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).
(g) (1) The department shall expand prenatal screening to include
all tests that meet or exceed the current standard of care as
recommended by nationally recognized medical or genetic
organizations, including, but not limited to, inhibin.
(2) The prenatal screening fee increase for expanding prenatal
screening to include those tests described in paragraph (1) is forty
dollars ($40).
(3) The department shall report to the Legislature regarding the
progress of the program with regard to implementing prenatal
screening for those tests described in paragraph (1) on or before
July 1, 2007. The report shall include the costs of screening,
followup, and treatment as compared to costs and morbidity averted by
this testing under the program.
(4) (A) The expenditure of funds from the Genetic Disease Testing
Fund for the expansion of the Genetic Disease Branch Screening
Information System to include the expansion of prenatal screenings,
pursuant to paragraph (1), 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.
(B) (i) The department may adopt emergency regulations to
implement and make specific the amendments to this section made
during the 2006 portion of the 2005-06 Regular Session 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.
(ii) 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.
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 labor or 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 decline this testing.
(d) If, during the final review of standard of prenatal care
medical tests, the medical records of the pregnant woman do not
document a test for rhesus (Rh) antibody 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 tests that have 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 decline the HIV test. 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 post partum
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 testing and care that are 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 and post partum care for
HIV-positive women and their infants. Health care providers are also
strongly encouraged to seek consultation with HIV specialists who
provide care for pregnant and post partum HIV-positive women and
their infants.
(f) The provisions of Section 125107 for counseling are equally
applicable to every pregnant patient covered by subdivisions (c) and
(d).
(g) Nothing in this section shall be construed to permit 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 to unlawfully disclose an individual's HIV status, or to
otherwise violate provisions of Section 54 of the Civil Code, the
Americans With Disabilities Act of 1990 (Public Law 101-336), or the
California Fair Employment and Housing Act (Part 2.8 (commencing with
Section 12900) of Division 3 of Title 2 of the Government Code),
which prohibit discrimination against individuals who are living with
HIV, or who test positive for HIV, or are presumed to be
HIV-positive.
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) Nothing in this section shall be construed to permit a
prenatal care provider to unlawfully disclose an individual's HIV
status, or to otherwise violate provisions of Section 54 of the Civil
Code, or the Americans With Disabilities Act of 1990 (Public Law
101-336), or the California Fair Employment and Housing Act (Part 2.8
(commencing with Section 12900) of Division 3 of Title 2 of the
Government Code), which prohibit discrimination against individuals
who are living with HIV, or who test positive for HIV, or are
presumed to be HIV-positive.
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) The State Department of Public Health 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, and the Guidelines for
Human Embryonic Stem Cell Research issued by the National Research
Council and Institute of Medicine of the National Academies in 2005.
125119. (a) (1) All research projects involving the derivation or
use of human embryonic stem cells shall be reviewed and approved by a
stem cell research oversight committee prior to being undertaken.
Any stem cell research oversight committee shall, in its review of
human embryonic stem cell research projects, consider and apply the
guidelines developed by the department pursuant to Section 125118. A
stem cell research oversight committee 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) A stem cell research oversight committee for purposes of this
article shall be established substantially in accordance with
Guidelines for Human Embryonic Stem Cell Research issued by the
National Research Council and the Institute of Medicine of the
National Academies in 2005. This committee shall be established in
accordance with standards issued by the California Institute for
Regenerative Medicine (CIRM) as authorized by Article XXXV of the
California Constitution. The intent of the Legislature is to avoid
inconsistencies for stem cell research oversight committees
established pursuant to this article with other existing standards
for research conducted in California.
(b) Not less than once per year, a stem cell research oversight
committee 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
stem cell research oversight committee approval. Pursuant to its
review in accordance with this subdivision, a stem cell research
oversight committee 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) A stem cell research oversight committee may provide
scientific and ethical review of research consistent with this
article.
125119.3. (a) Each stem cell research oversight committee 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 stem cell
research oversight committee has reviewed, and the status and
disposition of each of those projects, including the information
collected pursuant to Section 125342.
(b) Each stem cell research oversight committee shall also report
to the department regarding unanticipated problems, unforeseen
issues, or serious continuing investigator noncompliance with the
requirements or determinations of the stem cell research oversight
committee with respect to the review of human embryonic stem cell
research projects, and the actions taken by the stem cell research
oversight committee to respond to these situations.
125119.5. (a) The department shall at least annually review reports
from stem cell research oversight committees, and may revise the
guidelines developed pursuant to Section 125118, as it deems
necessary.
(b) The department shall provide a biennial review to the
Legislature on human embryonic stem cell research activity. These
biennial reviews shall be compiled from the reports from stem cell
research oversight committees.
