New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
For the purposes of this subchapter, the following definitions
				  shall apply:
"Cardiac catheterization" means the insertion of a thin, flexible
				  tube (catheter) into a vein or artery and guiding it into the heart for purposes of
				  determining cardiac anatomy and function.
"Cardiac surgery center" refers to a facility capable of providing
				  invasive diagnostic catheterization, and all invasive therapeutic cardiac services
				  including open and closed heart surgical procedures. This includes: coronary artery
				  bypass graft (CABG) surgery, PCI and complex EPS studies.
"Complex electrophysiology study" (EPS) refers to the more complex
				  variety of electrophysiology study and includes:
Procedures which intend to induce ventricular or supraventricular
				  tachycardia;
Activation sequence mapping of cardiac tachyarrhythmias;
Electrode catheter ablative procedures;
Implementation of anti-tachyarrhythmia devices and implantable
				  cardioverter defibrillators.
These complex procedures are in contrast to non-complex
				  electrophysiologic procedures, which primarily involve His-Purkinje conduction
				  evaluation without arrhythmia induction.
"Coronary artery bypass graft" surgery (CABG) means a surgical
				  procedure to treat narrowing or stenosis of the coronary arteries. The procedure is
				  performed by a cardiothoracic surgeon who creates bypasses around the obstructions
				  in the coronary arteries with arteries or veins from elsewhere in the body to
				  improve blood flow to the heart (that is, revascularization of the
				  myocardium).
"Full service adult diagnostic cardiac catheterization facility"
				  means an acute care general hospital providing invasive, cardiac diagnostic (cardiac
				  catheterization) services to adult patients without surgery cardiac backup. These
				  facilities have laboratories which must meet the higher requirement of procedures
				  performed on at least 400 patients annually.
"Hospital-based" means the provision of a health care service that
				  is physically located on the campus of, and is a permanent structure within, a
				  licensed acute care hospital offering inpatient support services.
"Hospital system" means a group of licensed acute care hospital
				  facilities owned or controlled by the same legal entity.
"Inner city cardiac satellite demonstration project" means a
				  cooperative expansion of invasive therapeutic cardiac services within a hospital
				  system, whereby a satellite hospital within the system is permitted to provide
				  invasive therapeutic cardiac services already provided by an inner city hospital
				  within the same hospital system and which meets all of the criteria set forth in
				  this chapter and N.J.A.C. 8:33.
"Inner city hospital" means an acute care hospital which is
				  located in a city with a population greater than 50,000 (or in a city with a
				  population greater than 10,000 located in a county of population density greater
				  than 2,500 persons per square mile) and in which more than 10 percent of families in
				  the city have income levels which are below the Federal poverty line, as determined
				  in accordance with
				  42 U.S.C.
				  §
										9902(2).
"Invasive therapeutic cardiac services" means the full array of
				  therapeutic cardiac interventional procedures that includes, but is not limited to,
				  coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention
				  (PCI), and complex electrophysiology studies (EPS).
"Left-heart catheterization" refers to the measurement of left
				  heart hemodynamics and definition of left heart anatomy/function by
				  catheter-delivered radiopaque contrast media.
"Low-risk patients" shall be as defined by the November 1, 1994
				  participation guidelines of the American College of Cardiology's Database Committee,
				  and "low-risk patients" are those patients excluded from the definition of "high
				  risk" who are able to be managed by the low risk facilities for diagnostic cardiac
				  catheterization.
"Low risk cardiac catheterization facility" means an acute care
				  general hospital providing invasive cardiac diagnostic (cardiac catheterization)
				  services within its permanent structure as defined in "hospital-based" above that is
				  limited in the provision of its service to low risk adult patients. Patients with
				  the following conditions listed below are to be considered high risk and must be
				  excluded from catheterization at pilot facilities and transferred in accordance with
				  8:33E-1.8:
1. Left main coronary syndrome;
2. Unstable myocardial infarction;
3. Acute myocardial infarction within three days;
4. Unstable angina with persistent angina;
5. Congestive heart failure, defined as NYHA Class III or
				  IV;
6. Cardiogenic shock or severe hemodynamic instability;
7. Aortic stenosis, as measured by Doppler mean gradient over 40
				  mm of Hg;
8. Ejection fraction below 30 percent; or
9. Concomitant severe medical or vascular problems.
"Normal coronary study" means a clinical finding subsequent to the
				  performance of a cardiac catheterization procedure indicating less than 50 percent
				  stenosis in all of the following arteries: left main, left anterior descending
				  (LAD), right coronary artery (RCA) or circumflex (LCX). A finding of any stenosis of
				  greater than or equal to 50 percent is considered an abnormal cardiac
				  catheterization study. A finding of valvular disease is to be considered as an
				  abnormal finding in a study. A case in which there is a finding of cardiomyopathy or
				  congenital cardiac disorder shall be excluded from the normal study
				  calculation.
"Open heart surgery" refers to a therapeutic operative procedure
				  performed on the heart and/or its coronary arteries in order to correct anomalous
				  conditions (for example, coronary artery bypass surgery, heart valve replacement),
				  often using a heart-lung by-pass machine to perform the functions of circulation
				  during surgery.
"Pediatric cardiac surgery centers" are those cardiac surgery
				  centers specifically designated to provide the full range of invasive cardiac
				  diagnostic, therapeutic and surgical services to patients less than 16 years of
				  age.
"Percutaneous coronary intervention (PCI)" means the passage of a
				  balloon-tipped catheter (thin tube) to the site of narrowing in an artery and the
				  inflation of the balloon to reduce the obstruction. For purposes of these rules, PCI
				  also includes other invasive procedures to dilate coronary obstruction such as
				  atherectomy of various kinds (for example, excisional, laser) and arterial stenting
				  procedures.
"Primary angioplasty" means the mechanical reopening of an
				  occluded vessel using a balloon-tipped catheter in patients with acute myocardial
				  infarction (AMI) who have not received antecedent thrombolytic therapy.
"Satellite hospital" means a non-inner city licensed acute care
				  hospital which is a member of a hospital system containing an inner city teaching
				  hospital and which is permitted to provide invasive therapeutic cardiac services
				  through implementation of an inner city cardiac satellite demonstration project, in
				  accordance with this chapter.
"Stent procedure" means the use of a wire mesh tube (a stent) to
				  prop open an artery that has recently been cleared using coronary angioplasty. The
				  stent is collapsed to a small diameter, placed over an angioplasty balloon catheter
				  and moved into the area of the blockage. Once the balloon is inflated, the stent
				  expands, locks in place and forms a permanent scaffold to hold the artery open.
				  Stents may be used as an alternative to--or in combination with--angioplasty.