Current through Register Vol. 48, No. 12, March 22, 2024
In addition to the provisions of Sections
360.10 through
360.30,
the requirements of this Section apply to particle accelerator systems
operating at energies of 1 MeV or greater. Accelerator systems capable of
producing radioactive materials in excess of the exempt quantities specified in
32 Ill. Adm. Code 330. Appendix B shall also be licensed pursuant to the
provisions of 32 Ill. Adm. Code 330.
a) Facility Design
1) The registrant shall consult a therapeutic
radiological physicist in the design of a particle accelerator
installation.
2) Shielding
Requirements
A) Each accelerator installation
shall be provided with such primary and secondary barriers as are necessary to
assure compliance with 32 Ill. Adm. Code 340.
B) Facility design information for all
accelerators installed after October 15, 1993 shall be submitted to the Agency
for review prior to installation. Information submitted to the Agency shall
include, but need not be limited to, the following:
i) Name and address of the planned
installation;
ii) Name, address and
telephone number of the therapeutic radiological physicist who was consulted in
the design of the installation;
iii) A scale drawing that includes the
location of the accelerator, control panel and doors to the room;
iv) The structural composition and thickness
of all walls, doors, partitions, floor and ceiling of the
installation;
v) The occupancy of
areas adjacent to the installation;
vi) Calculations that demonstrate the
adequacy of the amount of shielding specified for each primary and secondary
protective barrier; and
vii)
Projected weekly dose rates in areas adjacent to the installation.
3) Interlock. An
interlock shall be installed on each door of the therapy room. The interlock
shall be wired into the electrical circuit in such a manner that when the door
is opened for any reason, the generation of radiation beams will automatically
be terminated and irradiation can be resumed only by manually resetting the
controls on the control panel after the door is closed.
4) Warning lights that indicate when the beam
is on shall be provided in a readily observable position near the outside of
all access doors to the therapy room.
5) Viewing System. Windows, mirrors,
closed-circuit television or an equivalent system shall be provided to permit
continuous visual observation of the patient during irradiation and shall be
located so that the operator can observe the patient from the control panel.
AGENCY NOTE: When the primary viewing system is electronic, a
back-up system should be available for use in the event of failure of the
primary system in order to ensure compliance with the requirements of
subsection (g)(1)(H).
6)
The facility design shall permit two-way aural communications between the
patient and the operator at the control panel.
7) Signs required by 32 Ill. Adm. Code
340.920
shall be posted in the facility.
8)
The control panel shall be outside the therapy room.
9) The facility design shall include
emergency off buttons, at locations that allow shutting off the machine from
inside the therapy room and at the control panel.
10) The doors to the therapy room shall be
designed to allow opening from the inside at all times and shall be capable of
being opened manually.
b) Equipment Requirements
1) Leakage radiation to the patient area
shall be measured for each accelerator. Measurements shall be repeated
following maintenance or service performed on the accelerator, as determined by
a therapeutic radiological physicist.
A) For
operating conditions producing maximum leakage radiation, the absorbed dose due
to leakage radiation, excluding neutrons, at any point in a circular plane of 2
meters radius centered on and perpendicular to the central axis of the beam at
the isocenter or normal treatment distance and outside the maximum useful beam
size shall not exceed 0.1 percent of the maximum absorbed dose of the
unattenuated useful beam measured at the point of intersection of the central
axis of the beam and the plane surface. Radiation measurements shall be
averaged over an area up to but not exceeding 100 square centimeters.
B) Records of the most recent radiation
leakage measurements and the machine parameters used during the survey shall be
maintained at the facility for inspection by the Agency.
2) Beam-Limiting Devices. Adjustable or
interchangeable beam-limiting devices shall transmit no more than two percent
of the useful beam at the normal treatment distance for the portion of the
useful beam that is to be attenuated by the beam-limiting device. The neutron
component of the useful beam shall not be subject to this requirement. This
requirement does not apply to auxiliary blocks or materials placed in the
useful beam to shape the useful beam to the individual patient.
3) Source-Skin Distance (SSD) Indication
A) Means shall be provided to indicate the
SSD.
B) The SSD shall be indicated
in centimeters and/or inches and the measured SSD shall correspond to the
indicated value to within 0.5 percent.
