European Guidelines For Quality Assurance in Mammography Screening

EUROPEAN COMMISSION
PUBLIC HEALTH
EUROPEAN GUIDELINES FOR

QUALITY ASSURANCE
IN MAMMOGRAPHY SCREENING
2nd edition
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EUROPE AGAINST CANCER
JUNE 1996
EUROPEAN COMMISSION
Europe Against Cancer Programme Radiation Protection Actions
A great deal of additional Information on the European Union is available on the Internet.
It can be accessed through the Europa server (http://europa.eu.int)
Cataloguing data can be found at the end of this publication

Luxembourg: Office for Official Publications of the European Communities, 1996
ISBN 92-827-7454-6
ECSC-EC-EAEC, Brussels Luxembourg, 1996
Cover: Pablo Picasso, Les Demoiselles d'Avignon, Paris (June-July 1907)
Oil on canvas, 8' 7'8" (243.9 233.7 cm)
The Museum of Modern Art, New York. Acquired through the Lillie P.
Bliss bequest. Photograph 1996, The Museum of Modern Art, New York
Reproduction is authorized, except for commercial purposes, provided the source is acknowledged
Printed in Belgium
List of contents
I-1
EUROPEAN GUIDELINES FOR QUALITY ASSURANCE IN MAMMOGRAPHY SCREENING

1. Introduction
2. European network of reference centres (EUREF)
3. Key organisational aspects
Conditions for breast cancer screening
Objectives
4. QA programme
Identification of the target population
Data-administrative System
Screening age groups and intervals:
The Screening Examination:
Professional communication:
Radiation Protection Considerations:
Cost-effectiveness calculations:
Training:
Performance Indicators:
5. Quality Maintenance
6. Assessment Process
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I - 2.
THE IMPORTANCE OF THE RADIOGRAPHER IN MAMMOGRAPHY SCREENING

Compression
Positioning
Personal communication
Quality Assurance procedures
Teamwork
Training
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I-3
THE ROLE OF THE RADIOLOGIST IN THE SCREENING PROGRAMME

Introduction
Quality issues
Performance
Assessment
Teamwork
Interval cancers
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BIBLIOGRAPHY
1-12
GUIDELINES AND PROTOCOLS

II- A
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QUALITY ASSURANCE IN THE EPIDEMIOLOGY OF BREAST CANCER SCREENING

Introduction
Block I - Local conditions governing the screening process
Block II - Invitation scheme
Block III - Screening process and further assessment
Block IV - Evaluation / outcomes of screening
Block V - Disease stage of screen-detected cancers
Block VI - Treatment of screen-detected cancers
Block VII - Follow up and ascertainment of interval cancers
Block VIM - Impact on breast cancer mortality
Acknowledgements
Glossary of terms
CYTOPATHOLOGY GUIDELINES
Introduction
Registering basic information
Reporting categories
Quality assurance
II - A - 1
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II - A - 7
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Il - C
QUALITY ASSURANCE GUIDELINES FOR PATHOLOGY IN MAMMOGRAPHY SCREENING

INTRODUCTION
Il - D-
II-C-1
MACROSCOPIC EXAMINATION OF BIOPSY AND RESECTION SPECIMENS

Biopsy Specimens
Mastectomy Specimens
Axillary Dissection Specimens
-C-1
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USING THE HISTOPATHOLOGY REPORTING FORM

Introduction
Recording Basic Information
Recording Benign Lesions
Classifying Epithelial Proliferation
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-C-7
C-12
CLASSIFYING MALIGNANT NON-INVASIVE LESIONS

High Nuclear Grade DCIS
Low Nuclear Grade DCIS
Intermediate Nuclear Grade DCIS
Mixed Types
Other histological types
Paget's disease
Diagnosing Microinvasion
Classifying Invasive Carcinoma
Invasive cribriform carcinoma
II C - 1 5
II C - 1 5
II C - 1 5
II - C -16
II - C -16
II - C -16
II - C -17
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II - C -18
RECORDING PROGNOSTIC DATA
-C-19
REFERENCES
-C-24
INDEX FOR SCREENING OFFICE PATHOLOGY SYSTEM
II-C-26
MEMBERSHIP OF WORKING GROUP
II - C - 31
THE EUROPEAN PROTOCOL FOR THE QUALITY CONTROL OF THE PHYSICAL AND TECHNICAL
ASPECTS OF MAMMOGRAPHY SCREENING
Executive summary
-D-1
1. Introduction to the measurements
-D-3
2. Description of the measurements

