N.J. Admin. Code § 8:33E-2.1

Current through Register Vol. 56, No. 18, September 16, 2024
Section 8:33E-2.1 - Scope and purpose
(a) The purpose of this subchapter is to establish standards and general criteria for the planning of a regional cardiac surgical center and for the preparation of an application for a certificate of need for such a facility. A regional approach to the provision of cardiac services is necessary to provide safe, complete patient care, efficiently and effectively, at reasonable cost to the consumer. Cardiac surgery centers provide the full-range of diagnostic, therapeutic and surgical cardiac services.
(b) A regional cardiac surgical center is defined as a health care facility which specializes in most aspects of cardiac service, including at a minimum cardiovascular surgical services as well as invasive cardiac diagnostic and therapeutic catheterization (for example, PCI, complex EPS) services. With the exception of an inner city cardiac satellite demonstration project as specified at 8:33-3.11(c), these cardiac surgery services are to be provided at a single hospital location.
(c) In the regional cardiac surgical center, the primary diagnostic services are provided by a cardiac catheterization and coronary angiographic laboratory and a non-invasive laboratory. A cardiac catheterization, coronary angiographic laboratory is one which provides a service devoted to achieving physiological and angiographic studies of optimal quality. Application for certificate of need approval to provide and/or the provision of invasive cardiac diagnostic services by a regional cardiac surgery center shall be subject to all applicable standards and criteria for such services as set forth at N.J.A.C. 8:33E.
(d) At a minimum, the non-invasive laboratory shall include the capability to perform the following services:
1. Electrocardiography;
2. Exercise Stress Testing;
3. Echocardiography;
4. Ambulatory Electrocardiographic Monitoring; and
5. Nuclear Cardiology.
(e) Before heart surgery is performed, every patient shall undergo diagnosis through a recognized diagnostic service, except in an extreme emergency, as in the case of open wounds to the heart.
(f) The cardiovascular surgical services include open heart, closed heart and coronary artery surgery; surgery of the great vessels; and implantation of cardiac assist devices, such as the intra-aortic balloon pump. Therapeutic catheterization procedures include PCI. The requirements contained in this subchapter for facilities, personnel and equipment for open heart surgery shall be the minimum requirements for all cardiovascular surgical and interventional cardiology procedures.

N.J. Admin. Code § 8:33E-2.1

Amended by R.1998 d.280, effective 6/1/1998.
See: 30 New Jersey Register 1008(a), 30 New Jersey Register 1996(a).
Rewrote (b) and (f).
Amended by R.2001 d.210, effective 6/18/2001.
See: 33 New Jersey Register 616(b), 33 New Jersey Register 2105(a).
In (b), inserted "and therapeutic catheterization (for example, PTCA, complex EPS)" following "diagnostic"; rewrote (f).
Amended by R.2004 d.37, effective 1/20/2004.
See: 35 New Jersey Register 3773(a), 36 New Jersey Register 416(a).
Rewrote (d); in (f), rewrote the first sentence and deleted "or balloon angioplasty" in the second sentence.
Amended by R.2006 d.263, effective 7/17/2006.
See: 38 N.J.R. 53(a), 38 N.J.R. 3025(a).
In (b) and (f), substituted "PCI" for "PTCA".