Wis. Admin. Code Department of Health Services DHS 157.67 - Photon emitting remote afterloader, teletherapy and gamma stereotactic radiosurgery units
(1) USE OF A SEALED SOURCE IN A REMOTE
AFTERLOADER, TELETHERAPY OR GAMMA STEREOTACTIC RADIOSURGERY UNIT.
(a) A licensee shall use sealed sources in
photon emitting remote afterloader units, teletherapy units or gamma
stereotactic units for therapeutic medical uses that meet any of the following
criteria:
1. Is approved in the sealed source
and device registry.
Note: The sealed source and device registrations may be obtained from the manufacturer or by writing the department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659.
2. In research involving photon-emitting
remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery
units in accordance with an active effective investigational device exemption
application accepted by the FDA provided the requirements of s. DHS 157.61 (6)
(a) are met.
Note: The FDA requirements for investigational devices may be found at: http://www.fda.gov/radiation-emittingproducts/default.htm.
(b) A licensee shall use
photon-emitting remote afterloader units, teletherapy units, or
gammastereotactic radiosurgery units that meet any of the following criteria:
1. Is approved in the sealed source and
device registry to deliver a therapeutic dose for medical use. These devices
may be used for therapeutic medical treatments that are not explicitly provided
for in the sealed source and device registry, but must be used in accordance
with radiation safety conditions and limitations described in the sealed source
and device registry.
2. In research
in accordance with an active investigational device exemption application
accepted by the FDA and provided the requirements of s. DHS 157.61 (6) are
met.
(2)
SURVEYS OF PATIENTS AND HUMAN RESEARCH SUBJECTS TREATED WITH A REMOTE
AFTERLOADER UNIT.
(a) Before releasing a
patient or a human research subject from licensee control, a licensee shall
make a survey of the patient or the human research subject and the remote
afterloader unit with a portable radiation detection survey instrument to
confirm that the source has been removed from the patient or human research
subject and returned to the safe shielded position.
(b) A licensee shall retain a record of the
surveys under s. DHS 157.71 (16).
(3) INSTALLATION, MAINTENANCE, ADJUSTMENT AND
REPAIR.
(a) A person shall be specifically
licensed by the department, NRC or another agreement state to install,
maintain, adjust or repair a remote afterloader unit, teletherapy unit or gamma
stereotactic radiosurgery unit that involves work on the source shielding, the
source driving unit used to move the source or other electronic or mechanical
component that could expose the source, reduce the shielding around the source
or compromise the radiation safety of the unit or the source.
(b) Except for low dose-rate remote
afterloader units, only a person specifically licensed by the department, NRC
or another agreement state may install, replace, relocate or remove a sealed
source or source contained in other remote afterloader units, teletherapy units
or gamma stereotactic units.
(c)
For a low dose-rate remote afterloader unit, only a person specifically
licensed by the department, NRC or another agreement state, or an authorized
medical physicist, shall install, replace, relocate or remove a sealed source
contained in the unit.
(d) A
licensee shall retain a record of the installation, maintenance, adjustment and
repair done on remote afterloader units, teletherapy units and gamma
stereotactic radiosurgery units under s. DHS 157.71 (19).
(4) SAFETY PROCEDURES AND INSTRUCTIONS FOR
REMOTE AFTERLOADER, TELETHERAPY AND GAMMA STEREOTACTIC RADIOSURGERY UNITS.
(a) A licensee shall do all of the following:
1. Secure the unit, console, console keys and
the treatment room when unattended or not in use.
2. Permit only individuals approved by the
authorized user, radiation safety officer or authorized medical physicist to be
present in the treatment room during treatment with the source.
3. Prevent dual operation of more than one
radiation producing device in a treatment room, if applicable.