2.1 X-ray generation and control
2.1.1 X-ray source
Focal spot size
Focal spot size: star pattern method
Focal spot size, slit camera method
Focal spot size, pinhole method
Source-to-image distance
Alignment of X-ray field/image receptor
Radiation leakage
Tube output
2.1.2 Tube voltage
Reproducibility and accuracy
Half Value Layer
2.1.3 AEC-system
Optical density control setting: central value and difference per step
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Guard timer
Short term reproducibility
Long term reproducibility
Object thickness compensation
Tube voltage compensation
2.1.4 Compression
Compression force
Compression plate alignment
2.2 Bucky and image receptor
2.2.1 Anti scatter grid
Grid system factor
Grid imaging
2.2.2 Screen-film
Inter cassette sensitivity and attenuation variation
Screen-film contact
2.3 Film processing
2.3.1 Base line performance processor
Temperature
Processing time
2.3.2 Film and processor
Sensitometry
Daily performance
Artifacts
2.3.3 Darkroom
Light leakage
Safelights
Film hopper
Cassettes
2.4 Viewing conditions
2.4.1 Viewing box
Luminance
Homogeneity
2.4.2 Ambient light
Level
2.5 System properties
2.5.1 Dosimetry
Entrance surface air kerma
2.5.2 Image Quality
Spatial resolution
Image contrast
Threshold contrast visibility
Exposure time
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3. Daily and weekly QC tests.
l-D-21
4. Definition of terms
I - D - 22
5. Tables
I - D - 26
6. Bibliography
I - D - 29
Appendix 1: Calculation of film-parameters
I - D - 33
Appendix 2: A method to correct for the film curve
I - D - 34
Appendix 3: Typical values for other spectra and densities
I - D - 35
Appendix 4: Sample Data Sheets
I - D - 37
ANNEXES
ANNEX 1:
RECOMMENDATIONS OF THE COMMITTEE OF CANCER EXPERTS ON BREAST CANCER
SCREENING
Ill - 1
ANNEX 2:
EUREF PROTOCOL
Ill - 3
ANNEX 3:
POPULATION SCREENING ACT ( The Netherlands)
Ill - 5
ANNEX 4:
COUNCIL OF EUROPE , COMMITTEE OF MINISTERS,
RECOMMENDATION No. R (94)11 ON SCREENING AS A TOOL OF PREVENTIVE MEDICINE . . . . 111-11
ANNEX 5:
EUROPEAN PROTOCOL ON DOSIMETRY IN MAMMOGRAPHY
(EXECUTIVE SUMMARY OF EUR 16263)
111-17
ANNEX 6:
EUROPEAN CONSENSUS ON THE ROLE OF GENERAL PRACTITIONERS IN WOMEN'S CANCER
SCREENING
Ill - 22
Definition of Terms:
Quality Assurance as defined by the WHO (1982):

"All those planned and systematic actions necessary to provide adequate confidence that a structure,
system or component will perform satisfactorily in service (ISO 6215-1980). Satisfactory performance
in service implies the optimum quality of the entire diagnostic process-i.e., the consistent production
of adequate diagnostic information with minimum exposure of both patients and personnel."
Quality Control as defined by the WHO(1982):

