Compilation of Rules and Regulations of the State of Georgia › Department 111 - RULES OF DEPARTMENT OF COMMUNITY HEALTH › Chapter 111-2 - HEALTH PLANNING › Subject 111-2-2 - CERTIFICATE OF NEED › Rule 111-2-2-.23 - Specific Review Considerations for Pediatric Cardiac Catheterization and Open-Heart Surgery

Current through Rules and Regulations filed through June 27, 2024
(1)
Definitions.
(a) "Authorized service" means a pediatric
				cardiac catheterization service or pediatric cardiac surgery service that is
				either existing or approved. An existing service is an authorized service that
				has become operational, and an approved service is an authorized service that
				has not become operational.
(b)
				"Capacity" means:
1. for a pediatric
				catheterization service:
(i) in considering
				applications for a new pediatric cardiac catheterization service, 750
				procedures per year per authorized service regardless of the number of rooms
				used; or
(ii) in considering
				applications for expansion of an existing service, 750 pediatric cardiac
				catheterization procedures per dedicated room per year in the existing service
				(3 per day per room, 5 days per week, 50 weeks per year) and for each
				multipurpose room in the existing service, 750 procedures (special procedures
				and pediatric cardiac catheterization procedures) per year. If adult and
				pediatric cardiac catheterization are performed in the same room in a service
				seeking to expand, the capacity of the room shall be equivalent to 750
				pediatric procedures with adult procedures performed in the room weighted in
				proportion to pediatric procedures as being 0.50 for each adult cardiac
				catheterization or special procedure, except for each adult coronary
				angioplasty, which shall be 0.75, in order to determine the service's use rate;
				or
2. for a pediatric
				cardiac surgery service, the number of pediatric cardiac surgery procedures
				which could be performed annually as reported by each hospital with an
				authorized service and based on survey and other reported data. In determining
				capacity, a hospital must consider factors such as available operating rooms
				which can be used for pediatric cardiac surgery, cardiac surgical intensive
				care beds and other pediatric intensive care beds available for pediatric
				patients, general bed capacity, and any other factors which impact the
				determination.
(c)
				"Cardiac catheterization" means a medical diagnostic or therapeutic procedure
				during which a catheter is inserted into a vein or artery in the patient;
				subsequently, the free end of the catheter is manipulated by the physician to
				travel along the course of the blood vessel into the chambers or vessels of the
				heart. X-rays and an electronic image intensifier are used as aids in placing
				the catheter tip in the desired position. When the catheter is in place, the
				physician is able to perform various diagnostic studies and/or therapeutic
				procedures on the heart or its vessels.
(d) "Closed heart surgery" means an operation
				performed directly on the heart or its associated veins or arteries that does
				not require use of a heart and lung bypass machine (extracorporeal pump) to
				perform the work of the heart and lungs. Such operations often require the
				bypass machine to be available on standby for use if the surgery needs to be
				changed to open heart with the machine then performing the work of the heart
				and lungs.
(e) "Official State
				Component Plan" means the document related to specialized cardiovascular
				services developed by the Department, established by the Health Strategies
				Council, and adopted by the Board of Community Health.
(f) "Open heart surgery" means surgery
				performed directly on the heart or its associated veins or arteries during
				which a heart and lung bypass machine (extracorporeal pump) is used to perform
				the work of the heart and lungs.
(g) "Pediatric" refers to children 14 years
				of age and under.
(h) "Pediatric
				cardiac catheterization service" means an organized program which serves
				pediatric patients of a hospital which has a room or suite of rooms with the
				equipment, staff, and all support services required to perform angiographic,
				physiologic, and, as appropriate, therapeutic cardiac catheterization
				procedures. The pediatric cardiac catheterization service shall be located in a
				pediatric tertiary hospital. Procedures may be performed in a room dedicated to
				cardiac catheterization and/or in a special procedures or multipurpose room not
				exclusively used for cardiac catheterization.
(i) "Pediatric cardiac surgery" means an
				operation performed directly on a pediatric patient's heart or its associated
				veins or arteries, including open heart and closed heart surgery procedures but
				excluding surgical procedures for the closure of neonatal patent ductus
				arteriosus.
(j) "Pediatric cardiac
				surgery service" means an organized surgical program which serves pediatric
				inpatients of a hospital which has a suitable operating room or suite of
				operating rooms, equipment, staff, and all support services required to perform
				closed heart and open-heart operations for pediatric patients. The pediatric
				cardiac surgery service shall be located in a pediatric tertiary
				hospital.
(k) "Pediatric tertiary
				hospital" means a teaching center, specialty medical or large community
				hospital characterized by serving pediatric patients from a large region or the
				entire state with sophisticated technology and support services to provide
				highly specialized medical and surgical care for unusual and complex medical
				problems of pediatric patients.
(l)
				"Procedure" means a cardiac catheterization study or treatment or combination
				of studies and/or treatments performed in a single session on a single patient
				who appears for cardiac catheterization or a pediatric open or closed heart
				operation or combination of operations performed in a single session on a
				single patient who appears for pediatric cardiac surgery.
(m) "Service area", for pediatric cardiac
				catheterization and pediatric cardiac surgery means the State of
				Georgia.