Amended in Senate May 4, 2016

Amended in Senate April 18, 2016

Amended in Senate April 4, 2016

Senate Bill No. 1408

Introduced by Senator Allen

February 19, 2016

An act to amend Section 1644.5 of the Health and Safety Code, relating to public health.

LEGISLATIVE COUNSEL’S DIGEST

SB 1408, as amended, Allen. Tissue donation.

(1) 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), human T lymphotropic virus (HTLV), and syphilis, except as provided. Existing law requires that all donors of sperm be screened and found nonreactive under the above provisions, except as provided. Existing law authorizes the transplantation of tissue from a donor who has not been tested for specified infectious diseases or, with the exception of HIV and HTLV, has been found reactive, if specified conditions are satisfied.

This bill would delete the exception of HIV from this provision. begin insert The bill would require a physician and surgeon performing the transplantation of tissue from an HIV-reactive donor to ensure that the recipient is also HIV reactive and complying with federal law, as specified. end insert

(2) Under existing law, it is a felony for a person to donate blood, body organs or other tissue, or semen to a medical center or semen bank who knows that he or she has acquired immunodeficiency syndrome (AIDS) except if the person is a sperm donor who has been screened and found nonreactive under the above provisions. Under existing law, a person afflicted with any contagious, infectious, or communicable disease who willfully exposes himself or herself to another person, and any person who willfully exposes another person afflicted with the disease to someone else, is guilty of a misdemeanor, except as provided.

This bill would exempt those sperm donors and tissue donors from those criminal provisions.

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.  

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 lymphotropic 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 assisted 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 assisted 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 assisted 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 assisted 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 assisted
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) 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 assisted 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 assisted 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 assisted
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 assisted
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) If 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
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 begin delete both end delete begin insert all end insert 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.

begin insert

(2) The physician and surgeon performing the transplantation
has ensured that tissue from an individual who has been found
reactive for HIV may be transplanted only into an individual who
satisfies both of the following:

end insert begin insert

(A) The individual has been found reactive for HIV before
receiving the tissue.

end insert begin insert

(B) The individual is either participating in clinical research
approved by an institutional review board under the criteria,
standards, and regulations described in subsections (a) and (b) of
Section 274f-5 of Title 42 of the United States Code, or, if the
United States Secretary of Health and Human Services determines
under subsection (c) of Section 274f-5 of Title 42 of the United
States Code that participation in this clinical research is no longer
warranted as a requirement for transplants, the individual is
receiving the transplant under the standards and regulations under
subsection (c) of Section 274f-5 of Title 42 of the United States
Code.

end insert begin delete

(2)

end delete

begin insert (3) end insert  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 begin delete of end delete prescribed in Sections 1621.5 and 120290
do not apply to a sperm donor covered under subdivision (c) or a
tissue donor covered under subdivision (d).

(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.