Florida Regulations 64E-5.642: Periodic Spot-Checks or Teletherapy Units
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(1) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit at least every month.
(2) Spot-checks shall include the determination of:
(a) Timer constancy and timer 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; and
(f) The difference between the measurement made in Fl. Admin. Code R. 64E-5.642(2)(e), and the anticipated output, expressed as a percentage of the anticipated output, which is the value obtained at the last full calibration corrected mathematically for physical decay.
(3) A licensee shall use the dosimetry system described in Fl. Admin. Code R. 64E-5.640, to make the spot-check required in Fl. Admin. Code R. 64E-5.642(2)(e)
(4) A licensee shall perform spot-checks required by subsection 64E-5.642(1), F.A.C., following procedures established by the authorized medical physicist.
(5) A licensee shall have the authorized medical physicist review the results of each output spot-check within 15 days and promptly notify the licensee in writing of the results of each output spot-check. The licensee shall keep a copy of each written notification for 3 years.
(6) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility monthly and after each source installation.
(7) Safety spot-checks shall assure proper operation of:
(a) Electrical interlocks at each teletherapy room entrance;
(b) Electrical or mechanical stops installed to limit 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;
(c) Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;
(d) Viewing and intercom systems;
(e) Treatment room doors from inside and outside the treatment room; and
(f) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.
(8) If the results of the checks required in subsection 64E-5.642(7), F.A.C., of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit.
(9) A licensee shall promptly repair any system identified in subsection 64E-5.642(7), F.A.C., that is not operating properly. The teletherapy unit shall not be used until all repairs are completed.
(10) A licensee shall maintain a record of each spot-check required by subsections 64E-5.642(1) and (6), F.A.C., for 3 years and a copy of the procedures required by subsection 64E-5.641(4), F.A.C., until the licensee no longer possesses the teletherapy unit. The record shall include:
(a) The date of the spot-check;
(b) The manufacturer’s name, model number, and serial number for both the teletherapy unit and source;
(c) The manufacturer’s name, model number and serial number of the instrument used to measure the output of the teletherapy unit;
(d) The timer linearity and constancy;
(e) The calculated on-off error;
(f) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;
(g) The determined accuracy of each distance measuring or localization device;
(h) The difference between the anticipated output and the measured output;
(i) Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors; and
(j) 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.
Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 8-25-91, Formerly 10D-91.761, Amended 2-11-10.
(2) Spot-checks shall include the determination of:
(a) Timer constancy and timer 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; and
(f) The difference between the measurement made in Fl. Admin. Code R. 64E-5.642(2)(e), and the anticipated output, expressed as a percentage of the anticipated output, which is the value obtained at the last full calibration corrected mathematically for physical decay.
(3) A licensee shall use the dosimetry system described in Fl. Admin. Code R. 64E-5.640, to make the spot-check required in Fl. Admin. Code R. 64E-5.642(2)(e)
(4) A licensee shall perform spot-checks required by subsection 64E-5.642(1), F.A.C., following procedures established by the authorized medical physicist.
(5) A licensee shall have the authorized medical physicist review the results of each output spot-check within 15 days and promptly notify the licensee in writing of the results of each output spot-check. The licensee shall keep a copy of each written notification for 3 years.
(6) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility monthly and after each source installation.
(7) Safety spot-checks shall assure proper operation of:
(a) Electrical interlocks at each teletherapy room entrance;
(b) Electrical or mechanical stops installed to limit 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;
(c) Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;
(d) Viewing and intercom systems;
(e) Treatment room doors from inside and outside the treatment room; and
(f) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.
(8) If the results of the checks required in subsection 64E-5.642(7), F.A.C., of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit.
(9) A licensee shall promptly repair any system identified in subsection 64E-5.642(7), F.A.C., that is not operating properly. The teletherapy unit shall not be used until all repairs are completed.
(10) A licensee shall maintain a record of each spot-check required by subsections 64E-5.642(1) and (6), F.A.C., for 3 years and a copy of the procedures required by subsection 64E-5.641(4), F.A.C., until the licensee no longer possesses the teletherapy unit. The record shall include:
(a) The date of the spot-check;
(b) The manufacturer’s name, model number, and serial number for both the teletherapy unit and source;
(c) The manufacturer’s name, model number and serial number of the instrument used to measure the output of the teletherapy unit;
(d) The timer linearity and constancy;
(e) The calculated on-off error;
(f) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;
(g) The determined accuracy of each distance measuring or localization device;
(h) The difference between the anticipated output and the measured output;
(i) Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors; and
(j) 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.
Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 8-25-91, Formerly 10D-91.761, Amended 2-11-10.