Transcript IAEA 19.4 QUALITY ASSURANCE PROGRAMME FOR

Chapter 19: Quality Management
Slide set of 118 slides based on the chapter authored by
P. Hiles, D. McLean and S. Christofides
of the IAEA publication (ISBN 978-92-0-131010-1):
Diagnostic Radiology Physics:
A Handbook for Teachers and Students
Objective:
To introduce the principles and definitions of Quality
Management Systems for radiology facilities and provide a
framework for setting up such systems.
Slide set prepared
by E. Berry (Leeds, UK and
The Open University in
London)
IAEA
International Atomic Energy Agency
CHAPTER 19
19.1.
19.2.
19.3.
19.4.
19.5.
19.6.
IAEA
TABLE OF CONTENTS
Introduction
Definitions
Quality Management System requirements
Quality Assurance programme for equipment
Example of a Quality Control programme
Data management
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19. Slide 1 (02/118)
19.1 INTRODUCTION
19.1
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19.1 INTRODUCTION
19.1
Introduction
 Effective management of radiation medicine services
demands a quality culture
 Systematic approach
• all elements that govern delivery of the service
• factors that affect the intended outcome – a clinical diagnosis
 Overall Quality Management System includes a role for
the medical physicist
• especially with respect to equipment performance
• role is illustrated in section 19.5
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19.2 DEFINITIONS
19.2
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19.2 DEFINITIONS
19.2
Definitions
 Only the most relevant definitions included here, in the
context of radiology
 For a more comprehensive list see
• INTERNATIONAL ORGANIZATION FOR STANDARDS, Quality
Management Systems – Fundamentals and vocabulary Rep.
ISO9000:2000 (2000)
• HOYLE, D., ISO 9000 Quality Systems Handbook, 4th edn,
Butterworth Heinemann, Oxford (2001)
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19.2 DEFINITIONS
19.2
Definitions
 19.2.1
 19.2.2
 19.2.3
 19.2.4
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Quality Management System
Quality Assurance
Quality Control
Quality Standards and Good Practice
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19.2 DEFINITIONS
19.2.1 QUALITY MANAGEMENT SYSTEM
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19.2 DEFINITIONS
19.2
Definitions
 19.2.1
 19.2.2
 19.2.3
 19.2.4
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Quality Management System
Quality Assurance
Quality Control
Quality Standards and Good Practice
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19.2 DEFINITIONS
19.2.1 Quality Management System
Quality Management System
 A Quality Management System (QMS) is a framework to
support the operation of a facility’s service, with the
objective of continuous quality improvement
 A quality system involves:
• the organisation’s objectives and policies
• documented procedures consistent with these objectives and
policies
• written practice instructions for staff
• monitoring, recording and auditing of practice
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19.2 DEFINITIONS
19.2.1 Quality Management System
Quality Management System – customising
 Framework may suggest that a QMS is simply a collection
of procedures, tasks and documents
 But customisation is required
 Each QMS must be designed specifically for each
individual radiology facility
• all the components need to fit together
• the inputs and outputs need to be defined and connected
• system monitors need to feed information to processes that
cause changes in the performance of the facility
• all parts need to work together to achieve the common
purposes of the facility.
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19.2 DEFINITIONS
19.2.1 Quality Management System
QMS – Definition
 A set of interrelated and interacting processes that achieve
• the quality policy of the radiology facility
• quality objectives of the radiology facility
 The processes in turn
• form an integral part of the hospital’s management system
• focus on the achievement of the many aspects of service provision
and quality objectives
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19.2 DEFINITIONS
19.2.2 QUALITY ASSURANCE
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19.2 DEFINITIONS
19.2
Definitions
 19.2.1
 19.2.2
 19.2.3
 19.2.4
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Quality Management System
Quality Assurance
Quality Control
Quality Standards and Good Practice
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19.2 DEFINITIONS
19.2.2 Quality Assurance
Quality Assurance (QA)
 Those planned and systematic actions necessary to
provide adequate confidence that an item, process or
service will satisfy given requirements for quality
 QA is wide ranging, covering all relevant
•
•
•
•
procedures
activities
actions
and hence all groups of staff involved in the process under
consideration
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19.2 DEFINITIONS
19.2.2 Quality Assurance
Quality Assurance (QA) Programme
 Part of a QMS
 Focused on providing confidence that the quality needs or
expectations are fulfilled
• applies whether quality needs are stated, generally implied or
obligatory
