BILL NUMBER: AB 2599 CHAPTERED
BILL TEXT
CHAPTER 680
FILED WITH SECRETARY OF STATE SEPTEMBER 30, 2008
APPROVED BY GOVERNOR SEPTEMBER 30, 2008
PASSED THE SENATE AUGUST 29, 2008
PASSED THE ASSEMBLY AUGUST 31, 2008
AMENDED IN SENATE AUGUST 21, 2008
AMENDED IN SENATE AUGUST 4, 2008
AMENDED IN SENATE JULY 1, 2008
AMENDED IN ASSEMBLY APRIL 22, 2008
AMENDED IN ASSEMBLY APRIL 3, 2008
INTRODUCED BY Assembly Member De Leon
FEBRUARY 22, 2008
An act to amend Sections 124977, 124991, and 125002 of the Health
and Safety Code, relating to public health.
LEGISLATIVE COUNSEL'S DIGEST
AB 2599, De Leon. Birth Defects Monitoring Program.
Existing law establishes the Birth Defects Monitoring Program
within the State Department of Public Health, and requires the
department to provide any umbilical cord blood samples it receives
from hospitals to the program for storage and research.
This bill would also require that the program collect any
umbilical cord blood samples it receives from hospitals for storage
and research.
Existing law requires the department to charge a fee for prenatal
screening to support the pregnancy blood sample storage, testing, and
research activities of the program, with the revenues from those
fees required to be deposited into the Birth Defects Monitoring
Program Fund, and made available, upon appropriation by the
Legislature, to support the pregnancy blood sample storage, testing,
and research activities of the program.
Under existing law, the initial prenatal screening fee increase
for activities of the Birth Defects Monitoring Program is $10.
This bill would, instead, require the prenatal screening fee for
these activities to be $10.
The bill would also require the department to establish guidelines
for invoicing, charging, and collecting from approved researchers an
amount necessary to cover certain expenses associated with research
application requests made pursuant to the above provisions, data
linkage, retrieval, data processing, data entry, reinventory, and
shipping of blood samples or their components, and related data
management.
Existing law provides that when pregnancy blood samples are
stored, analyzed, or otherwise shared for research purposes with
nondepartmental staff, no information may be released identifying the
person from whom the samples were obtained.
This bill would require the department to adopt regulations
specifying the protocols and conditions under which blood samples
will be released for research purposes, as provided.
Existing law requires the department to establish fees in an
amount that does not exceed the costs of administering the Birth
Defects Monitoring Program to be collected from researchers and
health care providers, and requires that any fees collected pursuant
to those provisions be deposited into the Birth Defects Monitoring
Program Fund, for use by the department, upon appropriation by the
Legislature, for specified purposes related to data management, and
the collection, storage, retrieval, and processing of blood samples.
This bill would, instead, require that any fees collected from
researchers who have been approved by the department pursuant to
those provisions be deposited into the Birth Defects Monitoring
Program Fund, the Genetic Disease Testing Fund, or the Cord Blood
Banking Fund, which the bill would create as a special fund in the
State Treasury. The bill would require that the amounts of fees
deposited in these funds be based on the program providing those
samples, and the purpose for which the sample was obtained. The bill,
in addition, would provide that the moneys in those funds obtained
in those fees may be used by the department, upon appropriation by
the Legislature, for costs related to data management, and the
collection, storage, retrieval, and processing of those blood
samples.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 124977 of the Health and Safety Code is amended
to read:
124977. (a) It is the intent of the Legislature that, unless
otherwise specified, the genetic disease testing program carried out
pursuant to this chapter be fully supported from fees collected for
services provided by the program.
(b) (1) The department shall charge a fee to all payers for any
tests or activities performed pursuant to this chapter. The amount of
the fee shall be established by regulation and periodically adjusted
by the director in order to meet the costs of this chapter.
