BILL ANALYSIS �
SENATE JUDICIARY COMMITTEE
Senator Noreen Evans, Chair
2011-2012 Regular Session
AB 2356 (Skinner)
As Amended May 30, 2012
Hearing Date: July 3, 2012
Fiscal: No
Urgency: No
NR
SUBJECT
Tissue Donation
DESCRIPTION
Existing law prohibits the transfer of any tissues, including
sperm, 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. Sperm from anonymous donors is also subject
to repeat testing and quarantine requirements.
This bill would except sperm donated by a sexually intimate
partner of the recipient from second or repeat testing, if the
recipient is informed of the testing requirements and signs a
written waiver, as specified.
This bill would immunize a physician or surgeon for liability
based solely upon the use of sperm from a sexually intimate
partner of a recipient who has given informed consent to waive
repeat testing, as specified. This bill would also prohibit
disciplinary action against a physician and surgeon solely
because the physician and surgeon used sperm under these
conditions.
This bill would also provide that its provisions do not create a
duty for a physician or surgeon to use sperm from a sexually
intimate partner if the physician determines that the
insemination or services do not meet specified guidelines for
providing insemination or advanced reproductive technology
(more)
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services.
BACKGROUND
Infertility is defined by the Centers for Disease Control and
Prevention as not being able to get pregnant after one year of
trying, or, six months, if a woman is 35 years or older. Women
who can get pregnant but are unable to stay pregnant may also be
infertile. Many women are now waiting late in life to have
children. Because about one-third of couples in which the woman
is older than 35 years have fertility problems, infertility is a
growing concern. Infertility may be treated with medicine,
surgery, artificial insemination, assisted reproductive
technology, or a combination of these treatments. Unlike other
areas of medicine, which are regulated predominately at the
state level, assisted reproductive technologies are also
regulated at the federal level. In addition, the state
regulates physicians and tissue banks that deal with sperm, and
professional associations have extensive professional guidelines
for the use of sperm.
The Society for Assisted Reproductive Technology (SART) and the
American Society for Reproductive Medicine (ASRM), jointly
offered guidelines for sperm donation in 2008 that are widely
followed. Among the recommended laboratory tests were those for
HIV, HBV, HCV, syphilis, and HTLV. The guidelines made specific
recommendations for anonymous donation, donation from a known
source, and sexually intimate couples. The guidelines provide
that anonymous donors are tested and re-tested, which is also
required under regulations issued by the Food and Drug
Administration. Thus, if an initial donation produces negative
results, the semen samples should be collected, cryopreserved,
and quarantined for a minimum of 180 days, after which the semen
should be retested, and again found negative, before the samples
may be released. Directed, or known donors should undergo the
same screening and testing as anonymous donors, and directed
donor specimens are treated in the same manner as anonymous
donor specimens. Sexually intimate couples seeking fertility
treatment, however, are only advised to undergo testing to
minimize the risk of viral transmission to partners and
resulting children. Under these guidelines, sperm donated from
a sexually intimate partner is not required to be quarantined or
undergo repeat testing.
This bill would, for the purposes of the bill, define "sexually
intimate partner of the recipient" to include a known or
designated donor to whose sperm the recipient has previously
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been exposed in a nonmedical setting in an attempt to conceive,
and permit that recipient to waive a second or repeat testing of
that donor. This bill would exempt a physician who has obtained
informed consent from the recipient, from liability or
discipline based solely upon the use of sperm from a sexually
intimate partner of the recipient.
CHANGES TO EXISTING LAW
Existing federal law establishes procedures to prevent the
introduction, transmission, and spread of communicable diseases
by human cells, tissues, and cellular and tissue-based products
(HCT/Ps). Federal law defines HCT/Ps as "articles containing or
consisting of human cells or tissues that are intended for
implantation, transplantation, infusion, or transfer into a
human recipient, including semen or other reproductive tissue."
(21 C.F.R. Sec. 1270.1 et seq.)
Existing federal law authorizes the Food and Drug Administration
(FDA) to regulate establishments that engage in the manufacture
of HCT/Ps. (21 C.F.R. Sec. 1271.1.)