4) Filters
A) Each filter that is removable from the
system shall be clearly marked with an identification number. Documentation
available at the control panel shall contain a description of the filter. For
wedge filters, the wedge angle and maximum design field size shall appear on
the wedge or wedge tray.
B) If the
machine calibration measurements required by subsection (d) relate exclusively
to operation with an x-ray field flattening filter or electron beam scattering
filter in place, such filters shall be removable from the machine only by the
use of tools.
C) Equipment
utilizing a system of wedge filters, interchangeable field flattening filters
or interchangeable beam scattering filters shall meet the following
requirements:
i) The equipment shall have an
interlock that prevents irradiation if any filter selection operation carried
out in the therapy room is not consistent with the selection of filter, beam
type or beam energy at the control panel; and
ii) The equipment shall have an interlock
system that prevents irradiation if any selected filter is not in the correct
position.
5)
Beam Monitoring System. All accelerator systems shall be provided with a beam
monitoring system in the radiation head capable of monitoring and terminating
irradiation.
A) Each beam monitoring system
shall have a display at the treatment control panel which shall register
accumulated monitor units.
B) The
beam monitoring system shall terminate irradiation when the preselected number
of monitor units has been detected by the system.
C) Accelerator systems manufactured after
October 15, 1993 shall be equipped with a primary and a secondary beam
monitoring system. Each beam monitoring system shall be independently capable
of monitoring and terminating irradiation.
D) For units with a secondary beam monitoring
system, the primary beam monitoring system shall terminate irradiation when the
preselected number of monitor units has been detected. The secondary beam
monitoring system shall terminate irradiation if the primary system
fails.
E) An interlock device shall
prevent irradiation if any beam monitoring system is inoperable.
F) In the event of power failure, the display
information required in subsection (b)(5)(A), shall be retrievable in at least
one system for 20 minutes.
6) Beam Symmetry. For equipment equipped with
beam bending magnets, the symmetry of the radiation beam in two orthogonal
directions shall be monitored before the beam passes through the beam-limiting
device. The equipment shall provide means of terminating irradiation
automatically if the difference in dose rate between one region and another
region exceeds criteria specified by the manufacturer.
7) Control Panel
A) Selection and Display of Monitor Units
i) Irradiation shall not be possible until a
selection of a number of monitor units has been made at the control
panel.
ii) The selected number of
monitor units shall be displayed at the control panel until reset.
iii) After completion of irradiation, it
shall be necessary to reset the accumulated beam monitor units before treatment
can be restarted.
B)
Termination of Irradiation. It shall be possible to terminate irradiation and
equipment movements at any time from the operator's position at the control
panel.
C) Selection of Radiation
Type. Equipment capable of both photon and electron therapy shall meet the
following requirements:
i) Irradiation shall
not be possible until the radiation type has been selected and displayed at the
control panel.
ii) An interlock
shall be provided to ensure that the machine will emit only the radiation type
that has been selected.
iii) An
interlock shall be provided to prevent irradiation with x-rays, except to
obtain port films, when electron applicators are installed.
iv) An interlock shall be provided to prevent
irradiation with electrons if accessories specific for x-ray therapy are
installed.
D) Selection
of Radiation Energy. Equipment capable of producing radiation beams of
different energies shall meet the following requirements:
i) Irradiation shall not be possible until a
selection of energy has been made at the control panel.
ii) An interlock shall be provided to ensure
that the machine will emit only the nominal energy of radiation that has been
selected.
iii) The nominal value of
the energy selected shall be displayed at the treatment control
panel.
E) Selection of
Stationary or Moving Beam Therapy. Equipment capable of both stationary and
moving beam therapy shall meet the following requirements:
i) Irradiation shall not be possible unless
either stationary therapy or moving beam therapy has been selected at the
control panel. The selection of stationary therapy may be performed as a
default selection if moving beam therapy is not selected.
ii) An interlock shall be provided to ensure
that the machine will operate only in the mode that has been
selected.
iii) An interlock shall
be provided to terminate irradiation if the gantry fails to move properly
during moving beam therapy.
iv)
Means shall be provided to prevent movement of the gantry during stationary
therapy.
v) The mode of operation
shall be displayed at the control panel.