Notwithstanding any other provision of law, any fees charged for
prenatal screening and followup services provided to persons enrolled
in the Medi-Cal program, health care service plan enrollees, or
persons covered by health insurance policies, shall be paid in full
and deposited in the Genetic Disease Testing Fund or the Birth
Defects Monitoring Fund consistent with this section, subject to all
terms and conditions of each enrollee's or insured's health care
service plan or insurance coverage, whichever is applicable,
including, but not limited to, copayments and deductibles applicable
to these services, and only if these copayments, deductibles, or
limitations are disclosed to the subscriber or enrollee pursuant to
the disclosure provisions of Section 1363.
(2) The department shall expeditiously undertake all steps
necessary to implement the fee collection process, including
personnel, contracts, and data processing, so as to initiate the fee
collection process at the earliest opportunity.
(3) Effective for services provided on and after July 1, 2002, the
department shall charge a fee to the hospital of birth, or, for
births not occurring in a hospital, to families of the newborn, for
newborn screening and followup services. The hospital of birth and
families of newborns born outside the hospital shall make payment in
full to the Genetic Disease Testing Fund. The department shall not
charge or bill Medi-Cal beneficiaries for services provided under
this chapter.
(4) (A) The department shall charge a fee for prenatal screening
to support the pregnancy blood sample storage, testing, and research
activities of the Birth Defects Monitoring Program.
(B) The prenatal screening fee for activities of the Birth Defects
Monitoring Program shall be ten dollars ($10).
(5) The department shall set guidelines for invoicing, charging,
and collecting from approved researchers the amount necessary to
cover all expenses associated with research application requests made
under this section, data linkage, retrieval, data processing, data
entry, reinventory, and shipping of blood samples or their components
and related data management.
(6) The only funds from the Genetic Disease Testing Fund that may
be used for the purpose of supporting the pregnancy blood sample
storage, testing, and research activities of the Birth Defects
Monitoring Program are those prenatal screening fees assessed and
collected prior to the creation of the Birth Defects Monitoring
Program Fund specifically to support those Birth Defects Monitoring
Program activities.
(7) The Birth Defects Monitoring Program Fund is hereby created as
a special fund in the State Treasury. Fee revenues that are
collected pursuant to paragraph (4) shall be deposited into the fund
and shall be available upon appropriation by the Legislature to
support the pregnancy blood sample storage, testing, and research
activities of the Birth Defects Monitoring Program. Notwithstanding
Section 16305.7 of the Government Code, interest earned on funds in
the Birth Defects Monitoring Program Fund shall be deposited as
revenue into the fund to support the Birth Defects Monitoring
Program.
(c) (1) The Legislature finds that timely implementation of
changes in genetic screening programs and continuous maintenance of
quality statewide services requires expeditious regulatory and
administrative procedures to obtain the most cost-effective
electronic data processing, hardware, software services, testing
equipment, and testing and followup services.
(2) The expenditure of funds from the Genetic Disease Testing Fund
for these purposes shall not be subject to Section 12102 of, and
Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of,
the Public Contract Code, or to Division 25.2 (commencing with
Section 38070). The department shall provide the Department of
Finance with documentation that equipment and services have been
obtained at the lowest cost consistent with technical requirements
for a comprehensive high-quality program.
(3) The expenditure of funds from the Genetic Disease Testing Fund
for implementation of the Tandem Mass Spectrometry screening for
fatty acid oxidation, amino acid, and organic acid disorders, and
screening for congenital adrenal hyperplasia may be implemented
through the amendment of the Genetic Disease Branch Screening
Information System contracts and shall not be subject to Chapter 3
(commencing with Section 12100) of Part 2 of Division 2 of the Public
Contract Code, Article 4 (commencing with Section 19130) of Chapter
5 of Part 2 of Division 5 of Title 2 of the Government Code, and any
policies, procedures, regulations or manuals authorized by those
laws.
(4) The expenditure of funds from the Genetic Disease Testing Fund
for the expansion of the Genetic Disease Branch Screening
Information System to include cystic fibrosis and biotinidase may be
implemented through the amendment of the Genetic Disease Branch
Screening Information System contracts, and shall not be subject to
Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing
with Section 12100) of Part 2 of Division 2 of the Public Contract
Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part
2 of Division 5 of Title 2 of the Government Code, or Sections 4800
to 5180, inclusive, of the State Administrative Manual as they relate
to approval of information technology projects or approval of
increases in the duration or costs of information technology
projects. This paragraph shall apply to the design, development, and
implementation of the expansion, and to the maintenance and operation
of the Genetic Disease Branch Screening Information System,
including change requests, once the expansion is implemented.
