Current through all regulations passed and filed through September 16, 2024
(A) Each adult cardiac catheterization service, or "service" shall
provide adequate, properly designed space to perform cardiac catheterization
procedures safely and effectively. The amount of space may vary with the types
of procedures performed and the nature of the facility (e.g., interventional
versus diagnostic, teaching versus non-teaching).
(B) Each service shall utilize the following:
(1) Procedure rooms will:
(a)
Have a minimum
floor area of four hundred 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.
(c)
Procedure 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.
(d)
Hybrid procedure
rooms will meet the minimum floor area and clearances of paragraphs (B)(1)(a)
and (B)(1)(b) of this rule and include at least the additional minimum floor
area, clearances, and storage requirements for the imaging equipment contained
in the room.
(e)
Fixed encroachments into the minimum clear floor area
are permitted to be included when determining the minimum clear floor area for
a procedure room as long as:
(i)
There are no encroachments into the sterile
field;
(ii)
The encroachments do not extend more than twelve inches
into the minimum clear floor area outside the sterile field;
and
(iii)
The encroachment width along each wall does not exceed
ten percent of the length of that wall.
(2)
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 cardiac catheterization team;
(d)
Be permitted to
serve more than one hybrid procedure room, provided that manufacturer
recommendations for installation, service, and maintenance are accommodated for
all rooms served; and
(e)
Be physically separated from a hybrid procedure room
with walls and a door.
(f)
A door is not required where a control room serves only
one procedure room and is built, maintained, and controlled the same as the
procedure room.
(3)
Clean utility rooms that can sufficiently and efficiently supply the procedure
rooms.
(C) A general
radiology room cannot be used as a cardiac catheterization procedure
room.
(D) Equipment described in
this paragraph may be replaced by newer technology that has equivalent or
superior capability as determined by the provider of the service. In assessing
these new technologies, consideration should be given to recommendations of
recognized professional societies and accrediting bodies (e.g. the American
college of cardiology). All services
will, at a minimum have the following equipment:
(1) High quality x-ray imaging with mutiaxial
position capability;
(2) A
three-phase, twelve pulse generator with an output of eighty to one hundred
kilowatts or a constant potential generator with an output of at least one
hundred kilowatts at one hundred kilovolts;
(3) Multimode or cesium iodide image
intensifiers;
(4) High-quality
matched optics;
(5) Appropriate
imaging modality for review and storage of images;
(6) Digital imaging equipment;
(7) Carbon-fiber table tops;
(8) A mechanism for continuous monitoring of
a patient's blood pressure and electrocardiogram;
(9) An adequate supply and variety of
catheters, guide wires, and sheaths;
(10) A crash cart with equipment for
ventilatory support;
(11) A
defibrillator;
(12) A temporary
pacemaker; and
(13) An intra-aortic
balloon pump or other percutaneous mechanical circulatory assistance device of
superior capability.
(E)
Each adult cardiac catheterization service
will
provide and maintain radiation generating equipment in accordance with
applicable state and federal requirements as specified in Chapter 3748. of the
Revised Code and the rules adopted thereunder.
