BILL NUMBER: AB 2356 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY MAY 30, 2012
AMENDED IN ASSEMBLY MAY 8, 2012
AMENDED IN ASSEMBLY APRIL 25, 2012
AMENDED IN ASSEMBLY MARCH 29, 2012
INTRODUCED BY Assembly Member Skinner
FEBRUARY 24, 2012
An act to amend Section 1644.5 of, and to add Section 1644.6 to,
the Health and Safety Code, relating to human tissue.
LEGISLATIVE COUNSEL'S DIGEST
AB 2356, as amended, Skinner. Tissue donation.
Existing law prohibits the transfer of any tissues, as defined,
into the body of another person by means of transplantation, unless
the donor of the tissues has been screened and found nonreactive for
evidence of infection with human immunodeficiency virus (HIV), agents
of viral hepatitis (HBV and HCV), syphilis, and human T
lymphotrophic virus (HTLV), except as provided. Existing law requires
that all donors of sperm be screened and found nonreactive under the
above provisions, except as provided.
This bill would except sperm donated by a sexually intimate
partner of the recipient, as defined, from second or repeat testing
under these requirements if the recipient is informed of the testing
requirements and signs a written waiver, as specified. This bill
would exclude a physician and surgeon from liability for any cause of
action or disciplinary action, as specified, for providing
insemination or advanced reproductive technology services using
based solely upon the use of sperm from a
sexually intimate partner of the recipient when the physician and
surgeon provides insemination or advanced reproductive
technology services and has obtained the informed consent of
the recipient, who acknowledges and accepts the risks of using sperm
that has not undergone quarantine and repeat testing, as described.
The bill would exclude a physician and surgeon from disciplinary
action because the physician and surgeon used sperm in these
conditions in providing insemination or advanced
reproductive technology services.
The bill would exclude a physician and surgeon owned and operated
clinical laboratory or tissue bank from disciplinary action for
providing these insemination or advanced reproductive technology
services.
The bill would also exclude provide that
some of its provisions do not create a duty for a physician and
surgeon from liability for a cause of action based upon
discrimination against an individual or group if the physician and
surgeon refuses to provide insemination or advanced reproductive
technology services using to use sperm from a
sexually intimate partner of the recipient in providing
insemination or advanced reproductive technology services if
the physician and surgeon determines that the insemination or
services do not meet specified guidelines for providing insemination
or advanced reproductive technology services.
Vote: majority. Appropriation: no. Fiscal committee: no.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature finds and declares all of the
following:
(a) Single women and same-sex female couples using a known donor
are unable to access the same fertility services as women seeking to
conceive using a male partner.
(b) Women seeking fertility services to help them conceive with a
male partner are able to be inseminated using fresh sperm. Because of
the practical difficulty of performing the required testing and
fears of liability, most fertility services will not provide fresh
insemination services to a woman using a donor who is not her
partner.
(c) All other women are required to have their donors' sperm
frozen, which significantly reduces the chance of conceiving and, for
many donors, means that conception is not possible without much more
expensive procedures.
(d) Federal Food and Drug Administration (FDA) regulations require
extensive testing, except when the donor is a "sexually intimate
partner" (21 C.F.R. 1271.90). This term is not defined in
regulations. Based upon the term's ordinary meaning, the term has
been construed to apply to heterosexual couples with an ongoing
relationship. Because the explicit purpose of the term is to allow
donation without testing when the recipient has already been exposed,
this term can be interpreted to include women who have already
attempted at-home inseminations with their donors' sperm because they
have already been exposed through these attempts.
(e) Although California requires testing in all circumstances,
the state authorizes waivers of repeat testing for sperm donors known
to the recipient.
(f) Until the term sexually intimate partner
"sexually intimate partner " is explicitly
defined by the FDA, it is the intent of the Legislature to provide a
clarification that, for the purposes of tissues donated for
reproductive use, a "sexually intimate partner" includes any woman
who has been exposed to the donor's sperm outside of a medical
setting.
