N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 69-11.15

Current through Register Vol. 46, No. 51, December 18, 2024

Section 69-11.15 - Ova donation registry

(a) Any assisted reproduction service provider that performs ova donor evaluation and selection shall enroll in the Department's ova donation registry, the central tracking registry of ova donors in New York State who have voluntarily agreed to participate in such registry.

(b) Upon enrollment in the ova donation registry, the assisted reproduction service provider shall be provided with a unique identifier code, which shall identify only the assisted reproduction service provider's facility identification number as issued by the Department, business name, and business address.

(c) Following retrieval of oocytes from the donor who is not also the intended parent, the assisted reproduction service provider shall ask the donor whether they would like to participate in the ova donation registry. The donor shall be provided with written informational material regarding the ova donation registry which shall indicate, at a minimum, the following:

(1) participation in the ova donation registry is voluntary and consent can be withdrawn at any time;

(2) information will be de-identified; and

(3) the assisted reproduction service provider shall adhere to all state and federal laws regarding confidentiality of private health information, and the donor may pursue remedies against the assisted reproduction service provider under such laws for any unwarranted disclosure of their confidential health information.

(d) For any donor who indicates, by signed acceptance maintained on file with the assisted reproduction service provider, that they wish to voluntarily participate in the ova donation registry, the assisted reproduction service provider shall request a unique donor identifier code from the ova donation registry. Upon being provided such donor identifier code, the assisted reproduction service provider shall:

(1) attach such code to the donor's confidential record maintained by the tissue bank, or otherwise associate such code with the donor's confidential record, for tracking purposes; and

(2) generate a separate record, identified only with the donor identifier code, indicating the number of ova and the number of times ova have been donated by this particular donor, and the medical and health history of such donor, which shall include, at a minimum, all health screening criteria required under Part 52 of this Title. Such unique record shall be known as the "ova donation registry record."

(e) The assisted reproduction service provider shall maintain the confidentiality of the ova donation registry record in accordance with all applicable state and federal laws, including Public Health Law section 4365(4)(c).

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 69-11.15

Adopted New York State Register September 8, 2021/Volume XLIII, Issue 36, eff. 9/8/2021