IAEA Training Material on Radiation Protection in Radiotherapy
Radiation Protection in
Radiotherapy
Part 12
Quality Assurance
QUALITY as a goal

“The totality of features or
characteristics that bear on our ability to
satisfy the stated or implied goal of
effective patient care.”
Comprehensive QA for Radiation Oncology,
AAPM Task Group 40, 1994

To ensure the goal is reached requires a
fully implemented Quality Assurance
program throughout the facility.
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Part 12: Quality assurance
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What is Quality Assurance?

“All those planned and systematic
actions necessary to provide confidence
that a product or service will satisfy
given requirements for quality.”
ISO 9000
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Part 12: Quality assurance
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Quality Assurance
In the BSS seen in the context
of medical exposure as essential
for radiation protection of the
patient
 Quality Assurance and Control is
also important to assess the
overall effectiveness of protection
and safety measures

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Objectives




To be familiar with the concepts of Quality Assurance
as a multidisciplinary activity and its interrelation with
radiation protection in radiotherapy.
To be familiar with Quality Assurance procedures as
a tool for reviewing and assessing the overall
effectiveness of a radiation protection program.
To be able to understand the need for and role of
specific tests in the context of Quality Control and be
able to identify appropriate national and international
protocols for this task
To be aware of the need for involvement of
professionals in a Quality Assurance program and for
radiation protection
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Contents
1. Quality Assurance and the BSS
2. QA systems
3. Quality Control in radiotherapy
External Beam RT
Brachytherapy
4. QA and radiation protection
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Part 12: Quality assurance
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1. Quality Assurance and the
BSS (Managerial Requirements)
BSS 2.29. “Quality assurance programmes
shall be established that provide, as
appropriate:
(a) adequate assurance that the specified
requirements relating to protection and safety
are satisfied; and
(b) quality control mechanisms and procedures
for reviewing and assessing the overall
effectiveness of protection and safety
measures.”
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QA and QC
Quality Assurance is the overall process
which is supported by Quality Control
activities
 Quality Control describes the actual
mechanisms and procedures by which
one can assure quality

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Quality Assurance and Medical
Exposure
BSS appendix II.22. “Registrants and licensees, in
addition to applying the relevant requirements for
quality assurance specified elsewhere in the
Standards, shall establish a comprehensive quality
assurance programme for medical exposures with
the participation of appropriate qualified experts in
the relevant fields, such as radiophysics or
radiopharmacy, taking into account the principles
established by the WHO and the PAHO.”
You must establish a QA program!
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Relevant for radiotherapy


WORLD HEALTH ORGANIZATION, Quality
Assurance in Radiotherapy, WHO, Geneva
(1988).
PAN AMERICAN HEALTH ORGANIZATION,
Publicación Cientifica No. 499, Control de
Calidad en Radioterapia: Aspectos Clínicos y
Físicos, PAHO, Washington, DC (1986).
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BSS appendix II.23

“Quality assurance programmes for
medical exposures shall include:
(a) measurements of the physical parameters of the
radiation generators, imaging devices and
irradiation installations at the time of
commissioning and periodically thereafter;
(b) verification of the appropriate physical and
clinical factors used in patient diagnosis or
treatment; …”
Check machine and data!
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Consequences for radiotherapy
A good acceptance testing and
commissioning program is fundamental
for any QA activities
 QA activities are typically a subset of
the tests and procedures used for the
commissioning of a unit
 QA applies to both physical and clinical
aspects of the treatment

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BSS appendix II.23

“Quality assurance programmes for
medical exposures shall include:
...
(c) written records of relevant procedures and
results;
(d) verification of the appropriate calibration and
conditions of operation of dosimetry and
monitoring equipment; .…”
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Consequences for radiotherapy

Treatment records must be kept of all
relevant aspects of the treatment - including

Session and Summary Record information
Records all treatment parameters
Dose Calculations

Dose Measurements



Particular emphasis is placed on QA of
dosimetry
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Treatment records


Must contain all
relevant information
Can be in electronic
format
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BSS appendix II.23

“Quality assurance programmes for
medical exposures shall include:
...
and
(e) as far as possible, regular and independent
quality audit reviews of the quality assurance
programme for radiotherapy procedures”
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Consequences for radiotherapy
A QA system itself and its outcomes
must be critically reviewed
 External audits are recommended to
verify that the checks are not only done
but that they also achieve what they are
supposed to do
 Every good system requires an
independent look at times

