Ohio Admin. Code 3701-84-38 - Facilities, equipment, and supplies - open heart surgery service

(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.

(1) Standard operating rooms will:

(a) Have a minimum floor area of four hundred fifty square feet;

(b) Have the following minimum clearances:

(i) If anesthesia is utilized, six feet at the head of the operating table. This dimension will result in an anesthesia work zone with a clear floor area of six feet by eight feet; and

(ii) Sufficient footage on each side of the procedure table to ensure that movement around and in the sterile field does not compromise or contaminate the sterile field.

(2) Operating rooms utilizing image-guided surgery or procedures requiring more space for personnel or equipment will be sized to accommodate the personnel and equipment planned to be in the room during procedures and have a minimum floor area of six hundred square feet with a minimum clear dimension of twenty feet.

(3) Hybrid operating rooms will meet the minimum floor area and clearances of paragraphs (A)(1)(a) and (A)(1)(b) of this rule and include at least the additional minimum clear floor area, clearances, and storage requirements for the imaging equipment contained in the room.

(4) Fixed encroachments into the minimum floor area are permitted to be included when determining the minimum clear floor area for an operating room as long as:

(a) There are no encroachments into the sterile field;

(b) The encroachments do not extend more than twelve inches into the minimum clear floor area outside the sterile field; and

(c) The encroachment width along each wall does not exceed ten percent of the length of that wall.

(5) Control rooms if utilized, will:

(a) Accommodate the imaging system control equipment;

(b) Be sized and configured in compliance with manufacturer recommendations for installation, service, and maintenance;

(c) Have view panels that provide for a view of the patient and the open heart surgery team; and

(d) Be permitted to serve more than one hybrid operating room, provided that manufacturer recommendations for installation, service, and maintenance are accommodated for all rooms served.

(e) Be physically separated from a hybrid operating room with walls and a door.

(f) A door is not required where a control room serves only one operating room and is built, maintained, and controlled the same as the operating room.

(B) Each operating room used for open heart surgery shall will have appropriate numbers of oxygen and vacuum outlets and proper operating room lighting. Fiber optic headlights shall will 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 An open heart surgery service shall will 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;

(11) Defibrillators;

(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 will 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 where the open heart surgery is performed. The cardiac surgical intensive care unit shall will ensure that the a sufficient number of available intensive care unit beds shall are available to meet the needs of open heart surgery patients each week, 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 Each open heart surgery service shall will 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 will be approximately equal to the number of sufficient to meet the needs of open heart surgery patients each procedures performed per week, however, the beds are not required to be dedicated only to cardiac surgery patients.

Notes

Ohio Admin. Code 3701-84-38

Effective: 5/15/2023
Five Year Review (FYR) Dates: 2/27/2023 and 05/05/2028
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: 03/01/1997, 03/24/2003, 05/15/2008, 09/03/2009, 08/01/2017