Current through all regulations passed and filed through March 18, 2024
In addition to the rules in Chapters
3701:1-38 and 3701:1-67 of the Administrative Code, handlers shall comply with
paragraphs (A) to (H) of this rule.
(A) For therapy equipment subject to this
chapter, a qualified medical physicist shall develop a documented quality
assurance (QA) program using the appropriate "American Association of
Physicists in Medicine" (AAPM) reports or the "National Council of Radiation
Protection" (NCRP) report as a basis.
(1) The
quality assurance program shall:
(a) Identify
each QA performance test to be performed;
(b) Describe the procedures used to complete
each QA performance test;
(c)
Describe the method used to document the results of each QA performance
test;
(d) Identify the frequency of
each QA performance test; and
(e)
Specify the acceptable action limits and safety tolerance limits for each QA
performance test result and the action to be taken when exceeded.
(2) Any variation from the
identified tests, frequency or tolerance limits specified in the appropriate
AAPM or NCRP reports shall be based on a documented history of therapy
equipment performance or inherent therapy equipment design and be justified
by the qualified medical physicist in the quality
assurance program.
(3) Any QA
performance test result exceeding a factor of two from the tolerances in AAPM
or NCRP documents shall require immediate action prior to further
treatment.
(B)
Perform QA performance tests in accordance with the
written procedures established by the qualified medical physicist and comply
with the following:
(1) The authorized user
and qualified medical physicist shall be immediately notified if any QA
performance test result exceeds a safety tolerance limit set by the qualified
medical physicist. The cause for a parameter exceeding the safety tolerance
limit shall be investigated before the system is used for patient irradiation.
The medical physicist in collaboration with the authorized user shall determine
whether medical treatment may continue safely or be interrupted until
corrected;
(2)
Use a dosimetry system described in rule
3701:1-67-07
of the Administrative Code to perform absolute-dose related QA performance
tests required by this rule;
(3)
Have the qualified medical physicist review and sign
the results of each QA performance test within a month of the date that the
test was performed, by an individual other than the qualified medical
physicist;
(4)
Ensure that safety QA tests are performed monthly on
the following:
(a) Electrical interlocks at
each external beam radiation therapy room entrance;
(b) The "beam-on" and termination
switches;
(c) All beam indicator
lights;
(d) Patient audio visual
viewing system; and
(e) If
applicable, electrically operated treatment room doors from inside and outside
the treatment room.
(C) As used in this rule, "calibration" means
the determination of the exposure or dose per unit time or absorbed dose per
monitor unit (MU) under specified conditions as described
by the qualified medical physicist in the quality
assurance program. Calibration shall be performed:
(1) Before the first medical use following
installation or reinstallation;
(2)
Annually; and
(3) Before medical
use under the following conditions:
(a)
Whenever QA performance test results indicate the radiation output differs by
more than five per cent from the calibration value obtained during the most
recent annual QA performance tests and the difference cannot be reconciled.
Calibration of therapy equipment with multi-energy capabilities is required
only for those modes and/or energies that are not within their acceptable
range; and
(b) Following any major
mechanical, electrical or software based alterations affecting the radiation
source, its housing, power supply or controls or after replacement of the
radiation source. If an alteration or replacement does not affect all energies,
calibration shall be performed on the affected energy that is in most frequent
clinical use at the facility. The remaining energies may be validated with
quality assurance check procedures against the criteria in paragraph (C)(3)(a)
of this rule.
(D) For therapy equipment operating at less
than one megavolt (MV):
(1) The qualified
medical physicist shall use NCRP report 69, Dosimetry of X-Ray and Gamma Ray
Beams for Radiation Therapy in the Energy Range 10 keV to 50MeV (1981) for
commissioning, initial QA performance testing and to meet the requirements of
paragraph (A) of this rule. The term "QA performance test", as used in
paragraph (D) of this rule, shall have the same meaning as the term "check" in
the NCRP report.
(2) Commissioning
and initial QA performance testing shall be completed prior to medical use
following installation or reinstallation.
(3) Commissioning, initial and annual QA
performance tests shall be performed by or under direct supervision of a
qualified medical physicist.
(E) For therapy equipment operating at or
above one megavolt (MV):
(1) The qualified
medical physicist shall use the "AAPM Code of Practice for Radiotherapy
Accelerators: AAPM Report No. 47 (AAPM report 47)," prepared by "Radiation
Therapy Task Group 45" (this publication can be obtained from the American
association of physicists in medicine, 1631 Prince st,
Alexandria, VA 22314, telephone (301) 209-3350,
http://www.aapm.org/pubs/reports)
and the manufacturer's contractual specifications as a basis for acceptance
testing and commissioning.
(2) To
meet the requirements of paragraph (A) of this rule, the qualified medical
physicist shall use:
(a) The "Comprehensive QA
for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group
No. 40: AAPM Report No. 46 (AAPM report 46)" (this publication can be obtained
from the American association of physicists in medicine,
1631 Prince st, Alexandria, VA
22314, telephone (301) 209-3350,
http://www.aapm.org/pubs/reports).
