Section 4365. Powers and duties of the commissioner

1. The commissioner, in
  consultation  with the transplant council, may promulgate regulations to
  establish standards for banks and storage facilities  other  than  those
  owned  or  operated  by  the office of mental health. Such standards may
  provide for the following: the organizational  structure  of  banks  and
  storage  facilities;  the geographic scope of licensed banks and storage
  facilities; donor  selection  and  solicitation  practices;  tissue  and
  non-transplant  organ  retrieval  practices;  transportation  practices;
  required clinical laboratory tests for suitable donors,  recipients  and
  tissue;  histocompatibility  standards;  allocation  criteria; reporting
  requirements; record keeping requirements; accounting procedures;  staff
  requirements;  the  content  of  agreements  with  hospitals  from which
  tissues and non-transplant organs will be procured; and the  content  of
  agreements    with    organ   procurement   organizations,   educational
  institutions, other banks and storage  facilities,  and  other  entities
  providing services to banks or storage facilities in connection with the
  procurement,  storage,  and  distribution  of  tissue and non-transplant
  organs. The commissioner and the commissioner  of  mental  health  shall
  enter  into a cooperative agreement to establish standards for banks and
  storage facilities owned or operated by  the  office  of  mental  health
  which  may  include  standards  for  donor  selection  and  solicitation
  practices;  tissue  and  non-transplant   organ   retrieval   practices;
  transportation   practices;   reporting   requirements;  record  keeping
  requirements; the  content  of  agreements  with  hospitals  from  which
  tissues  and  non-transplant organs will be procured, and the content of
  agreements with other banks and storage facilities.
    2. Notwithstanding any inconsistent provision of article five of  this
  chapter,  the commissioner, in consultation with the transplant council,
  may  promulgate  regulations  to  establish  quality  control  standards
  governing  tissue  typing  conducted  by  or  at  the  request  of organ
  procurement organizations and facilities performing transplant services.
  Such regulations may eliminate duplicative testing  by  laboratories  by
  limiting  within  a  service  area the performance of histocompatibility
  matching and tissue typing services for cadaveric  organ  donations  for
  transplantation in New York state.
    3.  At  least sixty days prior to the commissioner's final approval of
  rules and regulations proposed pursuant  to  this  article,  other  than
  emergency  rules  and  regulations,  the  commissioner shall submit such
  proposed rules and regulations  to  the  council  for  its  review.  The
  council   shall  review  such  rules  and  regulations  and  submit  its
  recommendations to the commissioner within sixty days. The  commissioner
  shall  not  act in a manner inconsistent with the recommendations of the
  council without first providing to the council a written explanation  of
  the reasons therefor.
    4.  The  commissioner  may  inquire  into  the  operation of banks and
  storage facilities and may conduct periodic  inspections  of  banks  and
  storage  facilities  including methods, procedures, materials, staff and
  equipment.
    5. Organ procurement organizations,  banks,  storage  facilities,  and
  other  persons engaged in procurement activities shall submit, in a form
  prescribed by the department, periodic reports of  procurement,  storage
  and   distribution   activities   and  such  other  information  as  the
  commissioner may require to carry out the provisions  of  this  article.
  Where  available, the commissioner shall utilize information reported by
  organ  procurement  organizations   to   the   organ   procurement   and
  transplantation  network  established  pursuant to section three hundred
  seventy-two of the federal public health services act.

    6. In consultation with the transplant council,  the  commissioner  is
  authorized  to establish subcategories of licenses based upon the tissue
  and non-transplant organs to be procured or stored by banks and  storage
  facilities  and the activities to be conducted and may include different
  standards for each subcategory of license.
    7.  Nothing contained within this article shall limit the authority of
  the council on human blood and transfusion services to adopt  rules  and
  regulations  concerning blood and bone marrow in accordance with article
  thirty-one of this chapter.