§ 4365 — Powers and duties of the commissioner

§ 4365. Powers and duties of the commissioner. 1. The commissioner, in\nconsultation with the transplant council, may promulgate regulations to\nestablish standards for banks and storage facilities other than those\nowned or operated by the office of mental health. Such standards may\nprovide for the following: the organizational structure of banks and\nstorage facilities; the geographic scope of licensed banks and storage\nfacilities; donor selection and solicitation practices; tissue and\nnon-transplant organ retrieval practices; transportation practices;\nrequired clinical laboratory tests for suitable donors, recipients and\ntissue; histocompatibility standards; allocation criteria; reporting\nrequirements; record keeping requirements; accounting procedures; staff\nrequirements; the content of agreements with hospitals from which\ntissues and non-transplant organs will be procured; and the content of\nagreements with organ procurement organizations, educational\ninstitutions, other banks and storage facilities, and other entities\nproviding services to banks or storage facilities in connection with the\nprocurement, storage, and distribution of tissue and non-transplant\norgans. The commissioner and the commissioner of mental health shall\nenter into a cooperative agreement to establish standards for banks and\nstorage facilities owned or operated by the office of mental health\nwhich may include standards for donor selection and solicitation\npractices; tissue and non-transplant organ retrieval practices;\ntransportation practices; reporting requirements; record keeping\nrequirements; the content of agreements with hospitals from which\ntissues and non-transplant organs will be procured, and the content of\nagreements with other banks and storage facilities.\n 2. Notwithstanding any inconsistent provision of article five of this\nchapter, the commissioner, in consultation with the transplant council,\nmay promulgate regulations to establish quality control standards\ngoverning tissue typing conducted by or at the request of organ\nprocurement organizations and facilities performing transplant services.\nSuch regulations may eliminate duplicative testing by laboratories by\nlimiting within a service area the performance of histocompatibility\nmatching and tissue typing services for cadaveric organ donations for\ntransplantation in New York state.\n 3. At least sixty days prior to the commissioner's final approval of\nrules and regulations proposed pursuant to this article, other than\nemergency rules and regulations, the commissioner shall submit such\nproposed rules and regulations to the council for its review. The\ncouncil shall review such rules and regulations and submit its\nrecommendations to the commissioner within sixty days. The commissioner\nshall not act in a manner inconsistent with the recommendations of the\ncouncil without first providing to the council a written explanation of\nthe reasons therefor.\n 4. The commissioner, in consultation with the transplant council,\nshall promulgate regulations on the donation of ova. Such regulations\nshall include, but not be limited to:\n (a) guidelines and procedures for obtaining fully informed consent\nfrom potential donors, including but not limited to a full disclosure of\nany known or potential health risks of the ova donation process;\n (b) the development and distribution, in printed form and on the\ndepartment's website, of informational material relating to the donation\nof ova;\n (c) the establishment of a voluntary central tracking registry of ova\ndonor information, as reported by banks and storage facilities licensed\npursuant to this article upon the affirmative consent of an ova donor.\nSuch registry shall provide a means for gathering and maintaining\naccurate information on the:\n (i) number of ova and the number of times ova have been donated from a\nsingle donor;\n (ii) health information of the donor at the time of the donation; and\n (iii) other information deemed appropriate by the commissioner.\n In addition, all such regulations shall maintain the anonymity of the\ndonor and any resulting offspring and govern access to information\nmaintained by the registry. Such registry shall comply with all state\nand federal laws and regulations related to maintaining the privacy and\nconfidentiality of records contained within the registry; and\n (d) the development of best practices and procedures, in consultation\nwith the American college of obstetricians and gynecologists, American\nsociety for reproductive medicine and other medical organizations, for\nova donation, ova retrieval, and in vitro fertilization for the\nprotection of the health and safety of the donor.\n 5. The commissioner may inquire into the operation of banks and\nstorage facilities and may conduct periodic inspections of banks and\nstorage facilities including methods, procedures, materials, staff and\nequipment.\n 6. Organ procurement organizations, banks, storage facilities, and\nother persons engaged in procurement activities shall submit, in a form\nprescribed by the department, periodic reports of procurement, storage\nand distribution activities and such other information as the\ncommissioner may require to carry out the provisions of this article.\nWhere available, the commissioner shall utilize information reported by\norgan procurement organizations to the organ procurement and\ntransplantation network established pursuant to section three hundred\nseventy-two of the federal public health services act.\n 7. In consultation with the transplant council, the commissioner is\nauthorized to establish subcategories of licenses based upon the tissue\nand non-transplant organs to be procured or stored by banks and storage\nfacilities and the activities to be conducted and may include different\nstandards for each subcategory of license.\n 8. Nothing contained within this article shall limit the authority of\nthe council on human blood and transfusion services to adopt rules and\nregulations concerning blood and bone marrow in accordance with article\nthirty-one of this chapter.\n 9. The commissioner, in cooperation and consultation with the\ntransplant council and other interested parties, shall develop and\ndistribute, in printed form and on the department's internet website,\ninformational materials relating to the live donation of organs and\ntissue, including, but not limited to:\n (a) the benefits of live organ and tissue donation;\n (b) the impact of the donation of organs or tissue on the donors'\naccess to insurance and assistance;\n (c) the reduction in federal adjusted gross income, for state personal\nincome tax purposes, granted to living organ and tissue donors; and\n (d) the protections and benefits granted pursuant to the living donor\nprotection act of two thousand eighteen.\n