BILL ANALYSIS
SENATE JUDICIARY COMMITTEE
Senator Ellen M. Corbett, Chair
2007-2008 Regular Session
SB 962 S
Senator Migden B
As Amended April 19, 2007
Hearing Date: April 24, 2007 9
Health and Safety Code 6
ADM:rm 2
SUBJECT
Umbilical Cord Blood Biomedical Resources Program
DESCRIPTION
This bill would require the State Department of Public
Health (DPH) to establish the Umbilical Cord Blood
Biomedical Resources Program for the purpose of collecting,
processing, and storing umbilical cord blood stem cells to
be used for transplantation and research.
This bill would require DPH to establish fees to be
collected from researchers and health care providers
approved by the department to use umbilical cord blood for
research or transplantation, and would create the Umbilical
Cord Blood Biomedical Resources Program Fund into which the
fees collected would be deposited.
This bill would require DPH to develop standardized,
objective information about umbilical cord blood donation
that would enable a pregnant woman to be informed of her
options to: (1) discard umbilical cord blood; (2) donate
umbilical cord blood to a public bank; or (3) store the
umbilical cord blood in a private bank.
This bill would require a primary prenatal care provider,
during a pregnant woman's first prenatal visit, to provide
the cord blood banking information required by the bill's
provisions to the woman.
This bill would require DPH and health care providers to
(more)
SB 962 (Migden)
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maintain the confidentiality of patient information, and
would allow the use of patient information only for
specified research purposes.
This bill would provide that, for purposes of ensuring the
security of a cord donor's personal information, before any
umbilical cord blood could be released for research
purposes, the California Health and Human Services Agency
must determine if specified criteria and conditions have
been met.
BACKGROUND
In December 2005, the federal government enacted H.R. 2520,
the Stem Cell Therapeutic and Research Act of 2005, which
establishes a national umbilical cord blood program and
provides federal funding to expand and administer cord
blood transplants and research. Among the many provisions
in that measure is a requirement that the Secretary of
Health and Human Services, through a public process,
examine the issues of informed consent, including the
appropriate timing of such consent, and the information
provided a donor regarding medically appropriate cord blood
donation options. The National Institute of Medicine (IOM)
recommends that women be provided with balanced and clear
information in order to actively and knowledgeably
participate in the choice of whether or how to donate cord
blood, with informed consent procedures. The IOM also
recommends that appropriate measures should be taken to
ensure the security, safety, and confidentiality of medical
records, transplantable products, and patients.
According to the Cord Blood Donor Foundation, "cord blood"
(also known as "placental blood") is the blood that remains
in the umbilical cord and placenta following birth and
after the cord is cut. Newborn cord blood is recognized as
a rich and powerful source of stem cells, which can be
stored to retain their unique biological properties and
before exposure to bacterial, viral, or other environmental
factors. Stem cells recovered from umbilical cords can be
used to treat as many as 70 blood diseases, including
leukemia, myeloma and lymphoma; immunodeficiencies; and
genetic diseases, including sickle cell anemia,
thalassemia, inherited marrow failure disorders; and
inherited disorders or errors of metabolisms.
SB 962 (Migden)
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Senate Bill 1555 (Speier, Chapter 484, Statutes of 2006),
the Maternal and Child Health Advancement Act, provides,
among other things, that, in order to provide umbilical
cord blood banking storage services, a blood bank shall be
licensed to do so under current blood bank licensing law.
In addition, SB 1555, provides that a primary prenatal care
provider of a pregnant woman may, during the first prenatal
visit, provide a pregnant woman with information developed
by the State Department of Health Services regarding her
options with respect to cord blood banking at the same time
the provider provides required information regarding the
use and availability of prenatal screening for birth
defects of the fetus.
CHANGES TO EXISTING LAW
1. Existing law imposes various responsibilities on the
State Department of
Health Services (the department) and prenatal care
providers with respect to prenatal care, screening, and
counseling. [Health and Safety (H&S) Code Sections
120685-125107; 17 C.C.R. Sections 6404, 6500 et seq., and
6521 et seq.]
Existing law , administered by the department, contains
provisions governing the licensure of blood banks,
including licensure or accreditation for purposes of
umbilical cord blood banking. [H&S Sections
1602.5-1607.]