"The set of operations (programming, coordinating, carrying out) intended to maintain orto improve
[. . . ] (ISO 3534-1977). As applied to a diagnostic procedure, it covers monitoring, evaluation, and
maintenance at optimum levels of all characteristics of performance that can be defined, measured,
and controlled."
European Guidelines for QUALITY ASSURANCE in Mammography Screening 2 nd edition (JUNE 1996)
I -1
E U R O P E A N G U I D E L I N E S F O R Q U A L I T Y A S S U R A N C E IN M A M M O G R A P H Y
SCREENING
1. Introduction
Revision of the Guidelines for Mammography Screening has become necessary in the light of experience
gained from the operation of screening programmes in Europe since the publication of the first edition. For
this second edition we have included full guidelines for epidemiology and pathology.
Population screening for breast cancer is a major public health intervention and experience shows that
suitable performance parameters can only be achieved through strict adherence to Quality Assurance (QA)
guidelines. Since screening is targeted essentially at asymptomatic women, the narrow balance between
benefits and undesirable effects is completely dependent on programme quality. Achievement of the objective,
mortality reduction, is inevitably long term. There are, however, important early performance indicators which
can predict outcome and which therefore must be accurately documented. High quality data are essential.
This document outlines the requirements of a QA programme for a number of aspects of a screening system,
but does not yet attempt to define guidelines for treatment. It does, however, give more detailed guidance
for the medical diagnostic and technical aspects of the screening process itself.
The effectiveness of any screening programme is directly related to the quality of the individual parts ofthat
programme. For high quality mammography screening, the following aspects are of prime importance:
Epidemiology:
Epidemiological support underpins the entire process of a screening programme, from the
organisational and administrative aspects, through implementation to evaluation and assessment of
impact.
Physico-Technical:
The quality of the imaging process is linked to both the image quality and the dose absorbed by
breast tissue. Compliance with the criteria on image quality and breast dose, defined for radiographic
examinations of the breast (CEC EUR 16260, European Guidelines on Quality Criteria for Diagnostic
Radiographic Images, September 1995) is essential. Performance has to be monitored by regular
measurements of appropriate physical and technical parameters in order to verify that a satisfactory
and consistent technique is being employed. The results of this Quality Control (QC) of the technical
aspects can then be assessed by an independent service. This enables the comparability of the
performance of each centre and ensures that at least the basic level of performance required by a
QA Programme is being achieved.
Radiography:
The radiographer is in most cases the only member of the professional team who has physical
contact with every woman attending for screening. Adequate technique requires proper training
followed by strict and continual adherence to performance guidelines.
Radiology:
Radiologist screening performance will be maximised by appropriate training, adequate on-going
experience and sufficient volume of work with evaluation and appraisal of activities.
-1
Pathology:
The success of a breast screening programme depends heavily on the quality of the cytology and
pathology services. The accurate and standardized categorization of screen detected abnormalities
requires specialized skills and training.
Treatment:
Because of the enormous variation in treatment practices throughout Europe, it is not considered
practical at this stage to lay down detailed guidelines on a QA system for treatment. In any given
country or district the method and outcome of treatment requires to be closely audited.
No screening programme should be undertaken without clearly established goals, dedicated staff training and
proper QA. Training programmes should be established by centres of expertise. The certification of knowledge
acquired during training is recommended.
2. European network of reference centres (EUREF)

EUREF is the European network of reference centres for breast cancer screening established by the "Europe
against Cancer" programme. Its office acts as a training co-ordinating and documentation centre. The
"Europe against Cancer" programme is committed to ensuring that the pilot breast screening projects funded
by it, achieve sufficient quality and expertise to function as Quality Assurance Reference Centres in their own
country. To this end, EUREF is charged with the responsibility of responding to and coordinating a Quality
Assurance training requirement in a given programme. The nature of this response would be to facilitate
contacts and training activities between the pilot study concerned and the source of expertise seen as most
suitable by the "Europe against Cancer" programme. EUREF should further monitor the progress of the
programme in question to the point where a satisfactory outcome has been achieved. EUREF is also prepared
to offer advice on sources of training and coordination to other breast screening programmes upon request.
The full protocol is listed in annex III D
3. Key organisational aspects

