| (F) emergency "off" buttons.
(6) The licensee shall arrange for prompt repair of
any system identified in paragraph (4) of this subsection that is
not operating properly.
(7) If the results of the checks required in paragraph
(5) of this subsection indicate the malfunction of any system, the
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.
(8) The licensee shall retain a record of each check
required by paragraphs (4) and (5) of this subsection in accordance
with subsection (xxx) of this section for inspection by the department.
The record shall include the following:
(A) date of the spot check;
(B) manufacturer's name, and model and serial number
for the gamma stereotactic radiosurgery unit and the instrument used
to measure the output of the unit;
(C) an assessment of timer linearity and accuracy;
(D) the calculated "on-off" error;
(E) a determination of trunnion centricity;
(F) the difference between the anticipated output and
the measured output;
(G) an assessment of sealed source output against computer
calculations;
(H) notations indicating the operability of radiation
monitors, helmet microswitches, emergency timing circuits, emergency
"off" buttons, electrical interlocks, sealed source exposure indicator
lights, viewing and intercom systems, timer termination, treatment
table retraction mechanism, and stereotactic frames and localizing
devices (trunnions);
(I) the name of the individual who performed the periodic
spot check; and
(J) the signature of an authorized medical physicist
who reviewed the record of the spot check.
(ppp) Additional technical requirements for mobile
remote afterloader units.
(1) A licensee providing mobile remote afterloader
service shall do the following:
(A) check survey instruments before medical use at
each address of use or on each day of use, whichever is more frequent;
and
(B) account for all sealed sources before departure
from a client's address of use.
(2) In addition to the periodic spot checks required
by subsection (nnn) of this section, a licensee authorized to use
remote afterloaders for medical use shall perform checks on each remote
afterloader unit before use at each address of use. At a minimum,
checks shall be made to verify the operation of the following:
(A) electrical interlocks on treatment area access
points;
(B) sealed source exposure indicator lights on the
remote afterloader unit, on the control console, and in the facility;
(C) viewing and intercom systems;
(D) applicators, sealed source transfer tubes, and
transfer tube-applicator interfaces;
(E) radiation monitors used to indicate room exposures;
(F) sealed source positioning (accuracy); and
(G) radiation monitors used to indicate whether the
sealed source has returned to a safe shielded position.
(3) In addition to the requirements for checks in paragraph
(2) of this subsection, the 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.
(4) If the results of the checks required in paragraph
(2) of this subsection indicate the malfunction of any system, the
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.
(5) The licensee shall maintain a record for inspection
by the department, in accordance with subsection (xxx) of this section,
of each check required by paragraph (2) of this subsection. The record
shall include the following:
(A) date of the check;
(B) manufacturer's name, model number and serial number
of the remote afterloader unit;
(C) notations accounting for all sealed sources before
the licensee departs from a facility;
(D) notations indicating the operability of each entrance
door electrical interlock, radiation monitors, sealed source exposure
indicator lights, viewing and intercom system, applicators and sealed
source transfer tubes, and sealed source positioning accuracy; and
(E) the signature of the individual who performed the
check.
(qqq) Radiation surveys.
(1) In addition to the survey requirements of §289.202(p)
of this title, a person licensed to use sealed sources in this section
shall make surveys to ensure that the maximum radiation levels and
average radiation levels, from the surface of the main sealed source
safe with the sealed source(s) in the shielded position, do not exceed
the levels stated in the Sealed Source and Device Registry.
(2) The licensee shall make the survey required by
paragraph (1) of this subsection at installation of a new sealed source
and following repairs to the sealed source(s) shielding, the sealed
source(s) driving unit, or other electronic or mechanical component
that could expose the sealed source, reduce the shielding around the
sealed source(s), or compromise the radiation safety of the unit or
the sealed source(s).
(3) The licensee shall maintain a record for inspection
by the department, in accordance with subsection (xxx) of this section,
of the radiation surveys required by paragraph (1) of this subsection.
The record shall include:
(A) date of the measurements;
(B) manufacturer's name, model number and serial number
of the treatment unit, sealed source, and instrument used to measure
radiation levels;
(C) each dose rate measured around the sealed source
while the unit is in the "off" position and the average of all measurements;
and
(D) the signature of the individual who performed the
test.
(rrr) Full-inspection servicing for teletherapy and
gamma stereotactic radiosurgery units.
(1) The licensee shall have each teletherapy unit and
gamma stereotactic radiosurgery unit fully inspected and serviced
during each sealed source replacement to ensure proper functioning
of the sealed source exposure mechanism and other safety components.
The interval between each full-inspection servicing shall not exceed
five years for each teletherapy unit and shall not exceed seven years
for each gamma stereotactic radiosurgery unit.
(2) This inspection and servicing may only be performed
by persons specifically licensed to do so by the department, the NRC,
or an agreement state.
(3) The licensee shall maintain a record of the inspection
and servicing in accordance with subsection (xxx) of this section
for inspection by the department. The record shall include the following:
(A) date of inspection;
(B) manufacturer's name and model and serial number
of both the treatment unit and the sealed source;
(C) a list of components inspected and serviced, and
the type of service;
(D) the inspector's radioactive material license number;
and
(E) the signature of the inspector.
(sss) Therapy-related computer systems for photon-emitting
remote afterloader units, teletherapy units, and gamma stereotactic
radiosurgery units. The licensee shall perform acceptance testing
on the treatment planning system of therapy-related computer systems
in accordance with published protocols accepted by nationally recognized
bodies. At a minimum, the acceptance testing shall include, as applicable,
verification of the following:
(1) the sealed source-specific input parameters required
by the dose calculation algorithm;
(2) the accuracy of dose, dwell time, and treatment
time calculations at representative points;
(3) the accuracy of isodose plots and graphic displays;
(4) the accuracy of the software used to determine
sealed source positions from radiographic images; and
(5) the accuracy of electronic transfer of the treatment
delivery parameters to the treatment delivery unit from the treatment
planning system.
(ttt) Training for use of remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units. Except
as provided in subsection (l) of this section, the licensee shall
require an authorized user of a sealed source for a use authorized
in subsection (ddd) of this section for:
Cont'd... |
