(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.
2. Patient level data shall be submitted to the Department of Health and Senior Services on a quarterly basis, within 30 days after the close of the quarter. These patient care and outcome data shall include, but not be limited to, mortality and morbidity information and other information relative to the specific cardiac surgery center, as determined by the Department. Copies of the full text of the required quarterly reporting forms may be obtained upon written request to:
The New Jersey State Department of Health and Senior Services
Division of Health Care Systems Analysis
Research and Development Program