Conditions for breast cancer screening
Screening for breast cancer by means of mammography has been shown to be effective in reducing breast
cancer mortality in several studies. High compliance is crucial in maximising the effect on mortality reduction.
The process of cancer screening is one where asymptomatic women are invited to undergo a test procedure
aimed at identifying malignant disease.
In a screening situation it is of particular importance that both sensitivity and specificity are maintained at a
high level. This can only be achieved when mammographie screening is carried out by well trained,
experienced personnel, using high quality equipment purchased and maintained according to the European
protocol for the Quality Control of the Technical Aspects of Mammography Screening.
It is of major importance for the QA Programme to have a system which will detect cancers occurring in the
screened population during the intervals between successive screenings. The identification of these interval
cancers is necessary to assess performance. This aspect of the programme can only be fully evaluated with
the existence of an accurate and up-to-date cancer register.
Objectives
It must be understood that although the aim of the screening programme is to reduce mortality from breast
cancer, this effect cannot be measured until an interval of approximately a decade from the commencement
of screening. Adequate and accurate information is required to measure effectiveness. It is important that
clear operational objectives be employed, as listed below:
1-2
To identify and invite eligible1 women for mammography screening.

To maximise compliance in the eligible population.
To ensure that mammography of the highest possible standard is achieved and that the films are read
by personnel with proper training and proven skills in this area.
To maximise the acceptability of the service.
To provide prompt and effective further investigations and treatment where indicated.
To minimise the adverse effects of screening.
To optimize cancer detection.
To perform regular audit of the activities of the programme and to provide appropriate feedback.
To provide a cost-effective service.
To ensure that all staff undergo regular training and professional development.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
4. QA programme
A QA Programme for mammography screening has to be considered under headings relating to all elements
in the programme from the identification of the population to be screened to the evaluation and identification
of screen-detected abnormalities. Ideally, a comprehensive QA Programme in breast cancer screening should
also take into account an audit of treatment, but, in the wide context of Europe, with all the variations involved,
this is not seen as practical in the present instance.
The programme director has overall responsibility for implementing, evaluating and updating the QA
Programme. There must also be a nominated individual who is accountable for the implementation of
professional guidelines in each individual discipline.
The radiologist has a co-operative role with radiographers and physicists for technical aspects of screening,
he/she is wholly responsible for the reading and interpretative aspects.
Multidisciplinary analysis of individual case management and overall programme outcomes must be
undertaken with the relevant professional specialities.
A screening programme must be backed by comprehensive QA, covering not only tests to ensure optimum
choice and performance of equipment and accessories, but also optimum performance of staff in all
disciplines. Every mammography facility must have a QA Manual. This Document provides guidance
towards the creation of such a QA Manual. However, the physico-technical protocols can be regarded as a
framework. Any QA Manual must set out the essential features of all checks, tests and procedures in the QA
Programme, together with indications of who takes action in the light of test results, and who ensures that this
action is satisfactory. It must also be subject to almost continuous review as technology advances, and
knowledge and experience are gained.
Identification of the target population
Ideally each population to be screened should be derived from a population register. In the absence of such
a register, a listing of women in the target population will need to be compiled. For the screening programme
to have maximum effect it is essential that the screening register is both complete and accurate. The types
of error which occur in registers relate to wrong address, wrong name, wrong date of birth, mistakes in other
personal data, spelling and typing mistakes and wrong reference numbers. The register must be regularly
updated as in some urban populations the mobility may amount to 20% per annum. Without a defined
population, it is impossible to calculate accurately the attendance rate. The higher the attendance rate
achieved, the greater the potential benefit to the target population.
See epidemiology glossary for full definition

1-3
European Guidelines for QUALITY ASSURANCE in Mammography Screening 2nd edition (JUNE 1996)
Data-administrative System
The data-administrative system provides a basis for programme analysis and facilitates regular assessment
of results and for feedback of data to all involved in the screening programme.
The Call/Recall System should:
Issue all invitations to screening
Issue reminder letters to non-attenders.
Issue appointments for assessment of screen detected abnormalities.

