and any other disclosures required by
18 law apply to this Act.
19     Filed disclosures shall be public records.
20     (g) The Department shall do each of the following:
21         (1) Ensure that the donor banks within the network meet
22     the requirements of subsection (b) on a continuing basis.
23         (2) Encourage network donor banks to work
24     collaboratively with other network donor banks and
25     encourage network donor banks to focus their resources in
26     their respective local or regional area.

 

 

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1         (3) Designate one or more established national or
2     international cord blood registries to serve as a statewide
3     cord blood stem cell registry.
4         (4) Coordinate the donor banks in the network.
5     In performing these duties, the Department may seek the
6 advice of the advisory committee.
7     (h) Definitions. As used in this Section:
8         (1) "Cord blood unit" means the blood collected from a
9     single placenta and umbilical cord.
10         (2) "Donor" means a mother who has delivered a baby and
11     consents to donate the newborn's blood remaining in the
12     placenta and umbilical cord.
13         (3) "Donor bank" means a qualified cord blood stem cell
14     bank that enters into a contract with the Director under
15     this Section.
16         (4) "Human cord blood stem cells" means hematopoietic
17     stem cells and any other stem cells contained in the
18     neonatal blood collected immediately after the birth from
19     the separated placenta and umbilical cord.
20         (5) "Network" means the network of qualified cord blood
21     stem cell banks established under this Section.
 
22     Section 99. Effective date. This Act takes effect upon
23 becoming law.".