103825-103855

HEALTH AND SAFETY CODE
SECTION 103825-103855




103825.  The Legislature hereby finds and declares that birth
defects, stillbirths, and miscarriages represent problems of public
health importance about which too little is known; that these
conditions lead to severe mental anguish on the part of parents and
relatives and frequently to high medical care costs; and that a
system to obtain more information about these conditions could result
in development of preventive measures to decrease their incidence in
the future. Therefore, it is the intent of the Legislature in
enacting this section to accomplish all of the following:
   (a) To maintain an ongoing program of birth defects monitoring
statewide. "Birth defect" as used in this chapter means any medical
problem of organ structure, function, or chemistry of possible
genetic or prenatal origin.
   (b) To provide information on the incidence, prevalence, and
trends of birth defects, stillbirths, and miscarriages.
   (c) To provide information to determine whether environmental
hazards are associated with birth defects, stillbirths, and
miscarriages.
   (d) To provide information as to other possible causes of birth
defects, stillbirths, and miscarriages.
   (e) To develop prevention strategies for reducing the incidence of
birth defects, stillbirths, and miscarriages.
   (f) To conduct interview studies about the causes of birth
defects.
   (g) To affirm the authority of the state department to contract
with a qualified entity to operate the birth defects monitoring
program statewide.


103830.  The director shall maintain a system for the collection of
information, necessary to accomplish the purposes of this chapter.
The director shall require health facilities, with 15 days' notice,
to make available to authorized program staff the medical records of
children suspected or diagnosed as having birth defects, including
the medical records of their mothers. In addition, health facilities
shall make available the medical records of mothers suspected or
diagnosed with stillbirths or miscarriages and other records of
persons who may serve as controls for interview studies about the
causes of birth defects. If it is necessary to photocopy records made
available under this section, copying expenses shall be paid by the
state department.
   "Health facilities" as used in this section means general acute
care hospitals, and physician-owned or operated clinics, as defined
in Section 1200, that regularly provide services for the diagnosis or
treatment of birth defects, genetic counseling, or prenatal
diagnostic services.



103835.  The birth defects monitoring program shall operate
statewide. It is the intent of the Legislature that the adequacy of
program resources shall be assessed annually, and that the annual
assessment shall include a consideration of at least all the
following factors:
   (a) The numbers of births in the state.
   (b) The scope of program activities.
   (c) Any urgent situation requiring extraordinary commitment of
present or planned program staff or resources.



103840.  The director shall use the information collected pursuant
to Section 103830 and information available from other reporting
systems and health providers to conduct studies to investigate the
causes of birth defects, stillbirths, and miscarriages and to
determine and evaluate measures designed to prevent their occurrence.
The department's investigation of poor reproductive outcomes shall
not be limited to geographic, temporal, or occupational associations,
but may include investigation of past exposures.



103845.  The director shall appoint an advisory committee to advise
on the implementation of this chapter. Each of the disciplines of
epidemiology, hospital administration, biostatistics, maternal and
child health and public health shall be represented on the committee.
At least one of the members shall be a representative of the
manufacturing industry.



103850.  (a) All information collected pursuant to this chapter
shall be confidential and shall be used solely for the purposes
provided in this chapter. For purposes of this chapter, this
information shall be referred to as "confidential information."
Access to confidential information shall be limited to authorized
program staff, and persons with a valid scientific interest, who meet
qualifications as determined by the director, who are engaged in
demographic, epidemiological or other similar studies related to
health, and who agree, in writing, to maintain confidentiality.
   (b) The department shall maintain an accurate record of all
persons who are given access to confidential information. The record
shall include: the name of the person authorizing access; name,
title, address, and organizational affiliation of persons given
access; dates of access; and the specific purpose for which
information is to be used. The record of access shall be open to
public inspection during normal operating hours of the state
department.
   (c) All research proposed to be conducted by persons other than
program staff, using confidential information in the system, shall
first be reviewed and approved by the director and the State
Committee for the Protection of Human Subjects. Satisfaction of the
terms of the director's rules for data access shall be deemed to
establish a valid scientific interest for purposes of subdivision
(a), entitling the researcher to review records collected pursuant to
Section 103830 and to contact case subjects and controls. Before
confidential information is disclosed pursuant to this section to any
other person, agency, or organization, the requesting entity shall
demonstrate to the department that the entity has established the
procedures and ability to maintain the confidentiality of the
information.
   (d) Notwithstanding any other provision of law, any disclosure
authorized by this section shall include only the information
necessary for the stated purpose of the requested disclosure, and
shall be made only upon written agreement that the information will
be kept confidential, used for the approved purpose, and not be
further disclosed.
   (e) The furnishing of confidential information to the department
or its authorized representative in accordance with this section
shall not expose any person, agency, or entity furnishing the
information to liability, and shall not be considered a waiver of any
privilege or a violation of a confidential relationship.
   (f) Whenever program staff, pursuing program objectives, deems it
necessary to contact case subjects and controls, program staff shall
submit a protocol describing the research to the director and to the
State Committee for the Protection of Human Subjects. Once a protocol
is approved by that committee, program staff shall be deemed to have
established a bona fide research purpose, and shall be entitled to
complete the approved project and contact case subjects and controls
without securing any additional approvals or waivers from any entity.
   (g) Notwithstanding any other provision of law, no part of the
confidential information shall be available for subpoena, nor shall
it be disclosed, discoverable, or compelled to be produced in any
civil, criminal, administrative, or other proceeding, nor shall this
information be deemed admissible as evidence in any civil, criminal,
administrative, or other tribunal or court for any reason. Nothing in
this section shall prohibit the publishing by the department of
reports and statistical compilations relating to birth defects,
stillbirth, or miscarriage that do not in any way identify individual
cases or individual sources of information.
   (h) 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. That person shall also be subject to a
civil penalty of five hundred dollars ($500). 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.
   (i) Notwithstanding the restrictions in this section, an
individual to whom the information pertains shall have access to his
or her own information in accordance with Chapter 1 (commencing with
Section 1798) of Title 1.8 of the Civil Code.



103855.  The department may enter into a contract for the
establishment and implementation of the birth defects monitoring
program. The contract shall include provisions requiring full
compliance with all the requirements of this chapter. The term of the
contract may be in excess of one year, but no longer than three
years. Funds shall be allocated in accordance with the state Budget
Act. Funds withheld from the contractor at the conclusion of a fiscal
year until specified tasks are completed shall be released promptly
on proof of substantial completion, and shall not be offset against
any funding for the subsequent fiscal year.