(g) It is also the intent of the Legislature to address the
potential for confusion amongst treating professionals regarding
prevailing regulations and professional guidelines that reference
both the term "sexually intimate partner" and the term "known donor."
Due to this potential, and in recognition that there are multiple
entities that regulate physicians and surgeons and the area of
assisted reproductive technologies for which the physician or surgeon
is accountable, it is the intent of the Legislature to provide
physicians and surgeons with immunity when acting in a manner
consistent with this law. Physicians Both the
physician and surgeons who believe this bill and the
standard of care allows the use of fresh sperm from a known
donor to which the woman has already been exposed constitutes a
"sexually intimate partner" and the physician and surgeons who
believes believe that the use of fresh
sperm in this situation is a violation of professional guidelines and
declines decline to use of
fresh sperm both need assurances
that their actions under this new law should
would not be subjecting themselves to additional
professional risk.
(h) The definition of "sexually intimate partner" is limited to
this act and is not intended to have any effect on any provision of
the Family Code, including the definition of a "donor" for purposes
of determining legal parentage of a child.
(i) It is not the intent of the Legislature to prevent federal
regulators from exercising federal authority over facilities that
provide insemination or advanced reproductive technology services.
SEC. 2. Section 1644.5 of the Health and Safety Code is amended to
read:
1644.5. (a) Except as provided in subdivision (c) or (d), no
tissues shall be transferred into the body of another person by means
of transplantation, unless the donor of the tissues has been
screened and found nonreactive by laboratory tests for evidence of
infection with human immunodeficiency virus (HIV), agents of viral
hepatitis (HBV and HCV), and syphilis. For tissues that are rich in
viable leukocytes, the tissue shall be tested for evidence of
infection with human T lymphotrophic virus (HTLV) and found
nonreactive. The department may adopt regulations requiring
additional screening tests of donors of tissues when, in the opinion
of the department, the action is necessary for the protection of the
public, donors, or recipients.
(b) Notwithstanding subdivision (a), infectious disease screening
of blood and blood products shall be carried out solely in accordance
with Article 2 (commencing with Section 1602.5) of Chapter 4.
(c) All donors of sperm shall be screened and found nonreactive as
required under subdivision (a), except in the following instances:
(1) A recipient of sperm, from a sperm donor known to the
recipient, may waive a second or other repeat testing of that donor
if the recipient is informed of the requirements for testing donors
under this section and signs a written waiver.
(2) A recipient of sperm may consent to therapeutic insemination
of sperm or use of sperm in other advanced reproductive technologies
even if the sperm donor is found reactive for hepatitis B, hepatitis
C, syphilis, HIV , or HTLV if the sperm donor is the
spouse of, partner of, or designated donor for that recipient. The
physician providing insemination or advanced reproductive technology
services shall advise the donor and recipient of the potential
medical risks associated with receiving sperm from a reactive donor.
The donor and the recipient shall sign a document affirming that each
comprehends the potential medical risks of using sperm from a
reactive donor for the proposed procedure and that each consents to
it. Copies of the document shall be placed in the medical records of
the donor and the recipient.
(3) (A) Sperm whose donor has tested reactive for syphilis may be
used for the purposes of insemination or advanced reproductive
technology only after the donor has been treated for syphilis. Sperm
whose donor has tested reactive for hepatitis B may be used for the
purposes of insemination or advanced reproductive technology only
after the recipient has been vaccinated against hepatitis B.
(B) (i) Sperm whose donor has tested reactive for HIV or HTLV may
be used for the purposes of insemination or advanced reproductive
technology for a recipient testing negative for HIV or HTLV only
after the donor's sperm has been effectively processed to minimize
the infectiousness of the sperm for that specific donation and where
informed and mutual consent has occurred.