 In diagnostic radiology is an organized effort by the staff
operating a facility to reach the correct diagnosis by
• performing the most appropriate examination
• producing images of sufficiently high quality and consistency
• using the lowest possible dose
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19.2 DEFINITIONS
19.2.2 Quality Assurance
QA Programme in diagnostic radiology
 World Health Organisation
• “satisfactory performance in service implies the optimum quality of
the entire process, i.e., the consistent production of adequate
diagnostic information with minimum exposure of both patient and
personnel”
 A comprehensive QA programme should, therefore,
embrace the entire process of radiology
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19.2 DEFINITIONS
19.2.3 QUALITY CONTROL
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19.2 DEFINITIONS
19.2
Definitions
 19.2.1
 19.2.2
 19.2.3
 19.2.4
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Quality Management System
Quality Assurance
Quality Control
Quality Standards and Good Practice
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19.2 DEFINITIONS
19.2.3 Quality Control
Quality Control (QC)
 Quality Control is one part of overall quality assurance
• intended to verify that structures, systems and components
correspond to predetermined requirements
 It is concerned with operational techniques and activities
used
 QC is the process through which
• the actual quality performance is measured and compared with
existing standards to check that quality requirements are met
• if the requirements are found not to have been met, actions are
taken to adjust and correct performance in order to keep or regain
conformance with the standards
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19.2 DEFINITIONS
19.2.4 QUALITY STANDARDS AND GOOD PRACTICE
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19.2 DEFINITIONS
19.2
Definitions
 19.2.1
 19.2.2
 19.2.3
 19.2.4
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Quality Management System
Quality Assurance
Quality Control
Quality Standards and Good Practice
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19.2 DEFINITIONS
19.2.4 Quality Standards and Good Practice
Quality Standards
 A set of accepted criteria against which the quality of
particular activities can be assessed
 Recommendations for quality standards for diagnostic
radiology have been issued by
• IAEA, WHO and PAHO
• European Commission (EC), the American Association of
Physicists in Medicine (AAPM) and the Institute of Physics and
Engineering in Medicine (IPEM)
 Where recommended standards are not available, local
standards need to be developed, based on a local
assessment of requirements
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19.2 DEFINITIONS
19.2.4 Quality Standards and Good Practice
Good Practice
 The practice which can be recommended based on the
most recent considerations on the necessary structure,
process and outcome using
• evidence based data
• long term experience
• knowledge gained
 Quality standards and good practice form a basis for
clinical audit
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19.3 QUALITY MANAGEMENT
SYSTEM REQUIREMENTS
19.3
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19.3 QUALITY MANAGEMENT
SYSTEM REQUIREMENTS
19.3.1 GENERAL REQUIREMENTS
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19.3 QUALITY MANAGEMENT SYSTEM REQUIREMENTS
19.3.1 General requirements
General requirements for an effective QMS
 See
• INTERNATIONAL ORGANIZATION FOR STANDARDS, Quality
Management Systems – Requirements Rep. ISO9001:2000 (2000)
 The Organisation is required to establish, document,
implement and maintain a QMS and continually improve its
effectiveness in accordance with a list of requirements
 Following list includes key activities
• not intended as a sequence
• can be represented as a cycle
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19.3 QUALITY MANAGEMENT SYSTEM REQUIREMENTS
19.3.1 General requirements
General requirements for an effective QMS (ISO 9001)
 The Organisation shall:
• Identify the processes needed for the quality management system
•
•
•
•
•
and their application throughout the organisation
Determine the sequence and interaction of these processes
Determine criteria and methods needed to ensure that both the
operation and control of these processes are effective
Ensure the availability of resources and information necessary to
support the operation and monitoring of these processes
Monitor, measure and analyse these processes
Implement actions necessary to achieve planned results and
continual improvements of these processes
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19.3 QUALITY MANAGEMENT SYSTEM REQUIREMENTS
19.3.1 General requirements
QMS cycle (1 of 3)
 In planning to meet organizational objectives
• processes are identified
• their sequence and interaction are determined
 Once the relationship between the processes is known
• criteria and methods for effective operation and control developed
and documented
 For effective communication compile the process
descriptions into a quality manual
• references the associated procedures and records
• shows how the processes interact.
