Current through Bulletin 2024-06, March 15, 2024
(1) Leakage Radiation Outside the Maximum
Useful Beam in Photon and Electron Modes.
(a)
The absorbed dose rate due to leakage radiation (excluding neutrons) at any
point outside the maximum sized useful beam, but within a circular plane of
radius two meters which is perpendicular to and centered on the central axis of
the useful beam at the nominal treatment distance, that is at the plane of the
patient, shall not exceed a maximum of 0.2 percent and an average of 0.1
percent of the absorbed dose rate on the central axis of the beam at the
nominal treatment distance. Measurements shall be averaged over an area not
exceeding 100 square centimeters at a minimum of 16 points uniformly
distributed in the plane;
(b)
Except for the area defined in R313-30-7(1)(a), the absorbed dose rate,
excluding that from neutrons, at one meter from the electron path between the
electron source and the target or electron window shall not exceed 0.5 percent
of the absorbed dose rate on the central axis of the beam at the nominal
treatment distance. Measurements shall be averaged over an area not exceeding
100 square centimeters;
(c) For
equipment manufactured after the effective date of these rules, the neutron
absorbed dose outside the useful beam shall be in compliance with applicable
acceptance criteria; and
(d) For
therapeutic radiation machines, the registrant shall determine, or obtain from
the manufacturer, the leakage radiation existing at the positions specified in
R313-30-7(1)(a) through R313-30-7(1)(c) for the specified operating conditions.
Records on leakage radiation measurements shall be maintained at the
installation for inspection by representatives of the Director.
(2) Leakage Radiation Through Beam
Limiting Devices.
(a) Photon Radiation.
(i) Adjustable or interchangeable beam
limiting devices, such as the collimating jaws or x-ray cones, shall attenuate
the useful beam so that at the nominal treatment distance, the maximum absorbed
dose anywhere in the area shielded by the beam limiting devices shall not
exceed two percent of the maximum absorbed dose on the central axis of the
useful beam measured in a ten centimeters by ten centimeters radiation field;
and
(ii) Interchangeable beam
limiting devices, such as auxiliary beam blocking material, shall attenuate the
useful beam so that at the nominal treatment distance, the maximum absorbed
dose anywhere in the area shielded by the interchangeable beam limiting device
shall not exceed five percent of the maximum absorbed dose on the central axis
of the useful beam measured in a ten centimeter by ten centimeter radiation
field.
(b) Electron
Radiation. Adjustable or interchangeable electron applicators shall attenuate
the radiation, including but not limited to photon radiation generated by
electrons incident on the beam limiting device and electron applicator and
other parts of the radiation head, so that the absorbed dose in a plane
perpendicular to the central axis of the useful beam at the nominal treatment
distance shall not exceed:
(i) A maximum of
two percent of the absorbed dose on the central axis of the useful beam at the
nominal treatment distance. This limit shall apply beyond a line seven
centimeters outside the periphery of the useful beam; and
(ii) A maximum of ten percent of the absorbed
dose on the central axis of the useful beam at the nominal treatment distance.
This limit shall apply beyond a line two centimeters outside the periphery of
the useful beam.
(c)
Measurement of Leakage Radiation.
(i) Photon
Radiation. Measurements of leakage radiation through the beam limiting devices
shall be made with the beam limiting devices closed and residual apertures
blocked by at least two tenth value layers of suitable absorbing material. In
the case of overlapping beam limiting devices, the leakage radiation through
the sets of beam limiting devices shall be measured independently at the depth
of maximum dose. Measurements shall be made using a radiation detector of area
not exceeding ten square centimeters;
(ii) Electron Radiation. Measurements of
leakage radiation through the electron applicators shall be made with an
appropriate radiation detector suitably protected against radiation which has
been scattered from material beyond the radiation detector. Measurements shall
be made using an appropriate amount of water equivalent build up material for
the energies being measured.
(3) Filters and Wedges.
