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Title: Section 52-8.7 - Collection, storage and disposition of reproductive tissue

Effective Date

11/01/2000

52-8.7 Collection, storage and disposition of reproductive tissue.

(a) Semen collection containers shall be clean and non-toxic to sperm.

(b) Each semen collection container shall be labeled legibly prior to collection with the donor's or client-depositor's name or identification code, unless another system is used to ensure absolute identification, and shall also be labeled at the time of collection with the date and time of collection.

(c) Semen storage containers and support vehicles shall be labeled so as to maintain identification throughout all phases of processing, storage and distribution, in a manner not subject to deterioration at low temperatures. Such containers and/or vehicles shall be labeled with the reproductive tissue bank identification and semen specimen collection date, donor's identification code or, in the case of a client-depositor, his name and semen specimen collection date. Semen shall be frozen with a suitable cryopreservative and stored continuously until placed in either a freezer section reserved for semen, equipped with a thermometer, or a liquid nitrogen storage tank. The thermometer shall be calibrated at least annually against a National Institute of Standards and Technology (NIST)-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer. Thermometers shall be either visually monitored daily or continuously monitored mechanically, and, if applicable, liquid nitrogen levels shall be checked at least twice a week for fluctuations in temperature potentially affecting the quality of the semen. Storage shall be at a temperature of minus 130 degrees Celsius or lower. Semen from client-depositor shall be stored in freezer section or tank separate from that for donor semen, and shall not be exposed to ambient air unless absolutely necessary. Temperature records or liquid nitrogen level records shall be available for inspection by the department for the entire period of storage and for one year afterward.

(d) Frozen semen in transit from a reproductive tissue bank to an insemination/implantation site shall be maintained in liquid nitrogen or vapor until immediately prior to the artificial insemination or assisted reproductive procedure. Frozen semen shall be transported by the bank or its agents, the staff of the insemination/implantation site, or the recipient with the written authorization of her physician.
(e) The insemination/implantation site shall inspect semen samples for proper labeling and appearance immediately after thawing. If the physical appearance is abnormal or there is indication or suspicion of overt microbial contamination, the semen shall not be utilized for artificial insemination or other assisted reproductive procedures.

(f) Reproductive tissue stored for a client-depositor shall not be destroyed or released for other purposes as a result of nonpayment of storage fees or for any other reasons, without documentation that the client-depositor was given at least 30 days' written notice by certified mail, return receipt requested.

(g) Oocytes shall be collected, processed and stored as oocytes or embryos according to written procedures approved by the reproductive tissue bank director in consultation with the medical director and the medical advisory committee. Storage containers and support vehicles shall be labeled or segregated so as to maintain tissue identification throughout all phases of processing, storage and distribution, in a manner not subject to deterioration at low temperatures. Final embryo containers shall be labeled with the identification code or name of the source of both the component oocyte and spermatozoan. (h) Embryos shall not be created for donation by fertilizing donor oocytes with donor semen, except at the request of a specific patient who intends to use such embryos for her own treatment. (i) Embryos shall not be created using semen or oocytes of client-depositors or directed donors who are blood relatives of the other gamete provider to a degree that their sexual contact would constitute incest under New York State law.

Volume

VOLUME A-1 (Title 10)

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