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).
(g) (1) The department shall expand prenatal screening to include
all tests that meet or exceed the current standard of care as
recommended by nationally recognized medical or genetic
organizations, including, but not limited to, inhibin.
(2) The prenatal screening fee increase for expanding prenatal
screening to include those tests described in paragraph (1) is forty
dollars ($40).
(3) The department shall report to the Legislature regarding the
progress of the program with regard to implementing prenatal
screening for those tests described in paragraph (1) on or before
July 1, 2007. The report shall include the costs of screening,
followup, and treatment as compared to costs and morbidity averted by
this testing under the program.
(4) (A) The expenditure of funds from the Genetic Disease Testing
Fund for the expansion of the Genetic Disease Branch Screening
Information System to include the expansion of prenatal screenings,
pursuant to paragraph (1), 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.
(B) (i) The department may adopt emergency regulations to
implement and make specific the amendments to this section made
during the 2006 portion of the 2005-06 Regular Session 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.
(ii) 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.
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 labor or 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 decline this testing.
(d) If, during the final review of standard of prenatal care
medical tests, the medical records of the pregnant woman do not
document a test for rhesus (Rh) antibody 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 tests that have 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 decline the HIV test. 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 post partum
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 testing and care that are 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 and post partum care for
HIV-positive women and their infants. Health care providers are also
strongly encouraged to seek consultation with HIV specialists who
provide care for pregnant and post partum HIV-positive women and
their infants.
(f) The provisions of Section 125107 for counseling are equally
applicable to every pregnant patient covered by subdivisions (c) and
(d).
(g) Nothing in this section shall be construed to permit 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 to unlawfully disclose an individual's HIV status, or to
otherwise violate provisions of Section 54 of the Civil Code, the
Americans With Disabilities Act of 1990 (Public Law 101-336), or the
California Fair Employment and Housing Act (Part 2.8 (commencing with
Section 12900) of Division 3 of Title 2 of the Government Code),
which prohibit discrimination against individuals who are living with
HIV, or who test positive for HIV, or are presumed to be
HIV-positive.
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) Nothing in this section shall be construed to permit a
prenatal care provider to unlawfully disclose an individual's HIV
status, or to otherwise violate provisions of Section 54 of the Civil
Code, or the Americans With Disabilities Act of 1990 (Public Law
101-336), or the California Fair Employment and Housing Act (Part 2.8
(commencing with Section 12900) of Division 3 of Title 2 of the
Government Code), which prohibit discrimination against individuals
who are living with HIV, or who test positive for HIV, or are
presumed to be HIV-positive.
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) The State Department of Public Health 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, and the Guidelines for
Human Embryonic Stem Cell Research issued by the National Research
Council and Institute of Medicine of the National Academies in 2005.
125119. (a) (1) All research projects involving the derivation or
use of human embryonic stem cells shall be reviewed and approved by a
stem cell research oversight committee prior to being undertaken.
Any stem cell research oversight committee shall, in its review of
human embryonic stem cell research projects, consider and apply the
guidelines developed by the department pursuant to Section 125118. A
stem cell research oversight committee 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) A stem cell research oversight committee for purposes of this
article shall be established substantially in accordance with
Guidelines for Human Embryonic Stem Cell Research issued by the
National Research Council and the Institute of Medicine of the
National Academies in 2005. This committee shall be established in
accordance with standards issued by the California Institute for
Regenerative Medicine (CIRM) as authorized by Article XXXV of the
California Constitution. The intent of the Legislature is to avoid
inconsistencies for stem cell research oversight committees
established pursuant to this article with other existing standards
for research conducted in California.
(b) Not less than once per year, a stem cell research oversight
committee 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
stem cell research oversight committee approval. Pursuant to its
review in accordance with this subdivision, a stem cell research
oversight committee 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) A stem cell research oversight committee may provide
scientific and ethical review of research consistent with this
article.
125119.3. (a) Each stem cell research oversight committee 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 stem cell
research oversight committee has reviewed, and the status and
disposition of each of those projects, including the information
collected pursuant to Section 125342.
(b) Each stem cell research oversight committee shall also report
to the department regarding unanticipated problems, unforeseen
issues, or serious continuing investigator noncompliance with the
requirements or determinations of the stem cell research oversight
committee with respect to the review of human embryonic stem cell
research projects, and the actions taken by the stem cell research
oversight committee to respond to these situations.
125119.5. (a) The department shall at least annually review reports
from stem cell research oversight committees, and may revise the
guidelines developed pursuant to Section 125118, as it deems
necessary.
(b) The department shall provide a biennial review to the
Legislature on human embryonic stem cell research activity. These
biennial reviews shall be compiled from the reports from stem cell
research oversight committees.