Screening age groups and intervals:
The majority of scientific publications demonstrate a breast cancer mortality reduction from screening in the
age group 50 - 69. Routine population screening below the age of 50 is not recommended.
The optimal screening interval is likely to be from 2 to 3 years.
The Screening Examination:
For each woman's initial screening examination, a two view technique should be employed, using a mediolateral oblique combined with a cranio-caudal projection.
This examination must be carried out by radiographers who are properly trained and have documented
performance skills.
Professional communication:
The successful conduct of the screening programme is a multidisciplinary exercise and adequate results will
not be achieved without regular formal case management reviews. This is best organized in the format of a
multidisciplinary review meeting.
Radiation Protection Considerations:
All practices which involve radiological examinations of asymptomatic individuals shall be consistent with the
general principles of radiation protection:
all exposures shall be medically and epidemiologically justified by the benefits they produce in relation
to potential hazards;
all exposures shall be kept as low as reasonably achievable;
appropriate dose constraints shall be applied;
any alternative techniques likely to prove at least as effective from the diagnostic point of view and
presenting less potential hazards should be used.
All medical and paramedical staff involved in radiological examinations of asymptomatic individuals should
have received adequate training relevant to the techniques used.
Such staff also should have acquired competence in radiation protection according to article 2 of the Council
Directive of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing
medical examination or treatment (57).
1-4
Cost-effectiveness calculations:
Prior to inception the programme should undergo cost benefit analysis to demonstrate probable achievement
of its targets. Cost effectiveness is an important part of QA and a calculation model (MISCAN) developed by
the Erasmus University in Rotterdam (The Netherlands) has been tested in several screening programmes
throughout Europe.
Training:
It is fundamental to the success of screening that all staff involved in the programme must have attended a
course of instruction at an approved training centre. Professional staff may also require a period of
secondment to the centre (not necessarily the same training centre).
Performance Indicators:
1
The Application of the Results of the Screening Programme to the Q.A. Programme
The results of a screening programme provide statistics which form the basis of the most
accurate performance indicators for radiologists. A number of parameters therefore require to
be checked regularly and the information system must be capable of providing the appropriate
data. The first and most immediately available figure is the Recall Rate. Earlier recommendations
were that less than 10% of screened women should be recalled for assessment. Recent
experience suggests that 5% or below is a more realistic target and one which certainly should
be aimed for.
Crude Cancer Detection Rate

It has been stated that in a previously unscreened population in Northern and Western Europe,
a screening programme should detect not less than 5 invasive cancers per 1000 women
screened.
The detection rate at initial screening depends on the incidence of breast cancer which is
relatively low in Southern and Eastern Europe compared to the North and West.
Experience has already shown that a number of programmes detect a considerably higher rate
than this, but to allow for the considerable variations which may occur in different populations,
the figure of 3 times the numerical value of the local annual incidence rate should be adhered
to in the prevalent round. In the incident rounds of screening at a two years interval, 1,5 times
that value is acceptable.
Small Cancer Detection Rate

The detection of small invasive cancers is regarded as important in terms of mortality reduction
and as an indicator of image quality and radiologist performance. It is recommended that at least
25% of screen detected cancers should be of a size less than or equal to 10mm.
Interval Cancer Rate

As a direct consequence of a long screening interval (2-3 years) it will be some considerable
time before this rate becomes fully available, but it again forms a useful indication as to the
efficiency of the screening programme.
Positive Predictive Value of Recommendation for Open Biopsy

This value should be in order of at least 50% in the initial screen and increase in the following
screening rounds (see epidemiology glossary).
Monitoring performance indicators is an organisational responsibility to be carried out by the project leader
or relevant professional and administrative disciplines. In terms of the overall programme performance, the
following items should be recorded:
1.
2.
3.
4.
5.
6.
7.
8.
Number of women invited.

