Current through Register 1531, September 27, 2024
(A)
Records of Brachytherapy
Source Inventory.
(1) A licensee
shall maintain a record of brachytherapy source accountability required by
105 CMR
120.561 for three years.
(2) For temporary implants, the record must
include:
(a) The number and activity of
sources removed from storage, the time and date they were removed from storage,
the name of the individual who removed them from storage, and the location of
use; and
(b) The number and
activity of sources not implanted, the time and date they were returned to
storage, and the name of the individual who returned them from
storage.
(3) For
permanent implants, the record must include:
(a) The number and activity of sources
removed from storage, the date they were removed from storage, and the name of
the individual who removed them from storage;
(b) The number and activity of sources
returned to storage, the date they were returned to storage, and the name of
the individual who returned them to storage; and
(c) The number and activity of sources
permanently implanted in the patient or human research subject.
(B)
Records
of Calibration Measurements on Brachytherapy Sources. A licensee
shall maintain a record of the calibrations on brachytherapy sources required
by
105 CMR
120.564 for three years after the last use of
the source. The record must include the date of the calibration; the
manufacturer's name, model number, and serial number for the source and the
instruments used to calibrate the source; the source output or activity; source
positioning accuracy within applicators; and the signature of the authorized
medical physicist.
(C)
Records of Decay of Strontium-90 Sources for Opthalmic
Treatments. A licensee shall maintain a record of the activity of
a strontium-90 source required by 105 CMR 120.564A for the life of the source.
The record must include the date and initial activity of the source as
determined under
105 CMR
120.564, and for each decay calculation, the
date and the source activity as determined by 105 CMR 120.564A.
(D)
Records of Installation,
Maintenance, Adjustment, and Repair. A licensee shall retain a
record of the installation, maintenance, adjustment, and repair of remote
afterloader units, teletherapy units, and gamma stereotactic radiosurgery units
as required by
105 CMR
120.572 for three years. For each
installation, maintenance, adjustment and repair, the record must include the
date, description of the service, and name(s) of the individual(s) who
performed the work.
(E)
Records of Dosimetry Equipment.
(1) A licensee shall retain a record of the
calibration, intercomparison, and comparisons of its dosimetry equipment done
in accordance with
105 CMR
120.575 for the duration of the
license.
(2) For each calibration,
intercomparison, or comparison, the record must include:
(a) The date;
(b) The manufacturer's name, model numbers
and serial numbers of the instruments that were calibrated, intercompared, or
compared as required by
105 CMR 120.575(A) and
(B);
(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.
(F)
Records of
Teletherapy, Remote Afterloader, and Gamma Stereotactic Radiosurgery Full
Calibrations.
(1) A licensee
shall maintain a record of the teletherapy, remote afterloader, and gamma
stereotactic radiosurgery full calibrations required by
105 CMR
120.576,
120.577
and
120.578
for three years.
(2) The record
must include:
(a) The date of the
calibration;
(b) The manufacturer's
name, model number, and serial number for the teletherapy, remote afterloader,
and gamma stereotactic radiosurgery unit(s), the source(s), and instruments
used to calibrate the unit;
(c) The
results and assessments of the full calibrations;
(d) The results of the autoradiograph
required for low dose-rate remote afterloader units; and
(e) The signature of the authorized medical
physicist who performed the full calibration.
(G)
Records of Periodic
Spot-checks for Teletherapy Units.
(1) A licensee shall retain a record of each
periodic spot-check for teletherapy units required by
105 CMR
120.579 for three years.
(2) The record must include:
(a) The date of the spot-check;
(b) The manufacturer's name, model number,
and serial number for the teletherapy unit, source and instrument used to
measure the output of the teletherapy unit;
(c) An assessment of timer linearity and
constancy;
(d) The calculated
on-off error;
(e) A determination
of the coincidence of the radiation field and the field indicated by the light
beam localizing device;
(f) The
determined accuracy of each distance measuring and localization
device;
(g) The difference between
the anticipated output and the measured output;
(h) Notations indicating the operability of
each entrance door electrical interlock, each electrical or mechanical stop,
each source exposure indicator light, and the viewing and intercom system and
doors; and
(i) 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)
Records of Periodic Spot-checks for Remote Afterloader
Units.
(1) A licensee shall
retain a record of each spot-check for remote afterloader units required by
105 CMR
120.580 for three years.
(2) The record must include, as applicable:
(a) The date of the spot-check;
(b) The manufacturer's name, model number,
and serial number for the remote afterloader unit and source;
(c) An assessment of timer
accuracy;
(d) 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
(e) 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.
(I)
Records of Periodic
Spot-checks for Gamma Stereotactic Radiosurgery Units.
(1) A licensee shall retain a record of each
spot-check for gamma stereotactic radiosurgery units required by
105
CMR 120.581 for three years.
(2) The record must include:
(a) The date of the spot-check;
(b) 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;
(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 source output against
computer calculations;
(h)
Notations indicating the operability of radiation monitors, helmet
microswitchs, 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
(i) 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.
(J)
Records of Additional
Technical Requirements for Mobile Remote Afterloader Units.
(1) A licensee shall retain a record of each
check for mobile remote afterloader units required by
105
CMR 120.582 for three years.
(2) The record must include:
(a) The date of the check;
(b) The manufacturer's name, model number,
and serial number of the remote afterloader unit;
(c) Notations accounting for all sources
before the licensee departs from a facility;
(d) Notations indicating the operability of
each entrance door electrical interlock, radiation monitors, source exposure
indicator lights, viewing and intercom system, applicators and source transfer
tubes, and source positioning accuracy; and
(e) The signature of the individual who
performed the check and the signature of the authorized medical physicist who
reviewed the record of the spot-check.
(K)
Records of Surveys of
Therapeutic Treatment Units.
(1)
A licensee shall maintain a record of radiation surveys of treatment units made
in accordance with
105 CMR 120.583
for the duration of use of the unit.
(2) The record must include:
(a) The date of the measurements;
(b) The manufacturer's name, model number and
serial number of the treatment unit, source, and instrument used to measure
radiation levels;
(c) Each dose
rate measured around the 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.
(L)
Records of Full Inspection
Servicing for Teletherapy and Gamma Stereotactic Surgery Units.
(1) A licensee shall maintain a record of the
full inspection servicing for teletherapy and gamma stereotactic radiosurgery
units required by
105
CMR 120.584 for the duration of use of the
unit.
(2) The record must contain:
(a) The inspector's radioactive materials
license number;
(b) The date of
inspection;
(c) The manufacturer's
name and model number and serial number of both the treatment unit and
source;
(d) A list of components
inspected and serviced, and the type of service; and
(f) The signature of the inspector.