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19.3 QUALITY MANAGEMENT SYSTEM REQUIREMENTS
19.3.1 General requirements
QMS cycle (2 of 3)
 Before implementation
• processes need to be resourced
• information necessary to operate and control the processes
deployed and brought under document control
 Once operational
• processes monitored to ensure they are functioning as planned
• measurements taken to verify that the processes are delivering the
required output
• actions taken to achieve the planned results documented
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19.3 QUALITY MANAGEMENT SYSTEM REQUIREMENTS
19.3.1 General requirements
QMS cycle (3 of 3)
 Data obtained from monitoring and measurement captured
on controlled records
• data analysed
• opportunities for continual improvement identified
• agreed actions implemented
See ISO 9001 for more detail on italicised words in the cycle
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19.3 QUALITY MANAGEMENT
SYSTEM REQUIREMENTS
19.3.2 THE ROLE OF THE MEDICAL PHYSICIST
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19.3 QUALITY MANAGEMENT SYSTEM REQUIREMENTS
19.3.2 The role of the Medical Physicist
The role of the Medical Physicist
 Image quality
 Ionising radiation dose
• IAEA - International Basic Safety Standard (BSS) for protection
against ionising radiation and for the safety of radiation sources
• requires registrants and licensees to establish a comprehensive
programme of quality assurance for medical exposures; by, or
under the oversight of or with the advice of, a medical physicist
specialised in the relevant field
 Measurement, recording and analysis of QA data,
especially for complex equipment
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19.4 QUALITY ASSURANCE
PROGRAMME FOR EQUIPMENT
19.4
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19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4
Background
 A QA programme for equipment
• is essential as much of the complexity of modern radiological
imaging comes from the equipment and associated technical
processes
• should cover the entire process from the initial decision to adopt a
particular procedure through to the interpretation and recording of
results
• should include a systematic control methodology
 To be effective, a strong commitment from the facility and
institutional leadership is needed, to provide
• time, personnel, budget
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19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4
Elements of QA Programme for equipment (1 of 3)
 Measurements of the physical parameters of medical
radiological equipment
• at the time of acceptance and commissioning prior to clinical use
on patients
• periodically thereafter
• after any major maintenance that could affect patient safety
 Implementation of corrective actions if measured values of
the physical parameters are outside control limits
 Verification of the appropriate physical and clinical factors
used in patient diagnosis
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19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4
Elements of QA Programme for equipment (2 of 3)
 Records of relevant procedures and results, including a
manual that
•
•
•
•
•
•
defines clear lines of responsibility
outlines the individual quality control (QC) tests performed
gives the test frequencies
is useful for staff training
facilitates audit of a service
helps to keep information within the service
 Verification of the appropriate calibration and conditions of
the operation of dosimetry and monitoring equipment
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4
Elements of QA Programme for equipment (3 of 3)
 Optimisation of clinical protocols and equipment operation
to achieve the aims of quality assurance
 Regular and independent audits of the programme of
quality assurance for medical exposures
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19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4
QA Programme for equipment
 19.4.1
Multidisciplinary team
 19.4.2
Structure of an equipment quality assurance
programme
 19.4.3
Outline of quality control tests
 19.4.4
Specification for test equipment
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19.4 QUALITY ASSURANCE
PROGRAMME FOR EQUIPMENT
19.4.1 MULTIDISCIPLINARY TEAM
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19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4
QA Programme for equipment
 19.4.1
Multidisciplinary team
 19.4.2
Structure of an equipment quality assurance
programme
 19.4.3
Outline of quality control tests
 19.4.4
Specification for test equipment
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19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.1 Multidisciplinary team
Multidisciplinary team
 Many elements contribute to the imaging process
• experience of personnel, whether directly or indirectly involved, is
crucial to the final outcome
 Each discipline has an important role in the output of the
entire process
• roles are interdependent and require close cooperation
• responsibilities shared between disciplines must be clearly defined
 Each staff member must have
• appropriate qualifications (education, training and experience)
• access to appropriate opportunities for continuing education and
development
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19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.1 Multidisciplinary team
Multidisciplinary team
 Multidisciplinary teams have important roles when working
with quality systems, to:
•
•
•
•
•
lead
develop
maintain
manage
improve
 Well-directed team work is equally, if not more, important
than individual work in delivering systematic improvement
for a quality assurance programme
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19.4 QUALITY ASSURANCE
PROGRAMME FOR EQUIPMENT
19.4.2 STRUCTURE
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19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4
QA Programme for equipment
 19.4.1
Multidisciplinary team
 19.4.2
Structure of an equipment quality assurance
programme
 19.4.3
Outline of quality control tests
 19.4.4
Specification for test equipment
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19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.2 Structure
Life cycle of an imaging system
 Sometimes referred to as equipment QA cycle
• begins with the decision to acquire equipment, whether new or
used, to fulfil a need at the facility
• completed with the disposal of the equipment
• maintenance is a vital part of the cycle
 The stages of the life cycle are important for all pieces of
radiological equipment
• special attention should be paid to equipment designed for
paediatrics, health screening and those which may produce high
doses
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Example of the life cycle of an imaging system
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Five stages applicable to imaging equipment QA
 Equipment specification and tendering process
 Critical examination
 Acceptance
 Commissioning
 Routine performance testing
 All are part of the life cycle of imaging equipment
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Equipment specification
 An agreed need for equipment
 Translated into an equipment specification
 Formal tender or option appraisal process
 A critical part of the cycle
 Team that draws up the specifications
• the facility medical physicist responsible for diagnostic radiology
• engineering professionals
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Equipment specification
 Team should consider
• the construction of the installations site, power supply and air
conditioning.
• radiation shielding for X-ray equipment
• environmental shielding, for example magnetic and radio frequency
shielding, for other equipment such as MRI scanners
 Involvement continues after a contract is awarded
• during construction the medical physicist should ensure that
• architectural plans are being correctly followed
• shielding requirements are correctly installed
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Critical examination – what?
 Takes place after installation is complete
 The safety features and warning devices incorporated into
the equipment are inspected
• to assure correct operation
• to check that there is sufficient protection of the staff, visitors and
patients against exposure to ionising radiation
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Critical examination – who?
 Undertaken by medical physicist, in conjunction with other
appropriate personnel
• representative of the equipment supplier
• regulatory inspector
 Facility should not allow equipment to be used for medical
exposures unless the results of the critical examination are
satisfactory so
• medical physicist present should ideally represent the radiology
facility
• a medical physicist representing the installer may be agreed
instead, preferably at the contract stage
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Critical examination – when?