(a) Filters and wedges which are removable
from the system shall be clearly marked with an identification number;
(i) For removable wedge filters, the nominal
wedge angle shall appear on the wedge, or on the wedge tray if the wedge filter
is permanently mounted to the tray.
(ii) If the wedge or wedge tray is damaged,
the Radiation Therapy Physicist will decide if the wedge transmission factor
shall be redetermined;
(b) For equipment manufactured after the
effective date of these rules which utilize a system of wedge filters:
(i) Irradiation shall not be possible until a
selection of a wedge filter or a positive selection to use "no wedge filter"
has been made at the treatment control panel;
(ii) An interlock system shall be provided to
prevent irradiation if the wedge filter selected is not in the correct
position;
(iii) A display shall be
provided at the treatment control panel showing the wedge filters in use;
and
(iv) An interlock shall be
provided to prevent irradiation if a wedge filter selection operation, either
manual or automatic, carried out in the treatment room does not agree with the
wedge filter selection operation carried out at the treatment control
panel.
(c) If the
absorbed dose rate information required by R313-30-7(8) relates exclusively to
operation with a field flattening filter or beam scattering foil in place, the
filter or foil shall be removable only by the use of tools. If removable, the
filter or foil shall be interlocked to prevent incorrect selection and
incorrect positioning.
(d) For
equipment manufactured after the effective date of these rules which utilize a
system of interchangeable field flattening filters or interchangeable beam
scattering foils:
(i) An interlock system
shall be provided to prevent irradiation if the appropriate flattening filter
for the x-ray energy selected is not in the correct position in the
beam;
(ii) An interlock system
shall be provided to prevent irradiation if the appropriate beam scattering
foil for the electron energy selected is not in the correct position in the
beam;
(iii) An interlock system
shall be provided to prevent irradiation if no scattering foil is in place for
the electron beams, or if no flattening filter is in place for the x-ray beams;
and
(iv) A display shall be
provided at the treatment control panel showing a fault indicator when the
interlock system has prevented irradiation. The fault indicator will identify a
filter or foil error.
(4) Stray Radiation in the Useful Beam. For
equipment manufactured after the effective date of these rules, the registrant
shall determine during acceptance testing, or obtain from the manufacturer,
data sufficient to ensure that x-ray stray radiation in the useful electron
beam, absorbed dose at the surface during x-ray irradiation and stray neutron
radiation in the useful x-ray beam meet applicable acceptance
criteria.
(5) Beam Monitors.
Therapeutic radiation machines subject to R313-30-7 shall be provided with
redundant beam monitoring systems. The sensors for these systems shall be fixed
in the useful beam during treatment to indicate the dose monitor unit rate, and
to monitor other beam parameters.
(a)
Equipment manufactured after the effective date of these rules shall be
provided with at least two independently powered integrating dose meters.
Alternatively, common elements may be used if the production of radiation is
terminated upon failure of a common element.
(b) Equipment manufactured on or before the
effective date of these rules shall be provided with at least one radiation
detector. This detector shall be incorporated into a useful beam monitoring
system;
(c) The detector and the
system into which that detector is incorporated shall meet the following
requirements:
(i) Detectors shall be
removable only with tools and, if movable, shall be interlocked to prevent
incorrect positioning;
(ii)
Detectors shall form part of a beam monitoring system from whose readings in
dose monitor units the absorbed dose at a reference point can be
calculated;
(iii) The beam
monitoring systems shall be capable of independently monitoring, interrupting,
and terminating irradiation; and
(iv) For equipment manufactured after the
effective date of these rules, the design of the beam monitoring systems shall
ensure that the:
(A) Malfunctioning of one
system shall not affect the correct functioning of the secondary system;
and
(B) Failure of an element
common to both systems which could affect the correct function of both systems
shall terminate irradiation or prevent the initiation of radiation.
(v) Beam monitoring systems shall
have a legible display at the treatment control panel. For equipment
manufactured after the effective date of these rules, displays shall:
(A) Maintain a reading until intentionally
reset;
(B) Have only one scale and
no electrical or mechanical scale multiplying factors;
(C) Utilize a design so that increasing dose
monitor units are displayed by increasing numbers; and
(D) In the event of power failure, the dose
monitor units delivered up to the time of failure, or the beam monitoring
information required in R313-30-7(5)(c)(v)(C) displayed at the control panel at
the time of failure shall be retrievable in at least one system for a 20 minute
period of time.
