§ 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
‹ Prev All New York sections Next ›
Lexace provides legal information, not legal advice, and no attorney–client relationship is created. Statute text is provided for general information and may not reflect the most recent amendments; verify against the official state code.