 Appropriate when there could be radiation protection
implications associated with an incorrect installation
• failure of the safety features or warning devices to operate
correctly
• poor siting
• inadequate shielding - especially important if it has not been
possible to confirm that the correct shielding has been installed
during construction
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Critical examination – method?
 Concentrates on ‘critical’ features most likely to affect
safety
 Achieved by selective examination of those features
• depending on results obtained may then probe more deeply
 Does not involve a long list of prescriptive tests on every
part of the system
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Acceptance testing
 Verification of equipment specifications and features
• performed by representatives of the installer and the facility
medical physicist
 Completion of a checklist
 Any significant discrepancy should be notified formally to
the contractor, who should be required to undertake
corrective action
 During acceptance testing a qualified person should check
the electrical and mechanical safety of any new installation
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Commissioning
 Carried out after acceptance
• performed by the facility representative, usually a medical physicist
specializing in radiology physics
• sometimes undertaken jointly with the installer
 Aim is
• to ensure that the equipment is ready for clinical use
• to establish baseline values against which the results of
subsequent routine performance tests can be compared
• to optimize performance of the imaging system
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Commissioning tests
 Testing should include all parameters and conditions of
use that are expected in clinical use
 A check should be made that all relevant testing for the
unit has been completed and that no tests have been
omitted during either the critical examination or
acceptance
 After major work on the equipment, the relevant
commissioning tests may have to be repeated to establish
new baseline values, for example
• after an X-ray tube is replaced
• after new software is installed
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Critical examination, acceptance and commissioning
 Purpose of the tests should remain distinct
 Even if carried out by same personnel and at the same
time
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Commissioning – completion
 Commissioning tests described above are not the end
point
 Radiology personnel and users of equipment should check
•
•
•
•
clinical protocol settings
image processing
ergonomics
positioning of equipment
 May be done during, or after, training from the product
specialist
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Routine performance testing
 Or constancy testing
 Or quality control (QC) testing
 Those tests that are undertaken either regularly or after
maintenance or repairs, to detect whether any change in
the performance of the equipment has occurred that would
require corrective action
 Such tests are a sub-set of the commissioning tests
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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Routine performance testing – who?
 A collaborative, multidisciplinary approach to routine
performance testing is essential
 Involves staff with different levels of expertise, some of
whom may be external to the radiology facility
• for example, when a regional medical physics unit undertakes the
quality assurance programmes for a number of hospitals with
expert staff making periodic visits to a department
 Frequent tests, which are quick to perform, are usually
undertaken locally with advice from a medical physicist
 More complex and time-consuming tests may require
special expertise and instrumentation

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19.4 QUALITY ASSURANCE PROGRAMME FOR
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19.4.2 Structure
Reject analysis (1 of 2)
 Reject analysis of images from appropriate systems
should be performed in addition to routine QC testing
• to ensure optimal image quality
• to identify faults or long-term deterioration
 Rejects can be due to, for example
•
•
•
•
poor film processing
positioning errors or patient movement
incorrect exposure
faulty X-ray equipment
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19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.2 Structure
Reject analysis (2 of 2)
 Rejects can be reduced or prevented
• with adequate training for staff on all appropriate pieces of
equipment
• careful maintenance of equipment
• reject analysis should be undertaken on a regular basis, with
results fed back to staff and action undertaken as appropriate
 Applies to digital imaging as well as film
• there should be a simple procedure for rejecting images that does
not result in the image disappearing from the system.
• ideally, the rejected images should be categorised and stored
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.2 Slide 20 (63/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.2 Structure
Maintenance programme
 Maintenance and routine performance testing are
complementary
• maintenance ensures that any malfunction of equipment, revealed
by quality control testing, is rectified
• important in order for a QA programme to be effective
• tests need to be performed after maintenance or repairs that may
affect imaging and/or radiation characteristics of equipment
 Mechanical and electrical safety checks should be
described in the maintenance contract
• users of X ray equipment have a duty of care to be on the lookout
for obvious signs of mechanical or electrical deterioration
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.2 Slide 21 (64/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.2 Structure
Maintenance – aims
 To ensure that equipment is safe to use
 To ensure that equipment is working properly
 To allow the detailed performance specification,
demonstrated at commissioning, to continue to be
achieved during the working life of the equipment
 Additional critical examination or partial commissioning
tests may be necessary when the machine has been
subject to modification, maintenance, reinstallation or
repair
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.2 Slide 22 (65/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.2 Structure
Maintenance and performance against the specification
 Service contractors should demonstrate that they
undertake appropriate tests to check performance against
specification
• service engineers should feed back results
• particularly if these could affect the clinical image quality and
radiation dose
 Departments can use the results of their own routine
performance testing programme to audit the service
contract
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.2 Slide 23 (66/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.2 Structure
Disposal or alternative use
 When imaging equipment no longer meets the required
performance specifications, it should be withdrawn from
use and may be disposed of and replaced
 Alternatively, it may be used for less demanding imaging
tasks for which a lower specification of performance may
be acceptable
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.2 Slide 24 (67/118)
19.4 QUALITY ASSURANCE
PROGRAMME FOR EQUIPMENT
19.4.3 OUTLINE OF QUALITY CONTROL TESTS
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.3 Slide 1 (68/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4
QA Programme for equipment
 19.4.1
Multidisciplinary team
 19.4.2
Structure of an equipment quality assurance
programme
 19.4.3
Outline of quality control tests
 19.4.4
Specification for test equipment
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.3 Slide 2 (69/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.3 Outline of quality control tests
Outline of quality control tests
 These tests are intended to verify the stability in the
operation of the equipment or elements used to acquire
the image
 Described in terms of
•
•
•
•
frequency
priority
performance standards
test types
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.3 Slide 3 (70/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.3 Outline of quality control tests
Frequency
 The recommended frequency of a routine performance test varies from
daily to three yearly
• often given as a range, e.g. three to six monthly
• frequency selected should depend on the equipment characteristics (e.g.
