New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.4 - Utilization criteria for invasive cardiac diagnostic facilities

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Utilization
				criteria for all invasive cardiac diagnostic facilities are based on the number of
				patients upon whom invasive cardiac diagnostic procedures (cardiac catheterization)
				are performed.
(b) Except as
				specifically set forth with respect to low risk cardiac catheterization facility, at
				(c) below, all facilities licensed to provide full service invasive cardiac
				diagnostic services shall, as a condition of continued licensure, be required to
				maintain the following basic utilization criteria:
1. The minimum acceptable number of adult cardiac
				catheterization patients per full service cardiac laboratory is 400 per year. New
				full service providers (those previously operating as low risk cardiac
				catheterization laboratories) must provide documentation of full compliance with the
				minimum utilization level during their second year of operation or their most recent
				four quarters of operation, whichever is later and fully documented by the
				Department using audited data. Existing full service invasive cardiac diagnostic
				providers (with or without cardiac surgery on site) must achieve minimum utilization
				levels each year. Compliance with minimum annual facility volume requirements will
				be calculated on the basis of the last four quarters of operation prior to the
				facility's licensure anniversary date. Those new and existing full service
				laboratories unable to achieve the minimum level as set forth in this paragraph will
				be subject to the provisions of
				8:33E-1.13.
2. Each physician must perform left heart
				catheterizations on a minimum of 50 patients per year. (This minimum caseload may be
				accomplished at more than one laboratory in or out of State). For the Director of
				the laboratory, the standard is left-heart catheterizations on 150 patients per
				year, at least 100 of which must be performed at the full service laboratory of
				which the physician is Director (the remaining 50 case requirement may be
				accomplished at more than one laboratory in or out of State).
i. Exceptions for cardiologists to the minimum
				director and physician volume requirements may be granted by the Commissioner upon
				application by a hospital for specific facility circumstances. Such circumstances as
				the temporary inability to perform cardiac catheterization, physician not a member
				of the staff for an entire year, or new program in operation less than one year
				require only timely written notification to the Department. Any other extraordinary
				circumstances shall require the submission by the hospital of a written waiver
				request in accordance with the hospital licensing waiver provisions as set forth at
				8:43G-2.8.
ii. Compliance with the physician's minimum annual
				patient volume for cardiologists with laboratory privileges shall be based on the
				most recent calendar year's performance data available prior to the hospital's
				licensure anniversary date.
iii.
				Compliance with the Director's minimum annual patient volume, which includes the
				total number of catheterizations performed Statewide and the number of cases
				performed in the Director's laboratory, shall be based on the most recent four
				quarters of data available to the Department prior to the low risk laboratory's
				licensure anniversary date.
3. Those new and existing full-service
				laboratories unable to achieve the minimum volume levels set forth in this
				subsection shall be required to submit to the process that has been established at
				8:33E-1.13.