2007 California Health and Safety Code Chapter 4.2. Donations Of Organs, Tissues, Or Body Fluids

CA Codes (hsc:1644-1644.5)

1644.  For purposes of this chapter, "donor," "person," "tissue,"
"transplantation," and "state department" shall have the meaning as
defined for those terms in Section 1635.



1644.5.  (a) 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 HIV, agents of viral hepatitis (HBV
and HCV), human T lymphotrophic virus-1 (HTLV-1), and syphilis,
except as provided in subdivision (c). 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 1601) 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-1 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 medical repercussions 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-1
may be used for the purposes of insemination or advanced reproductive
technology for a recipient testing negative for HIV or HTLV-1 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 by January 1, 2010,
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-1, or any other virus as
deemed appropriate by the department. Until the department adopts
these regulations, facilities that perform sperm processing shall
follow facility and sperm processing guidelines developed by the
American Society of Reproductive Medicine.
   (iii) Prior to insemination or other advanced reproductive
technology services, the physician shall inform the recipient of
sperm from a donor who has tested reactive for HIV or HTLV-1 that
sperm processing may not eliminate all risks of HIV or HTLV-1
transmission, and that the sperm may be tested to determine whether
or not it is free of HIV or HTLV-1. The physician shall also inform
the recipient of potential adverse effects the testing may have on
the processed sperm.
   (iv) The physician providing insemination or advanced reproductive
technology services shall provide, as appropriate, prophylactic
treatments, including, but not limited to, antiretroviral treatments,
to the recipient to reduce the risk of acquiring infection during,
and subsequent to, insemination or advanced reproductive technology.
The physician providing 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-1 is under
the care of a physician managing the HIV or HTLV-l to minimize the
risk of transmission during the course of insemination or advanced
reproductive technology services. The physician shall perform
appropriate followup testing of the recipient for HIV or HTLV-1
following the insemination or other advanced reproductive technology,
and recommend ongoing monitoring by a physician during treatment and
pregnancy. The physician shall also recommend in the sperm recipient'
s medical record that the recipient be monitored during treatment and
pregnancy.
   (v) In the event that the recipient tests reactive for HIV or
HTLV-1 following insemination or other advanced reproductive
technology, the physician shall inform the recipient of appropriate
treatments during and after pregnancy, and of treatments or
procedures that may reduce the risk of transmission to the offspring.

   (vi) Sperm whose donor has tested reactive for HIV or HTLV-1 may
be used for the purposes of insemination or advanced reproductive
technology if the recipient already has been previously documented
with HIV or HTLV-1 infection, and where informed and mutual consent
has occurred.
   (4) The penalties of Section 1621.5 shall not apply to a sperm
donor covered under this subdivision.
   (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-1, 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) Human breast milk from donors who test reactive for agents of
viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1), HIV, or syphilis shall not be used for deposit into a milk
bank for human ingestion in California.