BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 962|
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THIRD READING
Bill No: SB 962
Author: Migden (D)
Amended: 5/1/07
Vote: 21
SENATE HEALTH COMMITTEE : 6-3, 4/18/07
AYES: Kuehl, Alquist, Cedillo, Ridley-Thomas, Steinberg,
Yee
NOES: Aanestad, Cox, Wyland
NO VOTE RECORDED: Maldonado, Negrete McLeod
SENATE JUDICIARY COMMITTEE : 3-2, 4/24/07
AYES: Corbett, Kuehl, Steinberg
NOES: Harman, Ackerman
SENATE APPROPRIATIONS COMMITTEE : 10-6, 5/31/07
AYES: Torlakson, Cedillo, Corbett, Florez, Kuehl, Oropeza,
Ridley-Thomas, Simitian, Steinberg, Yee
NOES: Cox, Aanestad, Ashburn, Dutton, Runner, Wyland
NO VOTE RECORDED: Battin
SUBJECT : Umbilical cord blood biomedical resources
program
SOURCE : Author
DIGEST :
This bill:
CONTINUED
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1.Requires the Department of Public Health 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.
2.Requires DPH to establish fees to be collected from
researchers and health are providers approved by the
department to use umbilical cord blood for research or
transplantation and creates the Umbilical Cord Blood
Biomedical Research Program Fund into which the fees
collected will be deposited.
3.Requires DPH to develop standardized, objective
information about umbilical cord blood donation that will
enable a pregnant woman to be informed of her options to
discard umbilical cord blood, donate umbilical cord blood
to a public bank, or store the umbilical cord blood in a
private bank.
4.Authorizes 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.
ANALYSIS : Existing law imposes various responsibilities
on the Department of Health Services (DHS) and prenatal
care providers with respect to prenatal care, screening and
counseling.
Existing law, administered by DHS, contains provisions
governing the licensure of blood banks, including licensure
or accreditation for purposes of umbilical cord blood
banking.
This bill requires the 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 will be required to
establish a public repository for umbilical cord blood
cells, a system to retrieve and transport donations, and a
system for matching donors with recipients.
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This bill requires DPH to establish fees to be collected
from researchers and health care providers approved by DHS
to use umbilical cord blood for research or transplantation
and creates the Umbilical Cord Blood Biomedical Resources
Program Fund in the State Treasury into which the fees
collected will be deposited.
Existing law requires DHS 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 DHS regarding her options with respect to
umbilical cord blood banking.
Existing law, the Hereditary Disorders Act, requires DHS to
establish regulations and standards for a hereditary
disorders program, including prenatal testing programs for
newborns. 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. Responsibility for the above provisions will be
transferred to DPH on July 1, 2007.
This bill authorizes 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 requires DHS, in addition to already required
cord blood banking information development, to develop
standardized, objective information about umbilical cord
blood donation that will enable a pregnant woman to be
informed of her option to day discard umbilical cord blood,
donate umbilical cord blood to a public bank, or store the
umbilical cord blood in a private bank.
This bill, upon the development of the required cord blood
banking information, requires DHS to include the
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information in the prenatal screening information materials
currently established in regulation.
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 DHS pursuant to the UCBCAC, and requires these
funds to be available upon a determination of the Director
of the Department of Finance that sufficient private
donations have been collected and deposited into the
account, and provides that no public funds may be used.
This bill allows both private and public funds to be used
for purposes of the UCBCAC.
Existing law, the Information Practices Act, provides
certain specified privacy and security provisions for
personal information held, used, or disseminated by a state
agency.
Under existing law, the Committee for the Protection of
Human Subjects (CPHS) serves as the institutional review
board for the Health and Human Services Agency for the
purpose of assuring that research involving human subjects
is conducted ethically and with minimum risk to
participants.
This bill requires 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 (1) to identify risk factors
for children's and women's diseases, (2) to develop and
evaluate screening tests, (3) to evaluate and develop
prevention strategies, and (4) to develop and evaluate
treatments.
This bill provides that, for purposes of ensuring the
security of a donor's personal information, before any
umbilical cord blood released for research purposes, the
CPHS must determine if specified criteria and conditions
are met.
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This bill provides that all information collected pursuant
to the Birth Defects Monitoring 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.
DHS shall maintain an accurate record of all persons who
are given confidential information.
This bill provides that 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 DHS. That
person shall also be subject to a civil penalty of $1,000.
The penalty provided in t his section shall not be
construed as restricting any remedy, provisional or
otherwise, provided by law for the benefit of DHS or any
person.
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
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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.
Prior Legislation
SB 1555 (Speier), Chapter 484, Statutes of 2006 . Created
the Maternal and Child Health Advancement Act, which
provided, 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, provided that a
primary prenatal care provider of a pregnant woman may,
during the first prenatal visit, provide a pregnant woman
with information developed by DHS 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.
Related Legislation
AB 34 (Portantino) - 2007-08 Session . Requires DPH to
establish, by July 1, 2009, the Umbilical Cord Blood
Collection Program for the purpose of collecting and
storing umbilical cord blood for public use. The bill also
required DPH to contract with up to five 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.
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FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
Major Provisions 2007-08 2008-09
2009-10 Fund
Collection/storage $200 $1,000
$1,000 General
DHS administration $200 $ 600
$ 600 General/
Special
Fee revenue Undetermined
Special*
*Umbilical Cord Blood Biomedical Resources Program Fund
SUPPORT : (Per Senate Judiciary Committee anlaysis)
Asian American Donor Program
California Catholic Conference
Cord Blood Donor Foundation
OPPOSITION : (Per Senate Judiciary Committee anlaysis)
California Medical Association
American College of Obstetricians and Gynecologists,
District IX/CA
AGB:cm 6/2/07 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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