N.J. Admin. Code § 8:33E-2.4

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

Section 8:33E-2.4 - Cardiac surgery center personnel

(a) The following shall apply to cardiovascular surgical units:

1. Cardiac surgery is most successful when performed by a smoothly functioning team. The basic team of the regional cardiac surgical center shall consist of the following permanently assigned staff:

i. One physician in charge of the operation (that is, primary surgeon), board-certified by the American Board of Thoracic and Cardiovascular Surgery as a cardiovascular surgeon who directs the team or the surgical unit. A minimum of 100 cases per year shall be performed by each cardiac surgeon as the primary surgeon on any case. This volume shall be achieved at each licensed site in New Jersey at which the physician practices as primary surgeon on any case.

(1) Exceptions for incumbent directors to this requirement for board certification may be granted by the Commissioner and upon application by an institution providing proper documentations as to the physician's qualifications;

(2) Exceptions for surgeons to the minimum physician volume requirement may be granted by the Commissioner upon application by a hospital for specific facility circumstances. Such circumstances as the temporary inability to perform surgery; physician not a member of the staff for an entire year; new program in operation less than one year require only timely written notification to the Department. Any other extraordinary circumstances will require the submission of a written waiver request by the hospital in accordance with the hospital licensing waiver provisions as set forth at 8:43G-2.8. Compliance with the physician's minimum annual patient volume for physicians with cardiac surgery privileges shall be based on the most recent calendar year's performance data available prior to the hospital's licensure anniversary date;

ii. One assistant to the physician in charge of the operation who will be a board qualified surgeon. A cardiothoracic surgery resident or fellow or a duly qualified physician assistant or duly qualified registered nurse first assistant, in accordance with 13:35-4.1(c), may serve as an assistant. There shall be at least one surgeon and one duly qualified assistant in the operating room;

iii. An anesthesiologist, meeting the licensing requirements contained at 8:43G-7.5(d)1 and 2 shall be responsible for the anesthetic management of cardiac surgery patients. This anesthesiologist may be assisted by additional personnel as specified at 8:43G-7.5(e);

iv. There shall be at least one registered nurse and an assistant meeting licensing requirements at 8:43G-7.5(i) in each operating room;

v. In accordance with 8:43G-7.5(j), a perfusionist who is certified by the American Board of Cardiovascular Perfusion or meets the experience requirements shall be available to operate the perfusion pump for each cardiac surgical procedure. A second perfusionist meeting the same requirements shall be available in the surgical suite to assist. In emergency cases, a second perfusionist may be off-site and readily summoned if needed;

vi. A cardiovascular nurse specialist (one for every 100 open heart procedures) and a physician's assistant may be employed to supplement the cardiovascular surgical team; and

vii. A board certified cardiologist shall be available to assist in the management of problems relating to unstable hemodynamic status and complex arrhythmias, if necessary.

2. The primary operating cardiac surgeon, in conjunction with the attending cardiologist, shall be responsible for overseeing and integrating all details of pre-operative evaluation and preparation of the operation procedures and of postoperative care.

(b) The intensive care cardiac recovery room (or Surgical Intensive Care Unit (SICU)) is the area where cardiac patients are held for postoperative care. At a minimum, patient coverage in this area shall be on a one specially trained cardiac nurse to one patient basis for the first 24 hours after surgery or in accordance with the diagnosis. During this period of intensive care the operating surgeon and team or qualified alternate shall be on call. Clinical appropriateness may permit the patient to be transferred sooner than 24 hours to a step-down unit where the above 1:1 nursing to patient ratio does not apply. After a full 24 hours following the operative day, and in accordance with patient diagnosis, nursing coverage may be reduced to a maximum of three patients to two nurses during the second and third days following the operative day as long as ventilatory and other life support systems have been discontinued.

1. It is recommended that there be at least six surgical intensive care beds for each operating room within the surgical center that is dedicated to open heart surgery patients.

