BILL NUMBER: AB 34 AMENDED
BILL TEXT
AMENDED IN SENATE SEPTEMBER 4, 2007
AMENDED IN SENATE JULY 17, 2007
AMENDED IN SENATE JULY 10, 2007
AMENDED IN SENATE JULY 2, 2007
AMENDED IN SENATE JUNE 18, 2007
AMENDED IN ASSEMBLY MAY 22, 2007
AMENDED IN ASSEMBLY APRIL 10, 2007
AMENDED IN ASSEMBLY MARCH 13, 2007
INTRODUCED BY Assembly Member Portantino
(Coauthors: Assembly Members Beall, Berg, De Leon, Dymally, Eng,
Garcia, Hancock, Horton, Huffman, Jeffries, Lieu, Mullin, Nakanishi,
and Wolk)
(Coauthor: Senator Romero)
DECEMBER 4, 2006
An act to add and repeal Article 8 (commencing with Section 1627)
of Chapter 4 of Division 2 of the Health and Safety Code, relating to
umbilical cord blood banking.
LEGISLATIVE COUNSEL'S DIGEST
AB 34, as amended, Portantino. Umbilical Cord Blood Collection
Program.
Existing law, administered by the State Department of Public
Health, contains provisions governing the licensure of blood banks,
including provisions relating to licensure for purposes of umbilical
cord blood banking storage services. Existing law also requires the
department to conduct the Umbilical Cord Blood Community Awareness
Campaign.
This bill would require the department to establish, by January 1,
2010, the Umbilical Cord Blood Collection Program for the purpose of
collecting and storing umbilical cord blood for public use, as
defined. 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 to medical providers and research facilities,
umbilical cord blood.
The bill would also establish an implementing committee composed
of specified representative 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 Legislature and the
Governor, 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.
The bill would require that any funds available for purposes of
the program be deposited into the Umbilical Cord Blood Collection
Program Fund, which this bill would create. The bill would require
that the moneys in the fund be available for expenditure, upon
appropriation by the Legislature, for that purpose. The bill would
also require that information collected pursuant to the program be
confidential, and be used solely for the purposes of the program, as
prescribed.
The bill would provide that its provisions shall only become
operative if SB 962 of the 2007-08 Regular Session is enacted and
becomes operative.
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 about 97 percent 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 about 70
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 successfully 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,
35,000 children and adults could benefit from a marrow or an
umbilical cord blood transplant each year. The Institute of Medicine
of the National Academies estimates patient candidates for HPC
transplants to be 11,700 annually.
(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. Article 8 (commencing with Section 1627) is added to
Chapter 4 of Division 2 of the Health and Safety Code, to read:
Article 8. Umbilical Cord Blood Collection Program
1627. (a) (1) On or before January 1, 2010, the State Department
of Public Health shall establish the Umbilical Cord Blood Collection
Program for the purpose of 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.
(2) For purposes of this article, "public use" means both of the
following:
(A) The creation of an inventory of genetically diverse umbilical
cord blood 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 to
medical providers and research facilities for purposes consistent
with the public use, as defined in paragraph (2) of subdivision (a).
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.
(3) The total amount of blood collected pursuant to this
subdivision shall not exceed 5,000 units per year.
(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, high-quality
inventory.
(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 Umbilical Cord
Blood Collection 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.
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, 2008, 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 Umbilical Cord Blood
Collection Program established pursuant to Section 1627, the
implementing committee, by January 1, 2009, 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.
1628. The department, in consultation with the implementing
committee established pursuant to Section 1627.5, shall submit two
reports to the Legislature, 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.
1628.5. (a) The department may accept public and private funds
for the purpose of implementing this article.
(b) 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 State Treasury. Moneys in the fund
shall be available, upon appropriation by the Legislature, for
purposes of this article.
(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.
1629. This article shall remain in effect only until January 1,
2020, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2020, deletes or extends
that date.
SEC. 3. This act shall only become operative if
Senate Bill 962 of the 2007-08 Regular Session is enacted and becomes
operative.