Chapter 4.2Donations of Organs, Tissues,or Body Fluids

Section § 1644

Explanation

This section defines key terms related to tissue donation, specifically for this chapter. It refers to existing definitions in another section for words like 'donor' and 'transplantation.' It clarifies that 'HIV' stands for human immunodeficiency virus. The section also defines 'identifying information' for donors, which includes their name, date of birth, and address, as well as 'medical information' that encompasses health history, including genetic and family history.

(a)CA Health and Safety Code § 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)CA Health and Safety Code § 1644(b) For purposes of this chapter, “HIV” shall mean human immunodeficiency virus.
(c)CA Health and Safety Code § 1644(c) “Identifying information” means the full name of the donor, the donor’s date of birth, and the permanent address or other contact information, or both, given at the time of donation, or, if different, the current address or other contact information, or both, of the donor retained by the gamete bank.
(d)CA Health and Safety Code § 1644(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.
donor identification HIV definition medical information tissue donation identifying information donor's address genetic history family history social history
(Amended by Stats. 2019, Ch. 539, Sec. 2. (AB 785) Effective January 1, 2020.)

Section § 1644.1

Explanation

In California, gamete banks must collect and keep personal and medical details from donors at the time of donation. If gametes are received from another bank, the receiving bank must also record the providing bank's contact information.

This requirement for collecting donor information doesn't apply if the gamete recipient already knows the donor's identity. Additionally, these rules only affect donations made on or after January 1, 2020.

(a)CA Health and Safety Code § 1644.1(a) 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. A gamete bank licensed in this state that receives gametes from a donor collected by another gamete bank shall collect and retain the name, address, telephone number, and email address of the gamete bank from which the gametes were received.
(b)CA Health and Safety Code § 1644.1(b) A gamete bank licensed in this state shall disclose the information collected under subdivision (a) as provided in Section 1644.3.
(c)CA Health and Safety Code § 1644.1(c) This section does not apply to gametes collected from a donor whose identity is known to the recipient of the gametes at the time of the donation.
(d)CA Health and Safety Code § 1644.1(d) This section shall apply only to gametes collected on or after January 1, 2020.
gamete bank donor identifying information medical information collection donor anonymity recipient-known donor third-party gamete transfer donation records post-2020 donations California reproductive law information retention requirements cross-bank donations
(Amended by Stats. 2019, Ch. 539, Sec. 3. (AB 785) Effective January 1, 2020.)

Section § 1644.2

Explanation

This law requires gamete banks in California to inform donors about their choices regarding whether to disclose their identity to children conceived with their gametes. Donors must declare their choice about identity disclosure, and the gamete bank must keep records of donor identity and medical information. Donors can choose to share their identity once the child turns 18 or decide not to disclose at all. If a donor initially chooses not to disclose but later changes their mind, they can update their declaration. Gamete banks aren't obligated to accept donations from donors who refuse future identity disclosure. The law doesn't apply when the recipient already knows the donor's identity before the donation. This applies to gametes collected starting January 1, 2020.

