Public Act 0406 95TH GENERAL ASSEMBLY

SB0019 Enrolled LRB095 06541 RCE 26643 b

Public Act 095-0406

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