Code Section Group

Health and Safety Code - HSC

DIVISION 2. LICENSING PROVISIONS [1200 - 1797.8]

  ( Division 2 enacted by Stats. 1939, Ch. 60. )

CHAPTER 4.2. Donations of Organs, Tissues,or Body Fluids [1644 - 1644.6]
  ( Heading of Chapter 4.2 renumbered from Chapter 4.1 by Stats. 1991, Ch. 801, Sec. 3. )

1644.
  

(a) For purposes of this chapter, “donor,” “person,” “tissue,” “transplantation,” and “department” shall have the meaning as defined for those terms in Section 1635.

(b) For purposes of this chapter, “HIV” shall mean human immunodeficiency virus.

(c) “Identifying information” means the full name of the donor, the donor’s date of birth, and the permanent and, if different, current address of the donor at the time of donation.

(d) “Medical information” means information regarding a present illness of the donor, past illness of the donor, and social, genetic, and family history of the donor.

(Amended by Stats. 2018, Ch. 876, Sec. 67. (AB 2684) Effective January 1, 2019.)

1644.1.
  

(a) (1) Except as provided in paragraph (2), a gamete bank licensed in this state shall collect and retain from a gamete donor the donor’s identifying information and medical information at the time of the donation. If the gamete bank sends the gametes of a donor to another gamete bank, the sending gamete bank shall forward any identifying information and medical information, including the donor’s signed declaration under Section 1644.2 regarding identity disclosure, to the receiving gamete bank and shall no longer be required to retain the information. A receiving gamete bank licensed in this state shall collect and retain the information about the donor and each sending gamete bank.

(2) A gamete bank obtaining gametes for the purpose of clinical utilization within one month from receipt shall not be considered a receiving gamete bank responsible for long-term retention of any identifying information or medical information other than what is typically documented in the medical record, and shall not be responsible for responding to any request under Section 1644.3 other than to identify the sending gamete bank.

(b) This section shall apply only to gametes collected on or after January 1, 2020.

(Added by Stats. 2018, Ch. 876, Sec. 68. (AB 2684) Effective January 1, 2019.)

1644.2.
  

(a) A gamete bank licensed in this state that collects gametes from a donor shall do both of the following:

(1) Provide the donor with information in a record about the donor’s choice regarding identity disclosure.

(2) Obtain a declaration from the donor regarding identity disclosure.

(b) A gamete bank licensed in this state shall give a donor the choice to sign a declaration, attested by a notary or witnessed, that does either of the following:

(1) States that the donor agrees to disclose his or her identity to a child conceived by assisted reproduction with the donor’s gametes, on request, once the child attains 18 years of age.

(2) States that the donor does not agree presently to disclose the donor’s identity to the child.

(c) A gamete bank licensed in this state shall permit a donor who has signed a declaration under paragraph (2) of subdivision (b) to withdraw the declaration at any time by signing a declaration under paragraph (1) of subdivision (b).

(d) This section shall apply only to gametes collected on or after January 1, 2020.

(Added by Stats. 2018, Ch. 876, Sec. 69. (AB 2684) Effective January 1, 2019.)

1644.3.
  

(a) On request of a child conceived by assisted reproduction who attains 18 years of age, a gamete bank licensed in this state that collected, stored, or released for use the gametes used in the assisted reproduction shall provide the child with identifying information of the donor who provided the gametes, unless the donor signed and did not withdraw a declaration under paragraph (2) of subdivision (b) of Section 1644.2. If the donor signed and did not withdraw the declaration, the gamete bank shall make a good faith effort to notify the donor, who may elect under subdivision (c) of Section 1644.2 to withdraw the declaration.

(b) Regardless whether a donor signed a declaration under paragraph (2) of subdivision (b) of Section 1644.2, on request from a child conceived by assisted reproduction who attains 18 years of age, or, if the child is a minor, by a parent or guardian of the child, a gamete bank licensed in this state shall provide the child or, if the child is a minor, the parent or guardian of the child, access to nonidentifying medical information provided by the donor.

(c) This section shall apply only to gametes collected on or after January 1, 2020.

