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.
(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 1644.5 of the Health and Safety Code is
2amended to read:
(a) Except as provided in subdivision (c) or (d), no
4tissues shall be transferred into the body of another person by
5means of transplantation, unless the donor of the tissues has been
6screened and found nonreactive by laboratory tests for evidence
7of infection with human immunodeficiency virus (HIV), agents
8of viral hepatitis (HBV and HCV), and syphilis. For tissues that
9are rich in viable leukocytes, the tissue shall be tested for evidence
10of infection with human T lymphotropic virus (HTLV) and found
11nonreactive. The department may adopt regulations requiring
12additional screening tests of donors of tissues when, in the opinion
13of the department, the action is necessary for the protection of the
14public, donors, or recipients.
15(b) Notwithstanding subdivision (a), infectious disease screening
16of blood and blood products shall be carried out solely in
17accordance with Article 2 (commencing with Section 1602.5) of
19(c) All donors of sperm shall be screened and found nonreactive
20as required under subdivision (a), except in the following instances:
21(1) A recipient of sperm, from a sperm donor known to the
22recipient, may waive a second or other repeat testing of that donor
23if the recipient is informed of the requirements for testing donors
24under this section and signs a written waiver.
P3 1(2) A recipient of sperm may consent to therapeutic insemination
2of sperm or use of sperm in other assisted reproductive technologies
3even if the sperm donor is found reactive for hepatitis B, hepatitis
4C, syphilis, HIV, or HTLV if the sperm donor is the spouse of,
5partner of, or designated donor for that recipient. The physician
6providing insemination or assisted reproductive technology services
7shall advise the donor and recipient of the potential medical risks
8associated with receiving sperm from a reactive donor. The donor
9and the recipient shall sign a document affirming that each
10comprehends the potential medical risks of using sperm from a
11reactive donor for the proposed procedure and that each consents
12to it. Copies of the document shall be placed in the medical records
13of the donor and the recipient.
14(3) (A) Sperm whose donor has tested reactive for syphilis may
15be used for the purposes of insemination or assisted reproductive
16technology only after the donor has been treated for syphilis. Sperm
17whose donor has tested reactive for hepatitis B may be used for
18the purposes of insemination or assisted reproductive technology
19only after the recipient has been vaccinated against hepatitis B.
20(B) (i) Sperm whose donor has tested reactive for HIV or HTLV
21may be used for the purposes of insemination or assisted
22reproductive technology for a recipient testing negative for HIV
23or HTLV only after the donor’s sperm has been effectively
24processed to minimize the infectiousness of the sperm for that
25specific donation and where informed and mutual consent has
27(ii) The department shall adopt regulations regulating facilities
28that perform sperm processing, pursuant to this subparagraph, that
29prescribe standards for the handling and storage of sperm samples
30of carriers of HIV, HTLV, or any other virus as deemed appropriate
31by the department. The department may propose to adopt, as initial
32regulations, the recommendations made within the “Guidelines
33for Reducing Risk of Viral Transmission During Fertility
34Treatment” as published by the American Society for Reproductive
35Medicine. Notice of the department’s proposed adoption of the
36regulations shall be posted on the department’s Internet Web site
37for at least 45 days. Public comment shall be accepted by the
38department for at least 30 days after the conclusion of the 45-day
39posting period. If a member of the public requests a public hearing
40during the 30-day comment period, the hearing shall be held prior
P4 1to the adoption of the regulations. If no member of the public
2requests a public hearing, the regulations shall be deemed adopted
3at the conclusion of the 30-day comment period. Comments
4received shall be considered prior to the adoption of the final initial
5regulations. The department may modify any guidance published
6by the American Society for Reproductive Medicine. Adoption of
7initial regulations by the department pursuant to this subdivision
8shall not be subject to the rulemaking requirements of Chapter 3.5
9(commencing with Section 11340) of Part 1 of Division 3 of Title
102 of the Government Code and written responses to public
11comments shall not be required. Updates to the regulations shall
12be adopted pursuant to the same process. Until the department
13adopts these regulations, facilities that perform sperm processing
14pursuant to this section shall follow facility and sperm processing
15guidelines for the reduction of viral transmission developed by the
16American Society for Reproductive Medicine. Nothing in this
17section shall prevent the department from monitoring and
18inspecting facilities that process sperm to ensure adherence to the
19regulations, or, until regulations are adopted, to the guidelines set
20forth by the American Society for Reproductive Medicine.
