Current through all regulations passed and filed through September 16, 2024
(A)
Operating rooms
used for pediatric cardiovascular 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 clear 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 per cent 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 cardiovascular surgery
team;
(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; and
(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 procedure
room.
(B)
Each operating room used for pediatric cardiovascular
surgery will have appropriate numbers of oxygen, vacuum and electrical outlets
sufficient in number to supply all necessary equipment and proper operating
room lighting, including fiber optic headlights.
(C)
Each pediatric
cardiovascular surgery service will have equipment appropriate for the safe
performance and care of pediatric cardiovascular surgery
patients.
(D)
Each pediatric cardiovascular surgery service will
ensure that a fully equipped and staffed pediatric intensive care unit is
available in the building and accessible by gurney from where the pediatric
cardiovascular surgery is performed. The number of available pediatric
intensive care unit beds will be approximately one-half the number of pediatric
open heart operations performed per week. The physical space of this unit will
meet joint commission, american osteopathic association, or any other national
accrediting body approved for deeming authority by the centers for medicare and
medicaid services recommended standards, which are in effect on the effective
date of this rule, for intensive care unit beds.
(E)
The equipment
described in this paragraph may be replaced by newer technology that has
equivalent or superior capability as determined by the pediatric cardiac
catheterization 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; the American
academy of pediatrics). All pediatric cardiovascular surgery services will have
the following equipment:
(1)
Immediate replay capabilities;
(2)
A blood gas
analyzer;
(3)
A pulse oximeter;
(4)
An infant warming
device;
(5)
Pacing equipment;
(6)
An external
pacemaker;
(7)
A defibrillator;
(8)
An emergency
cart; and
(9)
A comprehensive inventory of cannulas and
conduits.
Replaces: 3701-84-83