(d) (1) The department may adopt emergency regulations to
implement and make specific this chapter in accordance with Chapter
3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title
2 of the Government Code. For the purposes of the Administrative
Procedure Act, the adoption of regulations shall be deemed an
emergency and necessary for the immediate preservation of the public
peace, health and safety, or general welfare. Notwithstanding Chapter
3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title
2 of the Government Code, these emergency regulations shall not be
subject to the review and approval of the Office of Administrative
Law. Notwithstanding Sections 11346.1 and 11349.6 of the Government
Code, the department shall submit these regulations directly to the
Secretary of State for filing. The regulations shall become effective
immediately upon filing by the Secretary of State. Regulations shall
be subject to public hearing within 120 days of filing with the
Secretary of State and shall comply with Sections 11346.8 and 11346.9
of the Government Code or shall be repealed.
(2) The Office of Administrative Law shall provide for the
printing and publication of these regulations in the California Code
of Regulations. Notwithstanding Chapter 3.5 (commencing with Section
11340) of Part 1 of Division 3 of Title 2 of the Government Code, the
regulations adopted pursuant to this chapter shall not be repealed
by the Office of Administrative Law and shall remain in effect until
revised or repealed by the department.
(3) The Legislature finds and declares that the health and safety
of California newborns is in part dependent on an effective and
adequately staffed genetic disease program, the cost of which shall
be supported by the fees generated by the program.
SEC. 2. Section 124991 of the Health and Safety Code is amended to
read:
124991. (a) (1) The Birth Defects Monitoring Program, within the
State Department of Public Health, shall collect and store any
umbilical cord blood samples it receives from hospitals for storage
and research. For purposes of ensuring financial stability, the Birth
Defects Monitoring Program shall ensure that the following
conditions, alone or in combination, are met:
(A) The fees paid by researchers pursuant to subdivision (c) shall
be used for, and be sufficient to cover the cost of, collecting and
storing blood samples, including umbilical cord blood samples.
(B) The department receives confirmation that a researcher has
requested umbilical cord blood samples from the Birth Defects
Monitoring Program for research or has requested umbilical cord blood
samples to be included within a request for pregnancy or newborn
blood samples through the program and has provided satisfactory
evidence that adequate funding will be provided to the department
from the fees paid by the researcher for the request.
(C) The department receives federal grant moneys to pay for
initial startup costs for the collection and storage of umbilical
cord blood samples.
(2) The department may limit the number of umbilical cord blood
samples the program collects each year.
(b) (1) All information relating to umbilical cord blood samples
collected and utilized by the department shall be confidential, and
shall be used solely for the purposes of the program, or, if approved
by the department, research. Access to confidential information
shall be limited to authorized persons who agree, in writing, to
maintain the confidentiality of that information. Notwithstanding any
other provision of law, when the blood samples specified in
subdivision (c), including those samples with any information
identifying the person from whom the samples were obtained, are
stored, processed, analyzed, or otherwise shared for research
purposes with nondepartment staff, those samples may be shared by the
program with department-authorized researchers for research
purposes, and department representatives approved by the department,
subject to the confidentiality and security requirements for
confidential information established in this section and in Section
103850.
(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.
(c) In order to implement this section, the department shall
establish fees in an amount that shall not exceed the costs of
administering the program and the collection and storage of these
samples, which the department shall collect from researchers who have
been approved by the department and who seek to use the following
types of blood samples for research:
(1) Umbilical cord blood.
(2) Pregnancy blood collected by the Genetic Disease Screening
Program, and stored by the Birth Defects Monitoring Program.
(3) Newborn blood collected by the Genetic Disease Screening
Program.
