§ 4365. Powers and duties of the commissioner. 1. The commissioner, in
consultation with the transplant council, may promulgate regulations to
establish standards for banks and storage facilities other than those
owned or operated by the office of mental health. Such standards may
provide for the following: the organizational structure of banks and
storage facilities; the geographic scope of licensed banks and storage
facilities; donor selection and solicitation practices; tissue and
non-transplant organ retrieval practices; transportation practices;
required clinical laboratory tests for suitable donors, recipients and
tissue; histocompatibility standards; allocation criteria; reporting
requirements; record keeping requirements; accounting procedures; staff
requirements; the content of agreements with hospitals from which
tissues and non-transplant organs will be procured; and the content of
agreements with organ procurement organizations, educational
institutions, other banks and storage facilities, and other entities
providing services to banks or storage facilities in connection with the
procurement, storage, and distribution of tissue and non-transplant
organs. The commissioner and the commissioner of mental health shall
enter into a cooperative agreement to establish standards for banks and
storage facilities owned or operated by the office of mental health
which may include standards for donor selection and solicitation
practices; tissue and non-transplant organ retrieval practices;
transportation practices; reporting requirements; record keeping
requirements; the content of agreements with hospitals from which
tissues and non-transplant organs will be procured, and the content of
agreements with other banks and storage facilities.

2. Notwithstanding any inconsistent provision of article five of this
chapter, the commissioner, in consultation with the transplant council,
may promulgate regulations to establish quality control standards
governing tissue typing conducted by or at the request of organ
procurement organizations and facilities performing transplant services.
Such regulations may eliminate duplicative testing by laboratories by
limiting within a service area the performance of histocompatibility
matching and tissue typing services for cadaveric organ donations for
transplantation in New York state.

3. At least sixty days prior to the commissioner's final approval of
rules and regulations proposed pursuant to this article, other than
emergency rules and regulations, the commissioner shall submit such
proposed rules and regulations to the council for its review. The
council shall review such rules and regulations and submit its
recommendations to the commissioner within sixty days. The commissioner
shall not act in a manner inconsistent with the recommendations of the
council without first providing to the council a written explanation of
the reasons therefor.

4. The commissioner, in consultation with the transplant council,
shall promulgate regulations on the donation of ova. Such regulations
shall include, but not be limited to:

(a) guidelines and procedures for obtaining fully informed consent
from potential donors, including but not limited to a full disclosure of
any known or potential health risks of the ova donation process;

(b) the development and distribution, in printed form and on the
department's website, of informational material relating to the donation
of ova;

(c) the establishment of a voluntary central tracking registry of ova
donor information, as reported by banks and storage facilities licensed
pursuant to this article upon the affirmative consent of an ova donor.
Such registry shall provide a means for gathering and maintaining
accurate information on the:

(i) number of ova and the number of times ova have been donated from a
single donor;

(ii) health information of the donor at the time of the donation; and

(iii) other information deemed appropriate by the commissioner.

In addition, all such regulations shall maintain the anonymity of the
donor and any resulting offspring and govern access to information
maintained by the registry. Such registry shall comply with all state
and federal laws and regulations related to maintaining the privacy and
confidentiality of records contained within the registry; and

(d) the development of best practices and procedures, in consultation
with the American college of obstetricians and gynecologists, American
society for reproductive medicine and other medical organizations, for
ova donation, ova retrieval, and in vitro fertilization for the
protection of the health and safety of the donor.

5. The commissioner may inquire into the operation of banks and
storage facilities and may conduct periodic inspections of banks and
storage facilities including methods, procedures, materials, staff and
equipment.

6. Organ procurement organizations, banks, storage facilities, and
other persons engaged in procurement activities shall submit, in a form
prescribed by the department, periodic reports of procurement, storage
and distribution activities and such other information as the
commissioner may require to carry out the provisions of this article.
Where available, the commissioner shall utilize information reported by
organ procurement organizations to the organ procurement and
transplantation network established pursuant to section three hundred
seventy-two of the federal public health services act.

7. In consultation with the transplant council, the commissioner is
authorized to establish subcategories of licenses based upon the tissue
and non-transplant organs to be procured or stored by banks and storage
facilities and the activities to be conducted and may include different
standards for each subcategory of license.

8. Nothing contained within this article shall limit the authority of
the council on human blood and transfusion services to adopt rules and
regulations concerning blood and bone marrow in accordance with article
thirty-one of this chapter.

9. The commissioner, in cooperation and consultation with the
transplant council and other interested parties, shall develop and
distribute, in printed form and on the department's internet website,
informational materials relating to the live donation of organs and
tissue, including, but not limited to:

(a) the benefits of live organ and tissue donation;

(b) the impact of the donation of organs or tissue on the donors'
access to insurance and assistance;

(c) the reduction in federal adjusted gross income, for state personal
income tax purposes, granted to living organ and tissue donors; and

(d) the protections and benefits granted pursuant to the living donor
protection act of two thousand eighteen.