2007 California Health and Safety Code Article 1. Hereditary Disorders Act

CA Codes (hsc:124975-124996)

124975.  The Legislature hereby finds and declares that:
   (a) Each person in the State of California is entitled to health
care commensurate with his or her health care needs, and to
protection from inadequate health services not in the person's best
interests.
   (b) Hereditary disorders, such as sickle cell anemia, cystic
fibrosis, and hemophilia, are often costly, tragic, and sometimes
deadly burdens to the health and well-being of the citizens of this
state.
   (c) Detection through screening of hereditary disorders can lead
to the alleviation of the disability of some hereditary disorders and
contribute to the further understanding and accumulation of medical
knowledge about hereditary disorders that may lead to their eventual
alleviation or cure.
   (d) There are different severities of hereditary disorders, that
some hereditary disorders have little effect on the normal
functioning of individuals, and that some hereditary disorders may be
wholly or partially alleviated through medical intervention and
treatment.
   (e) All or most persons are carriers of some deleterious recessive
genes that may be transmitted through the hereditary process, and
that the health of carriers of hereditary disorders is substantially
unaffected by that fact.
   (f) Carriers of most deleterious genes should not be stigmatized
and should not be discriminated against by any person within the
State of California.
   (g) Specific legislation designed to alleviate the problems
associated with specific hereditary disorders may tend to be
inflexible in the face of rapidly expanding medical knowledge,
underscoring the need for flexible approaches to coping with genetic
problems.
   (h) State policy regarding hereditary disorders should be made
with full public knowledge, in light of expert opinion and should be
constantly reviewed to consider changing medical knowledge and ensure
full public protection.
   (i) The extremely personal decision to bear children should remain
the free choice and responsibility of the individual, and should not
be restricted by the state.
   (j) Participation of persons in hereditary disorders programs in
the State of California should be wholly voluntary, except for
initial screening for phenylketonuria (PKU) and other genetic
disorders treatable through the California newborn screening program.
  All information obtained from persons involved in hereditary
disorders programs in the state should be held strictly confidential.

   (k) In order to minimize the possibility for the reoccurrence of
abuse of genetic intervention in hereditary disorders programs, all
programs offering screening programs for heredity disorders shall
comply with the principles established in the Hereditary Disorders
Act (Section 27).  The Legislature finds it necessary to establish a
uniform statewide policy for the screening for heredity disorder in
the State of California.



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) 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.
   (5) The initial prenatal screening fee increase for activities of
the Birth Defects Monitoring Program shall be ten dollars ().
   (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 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 Section 11346.1 and Section 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.




124980.  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.  Standards shall
include licensure of master level genetic counselors and doctoral
level geneticists.  Regulations adopted shall implement the
principles established in this section.  These principles shall
include, but not be limited to, the following:
   (a) 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.
   (b) The incidence, severity, and treatment costs of each
hereditary disorder and its perceived burden by the affected
community should be considered and, 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 shall be consulted by the department.
   (c) Information on the operation of all programs on hereditary
disorders within the state, except for confidential information
obtained from participants in the programs, shall be open and freely
available to the public.
   (d) Clinical testing procedures established for use in programs,
facilities, and projects shall be accurate, provide maximum
information, and the testing procedures selected shall produce
results that are subject to minimum misinterpretation.
   (e) No test or tests may 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.
   (f) No testing, except initial screening for phenylketonuria (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.
   (g) Pretest and posttest counseling services for hereditary
disorders shall 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.  Genetic counseling shall be provided
by a physician, a certified advanced practice nurse with a genetics
specialty, or other appropriately trained licensed health care
professional and shall be nondirective, shall emphasize informing the
client, and shall not require restriction of childbearing.
   (h) All participants in programs on hereditary disorders shall be
protected from undue physical and mental harm, and except for initial
screening for phenylketonuria (PKU) and other diseases that may be
added to newborn screening programs, shall be informed of the nature
of risks involved in participation in the programs, and those
determined to be affected with genetic disease shall be informed of
the nature, and where possible the cost, of available therapies or
maintenance programs, and shall be informed of the possible benefits
and risks associated with these therapies and programs.
   (i) All testing results and personal information generated from
hereditary disorders programs shall 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 hereditary disorder shall be given
through a physician or other source of health care.
   (j) All testing results and personal information from hereditary
disorders programs obtained from any individual, or from specimens
from any individual, shall be held confidential and be considered a
confidential medical record except for information that 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 data
compiled without reference to the identity of any individual, and
except for research purposes, provided that pursuant to Subpart A
(commencing with Section 46.101) of Part 46 of Title 45 of the Code
of Federal Regulations entitled "Basic HHS Policy for 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.
   (k) A physician providing information to patients on expanded
newborn screening shall disclose to the parent the physician's
financial interest, if any, in the laboratory to which the patient is
being referred.
   (l) An individual whose confidentiality has been breached as a
result of any violation of the provisions of the Hereditary Disorders
Act, as defined in subdivision (b) of Section 27, may recover
compensatory and civil damages.  Any person who negligently breaches
the confidentiality of an individual tested under this article shall
be subject to civil damages of not more than ten thousand dollars
(,000), reasonable attorney's fees, and the costs of litigation.
Any person who knowingly breaches the confidentiality of an
individual tested under this article shall be subject to payment of
compensatory damages, and in addition, may be subject to civil
damages of fifty thousand dollars (,000), reasonable attorney's
fees, and the costs of litigation, or imprisonment in the county jail
of not more than one year.  If the offense is committed under false
pretenses, the person may be subject to a fine of not more than one
hundred thousand dollars (0,000), imprisonment in the county jail
of not more than one year, or both.  If the offense is committed with
the intent to sell, transfer, or use individually identifiable
health information for commercial advantage, personal gain, or
malicious harm, the person may be subject to a fine of not more than
two hundred fifty thousand dollars (0,000), imprisonment in the
county jail of not more than one year, or both.
   (m) "Genetic counseling" as used in this section shall not include
communications that occur between patients and appropriately trained
and competent licensed health care professionals, such as
physicians, registered nurses, and physicians assistants who are
operating within the scope of their license and qualifications as
defined by their licensing authority.