(d) Fees collected pursuant to subdivision (c) shall be collected
by the department and deposited into the Birth Defects Monitoring
Program Fund, the Genetic Disease Testing Fund, created pursuant to
Section 124996, or the Cord Blood Banking Fund, which is hereby
created as a special fund in the State Treasury. The amount of fees
deposited into each of these funds shall be based on the program that
is providing those pregnancy blood samples, and the purpose for
which the blood sample was obtained. Notwithstanding any other
provision of law, the moneys in the Birth Defects Monitoring Program
Fund, the Genetic Disease Testing Fund, and the Cord Blood Banking
Fund that are collected pursuant to subdivision (c), may be used by
the department, upon appropriation by the Legislature, for the
purposes specified in subdivision (e).
(e) Moneys in those funds shall be used for the costs related to
data management, including data linkage and entry, and blood
collection, storage, retrieval, processing, inventory, and shipping.
(f) The department shall comply with the existing requirements in
the Birth Defects Monitoring Program, as set forth in Chapter 1
(commencing with Section 103825) of Part 2 of Division 102.
(g) The department, any entities approved by the department, and
researchers shall maintain the confidentiality of patient information
and blood samples 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) (1) For purposes of ensuring the security of a donor's
personal information, before any blood samples are 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 department, contractors, researchers, 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 department, contractors, researchers, 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,
researchers, 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 department, contractors, researchers, 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) In addition to the fees described in subdivision (c), 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) 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. Section 125002 of the Health and Safety Code is amended to
read:
125002. (a) In order to align closely related programs and in
order to facilitate research into the causes of, and treatment for,
birth defects, the Birth Defects Monitoring Program provided for
pursuant to Chapter 1 (commencing with Section 103825) of Part 2 of
Division 102 shall become part of the Maternal, Child, and Adolescent
Health program provided for in Article 1 (commencing with Section
123225) of Chapter 1 of Part 2 of Division 106.
(b) It is the intent of the Legislature that pregnancy blood
samples, taken for prenatal screening, shall be stored and made
available to any researcher who is approved by the department 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.
(c) Before any pregnancy blood samples are released for research
purposes, all of the following conditions must be met:
(1) Individual consent at the time the sample is drawn to allow
confidential use of the sample for research purposes by the
department or the department's approved researchers.
(2) Protocol review for scientific merit by the department or
another entity authorized by the department.
(3) Protocol review by the State Committee for the Protection of
Human Subjects.
(d) Since the pregnancy blood samples described in this section
will be stored by the California Birth Defects Monitoring Program or
another entity authorized by the department, the storage, analysis,
and sharing of pregnancy blood samples for research purposes shall be
done in compliance with Section 103850, pertaining to
confidentiality of information.
(e) The department shall adopt regulations specifying the
protocols and conditions under which blood samples will be released
for research purposes, in accordance with the procedures set forth in
subdivision (d) of Section 124977.
(f) Until such time that regulations are adopted by the department
pursuant to subdivision (e), the Genetic Disease Screening Program
and the Birth Defects Monitoring Program shall release blood samples
to only those researchers who meet the requirements of this section,
including all of the following:
(1) The research project was approved by the State Committee for
the Protection of Human Subjects.
(2) The research project's protocol was approved by the State
Committee for the Protection of Human Subjects, and specifically
included a description of the number and type of blood samples
requested from the Genetic Disease Screening Program or the Maternal,
Child, and Adolescent Health Program, including the Birth Defects
Monitoring Program for the project.
(3) There is written documentation that the Genetic Disease
Screening Program or the Maternal, Child, and Adolescent Health
Program, including the Birth Defects Monitoring Program, approved a
request for the blood samples for the research project approved by
the State Committee for the Protection of Human Subjects.
(4) The researcher has agreed to pay fees to the department to pay
reasonable costs for processing the samples and information,
including, but not limited to, costs of data management, including
data linkage and entry, and costs of blood collection, storage,
retrieval, inventory, and shipping.
(g) Subdivision (f) shall become inoperative on the date that the
department adopts regulations specifying the protocols and conditions
for release of the blood samples for research purposes.