4. Develop, implement and maintain written
procedures for responding to an abnormal situation when the operator is unable
to place the source in the shielded position or remove the patient or human
research subject from the radiation field with controls from outside the
treatment room. The procedure shall include all the following:
a. Instructions for responding to equipment
failures and the names of the persons responsible for implementing corrective
actions.
b. The process for
restricting access to and posting signs in the proximity of the treatment area
to minimize the risk of inadvertent exposure.
c. The names and telephone numbers of the
authorized users, the authorized medical physicist and the radiation safety
officer to be contacted if the unit or console operates
abnormally.
(b)
A copy of the procedures required by par. (a) 4. shall be physically located at
the unit console.
(c) A licensee
shall post instructions at the unit console to inform the operator of both of
the following:
1. The location of the
procedures required by par. (a) 4.
2. The names and telephone numbers of the
authorized users, the authorized medical physicist and the radiation safety
officer to be contacted if the unit or console operates
abnormally.
(d) A
licensee shall provide operational and safety instruction, initially and at
least annually, at intervals not to exceed 13 months, to all persons who
operate the unit, as appropriate to the person's assigned duties, in all of the
following:
1. The procedures identified in
par. (a) 4.
2. The operating
procedures for the unit.
(e) A licensee shall ensure that operators,
authorized medical physicists and authorized users participate in drills of the
emergency procedures, initially and at least annually, at intervals not to
exceed 13 months, thereafter.
(f) A
licensee shall retain a record of individuals receiving instruction required
under s. DHS 157.71 (15).
(g) Prior
to the first use for patient treatment of a new unit or an existing unit with a
manufacturer upgrade that affects the operation and safety of the unit, a
licensee shall ensure that vendor operational and safety training is provided
to all individuals who will operate the unit. The vendor operational and safety
training must be provided by the device manufacturer or by an individual
certified by the device manufacturer to provide the operational and safety
training.
(h) A licensee shall
retain a copy of the procedures required by pars. (a) 4. and (d) 2. until the
licensee no longer possesses the remote afterloader, teletherapy unit, or gamma
stereotactic radiosurgery unit.
(5) SAFETY PRECAUTIONS FOR REMOTE
AFTERLOADER, TELETHERAPY AND GAMMA STEREOTACTIC RADIOSURGERY UNITS.
(a) A licensee shall control access to the
treatment room by a door at each entrance.
(b) A licensee shall equip each entrance to
the treatment room with an electrical interlock system that accomplishes all
the following:
1. Prevents the operator from
initiating the treatment cycle unless each treatment room entrance door is
closed.
2. Causes the source to be
shielded promptly when an entrance door is opened.
3. Prevents the source from being exposed
following an interlock interruption until all treatment room entrance doors are
closed and the source on-off control is reset at the
console.
(c) A licensee
shall require any person entering the treatment room to assure, via appropriate
radiation monitors, that radiation levels have returned to ambient
levels.
(d) Except for low-dose
remote afterloader units, a licensee shall construct or equip each treatment
room with viewing and intercom systems to permit continuous observation of the
patient or the human research subject from the treatment console during
irradiation.
(e) For licensed
activities where sources are placed within the patient's or human research
subject's body, a licensee shall only conduct treatments that allow for
expeditious removal of a decoupled or jammed source.
(f) A licensee shall do all the following:
1. For medium dose-rate and pulsed dose-rate
remote afterloader units, require all the following:
a. An authorized medical physicist and either
an authorized user or a physician, under the supervision of an authorized user,
who has been trained in the operation and emergency response for the unit to be
physically present during the initiation of all patient treatments involving
the unit.
b. An authorized medical
physicist and either an authorized user or a person under the supervision of an
authorized user who has been trained to remove the source applicator in the
event of an emergency involving the unit to be immediately available during
continuation of all patient treatments involving the unit.
2. For high dose-rate remote afterloader
units, require all the following:
a. An
authorized user and an authorized medical physicist to be physically present
during the initiation of all patient treatments involving the unit.
b. An authorized medical physicist and either
an authorized user or a physician, under the supervision of an authorized user,
who has been trained in the operation and emergency response for the unit to be
physically present during continuation of all patient treatments involving the
unit.
