BILL ANALYSIS
AB 52
Page 1
Date of Hearing: March 24, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
AB 52 (Portantino) - As Amended: March 5, 2009
SUBJECT : Umbilical Cord Blood Collection Program.
SUMMARY : Extends for one year the date by which the Department
of Public Health (DPH) is required to establish the Umbilical
Cord Blood Collection Program (UCBCP), and requires DPH to
contract with up to five licensed or accredited blood banks to
collect and store umbilical cord blood, as specified.
Establishes an implementing committee to provide guidance and
policy suggestions to DPH in implementing the UCBCP and imposes
a temporary $2 fee on specified birth certificates to fund the
program. Specifically, this bill :
1)Makes various findings and declarations related to the
importance of umbilical cord blood in treating many blood
cancers, immunodeficiency conditions, and genetic diseases;
the need for genetic diversity in cord blood and bone marrow
registries to ensure optimal transplant outcomes; and,
California being uniquely positioned because of its high birth
rate and ethnically diverse population to contribute to
efforts to substantially increase the inventory of genetically
diverse cord blood for public use.
2)Extends from January 1, 2010, to January 1, 2011, the date by
which DPH is required to establish the UCBCP.
3)Requires DPH to contract with up to five entities, including
entities that are licensed or accredited to provide umbilical
cord blood collection and data processing, and entities that
are licensed or accredited to provide cord blood banking
storage services, to build an inventory of anonymous umbilical
cord blood units and make the inventory available for
transplant or medical research. Permits DPH to use a
competitive process to identify qualified entities.
4)Requires entities selected pursuant to #3 above to have
experience in blood collection, labeling, storage,
transportation, and distribution. Requires DPH to endeavor to
select entities with demonstrated ability to retrieve
umbilical cord blood from ethnically diverse communities.
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5)Requires DPH to ensure that any cord blood bank receiving
funds through the UCBCP complies with existing federal
requirements to ensure that all cord blood units collected can
be listed through the National Cord Blood Inventory (NCBI).
6)Requires a medical provider or research facility to comply
with, and be subject to existing penalties for violations of,
all state and federal laws governing the protection of medical
information and any personally identifiable information
contained in the umbilical cord blood inventory.
7)Requires the UCBCP to meet specified objectives, including all
of the following:
a) Establish criteria for determining which units of
umbilical cord blood may be used for research versus
transplantation and under what circumstances umbilical cord
blood may be used for either purpose;
b) Create collection targets for ethnically diverse
populations based on identified deficiencies in
inventories;
c) Consider a medical contingency response program to
prepare for and respond to specified public health
emergencies requiring treatment with umbilical cord blood;
d) Develop a public awareness campaign, that may include,
but not be limited to, activities described in current law;
e) Increase hospital participation in collection and
storage efforts, and identify funding sources to offset the
financial impact on hospitals;
f) Determine whether the program will require health care
providers to be trained in handling, labeling,
transporting, and storing umbilical cord blood;
g) Determine policy with regard to patient consent, as
specified;
h) Determine whether current law and guidelines governing
donor confidentiality and security of donor information are
sufficient, as specified;
i) Determine whether a sibling donor component would help
achieve the overall inventory goals of the program;
j) Explore the feasibility of operating the program as a
self-funded program; and,
aa) Ensure that the program does not conflict with other
state, national, and international efforts.
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8)Requires DPH to make every effort to avoid duplication or
conflicts with existing and ongoing programs and to leverage
existing resources and use its existing authority to promote
the collection, storage, and use of umbilical cord blood and
advise the Legislature of its needs to accomplish these goals.
9)Requires information collected pursuant to the UCBCP to be
confidential and used solely for the program. Limits access
to confidential information to authorized persons who agree,
in writing, to maintain confidentiality.
10)Makes any person who violates a written confidentiality
agreement or who uses confidential information in an
unauthorized manner subject to a maximum civil penalty of
$1,000, as specified.
11)Specifies that an individual to whom the confidential
information pertains shall have access to his or her own
personal information.
12)Establishes within DPH a 15 member implementing committee, to
be composed of specified members, to provide guidance and
policy suggestions to DPH on the implementation of the UCBCP.
Requires the Governor, the Senate Committee on Rules, and the
Speaker of the Assembly to each appoint five members to the
committee. Requires committee members to serve without
compensation, except to be reimbursed for authorized travel
costs and expenses.
13)Requires the implementing committee, by January 1, 2012, to
make initial policy recommendations to DPH, the Legislature,
and the Governor on meeting the objectives in #7 above.
14)Requires DPH, in consultation with the implementing committee
to submit two reports to the Legislature and the Governor on
the effectiveness of the program by January 1, 2013, and
January 1, 2018, respectively.
15)Increases the fee for a certified copy of a birth certificate
from $7 to $9 and requires the additional two dollars to be
deposited in the existing UCBCP Fund.
16)Sunsets the provisions of this bill on January 1, 2020.
