Current through Register Vol. 56, No. 6, March 18, 2024
(a) The Department's goal in considering applications for provision of PCI without the availability of on-site cardiac surgery in emergent situations is to promote wider access to appropriate emergency PCI services while assuring quality of care to patients with acute myocardial infarction. Certificate of need applications shall be accepted on the first business day of each month and shall follow the expedited review process.
1. Any general hospital having a full service adult diagnostic cardiac catheterization program that has been licensed for at least six months as a full service adult diagnostic cardiac catheterization program prior to the application submission date may apply provided it has documented, to the satisfaction of the Department, licensure and full compliance with all cardiac catheterization program and facility utilization requirements as set forth in this chapter and N.J.A.C. 8:43G-7 for the most recent four quarters of operation fully documented by the Department.
(b) The criteria in (b)1 through 11 below shall be considered by the Commissioner in determining whether to grant a certificate of need. The Commissioner may also consider additional information provided by an applicant that the Commissioner deems relevant to such determination.
1. The applicant is able to document collaboration with a New Jersey cardiac surgery center located in the same municipality as the applicant, or, if there is none in the same municipality, with a New Jersey cardiac surgery center located in the same county or a contiguous county. The documented collaboration must include at a minimum:
i. Written protocols assuring that patients will be transferred to and received at the cardiac surgery center's operating room within one hour from time of the determination by the primary operator of the need for transfer. Protocols shall include provisions for emergency transport of patients requiring an intra-aortic balloon pump (IABP);
ii. Regular consultation on individual cases, including use of technology to share case information in a rapid manner; and
iii. Evidence of adequate cardiac surgery on-call back up;
2. The applicant is able to document how case selection for primary PCI will comply rigorously with the criteria identified in (c) below;
3. The applicant is able to document how the general public will be advised of the availability of primary PCI with off-site surgical back-up, and of the protocols for transfer; as well as how informed consent will be secured from patients;
4. The applicant is able to document, based on acute myocardial infarction (AMI) cases admitted in the previous two years in which thrombolytic therapy was administered or the patient was transferred to a cardiac surgery center for primary angioplasty, that it will in its second year of operation perform a minimum of 36 primary PCI cases per year. The applicant is able to document that it will maintain this minimum volume in subsequent years. Primary PCI intervention must be performed routinely as the treatment of choice for a large proportion of AMI patients to ensure adequate facility volume. Detailed policies to ensure effective care paths must be developed;
5. The applicant is able to document that primary PCI will be available 24 hours/day, seven days per week;
6. The applicant is able to document that each operator performing primary PCI is an experienced interventionalist who performed at least 75 PCI cases at a cardiac surgery center in the previous year and continues to do so during his or her tenure at the free-standing PCI site;
7. The applicant is able to document that its technical catheterization laboratory staff have been trained at an interventional laboratory in a cardiac surgery center;
8. The applicant is able to document that the catheterization laboratory will be equipped with resuscitative equipment, an intra-aortic balloon pump (IABP) support, and a broad array of interventional equipment, as well as meeting all equipment standards at 8:43G-7.19;
9. The applicant is able to document its ability to recruit a laboratory medical director board-certified in interventional cardiology by the Cardiovascular Subspecialty Board of the American Board of Internal Medicine, as well as a sufficient number of cardiac care unit nurses with training and experience in hemodynamic monitoring and IABP management. Physicians and support staff performing PCI services at the facility shall meet the minimum requirements for the performance of PCI procedures as set forth at 8:33E-2.4(e) and 8:43G-7.29 and 7.30;
10. The applicant is able to document its ability to perform primary PCI in a timely fashion, that is, balloon inflation no later than 120 minutes after admission; and
11. The applicant is able to document its ability to conduct a ongoing program of outcomes analysis and formalized periodic case review, as part of a broader quality assessment and error management system.
(c) The provision of primary PCI without the availability of on-site cardiac surgery shall be limited to patients with acute myocardial infarction (AMI) who present within 12 hours of onset of AMI and who demonstrate hypotension, congestive heart failure, frank cardiogenic shock, or ischemic symptoms (with ST-segment elevations compatible with AMI or an ECG that prevents diagnosis of an AMI) and these symptoms and ECG changes do not resolve with nitroglycerin. Intervention at facilities with off-site surgical back-up should be avoided in hemodynamically stable patients with:
1. Sixty percent or greater stenosis of an unprotected left main coronary artery upstream from an acute occlusion in the left coronary system that might be disrupted by the angioplasty catheter;
2. Extremely long or angulated infarct-related lesions with TIMI grade 3 flow;
3. Infarct-related lesions with TIMI grade 3 flow in stable patients with three-vessel disease;
4. Infarct-related lesions of small or secondary vessels; or
5. Lesions in other than the infarct artery.
(d) In order to facilitate the Department's review of the safety and effectiveness of facilities offering primary PCI services, the Department will:
1. Consistent with 8:33E-2.10, develop quarterly reporting requirements for facilities performing primary PCI without on-site surgical back-up; and
2. Communicate guidelines concerning the circumstances under which a licensed cardiac surgery center shall assume reporting responsibility for the outcomes of patients transferred from a facility performing primary PCI without on-site surgical back-up.
(e) Facilities granted a certificate of need to provide primary PCI in emergent situations without on-site cardiac surgery are required to operate in accordance with the provisions of 8:33E-2.3(d) as applicable and (b) above, and/or any conditions imposed on its certificate of need as a condition of continued licensure. Compliance with minimum annual facility volume requirements shall be calculated on the basis of the last four quarters of operation prior to the facility's licensure anniversary date. Compliance with annual physician volume standards shall be calculated on a calendar year basis. Facilities unable to comply with the requirements of this section 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; and
2. A detailed plan of correction shall be submitted to the Department within 30 days of notification of its failure to maintain compliance with one or more of the criteria at (b) above, 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 will not be considered final until it has been approved by the Department.
i. Failure to comply with the provisions of the corrective action plan in accordance with the approved timetables will 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 will 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 will be conducted by the Commissioner or transferred to the Office of Administrative Law. In exercising discretion, the Commissioner may consider the following:
(1) The scope and severity of the threat;
(2) The frequency of the occurrence;
(3) The presence or absence of attempts at remedial action by the facility;
(4) 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
(5) Any other factor which the Commissioner deems to be relevant to assessment of risk presented to patients.