age, reliability) and the clinical workload to which the equipment is
subjected
 A lower frequency of tests may be appropriate for simple imaging
equipment that is used less frequently
• e.g. in community hospitals or for equipment where experience shows that
parameters are unlikely to change.
 The frequency of tests may also be designated as essential and
desirable
• e.g. a test may be essential every year but desirable every six months
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.3 Slide 4 (71/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.3 Outline of quality control tests
Priority
 The priorities for whether a routine performance test is
recommended may be denoted as:
Essential: Represents the recommended minimum standard
• conformance to this standard of testing would be regarded as
good practice
Desirable: The inclusion of this level of testing would be regarded as
best practice
• it is recognised that the implementation of desirable tests may
be constrained by test equipment costs, manpower availability,
equipment characteristics, clinical workload or other factors
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.3 Slide 5 (72/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.3 Outline of quality control tests
Performance standards
 Quality control tests help maintain equipment performance
through the use of tolerance criteria that are applied to QC
test results. These performance standards can be
characterised as:
Acceptable: Performance must be within these tolerances
• if it is not, the equipment should not be used
Achievable: This level of performance should be attained under
favourable circumstances
• this is the level at which a facility should work if it is feasible
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.3 Slide 6 (73/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.3 Outline of quality control tests
Test types
 Many quality control tests are designed to measure
equipment performance consistency over time. These
performance standards can be characterised as:
• Repeatability: performance must be within given tolerances of self
consistency for a set of measurements taken at one time
• Consistency / reproducibility: performance parameters are not
changing over the period between QC tests
• achieved through comparison with an established baseline
measurement
• in cases where the baseline values are fixed to nominal values
it is known as accuracy testing
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.3 Slide 7 (74/118)
19.4 QUALITY ASSURANCE
PROGRAMME FOR EQUIPMENT
19.4.4 SPECIFICATION FOR TEST EQUIPMENT
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.4 Slide 1 (75/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4
QA Programme for equipment
 19.4.1
Multidisciplinary team
 19.4.2
Structure of an equipment quality assurance
programme
 19.4.3
Outline of quality control tests
 19.4.4
Specification for test equipment
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.4 Slide 2 (76/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.4 Specification for test equipment
Test equipment
 Equipment testers at radiology facilities should have
access to the necessary test equipment for the required
tests within the QA programme
 Instruments which measure physical parameters should be
calibrated to an appropriate standard prior to use and at
suitable intervals
 A range of phantoms may be needed
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.4 Slide 3 (77/118)
19.4 QUALITY ASSURANCE PROGRAMME FOR
EQUIPMENT
19.4.4 Specification for test equipment
Phantoms: real and virtual
 Phantoms may be needed for
• dosimetry measurements especially under automatic exposure
control modes
• image quality assessment
• the evaluation of digital images requires access to image data sets
and the use of a computer and appropriate software
 The evaluation of image display monitors further requires
specific test patterns
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.4.4 Slide 4 (78/118)
19.5 EXAMPLE OF A QUALITY
CONTROL PROGRAMME
19.5
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5 Slide 1 (79/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5
Introduction to examples (1 of 2)
 Provided as illustrations
 For various X-ray modalities in a radiology facility
• X-ray tubes and generators
• Screen-Film radiography
• Digital radiography
 Many factors influence the selection of QC tests
• e.g. age, condition and level of use of the equipment, equipment
performance and departmental resources
 So, flexibility needed in the programme
• avoid being too prescriptive about the detail of test types,
frequencies, priorities and tolerances
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5 Slide 2 (80/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5
Introduction to examples (2 of 2)
 Avoid testing for its own sake
• particularly with the increasing reliability of modern X-ray systems,
which have advanced considerably in the last decade
 Resources for quality assurance should match
• need to produce images of sufficiently high quality and consistency
• use of lowest dose needed to provide the required diagnostic
information
 QC programme may have to be more extensive and/or
frequent for
• equipment used for medical exposure of children, health screening
programmes or high dose procedures
