New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-2 - Tissue Banks And Nontransplant Anatomic Banks-licensure › Section 52-2.4 - Special criteria for tissue bank licensure

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Prior to approving an application for a
					 license to operate a tissue bank, other than a limited tissue procurement
					 service or a tissue transplantation facility, which acquires, processes, stores
					 and/or distributes tissue for transplantation, transfer, artificial
					 insemination or implantation, the department shall consider:
(1) the applicant's ability and intent to
					 arrange for the acquisition, processing, storage and/or distribution of usable
					 donated tissue within the designated geographic area of service;
(2) the applicant's ability to establish and
					 maintain effective agreements for tissue acquisition with hospitals;
(3) the applicant's ability to engage and
					 participate in systematic efforts, including professional and public education,
					 to acquire usable tissue;
(4) the
					 applicant's ability to establish and meet quality standards for the
					 acquisition, processing, storage and/or distribution of tissue;
(5) the applicant's ability to arrange for
					 the selection and testing of donors, and/or testing and processing of donated
					 tissue;
(6) the character and
					 competence of the tissue bank operator, the bank's officers, directors,
					 principal stockholders and any persons with a controlling interest, including
					 the quality of care or professional services provided by themselves or through
					 any health care entity or business operated or controlled by such persons;
					 and
(7) with respect to tissue
					 banks created after June 1, 1991, the existence and activities of other tissue
					 banks in the geographic area to be served by the applicant, and the statewide
					 need for tissue to be distributed by the applicant, as determined by a review
					 of the following factors, as applicable:
(i)
					 the current and projected population characteristics of the service area,
					 including relevant health status indicators;
(ii) normative criteria for age-specific and
					 sex-specific rates of tissue utilization;
(iii) procedures to assure that tissues are
					 distributed based on medical need and not preferentially distributed according
					 to the donor or recipient's membership in a category based on race, color,
					 creed, national origin, marital status, social organization or income, except
					 if medically indicated; and
(iv)
					 the need of the population served or to be served for the types of tissue
					 services proposed for each category of tissue, and the extent to which all
					 residents in the service area will have access to those services. The
					 population need analysis for each proposal shall include a determination of the
					 appropriate service area for distribution of tissues. After reviewing the
					 evidence, the commissioner may determine that the proposed service area is not
					 acceptable and may direct, as a condition of licensure, that additional, fewer,
					 or different areas be served.