Bill Text: CA SB1408 | 2015-2016 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Tissue donation.

Spectrum: Bipartisan Bill

Status: (Passed) 2016-05-27 - Chaptered by Secretary of State. Chapter 18, Statutes of 2016. [SB1408 Detail]

Download: California-2015-SB1408-Amended.html

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BILL NUMBER: SB 1408	AMENDED
	BILL TEXT

	AMENDED IN SENATE  MAY 4, 2016
	AMENDED IN SENATE  APRIL 18, 2016
	AMENDED IN SENATE  APRIL 4, 2016

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.
 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. 
   (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  both  
all  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) 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:  
   (A) The individual has been found reactive for HIV before
receiving the tissue.  
   (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.  
   (2) 
    (3)  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  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.