3. For gamma
stereotactic radiosurgery units, require an authorized user and an authorized
medical physicist to be physically present throughout all patient treatments
involving the unit.
4. Notify the
radiation safety officer or his or her designee and an authorized user
immediately if the patient or human research subject has a medical emergency or
if the patient dies.
(g)
A licensee shall have available near each treatment room, emergency response
equipment, as applicable, to respond to all of the following:
1. A source inadvertently remaining in the
unshielded position.
2. A source
inadvertently lodged within the patient following completion of the
treatment.
(6)
DOSIMETRY EQUIPMENT.
(a) Except for low
dose-rate remote afterloader sources where the source output or activity is
determined by the manufacturer, a licensee shall have a calibrated dosimetry
system available for use. To satisfy this requirement, one of the following
conditions shall be met:
1. The system shall
have been calibrated using a system or source traceable to the national
institute of standards and technology and published protocols accepted by
nationally recognized bodies, or by a calibration laboratory accredited by the
American association of physicists in medicine. The calibration shall have been
performed within the previous 2 years and after any servicing that may have
affected system calibration.
Note: An example of a nationally recognized body is the American Association of Physicists in Medicine.
2. The system shall have been calibrated
within the previous 4 years. Eighteen to 30 months after that calibration, the
system shall have been compared to another dosimetry system that was calibrated
within the past 24 months by the national institute of standards and technology
or by a calibration laboratory accredited by the American association of
physicists in medicine. The results of the comparison shall have indicated that
the calibration factor of the licensee's system had not changed by more than
2%. A licensee may not use the intercomparison result to change the calibration
factor. When comparing dosimetry systems to be used for calibrating sealed
sources for therapeutic units, a licensee shall use a comparable unit with beam
attenuators or collimators, as applicable, and sources of the same radionuclide
as the source used at the licensee's facility.
(b) A licensee shall have available for use a
dosimetry system for spot-check output measurements to periodically measure the
radiation output of the device for consistency, if applicable. To satisfy this
requirement, the system may be compared with a system that has been calibrated
under par. (a). The comparison shall have been performed within the previous 12
months and after each servicing that may have affected system calibration. The
spot-check system may be the same system used to meet the requirement in par.
(a).
(c) A licensee shall retain a
record of each calibration and comparison under s. DHS 157.71 (20).
(7) FULL
CALIBRATION MEASUREMENTS ON TELETHERAPY UNITS.
(a) A licensee authorized to use a
teletherapy unit for medical use shall perform full calibration measurements on
each teletherapy unit under any of the following circumstances:
1. Before the first medical use of the
unit.
2. Before medical use under
all of the following conditions:
a. Whenever
spot-check measurements indicate that the output differs by more than 5% from
the output obtained at the last full calibration corrected mathematically for
radioactive decay.
b. Following
replacement of the source or following reinstallation of the teletherapy unit
in a new location.
c. Following any
repair of the teletherapy unit that includes removal of the source or major
repair of the components associated with the source exposure
assembly.
3. At intervals
not exceeding one year.
(b) To satisfy the requirements of par. (a),
full calibration measurements shall include determination of all of the
following:
1. The output within plus or minus
3% for the range of field sizes and for the distance or range of distances used
for medical use.
2. The coincidence
of the radiation field and the field indicated by the light beam localizing
device.
3. The uniformity of the
radiation field and its dependence on the orientation of the useful
beam.
4. Timer accuracy and
linearity over the range of use.
5.
On-off error.
6. The accuracy of
all distance measuring and localization devices in medical
use.
(c) A licensee shall
use the dosimetry system described in sub. (6) (a) to measure the output for
one set of exposure conditions. The remaining radiation measurements required
in par. (b) may be made using a dosimetry system that indicates relative dose
rates.
(d) A licensee shall perform
a full calibration required by par. (a) under published protocols accepted by
nationally recognized bodies.
Note: An example of such a nationally recognized body is the American Association of Physicists in Medicine.
