Section 1110.220  Open Heart Surgery

a)         Introduction

This Section contains Review Criteria that pertain to the Open Heart Surgery category of service.  Open heart surgical procedures performed on an emergency basis due to a complication occurring during a cardiac catheterization procedure shall not constitute establishment of the open heart surgery category of service.

b)         Review Criteria

1)         Peer Review.  The applicant shall document the mechanism for peer review of an open heart surgery program.

2)         Establishment of Open Heart Surgery.  The applicant shall document that a minimum of 200 open heart surgical procedures will be performed during the second year of operation or that 750 cardiac catheterizations were performed in the latest 12-month period for which data is available. Anticipated open heart surgical volume shall be documented by historical referral volume of at least 200 patients directly referred following catheterization at the applicant facility to other institutions for open heart surgery for each of the last 2 years.

3)         Unnecessary Duplication of Services. The applicant shall document that the volume of any existing service within the relevant travel radius from the applicant will not be reduced below 350 procedures annually for adults and 75 procedures annually for pediatrics. Documentation shall consist of proof of contact of all facilities within the travel radius currently providing open heart surgery to determine the projected impact the project will have on existing open heart surgery volume. For purposes of subsection (b)(3), the following travel radii apply:

A)        Category 1:  For applicant facilities located in the counties of Cook, DuPage, Lake, Will and Kane, the radius shall be 20 miles.

B)        Category 2:  For applicant facilities in McHenry, Kankakee, Rock Island, St. Clair, Winnebago, Peoria, Sangamon and Champaign, the radius shall be 34 miles.

C)        Category 3:  For applicant facilities in all other counties, the radius shall be 42 miles.

4)         Support Services. The applicant shall document that the following support services and facilities are immediately available on a 24-hour basis and document how those services will be mobilized in the case of emergencies.

A)        Surgical and cardiological team appropriate for age group served.

B)        Cardiac surgical intensive care unit.

C)        Emergency room with full-time director, staffed 24 hours for cardiac emergencies with acute coronary suspect surveillance area and voice communication linkage to the ambulance service and the coronary care unit.

D)        Catheterization-angiographics laboratory services.

E)        Nuclear medicine laboratory.

F)         Cardiographics laboratory, electrocardiography, including exercise stress testing, continuous electrocardiograph (ECG) monitoring and phonocardiography.

G)        Echocardiography service.  This may or may not be a part of the cardiographics laboratory.

H)        Hematology laboratory.

I)         Microbiology laboratory.

J)         Blood gas and electrolyte laboratory with microtechniques for pediatric patients.

K)        Electrocardiographic laboratory.

L)        Blood bank and coagulation laboratory.

M)       Pulmonary function unit.

N)        Pacemaker installation.

O)        Organized cardiopulmonary resuscitation team or capability.

P)         Preventive maintenance program for all biomedical devices, electrical installations, and environmental controls.

Q)        Renal dialysis.

5)         Staffing

A)        The applicant shall document that a cardiac surgical team will be established.  The team shall be composed of at least the following:

i)          Two cardiac surgeons (at a minimum, one of which shall be certified and the other qualified by the American Board of Thoracic Surgery) with special competence in cardiology, including cardiopulmonary anatomy, physiology, pathology and pharmacology; extracorporeal perfusion technique; and interpretation of catheterization angiographic data.

ii)         Operating room nurse personnel (registered nurse (RN), licensed practical nurse (LPN), surgical technician).  The nurse to patient ratio for the ICU module of open heart surgery patient care shall be no less than one nurse per one patient in the immediate recovery phase and one nurse per 2 patients thereafter.

iii)        Anesthesiologists (board certified by the American Board of Anesthesiology).

iv)        Adult cardiologists (board certified by the American Board of Internal Medicine with subspecialty certification in cardiology).

v)         Physician who is board certified in anatomic and clinical pathology, with special expertise in microbiology, bloodbanking, lab aspects of blood coagulation, blood gases and electrolytes.

vi)        Pump technician, or operator of the extracorporeal pump oxygenator, who shall have in-depth experience on the active cardiac surgical service that includes perfusion physiology, mechanics of pump operation, sterile technique, and use of monitoring equipment, whether he or she be a physician, nurse or technician.

vii)       Radiologic technologist experienced in angiographic principles and catheterization procedure techniques who is experienced in the use, operation and care of all catheterization equipment.

B)        Documentation shall include a narrative explanation of how positions will be filled.

(Source:  Amended at 42 Ill. Reg. 24907, effective December 12, 2018)