(6) Beam Symmetry.
(a) Bent-beam linear accelerators subject to
R313-30-7 shall be provided with auxiliary devices to monitor beam
symmetry;
(b) The devices
referenced in R313-30-7(6)(a) shall be able to detect field asymmetry greater
than ten percent; and
(c) The
devices referenced in R313-30-7(6)(a) shall be configured to terminate
irradiation if the specifications in R313-30-7(6)(b) can not be
maintained.
(7)
Selection and Display of Dose Monitor Units.
(a) Irradiation shall not be possible until a
selection of a number of dose monitor units has been made at the treatment
control panel;
(b) The preselected
number of dose monitor units shall be displayed at the treatment control panel
until reset manually for the next irradiation;
(c) After termination of irradiation, it
shall be necessary to reset the dosimeter display before subsequent treatment
can be initiated; and
(d) For
equipment manufactured after the effective date of these rules, after
termination of irradiation, it shall be necessary for the operator to reset the
preselected dose monitor units before irradiation can be initiated.
(8) Air Kerma Rate and Absorbed
Dose Rate. For equipment manufactured after the effective date of these rules,
a system shall be provided from whose readings the air kerma rate or absorbed
dose rate at a reference point can be calculated. The radiation detectors
specified in R313-30-7(5) may form part of this system. In addition:
(a) The dose monitor unit dose rate shall be
displayed at the treatment control panel;
(b) If the equipment can deliver an air kerma
rate or absorbed dose rate at the nominal treatment distance more than twice
the maximum value specified by the manufacturer, a device shall be provided
which terminates irradiation when the air kerma rate or absorbed dose rate
exceeds a value twice the specified maximum. The dose rate at which the
irradiation will be terminated shall be a record maintained by the
registrant;
(c) If the equipment
can deliver, under any fault condition, an air kerma rate or absorbed dose rate
at the nominal treatment distance more than ten times the maximum value
specified by the manufacturer, a device shall be provided to prevent the air
kerma rate or absorbed dose rate anywhere in the radiation field from exceeding
twice the specified maximum value and to terminate irradiation if the excess
absorbed dose at the nominal treatment distance exceeds 4 Gy (400 rad);
and
(d) For therapeutic radiation
machines, the registrant shall determine, or obtain from the manufacturer, the
maximum values specified in R313-30-7(8)(b) and R313-30-7(8)(c) for the
specified operating conditions. Records of these maximum values shall be
maintained at the installation for inspection by representatives of the
Director.
(9)
Termination of Irradiation by the Beam Monitoring System or Systems During
Stationary Beam Radiation Therapy.
(a)
Primary systems shall terminate irradiation when the preselected number of dose
monitor units has been detected by the system;
(b) If the original design of the equipment
included a secondary dose monitoring system, that system shall be capable of
terminating irradiation when not more than 15 percent or 40 dose monitor units
above the preselected number of dose monitor units set at the control panel has
been detected by the secondary dose monitoring system; and
(c) For equipment manufactured after the
effective date of these rules, an indicator on the control panel shall show
which monitoring system has terminated irradiation.
(10) Termination Switches. It shall be
possible to terminate irradiation and equipment movement or go from an
interruption condition to termination condition at any time from the operator's
position at the treatment control panel.
(11) Interruption Switches. If a therapeutic
radiation machine has an interrupt mode, it shall be possible to interrupt
irradiation and equipment movements at any time from the treatment control
panel. Following an interruption, it shall be possible to restart irradiation
by operator action without a reselection of operating conditions. If a change
is made of a pre-selected value during an interruption, irradiation and
equipment movements shall be automatically terminated.
(12) Timer. A suitable irradiation control
device shall be provided to terminate the irradiation after a preset time
interval.
