BILL NUMBER: SB 962	AMENDED
	BILL TEXT

	AMENDED IN SENATE  MAY 1, 2007
	AMENDED IN SENATE  APRIL 19, 2007
	AMENDED IN SENATE  APRIL 12, 2007

INTRODUCED BY   Senator Migden

                        FEBRUARY 23, 2007

   An act to amend Section 123371 of, and to add Section 124991 to,
the Health and Safety Code, relating to umbilical cord blood banking.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 962, as amended, Migden. Umbilical cord blood biomedical
resources program.
   Existing law imposes various responsibilities upon the State
Department of Health Services and prenatal care providers with
respect to prenatal care, screening, and counseling.
   Existing law, administered by State Department of Health Services,
also contains provisions governing the licensure of blood banks,
including provisions relating to licensure or accreditation for
purposes of umbilical cord blood banking. Existing law also requires
the department to conduct the Umbilical Cord Blood Community
Awareness Campaign, which, among things, authorizes a primary
prenatal care provider, as defined, to provide to a woman who is
known to be pregnant, during the first prenatal visit, certain
information developed by the department regarding her options with
respect to umbilical cord blood banking.
   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 Umbilical Blood Community Awareness Campaign,
requires these funds to be available upon a determination by 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 for the purpose of funding the above-described
provisions.
   Existing law, the Hereditary Disorders Act, requires the State
Department of Health Services to establish regulations and standards
for a hereditary disorders program, including with respect to
prenatal testing programs for newborns. A violation of these
provisions is a crime.
   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 her the opportunity to read and sign a
consent document, as specified.
   Effective July 1, 2007, responsibility for the administration of
the above-mentioned provisions will be transferred to the State
Department of Public Health.
   This bill would delete the requirements that the Director of
Finance must make a determination that sufficient funds are available
in this account, and that no public funds may be used to develop the
information required pursuant to the Umbilical Blood Community
Awareness Campaign.  The bill would also require the
department to include the information developed by the department
about umbilical cord blood banking options in the information
provided to pregnant women about prenatal screening pursuant to the
above-described regulations.  It would also  to
require   authorize  a primary prenatal care
provider to provide this information to a woman who is known to be
pregnant during the first prenatal visit.
   The bill would also require, as part of the Hereditary Disorders
Act, the department to establish a state umbilical cord blood
biomedical resources program to collect, process, and store umbilical
cord blood stem cells for the purposes of transplantation and
research, and would require the department to establish fees relating
to these purposes to cover the costs of administering the program.
The bill would set forth the various duties of the department in
implementing the program  and would requi   re that
information collected pursuant to the program be confidential, and be
used solely for the purposes of the program, as   specified
 . The bill would create the Umbilical Cord Blood Biomedical
Resources Program Fund, into which fees collected pursuant to the
bill would be deposited, with the fund to be used by the department,
upon appropriation by the Legislature, for purposes of administering
the program, as prescribed.
   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.
   This bill would require CPHS to determine if certain criteria
relating to the security and confidentiality of donor's personal
information are met before umbilical cord blood collected under the
program may be used for research activities.
   By creating a new crime, this bill would create a state-mandated
local program.
   The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
   This bill would provide that no reimbursement is required by this
act for a specified reason.
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  The Legislature finds and declares that the removal and
discarding of umbilical cord blood from a pregnant woman at the time
of birth delivery, without the understanding and approval of the
expectant families, is a growing concern to the people of this state.

  SEC. 2.  Section 123371 of the Health and Safety Code is amended to
read:
   123371.  (a) (1) The State Department of Health Services shall
develop standardized, objective information about umbilical cord
blood donation that is sufficient to allow a pregnant woman to make
an informed decision on whether to participate in a private or public
umbilical cord blood banking program. The information developed by
the department shall enable a pregnant woman to be informed of her
option to do any of the following:
   (A) Discard umbilical cord blood.
   (B) Donate umbilical cord blood to a public umbilical cord blood
bank.
   (C) Store the umbilical cord blood in a family umbilical cord
blood bank for the use by immediate and extended family members.
   (2) The information developed pursuant to paragraph (1) shall
include, but not be limited to, all of the following:
    (A) The current and potential future medical uses of stored
umbilical cord blood.
    (B) The benefits and risks involved in umbilical cord blood
banking.
    (C) The medical process involved in umbilical cord blood banking.

