BILL NUMBER: AB 52 INTRODUCED
BILL TEXT
INTRODUCED BY Assembly Member Portantino
DECEMBER 2, 2008
An act to amend Sections 1627, 1628, and 1630 of, and to add
Sections 1627.5 and 1627.7 to, the Health and Safety Code, relating
to umbilical cord blood banking.
LEGISLATIVE COUNSEL'S DIGEST
AB 52, as introduced, Portantino. Umbilical Cord Blood Collection
Program.
Existing law requires the State Department of Public Health to
establish, by January 1, 2010, and until January 1, 2015, the
Umbilical Cord Blood Collection Program for the purpose of increasing
the amount of umbilical cord blood that is donated in the state and
that will be added to the national inventory. Existing law authorizes
the department, to the extent private or public funds are identified
for this purpose, to contract with blood banks that are licensed or
accredited to provide umbilical cord blood banking storage services,
for the purpose of collecting and storing umbilical cord blood.
This bill would, instead, require the department to establish the
Umbilical Cord Blood Collection Program from January 1, 2011, until
January 1, 2020, for the purpose of collecting and storing umbilical
cord blood for public use, as defined, for human transplantation and
human research. The bill would require the department to contract
with up to 5 entities, including blood banks that are licensed or
accredited to provide umbilical cord blood banking storage services,
to collect, and make available for transplant or medical research,
umbilical cord blood.
The bill would also establish an implementing committee composed
of specified members to develop policy recommendations for purposes
of implementing the program.
The bill would require the department, in consultation with the
implementing committee, to submit to the Governor and specified
committees of the Legislature, 2 reports on the effectiveness of the
program by January 1, 2013, and January 1, 2018, respectively, and
would require the program to conclude no later than December 31,
2019.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature finds and declares all of the
following:
(a) The umbilical cord and placenta are discarded as medical waste
in a large majority of American births. However, the blood retrieved
from the umbilical cord is rich in stem cells known as hematopoietic
progenitor cells (HPCs) and can be used today to treat nine
disorders and diseases. Clinical trials, which are currently at
various stages, may reveal that umbilical cord blood could be used to
treat many other disorders and diseases. These disorders and
diseases include: (1) blood cancers such as leukemia, myeloma, and
lymphoma; (2) immunodeficiencies and genetic diseases, including
sickle cell anemia, thalassemia, inherited marrow failure disorders;
and (3) inherited disorders or errors of metabolisms.
(b) Umbilical cord blood has been used in about 8,000 transplants
since 1988 and has many benefits over bone marrow. The donation
procedure, conducted after birth, is painless, quick, and risk free
for the mother and newborn baby.
(c) The National Marrow Donor Program has the largest registry in
the United States that can be searched for a marrow or umbilical cord
blood match when stem cell transplants are needed. In order to find
the best tissue match for optimal transplant outcome, genetic
diversity is needed since a patient's most likely match is someone of
the same heritage. According to the National Marrow Donor Program,
over 10,000 children and adults in the United States would benefit
from a transplant from someone unrelated to them, but only 25 percent
actually receive one. This is, in part, due to the lack of
acceptable stem cell source.
(d) Finding a marrow or blood donor match is challenging for
people of all races. Only 30 percent of patients in need of a marrow
or an umbilical cord blood transplant find a matched donor in their
family. The other 70 percent search registries for an unrelated donor
or umbilical cord blood units. Finding a match is particularly
difficult for people of color, including people of multiracial
ancestry, because they are underrepresented in the national
inventory. Many of these patients die while waiting for a transplant.
(e) Because most national health and medical organizations do not
recommend private umbilical cord blood banking unless there are known
health reasons, it is not the intent of the Legislature to collect
umbilical cord blood for private use.
(f) The Institute of Medicine of the National Academies' report
"Cord Blood: Establishing a National Hematopoietic Stem Cell Bank
Program (2005)" calls for an increase in the volume and genetic
diversity of umbilical cord blood public bank inventory. This report
was the basis for establishing the national Stem Cell Therapeutic and
Research Act of 2005 which provides for the collection and
maintenance of human umbilical cord blood stem cells for the
treatment of patients and research. This act dedicated funds for this
purpose.
(g) California has been a leader in umbilical cord blood
transplant research through a number of previous projects including a
sibling donor pilot project, through participation in the national
study, and its current involvement in the national cord blood
program.
(h) The national cord blood program has a goal of collecting
150,000 genetically diverse units in order to increase the best
chances of tissue matches. Due to a low supply of ethnically diverse
umbilical cord blood they have specified target collection goals for
specific ethnicities, including, but not limited to, Native American,
Latino, African American, and Asian populations, and persons of
multiracial ethnicities.
(i) California is uniquely situated to add volumes of genetically
diverse, high-quality umbilical cord blood units for public banking
because of its high birth rate of more than 550,000 births per year
and ethnically diverse population. This contribution will not only
serve the health needs of California constituents, but can contribute
to the national and international umbilical cord blood inventory
efforts.