Existing federal law requires all donors of cells and tissues
used in HCT/Ps to be screened and tested for relevant
communicable disease agents and diseases, and prohibits the
implantation, transplantation, infusion, or transfer of HCT/Ps
until the donor has been determined to be eligible, with
specified exemptions. (21 C.F.R. Sec. 1271.45.)
Existing federal law requires, before the completion of a
donor-eligibility determination that:
a donor's medical records be screened for specified risk
factors and evidence of relevant communicable diseases;
the semen from anonymous donors be quarantined in a physically
separate area clearly identified for such use for at least six
months after the date of donation; and
semen from anonymous donors be retested by collecting a new
specimen from the donor and testing it for evidence of
infection due to HIV, HBV and HCV, syphilis, and HTLV. (21
C.F.R. Sec. 1271.75.)
Existing federal law exempts reproductive cells or tissue
donated by a sexually intimate partner of the recipient for
reproductive use from specified donor eligibility requirements.
(21 C.F.R. Sec. 1271.90.)
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Existing law prohibits the transfer of any tissues 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 HIV, HBV, HCV,
syphilis, and HTLV, subject to specified exemptions. (Health &
Saf. Code Sec. 1644.5 (a).)
Existing law permits a recipient of sperm, from a sperm donor
known to the recipient, to waive a second or other repeat
testing of that donor if the recipient is informed of specified
requirements for testing donors and signs a written waiver.
(Health & Saf. Code Sec. 1644.5 (c).)
This bill would define, for the purposes of this bill, a
"sexually intimate partner of the recipient" to include a known
or designated donor to whose sperm the recipient has previously
been exposed in a nonmedical setting in an attempt to conceive.
This bill would authorize the recipient of sperm donated by a
sexually intimate partner for reproductive use to waive a second
or repeat testing of that donor for HIV, HBV, HCV, syphilis, and
HTLV, if the recipient is informed of existing donor testing
requirements and signs a written waiver.
This bill would exempt a physician, when the physician 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 specified, from:
liability for damages for any cause of action based solely on
the use of sperm donated by a SIP of the recipient; and
disciplinary action against his or her professional license
and peer review by a professional organization peer review
body, as defined.
This bill would exempt a clinical laboratory or tissue bank, as
specified, from disciplinary action against its license because
of the use of sperm donated by a sexually intimate partner of
the recipient when any physician 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
specified.
This bill would prohibit any provisions in the bill from
creating a duty for a physician to use sperm donated by a
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recipient's sexually intimate partner in providing insemination
or advanced reproductive technology services if the physician
reasonably concludes that the insemination or services do not
meet the American Society for Reproductive Medicine guidelines
for gamete and embryo donation. This bill would further
prohibit anything in this bill from being construed to affect
any liability that may be imposed pursuant to federal rule or
regulation when a physician, clinical laboratory, or tissue bank
provides insemination or advanced reproductive technology
services.
COMMENT
1.Stated need for the bill
According to the author:
Single women and same sex couples using a known donor do not
get the same insemination treatment as women with a male
partner when trying to conceive. A woman who receives
fertility services with a male is able to use fresh sperm for
insemination, greatly increasing the likelihood of the woman
conceiving. A woman who receives fertility services with a
known male donor can only receive frozen sperm, reducing her
chances of conceiving. . . . Not only is frozen sperm less
effective, but the six month waiting period can reduce the
chance of becoming pregnant for women over 40. Insemination
with frozen sperm is also significantly more expensive than
insemination with fresh sperm.
2.Physician and surgeon immunity
This bill would exclude a physician or surgeon from liability or
disciplinary action based solely upon the use of sperm from a
sexually intimate partner where the recipient waived repeat
testing, if the physician or surgeon has obtained informed
consent. This bill would also provide that its provisions do not
create a duty for a physician or surgeon to use sperm from a
sexually intimate partner if the physician determines that the
insemination or services do not meet specified guidelines for
providing insemination or advanced reproductive technology
services.