    (D) Medical or family history criteria that can impact a family's
consideration of umbilical cord banking.
    (E) An explanation of the differences between public and private
umbilical cord blood banking.
    (F) The availability and costs of public or private umbilical
cord blood banks.
    (G) Medical or family history criteria that can impact a family's
consideration of umbilical cord blood banking.
    (H) 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.
   (b) The information provided by the department pursuant to
subdivision (a) shall be made available in Cantonese, English,
Spanish, and Vietnamese, and shall be updated by the department as
needed.
   (c) The information provided by the department pursuant to
subdivision (a) shall be made available on the Internet Web sites of
the licensing boards that have oversight over primary prenatal care
providers. 
   (d) (1) (A) Upon the development of the information required by
subdivision (a), the department shall include this information in the
prenatal screening information required by Section 6527 of Title 17
of the California Code of Regulations.  
   (B) 
    (d)     (1)    A primary
prenatal care provider of a woman who is known to be pregnant
 shall   may  , during the first prenatal
visit, provide the information required by  subparagraph (A)
  subdivision (a)  to the pregnant woman.
   (2) For purposes of this article, a "prenatal care provider" means
a health care provider licensed pursuant to Division 2 (commencing
with Section 500) of the Business and Professions Code, or pursuant
to an initiative act referred to in that division, who provides
prenatal medical care within his or her scope of practice.
   (e) The department may accept private donations that have been
collected and deposited into the Umbilical Cord Blood Education
Account, which is hereby created in the State Treasury. The moneys in
the account shall be available, upon appropriation by the
Legislature, for the purposes of this article. If sufficient funds
are collected and deposited into the account, the Director of Finance
shall file a written notice thereof with the Secretary of State.
  SEC. 3.  Section 124991 is added to the Health and Safety Code, to
read:
   124991.  (a) The State Department of Public Health shall 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.
   (b) In implementing this program, the department shall do all of
the following:
   (1) Establish apublic repository for umbilical cord blood cells
that ensures that all umbilical cord blood is collected, stored, and
distributed in accordance with the donor's wishes. The department may
contract with existing facilities that are licensed and certified to
perform this task.
   (2) Establish a system to retrieve and transport umbilical cord
blood donations.
   (3) Establish a system for matching umbilical cord blood donors
with recipients of umbilical cord blood for medicinal use. 
   (c) (1) 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 the confidentiality of that
information.  
   (2) The department shall maintain an accurate record of all
persons who are given confidential information pursuant to this
section, and any disclosure of confidential information shall be made
only upon written agreement that the information will be kept
confidential, used for its approved purpose, and not be further
disclosed.  
   (3) 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 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.  
   (4) Notwithstanding the restrictions of this section, an
individual to whom the confidential information pertains shall have
access to his or her own personal information.  
   (c) 
    (d)  In order to implement this program, the department
shall establish fees of an amount that shall not exceed the costs of
administering the program, which the department shall collect from
researchers and health care providers who have been approved by the
department and who seek to use the umbilical cord blood for research
or transplantation. 
   (d) 
    (e)  Fees collected pursuant to subdivision  (c)
  (d)  shall be deposited into the Umbilical Cord
Blood Biomedical Resources Program Fund, which is hereby created in
the State Treasury. The fund shall be composed of all fees collected
pursuant to subdivision  (c)   (d)  and,
notwithstanding Section 16305.7 of the Government Code, all interest
and dividends earned on money in the fund. The fund may be used by
the department, upon appropriation by the Legislature, for the
purposes specified in subdivision  (e)   (f)
 . 
   (e) 
    (f)  The fund shall be used by the department in
accordance with both of the following:
   (1) For fees collected related to umbilical cord blood that is
used for research, the fees shall pay for costs related to data
management, including data linkage and entry, and umbilical cord
blood storage, retrieval, processing, inventory, and shipping.
   (2) For fees collected related to umbilical cord blood that is
used for transplantation, the fees shall pay for the costs related to
conducting and analyzing tests, transplants, or other medical
activities, as approved by the department and in accordance with this
section. 
   (f) 
    (g)  The department shall adopt rules and regulations
necessary for the purpose of implementing this section. 
   (g) 
    (h)  The department, health care providers, and local
health departments shall 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 shall use the information only for the following
purposes:
   (1) Research to identify risk factors for children's and women's
diseases.
   (2) Research to develop and evaluate screening tests.
   (3) Research to develop and evaluate prevention strategies.
   (4) Research to develop and evaluate treatments. 
   (h) 
    (i)  (1) For purposes of ensuring the security of a
donor's personal information, before any umbilical cord blood is
released pursuant to this section for research purposes, the State
Committee for the Protection of Human Subjects (CPHS) shall determine
if all of the following criteria have been met:
   (A) The Umbilical Cord Blood Biomedical Resources Program
contractors or other entities approved by the department have
provided a plan sufficient to protect personal information from
improper use and disclosures, including sufficient administrative,
physical, and technical safeguards to protect personal information
from reasonable anticipated threats to the security or
confidentiality of the information.
   (B) The Umbilical Cord Blood Biomedical Resources Program
contractors or other entities approved by the department have
provided a sufficient plan to destroy or return all personal
information as soon as it is no longer needed for the research
activity, unless the program contractors or other entities approved
by the department have demonstrated an ongoing need for the personal
information for the research activity and have provided a long-term
plan sufficient to protect the confidentiality of that information.
   (C) The Umbilical Cord Blood Biomedical Resources Program
contractors or other entities approved by the department have
provided sufficient written assurances that the personal information
will not be reused or disclosed to any other person or entity, or
used in any manner not approved in the research protocol, except as
required by law or for authorized oversight of the research activity.

   (2) As part of its review and approval of the research activity
for the purpose of protecting personal information held in agency
databases, CPHS shall accomplish at least all of the following:
   (A) Determine whether the requested personal information is needed
to conduct the research.
   (B) Permit access to personal information only if it is needed for
the research activity.
   (C) Permit access only to the minimum necessary personal
information needed for the research activity.
   (D) Require the assignment of unique subject codes that are not
derived from personal information in lieu of social security numbers
if the research can still be conducted without social security
numbers.
   (E) If feasible, and if cost, time, and technical expertise
permit, require the agency to conduct a portion of the data
processing for the researcher to minimize the release of personal
information. 
   (i) 
    (j)  In addition to the fees described in subdivision
 (c)   (d)  , the department may bill a
researcher for the costs associated with the department's process of
protecting personal information, including, but not limited to, the
department's costs for conducting a portion of the data processing
for the researcher, removing personal information, encrypting or
otherwise securing personal information, or assigning subject codes.

   (j) 
    (k)  Nothing in this section shall prohibit the
department from using its existing authority to enter into written
agreements to enable other institutional review boards to approve
research activities, projects or classes of projects for the
department, provided the data security requirements set forth in this
section are satisfied.
  SEC. 3.  No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.
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