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-2.13 - Compliance

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Existing pediatric
				and adult cardiac surgery centers shall continue to meet the minimum criteria and
				standards contained in this subchapter on an annual basis. Compliance with minimum
				annual facility volume/quality requirements will be calculated on the basis of the
				last four quarters of operation prior to the facility's licensure anniversary date.
				Those existing cardiac surgery centers unable to achieve the minimum level as set
				forth in this subchapter will be required to submit to the following:
1. An external review from an independent external
				organization approved by the Department to assess the overall performance of the
				facility and its staff;
2. A detailed
				plan of correction shall be submitted to the Department within 30 days of
				notification of its failure to maintain compliance with annual minimum facility
				volume standards in
				8:33E-2.3(a)2  and
				physician volume standards in
				8:33E-2.3(a)3. Where
				applicable, plans of correction shall be submitted indicating the licensure renewal
				criteria that have not been achieved, the corrective actions that are to be put in
				place or the systemic changes that will be employed to ensure future compliance, a
				timetable for compliance, and the methods used to monitor future actions to ensure
				eventual compliance. This plan of correction may include a formal request for
				waivers to licensure requirements as set forth at
				8:43G-2.8. The plan of correction shall
				not be considered final until it has been approved by the Department;
3. Failure to comply with the provisions of the
				corrective action plan in accordance with the approved timetables shall result in a
				revocation of the facility's license unless an appeal is filed with the Commissioner
				within 60 days after receiving the Department's notice of revocation. The Department
				may issue a notice of revocation up to 12 months after the facility's licensure
				anniversary date following the earliest compliance date within the plan of
				correction in which the facility was deficient. If the facility requests a hearing,
				it shall be held in accordance with the Administrative Procedure Act,
				52:14B-1 et seq., and 52:14F-1 et seq.,
				and the Uniform Administrative Procedure Rules, N.J.A.C. 1:1. At the Commissioner's
				discretion, the hearing shall be conducted by the Commissioner or transferred to the
				Office of Administrative Law. In exercising discretion, the Commissioner may
				consider the following:
i. The scope and severity
				of the threat;
ii. The frequency of the
				occurrence;
iii. The presence or absence
				of attempts at remedial action by the facility;
iv. The presence or absence of any citations,
				penalties, warnings, or other enforcement actions by any governmental entity
				pertinent to the condition giving rise to the threat; and
v. Any other factor which the Commissioner deems
				to be relevant to assessment of risk presented to patients.