This bill would require the State Department of Public
Health (DPH) to establish the Umbilical Cord Blood
Biomedical Resources Program for the purpose of
collecting, processing, and storing umbilical cord blood
stem cells to be used for transplantation and research.
DPH would be required to establish: (1) a public
repository for umbilical cord blood cells; (2) a system
to retrieve and transport donations; and (3) a system for
matching donors with recipients.
This bill would require DPH to establish fees to be
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collected from researchers and health care providers
approved by the department to use umbilical cord blood
for research or transplantation. The bill would create
the Umbilical Cord Blood Biomedical Resources Program
Fund in the State Treasury into which the fees collected
would be deposited.
2. Existing law requires the department to conduct the
Umbilical Cord Blood
Community Awareness Campaign (UCBCAC), which, among other
things, provides that a primary prenatal care provider,
as defined, may provide to a pregnant woman during the
first prenatal visit, certain information developed by
the department regarding her options with respect to
umbilical cord blood banking. [H&S Code Section 123370
et seq.]
Existing law , the Hereditary Disorders Act, requires the
department to establish regulations and standards for a
hereditary disorders program, including with respect to
prenatal testing programs for newborns. [H&S Section
124977.] Pursuant to this act, existing regulations
require clinicians to provide all pregnant women, at the
first prenatal visit, with information about the use and
availability of prenatal screening for birth defects of
the fetus. If a pregnant woman voluntarily requests
prenatal screening, these regulations, among other
things, require a clinician to make available to the
pregnant woman the opportunity to read and sign a consent
document, as specified. [17 C.C.R. Section 6527 (2007).]
Effective July 1, 2007, responsibility for the above
provisions will be transferred to the State Department of
Public Health.
This bill would, in addition, require a primary prenatal
care provider, during the first prenatal visit of a woman
who is known to be pregnant, to provide the cord blood
banking information required by the bill's provisions to
the woman.
This bill would require the department, in addition to
already required cord blood banking information
development, to develop standardized, objective
information about umbilical cord blood donation that
would enable a pregnant woman to be informed of her
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option to do any of the following:
(1) discard umbilical cord blood; (2) donate umbilical
cord blood to a public bank; or (3) store the umbilical
cord blood in a private bank.
This bill would, upon the development of the required
cord blood banking information, require the department to
include that information in the prenatal screening
information materials currently established in
regulation.
3. Existing law establishes the Umbilical Cord Blood
Education Account, in which private donations are
collected and deposited for the purpose of funding the
information developed by the department pursuant to the
UCBCAC, and requires these funds to be available upon a
determination of the Director of Finance that sufficient
private donations have been collected and deposited into
the account, and provides that no public funds may be
used. [H&S Code Section 123371.]
This bill would allow both private and public funds to be
used for purposes of the UCBCAC.
4. Existing law , the Information Practices Act, provides
certain specified privacy and security protections for
personal information held, used, or disseminated by a
state agency. [Civil Code (CC) Sections 1798-1798.78.]
Under existing law , the Committee for the Protection of
Human Subjects (CPHS) serves as the institutional review
board for the California Health and Human Services Agency
for the purpose of assuring that research involving human
subjects is conducted ethically and with minimum risk to
participants. [See, e.g., CC Section 1798.24.]
This bill would require DPH, health care providers, and
local health departments to maintain the confidentiality
of patient information in accordance with existing law
and in the same manner as other medical record
information with patient identification that they
possess, and that the information shall only be used for
the following research purposes: (1) to identify risk
factors for children's and women's diseases; (2) to
develop and evaluate screening tests; (3) to evaluate and
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develop prevention strategies; and (4) to develop and
evaluate treatments.
This bill would provide that, for purposes of ensuring
the security of a donor's personal information, before
any umbilical cord blood could be released for research
purposes, the CPHS must determine if specified criteria
and conditions are met. [See Comment 6 for details.]
COMMENT
1. Stated need for the bill
The author writes:
SB 962 [would] address two primary reasons why more
cord blood transplants are not done today: (1) the
lack of inventory and infrastructure in the state and
nation; and (2) the lack of awareness and consequent
opportunity on the part of pregnant women to exercise
their personal choice regarding the distribution of
their cord blood, now considered a valuable medical
resource.
Currently, 95% of cord blood is routinely discarded by
California physicians, without a woman's knowledge or
consent, so most physicians are already choosing one
of the three cord blood options available to women,
i.e., public donation, private donation, or
discarding.
