2005 California Health and Safety Code Sections 125050-125119.5 Article 4. Prenatal Testing

125050.  The department shall administer a statewide program for the
prenatal testing for genetic disorders and birth defects, including,
but not limited to, ultrasound, amniocentesis, chorionic villus
sampling, and blood testing for genetic disorders and birth defects.
125055.  The department shall:
   (a) Establish criteria for eligibility for the prenatal testing
program.  Eligibility shall include definition of conditions and
circumstances that result in a high risk of a detectable genetic
disorder or birth defect.
   (b) Develop an education program designed to educate physicians
and surgeons and the public concerning the uses of prenatal testing
and the availability of the program.
   (c) Ensure that genetic counseling be given in conjunction with
prenatal testing at the approved prenatal diagnosis centers.
   (d) Designate sufficient prenatal diagnosis centers to meet the
need for these services.  Prenatal diagnosis centers shall have
equipment and staff trained and capable of providing genetic
counseling and performing prenatal diagnostic procedures and tests,
including the interpretation of the results of the procedures and
tests.
   (e) Administer a program of subsidy grants for approved nonprofit
prenatal diagnosis centers.  The subsidy grants shall be awarded
based on the reported number of low-income women referred to the
center, the number of prenatal diagnoses performed in the previous
year at that center, and the estimated size of unmet need for
prenatal diagnostic procedures and tests in its service area.  This
subsidy shall be in addition to fees collected under other state
programs.
   (f) Establish any rules, regulations, and standards for prenatal
diagnostic testing and the allocation of subsidies as the director
deems necessary to promote and protect the public health and safety
and to implement the Hereditary Disorders Act (Section 27).
125060.  The participation by any individual in the prenatal testing
program shall be wholly voluntary and shall not be a prerequisite to
eligibility for, or receipt of, any other service or assistance
from, or to participation in, any other program.
125065.  All prenatal diagnosis centers shall meet standards
developed by the department and shall agree to accept patients from
state funded or administered programs, including, but not limited to,
Medi-Cal, Regional Centers, Maternal and Child Health, California
Children's Services, Genetically Handicapped Persons Program, and
Family Planning.  Only prenatal diagnosis centers meeting standards
developed by the department shall be eligible for reimbursement under
these state programs.
125070.  Laboratories licensed by the department shall not offer the
maternal serum-alpha fetoprotein screening test for prenatal
detection of neural tube defects of the fetus until the department
has developed regulations, under the authorization granted by Section
124980.  However, laboratories providing this testing, as of July
21, 1983, may continue to provide this testing until these
regulations become operative.  The department shall adopt regulations
pursuant to this section.
125075.  Every licensed physician and surgeon or other person
attending a newborn infant diagnosed as having had rhesus (Rh)
isoimmunization hemolytic disease shall report the condition to the
department on report forms prescribed by the department.
125080.  A licensed physician and surgeon or other person engaged in
the prenatal care of a pregnant woman or attending the woman at the
time of delivery shall obtain or cause to be obtained a blood
specimen of the woman.  Prior to obtaining the blood specimen, the
woman shall be notified of the fact that the blood specimen is going
to be obtained.  If the blood specimen is not obtained prior to
delivery, it shall be obtained at the time of delivery.
125085.  (a) As early as possible during prenatal care, a blood
specimen obtained pursuant to Section 125080 shall be submitted to a
clinical laboratory licensed by the department or to an approved
public health laboratory for a determination of rhesus (Rh) blood
type and the results shall be reported to both of the following:
   (1) The physician and surgeon or other person engaged in the
prenatal care of the woman or attending the woman at the time of
delivery.
   (2) The woman tested.
   (b) (1) In addition, as early as possible during prenatal care, a
blood specimen obtained pursuant to Section 125080 shall be submitted
to a clinical laboratory licensed by the department or to an
approved public health laboratory for a test to determine the
presence of hepatitis B surface antigen and the human
immunodeficiency virus (HIV), and the results shall be reported to
both of the following:
   (A) The physician and surgeon or other person engaged in the
prenatal care of the women or attending the woman at the time of
delivery who ordered the test, and who shall subsequently inform the
woman tested.
   (B) A positive test result shall be reported to the local health
officer, with the information required and within the timeframes
established by the department, pursuant to Chapter 4 (commencing with
Section 2500) of Title 17 of the California Code of Regulations.
   (2) In the event that other tests to determine hepatitis B
infection or HIV infection become available, the department may
approve additional tests.
125090.  (a) Subdivision (a) of Section 125085 shall not be
applicable if the licensed physician and surgeon or other person
engaged in the prenatal care of a pregnant woman or attending the
woman at the time of delivery has knowledge of the woman's blood type
and accepts responsibility for the accuracy of the information.
   (b) Subdivision (b) of Section 125085 shall not be applicable if
the licensed physician and surgeon or other person engaged in the
prenatal care of a pregnant woman or attending the woman at the time
of delivery has knowledge that the woman has previously been
determined to be chronically infected with hepatitis B or human
immunodeficiency virus (HIV) and accepts responsibility for the
accuracy of the information.
