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.