N.J. Admin. Code § 8:33E-2.13

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

Section 8:33E-2.13 - Compliance

(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.

(b) All certificate of need applications for new pediatric and adult cardiac surgery centers must document the ability of the applicant to meet the minimum standards and criteria contained in this subchapter in accordance with 8:33E-2.14 or 2.15, as applicable. The inability to achieve minimum utilization levels during the third year of operation or thereafter will be required to submit to the identical process that has been established at (a) above.

(c) Notwithstanding the duration of unimplemented certificates of need criteria as set forth at 8:33-3.10, all certificate of need applications for new pediatric and adult cardiac surgery services approved after the effective date of these rules shall have two years from the date of certificate of need approval to initiate such services by obtaining licensure approval. In accordance with 8:33-3.10(a)3, failure to implement the project within two years will result in the automatic termination of the certificate of need, unless the Commissioner determines that the failure of the applicant to complete the project within the timeframe was the result of extraordinary unforeseeable circumstances beyond the control of the applicant. In accordance with 8:33-3.10(a), extension of time requests shall be filed within 60 days prior to the current certificate of need expiration date and shall include detailed documentation of the following:

1. The current status of the project;

2. The reasons for the delays; and

3. A proposed detailed time frame identifying the remaining time needed for the project to be licensed by the Department's Certificate of Need and Acute Care Licensure Program.

N.J. Admin. Code § 8:33E-2.13

Amended by R.1998 d.280, effective 6/1/1998.
See: 30 New Jersey Register 1008(a), 30 New Jersey Register 1996(a).
In (a), deleted "reimbursement or" preceding "licensing sanctions"; and rewrote (b).
Recodified from N.J.A.C. 8:33E-2.14 and amended by R.2001 d.210, effective 6/18/2001.
See: 33 New Jersey Register 616(b), 33 New Jersey Register 2105(a).
Rewrote section. Former N.J.A.C. 8:33E-2.13, New facilities; diagnostic pilot cardiac catheterization programs at cardiac surgery centers, repealed.
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), substituted "volume/quality" for "volume" preceding "requirements" in the introductory paragraph; in (c), amended the N.J.A.C. reference in the second sentence.