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5 Slide 3 (81/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5
Examples
 19.5.1
 19.5.2
 19.5.3
IAEA
X-ray Tubes and Generators
Screen-Film Radiography
Digital radiography
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5 Slide 4 (82/118)
19.5 EXAMPLE OF A QUALITY
CONTROL PROGRAMME
19.5.1 QC PROGRAMME FOR X-RAY TUBES AND
GENERATORS
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.1 Slide 1 (83/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5
Examples
 19.5.1
 19.5.2
 19.5.3
IAEA
X-ray Tubes and Generators
Screen-Film Radiography
Digital radiography
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.1 Slide 2 (84/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.1 QC programme for x-ray tubes and generators
X-ray tubes and generators
 All equipment used for medical radiography requires
routine performance testing, including
• fixed installations (both radiographic and fluoroscopic)
• mobile radiography units
• mobile image intensifiers
 Table lists physical parameters to be assessed on each
item of equipment
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.1 Slide 3 (85/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.1 QC programme for x-ray tubes and generators
Outline quality control programme for X ray tubes and
generators
Parameter
X ray/light beam alignment
X ray/light beam centring
Light beam/Bucky centring
Distance & scales
Image receptor alignment & collimation
Radiation output index: repeatability and
consistency
Frequency
1 to 2 monthly
1 to 2 monthly
1to 2 monthly
1 to 2 monthly
3 to 6 monthly
1 to 2 monthly
Priority
Essential
Essential
Essential
Desirable
Desirable
Essential
Radiation output: repeatability and consistency
1 to 2 yearly
Essential
Exposure time repeatability and accuracy
Tube potential repeatability and accuracy
1 to 2 yearly
1 to 2 yearly
Essential
Essential
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.1 Slide 4 (86/118)
19.5 EXAMPLE OF A QUALITY
CONTROL PROGRAMME
19.5.2 QC PROGRAMME FOR SCREEN-FILM
RADIOGRAPHY
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.2 Slide 1 (87/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5
Examples
 19.5.1
 19.5.2
 19.5.3
IAEA
X-ray Tubes and Generators
Screen-Film Radiography
Digital radiography
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.2 Slide 2 (88/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.2 QC programme for screen-film radiography
Screen-film radiography
 Screen-film AEC systems
• use of AEC will reduce the number of repeated films, provided that
the AEC system is correctly set up for optimal operation
• optimal set up of AEC system established during commissioning
• QC tests are continued at regular intervals to ensure continuing
optimal performance
 Film processor and darkroom
 Light boxes and viewing conditions
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.2 Slide 3 (89/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.2 QC programme for screen-film radiography
Outline quality control programme for screen-film radiography
systems
Parameter
AEC backup timer operation
Resultant film density under AEC
Consistency between AEC chambers
AEC Repeatability and consistency
Frequency
12 monthly
1 to 3 monthly
12 monthly
12 monthly
Priority
Essential
Essential
Essential
Essential
AEC Image receptor dose
12 monthly
Essential
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.2 Slide 4 (90/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.2 QC programme for screen-film radiography
Screen-film radiography
 Screen-film AEC systems
 Film processor and darkroom
• 50% of the rejected films attributable to poorly controlled automatic
film processing systems
• essential to monitor through sensitometric control
 Light boxes and viewing conditions
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.2 Slide 5 (91/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.2 QC programme for screen-film radiography
Sensitometry (1 of 2)
 One box of film, of the type used clinically, is set aside for
daily sensitometric measurement
 Standardised light source: sensitometer
• exposes X ray film with logarithmically increasing intensity
• each intensity step typically 2, so intensity is doubled every two
steps
 Calibrated densitometer used to measure the resulting
optical density (OD) on the processed control film
• OD for a specified step is recorded as the ‘speed index’ on a trend
chart
• accepted tolerances identified on the chart
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.2 Slide 6 (92/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.2 QC programme for screen-film radiography
Sensitometry (2 of 2)
 Action should be taken to correct the film processing when
OD is outside of tolerance
 Similar indices for
• film contrast
• base + fog value
 In combination on a trend chart indices can assist in
determining the corrective action needed
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.2 Slide 7 (93/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.2 QC programme for screen-film radiography
Sample film
processor
QC chart
Dashed lines
indicate upper and
lower tolerance
limits
IAEA
Note that the
measurement
on the 6th of
April was
repeated
because the
initial value of
the contrast
index DD was
outside action
level.
