Ohio Administrative Code|Rule 3701:1-67-09 | Quality assurance for radiation therapy , simulation and image guidance equipment.

                                                
(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 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) The handler shall 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) The handler shall 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) The handler shall
			 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) The handler shall
			 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 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, One Physics Ellipse,
			 College Park, MD 20740, 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, One Physics Ellipse, College Park, MD
				20740, 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, One Physics Ellipse, College Park, MD
				20740, 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, One Physics Ellipse, College Park, MD
				20740, 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, One Physics Ellipse, College Park, MD
				20740, 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, One Physics Ellipse, College Park, MD
				20740, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for helical
				tomotherapy 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 percent.
(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 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, One Physics Ellipse, College Park, MD
			 20740, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) to meet the
			 requirements of paragraph (A) of this rule for a conventional simulator;
			 or
(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, One Physics Ellipse, College Park, MD 20740, 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) 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) The handler shall maintain a record
		  of each QA performance test result for three years 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.