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This set of 146 slides is based on Chapter 12 authored by D. I. Thwaites, B. J. Mijnheer, J. A. Mills of the IAEA publication (ISBN 92-0-107304-6): Radiation Oncology Physics: A Handbook for Teachers and Students Objective: To familiarize students with the need for and concept of a quality system in radiotherapy as well as with recommended quality procedures and tests.
Slide set prepared in 2006 (updated Aug2007) by G.H. Hartmann (DKFZ, Heidelberg) Comments to S. Vatnitsky: dosimetry@iaea.org
IAEA
International Atomic Energy Agency
CHAPTER 12.
TABLE OF CONTENTS
Introduction Managing a Quality Assurance Programme Quality Assurance Programme for Equipment Treatment Delivery Quality Audit
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12.1 INTRODUCTION
12.1.1 Definitions
Quality Control
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12.1 INTRODUCTION
12.1.1 Definitions
Quality Assurance
Quality Assurance is all those planned and systematic actions
necessary to provide adequate confidence that a product or service will satisfy the given requirements for quality.
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12.1 INTRODUCTION
12.1.1 Definitions
Quality Control
Quality Control is the regulatory process through which the actual
quality performance is measured, compared with existing standards, and the actions necessary to keep or regain conformance with the standards.
Quality control forms part of quality system management. Quality Control is concerned with operational techniques and
activities used:
To check that quality requirements are met. To adjust and correct performance if requirements are found not to have
been met.
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12.1 INTRODUCTION
12.1.1 Definitions
Quality Standards
Quality standards is the set of accepted criteria against
which the quality of the activity in question can be assessed.
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12.1 INTRODUCTION
12.1.1 Definitions
Quality System
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12.1 INTRODUCTION
12.1.1 Definitions
Examples of prescriptions:
Dose to the tumour (to the target volume). Minimal dose to normal tissue. Adequate patient monitoring aimed at determining the optimum
end result of the treatment.
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12.1 INTRODUCTION
12.1.1 Definitions
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12.1 INTRODUCTION
12.1.1 Definitions
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12.1 INTRODUCTION
12.1.2 The need for QA in radiotherapy
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12.1 INTRODUCTION
12.1.2 The need for QA in radiotherapy
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12.1 INTRODUCTION
12.1.2 The need for QA in radiotherapy
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12.1 INTRODUCTION
12.1.2 The need for QA in radiotherapy
Various procedures (related to patient and the technical aspects of radiotherapy) will be subjected to careful quality control.
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12.1 INTRODUCTION
12.1.2 The need for QA in radiotherapy
Full exploitation of improved technology and more complex treatments in modern radiotherapy
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12.1 INTRODUCTION
12.1.2 The need for QA in radiotherapy
Human errors in data transfer during the preparation and delivery of radiation treatment affecting the final result: "garbage in, garbage out"
Leunens, G; Verstraete, J; Van den Bogaert, W; Van Dam, J; Dutreix, A; van der Schueren, E Department of Radiotherapy, University Hospital, St. Rafal, Leuven, Belgium
Abstract
Due to the large number of steps and the number of persons involved in the preparation of a radiation treatment, the transfer of information from one step to the next is a very critical point. Errors due to inadequate transfer of information will be reflected in every next step and can seriously affect the final result of the treatment. We studied the frequency and the sources of the transfer errors. A total number of Radiother. Oncol. 1992: > 50 ofto data transfer 464 new treatments has been checked over a period of 9 occasions months (January October 1990). Erroneous data from one point tothan another each patient. transfer has been detected in 139/24,128 (less 1%) of for the transferred parameters; they affected 26% (119/464) of the checked Twenty-five of these deviations could have led to large geographical If one of treatments. them is wrong - the overall outcome is affected. miss or important over- or underdosage (much more than 5%) of the organs in the irradiated volume, thus increasing the complications or decreasing the tumour control probability, if not corrected. Such major deviations only occurring in 0 1% of the transferred parameters affected 5% (25/464) of the new
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12.1 INTRODUCTION
12.1.2 The need for QA in radiotherapy
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12.1 INTRODUCTION
12.1.3 Requirements on accuracy in radiotherapy
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12.1 INTRODUCTION
12.1.3 Requirements on accuracy in radiotherapy
Dose (Gy)
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12.1 INTRODUCTION
12.1.3 Requirements on accuracy in radiotherapy
Dose (Gy)
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12.1 INTRODUCTION
12.1.3 Requirements on accuracy in radiotherapy
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12.1 INTRODUCTION
12.1.3 Requirements on accuracy in radiotherapy
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12.1 INTRODUCTION
12.1.4 Accidents in radiotherapy
Generally speaking, treatment of a disease with radiotherapy represents a twofold risk for the patient:
Firstly, and primarily, there is the potential failure to control the
initial disease, which, when it is malignant, is eventually lethal to the patient;
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12.1 INTRODUCTION
12.1.4 Accidents in radiotherapy
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12.1 INTRODUCTION
12.1.4 Accidents in radiotherapy
Classification of potential
hazard.