   (c) Prior to obtaining a blood specimen collected pursuant to
subdivision (b) of Section 125085 or this section, the physician and
surgeon or other person engaged in the prenatal care of a pregnant
woman or attending the woman at the time of delivery shall ensure
that the woman is informed of the intent to perform a test for HIV
infection, the routine nature of the test, the purpose of the
testing, the risks and benefits of the test, the risk of perinatal
transmission of HIV, that approved treatments are known to decrease
the risk of perinatal transmission of HIV, and that the woman has a
right to accept or refuse this testing.  The acceptance of testing
for HIV shall be documented in writing on a form developed by the
department and the Office of AIDS pursuant to Section 125092, or on a
form that is substantially equivalent in content, and signed by the
patient.  A copy of this form shall be maintained in the medical
record.  A multispecialty medical group that provides health care
services to enrollees of a health care service plan may use a form
incorporating the information in this subdivision and in subdivision
(d) instead of any separate form developed pursuant to Section
125092.
   (d) If, during the final prenatal care standard medical tests, the
medical records of the pregnant woman do not document a test for
rhesus (Rh) blood type, a test for hepatitis B, or a test for HIV,
the physician and surgeon or other person engaged in the prenatal
care of the woman or attending the woman at the time of labor or
delivery shall obtain a blood specimen from the woman for the test
that has not been documented.  Prior to obtaining this blood
specimen, the provider shall ensure that the woman is informed of the
intent to perform the tests that have not been documented prior to
this visit, including a test for HIV infection, the routine nature of
the test, the purpose of the testing, the risks and benefits of the
test, the risk of perinatal transmission of HIV, that approved
treatments are known to decrease the risk of perinatal transmission
of HIV, and that the woman has a right to accept or refuse the HIV
test.  The acceptance of testing for HIV shall be documented in
writing on a form developed by the department and the Office of AIDS,
or on a form that is substantially equivalent in content, as
described in Section 125092, and signed by the patient.  A copy of
this form shall be maintained in the medical record.  The blood shall
be tested by a method that will ensure the earliest possible
results, and the results shall be reported to both of the following:
   (1) The physician and surgeon or other person engaged in the
prenatal care of the woman or attending the woman at the time of
delivery.
   (2) The woman tested.
   (e) After the results of the tests done pursuant to this section
and Section 125085 have been received, the physician and surgeon or
other person engaged in the prenatal care of the pregnant woman or
attending the woman at the time of labor, delivery, or postpartum
care at the time the results are received shall ensure that the woman
receives information and counseling, as appropriate, to explain the
results and the implications for the mother's and infant's health,
including any followup care that is indicated.  If the woman tests
positive for HIV antibodies, she shall also receive, whenever
possible, a referral to a provider, provider group, or institution
specializing in prenatal care for HIV positive women.  Health care
providers are also strongly encouraged to seek consultation with
other providers specializing in the care of pregnant HIV positive
women.
   (f) The provisions of Section 125107 for counseling are equally
applicable to every pregnant patient covered by subdivisions (c) and
(d).
125092.  The department, in consultation with the Office of AIDS and
with other stakeholders, including, but not limited to,
representatives of professional medical and public health advocacy
groups, providers of health care to women and infants infected with
or exposed to HIV, and women living with HIV, shall develop
culturally sensitive informational material adequate to fulfill the
requirements of subdivisions (c) and (d) of Section 125090, in
English, Spanish, and other languages used by the department when
providing information to clients under the Medi-Cal program.  This
material shall also include information on available referral and
consultation resources of experts in prenatal HIV treatment.  This
material shall be completed by December 31, 2004.
125095.  The department may adopt regulations as it determines are
reasonably necessary for the implementation of the Maternal and Child
Health Program Act (Section 27).
125100.  (a) Clinical laboratories licensed by the department,
approved public health laboratories, local health departments,
physicians and surgeons, or other persons engaged in the prenatal
care of a pregnant woman or in the care of an infant shall maintain
and make available to the department information necessary to
evaluate, for public health purposes, the effectiveness of testing
and followup treatment for the prevention of perinatally transmitted
hepatitis B infection.
   (b) The department shall make available, to the extent state funds
are appropriated therefor in the annual Budget Act or federal funds
are available for that purpose, money to each county requesting funds
for testing and followup treatment for the prevention of perinatally
transmitted hepatitis B infection or for any functions performed
pursuant to subdivision (a).  The money shall be allocated by the
department on the basis of the incidence of perinatally transmitted
hepatitis B infection and the need for necessary followup treatment
and evaluation in the requesting county.
125105.  (a) The blood specimen and test results pursuant to
subdivision (b) of Section 125085 shall be confidential and shall not
be disclosed, except as otherwise provided by law.
   (b) No person shall be compelled in any state, county, city, or
other local civil, criminal, administrative, legislative, or other
proceeding to provide test results determined pursuant to Section
125080 and Section 125085.
125107.  (a) For purposes of this section, "prenatal care provider"
means a licensed health care professional providing prenatal care
within his or her lawful scope of practice.  This definition shall
not include a licensed health care professional who provides care
other than prenatal care to a pregnant patient.