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Part 12: Quality assurance
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2. QA systems


Radiation Protection in Radiotherapy
Many QA systems exist - one
important example is the ISO
9000 system
They are highly successful in
manufacturing industry
because they do improve
productivity and avoid costly
mistakes
Part 12: Quality assurance
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Good QA systems in
radiotherapy


Improves work
practices
Would have
prevented most of
the major accidents
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ISO 9000
Comprehensive set of standards for QA
(mainly in manufacturing and service
industry)
 Adapted e.g. by ESTRO to the
radiotherapy environment

 European Society for Therapeutic Radiology and
Oncology (ESTRO) Advisory Report to the Commission
of the European Union for the 'Europe Against Cancer
Programme'. Quality Assurance in radiotherapy.
Radiother. Oncol. 35: 61-73; 1995.
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A Comprehensive Quality
Assurance Program

The details of such a program are often
wrapped up in a “Code of Practice”.
“Quality Assurance in Radiotherapy”,
ESTRO Advisory Report, 1995
 “Comprehensive QA for Radiation
Oncology: Report of AAPM Radiation
Therapy Committee Task Group 40”, 1994
 “Quality Assurance in Radiotherapy”,
WHO, 1988

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A Comprehensive QA Program
typically comprises
Quality Assurance Committee
 Policies and Procedures Manual
 Quality Assurance team
 Quality audit
 Resources

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QA Committee Membership






Must represent the many disciplines within the
department
Should be chaired by the Head of Department
As a minimum must include a medical doctor, a
physicist, a radiotherapy technologist and an
engineer responsible for service and maintenance
Must be appointed and supported by senior
management
Must have sufficient depth of experience to
understand the implications of the process
Must have the authority and access to the resources
to instigate and carry out the QA process
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Quality Assurance Committee






Should ‘represent’ the department
Should be ‘visible’ AND accessible to staff
Oversees the entire Quality Assurance program
Writes policies to ensure the quality of patient
care
Assists staff in tailoring the program to meet the
needs of the Department (using published
reports as a guide)
Monitor and audit the program to ensure that
each component is being performed and
documented
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Quality Assurance Committee



Set agreed “Action Levels”
Example: Physics is given the authority to
ensure correct accelerator output
For the daily output check two “Action Levels”
are set


For any daily measurement which exceeds 2% but
less than 4%, treatment may continue but the
Senior Physicist responsible must be notified
(immediately)
For any daily measurement which exceed 4%,
treatment must STOP immediately and the
problem investigated by the Senior Physicist
responsible
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Action levels
Are quantitative
 Reflect the required outcome
 Are informed by the achievable
outcome
 Must be unambiguous
 Should be easy to understand

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QA Committee review




Where “Action Levels” have been exceeded
Where set procedures have been discovered to be
faulty
After a review, recommendations must be formulated
in writing for improving the QA program
When errors are discovered the fault often lies in the
process rather than in the action of individuals
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Documentation for the Quality
Assurance Committee



Terms of Reference
The Committee must meet at established
intervals and retain for audit purposes the
minutes of its meetings, actions
recommended and the results attained.
In short, there is a QA program for the QA
Committee
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Policies and Procedures Manual
This manual contains clear and concise
statements of all the policies and
procedures carried out in the
Department
 Reviewed (typically) yearly
 Updated as procedures change
Policies and Procedures
Manual

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Policies and Procedures Manual

As a minimum, sections should exist for
Administrative procedures
 Clinical procedures
 Treatment procedures
 Physics procedures
 Radiation safety

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Policies and Procedures Manual



It must be “signed off” by the Head of
Department and appropriate section heads
It is important that all staff have
“ownership” to the manual - it should
reflect the opinions of all and be agreed to
by all
A list of all copies of the Manual and their
locations must be kept to ensure that each
copy is updated
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Quality Assurance Team
Includes all disciplines
 Well defined responsibility and reporting
structure
 Each member of the team must

Know his/her responsibility
 Be trained to perform them
 Know what actions are to be taken should
a test or action be outside the preset
“action levels”

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Responsibility Chart
Leer
Professional
Area
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Quality Assurance Team

Each member of the team must also
Have at least some understanding of the
consequences when tests or actions are
outside the “action levels”
 Maintain records documenting the
frequency of performance, the results and
the corrective action taken if necessary

