(c) The following minimum facility design
information shall be submitted to DHHS/RHS with any request for the therapeutic
radiation machine installation approval:
(1)
For any therapeutic radiation machine, the following basic facility
information:
a. Name;
b. Telephone number;
c. The DHHS/RHS registration number of the
individual responsible for preparation of the shielding plan;
d. Name and telephone number of the facility
supervisor;
e. The facility street
address;
f. The facility room
number for the therapeutic radiation machine;
g. Indication if this is a new structure or a
modification to existing structure(s);
h. The primary barriers for all wall, floor,
and ceiling areas struck by the useful beam;
i. All secondary barriers provided in all
wall, floor, and ceiling areas not having primary barriers;
j. If commercial software is used to generate
shielding requirements, the software name, version, and date of
revision;
k. If the software used
to generate shielding requirements is not in the open literature, quality
control sample calculations to verify the result obtained with the
software;
l. The structural
composition and thickness or lead equivalent of all walls, doors, partitions,
floor, and ceiling of the room(s) concerned;
m. The type of occupancy of all adjacent
areas inclusive of space above and below the room(s) concerned, and any
exterior wall(s), with distance to the closest area(s) where it is likely that
individuals may be present; and
n.
At least one example calculation which shows the methodology used to determine
the amount of shielding required for each primary and secondary/leakage
barriers, restricted and unrestricted areas, entry door(s), and shielding
material in the facility.
(2) In addition to the requirements listed in
He-P
4047.09(c) (1) , therapeutic
radiation machine facilities which produce only photons with a maximum energy
less than or equal to 150 kV shall submit shielding plans which contain, as a
minimum, the following additional information:
a. Equipment specifications, including the
manufacturer and model number of the therapeutic radiation machine, as well as
the maximum technique factors;
b.
Maximum design workload for the facility to include:
1. Total weekly radiation output expressed in
gray (rad) or air kerma at 1 meter;
2. Total beam-on time per day or
week;
3. The average treatment time
per patient; and
4. The anticipated
number of patients to be treated per day or week; and
c. A facility blueprint/drawing indicating:
1. Scale;
2. Direction of North;
3. Normal location of the therapeutic
radiation machine's radiation port(s);
4. The port's travel and traverse
limits;
5. General direction(s) of
the useful beam;
6. Locations of
any windows and doors;
7. The
location of the therapeutic radiation machine control panel;
8. The location of the operator's booth if
the control panel is located inside the therapeutic radiation machine treatment
room; and
9. The operator's station
at the control panel has a protective barrier sufficient to ensure compliance
with He-P
4020.05;
(3) In addition to the requirements listed in
He-P
4047.09(c) (1) , therapeutic
radiation machine facilities that produce photons with a maximum energy in
excess of 150 kV or electrons shall submit shielding plans which contain, as a
minimum, the following additional information:
a. Equipment specifications to include:
1. The manufacturer;
2. The model number of the therapeutic
radiation machine;
3. The gray or
rad at the isocenter;
4. The
energy(s) and type(s) of radiation produced; and
5. The target to isocenter
distance;
b. Maximum
design workload for the facility including:
1. Total weekly radiation output expressed in
gray rad at 1 meter;
2. Total
beam-on time per day or week;
3.
The average treatment time per patient; and
4. The anticipated number of patients to be
treated per day or week;
c. Facility blueprint or drawing indicating:
1. The floor plan and elevation views each
indicating relative orientation of the therapeutic radiation machine;
2. Type(s), thickness, and minimum density of
shielding material(s);
3. Direction
of North; and
4. The locations and
size of all beam penetrations through each ceiling, wall, floor, details of the
door(s) and maze shielding barrier; and
d. A description of all assumptions that were
in the shielding calculations including, but not limited to:
1. Design energy;
2. Work-load;
3. Presence of integral beam-stop in
unit;
4. Occupancy and use(s) of
adjacent areas;
5. Fraction of time
that useful beam will intercept each permanent barrier for all walls, floor and
ceiling; and
6. "Allowed" radiation
exposure in both restricted and unrestricted areas.
(4) In addition to the
requirements listed in
He-P
4047.09(c) (3) , therapeutic
radiation machine facilities which are capable of operating above 10 MV shall
submit shielding plans which contain, as minimum, the following additional
information:
a. The structural composition,
thickness, minimum density, and location of all neutron shielding
material;
b. Description of all
assumptions that were used in neutron shielding calculations including, but not
limited to;
1. Neutron spectra as a function
of energy;
2. Neutron fluence rate;
and
3. Absorbed dose and dose
equivalent for neutrons in both restricted and unrestricted areas;
c. At least one example
calculation which shows the methodology used to determine the amount of neutron
shielding required for each restricted and unrestricted areas, entry door(s),
maze and the neutron shielding material utilized in the facility; and
d. The method(s) and instrumentation which
will be used to verify the adequacy of all neutron shielding installed in the
facility.