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).
(g) (1) The department shall expand prenatal screening to include
all tests that meet or exceed the current standard of care as
recommended by nationally recognized medical or genetic
organizations, including, but not limited to, inhibin.
(2) The prenatal screening fee increase for expanding prenatal
screening to include those tests described in paragraph (1) is forty
dollars ($40).
(3) The department shall report to the Legislature regarding the
progress of the program with regard to implementing prenatal
screening for those tests described in paragraph (1) on or before
July 1, 2007. The report shall include the costs of screening,
followup, and treatment as compared to costs and morbidity averted by
this testing under the program.
(4) (A) The expenditure of funds from the Genetic Disease Testing
Fund for the expansion of the Genetic Disease Branch Screening
Information System to include the expansion of prenatal screenings,
pursuant to paragraph (1), 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.
(B) (i) The department may adopt emergency regulations to
implement and make specific the amendments to this section made
during the 2006 portion of the 2005-06 Regular Session 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.
(ii) 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.
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 labor or 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 decline this testing.
(d) If, during the final review of standard of prenatal care
medical tests, the medical records of the pregnant woman do not
document a test for rhesus (Rh) antibody 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 tests that have 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 decline the HIV test. 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 post partum
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 testing and care that are 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 and post partum care for
HIV-positive women and their infants. Health care providers are also
strongly encouraged to seek consultation with HIV specialists who
provide care for pregnant and post partum HIV-positive women and
their infants.
(f) The provisions of Section 125107 for counseling are equally
applicable to every pregnant patient covered by subdivisions (c) and
(d).
(g) Nothing in this section shall be construed to permit 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 to unlawfully disclose an individual's HIV status, or to
otherwise violate provisions of Section 54 of the Civil Code, the
Americans With Disabilities Act of 1990 (Public Law 101-336), or the
California Fair Employment and Housing Act (Part 2.8 (commencing with
Section 12900) of Division 3 of Title 2 of the Government Code),
which prohibit discrimination against individuals who are living with
HIV, or who test positive for HIV, or are presumed to be
HIV-positive.
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) Nothing in this section shall be construed to permit a
prenatal care provider to unlawfully disclose an individual's HIV
status, or to otherwise violate provisions of Section 54 of the Civil
Code, or the Americans With Disabilities Act of 1990 (Public Law
101-336), or the California Fair Employment and Housing Act (Part 2.8
(commencing with Section 12900) of Division 3 of Title 2 of the
Government Code), which prohibit discrimination against individuals
who are living with HIV, or who test positive for HIV, or are
presumed to be HIV-positive.
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) The State Department of Public Health 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, and the Guidelines for
Human Embryonic Stem Cell Research issued by the National Research
Council and Institute of Medicine of the National Academies in 2005.
125119. (a) (1) All research projects involving the derivation or
use of human embryonic stem cells shall be reviewed and approved by a
stem cell research oversight committee prior to being undertaken.
Any stem cell research oversight committee shall, in its review of
human embryonic stem cell research projects, consider and apply the
guidelines developed by the department pursuant to Section 125118. A
stem cell research oversight committee 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) A stem cell research oversight committee for purposes of this
article shall be established substantially in accordance with
Guidelines for Human Embryonic Stem Cell Research issued by the
National Research Council and the Institute of Medicine of the
National Academies in 2005. This committee shall be established in
accordance with standards issued by the California Institute for
Regenerative Medicine (CIRM) as authorized by Article XXXV of the
California Constitution. The intent of the Legislature is to avoid
inconsistencies for stem cell research oversight committees
established pursuant to this article with other existing standards
for research conducted in California.
(b) Not less than once per year, a stem cell research oversight
committee 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
stem cell research oversight committee approval. Pursuant to its
review in accordance with this subdivision, a stem cell research
oversight committee 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) A stem cell research oversight committee may provide
scientific and ethical review of research consistent with this
article.
125119.3. (a) Each stem cell research oversight committee 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 stem cell
research oversight committee has reviewed, and the status and
disposition of each of those projects, including the information
collected pursuant to Section 125342.
(b) Each stem cell research oversight committee shall also report
to the department regarding unanticipated problems, unforeseen
issues, or serious continuing investigator noncompliance with the
requirements or determinations of the stem cell research oversight
committee with respect to the review of human embryonic stem cell
research projects, and the actions taken by the stem cell research
oversight committee to respond to these situations.
125119.5. (a) The department shall at least annually review reports
from stem cell research oversight committees, and may revise the
guidelines developed pursuant to Section 125118, as it deems
necessary.
(b) The department shall provide a biennial review to the
Legislature on human embryonic stem cell research activity. These
biennial reviews shall be compiled from the reports from stem cell
research oversight committees.