(e) A licensee
shall mathematically correct the outputs determined in par. (b) 1. for physical
decay for intervals not exceeding one month for cobalt-60, 6 months for
cesium-137 or at intervals consistent with one percent decay for all other
nuclides.
(f) Full calibration
measurements required by par. (a) and physical decay corrections required by
par. (e) shall be performed by an authorized medical physicist.
(g) A licensee shall retain a record of each
calibration under s. DHS 157.71 (21).
(8) FULL CALIBRATION MEASUREMENTS ON REMOTE
AFTERLOADER UNITS.
(a) A licensee authorized
to use a remote afterloader unit for medical use shall perform a full
calibration measurement on each unit under any of the following circumstances:
1. Before the first medical use of the
unit.
2. Before medical use under
all the following conditions:
a. Following
replacement of any source or following reinstallation of the unit in a new
location outside the facility.
b.
Following any repair of the unit that includes removal of the source or major
repair of the components associated with the source exposure
assembly.
3. Each
calendar quarter, at intervals not exceeding 100 days for high dose-rate,
medium dose-rate and pulsed dose-rate remote afterloader units with sources
whose half-life exceeds 75 days.
4.
At intervals not exceeding one year for low dose-rate remote afterloader
units.
(b) To satisfy the
requirement of par. (a), a full calibration measurement shall include, as
applicable, determination of all the following:
1. The output within 5%.
2. Source positioning accuracy to within plus
or minus one millimeter.
3. Source
retraction with backup battery upon power failure.
4. Length of the source transfer
tubes.
5. Timer accuracy and
linearity over the typical range of use.
6. Length of the applicators.
7. Function of the source transfer tubes,
applicators and transfer tube-applicator interfaces.
(c) In addition to the requirement for full
calibration for low dose-rate remote afterloader units in par. (b), a licensee
shall perform an autoradiograph of the source to verify inventory and source
arrangement at intervals not exceeding one calendar quarter.
(d) A licensee shall use the dosimetry system
described in sub. (6) (a) to measure the output.
(e) A licensee shall make a full calibration
measurement required by par. (a) under published protocols accepted by
nationally recognized bodies.
(f)
For low dose-rate remote afterloader units, a licensee may use measurements
provided by the source manufacturer that are made under pars. (a) to
(e).
(g) A licensee shall
mathematically correct the outputs determined in par. (b) 1. for physical decay
at intervals consistent with one percent physical decay.
(h) A full calibration measurement required
by par. (a) and physical decay correction required by par. (g) shall be
performed by the authorized medical physicist.
(i) A licensee shall retain a record of each
calibration under s. DHS 157.71 (21).
(j) In addition to the requirements for full
calibration for low dose rate remote afterloaders, as specified in par. (b), a
licensee shall perform an autoradiograph of the source or sources to verify
inventory and source arrangement at intervals not to exceed 3
months.
(9) FULL
CALIBRATION MEASUREMENTS ON GAMMA STEREOTACTIC RADIOSURGERY UNITS.
(a) A licensee authorized to use a gamma
stereotactic radiosurgery unit for medical use shall perform full calibration
measurements on each unit under any of the following circumstances:
1. Before the first medical use of the
unit.
2. Before medical use under
all of the following conditions:
a. Whenever
spot-check measurements indicate that the output differs by more than 5% from
the output obtained at the last full calibration corrected mathematically for
radioactive decay.
b. Following
replacement of the sources or following reinstallation of the gamma
stereotactic radiosurgery unit in a new location.
c. Following any repair of the gamma
stereotactic radiosurgery unit that includes removal of the sources or major
repair of the components associated with the source
assembly.
3. At intervals
not exceeding one year, with the exception that relative helmet factors need
only be determined before the first medical use of a helmet and following any
damage to the helmet.
(b)
To satisfy the requirement of par. (a), a full calibration measurement shall
include determination of all the following:
1. The output within plus or minus
3%.
2. Relative helmet factors to
verify that the helmet material provides the required shielding to the
patient.
