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Public Act 095-0406


 

Public Act 0406 95TH GENERAL ASSEMBLY



 


 
Public Act 095-0406
 
SB0019 Enrolled LRB095 06541 RCE 26643 b

    AN ACT concerning public health.
 
    Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
 
    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
    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
    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.
    (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.
    (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
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.
        (9) Hospital administration from birthing hospitals.
    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.
        (4) Any other individual or entity with which that
    person has a business or professional relationship.
    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
    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.
    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.
    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.
    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.
    (g) The Department shall do each of the following:
        (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.
        (4) Coordinate the donor banks in the network.
    In performing these duties, the Department may seek the
advice of the advisory committee.
    (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.
 
    Section 99. Effective date. This Act takes effect upon
becoming law.

Effective Date: 8/24/2007