| (C) prevent the sealed source(s) from being exposed
following an interlock interruption until all treatment room entrance
doors are closed and the sealed source(s) "on-off" control is reset
at the console;
(3) require any individual entering the treatment room
to assure, through the use of appropriate radiation monitors, that
radiation levels have returned to ambient levels;
(4) except for low-dose remote afterloader units, 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;
(5) for licensed activities where sealed sources are
placed within the patient's or human research subject's body, only
conduct treatments that allow for expeditious removal of a decoupled
or jammed sealed source;
(6) in addition to the requirements specified in paragraphs
(1) - (5) of this subsection, require the following:
(A) for low dose-rate, medium dose-rate, and pulsed
dose-rate remote afterloader units:
(i) 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, be physically present during the initiation of all patient
treatments involving the unit; and
(ii) an authorized medical physicist, and either an
authorized user or an individual, under the supervision of an authorized
user, who has been trained to remove the sealed source applicator(s)
in the event of an emergency involving the unit, be immediately available
during continuation of all patient treatments involving the unit;
(B) for high dose-rate remote afterloader units:
(i) an authorized user and an authorized medical physicist
be physically present during the initiation of all patient treatments
involving the unit; and
(ii) 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, be physically present during continuation of all patient
treatments involving the unit;
(C) for gamma stereotactic radiosurgery units and teletherapy
units, require that an authorized user and an authorized medical physicist
be physically present throughout all patient treatments involving
gamma stereotactic radiosurgery units and teletherapy units; and
(D) notify the RSO, or his or her designee, and an
authorized user as soon as possible, if the patient or human research
subject has a medical emergency or dies; and
(7) have applicable emergency response equipment available
near each treatment room to respond to a sealed source that remains
in the unshielded position or lodges within the patient following
completion of the treatment.
(iii) Dosimetry equipment.
(1) Except for low dose-rate remote afterloader sealed
sources where the sealed source output or activity is determined by
the manufacturer, the licensee shall have a calibrated dosimetry system
available for use. To satisfy this requirement, one of the following
two conditions shall be met:
(A) the system shall have been calibrated using a system
or sealed source traceable to the National Institute of Standards
and Technology (NIST) and published protocols accepted by nationally
recognized bodies; or by a calibration laboratory accredited by the
American Association of Physicists in Medicine (AAPM). The calibration
shall have been performed within the previous two years and after
any servicing that may have affected system calibration; or
(B) the system shall have been calibrated within the
previous four years. Eighteen to 30 months after that calibration,
the system shall have been intercompared with another dosimetry system
that was calibrated within the past 24 months by NIST or by a calibration
laboratory accredited by the AAPM. The results of the intercomparison
shall have indicated that the calibration factor of the licensee's
system had not changed by more than two percent. The licensee may
not use the intercomparison result to change the calibration factor.
When intercomparing dosimetry systems to be used for calibrating sealed
sources for therapeutic unit, the licensee shall use a comparable
unit with beam attenuators or collimators, as applicable, and sealed
sources of the same radionuclide as the sealed source used at the
licensee's facility.
(2) The licensee shall have available for use a dosimetry
system for spot check output measurements, if such measurements are
required by this section. To satisfy this requirement, the system
may be compared with a system that has been calibrated in accordance
with paragraph (1) of this subsection. This comparison shall have
been performed within the previous year and after each servicing that
may have affected system calibration. The spot check system may be
the same system used to meet the requirements of paragraph (1) of
this subsection.
(3) The licensee shall retain a record of each calibration,
intercomparison, and comparison of dosimetry equipment in accordance
with subsection (xxx) of this section for inspection by the department.
The record shall include the following:
(A) complete date of the calibration including the
month, day, and year;
(B) manufacturer's model and serial numbers of the
instruments that were calibrated, intercompared, or compared;
(C) the correction factor that was determined from
the calibration or comparison or the apparent correction factor that
was determined from an intercomparison; and
(D) the names of the individuals who performed the
calibration, intercomparison, or comparison.
(jjj) Full calibration measurements on teletherapy
units.
(1) A licensee authorized to use a teletherapy unit
for medical use shall perform full calibration measurements on each
teletherapy unit as follows:
(A) before the first medical use of the unit; and
(B) before medical use under any of the following conditions:
(i) whenever spot check measurements indicate that
the output differs by more than five percent from the output obtained
at the last full calibration corrected mathematically for radioactive
decay;
(ii) following replacement of the sealed source or
following reinstallation of the teletherapy unit in a new location;
(iii) following any repair of the teletherapy unit
that includes removal of the sealed source or major repair of the
components associated with the sealed source exposure assembly; and
(C) at intervals not to exceed one year.
(2) Full calibration measurements shall include determination
of the following:
(A) the output within plus or minus three percent for
the range of field sizes and for the distance or range of distances
used for medical use;
(B) the coincidence of the radiation field and the
field indicated by the light beam localizing device;
(C) uniformity of the radiation field and its dependence
on the orientation of the useful beam;
(D) timer accuracy and linearity over the range of
use;
(E) "on-off" error; and
(F) the accuracy of all distance measuring and localization
devices in medical use.
(3) The licensee shall use the dosimetry system described
in subsection (iii)(1) of this section to measure the output for one
set of exposure conditions. The remaining radiation measurements required
in paragraph (2)(A) of this subsection may be made using a dosimetry
system that indicates relative dose rates.
(4) The licensee shall make full calibration measurements
required by paragraph (1) of this subsection in accordance with published
protocols accepted by nationally recognized bodies.
(5) The licensee shall mathematically correct the outputs
determined in paragraph (2)(A) of this subsection for physical decay
at intervals not to exceed one month for cobalt-60, six months for
cesium-137, or at intervals consistent with one percent decay for
all other nuclides.
(6) Full calibration measurements required by paragraph
(1) of this subsection and physical decay corrections required by
paragraph (5) of this subsection shall be performed by an authorized
medical physicist.
(7) The licensee shall retain a record of each calibration
in accordance with subsection (xxx) of this section for inspection
by the department. The record shall include the following:
(A) complete date of the calibration including the
month, day, and year;
(B) manufacturer's name, model number and serial number
of the teletherapy unit's sealed source and the instruments used to
calibrate the unit;
(C) results and an assessment of the full calibrations;
and
Cont'd... |