3. Isocenter coincidence
to confirm the centering accuracy of the radiation beam relative to the helmet
openings.
4. Timer accuracy and
linearity over the range of use.
5.
On-off error.
6. Trunnion
centricity to determine the rotational center of the source relative to the
helmet openings.
7. Treatment table
retraction mechanism, using backup battery power or hydraulic backups with the
main power to the unit off.
8.
Helmet microswitches to determine if the switches terminate the radiation beam
when tripped by unintended movement of the helmet.
9. Emergency timing circuits.
10. Stereotactic frames and localizing
devices (trunnions).
(c)
A licensee shall use the dosimetry system described in sub. (6) (a) to measure
the output for one set of exposure conditions. The remaining radiation
measurements required in par. (b) 1. may be made using a dosimetry system that
indicates relative dose rates.
(d)
A licensee shall make a full calibration measurement required by par. (a) under
published protocols accepted by nationally recognized bodies.
Note: An example of such a nationally recognized body is the American Association of Physicists in Medicine.
(e) A licensee
shall mathematically correct the outputs determined in par. (b) 1. at intervals
not exceeding one month for cobalt-60 and at intervals consistent with one
percent physical decay for all other radionuclides.
(f) A full calibration measurement required
by par. (a) and physical decay correction required by par. (e) shall be
performed by an authorized medical physicist.
(g) A licensee shall retain a record of each
calibration under s. DHS 157.71 (21).
(10) PERIODIC SPOT-CHECKS FOR TELETHERAPY
UNITS.
(a) A licensee authorized to use
teletherapy units for medical use shall perform output spot-checks on each
teletherapy unit once in each calendar month that include determination of all
of the following:
1. Timer constancy and
timer linearity over the range of use.
2. On-off error.
3. The coincidence of the radiation field and
the field indicated by the light beam localizing device.
4. The accuracy of all distance measuring and
localization devices used for medical use.
5. The output for one typical set of
operating conditions measured with the dosimetry system described in sub. (6)
(b).
6. The difference between the
measurement made in this subd. 5. and the anticipated output expressed as a
percentage of the anticipated output, which is the value obtained at last full
calibration corrected mathematically for physical decay.
(b) A licensee shall perform measurements
required by par. (a) under procedures established by the authorized medical
physicist. The authorized medical physicist need not actually perform the spot
check measurements.
(c) A licensee
shall have the authorized medical physicist review the results of each
spot-check within 15 working days. The authorized medical physicist shall
notify the licensee in writing of the results of each spot-check within 10
working days.
(d) A licensee
authorized to use a teletherapy unit for medical use shall perform safety
spot-checks of each teletherapy facility once in each calendar month and after
each source installation to assure proper operation of all of the following:
1. Electrical interlocks at each teletherapy
room entrance.
2. Electrical or
mechanical stops installed to limit use of the primary beam of radiation.
Note: Examples of the limitations in subd. 2. include restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism.
3. Source exposure indicator lights on the
teletherapy unit, on the control console and in the facility.
4. Viewing and intercom systems.
5. Treatment room doors from inside and
outside the treatment room.
6.
Electrically assisted treatment room doors with the teletherapy unit electrical
power turned off.
(e) If
the results of the checks required in par. (d) indicate the malfunction of any
system, a licensee shall lock the control console in the off position and not
use the unit except as may be necessary to repair, replace or check the
malfunctioning system.
(f) A
licensee shall retain a record of each spot-check required by pars. (a) and
(d), under s. DHS 157.71 (22).
(11) PERIODIC SPOT-CHECKS FOR REMOTE
AFTERLOADER UNITS.
(a) A licensee authorized
to use remote afterloader units for medical use shall perform a spot-check of
each remote afterloader facility and on each unit according to the following
criteria:
1. At the beginning of each day of
use of a high dose-rate, medium dose-rate or pulsed dose-rate remote
afterloader unit.
2. Prior to each
patient treatment with a low dose-rate remote afterloader unit.