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Quality Audit

“A systematic and independent
examination and evaluation to determine
whether quality activities and results
comply with planned arrangements and
whether the arrangements are
implemented effectively and are suitable
to achieve the objectives.”
“Quality assurance in radiotherapy.”, Radiother. Oncol., 1995
Do you do what you say you do?
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Quality Audit
Ideally performed by someone outside
of the organisation
 Examples

IAEA/WHO TLD program for check of dose
in therapy units
 EQUAL program in Europe
 Audits of clinical trials participation

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Quality Assurance does not
stop here!
The Quality Assurance Committee and
the Quality Assurance team must
continuously monitor new information and
implement this in their procedures
Continuous Quality Improvement






CQI - many other acronyms are available for this
Part of virtually all QA systems
Improved methods on cancer patient management
are documented in clinical trial reports.
Quality assurance protocols are continuously under
development in many countries
Regular Quality Assurance meeting for all members
of a Section
Continuing education - lectures, workshops, journal
clubs and must be available for all staff
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And finally: QA is not a threat, it is
an opportunity
It is essential in a QA program that all
staff feel free to report errors
 A non threatening environment must
exist
 Reward honesty with encouragement
 Education is the key, not punishment

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3. Quality Control in radiotherapy

Many documents exist that specify what QC
activities should be performed in
radiotherapy…
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QC should ensure every step in
the treatment chain...
e.g.: hand calculation of
treatment time
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e.g.: check source
activity
42
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. Rafaël, 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
464 new treatments has been checked over a period of 9 months (January to October 1990). Erroneous data
transfer has been detected in 139/24,128 (less than 1%) of the transferred parameters; they affected 26%
(119/464) of the checked treatments. Twenty-five of these deviations could have led to large geographical
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
treatments. The sources of these large deviations were nearly always human mistakes, whereas a
considerable number of the smaller deviations were, in fact, consciously taken decisions to deviate from the
intended treatment. Nearly half of the major deviations were introduced during input of the data in the
check-and-confirm system, demonstrating that a system aimed to prevent accidental errors, can lead to a
considerable number of systematic errors if used as an uncontrolled set-up system. The results of this study
show that human mistakes can seriously affect the outcome of patient treatments.(ABSTRACT
TRUNCATED AT 250 WORDS) [Journal Article; In English; Netherlands]
Radiother. Oncol. 1992: > 50 occasions of data transfer
from one point to another for each patient!
If one of them is wrong - the overall outcome is affected
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QC activities in radiotherapy

Three general areas:
Physical dosimetry
 Treatment planning (dealt with part 10
lecture 3C of the course)
 Patient treatment

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QC activities

Must be planned prospectively
daily
 weekly
 monthly
 annually
 whenever needed…


The following is only a suggestion!
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External Beam Radiotherapy
Examples for daily QC

Safety
door and other interlocks
 radiation warning lights
 audiovisual
 radiation area monitor

PTW Linacheck
Radiation constancy check
 Mechanical/optical “pointers”

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Test of optical components




Used for patient
set-up
Essential
Easy to perform
Jigs available
RMI test tool
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Alignment of lasers for patient
set-up
 Should point to the
Gammex
laser and test tool


Radiation Protection in Radiotherapy
isocentre
Check also line
width
Check line
alignment at least
20cm beyond
isocentre
Part 12: Quality assurance
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Quality Control - Weekly
Check of source positioning (cobalt 60)
 Couch movements (lateral, vertical,
longitudinal)

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Example for
weekly QC
summary
From Constantinou 1992
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Quality Control - Monthly
 Dosimetry
 Output
constancy
 Backup monitors
 Central axis %DD constancy
 Flatness/symmetry constancy
 Timer end effect
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Quality Control - Monthly

Safety interlocks
emergency
 wedge etc

Light/ radiation field coincidence
 Scales
 Isocentre position
 Cross hair position

PTW
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Test of optical components
Quality Control - Monthly
Used for patientRMI
set-up
 Essential
 Easy to perform
 Field size indicators
 Jigs available

Distance measuring indicators
 Jaw symmetry
 Latching of wedges, trays etc.
test tool
 Wedge position (factorsRMI
etc.)