Staff notes that civil immunity provisions are rarely preferable
because they, by their nature, prevent an injured party from
seeking a particular type of recovery. However, the immunity
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provisions under this bill are arguably appropriate because they
are narrowly tailored and mirror similar provisions of
applicable law.
California law authorizes a recipient using sperm from a "known
donor" to waive repeat testing. Federal regulations similarly
allow a waiver if the recipient is a "sexually intimate partner"
of the donor. Yet neither state nor federal law defines these
terms. At least in part, the ability to waive repeat testing
seems to be based on a social expectation that couples are
monogamous. Thus, repeat testing which may reveal diseases or
infections that the donor contracted since the initial testing
need not be required. On this point, the co-sponsors argue that
in practice, there is a "disparity between different-sex couples
and same-sex or single women using known donors when they may
need to seek fertility services in a medical setting after
failed attempts to conceive at home. Whereas different-sex
couples are permitted to use fresh sperm to inseminate when
using fertility services, all other women must typically have
their donor's sperm frozen and quarantined for up to six months
to allow for repeated donor screening for sexually transmitted
diseases. Yet, women who have attempted to inseminate at home
with a designated donor are exposed to exactly the same risk of
disease transmission as women who have sex with male partners to
conceive."
While no specific "immunity" language exists under current law
with respect to a recipient's ability to waive repeat testing,
there is an informed consent requirement. Because informed
consent essentially requires that the recipient assume at least
some of the risks involved in the procedure consented to,
physicians are arguably already protected to some degree by that
consent. For example, there is no guarantee that the male
partner in a same-sex couple will remain monogamous. Therefore,
if his partner, the recipient, waives repeat testing through
informed consent, she will not be able to sue the physician for
malpractice if she contracted a disease from the sperm, or if
the resulting child is born inflicted by an infection or disease
that the donor-father contracted after the first round of
testing.
Yet, if the assisted reproduction process was affected in a way
unrelated to the fact that the sperm had not been re-tested, a
recipient could still have a cause of action. This is true
under existing law and the provisions of this bill. For
example, if the physician failed to conduct the initial tests on
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the donor sperm, or inadvertently switched sperm, the
recipient's ability to seek damages would not be limited by the
fact that she waived repeat testing.
Further, this bill does not create a duty for a physician to use
sperm that has not been retested if the physician concludes that
doing so would render his or her reproductive technology
services in violation of federal guidelines. As noted by the
California Medical Association in support:
When this bill was first introduced, many of our members had
concerns about the potential impacts this bill may have on
physicians who chose to either follow these new provisions or
continue to follow federal guidelines. To address our
concerns, the author amended the bill by adding specific
provisions to protect physicians from liability for their
actions, including requiring that the recipient received
informed consent and an assumption of the risk.
The narrow immunity that this bill provides mirrors the
protections offered to physicians when same-sex couples waive
repeat testing, and in no way limits a physician's liability for
negligence or malpractice in the general administration of
assisted reproductive technologies. Further, this bill imposes
no duty upon the physician to act if he or she concludes that
doing so would be in violation of federal guidelines.
3.Informed consent
Existing California law authorizes a recipient of sperm from a
known donor to waive a second or other repeat testing if the
recipient is informed of the requirements for testing and signs
a written waiver. Existing federal law authorizes a recipient
to waive repeat testing only if the donor is a sexually intimate
partner of the recipient. This bill would define a sexually
intimate partner, for the purposes of this bill only, as a known
or designated donor to whose sperm the recipient has already
been exposed in a nonmedical setting. By including a definition
of sexually intimate partner in California law, this bill would
authorize waiver of repeat testing, arguably in compliance with
federal law as well.
Current law places the obligation on a physician to obtain
"informed consent" from a patient prior to a treatment or
procedure. First used in Salgo v. Leland Stanford Jr.
University Board of Trustees (1957) 154 Cal.App.2d 560 and
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followed by Cobbs v. Grant (1972) 8 Cal.3d 229, the principle of
"informed consent" has been fine-tuned, but not varied, by more
recent cases. The American Medical Association writes that
informed consent is "more than simply getting a patient to sign
a written consent form. It is a process of communication between
a patient and physician that results in the patient's
authorization or agreement to undergo a specific medical
intervention. In the communications process ? the patient
should have an opportunity to ask questions to elicit a better
understanding of the treatment or procedure, so that he or she
can make an informed decision to proceed or to refuse a
particular course of medical intervention." (American Medical
Association, �as of June 29, 2012].)
