New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-8 - Reproductive Tissue Banks › Section 52-8.7 - Collection, storage and disposition of reproductive tissue

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Semen
					 collection containers shall be clean and nontoxic 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-depositors
					 shall be stored in a 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
					 reproducted 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
					 except at the request of an intended parent as defined in section
					 69-11.1(f)  of
					 this Title.
(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.