3. After each source
installation.
(b) A
licensee shall have an authorized medical physicist establish written
procedures for performing the spot-checks required in par. (a) of this section.
The authorized medical physicist need not actually perform the spot check
measurements.
(c) To satisfy the
requirements of par. (a), a spot-check shall assure proper operation of all of
the following:
1. Electrical interlocks at
each remote afterloader unit room entrance.
2. Source exposure indicator lights on the
remote afterloader unit, on the control console and in the facility.
3. Viewing and intercom systems in each high
dose-rate, medium dose-rate and pulsed dose-rate remote afterloader
facility.
4. Emergency response
equipment.
5. Radiation monitors
used to indicate the source position.
6. Timer accuracy.
7. The date and time of the clock in the
unit's computer.
8. Decayed source
activity in the unit's computer.
(d) If the results of the checks required in
par. (c) indicate the malfunction of any system, a licensee shall lock the
control console in the off position and not use the unit except as necessary to
repair, replace or check the malfunctioning system.
(e) A licensee shall retain a record of each
check required by par. (c) under s. DHS 157.71 (23).
(f) A licensee shall have an authorized
medical physicist review the results of each spot-check within 15 working days
of the spot check. The authorized medical physicist shall notify the licensee
as soon as possible in writing of the results of each
spot-check.
(12) PERIODIC
SPOT-CHECKS FOR GAMMA STEREOTACTIC RADIOSURGERY UNITS.
(a) A licensee authorized to use a gamma
stereotactic radiosurgery unit for medical use shall perform spot-checks of
each gamma stereotactic radiosurgery facility and on each unit at all of the
following times:
1. Monthly.
2. At the beginning of each day of
use.
3. After each source
installation.
(b) A
licensee shall have an authorized medical physicist do all the following:
1. Establish written procedures for
performing the spot-checks required in par. (a).
2. Review the results of each spot-check
required by par. (a) 1. within 15 working days of the check. The authorized
medical physicist need not actually perform the spot-check
measurements.
3. The authorized
medical physicist shall notify the licensee as soon as possible in writing of
the results of the spot check.
(c) To satisfy the requirements of par. (a)
1., a spot-check shall do all of the following:
1. Assure proper operation of treatment table
retraction mechanism, using backup battery power or hydraulic backups with the
unit off; helmet microswitches; emergency timing circuits and stereotactic
frames and localizing devices.
2.
Determine all of the following:
a. The output
for one typical set of operating conditions measured with the dosimetry system
described in sub. (6) (b).
b. The
difference between the measurement made in subd. 2. a. and the anticipated
output expressed as a percentage of the anticipated output.
c. Source output against computer
calculation.
d. Timer accuracy and
linearity over the range of use.
e.
On-off error.
f. Trunnion
centricity.
(d)
To satisfy the requirements of par. (a) 2. and 3., a spot-check shall assure
proper operation of all of the following:
1.
Electrical interlocks at each gamma stereotactic radiosurgery room
entrance.
2. Source exposure
indicator lights on the gamma stereotactic radiosurgery unit, on the control
console and in the facility.
3.
Viewing and intercom systems.
4.
Timer termination of the radiation beam.
5. Radiation monitors used to indicate room
exposures.
6. Emergency off
buttons.
(e) A licensee
shall arrange for prompt repair of any system identified in par. (c) or (d)
that is not operating properly.
(f)
If the results of the checks required in par. (d) indicate the malfunction of
any system, a licensee shall lock the control console in the off position and
not use the unit except as may be necessary to repair, replace or check the
malfunctioning system.
(g) A
licensee shall retain a record of each check required by pars. (c) and (d)
under s. DHS 157.71 (24).
(13) ADDITIONAL TECHNICAL REQUIREMENTS FOR
MOBILE REMOTE AFTERLOADER UNITS.
(a) A
licensee providing mobile remote afterloader service shall do all of the
following:
1. Check survey instruments before
medical use at each client's address of use or on each day of use, whichever is
more frequent.