(a) A timer shall be provided which
has a display at the treatment control panel. The timer shall have a preset
time selector and an elapsed time indicator;
(b) The timer shall be a cumulative timer
which activates with an indication of "BEAM-ON" and retains its reading after
irradiation is interrupted or terminated. After irradiation is terminated and
before irradiation can be reinitiated, it shall be necessary to reset the
elapsed time indicator;
(c) The
timer shall terminate irradiation when a preselected time has elapsed, if the
dose monitoring systems have not previously terminated irradiation.
(13) Selection of Radiation Type.
Equipment capable of both x-ray therapy and electron therapy shall meet the
following additional requirements:
(a)
Irradiation shall not be possible until a selection of radiation type (x-rays
or electrons) has been made at the treatment control panel;
(b) The radiation type selected shall be
displayed at the treatment control panel before and during
irradiation;
(c) An interlock
system shall be provided to ensure that the equipment can principally emit only
the radiation type which has been selected;
(d) An interlock system shall be provided to
prevent irradiation with x-rays, except to obtain a verification film, when
electron applicators are fitted;
(e) An interlock system shall be provided to
prevent irradiation with electrons when accessories specific for x-ray therapy
are fitted; and
(f) An interlock
system shall be provided to prevent irradiation if selected operations carried
out in the treatment room do not agree with the selected operations carried out
at the treatment control panel.
(14) Selection of Energy. Equipment capable
of generating radiation beams of different energies shall meet the following
requirements:
(a) Irradiation shall not be
possible until a selection of energy has been made at the treatment control
panel;
(b) The nominal energy value
selected shall be displayed at the treatment control panel before and during
irradiation; and
(c) Irradiation
shall not be possible until the appropriate flattening filter or scattering
foil for the selected energy is in its proper location.
(15) Selection of Stationary Beam Radiation
Therapy or Moving Beam Radiation Therapy. Therapeutic radiation machines
capable of both stationary beam radiation therapy and moving beam radiation
therapy shall meet the following requirements:
(a) Irradiation shall not be possible until a
selection of stationary beam radiation therapy or moving beam radiation therapy
has been made at the treatment control panel;
(b) The mode of operation shall be displayed
at the treatment control panel;
(c)
An interlock system shall be provided to ensure that the equipment can operate
only in the mode which has been selected;
(d) An interlock system shall be provided to
prevent irradiation if a selected parameter in the treatment room does not
agree with the selected parameter at the treatment control panel;
(e) Moving beam radiation therapy shall be
controlled to obtain the selected relationships between incremental dose
monitor units and incremental angle of movement. For equipment manufactured
after the effective date of these rules:
(i)
An interlock system shall be provided to terminate irradiation if the number of
dose monitor units delivered in increments of ten degrees of rotation or one
centimeter of motion differs by more than 20 percent from the selected
value;
(ii) Where angle terminates
the irradiation in moving beam radiation therapy, the dose monitor units shall
differ by less than five percent from the dose monitor unit value
selected;
(iii) An interlock shall
be provided to prevent motion of more than five degrees or one centimeter
beyond the selected limits during moving beam radiation therapy;
(iv) For equipment manufactured after the
effective date of these rules, an interlock shall be provided to require that a
selection of direction be made at the treatment control panel in units which
are capable of both clockwise and counter-clockwise moving beam radiation
therapy.
(v) Moving beam radiation
therapy shall be controlled with both primary position sensors and secondary
position sensors to obtain the selected relationships between incremental dose
monitor units and incremental movement.
(f) Where the beam monitor system terminates
the irradiation in moving beam radiation therapy, the termination of
irradiation shall be as required by R313-30-7(9); and
(g) For equipment manufactured after the
effective date of these rules, an interlock system shall be provided to
terminate irradiation if movement:
(i) Occurs
during stationary beam radiation therapy; or
(ii) Does not start or stops during moving
beam radiation therapy unless the stoppage is a preplanned function.