124981.  (a) No person shall use the title of genetic counselor
unless the person has applied for and obtained a license from the
department.
   (b) The applicant for a genetic counselor license shall meet
minimum qualifications that include but are not limited to all of the
following:
   (1) Has earned a master's degree or above from a program
specializing in or having substantial course content in genetics.
   (2) Has demonstrated competence by an examination administered or
approved by the department.
   (c) The license shall be valid for three years unless at any time
during that period it is revoked or suspended.  The license may be
renewed prior to the expiration of the three-year period.
   (d) To qualify to renew the license, a licenseholder shall have
completed 45 hours of continuing education units during the
three-year license renewal period.  At least 30 hours of the
continuing education units shall be in genetics.
   (e) The license fee for an original license and license renewal
shall not exceed two hundred dollars (0).



124985.  A violation of any of the provisions of the Hereditary
Disorders Act (Section 27) or any of the regulations adopted pursuant
to that act shall be punishable as a misdemeanor.



124990.  For the purposes of the Hereditary Disorders Act (Section
27), hereditary disorders programs shall include, but not be limited
to, all antenatal, neonatal, childhood, and adult screening programs,
and all adjunct genetic counseling services.



124991.  (a) (1) The State Department of Public Health shall provide
any umbilical cord blood samples it receives pursuant to Section
123371 to the Birth Defects Monitoring Program for storage and
research.  In administering this section the department shall ensure
that the Birth Defects Monitoring Program meets at least one of the
following conditions:
   (A) The fees paid by researchers, investigators, and health care
services providers pursuant to subdivision (c) shall be used to cover
the cost of collecting and storing blood, including umbilical cord
blood.
   (B) The department receives confirmation that an investigator,
researcher, or health care provider has requested umbilical cord
blood samples for research or has requested cord blood samples to be
included within a request for pregnancy and newborn blood samples
through the program.
   (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 units the program
collects each year.
   (b) (1) All information relating to umbilical cord blood samples
collected and utilized by the Birth Defects Monitoring 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 (,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 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 following types of blood samples,
collected by the Birth Defects Monitoring Program, for research:
   (1) Umbilical cord blood.
   (2) Pregnancy blood.
   (3) Newborn blood.
   (d) Fees collected pursuant to subdivision (c) shall be deposited
into the Birth Defects Monitoring Program Fund created pursuant to
paragraph (7) of subdivision (b) of Section 124977. Moneys deposited
into the fund pursuant to this section may be used by the department,
upon appropriation by the Legislature, for the purposes specified in
subdivision (e).
   (e) Moneys in the fund shall be used for the costs related to data
management, including data linkage and entry, and umbilical cord
blood storage, retrieval, processing, inventory, and shipping.
   (f) The department shall adopt rules and regulations pursuant to
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, 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) (1) For purposes of ensuring the security of a donor's
personal information, before any umbilical cord 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 Birth Defects Monitoring 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 Birth Defects Monitoring 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 Birth Defects Monitoring 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) 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.



124995.  The following programs shall comply with the regulations
established pursuant to the Hereditary Disorders Act (Section 27):
   (a) The California Children's Services Program under Article 5
(commencing with Section 123800) of Chapter 3 of Part 2.
   (b) Prenatal testing programs for newborns under Sections 125050
to 125065, inclusive.
   (c) Medical testing programs for newborns under the Maternal and
Child Health Program Act (Section 27).
   (d) Programs of the genetic disease unit under Section 125000.
   (e) Child health disability prevention programs under Article 6
(commencing with Section 124025) of Chapter 3 of Part 2 and Section
120475.
   (f) Genetically handicapped person's programs under Article 1
(commencing with Section 125125) of Chapter 2.
   (g) Medi-Cal Benefits Program under Article 4 (commencing with
Section 14131) of Chapter 7 of Part 3 of Division 9 of the Welfare
and Institutions Code.


124996.  (a) The Genetic Disease Testing Fund is continued in
existence as a special fund in the State Treasury.  The department
may charge a fee for any activities carried out pursuant to the
Hereditary Disorders Act, including licensing activities conducted
pursuant to Section 124980.  All moneys collected by the department
under the act shall be deposited in the Genetic Disease Testing Fund,
that is continuously appropriated to the department to carry out the
purposes of the act.
   (b) It is the intent of the Legislature that the program carried
out pursuant to the act be fully supported from fees collected under
the act.
   (c) The director shall adopt regulations establishing the amount
of fees for activities carried out pursuant to the act.
   (d) The "Hereditary Disorders Act" or "act" referred to in this
section is the act described in subdivision (b) of Section 27.