2. Account for all
sources before departure from a client's address of use.
(b) In addition to the periodic spot-checks
required by sub. (11), a licensee authorized to use mobile afterloaders for
medical use shall perform checks on each remote afterloader unit before use at
each address. A check shall be made to verify the operation of all the
following:
1. Electrical interlocks on
treatment area access points.
2.
Source exposure indicator lights on the remote afterloader unit, on the control
console and in the facility.
3.
Viewing and intercom systems.
4.
Applicators, source transfer tubes and transfer tube-applicator
interfaces.
5. Radiation monitors
used to indicate room exposures.
6.
Accuracy of source positioning.
7.
Radiation monitors used to indicate whether the source has returned to a safe
shielded position.
(c) A
licensee shall ensure overall proper operation of the remote afterloader unit
by conducting a simulated cycle of treatment before use at each address of
use.
(d) If the results of the
checks required in par. (b) indicate the malfunction of any system, a licensee
shall lock the control console in the off position and not use the unit except
as may be necessary to repair, replace or check the malfunctioning
system.
(e) A licensee shall retain
a record of each check required by par. (b) under s. DHS 157.71 (25).
(14) RADIATION
SURVEYS.
(a) In addition to the survey
requirement in s. DHS 157.25 (1), a person licensed to possess or use photon
emitting remote afterloader, teletherapy or gamma stereotactic radiosurgery
units shall perform surveys of the device and ensure the results of the surveys
from the surface of the main source safe, with the sources in the shielded
position, do not exceed the maximum and average radiation levels listed in the
sealed source and device registry.
(b) A licensee shall make the survey required
by par. (a) at installation of a new source and following repairs to source
shielding, a source driving unit or other electronic or mechanical component
that could expose a source, reduce the shielding around a source or compromise
the radiation safety of the unit or a source.
(c) A licensee shall retain a record of the
radiation surveys required by par. (a) under s. DHS 157.71 (26).
(15) FULL
INSPECTION FOR TELETHERAPY AND GAMMA STEREOTACTIC RADIOTHERAPY UNITS.
(a) A licensee shall have each teletherapy
unit and gamma stereotactic radiosurgery unit inspected for proper operation
and serviced during source replacement to assure proper functioning of the
source exposure mechanism. The intervals between full inspection and servicing
shall not to exceed 5 years for each teletherapy unit and shall not exceed 7
years for each gamma stereotactic radiosurgery unit.
(b) Inspection and servicing of a teletherapy
or gamma stereotactic radiosurgery unit may only be performed by a person
specifically licensed to do so by the department, the NRC or another agreement
state.
(c) A licensee shall keep a
record of the inspection and servicing under s. DHS 157.71 (27).
(16)
THERAPY-RELATED COMPUTER SYSTEMS. A licensee shall perform acceptance testing
on the treatment planning system under published protocols accepted by
nationally recognized bodies. The acceptance testing shall include, as
applicable, verification of all of the following:
(a) Source-specific input parameters required
by the dose calculation algorithm used to calculate the dose to the
patient.
(b) Accuracy of dose,
dwell time of the radioactive source at a particular location and treatment
time calculations at representative points.
(c) Accuracy of isodose graphic plots on
paper and graphic displays.
(d)
Accuracy of the software used to determine radioactive source positions from
radiographic images.
(e) Accuracy
of electronic transfer of the treatment delivery parameters to the treatment
delivery unit from the treatment planning system that was used to calculate the
patient dose and radioactive source dwell times.
Note: An example of such a nationally recognized body is the American Association of Physicists in Medicine.
