2019 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.