2. The surgical intensive care unit shall include physiologic monitoring equipment capable of arrhythmia detection (including slave scopes). Portable x-ray equipment and computers for laboratory work should also be available.

(c) The following shall apply to cardiac diagnostic facilities located in a cardiac surgery center.

1. Except as specifically set forth below in accordance with 8:33E-2.1(c), the provision of cardiac catheterization services by regional cardiac surgery centers shall be subject to all facility personnel requirements for such services as set forth at 8:33E-1.5.

2. Exceptions to these minimum training and certification requirements for incumbent directors and associate physicians may be granted by the Commissioner and upon application by an institution providing proper documentation as to the physician's qualifications, in accordance with the requirements of this chapter, 8:43G-7.15(b), 7.25 and 7.44; and N.J.A.C. 13:35.

(d) Only the special personnel required by a cardiac diagnostic center established within an existing hospital are specified in (c) above. Appropriate supporting staff or personnel shall be available in existing departments within the hospital, in accordance with the requirements of all applicable laws, rules and regulations.

(e) The following shall apply to invasive cardiac diagnostic facilities located in cardiac surgery centers that seek to perform PCI:

1. Each invasive diagnostic facility must be staffed, at a minimum, by the following personnel during a PCI procedure:

i. The physician directing the procedure shall be a board-certified cardiologist with well-recognized excellence in the management of routine cardiac catheterization and who has participated in a minimum of 100 PCI procedures (with at least 50 as primary operator) and meets the licensing qualifications specified at 8:43G-7.29(a);

ii. An assisting physician, if needed, may be a board-certified cardiologist or a cardiology fellow;

iii. A registered nurse meeting the licensing requirements specified at 8:43G-7.30(a)2 shall be available to assist with PCI procedures; and

iv. One assistant meeting the licensing requirements specified at 8:43G-7.30(a)3 shall be available to assist with PCI procedures.

(f) The following shall apply to invasive cardiac diagnostic services located in cardiac surgery centers that seek to perform complex electrophysiology studies (EPS):

1. Each invasive cardiac diagnostic service shall be staffed, at a minimum, by the following personnel during a complex electrophysiology study.

i. The physician directing the procedure must be a board-certified cardiologist with well-recognized excellence in the management of routine cardiac catheterization who has obtained at least one additional year of specialized training in complex EPS and cardiac arrhythmias including participation in 100 complex EPS procedures, and meets the licensing qualifications specified at 8:43G-7.32(a).

ii. An assisting board-certified cardiologist, if needed, shall be present during complex EPS procedures.

iii. A registered nurse meeting the licensing requirements specified at 8:43G-7.33(a)2 shall be present during the procedure.

iv. One assistant meeting the licensing requirements specified at. 8:43G-7.33(a)3 shall be present during the procedure.

N.J. Admin. Code § 8:33E-2.4

Amended by R.1998 d.280, effective 6/1/1998.
See: 30 N.J.R. 1008(a), 30 N.J.R. 1996(a).
Rewrote (a).
Amended by R.2001 d.210, effective 6/18/2001.
See: 33 N.J.R. 616(b), 33 N.J.R. 2105(a).
Rewrote section.
Amended by R.2004 d.37, effective 1/20/2004.
See: 35 N.J.R. 3773(a), 36 N.J.R. 416(a).
In (a), rewrote 1i(2) and 1ii; in (b), substituted "Surgical Intensive Care Unit (SICU)" for "Surgical Critical Care Unit (SCCU)"; amended the N.J.A.C. references throughout.
Amended by R.2006 d.263, effective 7/17/2006.
See: 38 N.J.R. 53(a), 38 N.J.R. 3025(a).
Substituted "PCI" for "PTCA" throughout; in introductory paragraph of (e), substituted "PCI" for "percutaneous transluminal coronary angioplasty (PTCA)"; in (e)1i, inserted a hyphen following "board"; and in (e)1ii and (f)1ii , deleted "or board-eligible" preceding "cardiologist".