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12.1 INTRODUCTION
12.1.4 Accidents in radiotherapy
Number
15 9 8 4 4 3 3
Cause
Human error during simulation Decommissioning of teletherapy source error Error in commissioning of TPS Technologist misread the treatment time or MU Malfunction of accelerator Treatment unit mechanical failure Accelerator software error Wrong repair followed by error
Number
2 2 2 2 1 1 1 1
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Dosimetrists
Engineering etc.
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Dosimetrists
In many systems there is no separate group of dosimetrists; these functions
are carried out variously by physicists, medical physics technicians or technologists, radiation dosimetry technicians or technologists, radiotherapy technologists, or therapy radiographers.
Engineering technologists
In some systems medical physics technicians or technologists, clinical technologists, service technicians, electronic engineers or electronic technicians.
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Input
Control QA System
Output
Control QA control
Measure
Outcome can be considered of good quality when the handling of the quality system organizes well the five aspects shown in the illustration above.
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Must have a clear definition of its scope and of all the quality standards
to be met.
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Externally to collaborators in other departments, in management and in other institutions, it helps to indicate that the department is strongly concerned with quality.
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ESTRO Booklet 4:
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Document control. Procedures to ensure that the quality system is followed. Ensuring that the status of all parts of the service is clear. Reporting all non-conforming parts and taking corrective action. Recording all quality activities. Establishing regular review and audits of both the implementation of the quality system (quality system audit) and its effectiveness (quality audit).
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Example for the organizational structure of a radiotherapy department and the integration of a QA team
Chief Executive Officer
............
Management Services
QA Team (Committee)
Physics
Radiation Oncology
Radiation Therapy
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Membership and Responsibilities of the QA team (QA Committee) QA Team (Committee) Membership:
Radiation Oncologist(s) Medical Physicist(s) Radiation Therapist(s) ..........
Responsibilities:
Patient safety Personnel safety Dosimetry instrumentation Teletherapy equipment Treatment planning Treatment delivery Treatment outcome Quality audit
Chair:
Physicist or Radiation Oncologist
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VAN DYK, J., (editor), The Modern Technology for Radiation Oncology: A
Compendium for Medical Physicists and Radiation Oncologists, Medical Physics Publishing, Madison, Wisconsin, U.S.A. (1999)
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(3) Additional quality control tests after any significant repair, intervention or adjustment or when there is any indication of a change in performance
(4) Planned preventive maintenance programme in accordance with the manufacturers recommendations
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Acceptance of equipment
Acceptance of equipment is the process in which the supplier
demonstrates the baseline performance of the equipment to the satisfaction of the customer.
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Acceptance of equipment
It is a matter of professional judgment of the responsible medical
physicist to decide whether or not any aspect of the agreed acceptance criteria is to be waived.
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Commissioning of equipment
Commissioning is the process of preparing the equipment for
clinical service.
In this way the baseline standards of performance are established to which all future performance and quality control tests will be referred.
Commissioning includes the preparation of procedures, protocols, instructions, data, etc., on the clinical use of the equipment.
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Quality control
It is essential that the performance of treatment equip-ment
remain consistent within accepted tolerances throughout its clinical life.
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The "Concept of Uncertainty" is used for this purpose. In 1993, the International Standards Organisation (ISO) published
a Guide to the expression of uncertainty in measurement, in order to ensure that the method for evaluating and expressing uncertainty is uniform all over the world.
