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§ 1236. Standards for Handling and Storage of Sperm from Donors Reactive for HIV or HTLV.

17 CA ADC § 1236Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 17. Public Health
Division 1. State Department of Health Services (Refs & Annos)
Chapter 2. Laboratories (Refs & Annos)
Subchapter 1. Service Laboratories
Group 10. Facilities Processing Sperm from Donors with Sexually Transmitted Infections
17 CCR § 1236
§ 1236. Standards for Handling and Storage of Sperm from Donors Reactive for HIV or HTLV.
(a) All donors of sperm shall be screened and found nonreactive by laboratory tests for evidence of infection pursuant to section 1644.5(a) of the Health and Safety Code, prior to initiation of insemination or ART services.
(b) For a serodiscordant donor and recipient in which the recipient tests nonreactive and the donor tests reactive for HIV or HTLV, the facility providing insemination or ART services shall be responsible for the following:
(1) Maintaining a current and valid tissue bank license issued under chapter 4.1 of division 2 of the Health and Safety Code.
(2) Processing, transferring, and storing sperm, ova, and zygotes used for insemination or ART where either the donor or recipient has tested reactive for HIV or HTLV in an area of the facility separate from specimens not infected.
(3) Processing sperm from a donor who has tested reactive for HIV or HTLV using protocols to minimize the infectiousness of the sperm as specified in subdivision (c) of this section.
(c) A facility providing insemination or ART services shall only use sperm from a donor who has tested reactive for HIV or HTLV when the sperm is processed according 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, incorporated by reference herein. 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/asrmcontent/news-and-publications/practice-guidelines/for-non-members/recs_for_reducingrisk-of-viral-transmission-noprint.pdf.
(d) Any amendments to the 2013 publication of “Recommendations for Reducing the Risk of Viral Transmission During Fertility Treatment with the Use of Autologous Gametes: A Committee Opinion,” any later editions, or any amendments thereto, published by ASRM shall become effective for all department-licensed facilities providing insemination or ART services 90 days after publication by ASRM, unless the department provides written notice to the contrary to all such facilities. 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/practiceguidelines/for-non-members/recs_for_reducing-risk-of-viral-transmission-noprint.pdf.

Credits

Note: Authority cited: Sections 1639, 1644.5 and 131200, Health and Safety Code. Reference: Sections 1644.5, 1644.6, 131050 and 131051, Health and Safety Code.
History
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).
This database is current through 5/10/24 Register 2024, No. 19.
Cal. Admin. Code tit. 17, § 1236, 17 CA ADC § 1236
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