Current through all regulations passed and filed through September 16, 2024
(A) Operating rooms used for open heart
surgery :
(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
will have
appropriate numbers of oxygen and vacuum outlets and proper operating room
lighting. Fiber optic headlights
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.
An open heart surgery
service
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
open heart surgery service
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
will
ensure that
a
sufficient number of
intensive care unit beds
are available to meet the needs of open heart surgery
patients each week,
however, the
beds are not required to be dedicated only to cardiac surgery
patients.
(E)
Each open heart surgery service
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
will be
sufficient to meet the needs of open heart surgery
patients each
week, however, the beds are not required to be dedicated only to
cardiac surgery patients.
