N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.4

Current through Register Vol. 46, No. 45, November 2, 2024

Section 52-2.4 - Special criteria for tissue bank licensure

(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.

(b) Prior to approving an application for a license to operate a tissue transplantation facility, the department shall consider the special criteria listed in subdivision (a) of this section except for paragraphs (1), (2), (3), (5) and (7).

(c) Prior to approving an application for a license to operate a limited tissue procurement service, the department shall consider the special criteria listed in subdivision (a) of this section except for paragraphs (1), (2), (5) and (7).

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.4