(16) Facility Design
Requirements for Therapeutic Radiation Machines Operating above 500 kV. In
addition to shielding adequate to meet requirements of
R313-30-9,
the following design requirements are made:
(a) Protective Barriers. Protective barriers
shall be fixed, except for access doors to the treatment room or movable beam
interceptors;
(b) Control Panel. In
addition to other requirements specified in R313-30, the control panel shall
also:
(i) Be located outside the treatment
room;
(ii) Provide an indication of
whether electrical power is available at the control panel and if activation of
the radiation is possible;
(iii)
Provide an indication of whether radiation is being produced; and
(iv) Include an access control device which
will prevent unauthorized use of the therapeutic radiation machine;
(c) Viewing Systems. Windows,
mirrors, closed-circuit television or an equivalent viewing system shall be
provided to permit continuous observation of the patient following positioning
and during irradiation and shall be so located that the operator may observe
the patient from the treatment control panel. The therapeutic radiation machine
shall not be used for patient irradiation unless at least one viewing system is
operational;
(d) Aural
Communications. Provision shall be made for continuous two-way aural
communication between the patient and the operator at the control panel. The
therapeutic radiation machine shall not be used for irradiation of patients
unless continuous two-way aural communication is possible;
(e) Room Entrances. Treatment room entrances
shall be provided with warning lights in a readily observable position near the
outside of access doors, which will indicate when the useful beam is
"ON;"
(f) Entrance Interlocks.
Interlocks shall be provided so that access controls are activated before
treatment can be initiated or continued. If the radiation beam is interrupted
by an access control, it shall not be possible to restore the machine to
operation without closing the door and reinitiating irradiation by manual
action at the control panel;
(g)
Beam Interceptor Interlocks. If the shielding material in a protective barrier
requires the presence of a beam interceptor to ensure compliance with
R313-30-301(1), interlocks shall be provided to prevent the production of
radiation, unless the beam interceptor is in place, whenever the useful beam is
directed at the designated barriers;
(h) Emergency Cutoff Switches. At least one
emergency power cutoff switch shall be located in the radiation therapy room
and shall terminate equipment electrical power including radiation and
mechanical motion. This switch is in addition to the termination switch
required by R313-30-7(11). Emergency power cutoff switches shall include a
manual reset so that the therapeutic radiation machine cannot be restarted from
the unit's control panel without resetting the emergency cutoff switch.
Alternatively, power cannot be restarted without pressing a RESET button in the
treatment room after resetting the power breaker, and the operator shall check
the treatment room and patient prior to turning the power back on;
(i) Safety Interlocks. Safety interlocks
shall be designed so that defects or component failures in the safety interlock
system prevent or terminate operation of the therapeutic radiation machine;
and
(j) Surveys for Residual
Radiation. Surveys for residual activity shall be conducted on therapeutic
radiation machines capable of generating photon and electron energies above 10
MV prior to machining, removing, or working on therapeutic radiation machine
components which may have become activated due to photo-neutron
production.
(17)
Radiation Therapy Physicist Support.
(a) The
services of a Radiation Therapy Physicist shall be required in facilities
having therapeutic radiation machines with energies of 500 kV and above. The
Radiation Therapy Physicist shall be responsible for:
(i) Full calibrations required by
R313-30-7(19) and protection surveys required by
R313-30-4(1);
(ii) Supervision and review of
dosimetry;
(iii) Beam data
acquisition and transfer for computerized dosimetry, and supervision of its
use;
(iv) Quality assurance,
including quality assurance check review required by R313-30-7(20)(e) of these
rules;
(v) Consultation with the
authorized user in treatment planning, as needed; and
(vi) Perform calculations and assessments
regarding misadministrations.
(b) If the Radiation Therapy Physicist is not
a full-time employee of the registrant, the operating procedures required by
R313-30-7(18) shall also specifically address how the Radiation Therapy
Physicist is to be contacted for problems or emergencies, as well as the
specific actions to be taken until the Radiation Therapy Physicist can be
contacted.
(18)
Operating Procedures.
