(A) Operating rooms used for open heart surgery shall have at a minimum four hundred and fifty square feet provided sufficient additional support space is available adjacent to each room for perfusion supplies, set up, and other storage. Operating rooms for open heart surgery constructed or renovated or open heart surgery services initiated after March 1, 1997 shall have at a minimum of six hundred square feet.
(B) Each operating room used for open heart surgery shall have appropriate numbers of oxygen and vacuum outlets and proper operating room lighting. Fiber optic headlights shall be provided.
(C) Equipment and technology described in this paragraph may be replaced by newer technology and equipment with equivalent or superior capability. In assessing this new equipment and technology, consideration should be given to the recommendations of recognized professional societies and accrediting bodies. The provider of an open heart surgery service shall have at least the following:
(1) Two fully operational cardiopulmonary bypass machines equipped with;
(a) A time and temperature module;
(b) An air bubble and level detector system;
(c) A blender (air and oxygen mixer);
(d) An oxygen analyzer;
(e) A saturation monitor;
(f) Two pressure monitors;
(g) A back up pump head; and (h) A heater/cooler (one back up).
(2) Appropriate patient monitoring equipment with overhead slave, electrocardiogram, three pressure reading, and cardiac output;
(3) An electrocauter;
(4) A heat exchanger;
(5) Drug infusion equipment;
(6) Transportable monitoring equipment including electrocardiogram, defibrillator, oxygen saturation monitor, and pressure transducer;
(7) An intra-aortic balloon pump or other percutaneous mechanical circulatory assistance device of superior capability;
(8) The availability of a transesophageal echo;
(9) A cardiac pacemaker;
(10) Routine blood gas analysis and chemistry including blood sugar analysis in the operating room;
(12) A heating blanket;
(13) An ice bath;
(14) An automated coagulation timer (ACT) machine; and
(15) A cell saver.
(D) Each provider of an open heart surgery service shall ensure that a fully equipped and staffed cardiac surgical intensive care unit that meets the needs of the cardiac surgery patient is available in the building and accessible by gurney from the open heart surgery is performed. The cardiac surgical intensive care unit shall ensure that the number of available intensive care unit beds shall be approximately one-half the number of open heart operations performed per week; however, the beds are not required to be dedicated only to cardiac surgery patients.
(E) The provider of an open heart surgery service shall ensure that a post-intensive care "step-down" unit with telemetry is available in the building and accessible by gurney from where the open heart surgery is performed. The number of "step-down" beds shall be approximately equal to the number of procedures performed per week; however, the beds are not required to be dedicated only to cardiac surgery patients.
Five Year Review (FYR) Dates: 02/27/2017 and 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.11, 3702.12, 3702.13 , 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Prior Effective Dates: 3/1/1997, 3/24/03, 5/15/08, 9/3/09