(Added by Stats. 2018, Ch. 876, Sec. 70. (AB 2684) Effective January 1, 2019.)

1644.5.
  

(a) Except as provided in subdivision (c) or (d), tissues shall not 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 person 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 likelihood of transmission through the sperm for that specific donation and if 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 most relevant and up-to-date recommendations 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 recommendations 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 recommendations for the reduction of viral transmission developed by the American Society for Reproductive Medicine. This section does not prevent the department from monitoring and inspecting facilities that process sperm to ensure adherence to the regulations, or, until regulations are adopted, to the recommendations set forth by the American Society for Reproductive Medicine.

(iii) Before insemination or other assisted reproductive technology services are performed, 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 shall 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 most relevant and up-to-date recommendations 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 most relevant and up-to-date guidelines 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) does 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 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 an organ 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 organ.

(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.

(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” means spouse, adult son or daughter, either parent, adult brother or sister, or grandparent.

(e) The penalties prescribed in Section 120290 do not apply to a sperm donor covered under subdivision (c) or an organ or tissue donor who donates an organ or tissue for transplantation or research purposes.

(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.

(Amended by Stats. 2017, Ch. 537, Sec. 3. (SB 239) Effective January 1, 2018.)

1644.6.
  

(a) No physician and surgeon shall be subject to liability for damages for any cause of action based solely on the use of sperm donated by a sexually intimate partner of the recipient if both of the following conditions are met:

(1) The physician and surgeon provides insemination or assisted reproductive technology services and has obtained the informed consent of the recipient, who waives second or other repeat testing of the sexually intimate partner and acknowledges and accepts the risks of using sperm from a sexually intimate partner who has not undergone repeat testing, in accordance with paragraph (1) of subdivision (c) of Section 1644.5.

(2) The physician and surgeon complies with the applicable requirements specified in Section 1644.5.

(b) No physician and surgeon shall be subject to disciplinary action against his or her professional license, or subject to peer review by a professional association peer review body, as defined in clause (iii) of subparagraph (B) of paragraph (1) of subdivision (a) of Section 805 of the Business and Professions Code, because the physician and surgeon used sperm donated by a sexually intimate partner of the recipient in providing insemination or assisted reproductive technology services if both of the following conditions are met:

(1) The physician and surgeon has obtained the informed consent of the recipient who waives second or other repeat testing of the sexually intimate partner and acknowledges and accepts the risks of using sperm from a sexually intimate partner who has not undergone repeat testing, in accordance with paragraph (1) of subdivision (c) of Section 1644.5.

(2) The physician and surgeon complies with the applicable requirements specified in Section 1644.5.

(c) A tissue bank that is owned and operated by a physician and surgeon shall not be subject to disciplinary action against its license because of the use of sperm donated by a sexually intimate partner of the recipient in providing insemination or assisted reproductive technology services if both of the following conditions are met:

(1) A physician and surgeon affiliated with the tissue bank has obtained the informed consent of the recipient, who waives second or other repeat testing of the sexually intimate partner and acknowledges and accepts the risks of using sperm from a sexually intimate partner who has not undergone repeat testing, in accordance with paragraph (1) of subdivision (c) of Section 1644.5.

(2) The physician and surgeon complies with the applicable requirements specified in Section 1644.5.

(d) Nothing in this section shall create a duty for a physician and surgeon to use sperm donated by a sexually intimate partner of the recipient in providing insemination or assisted reproductive technology services if the physician and surgeon reasonably concludes that the insemination or services do not meet the 2008 American Society for Reproductive Medicine guidelines for gamete and embryo donation.

(e) Nothing in this section shall be construed to affect any liability that may be imposed pursuant to a federal rule or regulation when a physician and surgeon, or tissue bank provides insemination or assisted reproductive technology services.

(f) For purposes of this section, “sexually intimate partner” includes a known or designated donor to whose sperm the recipient has previously been exposed in a nonmedical setting in an attempt to conceive.

(Added by Stats. 2012, Ch. 699, Sec. 3. (AB 2356) Effective January 1, 2013.)

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