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.2 Slide 8 (94/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.2 QC programme for screen-film radiography
Outline quality control programme for film processor and
darkroom
Parameter
Developer temperature
Gross fog
Film speed: speed index
Film contrast: contrast index
Replenishment rates
Fixer pH
Silver content of fixer
Condition of cassettes and screens
Relative speed of intensifying screens
Film fogging
Darkroom lightproofing
IAEA
Frequency
Daily to weekly
Daily to weekly
Daily to weekly
Daily to weekly
1 -3 monthly
1 -3 monthly
1 -3 monthly
6 to 12 monthly
12 monthly
12 monthly
12 monthly
Priority
Essential
Essential
Essential
Essential
Desirable
Desirable
Desirable
Essential
Desirable
Desirable
Desirable
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.2 Slide 9 (95/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.2 QC programme for screen-film radiography
Screen-film radiography
 Screen-film AEC systems
 Film processor and darkroom
 Light boxes and viewing conditions
• optimal film viewing is critical for the successful reading of
radiographic films
• once identified poor viewing conditions can often be quite easily
rectified
• care must be taken that
• view boxes have uniform luminance and colour temperature
• ambient lighting illumination levels are low
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.2 Slide 10 (96/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.2 QC programme for screen-film radiography
Outline quality control programme for lightboxes and viewing
conditions
Parameter
Film viewer condition
Film viewer luminance
Film viewer uniformity
Variation between adjacent film viewers
Room illumination
IAEA
Frequency
6 monthly
6 to 12 monthly
6 to 12 monthly
6 to 12 monthly
6 to 12 monthly
Priority
Essential
Essential
Essential
Desirable
Essential
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.2 Slide 11 (97/118)
19.5 EXAMPLE OF A QUALITY
CONTROL PROGRAMME
19.5.3 QC PROGRAMME FOR DIGITAL RADIOGRAPHY
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.3 Slide 1 (98/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5
Examples
 19.5.1
 19.5.2
 19.5.3
IAEA
X-ray Tubes and Generators
Screen-Film Radiography
Digital radiography
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.3 Slide 2 (99/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.3 QC programme for digital radiography
Digital radiography
 Image acquisition, processing and display
• Computed Radiography (CR): cassette and image processor
combination
• Digital radiography (DR): direct digital detector and processor
 Automatic Exposure Control (AEC) involved in both
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.3 Slide 3 (100/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.3 QC programme for digital radiography
Digital radiography
 Separation of acquisition, processing and display functions
• wide dynamic range, so images of varying exposure level can be
displayed optimally
• but removes link between image brightness and image receptor /
patient exposure
• not obvious to users if exposure levels are changing, so QC
important
 Exposure index (EI)
• indicates detector response to radiation
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.3 Slide 4 (101/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.3 QC programme for digital radiography
Optimization
 Digital systems may appear to be fully automatic, but
• functions of acquisition, processing and display can be altered for
different examination types
• to gain optimal image quality for diagnosis at acceptable dose to
the patient
 Once optimization is achieved, quality control testing
should be undertaken to maintain equipment performance
 QC testing should use consistent image processing
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.3 Slide 5 (102/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.3 QC programme for digital radiography
Picture Archiving and Communication System (PACS)
 QC includes:
 Setup and performance maintenance of image display
devices
 Use of DICOM structures to record equipment-generated
dose related data
• data is increasingly available to patients, is stored in records
• important for medical physicists to verify recorded dose accuracy
• verification of DICOM dose indicators during the commissioning
of new equipment
• routine calibration of KAP meters and other dose indicators
such as those used in CT etc.
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.3 Slide 6 (103/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.3 QC programme for digital radiography
Digital radiography
 Tables show outline quality control programmes for
• General
• Computed Radiography (CR)
• Digital Radiography (DR)
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.3 Slide 7 (104/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.3 QC programme for digital radiography
Outline quality control programme for digital radiography
systems – general tests
Parameter
Frequency
Priority
EI monitoring
Image uniformity (visual check)
Threshold contrast visibility
Limiting spatial resolution
EI repeatabilitya and consistencyb
1 to 3 monthly
1 to 3 monthly
4 to 6 monthly
4 to 6 monthly
12 monthly
Essential
Essential
Desirable
Desirable
Essential
Image uniformity
Threshold contrast detail detectability
Limiting spatial resolution
Scaling errors
Dark noise
AEC sensitivity
AEC backup timer operation
AEC Consistency between chambers
AEC Repeatability and consistency
12 monthly
12 monthly
12 monthly
12 monthly
12 monthly
1 to 3 monthly
12 monthly
12 monthly
12 monthly
Essential
Essential
Desirable
Desirable
Desirable
Essential
Essential
Essential
Essential
AEC Image receptor dose
12 monthly
Essential
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.3 Slide 8 (105/118)
19.5 EXAMPLE OF A QUALITY CONTROL PROGRAMME
19.5.3 QC programme for digital radiography
Outline quality control programme for digital radiography
systems – CR specific tests
Parameter
Condition of cassettes and image plates
Erasure cycle efficiency
Frequency
1 to 3 monthly
12 monthly
Priority
Essential
Essential
Outline quality control programme for digital radiography
systems – DR specific tests
Parameter
Sensitivity reproducibility between DR
detectors connected to the same generator
IAEA
Frequency
12 monthly
Priority
Essential
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.5.3 Slide 9 (106/118)
19.6 DATA MANAGEMENT
19.6
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.6 Slide 1 (107/118)
19.6 DATA MANAGEMENT
19.6
Data management
 Quality management will lead to the accumulation of a
significant volume of data
• requires a suitable repository for storage and retrieval
 The data can also be used in an active way to help
manage the quality control system
• requires the development of a suitable data management system,
which could be either paper based or computer based
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.6 Slide 2 (108/118)
19.6 DATA MANAGEMENT
19.6
Elements of a data management system ( 1 of 2)
 Policy and control manuals that determine
• the nature of the quality assurance programmes
• the details of the QC testing procedures
 The results from QC tests need to recorded and compared
to the required performance criteria
• some tests involve performance constancy and comparison to
baseline data - graphical representation, such as a trend chart is
very useful for review
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.6 Slide 3 (109/118)
19.6 DATA MANAGEMENT
19.6
Elements of a data management system ( 2 of 2)
 A test report is often required to
• document the test results
• initiate action if needed for equipment adjustment
 Trend analysis is an important tool that can be used to
• assess drifts in performance
• highlight tests which consistently fail
• enable comparisons of similar types of equipment
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.6 Slide 4 (110/118)
19.5 DATA MANAGEMENT
19.6
Example of a test report
Sample film
processor
QC chart
Dashed lines
indicate upper and
lower tolerance
limits
IAEA
Note that the
measurement on the
6th of April was
repeated because the
initial value of the
contrast index DD
was outside action
level.
