New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-1 - Definitions › Section 52-1.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
For purposes of this Part, unless the context indicates
						otherwise, the following terms shall have the following meanings:
(a) Acquisition means any activity, including
					 solicitation, retrieval, and donor selection and testing, which is necessary to
					 obtain tissue for transplantation, transfer, artificial insemination or
					 implantation, or to obtain nontransplant anatomic parts for research or
					 education.
(b) Allogeneic tissue
					 collection means the retrieval of tissue from a donor for the purpose of
					 transplantation or transfer into another individual, including tissue provided
					 by a donor for transplantation, artificial insemination, implantation or
					 transfer into a designated recipient.
(c) Aseptic processing means the handling,
					 preservation and packaging of tissue not intended for viral inactivation, using
					 methods designed to prevent contamination with pathogenic organisms.
(d) Aseptic retrieval means the recovery of
					 tissue in a clean surgical field, using standard operating room
					 techniques.
(e) Autogeneic tissue
					 collection means the retrieval of tissue from a donor for subsequent
					 reimplantation into that same donor.
(f) Clinical laboratory means a laboratory
					 operating under a permit issued pursuant to article V, title 5 of the Public
					 Health Law and/or which meets the requirements of the state in which it is
					 located and of the Federal government (see clinical laboratory improvement
					 amendments of 1988), and is acceptable to the commissioner as specified
					 herein.
(g) Clinical use means the
					 use of tissue for allogeneic or autogeneic transplantation, transfer,
					 artificial insemination or implantation.
(h) Commissioner means the Commissioner of
					 the New York State Department of Health.
(i) Controlling interest means the ability to
					 direct or control the operation or management of a tissue bank, tissue
					 processing facility or tissue storage facility (herein referred to as a
					 facility), including, but not limited to, the ability or authority, expressed
					 or reserved, to:
(1) amend or change the
					 corporate or operating identity (e.g., joint venture agreement or
					 unincorporated business status) of the facility;
(2) approve operating and capital budgets of
					 the facility;
(3) adopt, approve or
					 direct facility fiscal operating policies and procedures;
(4) approve debt necessary to finance the
					 facility's costs of compliance with operational or plant standards required by
					 law;
(5) approve contracts for
					 management of facility services;
(6) hire or dismiss the medical director or
					 tissue bank director and nontechnical personnel;
(7) maintain and control the books and
					 financial records of the facility;
(8) control any of the assets of the
					 facility;
(9) encumber the assets
					 of the facility by way of mortgage or other indebtedness; and
(10) dissolve the facility or arrange for the
					 sale or transfer of the facility to new ownership or control.