N.Y. Public Health Law § 4365: Powers and duties of the commissioner

§ 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.