§ 4364 — Licensure of banks and storage facilities

§ 4364. Licensure of banks and storage facilities. 1. No person shall\nown or operate a bank or storage facility that conducts procurement\nactivity in New York state unless a license has been issued pursuant to\nthis article.\n 2. An application for a license for a bank or storage facility shall\ncontain the name of the operator, its officers, directors, principal\nstockholders, and controlling persons, a description of its\norganizational structure, the kind or kinds of procurement or storage\nservices to be provided, the location and physical description of the\nbank or storage facility, and such other information as the department\nmay require.\n 3. A license shall not be issued unless the department finds that the\npremises, equipment, personnel, rules and by-laws, and standards of\nservice are fit and adequate and that the bank or storage facility will\nbe operated in the manner required by this article.\n 4. Prior to approving an application for a license to operate a bank\nor storage facility which procures or stores tissue for transplantation\nor therapy purposes, the department shall consider:\n (a) the applicant's ability to arrange for the acquisition and\npreservation of usable donated tissue within a designated geographic\narea of service and to arrange for the transportation of such tissue\nwhen necessary;\n (b) the applicant's ability to obtain effective agreements for tissue\nprocurement with hospitals;\n (c) the applicant's ability to conduct and participate in systematic\nefforts, including professional and public education, to procure usable\ntissue from potential donors;\n (d) the applicant's ability to establish and meet quality standards\nfor the acquisition and storage of tissue;\n (e) the applicant's ability to arrange for the selection and testing\nof donors and donated tissue, including the performance of donor\nselection and required laboratory tests including typing and processing;\n (f) the applicant's ability to moderate and record temperature,\nincluding an adequate alarm notification system;\n (g) the applicant's ability to establish a chain of custody for\nspecimens;\n (h) the applicant's ability to establish administrative, technical,\nand physical safeguards to protect patient records;\n (i) the character and competence of the operator, its officers,\ndirectors, principal stockholders and controlling persons, including the\nquality of care provided through any health care entities operated or\ncontrolled by such persons; and\n (j) with respect to banks and storage facilities created after the\neffective date of this paragraph, the existence and activities of other\nbanks and storage facilities in the geographic area to be served by the\napplicant.\n 5. No hospital or other facility and no physician shall permit any\nperson to procure tissue or non-transplant organs unless such person has\nbeen licensed in accordance with this article, or has been asked by a\nlicensed bank or storage facility to procure a specified tissue or\nnon-transplant organ. No bank or storage facility shall sell or\notherwise transfer tissue for valuable consideration. Valuable\nconsideration shall not include reasonable costs associated with the\nprocurement, processing, storage and distribution of tissue. Nothing\nherein shall impair the provisions of section forty-three hundred seven\nof this chapter.\n 6. The commissioner is authorized to promulgate rules and regulations\nnecessary to implement the provisions of this section.\n