2019 New York Laws
PBH - Public Health
Article 43-B - Organ, Tissue and Body Parts Procurement and Storage
4365 - Powers and Duties of the Commissioner.

§ 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.
  8.  The  commissioner,  in  cooperation  and  consultation  with   the
transplant  council  and  other  interested  parties,  shall develop and
distribute, in printed form and on the  department's  internet  website,
informational  materials  relating  to  the  live donation of organs and
tissue, including, but not limited to:
  (a) the benefits of live organ and tissue donation;
  (b) the impact of the donation of organs  or  tissue  on  the  donors'
access to insurance and assistance;
  (c) the reduction in federal adjusted gross income, for state personal
income tax purposes, granted to living organ and tissue donors; and
  (d)  the protections and benefits granted pursuant to the living donor
protection act of two thousand eighteen.