BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 164|
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THIRD READING
Bill No: SB 164
Author: Migden (D)
Amended: 5/16/07
Vote: 21
SENATE HEALTH COMMITTEE : 10-0, 3/14/07
AYES: Kuehl, Aanestad, Alquist, Cedillo, Cox, Negrete
McLeod, Ridley-Thomas, Steinberg, Wyland, Yee
NO VOTE RECORDED: Maldonado
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SUBJECT : Prenatal screening
SOURCE : March of Dimes
DIGEST : This bill changes the name of the Birth Defects
Monitoring Program to the Birth Defects Monitoring and
Biomedical Research Program (Program), directs the
Department of Public Health to charge investigators
approved by the department a fee for access to the Program
for research, creates the Birth Defects Monitoring and
Biomedical Research Fund and requires the Program to
develop protocols for actions related to pregnancy blood
specimens, as determined by the Program.
Senate Floor Amendments of 5/16/07 attempt to ensure that
patient information for research purposes is handled in
accordance with existing law and in the same manner as
other medical record information.
CONTINUED
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ANALYSIS :
Existing law:
1. Requires the Department of Public Health (DPH) to
administer a statewide program of prenatal testing for
genetic disorders and birth defects.
2. Establishes the Birth Defects Monitoring Program, under
DPH's Maternal, Child, and Adolescent Health Program, to
maintain a system for the collection of prescribed
information on birth defects. Under legislation passed
in 2006, the program is supported by a $10 increase in
fees for screening of prenatal blood.
3. Specifies the research purposes for which pregnancy
blood samples may be used and conditions that must be
met for the release of blood samples for use by DPH, or
by investigators approved by DPH, for research purposes.
4. Prohibits the release of information identifying the
person from whom pregnancy blood samples are stored,
analyzed, or otherwise share for research purposes with
non-department staff.
This bill:
1. Changes the name of the Birth Defects Monitoring Program
to the Birth Defects Monitoring and Biomedical Resources
Program.
2. Requires DPH to charge investigators, approved by DPH to
use pregnancy blood for research purposes, a new fee for
costs related to data linkage, storage, retrieval,
processing, data entry, reinventory, and shipping of
pregnancy blood or its components, and related data
management, as provided.
3. Requires the moneys collected from the prenatal fee
increase and the usage and retrieval charge to be
deposited in a new Birth Defects Monitoring and
Biomedical Resources Program Fund, which the bill
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creates, and which would be continuously appropriated to
support the activities of the Program.
4. Requires that the Program develop pregnancy blood
collection and processing protocols, determine
conditions and recommendations for the duration of blood
storage, establish exclusion criteria for blood
specimens, and institute safe and secure methods for the
disposal of specimens, as determined by the Program.
5. Requires DPH to store the pregnancy blood for research
purposes, as prescribed, analyze the costs of pregnancy
blood storage, annual data linkage and management, and
to adjust the fee accordingly.
6. Exempts from the prohibition regarding the release of
information identifying the person from whom the blood
samples were obtained to Birth Defects Monitoring and
Biomedical Resources Program contractors or other
entities approved by the DPH.
7. 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 information, for the
purposes of research to identify risk factors for
children's and women's diseases, and to develop and
evaluate screening tests, prevention strategies and
treatments.
8. Requires program contractors and other entities approved
by DPH, to provide a plan sufficient to protect personal
information from improper use and disclosure, and for
the destruction or return of all personal information as
soon as it is no longer needed for the research
activity.
9. Requires program contractors and other entities approved
by DPH, to provide 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.
10.Requires the State Committee for the Protection of Human
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Subjects to (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, and (c) permit access
only to the minimum necessary personal information.
11.Requires assignment of unique subject codes in lieu of
social security numbers when appropriate.
12.Requires, if feasible, the associated agency or public
entity who maintains the date, to conduct a portion of
the data processing for the researcher to minimize the
release of personal information. DPH will also be
allowed to bill an investigator for the costs associated
with the DPH's process of protecting personal
information.
FISCAL EFFECT : Appropriation: Yes Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 5/17/07)
March of Dimes (source)
American College of Obstetricians and Gynecologists,
District IX/CA
American Federation of State, County and Municipal
Employees, AFL-CIO
California NOW
California WIC Association
California Church IMPACT
California Nurse Midwives Association
Golden Gate Regional Center
UCSF School Of Medicine, Division of Neonatology
ARGUMENTS IN SUPPORT : The American College of
Obstetricians and Gynecologists, District IX/CA states that
this bill supports efforts to achieve further research in
the causes of birth defects by developing standardized
processes and procedures to make it easier for research to
occur using blood samples obtained during pregnancy. With
over a half-million births annually occurring in
California, California has a very large data set from which
to investigate the causes of birth defects, and to develop
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prevention models.
CTW:mw 5/17/07 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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