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1     AN ACT concerning public health.
 
2     Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
 
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:
17         (1) Has obtained all applicable federal and State
18     licenses, accreditations, certifications, registrations,
19     and other authorizations required to operate and maintain a
20     cord blood stem cell bank.
21         (2) Has implemented donor screening and cord blood
22     collection practices adequate to protect both donors and
23     transplant recipients and to prevent transmission of

 

 

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1     potentially harmful infections and other diseases.
2         (3) Has established a system of strict confidentiality
3     to protect the identity and privacy of patients and donors
4     in accordance with existing federal and State law and
5     consistent with regulations promulgated under the Health
6     Insurance Portability and Accountability Act of 1996,
7     Public Law 104-191, for the release of the identity of
8     donors, the identity of recipients, or identifiable
9     records.
10         (4) Has established a system for encouraging donation
11     by an ethnically and racially diverse group of donors.
12         (5) Has developed adequate systems for communication
13     with other cord blood stem cell banks, transplant centers,
14     and physicians with respect to the request, release, and
15     distribution of cord blood units nationally and has
16     developed those systems, consistent with the regulations
17     promulgated under the Health Insurance Portability and
18     Accountability Act of 1996, Public Law 104-191, to track
19     recipients' clinical outcomes for distributed units.
20         (6) Has developed an objective system for educating the
21     public, including patient advocacy organizations, about
22     the benefits of donating and utilizing cord blood stem
23     cells in appropriate circumstances.
24         (7) Has policies and procedures in place for the
25     procurement of materials for the conduct of stem cell
26     research, including policies and procedures ensuring that

 

 

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1     persons are empowered to make voluntary and informed
2     decisions to participate or to refuse to participate in the
3     research, and ensuring confidentiality of the decision.
4         (8) Has policies and procedures in place to ensure the
5     bank is following current best practices with respect to
6     medical ethics, including informed consent of patients and
7     the protection of human subjects.
8     (c) A donor bank that enters into the network shall do all
9 of the following:
10         (1) Acquire, tissue-type, test, cryopreserve, and
11     store donated units of human cord blood acquired with the
12     informed consent of the donor, in a manner that complies
13     with applicable federal regulations.
14         (2) Make cord blood units collected under this Section,
15     or otherwise, available to transplant centers for stem cell
16     transplantation.
17         (3) Allocate up to 10% of the cord blood inventory each
18     year for peer-reviewed research. This quota may be met by
19     using cord blood units that did not meet the cell count
20     standards necessary for transplantation.
21         (4) Make agreements with obstetrical health care
22     facilities, consistent with federal regulations, for the
23     collection of donated units of human cord blood.
24     (d) An advisory committee shall advise the Department
25 concerning the administration of the cord blood stem cell bank
26 network. The committee shall be appointed by the Director and

 

 

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

 

 

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

 

 

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

 

 

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