New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter V - Medical Facilities › Subchapter C - State Hospital Code › Article 1 - General Provisions › Part 709 - Determination Of Public Need For Medical Facility Construction › Section 709.9 - Human heart transplantation services

Current through Register Vol. 46, No. 28, July 10, 2024
(a) This methodology will be utilized to
					 evaluate certificate of need applications involving the initiation of human
					 heart transplantation services. It is the intent of the State Hospital Review
					 and Planning Council that this methodology, when used in conjunction with the
					 planning standards and criteria set forth in section
					 709.1 of this Part, become a
					 statement of planning principles and decisionmaking tools for directing the
					 distribution of human heart transplantation services. The goals and objectives
					 of the methodology expressed herein are expected to insure that an adequate
					 number of human heart transplantation services are available to provide access
					 to care and avoid the unnecessary duplication of resources.
(b) The factors and methodology for
					 determining the public need for human heart transplantation services shall
					 include, but not be limited to the following:
(1) The need for human heart transplantation
					 services will be planned initially on a statewide basis, based upon the need
					 for two human heart transplantation centers.
(2) Each applicant for a human heart
					 transplantation service must present evidence that a minimum of 14 transplants
					 per year shall be achieved within two years of initial operation.
(3) There shall be no additional human heart
					 transplantation services approved until each existing transplantation service
					 is performing at least 30 transplantations per year at which time additional
					 applications will be accepted and reviewed by the department.
(4) Priority consideration will be given to
					 applicants that propose to provide this service within the facility's current
					 capacity.
(5) Where public need is
					 established herein, priority consideration will be given to applicants that
					 agree to serve the medically indigent and patients regardless of the source of
					 payment.
(6) In addition, each
					 applicant applying to initiate a heart transplantation service must meet the
					 following standards:
(i) Each applicant must
					 demonstrate the availability of a heart transplantation surgeon with the
					 ability to perform heart transplantation as evidenced by clinical experience in
					 an existing heart transplantation program.
(ii) Each applicant must demonstrate the
					 availability of a heart transplantation team that includes qualified
					 specialists in cardiology, cardiovascular surgery, infectious disease,
					 pulmonary medicine, pediatrics, neurosurgery, anesthesiology, psychiatry,
					 immunologist, and pathologist.
(iii) Each applicant must demonstrate its
					 participation in a donor organ procurement system, or a donor organ harvesting
					 program, or a written affiliation agreement with an existing approved or
					 registered donor organ procurement or harvesting agency.