§ 4364. Licensure of banks and storage facilities. 1. No person shall
own or operate a bank or storage facility that conducts procurement
activity in New York state unless a license has been issued pursuant to
this article.

2. An application for a license for a bank or storage facility shall
contain the name of the operator, its officers, directors, principal
stockholders, and controlling persons, a description of its
organizational structure, the kind or kinds of procurement or storage
services to be provided, the location and physical description of the
bank or storage facility, and such other information as the department
may require.

3. A license shall not be issued unless the department finds that the
premises, equipment, personnel, rules and by-laws, and standards of
service are fit and adequate and that the bank or storage facility will
be operated in the manner required by this article.

4. Prior to approving an application for a license to operate a bank
or storage facility which procures or stores tissue for transplantation
or therapy purposes, the department shall consider:

(a) the applicant's ability to arrange for the acquisition and
preservation of usable donated tissue within a designated geographic
area of service and to arrange for the transportation of such tissue
when necessary;

(b) the applicant's ability to obtain effective agreements for tissue
procurement with hospitals;

(c) the applicant's ability to conduct and participate in systematic
efforts, including professional and public education, to procure usable
tissue from potential donors;

(d) the applicant's ability to establish and meet quality standards
for the acquisition and storage of tissue;

(e) the applicant's ability to arrange for the selection and testing
of donors and donated tissue, including the performance of donor
selection and required laboratory tests including typing and processing;

(f) the character and competence of the operator, its officers,
directors, principal stockholders and controlling persons, including the
quality of care provided through any health care entities operated or
controlled by such persons; and

(g) with respect to banks and storage facilities created after the
effective date of this paragraph, the existence and activities of other
banks and storage facilities in the geographic area to be served by the
applicant.

5. No hospital or other facility and no physician shall permit any
person to procure tissue or non-transplant organs unless such person has
been licensed in accordance with this article, or has been asked by a
licensed bank or storage facility to procure a specified tissue or
non-transplant organ. No bank or storage facility shall sell or
otherwise transfer tissue for valuable consideration. Valuable
consideration shall not include reasonable costs associated with the
procurement, processing, storage and distribution of tissue. Nothing
herein shall impair the provisions of section forty-three hundred seven
of this chapter.