New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.3 - Utilization of cardiac surgical centers

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The following shall
				apply to adult cardiovascular surgical units:
1.
				An applicant for a certificate of need to initiate adult cardiac surgery services
				shall provide written documentation of the ability to achieve an annual volume of
				350 open heart surgical cases by the end of the third year of operation and annually
				thereafter.
2. All existing regional
				adult cardiac surgical centers shall continue to perform at least 350 open heart
				surgical procedures per year to ensure the competency of the surgical services team
				and to provide for efficient and economical operation. Compliance with this annual
				facility volume requirement will be calculated on the basis of the last four
				quarters of data submitted to and reviewed by the Department prior to the facility's
				licensure anniversary date. Facilities that perform fewer than 350 open heart
				surgical procedures per year shall alternatively achieve a risk-adjusted mortality
				rate (mortality at discharge) for isolated coronary artery bypass graft (CABG)
				surgery for the most recent four quarters that is lower than the Statewide observed
				mortality rate (mortality at discharge) for isolated CABG surgery (the alternative
				method).
i. Data for calculating a facility's
				risk-adjusted isolated CABG mortality rate shall be derived from the Department's
				open heart data base.
ii. The Statewide
				observed isolated CABG mortality rate shall be the Statewide rate for the most
				recent calendar year reported in the Department's most recent published report on
				cardiac surgery performance.
iii.
				Calculation of a facility's risk-adjusted mortality rate shall be based on the
				risk-adjustment model used to create the Department's most recent published report
				on cardiac surgery performance. However, there shall be no use of a confidence
				interval in determining how a facility's risk-adjusted mortality rate compares to
				the Statewide observed mortality rate.
iv. The facility risk-adjusted and Statewide
				observed mortality rates shall be expressed as a percentage calculated to two
				decimal places.
v. A facility that
				demonstrates compliance through the alternative method shall be licensed
				unconditionally for the licensure period. However, a sample of patient medical
				records designated by the Department shall be examined in a timely fashion by a
				Department-approved auditor at the facility's expense to confirm the accuracy of the
				information relevant to the risk-adjustment calculation submitted by the facility to
				the Department's open heart data base. Audit results shall be submitted directly by
				the auditor to the Department. If audit adjustments result in a revised facility
				risk-adjusted mortality rate that is higher than the Statewide observed mortality
				rate, then the facility shall be licensed conditionally and the provisions of
				8:33E-2.13(a)  shall
				apply.
3. Each cardiac
				surgical center shall establish a minimum caseload per physician in order to ensure
				a consistent level of proficiency within the surgical program. A minimum of 100
				cases per year shall be performed by each cardiac surgeon performing as the primary
				surgeon on any case. This volume shall be achieved at each licensed site in New
				Jersey at which the physician practices as primary surgeon on any case. Compliance
				with annual physician volume standards will be calculated on a calendar year basis.
				Physicians that perform fewer than 100 open heart surgical procedures per year shall
				alternatively achieve a risk-adjusted mortality rate (mortality at discharge) for
				isolated coronary artery bypass graft (CABG) surgery that is lower than the
				Statewide observed mortality rate (mortality at discharge) for isolated CABG surgery
				(the alternative method).
i. Data for calculating a
				physician's risk-adjusted isolated CABG mortality rate shall be derived from the
				isolated CABG cases in the Department's open heart database for the most recent four
				years that the physician has performed open heart cases. For physicians performing
				surgery in New Jersey for less than four years, the review shall include all
				isolated CABG cases performed in a New Jersey cardiac surgery center.
ii. The Statewide observed isolated CABG mortality
				rate shall be the Statewide rate for the most recent calendar year reported in the
				Department's most recent published report on cardiac surgery performance.
iii. Calculation of a physician's risk-adjusted
				mortality rate shall be based on the risk-adjustment model used to create the
				Department's most recent published report on cardiac surgery performance. However,
				there shall be no use of a confidence interval in determining how a physician's
				risk-adjusted mortality rate compares to the Statewide observed mortality
				rate.
iv. The physician risk-adjusted
				and Statewide observed mortality rates shall be expressed as a percentage calculated
				to two decimal places.
v. A physician
				who demonstrates compliance through the alternative method shall be considered in
				compliance with the minimum annual physician volume standard and the physician's
				annual volume will not be considered in the hospital's relicensure evaluation for
				that year. However, the Department reserves the right to confirm the accuracy of the
				information relevant to the risk-adjustment calculation submitted by the facility to
				the Department's open heart database. If the Department's audit adjustments result
				in a revised physician risk-adjusted mortality rate that is higher than the
				Statewide observed mortality rate, then the facility shall be licensed conditionally
				and the provisions of
				8:33E-2.13(a)  shall
				apply.