Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 1110 - PROCESSING, CLASSIFICATION POLICIES AND REVIEW CRITERIA › Subpart C - CATEGORY OF SERVICE REVIEW CRITERIA › Section 1110.220 - Open Heart Surgery

Current through Register Vol. 48, No. 28, July 12, 2024
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.