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4 sd 2 sd 1 sd action level = 2 x tolerance level mean value action level = 2 x tolerance level
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Daily Tests
Procedure or item to be tested Door interlock Radiation room monitor Audiovisual monitor Lasers Distance indicator Action level functional functional functional 2 mm 2 mm
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Daily Tests
Procedure or item to be tested Door interlock Action level functional
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Daily Tests
Procedure or item to be tested Lasers Optical distance indicator Action level 2 mm 2 mm
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Weekly Tests
Procedure or item to be tested Check of source position Action level 3 mm
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Monthly Tests
Procedure or item to be tested Output constancy Light/radiation field coincidence Field size indicator Gantry and collimator angle indicator Cross-hair centering Latching of wedges and trays Emergency off Wedge interlocks Action level 2% 3 mm 2 mm 1 1 mm functional functional functional
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Annual Tests
Procedure or item to be tested Output constancy Field size dependence of output constancy Central axis dosimetry parameter constancy Transmission factor constancy for all standard accessories Wedge transmission factor constancy Timer linearity and error Output constancy versus gantry angle Action level 2% 2% 2% 2% 2% 1% 2%
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Daily Tests
Procedure or item to be tested Lasers Optical distance indicator Action level 2 mm 2 mm
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Daily Tests
Procedure or item to be tested Audiovisual monitor Action level functional
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Daily Tests
Procedure or item to be tested X ray output constancy Electron output constancy Action level 3% 3%
Daily output checks and verification of flatness and symmetry can be done using different multi-detector devices.
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Daily Tests
Procedure or item to be tested X ray output constancy Electron output constancy Action level 3% 3%
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Monthly Tests
Procedure or item to be tested X ray output constancy Electron output constancy Backup monitor constancy X ray central axis dosimetry parameter constancy (PDD, TAR, TPR) Electron central axis dosimetry parameter constancy (PDD) X-ray beam flatness constancy Action level 2% 2% 2% 2% 2 mm at therapeutic depth 2%
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Annual Tests
Procedure or item to be tested X ray/electron output calibration constancy Field size dependence of X ray output constancy Output factor constancy for electron applicators Central axis parameter constancy (PDD, TAR, TPR) Off-axis factor constancy Transmission factor constancy for all treatment accessories Action level 2% 2% 2% 2% 2% 2%
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Daily Tests
Procedure or item to be tested Safety switches Door interlock Lasers Distance indicator Action level functional functional 2 mm 2 mm
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Monthly Tests
Procedure or item to be tested Field size indicator Gantry/collimator angle indicators Cross-hair centering Focal spot-axis indicator Fluoroscopic image quality Emergency/collision avoidance Light/radiation field coincidence Film processor sensitometry Action level 2 mm 1 2 mm diameter 2 mm baseline functional 2 mm or 1% baseline
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Annual Tests
Procedure or item to be tested Collimator rotation isocenter Gantry rotation isocenter Couch rotation isocenter Coincidence of collimator, gantry, couch axes with isocenter Table top sag Vertical travel of couch Action level 2 mm diameter 2 mm diameter 2 mm diameter 2 mm diameter 2 mm 2 mm
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Daily Tests
Procedure or item to be tested Safety switches Door interlock Lasers Distance indicator Action level functional functional 2 mm 2 mm
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Monthly Tests
Procedure or item to be tested Field size indicator Gantry/collimator angle indicators Cross-hair centering Focal spot-axis indicator Fluoroscopic image quality Emergency/collision avoidance Light/radiation field coincidence Film processor sensitometry Action level 2 mm 1 2 mm diameter 2 mm baseline functional 2 mm or 1% baseline
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Annual Tests
Procedure or item to be tested Collimator rotation isocenter Gantry rotation isocenter Couch rotation isocenter Coincidence of collimator, gantry, couch axes with isocenter Table top sag Vertical travel of couch Action level 2 mm diameter 2 mm diameter 2 mm diameter 2 mm diameter 2 mm 2 mm
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Treatment planning quality management is a subcomponent of the total quality management process.
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IPEM Reports 68
(1996) and 81 (1999),
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Purchase
Purchase of a TPS is a major step for most radiation oncology
departments.
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Level of sophistication of treatment planning Imaging availability CT simulation availability Multileaf collimation available now or in the future 3-D CRT capabilities on the treatment machines IMRT capabilities Treatment trends over the next35 years Case load and throughput
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Acceptance
Acceptance testing is the process to verify that the TPS
behaves according to specifications (users tender document, manufacturer' specifications).