21(iii) Prior to insemination or other assisted reproductive
22technology services, the physician providing the services shall
23inform the recipient of sperm from a spouse, partner, or designated
24donor who has tested reactive for HIV or HTLV of all of the
26(I) That sperm processing may not eliminate all of the risks of
27HIV or HTLV transmission.
28(II) That the sperm may be tested to determine whether or not
29it is reactive for HIV or HTLV.
30(III) That the recipient must provide documentation to the
31physician providing insemination or assisted reproductive
32technology services prior to treatment that she has established an
33ongoing relationship with another physician to provide for her
34medical care during and after completion of fertility services.
35(IV) The recommendations made within the “Guidelines for
36Reducing the Risk of Viral Transmission During Fertility
37Treatment” published by the American Society for Reproductive
38Medicine regarding followup testing for HIV and HTLV after use
39of sperm from an HIV or HTLV reactive donor and have the
P5 1recommendations regarding followup testing be documented in
2the recipient’s medical record.
3(iv) The physician providing
insemination or assisted
4reproductive technology services shall also verify, and document
5in the recipient’s medical record, that the donor of sperm who tests
6reactive for HIV or HTLV is under the care of a physician
7managing the HIV or HTLV.
8(v) The physician providing insemination or assisted
9reproductive technology services shall recommend to the physician
10who will be providing ongoing care to the recipient recommended
11followup testing for HIV and HTLV according to the “Guidelines
12for Reducing the Risk of Viral Transmission During Fertility
13Treatment” published by the American Society for Reproductive
14Medicine, which shall be documented in the recipient’s medical
16(vi) If the recipient becomes HIV or HTLV positive, the
17physician assuming ongoing care of the recipient shall treat or
18provide information regarding referral to a physician who can
19provide ongoing treatment of the HIV or HTLV.
20(4) A recipient of sperm donated by a sexually intimate partner
21of the recipient for reproductive use may waive a second or repeat
22testing of that donor if the recipient is informed of the donor testing
23requirements of this section and signs a written waiver. For
24purposes of this paragraph, “sexually intimate partner of the
25recipient” includes a known or designated donor to whose sperm
26the recipient has previously been exposed in a nonmedical setting
27in an attempt to conceive.
28(d) Subdivision (a) shall not apply to the transplantation of tissue
29from a donor who has not been tested or, with the exception of
30HTLV, has been found reactive for the infectious diseases listed
31in subdivision (a) or for which the department has, by regulation,
32required additional screening tests, if
begin delete bothend delete of the following
33conditions are satisfied:
34(1) The physician and surgeon performing the transplantation
35has determined any one or more of the following:
36(A) Without the transplantation the intended recipient will most
37likely die during the period of time necessary to obtain other tissue
38or to conduct the required tests.
39(B) The intended recipient already is diagnosed with the
40infectious disease for which the donor has tested positive.
P6 1(C) The symptoms from the infectious disease for which the
2donor has tested positive will most likely not appear during the
3intended recipient’s likely lifespan after transplantation with the
4tissue or may be treated prophylactically if they do appear.
23 Consent for the use of the
tissue has been obtained from the
24recipient, if possible, or if not possible, from a member of the
25recipient’s family, or the recipient’s legal guardian. For purposes
26of this section, “family” shall mean spouse, adult son or daughter,
27either parent, adult brother or sister, or grandparent.
28(e) The penalties
begin delete ofend delete prescribed in Sections 1621.5 and 120290
29do not apply to a sperm donor covered under subdivision (c) or a
30tissue donor covered under subdivision (d).
31(f) Human breast milk from donors who test reactive for agents
32of viral hepatitis (HBV and HCV), HTLV, HIV, or syphilis shall
33not be used for deposit into a milk bank for human ingestion in