   (b) The prenatal care provider primarily responsible for providing
prenatal care to a pregnant patient shall offer human
immunodeficiency virus (HIV) information and counseling to every
pregnant patient.  This information and counseling shall include, but
shall not be limited to, all of the following:
   (1) A description of the modes of HIV transmission.
   (2) A discussion of risk reduction behavior modifications
including methods to reduce the risk of perinatal transmission.
   (3) If appropriate, referral information to other HIV prevention
and psychosocial services including anonymous and confidential test
sites approved by the Office of AIDS.
   (c) Nothing in this section shall be construed to require
mandatory testing.  Any documentation or disclosure of HIV related
information shall be made in accordance with Chapter 7 (commencing
with Section 120975) of Part 4 of Division 105 regarding
confidentiality and informed consent.
   (d) Notwithstanding Section 125090 or any other provision of law,
completion of a statement of acceptance of an HIV test pursuant to
Sections 125090 and 125092 shall be sufficient documentation of
consent for HIV testing of a pregnant woman or of a woman at the time
of labor and delivery, and no laboratory or health care provider
shall require any additional written consent or written form as a
condition for HIV testing from any woman who is reasonably believed
to be pregnant, who is receiving prenatal care, or who is undergoing
a panel of tests designated for prenatal patients.
125110.  The Maternal and Child Health Program Act (Section 27)
shall not apply if the pregnant woman objects to the test required by
that act on the ground that the test conflicts with her religious
beliefs or practices.
125118.  (a) On or before January 1, 2005, the department shall
develop guidelines for research involving the derivation or use of
human embryonic stem cells in California.
   (b) In developing the guidelines specified in subdivision (a), the
department may consider other applicable guidelines developed or in
use in the United States and in other countries, including, but not
limited to, the Guidelines for Research Using Human Pluripotent Stem
Cells developed by the National Institutes of Health and published in
August 2000, and corrected in November 2000.
   (c) The department may contract with a public or private
organization, to the extent permitted by state law, for assistance in
developing the guidelines.
   (d) This section shall remain in effect only until January 1,
2007, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2007, deletes or extends
that date.
125118.5.  (a) For purposes of developing the guidelines required by
Section 125118, the director shall establish a Human Stem Cell
Research Advisory Committee.
   (b) The advisory committee shall consist of 13 members, as
follows:
   (1) Seven scientists with experience in biomedical research in the
fields of cell differentiation, nuclear reprogramming, tissue
formation and regeneration, stem cell biology, developmental biology,
regenerative medicine, or related fields.
   (2) Two medical ethicists.
   (3) Two persons with backgrounds in legal issues related to human
embryonic stem cell research, in vitro fertilization, or family law,
as it applies to the donation of embryos and oocytes.
   (4) Two persons who are members or leaders of religious
organizations.
   (c) This section shall remain in effect only until January 1,
2007, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2007, deletes or extends
that date.
125119.  (a) (1) All research projects involving the derivation or
use of human embryonic stem cells shall be reviewed and approved by
an institutional review board that is established in accordance with
federal regulations, including Part 46 (commencing with Section
46.101) of Subchapter A of Subtitle A of Title 45 of the Code of
Federal Regulations, prior to being undertaken.  Any such
institutional review board shall, in its review of human embryonic
stem cell research projects, consider and apply the guidelines
developed by the department pursuant to Section 125118.  An
institutional review board may require modifications to the plan or
design of a proposed human embryonic stem cell research project as a
condition of approving the research project.
   (2) For purposes of this article, "IRB" means an institutional
review board described in paragraph (1).
   (b) Not less than once per year, an IRB shall conduct continuing
review of human embryonic stem cell research projects reviewed and
approved under this section in order to ensure that the research
continues to meet the standards for IRB approval.  Pursuant to its
review in accordance with this subdivision, an IRB may revoke its
prior approval of research under this section and require
modifications to the plan or design of a continuing research project
before permitting the research to continue.
   (c) This section shall remain in effect only until January 1,
2007, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2007, deletes or extends
that date.
125119.3.  (a) Each IRB that has reviewed human embryonic stem cell
research pursuant to Section 125119 shall report to the department,
annually, on the number of human embryonic stem cell research
projects that the IRB has reviewed, and the status and disposition of
each of those projects.
   (b) Each IRB shall also report to the department regarding
unanticipated problems, unforeseen issues, or serious continuing
investigator noncompliance with the requirements or determinations of
the IRB with respect to the review of human embryonic stem cell
research projects, and the actions taken by the IRB to respond to
these situations.
   (c) This section shall remain in effect only until January 1,
2007, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2007, deletes or extends
that date.
125119.5.  (a) The department shall at least annually review reports
from IRBs pursuant to Section 125120, and may revise the guidelines
developed pursuant to Section 125118, as it deems necessary.
   (b) The department shall report annually to the Legislature on
human embryonic stem cell research activity.  These annual reports
shall be compiled from the reports from IRBs pursuant to Section
125120.
   (c) This section shall remain in effect only until January 1,
2007, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2007, deletes or extends
that date.