Florida Regulations 64E-5.6422: Periodic Spot-Checks for Gamma Stereotactic Radiosurgery Units
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(1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform the following spot-checks:
(a) Monthly:
(b) Before the first use of the unit on a given day; and
(c) After each source installation.
(2) To satisfy the requirements of Fl. Admin. Code R. 64E-5.6422(1)(a), spot checks shall include the determination of:
(a) Assure the proper operation of the:
1. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;
2. Helmet microswitches;
3. Emergency timing circuits; and
4. Stereotactic frames and localizing devices (trunnions).
(b) Determine the following elements:
1. The output for one typical set of operating conditions measured with the dosimetry system described in subsection 64E-5.640(2), F.A.C.;
2. The difference between the measurement made in subFl. Admin. Code R. 64E-5.6422(2)(b)1., and the anticipated output, expressed as a percentage of the anticipated output value obtained at last full calibration corrected mathematically for physical decay;
3. Source output against computer calculation;
4. Timer accuracy and linearity over the range of use;
5. On-off error; and
6. Trunnion centricity.
(3) A licensee shall perform spot-checks required by subsection 64E-5.6422(1), F.A.C., following procedures established by the authorized medical physicist.
(4) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days and promptly notify the licensee in writing of the results of each spot-check. The licensee shall keep a copy of each written notification for 3 years.
(5) To satisfy the requirements of paragraphs 64E-5.6422(1)(b) and (c), F.A.C., the licensee’s spot-checks must assure proper operation of the following:
(a) Electrical interlocks at each gamma stereotactic radiosurgery room entrance;
(b) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;
(c) Viewing and intercom systems;
(d) Timer termination;
(e) Radiation monitors used to indicate room exposures; and
(f) Emergency off buttons.
(6) If the results of the checks required in subsection 64E-5.6422(5), 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 except as may be necessary to repair, replace, or check the malfunctioning system.
(7) A licensee shall arrange for the repair of any system identified in subsection 64E-5.6422(2), F.A.C., that is not operating properly as soon as possible.
(8) A licensee shall maintain a record of each spot-check required by subsections 64E-5.6422(2) and (5), F.A.C., for 3 years and a copy of the procedures required in subsections 64E-5.6422(2) and (3), F.A.C., until the licensee no longer possesses the gamma stereotactic radiosurgery unit. The record shall include:
(a) The date of the spot-check;
(b) The manufacturer’s name, model number, and serial number for the gamma stereotactic radiosurgery unit;
(c) The manufacturer’s name, model number and serial number of the instrument used to measure the output of the gamma stereotactic radiosurgery unit;
(d) The timer linearity and constancy;
(e) The calculated on-off error;
(f) A determination of trunnion centricity;
(g) The difference between the anticipated output and the measured output;
(h) An assessment of source output against computer calculations;
(i) 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
(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 404.051, 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 2-11-10, Amended 12-26-13.
(b) Before the first use of the unit on a given day; and
(c) After each source installation.
(2) To satisfy the requirements of Fl. Admin. Code R. 64E-5.6422(1)(a), spot checks shall include the determination of:
(a) Assure the proper operation of the:
1. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;
2. Helmet microswitches;
3. Emergency timing circuits; and
4. Stereotactic frames and localizing devices (trunnions).
(b) Determine the following elements:
1. The output for one typical set of operating conditions measured with the dosimetry system described in subsection 64E-5.640(2), F.A.C.;
2. The difference between the measurement made in subFl. Admin. Code R. 64E-5.6422(2)(b)1., and the anticipated output, expressed as a percentage of the anticipated output value obtained at last full calibration corrected mathematically for physical decay;
3. Source output against computer calculation;
4. Timer accuracy and linearity over the range of use;
5. On-off error; and
6. Trunnion centricity.
(3) A licensee shall perform spot-checks required by subsection 64E-5.6422(1), F.A.C., following procedures established by the authorized medical physicist.
(4) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days and promptly notify the licensee in writing of the results of each spot-check. The licensee shall keep a copy of each written notification for 3 years.
(5) To satisfy the requirements of paragraphs 64E-5.6422(1)(b) and (c), F.A.C., the licensee’s spot-checks must assure proper operation of the following:
(a) Electrical interlocks at each gamma stereotactic radiosurgery room entrance;
(b) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;
(c) Viewing and intercom systems;
(d) Timer termination;
(e) Radiation monitors used to indicate room exposures; and
(f) Emergency off buttons.
(6) If the results of the checks required in subsection 64E-5.6422(5), 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 except as may be necessary to repair, replace, or check the malfunctioning system.
(7) A licensee shall arrange for the repair of any system identified in subsection 64E-5.6422(2), F.A.C., that is not operating properly as soon as possible.
(8) A licensee shall maintain a record of each spot-check required by subsections 64E-5.6422(2) and (5), F.A.C., for 3 years and a copy of the procedures required in subsections 64E-5.6422(2) and (3), F.A.C., until the licensee no longer possesses the gamma stereotactic radiosurgery unit. The record shall include:
(a) The date of the spot-check;
(b) The manufacturer’s name, model number, and serial number for the gamma stereotactic radiosurgery unit;
(c) The manufacturer’s name, model number and serial number of the instrument used to measure the output of the gamma stereotactic radiosurgery unit;
(d) The timer linearity and constancy;
(e) The calculated on-off error;
(f) A determination of trunnion centricity;
(g) The difference between the anticipated output and the measured output;
(h) An assessment of source output against computer calculations;
(i) 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
(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 404.051, 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 2-11-10, Amended 12-26-13.