2006 New York Code - 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.

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