EXISTING LAW :
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1)Requires DPH to establish the UCBCP by January 1, 2010, and
until January 1, 2015, for the purpose of increasing the
amount of umbilical cord blood that is donated in the state
and added to the NCBI.
2)Authorizes the UCBCP, to the extent private or public funds
are identified and secured for these purposes, to identify and
provide funds for grants or contracts with qualified blood
banks that are licensed and accredited to collect and store
umbilical cord blood for public transplantation services.
Permits DPH to implement any additional standards for blood
banks to collect and store umbilical cord blood through the
adoption of regulations.
3)Requires DPH, contingent upon private funding, to conduct the
Umbilical Cord Blood Community Awareness Campaign to provide
awareness, assistance, and information regarding umbilical
cord blood banking options using brochures, television, print
media, radio, the Internet, outdoor advertising, and other
media; establish an Internet Web site with specified
information; and, undertake public education activities
related to umbilical cord blood donation to targeted
populations, as appropriate.
FISCAL EFFECT : This bill has not yet been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . The author states that the NCBI
currently lacks ethnic and multiracial cord blood and the
UCBCP is intended to collect cord blood for public use and
increase the volume of cord blood that can be added to the
national inventory. According to the author, this bill
prescribes important requirements relating to donor
confidentiality protections, an implementing committee,
minimum program standards, reporting requirements, and a
temporary $2 funding mechanism, that are needed to fully
implement the UCBCP. The author believes this bill will
ensure that collections from California's ethnically diverse
communities will help to address shortages in cord blood
donations from minority groups and increase the likelihood of
transplant patients finding suitable donor matches.
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2)UMBILICAL CORD BLOOD . According to information from the
National Marrow Donor Program (NMDP), cord blood refers to the
blood collected from the umbilical cord and placenta after a
baby is born. The NMDP notes that cord blood is rich in
blood-forming cells that can be used in transplants for
patients with leukemia, lymphoma, and many other
life-threatening diseases. Cord blood is one of three sources
of cells used in transplants; the other two are bone marrow
and peripheral blood stem cells. The NMDP estimates that, on
any given day, more than 6,000 patients around the world are
searching the NMDP's registry for a matching bone marrow or
cord blood donor. Since cord blood is stored and ready to use
and it does not require a perfect donor match, the NMDP states
that it is especially useful for patients who need a
transplant quickly, patients who have difficulty finding a
matched bone marrow donor, and patients from racially diverse
communities who often have uncommon tissue types. Patients
are more likely to match someone who shares their racial and
ethnic heritage. The NMDP reports that, in 2008, 36% of the
90,000 cord blood units in its registry went to patients from
racially or ethnically diverse communities and the need for
cord blood donations from these populations remains high.
In January 2007, the American Academy of Pediatrics (AAP) issued
an updated policy statement on cord blood banking for
potential future transplantation. The AAP estimates that the
chances of a child needing his or her own cord blood stem
cells in the future range from one in 1,000 to one in 200,000.
In the event that a child requires a stem cell transplant,
the AAP indicates that it is unlikely that the child's own
cord blood would be the desired source of stem cells because
the cells would reintroduce the disease into the child's body.
In these cases, a sibling donor is ideal and usually still
alive and available as a donor so banked blood is not needed.
AAP states that storing a child's cord blood is only
worthwhile when there is a sibling with a disease that can be
treated by a transplant. Under these circumstances there is a
one-in-four chance that the new baby will be a match for his
or her sibling. Given that the probability of using one's own
cord blood in the first 20 years of life is very small, the
AAP does not favor storage of cord blood for personal use and
encourages families to donate their newborn's cord blood to
public banks, if accessible in their area, for use by other
individuals in need.
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3)CORD BLOOD BANKS . Public and private banks provide for the
collection and storage of cord blood. Public banks promote
related and unrelated donation, similar to the current
collection of whole blood units in the U.S., for
transplantation or research purposes. Private banks store
cord blood from an individual for subsequent use by the same
individual or his or her family members should the need arise.
Private banks typically charge between $1,000 and $2,000 in
collection fees and between $50 and $150 annually for storage.
Public banks do not charge for cord blood that is donated for
public use. The American Association of Blood Banks (AABB)
and the Foundation for the Accreditation of Cellular Therapy
(FACT) provide voluntary accreditation of cord blood banks
using standards governing all aspects of operation, including
collection, processing, and transplantation. According to
their respective Web sites, 27 facilities nationwide are
currently accredited by the AABB and 17 currently have FACT
accreditation.
4)FEDERAL REGULATORY ACTION . The federal Food and Drug
Administration (FDA) regulates cord blood under the category
of human cells, tissues, and cellular and tissue
based-products. In 2005, the FDA issued final rules requiring
all public and private cord banks to register with the FDA and
screen both the mother and the baby's blood for specified
infectious diseases, a practice common by banks.
Additionally, the FDA requires all registered banks to follow
federal safety standards applicable to the collection,
processing, packaging, labeling, and distribution of cord
blood units, and conducts inspections to monitor compliance.
