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-.22 - Specific Review Considerations for Adult Open Heart Surgery Services

Current through Rules and Regulations filed through June 27, 2024
(1)
Applicability.
A Certificate of Need will be required prior to the
				establishment of a new or, subject to certain stipulations, expanded adult open
				heart surgical service.
(2)
Definitions.
(a) "Adult" means
				persons 15 years of age and over.
(b) "Authorized service" means an adult open
				heart 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.
(c) "Coronary Angioplasty" means a cardiac
				catheterization procedure to treat coronary heart disease by utilizing a
				catheter with a balloon, laser, laser-assisted device, rotational device, stent
				placement or other mechanical means to unblock an occluded coronary
				artery.
(d) "Expanded Service" or
				"Expansion" means an adult open heart surgery service that undertakes any
				capital renovation or construction project in and to the physical space within
				the hospital where the adult open heart surgery service is or will be offered,
				the costs of which exceed the capital expenditure threshold at that time; or
				that acquires a piece of diagnostic or therapeutic equipment with a value above
				the equipment threshold at that time which is to be utilized in the provision
				of open heart surgery services; or, for any service a full four (4) years or
				more following implementation of an approved Certificate of Need, that
				increases adult open heart surgery volume to a level resulting in a twenty-five
				percent (25%) or more increase in procedures being performed by the service
				over the higher annual number of procedures having been performed during the
				most recent prior two calendar years. Replacement or repair of existing
				diagnostic or therapeutic equipment utilized in the provision of such service
				is not an expansion for purposes of these Rules.
(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 by-pass machine
				(extracorporeal pump) may be used to perform the work of the heart and
				lungs.
(g) "Open heart surgery
				service" means an organized surgical program that serves inpatients of a
				hospital that has a suitable operating room or suite of operating rooms,
				equipment, staff, intensive care unit, and all support services required to
				perform adult open-heart surgery. The adult open heart surgery service shall be
				located in an acute care hospital that has an authorized adult cardiac
				catheterization service.
(h)
				"Procedure" means an adult open heart surgery operation or combination of
				operations performed in a single session on a single patient who appears for
				open heart.