BILL NUMBER: SB 1800 CHAPTERED
BILL TEXT
CHAPTER 897
FILED WITH SECRETARY OF STATE SEPTEMBER 28, 1998
APPROVED BY GOVERNOR SEPTEMBER 27, 1998
PASSED THE SENATE AUGUST 31, 1998
PASSED THE ASSEMBLY AUGUST 17, 1998
AMENDED IN ASSEMBLY AUGUST 10, 1998
AMENDED IN ASSEMBLY JULY 7, 1998
AMENDED IN ASSEMBLY JUNE 24, 1998
AMENDED IN ASSEMBLY JUNE 10, 1998
AMENDED IN SENATE MAY 5, 1998
INTRODUCED BY Senator Johnston
FEBRUARY 18, 1998
An act to amend Section 124980 of the Health and Safety Code,
relating to hereditary disorders.
LEGISLATIVE COUNSEL'S DIGEST
SB 1800, Johnston. Hereditary disorders: genetic counselors.
Existing law requires the Director of Health Services to establish
any regulations and standards for hereditary disorders programs as
the director deems necessary to promote and protect the public health
and safety in accordance with certain principles.
This bill would require the State Department of Health Services to
recommend appropriate criteria and standards for licensing genetic
counselors, and would require the department to consult with a group
of medical experts representing medical professional organizations
during the process of developing and recommending the criteria and
standards. It would further require the department to report its
recommendations to the Legislature by January 1, 2000.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 124980 of the Health and Safety Code is amended
to read:
124980. (a) The director shall establish any regulations and
standards for hereditary disorders programs as the director deems
necessary to promote and protect the public health and safety, in
accordance with the principles established pursuant to this section.
These principles shall include, but not be limited to, the
following:
(1) The public, especially communities and groups particularly
affected by programs on hereditary disorders, should be consulted
before any regulations and standards are adopted by the department.
(2) The incidence, severity and treatment costs of each hereditary
disorder and its perceived burden by the affected community should
be considered; and that where appropriate, state and national experts
in the medical, psychological, ethical, social, and economic effects
or programs for the detection and management of hereditary disorders
be consulted by the department.
(3) Information on the operation of all programs on hereditary
disorders within the state, except for confidential information
obtained from participants in the programs, be open and freely
available to the public.
(4) Clinical testing procedures established for use in programs,
facilities, and projects be accurate, provide maximum information,
and that the testing procedures selected produce results that are
subject to minimum misinterpretation.
(5) No test or tests shall be performed on any minor over the
objection of the minor's parents or guardian, nor may any tests be
performed unless the parent or guardian is fully informed of the
purposes of testing for hereditary disorders, and is given reasonable
opportunity to object to the testing.
(6) No testing, except initial screening for PKU and other
diseases that may be added to the newborn screening program, shall
require mandatory participation, and no testing programs shall
require restriction of childbearing, and participation in a testing
program shall not be a prerequisite to eligibility for, or receipt
of, any other service or assistance from, or to participate in, any
other program, except where necessary to determine eligibility for
further programs of diagnoses of or therapy for hereditary
conditions.
(7) Counseling services for hereditary disorders be available
through the program or a referral source for all persons determined
to be or who believe themselves to be at risk for a hereditary
disorder as a result of screening programs; the counseling is
nondirective, emphasizes informing the client, and not require
restriction of childbearing.
(8) All participants in programs on hereditary disorders be
protected from undue physical and mental harm, and except for initial
screening for PKU and other diseases that may be added to newborn
screening programs, be informed of the nature of risks involved in
participation in the programs, and those determined to be affected
with genetic disease be informed of the nature, and where possible,
the cost of available therapies or maintenance programs, and be
informed of the possible benefits and risks associated with such
therapies and programs.
(9) All testing results and personal information generated from
hereditary disorders programs be made available to an individual over
18 years of age, or to the individual's parent or guardian. If the
individual is a minor or incompetent, all testing results that have
positively determined the individual to either have, or be a carrier
of, a heredity disorder shall be given through a physician or other
source of health care.
(10) All testing results and personal information from hereditary
disorders programs obtained from any individual, or from specimens
from any individual, be held confidential and be considered a
confidential medical record except for such information as the
individual, parent, or guardian consents to be released; provided
that the individual is first fully informed of the scope of the
information requested to be released, of all of the risks, benefits,
and purposes for the release, and of the identity of those to whom
the information will be released or made available, except for
statistical data compiled without reference to the identity of any
individual, and except for research purposes, provided that pursuant
to 45 Code of Federal Regulations Section 46.101 et seq. entitled
"Protection of Human Subjects," the research has first been reviewed
and approved by an institutional review board that certifies the
approval to the custodian of the information and further certifies
that in its judgment the information is of such potentially
substantial public health value that modification of the requirement
for legally effective prior informed consent of the individual is
ethically justifiable.
(11) An individual whose confidentiality has been breached as a
result of any violation of the provisions of the Hereditary Disorders
Act (Section 27) may recover compensatory damages, and in addition,
may recover civil damages not to exceed ten thousand dollars
($10,000), reasonable attorney's fees, and the costs of litigation.
(b) The department shall recommend appropriate criteria and
standards for licensing genetic counselors. In the process of
developing the recommended criteria and standards, the department
shall consult with a group of medical experts representing medical
professional organizations including, but not limited to, the Medical
Board of California, the California Medical Association, and
organizations representing genetic counselors in California. The
department shall report its recommendations to the Legislature by
January 1, 2000.