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Quality Control - Annual
Dosimetry
 Safety
 Mechanical

These checks are a scaled down version of
the commissioning checks. It is a major QC
exercise and is intended to validate the unit
for another twelve months.
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How to decide on frequency for
tests?
Likelihood of failure
 Severity of the consequences if
something goes wrong
 Ease of the test - resources required

This depends on local circumstances!!!
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Time requirements for QC

External beam per megavoltage unit
daily: 30 minutes
 weekly: 2 hours
 monthly: > 4 hours
 annual: 2 days +


Siemens
Primus
Linac
These are estimates only - a qualified
expert must decide on the actual
requirements for a particular treatment
unit
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QC for Brachytherapy
Sources

The following QC should be done on
receipt of the sources and documented
Physical/chemical form
Mentor
 Source encapsulation
 Radionuclide distribution and uniformity

 Autoradiograph
 Uniformity of activity amongst seeds
 Visual inspection of seeds in ribbons
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QC for Brachytherapy
Sources

Calibration
Do on receipt and document
 Ideal - every source
 Long half-life sources (e.g. Cs 137)

Nucletron
 All

Short half-life sources (e.g. I 125)
 If only a few, do them all
 If a large number, do a sample e.g. 10%
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QC for Brachytherapy Sourcesmultiple seeds

Suggested calibration tolerances

Ideal
 mean of batch (3%)
 Deviation from mean (5%)

Practical
 Review manufacturer’s documentation for
tolerances

Review ALL the manufacturer’s
documentation
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QC for Remote Afterloading

Before each treatment day
Room safety door interlocks
 Lights and alarms
 Radiation monitor
Gammasonics
 Console functions
 Visual inspection of source guides
 Verify accuracy of ribbon preparation

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QC for Remote Afterloading

Weekly
Accuracy of source and dummy loading
 Source positioning


At each source change or quarterly
Calibration
 Timer function
 Accuracy of source guides and connectors

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QC for Remote Afterloading

Annual
Dose calculation algorithm
 Simulate emergency conditions
 Verify source inventory

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QC Documentation

Forms shall be
established to guide
the process


easy to follow (even
late in the evening
after normal
treatment has
finished)
diagrams useful
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Examples for
forms
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Forms are useful for all tests
Simple ticks
may be sufficient
Empty space for
comments and
drawings
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Special equipment and
procedures
All equipment and all procedures should
be tested
 To design a QC protocol, one needs to
fully understand the goals and all steps
of the procedure
 Requires a qualified expert
 Action levels should be set

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A note on action levels
Not too tight - one must be realistic
about what can be achieved
 Not too lax - one must identify
unsatisfactory practice
 As the practice improves, the action
levels may be tightened

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Not only treatment units require QC:
Simulator
Appropriate sections from the QC
activities for a treatment unit
 kVp and mAs calibration
 Image intensifier quality checks
 Automatic exposure control if applicable
 Film processor

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CT scanner




Image quality
Scaling and
deformation
Transfer of data
Transfer of patient
(is positioning OK, is
couch on CT and
linac identical?)
Radiation Protection in Radiotherapy
Gammex RMI CT test tool
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QC for Dosimetry Equipment

Local standard


2 yearly calibration
Field instruments

yearly calibration
PTW
Linearity
 Leakage
 Recombination

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QC for Measuring Equipment

Automated scanners
Positional accuracy
 Alignment
 Accuracy of data analysis


Accessories
Thermometer
 Barometer

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Clinical QC


Not only physics
and dosimetry must
be subject to QC,
also clinical
management
A good way to do
this are ‘chart
rounds’
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Chart Rounds
Regular review of patients
 Can be all patients or randomly selected
patients
 Should include all patients with
unexpected severe complications

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4. QA and radiation protection


Quality assurance is essential for a
functioning system of radiation protection
The BSS identifies the following areas in
particular:




Requirements for Practices
Safety of Sources
Medical Exposure
Occupational Exposures
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QA in
medical
exposures
Physical QA
as discussed
before
 Process QA

Leer
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QA Program: Arrangements to be
required from the licensee



Procedures to establish patient identity
Procedures to ensure accordance with
prescription by a medical practitioner
Procedures to ensure that radiation sources,
including equipment can only be purchased
from manufacturers and distributors
authorized by the Regulatory Authority
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Also the radiation protection
program itself requires QA
Check that the program meets its
objectives
 Document improvements
 Document and rectify deficiencies
 Raise awareness

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The cost of QA
Dedicated staff - qualifications, training
and numbers
 Equipment - include allowance for
redundancy
 Time - commissioning, QA, reports,
meetings, training

