2013 Indiana Code
TITLE 12. HUMAN SERVICES
ARTICLE 31. UMBILICAL CORD BLOOD
CHAPTER 1. PUBLIC UMBILICAL CORD BLOOD BANK
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IC 12-31
ARTICLE 31. UMBILICAL CORD BLOOD
IC 12-31-1
Chapter 1. Public Umbilical Cord Blood Bank
IC 12-31-1-1
"Nonprofit corporation"
Sec. 1. As used in this article, "nonprofit corporation" refers to the
Indiana nonprofit corporation formed by the office of the secretary
under section 3 of this chapter to establish and operate a public
umbilical cord blood bank.
As added by P.L.134-2008, SEC.7.
IC 12-31-1-2
"Postnatal donation"
Sec. 2. As used in this article, "postnatal donation" means any of
the following donations by a patient to the public umbilical cord
blood bank:
(1) Postnatal fluid, including umbilical cord blood.
(2) Postnatal tissue, including the placenta and tissue extracted
from an umbilical cord.
As added by P.L.134-2008, SEC.7.
IC 12-31-1-3
Formation of nonprofit corporation by office of the secretary;
adoption of rules concerning protection of information
Sec. 3. (a) The office of the secretary shall form a nonprofit
corporation to establish and provide for the operation of a public
umbilical cord blood bank to promote public health and to exercise
other essential governmental functions.
(b) The office of the secretary shall adopt rules under IC 4-22-2
concerning the protection of individual identifiable health
information regarding the operation of the public umbilical cord
blood bank.
As added by P.L.134-2008, SEC.7.
IC 12-31-1-4
Board of directors of nonprofit corporation; advisory board;
review of applications; contract for administrative operations;
employment; participating agreement
Sec. 4. (a) The board of directors of the nonprofit corporation
consists of the following:
(1) The state health commissioner or the commissioner's
designee.
(2) The secretary or the secretary's designee.
(3) The secretary of commerce appointed under IC 5-28-3-4 or
the secretary's designee.
(4) The director of the state department of health's office of
minority health.
(5) The following individuals appointed by the governor:
(A) One (1) president or chief executive officer of an
Indiana based hospital.
(B) One (1) research scientist with expertise in umbilical
cord blood research.
(C) One (1) ethicist with expertise in bioethics.
(D) One (1) physician licensed under IC 25-22.5 who
specializes in birthing and delivery.
(E) One (1) representative of a donor umbilical cord blood
bank facility.
(F) One (1) member of the interagency state council on black
and minority health established under IC 16-46-6.
(b) The board of directors shall appoint an advisory board. At
least fifty-one percent (51%) of the advisory board members must be
research scientists with expertise in stem cell research.
(c) The advisory board, using criteria established by the board of
directors, is responsible for reviewing applications from research
scientists, research institutions, and other persons interested in
receiving a postnatal donation that is ineligible for transplant use
from the public umbilical cord blood bank.
(d) The board of directors may contract with a person to perform
the management and administrative operations of the public
umbilical cord blood bank. The person shall follow the federal Food
and Drug Administration's current good tissue practices.
(e) Subject to approval by the budget agency, the board of
directors may, without the approval of the attorney general, employ
legal counsel, technical experts, and other officers, agents, and
employees that the board of directors considers necessary to carry
out the efficient operation of a public umbilical cord blood bank.
(f) The board of directors shall determine the terms and conditions
of the participating agreement that is executed with each
participating hospital.
As added by P.L.134-2008, SEC.7.
IC 12-31-1-5
Nonprofit corporation duties
Sec. 5. The nonprofit corporation shall do the following:
(1) Establish procedures and guidelines for collecting,
maintaining, and receiving postnatal donations.
(2) Educate health care professionals about the procedures and
requirements for collecting and maintaining postnatal donations
following the birth of a newborn infant.
(3) Establish procedures concerning patient informed consent
and privacy that are approved by an independent institutional
review board selected by the board of directors.
As added by P.L.134-2008, SEC.7.
IC 12-31-1-6
Acceptance of postnatal donations; use and allocation of postnatal
donations; liability insurance
Sec. 6. (a) The nonprofit corporation shall accept postnatal
donations at no charge or cost to the donor.
(b) The nonprofit corporation may allow the following to use the
postnatal donations:
(1) Transplant centers.
(2) Research centers approved by the nonprofit corporation that
will use the postnatal donation to promote medical advances,
life science research, or biotechnology research.
(3) Any other entity approved by the nonprofit corporation if
the entity will use the postnatal donation to promote medical
advances, life science research, or biotechnology research.
(c) Any postnatal donations maintained by the public umbilical
cord blood bank must be allocated as follows:
(1) Postnatal donations that are of transplantable quality
according to the National Marrow Donor Program, the federal
Food and Drug Administration's approved protocol, or other
relevant national practice and quality standards must be
allocated for medical transplants.
(2) Postnatal donations that do not meet the transplant quality
standards referred to in subdivision (1) and that are suitable for
research must be made available for scientific research or
medical treatments that comply with relevant national practice
and quality standards.
(d) The nonprofit corporation shall acquire and maintain adequate
liability insurance coverage.
As added by P.L.134-2008, SEC.7.
IC 12-31-1-7
Maintenance of postnatal donations at no charge to donor
Sec. 7. The nonprofit corporation may maintain postnatal
donations at no charge or cost to the donor.
As added by P.L.134-2008, SEC.7.
IC 12-31-1-8
Authority to award grants
Sec. 8. The nonprofit corporation may award a grant to a person
for work with postnatal donations.
As added by P.L.134-2008, SEC.7.
IC 12-31-1-9
Report to health finance commission
Sec. 9. The nonprofit corporation shall report annually to the
health finance commission established by IC 2-5-23-3 concerning the
following:
(1) The implementation of the umbilical cord blood bank.
(2) The number of postnatal donations used for transplants and
the number of postnatal donations used for research.
As added by P.L.134-2008, SEC.7.
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