(a)CA Health and Safety Code § 1644.2(a) A gamete bank licensed in this state that collects gametes from a donor shall do all of the following:
(1)CA Health and Safety Code § 1644.2(a)(1) Provide the donor with information in a record about the donor’s choice regarding identity disclosure.
(2)CA Health and Safety Code § 1644.2(a)(2) Obtain a declaration from the donor regarding identity disclosure.
(3)CA Health and Safety Code § 1644.2(a)(3) Maintain identifying information and medical information about each gamete donor. The gamete bank shall maintain records of gamete screening and testing and comply with reporting requirements, in accordance with federal law and applicable law of this state other than this chapter.
(b)CA Health and Safety Code § 1644.2(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)CA Health and Safety Code § 1644.2(b)(1) States that the donor agrees to disclose the donor’s identity to a child conceived by assisted reproduction with the donor’s gametes, on request, once the child attains 18 years of age.
(2)CA Health and Safety Code § 1644.2(b)(2) States that the donor does not agree presently to disclose the donor’s identity to the child.
(c)CA Health and Safety Code § 1644.2(c) A gamete bank licensed in this state shall permit a donor who has signed a declaration that the donor does not agree to disclose the donor’s identity under paragraph (2) of subdivision (b) to withdraw the declaration at any time by signing a declaration that the donor agrees to disclose the donor’s identity under paragraph (1) of subdivision (b).
(d)CA Health and Safety Code § 1644.2(d) A gamete bank licensed in this state is not required to collect gametes from a donor who does not agree to disclose the donor’s identity under paragraph (2) of subdivision (b).
(e)CA Health and Safety Code § 1644.2(e) This section does not apply to gametes collected from a donor whose identity is known to the recipient of the gametes at the time of the donation.
(f)CA Health and Safety Code § 1644.2(f) This section shall apply only to gametes collected on or after January 1, 2020.
gamete banks donor identity disclosure assisted reproduction child conceived donor declaration medical information identity disclosure choice record maintenance notarized declaration witnessed declaration donor's identity withdraw declaration donor's agreement know donor identity January 1 2020
(Amended by Stats. 2019, Ch. 539, Sec. 4. (AB 785) Effective January 1, 2020.)

Section § 1644.3

Explanation

This section of California law deals with the rights of children conceived through assisted reproduction using donor gametes. Once these children turn 18, they can request identifying information about their donor if the donor hasn't opted out via a specific declaration. If the gametes were acquired from another bank, the child can obtain the contact details of that original bank. Regardless of a donor's declaration, the child or their parent can access non-identifying medical information about the donor. This only applies to donations made on or after January 1, 2020, and does not cover cases where the donor's identity is already known to the recipient.

(a)CA Health and Safety Code § 1644.3(a) On request of a child conceived by assisted reproduction using donor gametes who attains 18 years of age, a gamete bank licensed in this state that collected 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 and agree to release the donor’s information.
(b)CA Health and Safety Code § 1644.3(b) On request of a child conceived by assisted reproduction using donor gametes who attains 18 years of age, a gamete bank licensed in this state that received the gametes used in the assisted reproduction from another gamete bank shall disclose the name, address, telephone number, and email address of the gamete bank from which the gametes were received.
(c)CA Health and Safety Code § 1644.3(c) 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 using donor gametes 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 that collected the gametes used in the assisted reproduction 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.
(d)CA Health and Safety Code § 1644.3(d) This section does not apply to gametes collected from a donor whose identity is known to the recipient of the gametes at the time of the donation.
(e)CA Health and Safety Code § 1644.3(e) This section shall apply only to gametes collected on or after January 1, 2020.
assisted reproduction donor gametes gamete bank donor information declaration withdrawal identifying donor non-identifying medical information donor identity gamete donation reproductive rights child rights donor anonymity parental access original gamete bank January 1 2020
(Amended by Stats. 2019, Ch. 539, Sec. 5. (AB 785) Effective January 1, 2020.)

Section § 1644.5

Explanation

This law sets the rules for transplanting tissues, sperm, and breast milk in California. Generally, tissues can't be used for transplants unless the donor is tested and shows no signs of infections like HIV, hepatitis, or syphilis. Sperm donors need similar testing, but there are exceptions: recipients can waive some tests if informed and consented, or use sperm from their partner even if there are reactive test results, provided both understand the risks. Additionally, sperm from reactive donors can be used if processed to reduce transmission risk and facilities handle it according to strict standards. For those needing urgent transplants, exceptions exist if not receiving the tissue could be life-threatening. Consent for tissue use must be obtained from the recipient or their family. Breast milk from donors with certain infections can't be used in milk banks.

