N.J. Admin. Code § 8:33E-1.1
Current through Register Vol. 56, No. 9, May 6, 2024
Section 8:33E-1.1 - Scope and purpose(a) The purpose of this subchapter is to establish standards and general criteria for the planning of cardiac diagnostic facilities and for the preparation of an application for a certificate of need for such a facility. The invasive cardiac diagnostic facility specializes in the detection and diagnosis of cardiac disorders. Unlike the cardiac surgery center in which both diagnostic and therapeutic services are co-located, the invasive cardiac diagnostic facility does not provide cardiac surgery or percutaneous coronary intervention (PCI) but rather on the basis of diagnostic studies refers patients, where appropriate, to facilities offering cardiac surgery and other advanced cardiac diagnostic and treatment modalities. To increase access to these services, low risk cardiac catheterization programs have been established that are subject to facility performance standards contained at 8:33E-1.4(c) and 1.14 intended to ensure the continual delivery of safe patient care, efficiently and effectively provided.1. As of February 20, 1996, a new category of invasive cardiac diagnostic catheterization facility was established to treat only low risk adult patients as defined at 8:33E-1.2.(b) In the invasive cardiac diagnostic facility, the primary diagnostic services are provided by cardiac catheterization, coronary angiographic and non-invasive laboratories. The cardiac catheterization and coronary angiographic laboratories are devoted to achieving optimal quality physiological and angiographic studies. Non-invasive cardiac diagnostic services are commonly available at all acute care hospitals and may include, at a minimum, electrocardiography, exercise stress testing, echocardiography monitoring, and nuclear cardiology.(c) The American College of Cardiology/American Heart Association Task Force on Cardiac Catheterization supports the position that the safety and efficacy of laboratory performance requires a caseload of adequate size to maintain the skills and efficiency of the staff. In the interest of patient care, then, it is important to encourage optimal utilization of diagnostic resources. It is also essential that in view of the invasive nature of the cardiac catheterization procedure and the extent of possible complications associated with these procedures, cardiac surgery services must be accessible promptly, either in-house or by immediate transfer, in the event of an emergency or complication. Finally, catheterization must be performed in a laboratory that is physically part of, and is a permanent structure within, a health care facility offering inpatient support services.(d) The standards and criteria defined in this subchapter shall apply to the efficient delivery of quality diagnostic services within the setting of the cardiac catheterization laboratory. In addition to meeting these minimal requirements, the invasive cardiac diagnostic facility is expected to operate a well-established non-invasive cardiac diagnostic laboratory. Additional requirements are set forth for the more comprehensive cardiac surgery centers and are identified within N.J.A.C. 8:33E-2.N.J. Admin. Code § 8:33E-1.1
Amended by R.2001 d.210, effective 6/18/2001.
See: 33 New Jersey Register 616(b), 33 New Jersey Register 2105(a).
Rewrote (a); in (b), rewrote last sentence; in (c), substituted "optimal" for "maximum" and deleted "the State's existing" preceding "diagnostic resources".
Amended by R.2004 d.37, effective 1/20/2004.
See: 35 New Jersey Register 3773(a), 36 New Jersey Register 416(a).
In (a) and (b), rewrote the last sentence; in (c), deleted the former second and third sentences.
Amended by R.2006 d.263, effective 7/17/2006.
See: 38 N.J.R. 53(a), 38 N.J.R. 3025(a).
In (a), substituted "percutaneous coronary intervention (PCI)" for "PTCA".