N.J. Admin. Code § 8:43G-7.1

Current through Register Vol. 56, No. 21, November 4, 2024
Section 8:43G-7.1 - Scope and definitions
(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.

N.J. Admin. Code § 8:43G-7.1

Amended by R.1999 d.436, effective 12/20/1999.
See: 31 New Jersey Register 367(a), 31 New Jersey Register 614(a), 31 New Jersey Register 4293(c).
Rewrote the section.