New Jersey Administrative Code › Title 8 - HEALTH › Chapter 43G - HOSPITAL LICENSING STANDARDS › Subchapter 7 - CARDIAC › Section 8:43G-7.1 - Scope and definitions

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The standards set
				forth in this subchapter shall apply only to separate, designated units or services
				for adult and/or pediatric cardiac surgery, cardiac catheterization, and
				interventional cardiac procedures. All hospitals licensed to provide any of these
				services shall also comply with all applicable staffing, staff qualification,
				volume, equipment and physical plant requirements contained in N.J.A.C.
				8:33E.
(b) The following words and
				terms, when used in this subchapter, shall have the following meanings, unless the
				context clearly indicates otherwise:
"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" means a facility capable of providing
				  invasive diagnostic catheterization, and all treatment modalities including open and
				  closed heart surgical procedures. This includes: coronary artery bypass graft (CABG)
				  surgery, PTCA and EPS studies.
"Complex electrophysiology study" (EPS) means the more complex
				  variety of electrophysiology study, in contrast to non-complex electrophysiologic
				  procedures, which primarily involve His Purkinje conduction evaluation without
				  arrhythmia induction. EPS includes:
1. Procedures which intend to induce ventricular or
				  supraventricular tachycardia;
2. Activation sequence mapping of cardiac tachyarrhythmias;
3. Electrode catheter ablative procedures; and
4. Implantation of anti-tachyarrhythmia devices and implantable
				  cardioverter defibrillators.
"Diagnostic cardiac catheterization facility" means an acute care
				  general hospital providing invasive cardiac diagnostic (cardiac catheterization)
				  services to adult patients without surgery backup. These facilities have
				  laboratories which perform procedures on at least 500 patients annually.
"Hospital-based" means the provisions of a health care service
				  that is physically located on the campus of, and is a permanent structure within, a
				  licensed care hospital offering inpatient support services.
"Left-heart catheterization" means the measurement of left heart
				  hemodynamics and definitions of left heart anatomy/function by catheter delivered
				  radiopaque contrast media.
"Low-risk patients" means those patients excluded from the
				  definition of "high risk" who are able to be managed by the pilot facilities for
				  diagnostic cardiac catheterization, as defined at
				  26:6-57 et seq.
"Open heart surgery" refers to a procedure using a heart-lung
				  by-pass machine to perform the functions of circulation during surgery.
"Pediatric cardiac surgery centers" means 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.
"Pilot catheterization program" 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 shall 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 myocardiac infarction within three days;
4. Unstable angina with persistent angina;
5. Congestive heart failure, defined as NYHA Class II 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.
"Percutaneous transluminal coronary angioplasty" (PTCA) 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, PTCA also includes other invasive procedures to dilate coronary
				  obstruction such as atherectomy of various kinds (for example, excisional, laser)
				  and arterial stenting procedures.