| (D) signature of the authorized medical physicist who
performed the full calibration.
(kkk) Full calibration measurements on remote afterloader
units.
(1) A licensee authorized to use a remote afterloader
for medical use shall perform full calibration measurements on each
unit as follows:
(A) before the first medical use of the unit;
(B) before medical use under any of the following conditions:
(i) following replacement of the sealed source;
(ii) following reinstallation of the unit in a new
location outside the facility; and
(iii) following any repair of the unit that includes
removal of the sealed source or major repair of the components associated
with the sealed source exposure assembly;
(C) at intervals not to exceed three months for high
dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader
units with sealed sources whose half-life exceeds 75 days; and
(D) at intervals not to exceed one year for low dose-rate
afterloader units.
(2) Full calibration measurements shall include, as
applicable, determination of the following:
(A) the output within plus or minus five percent;
(B) sealed source positioning accuracy to within plus
or minus 1 millimeter (mm);
(C) sealed source retraction with backup battery upon
power failure;
(D) length of the sealed source transfer tubes;
(E) timer accuracy and linearity over the typical range
of use;
(F) length of the applicators; and
(G) function of the sealed source transfer tubes, applicators,
and transfer tube-applicator interfaces.
(3) A licensee shall use the dosimetry system described
in subsection (iii)(1) of this section to measure the output.
(4) A licensee shall make full calibration measurements
required by paragraph (1) of this subsection in accordance with published
protocols accepted by nationally recognized bodies.
(5) In addition to the requirements for full calibrations
for low dose-rate remote afterloader units in paragraph (2) of this
subsection, a licensee shall perform an autoradiograph of the sealed
source(s) to verify inventory and sealed source(s) arrangement at
intervals not to exceed three months.
(6) For low dose-rate remote afterloader units, a licensee
may use measurements provided by the sealed source manufacturer that
are made in accordance with paragraphs (1) - (5) of this subsection.
(7) The licensee shall mathematically correct the outputs
determined in paragraph (2)(A) of this subsection for physical decay
at intervals consistent with one percent physical decay.
(8) Full calibration measurements required by paragraph
(1) of this subsection and physical decay corrections required by
paragraph (7) of this subsection shall be performed by an authorized
medical physicist.
(9) 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 remote afterloader unit's sealed source, and the instruments
used to calibrate the unit;
(C) results and an assessment of the full calibrations;
(D) signature of the authorized medical physicist of
this section; and
(E) results of the autoradiograph required for low
dose-rate remote afterloader unit.
(lll) Full calibration measurements on gamma stereotactic
radiosurgery units.
(1) A licensee authorized to use a gamma stereotactic
radiosurgery unit for medical use shall perform full calibration measurements
on each gamma stereotactic radiosurgery unit as follows:
(A) before the first medical use of the unit;
(B) before medical use under 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 sources or
following reinstallation of the gamma stereotactic radiosurgery unit
in a new location; and
(iii) following any repair of the gamma stereotactic
radiosurgery unit that includes removal of the sealed sources or major
repair of the components associated with the sealed source exposure
assembly; and
(C) at intervals not to exceed 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 a helmet.
(2) Full calibration measurements shall include determination
of the following:
(A) the output within plus or minus three percent;
(B) relative helmet factors;
(C) isocenter coincidence;
(D) timer accuracy and linearity over the range of
use;
(E) "on-off" error;
(F) trunnion centricity;
(G) treatment table retraction mechanism, using backup
battery power or hydraulic backups with the unit "off";
(H) helmet microswitches;
(I) emergency timing circuits; and
(J) stereotactic frames and localizing devices (trunnions).
(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 at intervals not
to exceed one month for cobalt-60 and at intervals consistent with
one percent physical decay for all other radionuclides.
(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
for the unit and the unit's sealed source and the instruments used
to calibrate the unit;
(C) results and an assessment of the full calibration;
and
(D) signature of the authorized medical physicist who
performed the full calibration.
(mmm) Periodic spot checks for teletherapy units.
(1) 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 the
following:
(A) timer constancy and linearity over the range of
use;
(B) "on-off" error;
(C) the coincidence of the radiation field and the
field indicated by the light beam localizing device;
(D) the accuracy of all distance measuring and localization
devices used for medical use;
(E) the output for one typical set of operating conditions
measured with the dosimetry system described in subsection (iii)(2)
of this section; and
(F) the difference between the measurement made in
subparagraph (E) of this paragraph and the anticipated output, expressed
as a percentage of the anticipated output, the value obtained at last
full calibration corrected mathematically for physical decay.
(2) The licensee shall perform measurements required
by paragraph (1) of this subsection in accordance with written procedures
established by an authorized medical physicist. That authorized medical
physicist need not actually perform the spot check measurements. The
licensee shall maintain a copy of the written procedures in accordance
with subsection (xxx) of this section for inspection by the department.
(3) The 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 sealed source
installation to assure proper operation of the following:
Cont'd... |
