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Public Act 095-0406 |
SB0019 Enrolled |
LRB095 06541 RCE 26643 b |
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AN ACT concerning public health.
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Be it enacted by the People of the State of Illinois,
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represented in the General Assembly:
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Section 5. The Department of Public Health Powers and |
Duties Law of the
Civil Administrative Code of Illinois is |
amended by adding Section 2310-577 as follows: |
(20 ILCS 2310/2310-577 new) |
Sec. 2310-577. Cord blood stem cell banks. |
(a) Subject to appropriation, the Department shall |
establish a network of human cord blood stem cell banks. The |
Director shall enter into contracts with qualified cord blood |
stem cell banks to assist in the establishment, provision, and |
maintenance of the network. |
(b) A cord blood stem cell bank is eligible to enter the |
network and be a donor bank if it satisfies each of the |
following: |
(1) Has obtained all applicable federal and State |
licenses, accreditations, certifications, registrations, |
and other authorizations required to operate and maintain a |
cord blood stem cell bank. |
(2) Has implemented donor screening and cord blood |
collection practices adequate to protect both donors and |
transplant recipients and to prevent transmission of |
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potentially harmful infections and other diseases. |
(3) Has established a system of strict confidentiality |
to protect the identity and privacy of patients and donors |
in accordance with existing federal and State law and |
consistent with regulations promulgated under the Health |
Insurance Portability and Accountability Act of 1996, |
Public Law 104-191, for the release of the identity of |
donors, the identity of recipients, or identifiable |
records. |
(4) Has established a system for encouraging donation |
by an ethnically and racially diverse group of donors. |
(5) Has developed adequate systems for communication |
with other cord blood stem cell banks, transplant centers, |
and physicians with respect to the request, release, and |
distribution of cord blood units nationally and has |
developed those systems, consistent with the regulations |
promulgated under the Health Insurance Portability and |
Accountability Act of 1996, Public Law 104-191, to track |
recipients' clinical outcomes for distributed units. |
(6) Has developed an objective system for educating the |
public, including patient advocacy organizations, about |
the benefits of donating and utilizing cord blood stem |
cells in appropriate circumstances. |
(7) Has policies and procedures in place for the |
procurement of materials for the conduct of stem cell |
research, including policies and procedures ensuring that |
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persons are empowered to make voluntary and informed |
decisions to participate or to refuse to participate in the |
research, and ensuring confidentiality of the decision. |
(8) Has policies and procedures in place to ensure the |
bank is following current best practices with respect to |
medical ethics, including informed consent of patients and |
the protection of human subjects.
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(c) A donor bank that enters into the network shall do all |
of the following: |
(1) Acquire, tissue-type, test, cryopreserve, and |
store donated units of human cord blood acquired with the |
informed consent of the donor, in a manner that complies |
with applicable federal regulations. |
(2) Make cord blood units collected under this Section, |
or otherwise, available to transplant centers for stem cell |
transplantation. |
(3) Allocate up to 10% of the cord blood inventory each |
year for peer-reviewed research. This quota may be met by |
using cord blood units that did not meet the cell count |
standards necessary for transplantation. |
(4) Make agreements with obstetrical health care |
facilities, consistent with federal regulations, for the |
collection of donated units of human cord blood.
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(d) An advisory committee shall advise the Department |
concerning the administration of the cord blood stem cell bank |
network. The committee shall be appointed by the Director and |
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consist of members who represent each of the following: |
(1) Cord blood stem cell transplant centers. |
(2) Physicians from participating birthing hospitals. |
(3) The cord blood stem cell research community. |
(4) Recipients of cord blood stem cell transplants. |
(5) Family members who have made a donation to a |
statewide cord blood stem cell bank. |
(6) Individuals with expertise in the social sciences. |
(7) Members of the general public. |
(8) Each network donor bank.
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(9) Hospital administration from birthing hospitals.
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Except as otherwise provided under this subsection, each |
member of the committee shall serve for a 3-year term and may |
be reappointed for one or more additional terms. Appointments |
for the initial members shall be for terms of 1, 2, and 3 |
years, respectively, so as to provide for the subsequent |
appointment of an equal number of members each year. The |
committee shall elect a chairperson. |
(e) A person has a conflict of interest if any action, |
advice, or recommendation with respect to a matter may directly |
or indirectly financially benefit any of the following: |
(1) That person. |
(2) That person's spouse, immediate family living with |
that person, or that person's extended family. |
(3) Any individual or entity required to be disclosed |
by that person. |
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(4) Any other individual or entity with which that |
person has a business or professional relationship.
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An advisory committee member who has a conflict of interest |
with respect to a matter may not discuss that matter with other |
committee members and shall not vote upon or otherwise |
participate in any committee action, advice, or recommendation |
with respect to that matter. Each recusal occurring during a |
committee meeting shall be made a part of the minutes or |
recording of the meeting in accordance with the Open Meetings |
Act. |
The Department shall not allow any Department employee to |
participate in the processing of, or to provide any advice or |
recommendation concerning, any matter with which the |
Department employee has a conflict of interest. |
(f) Each advisory committee member shall file with the |
Secretary of State a written disclosure of the following with |
respect to the member, the member's spouse, and any immediate |
family living with the member: |
(1) Each source of income. |
(2) Each entity in which the member, spouse, or |
immediate family living with the member has an ownership or |
distributive income share that is not an income source |
required to be disclosed under item (1) of this subsection |
(f). |
(3) Each entity in or for which the member, spouse, or |
immediate family living with the member serves as an |
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executive, officer, director, trustee, or fiduciary. |
(4) Each entity with which the member, member's spouse, |
or immediate family living with the member has a contract |
for future income.
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Each advisory committee member shall file the disclosure |
required by this subsection (f) at the time the member is |
appointed and at the time of any reappointment of that member.
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Each advisory committee member shall file an updated |
disclosure with the Secretary of State promptly after any |
change in the items required to be disclosed under this |
subsection with respect to the member, the member's spouse, or |
any immediate family living with the member.
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The requirements of Section 3A-30 of the Illinois |
Governmental Ethics Act and any other disclosures required by |
law apply to this Act. |
Filed disclosures shall be public records.
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(g) The Department shall do each of the following:
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(1) Ensure that the donor banks within the network meet |
the requirements of subsection (b) on a continuing basis. |
(2) Encourage network donor banks to work |
collaboratively with other network donor banks and |
encourage network donor banks to focus their resources in |
their respective local or regional area. |
(3) Designate one or more established national or |
international cord blood registries to serve as a statewide |
cord blood stem cell registry. |
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(4) Coordinate the donor banks in the network.
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In performing these duties, the Department may seek the |
advice of the advisory committee.
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(h) Definitions. As used in this Section: |
(1) "Cord blood unit" means the blood collected from a |
single placenta and umbilical cord. |
(2) "Donor" means a mother who has delivered a baby and |
consents to donate the newborn's blood remaining in the |
placenta and umbilical cord. |
(3) "Donor bank" means a qualified cord blood stem cell |
bank that enters into a contract with the Director under |
this Section. |
(4) "Human cord blood stem cells" means hematopoietic |
stem cells and any other stem cells contained in the |
neonatal blood collected immediately after the birth from |
the separated placenta and umbilical cord. |
(5) "Network" means the network of qualified cord blood |
stem cell banks established under this Section.
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Section 99. Effective date. This Act takes effect upon |
becoming law.
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