(a) No individual,
other than the patient, shall be in the treatment room during treatment or
during an irradiation for testing or calibration purposes;
(b) Therapeutic radiation machines shall not
be made available for medical use unless the requirements of
R313-30-4(1),
R313-30-7(19) and R313-30-7(20) have been met;
(c) Therapeutic radiation machines, when not
in operation, shall be secured to prevent unauthorized use;
(d) If a patient must be held in position
during treatment, mechanical supporting or restraining devices shall be
used;
(e) A copy of the current
operating and emergency procedures shall be maintained at the therapeutic
radiation machine control console; and
(f) When adjustable beam limiting devices or
beam limiting devices that do not contact the skin are used, the position and
shape of the radiation field shall be indicated by a light field.
(19) Full Calibration
Measurements.
(a) Full calibration of a
therapeutic radiation machine subject to R313-30-7 shall be performed by, or
under the direct supervision of, a Radiation Therapy Physicist:
(i) Before the first medical use following
installation or reinstallation of the therapeutic radiation machine;
(ii) Annually. The intervals should not
exceed 12 months and shall not exceed 13 months; and
(iii) Before medical use under the following
conditions:
(A) Whenever quality assurance
check measurements indicate that the radiation output differs by more than five
percent from the value obtained at the last full calibration and the difference
cannot be easily reconciled; and
(B) Following component replacement, major
repair, or modification of components, if the appropriate Quality Assurance
checks demonstrate that the characteristics of the radiation beam have been
significantly affected as determined by a Radiation Therapy Physicist. The
Quality Assurance checks shall be performed by, or under the direct supervision
of a Radiation Therapy Physicist. The determination of the need for a full
calibration shall be made by a Radiation Therapy Physicist.
(iv) Notwithstanding the
requirements of R313-30-7(19)(a)(iii):
(A)
Full calibration of therapeutic radiation machines with multi-energy and
multi-mode capabilities is required only for those modes and energies that are
not within their range and the difference cannot be easily reconciled;
and
(B) If the repair, replacement
or modification does not affect all modes and energies, full calibration shall
be performed on the effected mode or energy if the Quality Assurance checks
demonstrate that the characteristics of the radiation beam have been
significantly affected as determined by a Radiation Therapy Physicist. The
Quality Assurance checks shall be performed by, or under the direct supervision
of, a Radiation Therapy Physicist. The determination of the need for a full
calibration shall be made by a Radiation Therapy Physicist. The remaining
energies or modes may be validated with quality assurance check procedures
against the criteria in R313-30-7(19)(a)(iii)(A).
(b) To satisfy the requirement of
R313-30-7(19)(a), full calibration shall include measurements required for
annual calibration by American Association of Physicists in Medicine (AAPM)
Report 46, "Comprehensive Quality Assurance for Radiation Oncology," 1994 ed.,
which is adopted and incorporated by reference;
(c) The registrant shall use the dosimetry
system described in
R313-30-8(6)
to measure the radiation output for one set of exposure conditions. The
remaining radiation measurements required in R313-30-7(19)(b) may then be made
using a dosimetry system that indicates relative dose rates; and
(d) The registrant shall maintain a record of
calibrations for the duration of the registration. The record shall include the
date of the calibration, the manufacturer's name, model number, and serial
number for the therapeutic radiation machine, the model numbers and serial
numbers of the instruments used to calibrate the therapeutic radiation machine,
and the signature of the Radiation Therapy Physicist responsible for performing
the calibration.
(20)
Periodic Quality Assurance Checks.
(a)
Periodic quality assurance checks shall be performed on therapeutic radiation
machines subject to R313-30-7. These checks should be performed at intervals
not to exceed those intervals recommended in American Association of Physicists
in Medicine (AAPM) Report 46, "Comprehensive Quality Assurance for Radiation
Oncology," 1994 ed., which is adopted and incorporated by reference.
(i) Determination of parameters for central
axis radiation output shall be done at least weekly. The interval shall not
exceed ten days.