(ii) Not later than January 1, 2014, the department shall adopt
regulations regulating facilities that perform sperm processing,
pursuant to this subparagraph, that prescribe standards for the
handling and storage of sperm samples of carriers of HIV, HTLV, or
any other virus as deemed appropriate by the department. The
department may propose to adopt, as initial regulations, the
recommendations made within the "Guidelines for Reducing Risk of
Viral Transmission During Fertility Treatment" as published by the
American Society for Reproductive Medicine. Notice of the department'
s proposed adoption of the regulations shall be posted on the
department's Internet Web site for at least 45 days. Public comment
shall be accepted by the department for at least 30 days after the
conclusion of the 45-day posting period. If a member of the public
requests a public hearing during the 30-day comment period, the
hearing shall be held prior to the adoption of the regulations. If no
member of the public requests a public hearing, the regulations
shall be deemed adopted at the conclusion of the 30-day comment
period. Comments received shall be considered prior to the adoption
of the final initial regulations. The department may modify any
guidance published by the American Society for Reproductive Medicine.
Adoption of initial regulations by the department pursuant to this
subdivision shall not be subject to the rulemaking requirements of
Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3
of Title 2 of the Government Code and written responses to public
comments shall not be required. Updates to the regulations shall be
adopted pursuant to the same process. Until the department adopts
these regulations, facilities that perform sperm processing pursuant
to this section shall follow facility and sperm processing guidelines
for the reduction of viral transmission developed by the American
Society for Reproductive Medicine. Nothing in this section shall
prevent the department from monitoring and inspecting facilities that
process sperm to ensure adherence to the regulations, or, until
regulations are adopted, to the guidelines set forth by the American
Society for Reproductive Medicine.
(iii) Prior to insemination or other advanced reproductive
technology services, the physician providing the services shall
inform the recipient of sperm from a spouse, partner, or designated
donor who has tested reactive for HIV or HTLV of all of the
following:
(I) That sperm processing may not eliminate all of the risks of
HIV or HTLV transmission.
(II) That the sperm may be tested to determine whether or not it
is reactive for HIV or HTLV.
(III) That the recipient must provide documentation to the
physician providing insemination or advanced reproductive technology
services prior to treatment that she has established an ongoing
relationship with another physician to provide for her medical care
during and after completion of fertility services.
(IV) The recommendations made within the "Guidelines for Reducing
the Risk of Viral Transmission During Fertility Treatment" published
by the American Society for Reproductive Medicine regarding followup
testing for HIV and HTLV after use of sperm from an HIV or HTLV
reactive donor and have the recommendations regarding followup
testing be documented in the recipient's medical record.
(iv) The physician providing insemination or advanced reproductive
technology services shall also verify, and document in the recipient'
s medical record, that the donor of sperm who tests reactive for HIV
or HTLV is under the care of a physician managing the HIV or HTLV.
(v) The physician providing insemination or advanced reproductive
technology services shall recommend to the physician who will be
providing ongoing care to the recipient recommended followup testing
for HIV and HTLV according to the "Guidelines for Reducing the Risk
of Viral Transmission During Fertility Treatment" published by the
American Society for Reproductive Medicine, which shall be documented
in the recipient's medical record.
(vi) In the event that the recipient becomes HIV or HTLV positive,
the physician assuming ongoing care of the recipient shall treat or
provide information regarding referral to a physician who can provide
ongoing treatment of the HIV or HTLV.
(4) A recipient of sperm donated by a sexually intimate partner of
the recipient for reproductive use may waive a second or repeat
testing of that donor if the recipient is informed of the donor
testing requirements of this section and signs a written waiver. For
purposes of this paragraph, "sexually intimate partner of the
recipient" includes a known or designated donor to whose sperm the
recipient has previously been exposed in a nonmedical setting in an
attempt to conceive.