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What do we get?
Yes, correct - lots of documentation.
But there are other benefits...
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The benefits of QA

Benefits for the department
improved management system
 improved communication
 improved safety
 less duplication and waste


Benefits to patients
optimized procedure
 re-assurance

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Additional benefits
Credibility
 Potential to attract funding (and account
for it…)
 Participation in multicenter clinical trials
 Regular updates and audits to continue
the improvements
 Pride and confidence of staff

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Involvement of Administration



Without the support of the Administration the
financial resources will not be made available
The AAPM considers this to be so important
that in their Quality Assurance policy they
make the very first section “Part A: Information
for Radiation Oncology Administrators”.
“Educate those who control funding”
Comprehensive QA for Radiation Oncology, Task Group 40, 1994
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But - Beware the Administration “Tick
in the Box” syndrome!





Administration will agree with QA
They may even insist upon it
Without education they will not understand
what that really means in our environment
Most administrators equate QA with an “audit”
Many simply require the right boxes get
ticked so they can be seen to do have done
their job - this is not enough...
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What do we risk without a
Quality Assurance Program?
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Exeter, UK
New cobalt 60 source installed
 Over the next 5 months, 207 patients were
overdosed by 25% due to an incorrect
calibration
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Contributing factors
Calibration details not recorded
 Little documentation or protocols
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What do we risk without a
Quality Assurance Program?

Exeter: Contributing factors (cont.)
Reduced staffing levels (money)
 No independent check of calculations
 No independent check calibration
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It was detected during a Nation wide
survey!
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Where to get more information
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AAPM task group 40: Kutcher GJ, Coia L, Gillin M, Hanson W, Leibel S, Morton
RJ, Palta J, Purdy J, Reinstein L, Svensson G, et al. Comprehensive QA for
radiation oncology: report of AAPM therapy committee task group 40. Med Phys
1994;21:581-618.
AAPM task group 53: Fraas, B. et al. Quality assurance for clinical radiotherapy
treatment planning. Med. Phys. 25: 1773-1829; 1997.
AAPM task group 56: Nath R.; Anderson L.; Meli J.; Olch A.; Stitt J. A.;
Williamson J. Code of practice for brachytherapy physics: report of the AAPM
Radiation Therapy Committee Task Group No 56. Med. Phys. 24:1558-98;
1997.
ACPSEM Position Paper: Millar M, Cramb J, Das R, Ackerly T, Brown G, Webb
D. ACPSEM Position Paper: Recommendations for the safe use of external
beams and sealed brachytherapy sources in radiation oncology.
Aust.Phys.Eng.Sci.Med. 1997; 20 (Supp): 1-35
Institute of Physical Sciences in Medicine. Commissioning and quality
assurance of linear accelerators, IPSM report 54. York: IPSM; 1988.
International Standards Organisation. Quality management and quality
assurance standards. ISO 9000 series.
PAN AMERICAN HEALTH ORGANIZATION, Publicación Cientifica No. 499,
Control de Calidad en Radioterapia: Aspectos Clínicos y Físicos, PAHO,
Washington, DC (1986).
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WHO (World Health
Organisation). Quality
Assurance in
radiotherapy. Geneva
1988.
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Summary
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Quality Assurance is an essential part of radiotherapy
It affects all aspects including the radiation protection
program
There are many different standards and guidelines
for specific QA activities - it requires a qualified expert
to choose the most appropriate for a particular center
QA requires and encourages regular external audits
QA is a continuous process - it is aimed at achieving
improvements not laying blame.
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Any questions?
Question
Please give an example for the concept
of Continuous Quality Improvement from
your practice.
Example… just one of many
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A centre intends to improve treatment set-up. The measure
patient positioning using port films on 20 patients e.g. of the
prostate. The random variations are of the order of 8mm and the
systematic error on average 9mm.
The systematic error could at least partially attributed to different
couch sag in simulator and treatment unit. This is reflected in
update of the procedures.
A repeat test shows that not only the systematic but also the
random uncertainty have improved (the latter potentially
because of heightened awareness). The smaller random
variation allows to pick up other systematic errors…
In addition to this the positive experience leads to the same
tests to be done for other treatment sites...
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Acknowledgment
Lee Collins, Westmead Hospital,
Sydney
 Lyn Oliver, Royal North Shore Hospital,
Sydney
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