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RTPS
VENDOR
Acceptance tests
USER
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RTPS
USER
Commissioning procedures Commissioning results Periodic QA program
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Issues
CPUs, memory and disk operation. Input devices: Digitizer tablet, Film digitizer, Imaging data (CT, MRI, ultrasound, etc.), Simulator control systems or virtual simulation workstation, Keyboard and mouse entry Output: Hard copy output (plotter and/or printer), Graphical display units that produce DRRs and treatment aids, Unit for archiving (magnetic media, optical disk, etc.)
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Issues
Network traffic and the transfer of CT, MRI or ultrasound image data to the TPS. Positioning and dosimetric parameters communicated to the treatment machine or to its record and verify system. Transfer of MLC parameter to the leaf position. Transfer of DRR information. Data transfer from the TPS to auxiliary devices (i.e. computer controlled block cutters and compensator machining devices). Data transfer between the TPS and the simulator Data transfer to the radiation oncology management system. Data transfer of measured data from a 3-D water phantom system
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Issues
CT input Anatomical description 3-D objects and display. Beam description Photon beam dose calculations various open fields, different SSDs, blocked fields, MLC shaped fields, inhomogeneity test cases, multibeam plans, asymmetric jaw fields, wedged fields and others. Electron beam dose calculations open fields, different SSDs, shaped fields, Dose display, DVHs Hard copy output
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Frequency
Daily Monthly
Procedure
Input and Output devices Check sum Reference subset of data Reference prediction subset Processor tests CT transfer Monitor Unit calculations Reference QA test set
Tolerance level
1 mm No change 2% or 2 mm 2% or 2 mm pass 1 mm 2% 2% or 2 mm
Annually
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Quarterly
Annually
After upgrade
CPU Digitizer
Hardware
Digitizer
CT transfer
Anatomical information
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Review be signed and dated by the reviewer. QA team oversee implementation of a program which defines:
Which items are to be reviewed. Who is to review them. When are they to be reviewed. Definition of minor and major errors. What actions are to be taken, and by whom, in event of errors.
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Portal imaging is frequently applied in order to check geometric accuracy of the patient set-up with respect to the position of the radiation beam
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Port film for a lateral irregular MLC field used in a treatment of the maxillary sinus. This method allows to visualization of both the treatment field and the surrounding anatomy.
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2. Matrix of liquid filled ionization chambers. 3. Amorphous silicon flat panel systems.
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Comparison between digitally reconstructed radiograph (DRR) and image obtained with EPID
DRR treatment fields DRR EPID fields EPID images
DRRs from treatment fields and large fields to verify the position of isocentre and the corresponding EPID fields.
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QA in portal imaging
Process control requires that local protocols must be
established to specify:
Who has the responsibility for verification of portal images (generally a
clinician), and
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To assess the dose to organs at risk (e.g., eye lens, gonads and
lungs during TBI) or situations where the dose is difficult to predict (e.g., non-standard SSD or using bolus).
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TLD detector
TLD detectors
lens of eye
lens of eye
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If discrepancies are present, this is indicated, the parameters concerned are highlighted, and the treatment cannot start until the discrepancies are corrected or overridden.
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QA of Record-and-verify systems
Treatment delivered, if relying on record-and-verify system setting
or verifying the parameters, is only as good as the information input to the system.
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Quality activities and results comply with planned arrangements. Arrangements are implemented effectively and are suitable to
achieve the stated objectives
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Quality audits:
Can be conducted for internal or external purposes. Can be applied at any level of a QA program. Are performed by personnel not directly responsible for the
areas being audited, however in cooperative discussion with the responsible personnel.
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Quality audits:
Should be regular and form part of a quality feedback loop to
improve quality.
Can be mainly procedural, looking at QA procedures, protocols, QC programs, QC and QA results and records, etc.
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The content of a quality audit visit must be pre-defined. It will depend on the purpose of the visit:
Is it a routine regular visit within a national or regional quality
audit network?
Is it regulatory or co-operative between peer professionals? Is it a visit following a possible misadministration? Is it a visit following an observed higher-than-expected deviation
in a mailed TLD audit program that the centre cannot explain?
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Assess treatment planning data and procedures. Measure some planned distributions in phantoms.
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Example of a comprehensive international external audit: The QATRO (Quality Assurance Team for Radiation Oncology) project developed by the IAEA.
Based on:
Long history of providing assistance for dosimetry audits in radiotherapy to its Member States.
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