Cal. Code Regs. Tit. 17, § 1237 - Responsibility for Compliance

(a) A licensed tissue bank that provides insemination or ART services, along with the owner(s) and director of the tissue bank, shall be responsible for the following when using sperm from a donor who has tested reactive for HIV or HTLV:

(1) Ensuring that the donor and recipient have each established an ongoing relationship with a qualified physician to provide for their medical care during and after completion of fertility services.

(2) Developing and implementing procedures for minimizing the infectiousness of sperm from donors who have tested reactive for HIV or HTLV, pursuant to the standards set forth in "Recommendations for Reducing the Risk of Viral Transmission During Fertility Treatment with the Use of Autologous Gametes: A Committee Opinion," published by the American Society for Reproductive Medicine (ASRM) in 2013, and any amendments thereto or later-published editions or amendments thereto that become effective. The "Recommendations for Reducing the Risk of Viral Transmission During Fertility Treatment with the Use of Autologous Gametes: A Committee Opinion," is available at http://www.asrm.org/globalassets/asrm/asrm-content/news-and-publications/practice-guidelines/for-non-members/recs_for_reducing-risk-of-viral-transmission-noprint.pdf.

(3) Obtaining and documenting informed consent from the donor and recipient regarding the potential medical risks of using sperm from a reactive donor for the proposed procedure, prior to initiation of the procedure. Documentation of informed consent shall be maintained on file in the tissue bank for at least five (5) years.

(b) If a licensed tissue bank fails to comply with the requirements of this section, the department may initiate an action to suspend or revoke its license pursuant to section 1643.1 of the Health and Safety Code.

Notes

Cal. Code Regs. Tit. 17, § 1237

1. New section filed 10-19-2017; operative 9-6-2017 pursuant to Health and Safety Code section 1644.5(c)(3)(B)(ii). Submitted to OAL for as a file and print only pursuant to pursuant to Health and Safety Code section 1644.5(c)(3)(B)(ii) (Register 2017, No. 42).

Note: Authority cited: Sections 1639, 1644.5 and 131200, Health and Safety Code. Reference: Sections 1639.3, 1643, 1643.1, 1644.5, 1644.6, 131050 and 131051, Health and Safety Code.

1. New section filed 10-19-2017; operative 9/6/2017 pursuant to Health and Safety Code section 1644.5(c)(3)(B)(ii). Submitted to OAL for as a file and print only pursuant to pursuant to Health and Safety Code section 1644.5(c)(3)(B)(ii) (Register 2017, No. 42).