NY Pub Health L § 4364 (2021)
2021 New York Laws PBH - Public Health Article 43-B - Organ, Tissue and Body Parts Procurement and Storage 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 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.