F) Timers. A timer shall be provided with a
display at the treatment control panel, as a back-up device to the beam
monitoring system.
i) The timer shall permit
presetting and determination of exposure times.
ii) The timer shall be a cumulative timer
which activates with the production of radiation and retains its reading after
irradiation is interrupted or terminated.
iii) The timer shall terminate irradiation
when a preselected time has elapsed if the beam monitoring system has not
previously terminated irradiation. If set at zero, the timer shall not permit
irradiation.
G)
Security. The control panel shall be capable of being locked to prevent
unauthorized use.
c) Radiation Protection Survey. A radiation
protection survey shall be performed by a therapeutic radiological physicist on
each accelerator. The registrant shall maintain at the facility a copy of the
most recent radiation protection survey report for review by the Agency.
Radiation protection surveys shall meet the following additional requirements:
1) For each accelerator installed after
October 15, 1993, a radiation protection survey shall be performed by a
physicist before the system is first used for irradiation of a patient. The
physicist who performs the radiation protection survey shall be a person who
did not consult in the design of the accelerator installation (see subsection
(a)) and is not employed by or within any corporation or partnership with the
person who consulted in the design of the installation.
2) A radiation protection survey shall be
performed by a physicist after any change in the accelerator or facility that
might produce a radiation hazard. Such survey shall be performed before the
system is used to treat patients.
3) The survey report shall include, but need
not be limited to, the following:
A) A
diagram of the facility which details building structures and the position of
the control panel, accelerator and associated equipment;
B) A description of the accelerator system
including the manufacturer, model number, beam type and beam energy
range;
C) A description of the
instrumentation used to determine radiation measurements, including the date
and source of the most recent calibration for each instrument used;
D) Conditions under which radiation
measurements were taken;
E) Survey
data including:
i) Projected weekly dose
equivalent in areas adjacent to the therapy room; and
ii) A description of workload, use and
occupancy factors employed in determining the projected weekly dose
equivalent.
4) The registrant shall retain a copy of the
radiation protection survey report and a copy of the report shall be provided
to the Agency within 30 days after completion of the survey.
5) Any deficiencies detected during the
radiation protection survey that would constitute or result in a violation of
32 Ill. Adm. Code 340 shall be corrected prior to using the machine for
treatment of patients.
6) The
facility shall be operated in compliance with any limitations indicated by the
therapeutic radiological physicist as a result of the radiation protection
survey.
d) Machine
Calibration. Calibration measurements shall be performed on each accelerator
system by a therapeutic radiological physicist before the therapy system is
first used for irradiation of a patient. Subsequent calibrations shall be
performed at intervals not exceeding 1 year.
1) Calibration measurements shall include,
but need not be limited to, the following determinations:
A) Verification that the equipment is
operating in compliance with the design specifications concerning the light
localizer, variation in the axes of rotation for the table, gantry and jaw
system and the beam flatness and symmetry at the specified depth;
B) The absorbed dose rate at various depths
in water for the range of field sizes used, for each beam type and
energy;
C) The uniformity of the
radiation field and any dependency upon the direction of the beam;
D) Verification that existing depth-dose data
and isodose charts applicable to the specific machine continue to be valid or
are updated to existing machine conditions; and
E) Verification of transmission factors for
all accessories such as wedges, shadow trays and compensators, as
applicable.
2)
Calibration radiation measurements shall be performed using a dosimetry system
that has been calibrated by a calibration laboratory accredited by the American
Association of Physicists in Medicine (AAPM), and meets the requirements of
either subsection (d)(2)(A) or (B):
A) The
calibration shall have been performed within the previous 2 years and after any
servicing that may have affected calibration of the dosimetry system;
or
B) The dosimetry system shall
have been calibrated within the previous 4 years and shall have been:
i) Compared at annual intervals following the
calibration to a dosimetry system with calibration obtained within the previous
2 years from a calibration laboratory accredited by the AAPM, and the results
of the comparison indicate the calibration factor has not changed by more than
two percent; or
ii) Subjected to a
testing protocol that has been established by a therapeutic radiological
physicist and that provides for checks of dosimetry constancy and provides for
corrective action when results deviate more than two percent from the expected
values.