(d) Subdivision (a) shall not apply to the transplantation of
tissue from a donor who has not been tested or, with the exception of
HIV and HTLV, has been found reactive for the infectious diseases
listed in subdivision (a) or for which the department has, by
regulation, required additional screening tests, if both of the
following conditions are satisfied:
(1) The physician and surgeon performing the transplantation has
determined any one or more of the following:
(A) Without the transplantation the intended recipient will most
likely die during the period of time necessary to obtain other tissue
or to conduct the required tests.
(B) The intended recipient already is diagnosed with the
infectious disease for which the donor has tested positive.
(C) The symptoms from the infectious disease for which the donor
has tested positive will most likely not appear during the intended
recipient's likely lifespan after transplantation with the tissue or
may be treated prophylactically if they do appear.
(2) Consent for the use of the tissue has been obtained from the
recipient, if possible, or if not possible, from a member of the
recipient's family, or the recipient's legal guardian. For purposes
of this section, "family" shall mean spouse, adult son or daughter,
either parent, adult brother or sister, or grandparent.
(e) The penalties of Section 1621.5 shall not apply to a sperm
donor covered under subdivision (c).
(f) Human breast milk from donors who test reactive for agents of
viral hepatitis (HBV and HCV), HTLV, HIV, or syphilis shall not be
used for deposit into a milk bank for human ingestion in California.
SEC. 3. Section 1644.6 is added to the Health and Safety Code, to
read:
1644.6. (a) A No physician and
surgeon shall not be subject to liability for
damages for any cause of action for providing insemination
or advanced reproductive technology services using sperm from
based solely on the use of sperm donated by a
sexually intimate partner of the recipient when the physician and
surgeon provides insemination or advanced reproductive
technology services and has obtained the informed consent of
the recipient, who acknowledges and accepts the risks of using sperm
that has not undergone quarantine and repeat testing, as described in
Section 1644.5.
(b) A No physician and surgeon shall
not be subject to disciplinary action against his
or her professional license, or subject to peer review by a
professional association peer review body, as defined in clause (iii)
of subparagraph (B) of paragraph (1) of subdivision (a) of Section
805 of the Business and Professions Code, for providing
insemination or advanced reproductive technology services using
because the physician and surgeon used sperm
from donated by a sexually intimate
partner of the recipient in providing insemination or advanced
reproductive technology services when the physician and surgeon
has obtained the informed consent of the recipient who acknowledges
and accepts the risks of using sperm that has not undergone
quarantine and repeat testing, as described in Section 1644.5.
(c) A clinical laboratory that is owned and operated by a
physician and surgeon or a tissue bank that is owned and operated by
a physician and surgeon shall not be subject to disciplinary action
against its license for because of the use of
sperm donated by a sexually intimate partner of the recipient in
providing insemination or advanced reproductive technology
services using sperm from a sexually intimate partner of the
recipient when the any
physician and surgeon affiliated with the clinical laboratory or
tissue bank has obtained the informed consent of the
recipient, who acknowledges and accepts the risks of using sperm that
has not undergone quarantine and repeat testing, as described in
Section 1644.5.
(d) A Nothing in this section shall create
a duty for a physician and surgeon shall not be
liable for a cause of action based upon discrimination against an
individual or group if the physician and surgeon refuses to provide
insemination or advanced reproductive technology services using sperm
from a sexually intimate partner of the recipient to
use sperm donated by a sexually intimate partner of the recipient in
providing insemination or advanced reproductive technology services
if the physician and surgeon determines
reasonably concludes that the insemination or services do not
meet the 2008 American Society for Reproductive Medicine guidelines
for gamete and embryo donation.
(e) Nothing in this section shall be construed to affect any
liability that may be imposed pursuant to a federal rule or
regulation when a physician and surgeon, clinical laboratory, or
tissue bank provides insemination or advanced reproductive technology
services.
(e)
(f) For purposes of this section, "sexually intimate
partner" includes a known or designated donor to whose sperm the
recipient has previously been exposed in a nonmedical setting in an
attempt to conceive.