Cord blood banks must also notify the FDA of specific adverse
reactions in the units that they process to prevent
contamination.
5)CALIFORNIA BANKS . According to the NMDP, there are currently
two participating public banks in California, StemCyte
International Cord Blood Center in West Covina, which provides
both public and private banking services, and Children's
Hospital of Orange County Cord Blood Bank. Another public
bank in San Diego, the Ashley Ross Cord Blood Program,
participates in the NMDP, but it is not actively collecting
cord blood at this time due to funding shortages. According
to the nonprofit Parent's Guide to Cord Blood Foundation,
there are currently four private banks operating in the state:
CordBancUSA in Monterey, Cord Blood America and FamilyCord,
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both based in Los Angeles, and Cord Blood Registry in San
Bruno.
The Laboratory Field Services Branch of DPH regulates cord blood
banks in California. A cord blood bank that operates within
California, accepts collections from California, or releases
cord blood units to California, is required to obtain a
biologics license from DPH which must be renewed annually.
DPH requires applicants to comply with specific requirements
relating to personnel, relevant business permits, standard
operating procedure manuals, informed consent, laboratory
testing, equipment, safety manuals and emergency plans,
supplier and vendor information, and quality control records.
Generally DPH requires facilities to be inspected prior to
approving a license but will accept accreditation by AABB in
lieu of an inspection in limited cases.
6)NATIONAL CORD BLOOD INVENTORY . The NCBI, administered by the
federal Health Resources and Services Administration (HRSA),
was formed in 2006 to build a genetically and ethnically
diverse inventory of 150,000 new units of high-quality
umbilical cord blood for transplantation and make these cord
blood units available to physicians and patients for blood
stem cell transplants, and for research focusing on cord blood
stem cell biology and the use of cord blood for human
transplantation and cellular therapies. The NCBI works to
achieve these goals by providing funds to reimburse a network
of eight participating cord blood banks nationwide for the
collection and storage of qualified cord blood units. HRSA
has requested nearly $12 million in funding for the NCBI in
2009 to add approximately 8,650 new units of cord blood, for a
total of approximately 37, 280 units collected to date.
7)PRIOR LEGISLATION .
a) AB 34 (Portantino), Chapter 516, Statutes of 2007,
directs DPH to establish the UCBCP by January 1, 2010, and
permits the UCBCP, to the extent public or private funds or
grants are identified, to contract with blood banks that
are licensed and accredited to provide cord blood storage
services.
b) SB 962 (Migden), Chapter 517, Statutes of 2007, requires
DPH to provide umbilical cord blood samples to the Birth
Defect Monitoring Program, for storage and research, as
AB 52
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specified.
c) SB 1555 (Speier), Chapter 484, Statutes of 2006,
requires blood banks to be licensed in order to provide
umbilical cord blood banking storage services and directs
the Department of Health Services (now DPH) to conduct the
Umbilical Blood Community Awareness Campaign, contingent
upon private funding.
8)URGENCY CLAUSE . The author has requested an urgency clause be
adopted so that the provisions of this bill take effect
immediately upon enactment. This request is scheduled to be
heard by the Assembly Rules Committee on Monday, March 23rd.
9)SUPPORT . The sponsor of this bill, the American College of
Obstetricians and Gynecologists, asserts that this bill builds
on the highly-supported UCBCP to increase public banking of
cord blood and adds important details to help DPH administer
the program more efficiently using a modest $2 temporary fee
increase on certain birth certificates. The Blood Centers of
California point out that the continuing lack of multi-ethnic
cord blood donations is a pressing issue for many patients in
need of transplants and this bill will help to increase the
supply of cord blood units to ensure more compatible matches
are available. The California Medical Association adds that
this bill aims to improve collection of a genetically diverse
cord blood supply that mirrors California's population for
public use. Lastly, the American Federation of State, County
and Municipal Employees writes that it is important to utilize
this valuable resource for the benefit of persons with certain
blood deficiencies and genetic diseases.
10)POLICY COMMENTS .
a) Clarification of objectives . This bill requires the
UCBCP to meet a number of specified objectives and directs
the implementing committee to make initial policy
recommendations to the Legislature, Governor, and DPH on
meeting these objectives. Given the scope and variety of
these objectives, the author may wish to consider amending
this bill to clarify that DPH, in conjunction with the
implementing committee, should be charged with meeting the
objectives.
b) Funding mechanism . This bill imposes a temporary $2 fee
AB 52
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increase on certified copies of birth certificates to fund
the UCBCP. It is unclear whether the revenue generated
from this fee will adequately cover the costs associated
with implementing the UCBCP to the extent required by this
bill.
REGISTERED SUPPORT / OPPOSITION :
Support
American College of Obstetricians and Gynecologists, District IX
(sponsor)
American Federation of State, County and Municipal Employees,
AFL-CIO
Blood Centers of California
California Catholic Conference
California Communities United Institute
California Medical Association
Opposition
None on file.
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097