AGENCY NOTE: Redundancy is a basic tenet of radiation
dosimetry, therefore the therapeutic radiological physicist should establish a
program of inter-comparison and constancy testing of calibrated dosimetry
instruments to assure, as much as possible, the accuracy, reliability and
reproducibility of the measurements performed with those instruments.
3)
Calibration of the radiation output of the accelerator shall be performed in
accordance with:
A) The protocol of Task
Group 21, Radiation Therapy Committee, American Association of Physicists in
Medicine (AAPM), entitled "A Protocol for the Determination of Absorbed Dose
from High-Energy Photon and Electron Beams" published in Medical Physics,
Volume 10, pages 741-771 (1983), exclusive of subsequent amendments or
editions; or
B) The protocol of the
Scientific Committee on Radiation Dosimetry of the AAPM, entitled "Protocol for
the Dosimetry of X and Gamma Ray Beams with Maximum Energies Between 0.6 and 50
MeV", published in Physics, Medicine, and Biology, Volume 16, pages 379-396
(1971), exclusive of subsequent amendments or editions; or
C) Other machine calibration protocols
provided that the registrant has submitted the protocols to the Agency and the
protocols cover the same topics as those contained in subsections (d)(3)(A) and
(B).
AGENCY NOTE: Copies of the two protocols referenced in
subsections (d)(3)(A) and (B) are available for public inspection at the
Illinois Emergency Management Agency, 1035 Outer Park Drive, Springfield,
Illinois. The protocols may also be obtained directly from the AAPM, One
Physics Ellipse, College Park MD 20740-3846.
4) The radiation output of each therapy
system shall be independently verified at intervals not to exceed 2 years.
Independent verification shall consist of:
A)
Verification of the machine output by a therapeutic radiological physicist who
is not employed at the facility and does not perform the annual calibration;
or
B) Alternate methods of
verification of machine output, such as the use of mailed dosimetry devices,
that use devices and procedures approved by the AAPM.
5) Machine calibration records shall include
identification of the accelerator calibrated, the results of the tests
specified in subsection (d)(1) and shall be signed and dated by the therapeutic
radiological physicist who performed the calibration.
6) The registrant shall maintain at the
facility, for a period of 5 years, records of machine calibrations, instrument
calibrations and independent verifications of machine output for inspection by
the Agency.
e) Quality
Assurance Checks. A quality assurance (QA) check shall be performed by a
therapeutic radiological physicist on each therapy system each calendar month.
The interval between QA checks shall not exceed 45 days. QA checks shall also
be performed after any change which could affect the radiation output, spatial
distribution or other characteristics of the therapy beam, as determined by the
physicist. Quality assurance checks shall also meet the following requirements:
1) Quality assurance checks shall include
determination of:
A) The radiation output for
a set of operating conditions specified by a therapeutic radiological
physicist; and
B) The coincidence
of the radiation field and the field indicated by the localizing
device.
2) Radiation
measurements shall be obtained using a dosimetry system that:
A) Meets the requirements of subsection
(d)(2); or
B) Has been directly
compared by a therapeutic radiological physicist within the previous year with
a dosimetry system which meets the requirements of subsection (d)(2).
3) The therapeutic radiological
physicist shall establish criteria for quality assurance check measurements and
shall determine corrective actions to be implemented if the criteria are
exceeded.
4) The registrant shall
retain a record of quality assurance check measurements for inspection by the
Agency for a period of 5 years. The record shall include the date of the
quality assurance check, identification of the accelerator, results of the
quality assurance check measurements and the signature of the individual who
performed the quality assurance check.
f) Quality Control. A comprehensive quality
control program shall be implemented as specified by a therapeutic radiological
physicist and shall meet the following requirements:
1) The program shall be designed to test the
operation and performance of the accelerator in order to maintain radiation
safety and clinical reliability. The program shall include as a minimum the
items listed in Section 360. Appendix E.
2) The physicist shall specify the tolerance
and frequency of performance for each item of the quality control
program.
3) The physicist shall
specify what actions are to be taken for any item exceeding the specified
tolerance.
4) The physicist shall
review, sign and date the results of the quality control program each calendar
month.