(b) "Task Group 142 report: Quality assurance
of medical accelerators" (this publication can be obtained from the American
association of physicists in medicine, 1631 Prince st,
Alexandria, VA 22314, telephone (301) 209-3350,
http://www.aapm.org/pubs/reports)
for therapy equipment provided with asymmetric jaws, multileaf collimation,
dynamic or virtual wedges, planar imaging devices, tomographic imaging devices
or those used for stereotactic radiosurgery, stereotactic body radiation
therapy, total body photon irradiation or intensity-modulated
radiotherapy.
(c) The
"Intraoperative radiation therapy using mobile electron linear accelerators:
Report of AAPM Radiation Therapy Committee Task Group No. 72" (this publication
can be obtained from the American association of physicists in medicine,
1631 Prince st, Alexandria, VA
22314, telephone (301) 209-3350,
http://www.aapm.org/pubs/reports)
for mobile electron linear accelerator therapy equipment.
(d) The "Report of AAPM TG 135: Quality
assurance for robotic radiosurgery" (this publication can be obtained from the
American association of physicists in medicine, 1631
Prince st, Alexandria, VA 22314, telephone (301) 209-3350,
http://www.aapm.org/pubs/reports)
for robotic radiosurgery therapy equipment.
(e) The "QA for helical tomotherapy: Report
of the AAPM Task Group 148" (this publication can be obtained from the American
association of physicists in medicine, 1631 Prince st,
Alexandria, VA 22314, telephone (301) 209-3350,
http://www.aapm.org/pubs/reports)
for helical tomotherapy equipment.
(f)
The
"Comprehensive proton therapy machine quality assurance AAPM Task Group 224"
(this publication can be obtained from the American association of physicists
in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301)
209-3350,
http://www.aapm.org/pubs/reports) for proton therapy equipment.
(3) Acceptance testing, commissioning and
baseline QA performance testing shall be completed prior to medical use
following installation or reinstallation.
(4) Acceptance testing, commissioning,
baseline and annual QA performance tests shall be performed by or under direct
supervision of a qualified medical physicist.
(5) An independent verification of the
calibration of all photon beams and a sample of available electron beams shall
be performed annually by:
(a) A second
radiation expert using a dosimetry system other than the dosimetry system that
was used during the annual calibration; or
(b) A national institute of science and
technology traceable third-party dosimetry service or an equivalent method
which is capable of measuring doses with an accuracy within five per
cent.
(6) Proper
operation of each emergency power cutoff switch shall be verified annually. If
more than one switch is installed, they may be evaluated on a rotating basis
throughout the year.
(F)
For image guidance systems and conventional or
virtual simulation:
(1) The qualified medical
physicist shall use the "Comprehensive QA for Radiation Oncology: Report of
AAPM Radiation Therapy Committee Task Group No. 40: AAPM Report No. 46 (AAPM
report 46)" (this publication can be obtained from the American association of
physicists in medicine, 1631 Prince st, Alexandria, VA
22314, telephone (301) 209-3350,
http://www.aapm.org/pubs/reports)
to meet the requirements of paragraph (A) of this rule for a conventional
simulator.
(2) The
qualified medical physicist shall use the "Quality assurance for computed
tomography simulators and the computed tomography-simulation process: Report of
the AAPM Radiation Therapy Committee Task Group No. 66: AAPM Report No. 83
(AAPM report 83)" (this publication can be obtained from the American
association of physicists in medicine, 1631 Prince st,
Alexandria, VA 22314, telephone (301) 209-3350,
http://www.aapm.org/pubs/reports)
for acceptance testing, commissioning and to meet the requirements of paragraph
(A) of this rule for a virtual simulator.
(3)
The qualified
medical physicist shall use the "Quality assurance for image-guided radiation
therapy utilizing CT-based technologies AAPM Task Group 179" (this publication
can be obtained from the American association of physicists in medicine, 1631
Prince st, Alexandria, VA 22314, telephone (301) 209-3350,
http://www.aapm.org/pubs/reports) to meet the requirements of paragraph (A) of this rule for
CT-based image guidance systems.
(4) Acceptance testing,
commissioning, initial QA performance testing, annual QA performance testing
and semiannual (if appropriate) QA performance testing shall be performed by or
under the direct supervision of a qualified medical physicist.
(G) For therapy equipment used for
IMRT, patient specific treatment QC shall be performed before the first
fraction is delivered unless extenuating circumstances are documented by the
medical physicist. If a direct measurement for individual plans is not
performed, the checks shall include both a dose calculation second check and a
method to validate patient plan transfer and deliverability to the treatment
unit.
(H)
Maintain a record of each QA performance test result
for three years and acceptance testing, commissioning
and each calibration for the duration of the registration. The records
shall include:
(1) The date of the QA test or
calibration;
(2) The manufacturer's
name, model number, and serial number of the therapy equipment;
(3) The manufacturer's name, model numbers
and serial numbers for the instrument(s) used to measure the radiation output
of the therapy equipment; and
(4)
The signature of the individual who performed the QA performance test or
calibration.