Thus, the obligation to ensure that the recipient is given
material information about the nature, associated and inherent
risks, and other important and material facts about waiving
repeat testing of donor sperm is the responsibility of the
physician providing the insemination or advanced reproductive
technology services. This bill would require the physician to
inform the recipient of the donor testing requirements. The
recipient must then acknowledge and accept the risks of using
sperm that has not undergone quarantine and repeat testing
before she may waive the repeat testing requirements. Because
this information is material to a recipient's decision whether
to accept or reject the reproductive treatment under question,
it is entirely consistent with statutory, regulatory, and
decisional law on informed consent.
4.Technical amendments
Due to procedural timing constraints, the following author's
amendments were agreed to in the Senate Health Committee with a
commitment that they would be taken in this Committee.
Author's amendments
Change references from "advanced reproductive technology" and
"advanced reproductive technologies" to "assisted reproductive
technology" and "assisted reproductive technologies".
On Page 3, Lines 20-21, strike out "includes any woman who has
been exposed to the donor's sperm outside of a medical
setting" and insert "includes a known or designated donor to
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whose sperm the recipient has previously been exposed in a
nonmedical setting in an attempt to conceive".
Support : ACLU of California; ACLU, Paul Robeson Chapter;
American Federation of State, County and Municipal Employees,
AFL-CIO; API Equality-Northern California; Asian & Pacific
Islander Wellness Center; At Home Fertility ; California Medical
Association; Colage; GroundSpark; Kaiser Permanente; L.A. Gay &
Lesbian Center; Laparoscopic Institute for Gynecologic Oncology;
Our Family Coalition; Rainbow Flag Health Services; Somos
Familia; Tres Lunas Midwifery ; Betty T. Yee, First District
Member, BOE; Two individuals
Opposition : California Right to Life Committee, Inc.
HISTORY
Source : Equality California; National Center for Lesbian Rights
Related Pending Legislation : None Known
Prior Legislation :
AB 1487 (Hill, Chapter 444, Statutes of 2010) required testing
for evidence of infection with HTLV, as specified, until January
1, 2014, at which point regulations must be adopted by the State
Department of Public Health.
AB 1397 (Hill, 2009) was substantially similar to AB 1487 but
was vetoed by the Governor who found that some of the provisions
inappropriately restricted the administrative and regulatory
authority of the Department of Public Health.
SB 1184 (Kuehl, Chapter 347, Statutes of 2008), required a
physician providing assisted reproductive technologies to verify
and document in the recipient's medical record, that the donor
of sperm who tests reactive for HIV or HTLV-1 is under the care
of a physician managing the HIV or HTLV-1 to minimize the risk
of transmission during the course of insemination or ART
services.
SB 443 (Migden, Chapter 207, Statutes of 2007) authorized the
use of sperm whose donor has tested reactive for HIV or HTLV-1
for the purposes of insemination or ART only after the donor's
sperm has been effectively processed to minimize the
infectiousness of the sperm, as specified, and with informed and
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mutual consent.
AB 441 (Richter and Mazzoni, Chapter 511, Statutes of 1997),
created an exception to the prohibition on the transfer of
tissues into another person unless the tissue donor has been
screened and found nonreactive for evidence of infection, as
specified, if the sperm donor is the spouse, partner, or
designated donor of the recipient, and if certain other
conditions are met.
AB 525 (Speier, Chapter 659, Statutes of 1993), authorized the
recipient of sperm, from a donor known to the recipient, to
waive a second or repeat screening of that donor if the
recipient is informed of the requirements for testing donors
under California law and signs a written waiver.
Prior Vote :
Senate Committee on Health (Ayes 6, Noes 2)
Assembly Floor (Ayes 50, Noes 24)
Assembly Committee on Health (Ayes 13, Noes 5)
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