June 29, 2006, Introduced by Senators BROWN, VAN WOERKOM, BIRKHOLZ, ALLEN, GILBERT, KUIPERS, GOSCHKA, JOHNSON, HAMMERSTROM, TOY, PATTERSON and GARCIA and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
(MCL 333.1101 to 333.25211) by adding section 2681.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 2681. (1) The department shall establish a statewide
network of cord blood stem cell banks that contain at least 150,000
units of human cord blood stem cells. The director of the
department shall enter into contracts with qualified cord blood
stem cell banks to assist in the establishment, provision, and
maintenance of the network.
(2) A cord blood stem cell bank is eligible to enter the
network and be a donor bank if it satisfies each of the following:
(a) Has obtained all applicable federal and state licenses,
certifications, registrations, and other authorizations required to
operate and maintain a cord blood stem cell bank.
(b) 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.
(c) 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, recipients, or identifiable records.
(d) Has established a system for encouraging donation by an
ethnically diverse group of donors.
(e) 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 such 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.
(f) Has developed a system for educating the public, including
patient advocacy organizations, about the benefits of donating and
utilizing cord blood stem cells in appropriate circumstances.
(3) A donor bank that enters into the network shall do all of
the following:
(a) 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.
(b) Make cord blood units collected under this section, or
otherwise, available to transplant centers for stem cell
transplantation.
(c) Allocate up to 10% of the cord blood inventory each year
for peer-reviewed research.
(4) A board of directors shall govern and administer the state
cord blood stem cell bank network. The board shall be appointed by
the director and consist of members who represent each of the
following:
(a) Cord blood stem cell transplant centers.
(b) Physicians from participating birthing hospitals.
(c) The cord blood stem cell research community.
(d) Recipients of cord blood stem cell transplants.
(e) Family members of a patient of the statewide cord blood
stem cell bank.
(f) Individuals with expertise in the social sciences.
(g) Members of the general public.
(h) Network donor banks.
(5) Except as otherwise provided under this subsection, each
member of the board shall serve for a 3-year term and may be
reappointed for 1 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 board shall elect a
chairperson and do each of the following:
(a) Ensure that the donor banks within the network meet the
requirements of subsection (2) on a continuing basis.
(b) Ensure that the statewide cord blood stem cell bank
network and the birthing hospital collection sites are
geographically distributed throughout the state.
(c) Establish a statewide cord blood stem cell registry.
(d) Coordinate the donor banks in the network.
(6) The statewide cord blood stem cell registry shall be a
system for identifying, acquiring, and distributing donated units
of cord blood that are suitably matched to candidate patients and
shall include a database to document the collection, storage,
distribution, and transplantation of cord blood units and the
clinical outcomes of all transplantations related to the network.
The registry shall provide transplant physicians and other
appropriate health care professionals a website function that
enables them to search the entire registry for suitable donor
matches for patients and to request specific cord blood units.
(7) As used in this section:
(a) "Cord blood unit" means the blood collected from a single
placenta and umbilical cord.
(b) "Donor" means a mother who has delivered a baby and
consents to donate the newborn's blood remaining in the placenta
and umbilical cord.
(c) "Donor bank" means a qualified cord blood stem cell bank
that enters into a contract with the director under subsection (1).
(d) "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.
(e) "Network" means the statewide network of qualified cord
blood stem cell banks established under subsection (1).