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.6 Slide 5 (111/118)
19.6 DATA MANAGEMENT
19.6
Additional functionality (1 of 2)
 Ability to perform auditing of the data to help determine
• suitability of tests
• optimum test frequency
 Automation using database software
• replaces use of spreadsheet software
• more likely to accomplish a satisfactory set of outcomes
• can include test scheduling, trend analysis, automated report
generation and auditing of performance
 A medical physicist who is involved in the establishment
and maintenance of the data management system
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.6 Slide 6 (112/118)
19.6 DATA MANAGEMENT
19.6
Additional functionality (2 of 2)
Example data management structure
 System that enables
quality control to be a
dynamic process
 Continued analysis of
results feeds back into
an on-going QC
programme review
• suitability and relevance
of tests performed
• frequency of testing
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19.6 Slide 7 (113/118)
19. BIBLIOGRAPHY
19.
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Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19. Bibliography Slide 1 (114/118)
19. BIBLIOGRAPHY
19.
 AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE, An Exposure




Indicator for Digital Radiography: Report of AAPM Task Group 116, AAPM
Rep. 116, New York (2009). http://www.aapm.org/pubs/reports/RPT_116.pdf
AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE, Quality control in
diagnostic radiology AAPM Rep. 74, New York (2002).
http://www.aapm.org/pubs/reports/rpt_74.PDF
AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE, Quality control in
diagnostic radiology, Report of AAPM Diagnostic X-ray Imaging Committee,
Task Group 12, AAPM Report 74 (2002)
EUROPEAN COMMISSION, Radiation Protection 91: Criteria for acceptability
of radiological (including radiotherapy) and nuclear medicine installations, EC,
Luxembourg (1997)
HAUS, A.G., Advances in Film Processing Systems Technology and Quality
Control in Medical Imaging, (2001)
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19. Bibliography Slide 2 (115/118)
19. BIBLIOGRAPHY
19.
 HEALTH AND SAFETY EXECUTIVE, Equipment used in connection with




medical exposure, Guidance Note PM77.
http://www.hse.gov.uk/pubns/guidance/pm77.pdf
HOYLE, D., ISO 9000 Quality Systems Handbook, 4th edn, Butterworth
Heinemann, Oxford (2001)
INSTITUTE OF PHYSICS AND ENGINEERING IN MEDICINE, Quality Control
in Magnetic Resonance Imaging, IPEM Rep. 80, York (2002)
INSTITUTE OF PHYSICS AND ENGINEERING IN MEDICINE, Measurement
of the Performance Characteristics of Diagnostic X-ray Systems used in
Medicine. Report No 32, second edition, Part III: Computed Tomography X-ray
Scanners IPEM York (2003)
INSTITUTE OF PHYSICS AND ENGINEERING IN MEDICINE,
Recommended standards for the routine performance testing of diagnostic xray imaging systems, IPEM Report 91, IPEM, York (2005)
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19. Bibliography Slide 3 (116/118)
19. BIBLIOGRAPHY
19.
 INSTITUTE OF PHYSICS AND ENGINEERING IN MEDICINE, The critical



examination of X-ray generating equipment in diagnostic radiology, IPEM
Report 79, IPEM, York (1998)
INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Assurance
Programme for Screen–Film Mammography, Human Health Series, 2, IAEA,
Vienna (2009). http://wwwpub.iaea.org/MTCD/publications/PDF/Pub1381_web.pdf
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INTERNATIONAL ORGANIZATION FOR STANDARDS, Quality Management
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IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19. Bibliography Slide 4 (117/118)
19. BIBLIOGRAPHY
19.
 INTERNATIONAL ORGANIZATION FOR STANDARDS, Quality Management

Systems – Requirements Rep. ISO9001:2000 (2000)
PAN AMERICAN HEALTH ORGANISATION, WORLD HEALTH
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protection in radiology service: Imaging and radiation therapy (Borras, C., Ed.),
PAHO, Washington, DC (1997)
IAEA
Diagnostic Radiology Physics: A Handbook for Teachers and Students – 19. Bibliography Slide 5 (118/118)