(j) An increase in stem cell transplants is also cost effective.
It will save the state, insurers, donors, and patients significant
moneys now being spent on lifetime medical treatments and relieve
ongoing pain and anguish of affected patients and their families.
SEC. 2. Section 1627 of the Health and Safety Code is amended to
read:
1627. (a) (1) On or before January 1,
2010 2011 , the State Department of
Public Health shall establish the Umbilical Cord Blood Collection
Program (hereafter program) for the purpose of
increasing the inventory of umbilical cord blood donated from
Californians which will be part of the national umbilical cord blood
inventory. Units collected shall be entered into a national registry
and made available to the public for purposes of human stem cell
transplant. Units collected but unusable for transplant may be made
available for research to further the understanding of the use of
umbilical cord blood as tissue to treat human diseases
collecting and storing umbilical cord blood for public use for human
transplantation and human research. The program shall conclude no
later than December 31, 2019 .
(b) When umbilical cord blood is used for research, research
protocols shall be approved by the Committee for the Protection of
Human Subjects or an institutional review board, as defined in
subdivision (e) of Section 125330.
(c) All blood collected for either transplant or research shall
follow all applicable law and guidelines applicable to donor
confidentiality and security of donor information. All information
collected shall be confidential and shall be used solely for the
purposes of the program.
(2) For purposes of this article, "public use" means both of the
following:
(A) The collection of an inventory of genetically diverse
umbilical cord blood, for placement in the National Cord Blood
Inventory Registry, to increase the likelihood of a patient obtaining
a suitable donor match.
(B) The use of research protocols approved by the Committee for
the Protection of Human Subjects or an institutional review board, as
defined in subdivision (e) of Section 125330, to further the
understanding of the use of umbilical cord blood as tissue to treat
human diseases.
(b) In implementing this program, the department shall consider
the policy recommendations of the implementing committee established
pursuant to Section 1627.5.
(c) (1) In order to implement the program, the department shall
contract with up to five entities, including entities that are
licensed or accredited to provide umbilical cord blood collection and
data processing services, and entities that provide umbilical cord
blood banking storage services that are licensed or accredited
pursuant to Section 1604.6, to build an inventory of anonymous
umbilical cord blood units and make the inventory available for
transplant or medical research for purposes consistent with the
public use, as defined in paragraph (2) of subdivision (a). The
department shall ensure that any cord blood bank receiving funds
through the program also meets the federal requirements outlined in
the C.W. Bill Young Cellular Transplantation Program (42 U.S.C. Sec.
274k et seq.) so that all umbilical cord blood units collected can be
listed through the National Cord Blood Inventory Registry. A medical
provider or research facility shall comply with, and shall be
subject to existing penalties for violations of, all state and
federal laws with respect to the protection of any medical
information, as defined in subdivision (g) of Section 56.05 of the
Civil Code, and any personally identifiable information contained in
the umbilical cord blood inventory.
(2) In selecting qualified entities under this subdivision, the
following shall apply:
(A) The department may use a competitive process to identify
qualified entities to administer the program.
(B) In order to qualify for selection under this section, an
entity shall have experience in blood collection, labeling, storage,
transportation, or distribution. The department shall select entities
with demonstrated ability to retrieve umbilical cord blood from
ethnically diverse communities.
(d) The program shall attempt to meet at least all of the
following objectives:
(1) Define and identify qualified umbilical cord blood collection
entities.
(2) Design a competitive process to identify qualified
participants licensed or accredited to harvest umbilical cord blood
in a manner that complies with state and federal regulations.
(3) Establish criteria for determining which units of umbilical
cord blood may be used for research versus transplantation, and
policy addressing circumstances under which umbilical cord blood may
be used for either purpose.
(4) Create collection targets for ethnically diverse populations
in accordance with identified deficiencies in inventories.
(5) Consider a medical contingency response program to prepare for
and respond effectively to biological, chemical, or radiological
attacks, and other public health emergencies requiring treatment with
umbilical cord blood.
(6) Develop a public awareness campaign that includes, but is not
limited to, activities described in Section 123370.
(7) Increase hospital participation in collection and storage
efforts, and identify funding sources to offset the financial impact
on hospitals.
(8) Determine whether the program will require training of health
care providers relative to handling, labeling, transporting, and
storing umbilical cord blood.
(9) Determine policy on obtaining patient consent and timing of
consent in relation to existing law and standards of care.
(10) Determine whether current law and guidelines applicable to
donor confidentiality and security of donor information are
sufficient and, if they are insufficient, what additional
requirements or guidelines are necessary.
(11) Determine whether a sibling donor component would help
achieve the overall inventory goals of the program.
(12) Explore feasibility of operating the Umbilical Cord Blood
Collection Program as a self-funding program.
(13) Ensure that California's Umbilical Cord Blood Collection
Program does not conflict with other state, national, and
international efforts to generate an adequate inventory of,
high-quality umbilical cord blood.
