N.Y. Public Health Law § 4364: Licensure of banks and storage facilities

§ 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 applicant's ability to moderate and record temperature,

including an adequate alarm notification system;

(g) the applicant's ability to establish a chain of custody for

specimens;

(h) the applicant's ability to establish administrative, technical,

and physical safeguards to protect patient records;

(i) 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

(j) 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.

6. The commissioner is authorized to promulgate rules and regulations

necessary to implement the provisions of this section.