N.J. Admin. Code § 8:33E-1.13

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:33E-1.13 - Requirements for licensure of certificate of need approved invasive cardiac diagnostic facilities

(a) All facilities seeking to initiate invasive cardiac diagnostic services pursuant to an approved certificate of need shall be initially licensed on an annual basis in accordance with the provisions of N.J.A.C. 8:43G.

(b) Licenses for facilities referenced in (a) above may be renewed on an annual basis only upon a demonstration by the license holder to the satisfaction of the Commissioner, of full compliance with all applicable standards and criteria of this chapter, N.J.A.C. 8:43G; N.J.A.C. 8:33; 26:2H-1 et seq.; any applicable Federal law; and any additional conditions imposed upon the license holder in the original certificate of need approval.

1. All facilities seeking renewal of licenses issued pursuant to the full service or low risk cardiac catheterization facility described in this subchapter shall submit to the Department of Health and Senior Services, documentation of their full compliance with all standards and criteria referenced in (b) above, specifically including, but not limited to, the verified utilization criteria pursuant to 8:33E-1.4(b) and 1.9 for full service cardiac catheterization facilities and independently audited and verified utilization criteria pursuant to 8:33E-1.4(c) and 1.9(a)1 for low risk cardiac catheterization facilities. Where applicable, plans of correction shall be submitted indicating what licensure renewal criteria are deficient, what corrective actions are to be put in place or what systemic changes shall be employed to ensure future compliance, a timetable for compliance, and the methods used to monitor future actions to ensure eventual compliance.

i. Failure to submit all information/documentation and corrective actions required for consideration of renewal in the time and manner set forth in (b) above shall, absent the express written consent of the Department, constitute a basis for denial of the request for license renewal.

ii. The Department will not consider in its annual licensing evaluation the annual volume of physicians with hospital privileges to perform diagnostic cardiac catheterization with the exception of annual laboratory director volumes set forth at 8:33E-1.4(b)2.

(c) Upon receipt of the documentation required for renewal as set forth in (b) and (b)1 above, the Department shall review and evaluate the documentation, shall communicate with the facility to clarify and/or supplement the documentation as it in its sole discretion deems appropriate, and shall communicate in a timely manner a decision to the facility as to whether the license to provide full service or low risk cardiac catheterization services, whichever is applicable, will be renewed.

(d) Any renewal of licensure under this section shall be valid for a period of one year only and shall be limited to the same invasive cardiac diagnostic services as were approved under the license holder's original certificate of need and initial license. Failure of an existing cardiac catheterization provider to document compliance with annual licensure renewal criteria will require the provider 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 standard in 8:33E-1.4(b)1 or (c)1 and physician volume standard in 8:33E-1.4(b)2 or (c)2, whichever are applicable. Where applicable, plans of correction shall be submitted indicating what licensure renewal criteria are deficient, what corrective actions are to be put in place or what systemic changes shall 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 shall include a formal request for waivers to licensure requirements as set forth at 8:43G-2.8. The plan of correction will 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.

(e) These requirements for licensure shall be in addition to and not in limitation of any other applicable authorities not specifically mentioned herein and from which the facility in question has not been specifically exempted by law.

N.J. Admin. Code § 8:33E-1.13

Amended by R.2001 d.210, effective 6/18/2001.
See: 33 New Jersey Register 616(b), 33 New Jersey Register 2105(a).
Rewrote (b); added new (c) and (d); recodified former (c) as (e).
Amended by R.2006 d.263, effective 7/17/2006.
See: 38 N.J.R. 53(a), 38 N.J.R. 3025(a).
Added (b)1ii.