(ii) The interval
at which periodic quality assurance checks are to be performed shall be
determined by the Radiation Therapy Physicist and shall be documented in the
registrant's quality management program. The interval for a specific
performance check may be based on the history of that performance check for a
particular machine. The interval may be increased above the recommended limits
only if the Radiation Therapy Physicist determines the increase is justified
based on the history of the performance check for that machine or a machine of
the same manufacturer and the same model.
(iii) If the performance check demonstrates a
need to decrease the interval, the Radiation Therapy Physicist shall decide if
the interval should be decreased. The decreased interval shall be continued
until the performance check demonstrates that the decreased interval is not
necessary.
(b) To
satisfy the requirement of R313-30-7(20)(a), quality assurance checks shall
include determination of central axis radiation output and shall include a
representative sampling of periodic quality assurance checks contained in
American Association of Physicists in Medicine (AAPM) Report 46, "Comprehensive
Quality Assurance for Radiation Oncology," 1994 ed., which is adopted and
incorporated by reference.
(i) A
representative sampling shall include those referenced periodic quality
assurance checks necessary to assure that the radiation beam and alignment
parameters for all therapy machines and modes of operation are within limits
prescribed by AAPM Report 46.
(ii)
The intervals for a representative sampling of referenced periodic quality
assurance checks should not exceed 12 consecutive months and shall not exceed
13 consecutive months.
(c) The registrant shall use a dosimetry
system which has been inter-compared semi-annually. The intervals should not
exceed six months and shall not exceed seven months, with a dosimetry system
described in
R313-30-8(6)(a)
to make the periodic quality assurance checks required in
R313-30-7(20)(a)(i);
(d) The
registrant shall perform periodic quality assurance checks required by
R313-30-7(20)(a) in accordance with procedures established by the Radiation
Therapy Physicist;
(e) The
registrant shall review the results of periodic radiation output checks
according to the following procedures:
(i)
The authorized user and Radiation Therapy Physicist shall be immediately
notified if a parameter is not within its acceptable range. The therapeutic
radiation machine shall not be made available for subsequent medical use until
the Radiation Therapy Physicist has determined that all parameters are within
their acceptable range;
(ii) If
periodic radiation output check parameters appear to be within their acceptable
range, the periodic radiation output check shall be reviewed and signed by
either the authorized user or Radiation Therapy Physicist within two
weeks;
(iii) The Radiation Therapy
Physicist shall review and sign the results of radiation output quality
assurance checks at intervals not to exceed one month; and
(iv) Other Quality Assurance checks shall be
reviewed at intervals specified in the Quality Management Program, as required
by
R313-30-5.
(f) Therapeutic radiation machines
subject to R313-30-7 shall have safety quality assurance checks of external
beam radiation therapy facilities performed weekly at intervals not to exceed
ten days;
(g) To satisfy the
requirement of R313-30-7(20)(f), safety quality assurance checks shall ensure
proper operation of:
(i) Electrical
interlocks at external beam radiation therapy room entrances;
(ii) Proper operation of the "BEAM-ON",
interrupt and termination switches;
(iii) Beam condition indicator lights on the
access doors, control console, and in the radiation therapy room;
(iv) Viewing and aural communication
systems;
(v) Electrically operated
treatment room doors from inside and outside the treatment room;
(vi) At least one emergency power cutoff
switch. If more than one emergency power cutoff switch is installed and not all
switches are tested at once, switches shall be tested on a rotating basis.
Safety quality assurance checks of the emergency power cutoff switches may be
conducted at the end of the treatment day in order to minimize possible
stability problems with the therapeutic radiation machine.
(h) The registrant shall promptly repair a
system identified in R313-30-7(20)(g) that is not operating properly;
and
(i) The registrant shall
maintain a record of quality assurance checks required by R313-30-7(20)(a) and
R313-30-7(20)(g) for three years. The record shall include the date of the
quality assurance check, the manufacturer's name, model number, and serial
number for the therapeutic radiation machine, the manufacturer's name, model
number and serial number of the instruments used to measure the radiation
output of the therapeutic radiation machine, and the signature of the
individual who performed the periodic quality assurance check.