HB-6291, As Passed House, September 13, 2006

 

 

 

 

 

 

 

 

 

 

 

 

SUBSTITUTE FOR

 

HOUSE BILL NO. 6291

 

 

 

 

 

 

 

 

 

 

 

 

     A bill to amend 1978 PA 368, entitled

 

"Public health code,"

 

(MCL 333.1101 to 333.25211) by adding section 2682.

 

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 

     Sec. 2682. (1) If funding is made available, the department

 

shall establish a statewide network of cord blood stem cell banks.

 

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,

 

accreditations, 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 and racially 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 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.

 

     (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. This quota may be met by using cord

 

blood units that did not meet the cell count standards necessary

 

for transplantation.

 

     (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 who have made a donation to a statewide

 

cord blood stem cell bank.

 

     (f) Individuals with expertise in the social sciences.

 

     (g) Members of the general public.

 

     (h) Each network donor bank.

 

     (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) 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.

 

     (c) Designate 1 or more established national or international

 

cord blood registries to serve as a statewide cord blood stem cell

 

registry.

 

     (d) Coordinate the donor banks in the network.

 

     Enacting section 1. This amendatory act does not take effect

 

unless all of the following bills of the 93rd Legislature are

 

enacted into law:

 

     (a) Senate Bill No. 1353.

 

     (b) House Bill No. 6293.