(17)
TRAINING FOR USE OF REMOTE AFTERLOADER, TELETHERAPY AND GAMMA STEREOTACTIC
RADIOSURGERY UNITS. A licensee shall require an authorized user of a sealed
source for a use authorized under sub. (1) to have received training in device
operation, safety procedures, and clinical use for the type of use for which
authorization is sought. This training requirement may be satisfied by
successful completion of a training program provided by the vendor for new
users or by receiving training supervised by an authorized user or authorized
medical physicist, as appropriate, who is authorized for the type of use for
which the individual is seeking authorization. Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user of a sealed source for
a use authorized under sub. (1) to be a physician who meets any of the
following requirements:
(a) Is certified by a
medical specialty board whose certification process has been recognized by the
department, the NRC or an agreement state. To have its certification process
recognized, a specialty board shall require all candidates for certification to
do all of the following:
1. Successfully
complete a minimum of 3 years of residency training in a radiation therapy
program approved by the Residency Review Committee of the Accreditation Council
for Graduate Medical Education or the Royal College of Physicians and Surgeons
of Canada or the Council of Postdoctoral Training of the American Osteopathic
Association.
2. Pass an
examination, administered by diplomates of the specialty board, which tests
knowledge and competence in radiation safety, radionuclide handling, treatment
planning, quality assurance, and clinical use of stereotactic radiosurgery,
remote afterloaders and external beam therapy.
Note: Specialty boards whose certification processes have been recognized by the Department, the NRC or an agreement state will be posted on the NRC's web site at www.nrc.gov.
(b) Has completed a structured educational
program in basic radionuclide techniques applicable to the use of a sealed
source in a therapeutic medical unit that includes all of the following:
1. Two hundred hours of classroom and
laboratory training in all the following areas:
a. Radiation physics and
instrumentation.
b. Radiation
protection.
c. Mathematics
pertaining to the use and measurement of radioactivity.
d. Radiation biology.
2. Five hundred hours of work experience,
under the supervision of an authorized user who meets the requirements in this
subsection, s. DHS 157.61 (10), or equivalent NRC or agreement state
requirements at a medical facility authorized to use byproduct materials under
sub. (1), involving all of the following:
a.
Reviewing full calibration measurements and periodic spot checks.
b. Preparing treatment plans and calculating
treatment doses and times.
c. Using
administrative controls to prevent a medical event involving the use of
radioactive material.
d.
Implementing emergency procedures to be followed in the event of the abnormal
operation of the medical unit or console.
e. Checking and using survey
meters.
f. Selecting the proper
dose and how it is to be administered.
3. Three years of supervised clinical
experience in radiation therapy under an authorized user who meets the
requirements in this subsection, s. DHS 157.61 (10), or equivalent NRC or
agreement state requirements, as part of a formal training program approved by
the Residency Review Committee for Radiation Oncology of the Accreditation
Council for Graduate Medical Education or Royal College of Physicians and
Surgeons of Canada or the Committee on Postdoctoral Training of the American
Osteopathic Association. This experience may be obtained concurrently with the
supervised work experience required by subd. 2.
4. A written attestation obtained under sub.
(18).
(18)
WRITTEN ATTESTATION. A licensee shall require an authorized user of a sealed
source for a use authorized under sub. (17) to have obtained written
attestation that the individual has successfully completed the requirements in
sub. (17) (b), and has achieved a level of competency sufficient to function
independently as an authorized user of each type of therapeutic medical unit
for which the individual is requesting authorized user status. The attestation
must be obtained from either of the following:
(a) A preceptor authorized user who meets the
requirements in sub. (17), s. DHS 157.61 (10), or equivalent NRC or agreement
state requirements for an authorized user for each type of therapeutic medical
unit for which the individual is requesting authorized user status.
(b) A residency program director who affirms
in writing that the attestation represents the consensus of the residency
program faculty where at least one faculty member is an authorized user who
meets the requirements in sub. (17), s. DHS 157.61 (10), or equivalent NRC or
agreement state requirements user for each type of therapeutic medical unit for
which the individual is requesting authorized user status. The residency
training program must be approved by the Residency Review Committee of the
Accreditation Council for Graduate Medical Education or the Royal College of
Physicians and Surgeons of Canada or the Council on Postdoctoral Training of
the American Osteopathic Association and must include training and experience
specified in sub. (17) (b).
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.