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-2.10 - Data to be maintained and reported

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Every cardiac
				facility licensed to provide therapeutic interventional cardiac-procedures that
				include, but are not limited to, cardiac surgery and PCI or coronary angioplasty
				services in accordance with this subchapter shall maintain and provide data on
				patient characteristics and outcomes, services to medically underserved populations,
				community outreach, and individual program components as determined by the
				Department. All hospitals shall report these data to the Department of Health and
				Senior Services on a quarterly basis and in a standardized format determined by the
				Department. If necessary to determine whether a facility is in compliance with this
				chapter, the Department shall require that the data submitted shall be audited at
				the hospital's expense by an independent third party approved by the Department.
1. The criteria for auditor approval are as
				follows:
i. All potential auditing firms shall
				document their experience in medical record review. Prior to approval by the
				Department, an auditing firm shall submit three references from entities for which
				it has performed medical record reviews within the past five years. Prior experience
				does not necessarily have to pertain to cardiac care.
ii. Auditing firms shall be independent from the
				facility being audited. To be independent, an auditor shall have no financial or
				familial interest in the facility being audited. Auditors shall be independent both
				in fact and in appearance. Further, the auditor shall not have had any involvement
				in the audited facility's cardiac surgery center certificate of need
				application.
iii. Auditing firms shall
				submit the names and qualifications of all staff assigned to the relevant audit
				team. Staff who review the medical records and determine the accuracy of data
				submitted to the Department shall include at least one registered nurse trained and
				experienced in assisting invasive cardiac therapeutic procedures. In addition, the
				audit team shall include at least one accredited records technician or a registered
				record administrator accredited under a certification program approved by the
				American Medical Records Association. Other staff shall have experience either in
				medical record review or with the provision of invasive cardiac therapeutic
				procedures.
iv. Auditing firms shall
				identify and contract with at least two board certified cardiologists then in
				practice to review data from which medical diagnoses are made. The two cardiologists
				shall not be on staff at the audited facility. They shall be certified by the
				Cardiovascular Subspecialty Board of the American Board of Internal Medicine. They
				shall have broad experience and training in invasive cardiac therapeutic procedures,
				including, but not limited to, a minimum of 12 months in an invasive therapeutic
				cardiac services program and the performance of at least 200 invasive cardiac
				therapeutic procedures, with 100 of those procedures performed as the head
				cardiologist.
v. Any change in audit
				firms by an audited facility shall be approved by the Department based upon the
				criteria set forth in this section. Additionally, any change in personnel of the
				relevant audit team shall be done in accordance with the standards as set forth in
				this section and reported to the Department.
vi. All employees of the audit firm with access to
				confidential data shall sign a confidentiality assurance statement with the audited
				facility prior to access to the confidential data.