Current through Register No. 40, October 3, 2024
(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:
(1) Timer accuracy 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 1 typical set of operating
conditions measured with the dosimetry system described in
He-P
4035.53(g); and
(6) The difference between the measurement
made in He-P 4035.55(a)(5) and the anticipated output, expressed as a
percentage of the anticipated output (, the value obtained at last full
calibration corrected mathematically for physical decay).
(b) A licensee shall perform spot-checks
required by He-P 4035.55(a) in accordance with written procedures established
by the authorized medical physicist. That individual need not actually perform
the spot check measurements.
(c) A
licensee shall have the authorized medical physicist review the results of each
output spot-check within 15 days. The authorized medical physicist shall
promptly notify the licensee in writing of the results of each output
spot-check.
(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:
(1) Electrical interlocks at each teletherapy
room entrance;
(2) Electrical or
mechanical stops installed for the purpose of limiting use of the primary beam
of radiation 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; and
(6)
Electrically assisted treatment room doors with the teletherapy unit electrical
power turned "off".
(e)
A licensee shall lock the control console in the "off" position if the results
of the checks required in He-P 4035.55(d) indicates the malfunction of any
system, and not use the unit except as may be necessary to repair, replace, or
check the malfunctioning system.
(f) A licensee shall maintain a record of
each spot-check required by He-P 4035.55(a) and (d) for 3 years.
(g) The record shall include:
(1) The date of the spot-check;
(2) The manufacturer's name, model number,
and serial number of the teletherapy unit, source, and instrument used to
measure the output of the teletherapy unit;
(3) An assessment of timer linearity and
constancy;
(4) The calculated
"on-off" error;
(5) A determination
of the coincidence of the radiation field and the field indicated by the light
beam-localizing device;
(6) The
determined accuracy of each distance measuring or localization
device;
(7) The difference between
the anticipated output and the measured output;
(8) Notations indicating the operability of
each entrance door electrical interlock, each electrical or mechanical stop,
each source exposure indicator light, the viewing and intercom system and
doors; and
(9) The name of the
individual who performed the periodic spot-check and the signature of the
authorized medical physicist who reviewed the record of the
spot-check.
(h) A
licensee shall retain a copy of the procedures required by He-P 4035.55(b)
until the licensee no longer possesses the teletherapy unit.
(i) A licensee authorized to use a remote
afterloader unit for medical use shall perform spot-checks of each remote
afterloader facility and on each unit:
(1)
Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate
afterloader unit on a given day;
(2) Before each patient treatment with a low
dose-rate remote afterloader unit; and
(3) After each source installation.
(j) A licensee shall perform the
measurements required by He-P 4035.55(i) in accordance with written procedures
established by the authorized medical physicist. That individual need not
actually perform the spot check measurements.
(k) A licensee shall have the authorized
medical physicist review the results of each spot-check within 15 days. The
authorized medical physicist shall promptly notify the licensee in writing of
the results of each spot-check.
(l)
To satisfy the requirements of He-P 4035.55(i), spot-checks shall, at a
minimum, assure proper operation of:
(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) Clock (date and time) in the unit's
computer; and
(8) Decay source(s)
activity in the unit's computer.
(m) If the results of the checks required in
He-P 4035.55(l) 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.
(n) A licensee shall retain a record of each
check required by He-P 4035.55(l) for 3 years. The record shall include, as
applicable:
(1) The date of the
spot-check;
(2) The manufacturer's
name, model number, and serial number for the remote afterloader unit and
source;
(3) An assessment of timer
accuracy;
(4) Notations indicating
the operability of each entrance door electrical interlock, radiation monitors,
source exposure indicator lights, viewing and intercom systems, and clock and
decayed source activity in the unit's computer; and
(5) The name of the individual who performed
the periodic spot-check and the signature of the authorized medical physicist
who reviewed the record of the spot-check.
(o) A licensee shall retain a copy of the
procedures required by He-P 4035.55(j) until the licensee no longer possesses
the remote afterloader unit.
(p) 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:
(1) Monthly;
(2) Before the first use of the unit on a
given day; and
(3) After each
source installation.
(q)
A licensee shall:
(1) Perform the measurements
required by He-P 4035.55(p) in accordance with written procedures established
by the authorized medical physicist. That individual need not actually perform
the spot check measurements.
(2)
Have the authorized medical physicist review the results of each spot-check
within 15 days. The authorized medical physicist shall promptly notify the
licensee in writing of the results of each spot-check.
(r) To satisfy the requirements of He-P
4035.55(p)(1), spot-checks shall, at a minimum:
(1) Assure proper operation of:
a. Treatment table retraction mechanism,
using backup battery power or hydraulic backups with the unit off:
b. Helmet microswitches;
c. Emergency timing circuits; and
d. Stereotactic frames and localizing devices
(trunnions).
(2) Determine:
a. The output for one typical set of
operating conditions measured with the dosimetry system described in
He-P
4035.53(g);
b. The difference between the measurement
made in He-P 4035.55(r)(2)a. and the anticipated output, expressed as a
percentage of the anticipated output (i.e., the value obtained at last full
calibration corrected mathematically for physical decay);
c. Source output against computer
calculation;
d. Timer accuracy and
linearity over the range of use;
e.
"On-off" error; and
f. Trunnion
centricity.
(s) To satisfy the requirements of He-P
4035.55(p)(2) and (p) (3), spot-checks shall assure proper operation of:
(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;
(5) Emergency "off"
buttons; and
(6) Radiation monitors
used to indicate room exposures.
(t) A licensee shall arrange for repair of
any system identified in He-P 4035.55(r) that is not operating as soon as
possible.
(u) If the results of the
checks required in He-P 4035.55(s) 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.
(v) A licensee shall retain
a record of each check required by He-P 4035.55(r) and (s) for 3 years. The
record shall include:
(1) The date of the
spot-check;
(2) The manufacturer's
name, model number, and serial number for the gamma stereotactic radiosurgery
unit and the instrument used to measure the output of the unit;
(3) An assessment of timer linearity and
accuracy;
(4) The calculated
"on-off" error;
(5) A determination
of trunnion centricity;
(6) The
difference between the anticipated output and the measured output;
(7) An assessment of source output against
computer calculations;
(8)
Notations indicating the operability of radiation monitors, helmet
microswitches, emergency timing circuits, emergency "off" buttons, electrical
interlocks, source exposure indicator lights, viewing and intercom systems,
timer termination, treatment table retraction mechanism, and stereotactic
frames and localizing devices (trunnions); and
(9) The name of the individual who performed
the periodic spot-check and the signature of the authorized medical physicist
who reviewed the record of the spot-check.
(w) A licensee shall retain a copy of the
procedures required by He-P 4035.55(r) and (s) until the licensee no longer
possesses the gamma stereotactic radiosurgery unit.
(See Revision Note at part heading for He-P 4035) #6942,
eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
New. #8959, eff 8-7-07; ss by
#10897, INTERIM, eff 7-22-15, EXPIRES: 1-18-16; ss by #11011, eff 1-15-16; amd
by #12054, eff 11-19-16