Given increasing reports this year that cord blood may
be being taken without a woman's consent, and that
doctors are receiving financial compensation only to
discuss private banking with patients, this bill is
needed to ensure that women receive full information
about their options and are able to exercise their
personal wishes regarding the final destination of
their cord blood. Patient documentation will provide
future liability protection for doctors.
DHS [Department of Health Services] has requested that
the author update the current AFP [alpha-protein]
screening [for some genetic abnormalities] regulation,
which requires informed consent for prenatal
screening, to also include a requirement for
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information and consent for cord blood. DHS indicated
to the author's office that they are already beginning
to make revisions to the pamphlet to at least include
a discussion of cord blood options. This prenatal
informed consent booklet has been given to pregnant
women for the last 20 years.
2. Related pending legislation
Assembly Bill 34 (Portantino) would require DPH to
establish, by July 1, 2009, the Umbilical Cord Blood
Collection Program (the program) for the purpose of
collecting and storing umbilical cord blood for public
use. The bill would require DHP to contract with up to 5
blood banks that are licensed or accredited to provide
umbilical cord blood banking storage services to collect,
and make available to doctors and their patients,
umbilical cord blood.
The bill would establish a 15-member implementing
committee, as specified, to provide guidance and policy
suggestions to DPH on implementation of the program. The
bill would allow DPH to accept both public and private
funds to implement its provisions.
The bill would require DPH, on or before January 1, 2012,
to submit an interim report to the Assembly and Senate
Health Committees on the effectiveness of the program in
diversifying the umbilical cord blood supply, and would
sunset the program December 31, 2018.
This bill is currently in the Assembly Appropriations
Committee.
3. Related federal legislation
The Stem Cell Therapeutic and Research Act of 2005,
enacted in December 2005, allows the Secretary of Health
and Human Services to enter into one-time contracts with
qualified cord blood banks to assist in the collection
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and maintenance of 150,000 new units of high-quality cord
blood to be made available for transplantation (through
the C.W. Bill Young Cell Transplantation Program) and
other specified purposes, including peer-reviewed
research. [H.R. 2520, Public Law No. 109-129.]
A contract recipient is required to, among other things,
acquire, tissue-type, test, cryopreserve, and store
donated units of cord blood acquired with donor informed
consent, in compliance with federal and state
regulations; encourage donation from a genetically
diverse population; and ensure that collected cord blood
units meet all applicable federal transplantation
standards.
The act requires the secretary to, through a public
process, examine the following with respect to donor
informed consent: (1) the appropriate timing of such
consent; and (2) the information provided to the maternal
donor regarding her medically appropriate cord blood
options.
To the best of committee staff's knowledge, the above
public process and examination has not been completed.
4. SB 1555 (Speier, Chapter 484, Statutes of 2006); SB
962 would substantively alter SB 1555
Senate Bill 1555, the Maternal and Child Health
Advancement Act, provides, among other things, that the
State Department of Health Services is required to
develop standardized, objective information about
umbilical cord blood donation that is sufficient to allow
a pregnant woman to make an informed decision on whether
or not to participate in a private or public umbilical
cord blood banking program. [H&S Section 123371.]
Section 123371 outlines seven pieces of information to be
included in the department's information: (1) current and
potential future medical uses of stored umbilical cord
blood; (2) benefits and risks involved in umbilical cord
blood banking; (3) the medical process involved in
umbilical cord blood banking; (4) medical or family
history criteria that may impact a family's consideration
of umbilical cord blood banking; (5) an explanation of
the differences between public and private umbilical cord
blood banking; (6) availability and costs of public or
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private umbilical cord blood banks; and (7) an
explanation that the practices and policies of blood
banks may vary with respect to accreditation, cord blood
processing and storage methods, costs, and donor privacy.
Section 123371 also provides that the primary prenatal
care provider of a pregnant woman may, during the first
prenatal visit, provide the woman with information
developed by the department regarding her options with
respect to cord blood banking at the same time the
provider provides required information regarding the use
and availability of prenatal screening for birth defects
of the fetus.
Senate Bill 962 would require the primary prenatal care
provider of a pregnant woman, during the first prenatal
visit, to provide information developed by the department
regarding her options with respect to cord blood banking.
Senate Bill 962 would thus substantively alter the
provisions of SB 1555.
The author and sponsor report that the implementing
regulations called for in SB 1555, with the required
standardized, objective umbilical cord blood banking
information, have not been adopted or promulgated.