(e) In implementing the program, the department shall make every
effort to avoid duplication or conflicts with existing and ongoing
programs and to leverage existing resources. The department shall use
its existing authority to promote the collection, storage,
retrieval, and distribution of umbilical cord blood and advise the
Legislature of its needs to accomplish these goals.
(f) (1) All information collected pursuant to the program shall be
confidential, and shall be used solely for the purposes of the
program. Access to confidential information shall be limited to
authorized persons who agree, in writing, to maintain the
confidentiality of that information.
(2) Any person who, in violation of a written agreement to
maintain confidentiality, discloses any information provided pursuant
to this section, or who uses information provided pursuant to this
section in a manner other than as approved pursuant to this section,
may be denied further access to any confidential information
maintained by the department, and shall be subject to a civil penalty
not exceeding one thousand dollars ($1,000). The penalty provided
for in this section shall not be construed as to limit or otherwise
restrict any remedy, provisional or otherwise, provided by law for
the benefit of the department or any other person covered by this
section.
(3) Notwithstanding the restrictions of this section, an
individual to whom the confidential information pertains shall have
access to his or her own personal information.
SEC. 3. Section 1627.5 is added to the Health and Safety Code, to
read:
1627.5. (a) There shall be established, within the State
Department of Public Health, an implementing committee to provide
guidance and policy suggestions to the department on the
implementation of the Umbilical Cord Blood Collection Program created
pursuant to Section 1627.
(b) (1) The implementing committee shall be composed of 15
members. The committee shall include representatives with expertise
and experience in all aspects of umbilical cord collection and
storage. On or before March 1, 2011, the Governor, the Senate
Committee on Rules, and the Speaker of the Assembly shall each
appoint five members of the implementing committee.
(2) The implementing committee shall include all of the following:
(A) Two representatives of blood banks licensed or accredited to
provide umbilical cord blood services.
(B) A representative of a stem cell transplant center that uses
umbilical cord blood.
(C) Two representatives from hospitals providing labor and
delivery services, including one representative from a large hospital
system and one representative from an independent hospital. At least
one representative shall represent a hospital currently
participating in umbilical cord blood collections.
(D) Three physicians of different practice types or geographical
regions. One physician shall have expertise in umbilical cord blood
transplantation, one physician shall have expertise in obstetrics or
gynecology, and one shall have expertise in oncology, hematology, or
a pediatric specialty that treats children with anemia, immune
disorders, or cancers that may be treated with stem cell
transplantation.
(E) A patient or relative of a patient who has received
transplants using umbilical cord blood.
(F) A previous donor of umbilical cord blood or a person who has
searched or has been involved in searching for an unrelated donor of
umbilical cord blood.
(G) A person with expertise in typing, matching, and transplant
outcome data analysis.
(H) A scientist with expertise in stem cell biology.
(I) Two representatives of organizations focusing on medical
conditions that involve umbilical cord blood treatments or ethnic or
racial health disparities.
(J) A health plan medical director.
(c) Implementing committee members shall serve without
compensation, except that members shall be reimbursed for authorized
travel costs and expenses.
(d) For purposes of implementing the program established pursuant
to Section 1627, the implementing committee, by January 1, 2012,
shall make initial policy recommendations to the Legislature, the
Assembly and Senate Health Committees, the Assembly and Senate
Judiciary Committees, the Governor, and the department on meeting the
objectives contained in subdivision (d) of Section 1627.
SEC. 4. Section 1627.7 is added to the Health and Safety Code, to
read:
1627.7. The department, in consultation with the implementing
committee established pursuant to Section 1627.5, shall submit two
reports to the Assembly and Senate Health Committees, the Assembly
and Senate Judiciary Committees, and the Governor on the
effectiveness of the program. The first report shall be submitted no
later than January 1, 2013, and the second report, no later than
January 1, 2018.
SEC. 5. Section 1628 of the Health and Safety Code is amended to
read:
1628. (a) To the extent public or private funds or
grants are identified and secured for these purposes, the Umbilical
Cord Blood Collection Program may identify and provide funds for
grants or contracts with qualified umbilical cord blood banks,
licensed or accredited pursuant to Section 1604.6, for the purposes
of collecting and storing genetically diverse umbilical cord blood
for public transplantation purposes The department may
accept public and private funds for the purpose of implementing this
article .
(b) No state funds, unless specifically appropriated for
this purpose, shall be used for implementation of this section.
Any funds made available for purposes of this article shall
be deposited into the Umbilical Cord Blood Collection Program Fund,
which is hereby created in the General Fund
State Treasury . Moneys in the fund shall be available, upon
appropriation by the Legislature, for purposes of this article.
The
(c) The fund shall include any
federal, state, and private funds made available for purposes of the
program, and, notwithstanding Section 16305.7 of the Government Code,
any interest earned on moneys in the fund.
SEC. 6. Section 1630 of the Health and Safety Code is amended to
read:
1630. This article shall remain in effect only until January 1,
2015 2020 , and as of that date is
repealed, unless a later enacted statute, that is enacted before
January 1, 2015 2020 , deletes or
extends that date.