AGENCY NOTE: The elements of a comprehensive quality control
program are described in Report No. 13 published by the AAPM, entitled
"Physical Aspects of Quality Assurance in Radiation Therapy" (1984). A copy of
this report is available for public inspection at the Illinois Emergency
Management Agency, 1035 Outer Park Drive, Springfield, Illinois. Report No. 13
may also be obtained directly from the AAPM, One Physics Ellipse, College Park
MD 20740-3846.
g) Operating Procedures. The registrant shall
have a therapeutic radiological physicist establish written operating and
emergency procedures and shall ensure that the procedures are implemented
before the accelerator is used for treatment of patients. Operators of
accelerators shall receive training in the application of the procedures before
using the accelerator to irradiate patients. A copy of the current operating
and emergency procedures shall be maintained at the treatment control panel for
use and review.
1) Operating procedures to be
implemented shall include instructions that:
A) The accelerator is used in such a manner
that patients, workers and the general public are protected from radiation
hazards and the provisions of 32 Ill. Adm. Code 340 are met;
B) No accelerator shall be left unattended
unless it is secured against unauthorized use;
C) The safety interlock system shall not be
used to turn off the beam except in an emergency;
D) The safety interlocks and warning systems
required in subsections (a)(3), (a)(4) and (a)(9) shall be tested for proper
operation at monthly intervals;
E)
Mechanical supporting or restraining devices shall be used when a patient must
be held in position for radiation therapy;
F) No individual other than the patient shall
be in the therapy room during irradiation;
G) Start-up procedures for the accelerator,
specified by the therapeutic radiological physicist, shall be performed daily
prior to treatment of patients; and
H) The accelerator shall not be used for
treatment of patients unless the operator can maintain visual observation of
the patient and audible communication with the patient.
2) Emergency procedures shall include
instructions for alternate methods for termination of irradiation and machine
movements.
AGENCY NOTE: The operating and emergency procedures should
contain as a minimum the machine manufacturer's operations manual for the
accelerator.
3) Operating
and emergency procedures shall include instructions for contacting the
therapeutic radiological physicist when operational problems or emergencies
occur and the actions that are to be taken until the physicist can be
contacted.
h) Machine
Maintenance. The therapeutic radiological physicist shall establish accelerator
maintenance procedures that meet the following requirements:
1) Whenever service or maintenance is
performed on the accelerator, a therapeutic radiological physicist shall be
notified of such service or maintenance.
2) Following completion of service or
maintenance involving radiation beam generation, beam steering or monitoring of
the beam, but before the accelerator is again used for treatment of patients,
the therapeutic radiological physicist shall review the service or maintenance
report and shall determine whether a calibration or quality assurance check is
necessary to verify the characteristics of the beams. If the therapeutic
radiological physicist determines that a calibration or quality assurance check
is necessary, the calibration or quality assurance check shall be performed
before the accelerator is again used for treatment of patients.
3) The therapeutic radiological physicist
shall establish the frequency of routine maintenance and ensure that records of
all service and maintenance performed on the machine are maintained at the
facility.
4) The therapeutic
radiological physicist shall sign and date records of all service and
maintenance performed on the machine.
5) The therapeutic radiological physicist
shall specify the qualifications of maintenance personnel and prohibit
non-qualified personnel from repairing the machine or adjusting parameters on
the machine.
6) Circuit diagrams of
the accelerator and interlock systems shall be maintained at the facility and
kept current.
i) Quality
Management Program. Each registrant shall develop, implement, and maintain a
quality management program to provide high confidence that radiation will be
administered as directed by the physician. The quality management program shall
address, as a minimum, the following specific objectives:
1) Written Directives. A written directive
must be dated and signed by a physician prior to the administration of
radiation.
A) A written directive must contain
the patient or human research subject's name, the type and energy of the beam,
the total dose, dose per fraction, treatment site, and number of
fractions.
B) A written revision to
an existing written directive may be made provided that the revision is dated
and signed by a physician prior to the administration of the external beam
dose, or the next fractional dose.
C) An oral revision to an existing written
directive is acceptable provided that:
i) a
delay in providing a written revision would jeopardize the patient's health;
and
ii) the oral revision is
documented as soon as possible in writing in the patient's record;
and
iii) a revised written
directive is signed by a physician within 48 hours after the oral
revision.