In addition, neither the specificity of what cord blood
banking information nor the appropriate timing of when
such information should be provided to a pregnant woman
have been determined at the state or federal level.
5. Privacy and confidentiality concerns raised by the
bill; suggested amendments
Because this bill would allow for the collection,
processing, and storage of umbilical cord blood stem
cells for transplantation and research, a donor's
personal and confidential information and privacy
interests should be protected to the greatest extent
possible. And, while the Information Practices Act
provides some privacy and confidentially protections,
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committee staff suggests that further protections be
added to the bill.
Suggested amendments:
On page 6, after line 15, add the following:
All information collected pursuant to the Umbilical
Cord Blood Biomedical Resources 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 confidentiality.
The department shall maintain an accurate record of
all persons who are given confidential information.
Any disclosure of confidential information shall be
made only upon written agreement that the information
will be kept confidential, used for the approved
purpose, and not be further disclosed.
Any person who, in violation of a written agreement to
maintain confidentiality, discloses any information
provided pursuant to this section, or who uses
information 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. That person shall also
be subject to a civil penalty of $1,000. The penalty
provided in this section shall not be construed as
restricting any remedy, provisional or otherwise,
provided by law for the benefit of the department or
any person.
Notwithstanding the restrictions of this section, an
individual to whom the information pertains shall have
access to his or her own information.
6. Research security provisions provided in the bill
This bill would require the following for purposes of
security of a donor's personal information for research:
(1) a plan sufficient to protect personal information
from improper use and disclosures, including sufficient
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administrative, physical, and technical safeguards; (2) a
sufficient plan to destroy or return all personal
information as soon as it is no longer needed for the
research activity; and (3) sufficient written assurances
that the personal information will not be reused or
disclosed to other persons or entities, except as
specified.
7. Opponents California Medical Assoc. (CMA) and American
College of Obstetricians and Gynecologists (ACOG)
arguments
CMA and ACOG oppose the bill for a number of reasons.
Both opponents argue that SB 962 reverses work done on SB
1555. "SB 962 puts physicians in an untenable 'Catch-22'
situation requiring them to hand out informational
brochures that the state is only required to provide and
keep current if there is funding to do so. This could
require doctors to give out outdated, medically
inaccurate brochures or risk violating the law. SB 1555
solved this problem by making this provision voluntary on
the part of the doctor."
Opponent ACOG argues that the bill would interfere with
and diminish "the physician-patient relationship by
requiring mandated, possibly out-of-date and medically
inappropriate material for the physician-patient
discussion. ACOG Perinatal Guidelines state a discussion
should occur, but that discussion will vary depending on
that particular woman's genetic background and
situation."
ACOG also argues that even when a statute, such as this
one, requires the state-mandated materials to be kept
up-to-date, in practice that does not occur. For
example, the breast cancer brochure is required to be
updated every three years, but it has yet to be updated
since its initial 1995 version. This "puts physicians in
a legally tenuous position when they are mandated to
distribute medically inaccurate information to their
patients, potentially opening them up to allegations of
negligence. At a minimum, it creates confusion and a
potential situation for suspicion of the physician when
the physician's statements and the materials conflict.
This scenario is why SB 1555 was changed to having the
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distribution of materials be voluntary."
Opponent CMA also states it is "troubled by the link this
bill makes between umbilical cord blood banking and
prenatal genetic screening. Requiring these
conversations to occur concurrently may send the wrong
message to expectant parents and could pressure them to
privately bank their baby's cord blood, which is usually
unnecessary and can be very costly. The universal
solicitation this bill [would mandate] is inappropriate
and unnecessary since it is already the ACOG standard of
care for a discussion to occur between physician and
patient about umbilical cord blood banking options."
Support: Asian American Donor Program; CA Catholic
Conference; Cord Blood Donor Foundation
Opposition: CA Medical Assoc.; American College of
Obstetricians and
Gynecologists, District IX/CA
HISTORY
Source: Author; American Association of University Women;
Planned
Parenthood Affiliates of CA
Related Pending Legislation: AB 34 (Portantino of 2007)
(See Comment 2.)
Prior Legislation: SB 1555 (Speier, Chapter 484,
Statutes of 2006). (See Comment 4.)
Prior Vote: Senate Health Committee (Ayes 6, Noes 3)
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