(a)CA Health and Safety Code § 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)CA Health and Safety Code § 1644.5(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)CA Health and Safety Code § 1644.5(c) All donors of sperm shall be screened and found nonreactive as required under subdivision (a), except in the following instances:
(1)CA Health and Safety Code § 1644.5(c)(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)CA Health and Safety Code § 1644.5(c)(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)Copy CA Health and Safety Code § 1644.5(c)(3)
(A)Copy CA Health and Safety Code § 1644.5(c)(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)Copy CA Health and Safety Code § 1644.5(c)(3)(A)(B)
(i)Copy CA Health and Safety Code § 1644.5(c)(3)(A)(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)CA Health and Safety Code § 1644.5(c)(3)(A)(B)(i)(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)CA Health and Safety Code § 1644.5(c)(3)(A)(B)(i)(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)CA Health and Safety Code § 1644.5(c)(3)(A)(B)(i)(iii)(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)CA Health and Safety Code § 1644.5(c)(3)(A)(B)(i)(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)CA Health and Safety Code § 1644.5(c)(3)(A)(B)(i)(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)CA Health and Safety Code § 1644.5(c)(3)(A)(B)(i)(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)CA Health and Safety Code § 1644.5(c)(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)CA Health and Safety Code § 1644.5(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)CA Health and Safety Code § 1644.5(d)(1) The physician and surgeon performing the transplantation has determined any one or more of the following:
(A)CA Health and Safety Code § 1644.5(d)(1)(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)CA Health and Safety Code § 1644.5(d)(1)(B) The intended recipient already is diagnosed with the infectious disease for which the donor has tested positive.
(C)CA Health and Safety Code § 1644.5(d)(1)(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)CA Health and Safety Code § 1644.5(d)(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)CA Health and Safety Code § 1644.5(d)(2)(A) The individual has been found reactive for HIV before receiving the organ.
(B)CA Health and Safety Code § 1644.5(d)(2)(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)CA Health and Safety Code § 1644.5(d)(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)CA Health and Safety Code § 1644.5(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)CA Health and Safety Code § 1644.5(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.
tissue transplantation donor screening HIV testing hepatitis testing syphilis testing sperm donation informed consent assisted reproductive technology sperm processing standards HIV risk HTLV testing organ transplants urgent transplants reactive donors breast milk bank restrictions
(Amended by Stats. 2017, Ch. 537, Sec. 3. (SB 239) Effective January 1, 2018.)

Section § 1644.6

Explanation

This law protects doctors from being sued for damages or facing disciplinary actions when using sperm donated by a recipient's sexually intimate partner for insemination or assisted reproductive technology. This protection applies if the intended parent consents, waives additional testing of the partner, and acknowledges the risks. The doctor must also meet specific requirements outlined in another section of the law. Additionally, a doctor's tissue bank won't face action against its license if the same conditions are met. Despite these protections, doctors aren't obligated to use such sperm if it's not advisable under certain medical guidelines.

Lastly, a "sexually intimate partner" includes known donors whose sperm the recipient has previously tried to conceive with outside a medical setting. Federal liabilities still apply, meaning doctors must consider those if relevant.

(a)CA Health and Safety Code § 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)CA Health and Safety Code § 1644.6(a)(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)CA Health and Safety Code § 1644.6(a)(2) The physician and surgeon complies with the applicable requirements specified in Section 1644.5.
(b)CA Health and Safety Code § 1644.6(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)CA Health and Safety Code § 1644.6(b)(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)CA Health and Safety Code § 1644.6(b)(2) The physician and surgeon complies with the applicable requirements specified in Section 1644.5.
(c)CA Health and Safety Code § 1644.6(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)CA Health and Safety Code § 1644.6(c)(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)CA Health and Safety Code § 1644.6(c)(2) The physician and surgeon complies with the applicable requirements specified in Section 1644.5.
(d)CA Health and Safety Code § 1644.6(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)CA Health and Safety Code § 1644.6(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)CA Health and Safety Code § 1644.6(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.
sperm donation sexually intimate partner insemination services assisted reproductive technology physician liability informed consent waiver of testing medical guidelines tissue bank license federal regulations partner donor reproductive services potential risks acknowledgment ASRM guidelines nonmedical donor usage
(Added by Stats. 2012, Ch. 699, Sec. 3. (AB 2356) Effective January 1, 2013.)