D) The
registrant shall retain a copy of each written directive for 3 years.
2) Procedures for Administrations.
The registrant shall develop, implement, and maintain written procedures to
provide high confidence that:
A) Prior to the
administration of each course of radiation treatments, the patient's or human
research subject's identity is verified by more than one method as the
individual named in the written directive;
B) Each administration is in accordance with
the written directive;
C) External
beam radiation therapy final plans of treatment and related calculations are in
accordance with the respective written directives;
D) Any unintended deviation from the written
directive is identified and evaluated, and appropriate action is taken;
and
E) The registrant retains a
copy of the procedures for administrations for three years.
3) Reports and Notifications of
Medical Events
A) A registrant shall report
any event in which the administration of therapeutic radiation machine
radiation results, or will result, in unintended permanent functional damage to
an organ or a physiological system, as determined by a physician.
B) Other than events that result from
intervention by a patient or human research subject, a registrant shall report
any event in which:
i) The administration of a
therapeutic radiation machine therapy dose involves the wrong patient, wrong
treatment modality, or wrong treatment site; or
ii) The calculated weekly administered dose
differs from the weekly prescribed dose by more than (30%); or
iii) The calculated total administered dose
differs from the total prescribed dose by more than (20%) of the total
prescribed dose;
C) The
registrant shall notify the Agency by telephone no later than
the next calendar day after the discovery of a medical
event.
D) The registrant
shall submit a written report to the Agency within 15 days after the discovery
of a medical event. The written report must include:
i) The registrant's name;
ii) The name of the prescribing
physician;
iii) A brief description
of the event;
iv) Why the event
occurred;
v) The effect, if any, on
the individuals who received the administration;
vi) Actions, if any, that have been taken, or
are planned, to prevent recurrence;
vii) Certification that the registrant
notified the individual (or the individual's responsible relative or guardian)
and if not, why not.
E)
The report shall not contain the individual's name or any other information
that could lead to the identification of the individual.
F) The registrant shall provide notification
of the event to the referring physician and shall notify the individual who is
the subject of the medical event no later than 24 hours after its discovery,
unless the referring physician personally informs the registrant either that he
or she will inform the individual or that, based on medical judgment, telling
the individual would be harmful. The registrant is not required to notify the
individual without first consulting the referring physician. If the referring
physician or the affected individual cannot be reached within 24 hours, the
registrant shall notify the individual as soon as possible thereafter. The
registrant may not delay any appropriate medical care for the individual,
including any necessary remedial care required as a result of the medical
event, because of any delay in notification. To meet the requirements of this
subsection (i)(3)(F), the notification of the individual who is the subject of
the medical event may be made instead to that individual's responsible relative
or guardian. If a verbal notification is made, the registrant shall inform the
individual, or appropriate responsible relative or guardian, that a written
description of the event can be obtained from the registrant upon request. The
registrant shall provide the written description if requested.
G) Aside from the notification requirement,
nothing in this Section affects any rights or duties of registrants and
physicians in relation to each other, to an individual affected by the medical
event, or to that individual's responsible relatives or guardians.
H) The registrant shall retain a record of a
medical event in accordance with subsection (i)(4). A copy of the record
required shall be provided to the referring physician, if other than the
registrant, within 15 days after discovery of the medical event.
I) The registrant shall annotate a copy of
the report provided to the Agency with:
i) The
name of the individual who is the subject of the event;
ii) The social security number or other
identification number, if one has been assigned, of the individual who is the
subject of the event; and
iii) A
copy of the annotated report to the referring physician, if other than the
registrant, no later than 15 days after the discovery of the event.
4) Records of Medical
Events. A registrant shall retain a record of medical events for 3 years. The
record must contain the following:
A) The
registrant's name and the names of the individuals involved;
B) The social security number or other
identification number, if one has been assigned, of the individual who is the
subject of the medical event;
C) A
brief description of the event; why it occurred; the effect, if any, on the
individual;
D) The actions, if any,
taken or planned to prevent recurrence; and
E) Whether the registrant notified the
individual (or the individual's responsible relative or guardian) and, if not,
whether such failure to notify was based on guidance from the referring
physician.