NY Pub Health L § 4365 (2021)
2021 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,  in  consultation  with the transplant council, shall promulgate regulations on the donation of  ova.  Such  regulations shall include, but not be limited to:  (a)  guidelines  and  procedures  for obtaining fully informed consent from potential donors, including but not limited to a full disclosure of any known or potential health risks of the ova donation process;  (b) the development and distribution,  in  printed  form  and  on  the department's website, of informational material relating to the donation of ova;  (c)  the establishment of a voluntary central tracking registry of ova donor information, as reported by banks and storage facilities  licensed pursuant  to  this article upon the affirmative consent of an ova donor. Such registry shall  provide  a  means  for  gathering  and  maintaining accurate information on the:  (i) number of ova and the number of times ova have been donated from a single donor;  (ii) health information of the donor at the time of the donation; and  (iii) other information deemed appropriate by the commissioner.   In  addition, all such regulations shall maintain the anonymity of the donor and any resulting  offspring  and  govern  access  to  information maintained  by  the  registry. Such registry shall comply with all state and federal laws and regulations related to maintaining the privacy  and confidentiality of records contained within the registry; and  (d)  the development of best practices and procedures, in consultation with the American college of obstetricians and  gynecologists,  American society  for  reproductive medicine and other medical organizations, for ova  donation,  ova  retrieval,  and  in  vitro  fertilization  for  the protection of the health and safety of the donor.   5.  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.   6. 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.   7. 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.   8. 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.   9.   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.