Number of women screened.
Number of women recalled for technical reasons.
The time interval between invitation to screening and referral to assessment unit.
Type and number of additional tests performed.
Number of fine needle aspiration cytology or core biopsy examinations performed.
Number of preoperative localisations performed.
Number of women subjected to short term recall.
5. Quality Maintenance
1
Double Reading
It is highly recommended, and in a decentralised system essential, that screening mammograms are
read by two radiologists acting independently. Second reading should be performed by a radiologist
trained and experienced in mammography screening. Decentralised second reading is not
recommended. The administering radiologists should be able to extract data from screening records
to monitor individual radiologist performance. These records, of course, must remain confidential
within the profession.
Internal Review
Each Screening/Assessment Centre should hold local meetings on a regular basis to review
screening programme results and to review in detail films of:
(a) Early cancers detected
(b) Interval cancers
(c) Early cancers missed by one or more film readers
Review Meetings
On a wider basis, regular meetings should be held to review radiologist performance and to cover
problems such as those outlined above under Local Meetings and other topics related to the
radiological aspects of the QA Programme, e.g. performance of ultrasound or stereotactic fine needle
aspiration cytology.
Structure and Monitoring of QA

QA is best achieved by the help of some qualified national external authority. Visiting by staff to other
screening units has been found of benefit in maintaining quality. It is also of benefit to occasionally
receive visits by acknowledged expert staff from other major centres or a reference centre.
Technical Quality Control

Each Screening unit must perform Technical Quality Control on their mammographie devices and
equipment, in order to assure the appropriate image quality of the mammograms of each woman
attending the screening service. Some of the daily or weekly quality control actions can be performed
by the local staff. More elaborate measurements should be performed every six months by an
independent authority.
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6. A s s e s s m e n t Process
The outcome of assessment of screen-detected abnormalities must be closely audited and the results
recorded. The objectives and measurements are given below:
OBJECTIVE
MEASUREMENT
To minimise the number of women

referred unnecessarily for further tests.
Onward referral to assessment.
To minimise the number of false

negative results in screened women.
In the prevalent round the number of invasive

cancers presenting in screened women in the
subsequent 12 or 24 months.
3.
To maximise the number of cancers

detected.

cancers detected in women invited and
screened. The numbers may vary according
to national incidence.
4.
To maximise the number of small

cancers detected.

cancers s10 mm in diameter, pathological
measurement, detected in women invited and
screened.
To minimise the number of

unnecessary invasive procedures.
Benign to malignant biopsy ratio.
The target values are given in the Epidemiology guidelines and other relevant sections of this document.
AUTHORS:
M. Broeders (Nijmegen NL)
M. Codd (Dublin IRL)
A. Kirkpatrick (Edinburg UK)
. Perry (London UK)
M. Thijssen (Nijmegen NL)
S. Trnberg (Stockholm S)
C. de Wolf (European Commission LUX)
1-7
I - 2.
THE
IMPORTANCE
OF
THE
RADIOGRAPHER
IN
MAMMOGRAPHY
SCREENING
This is a brief summary of the role of the radiographers in mammography screening. Full QA guidelines are
at present been drawn up.
Mammography as a screening test for breast cancer has to meet stringent quality requirements. These
requirements can only be met when a comprehensive Quality Assurance (QA) programme is in place. The
requirements for a complete QA programme must include the role of the radiographer in the screening system
and/or QA requirements for radiographers. This chapter provides a brief outline of quality assurance for
radiographers in mammography screening.
For the majority of women attending the programme, the radiographer is the only health professional they will
encounter. The radiographer has the following tasks:
To perform an excellent quality mammogram from both the positioning and technical point of view.
To have the social skills to support the woman during the examination and encourage her to attend
regularly.
To carry out quality assurance procedures.
Compression
Adequate compression is essential for a high quality mammogram. Compression reduces radiation dose to
the woman. It contributes to improving the image quality, because it provides a uniform thickness of the breast
and separates structures within the breast. Since compression reduces the thickness of the breast, scattered
radiation diminishes, thus improving contrast. To compress the breast may cause brief discomfort, therefore
the radiographer should explain the importance of the compression before starting the procedure. A footpedal
operated compression plate is essential in order to allow the radiographer to use both hands for positioning
the breast.
Positioning
Breast positioning is an art. When evaluating a mammogram, incorrect positioning is the most common
problem. The skills required to perform optimal mammographie positioning are high. When the woman is able
to cooperate and to relax, the radiographer find positioning easier to perform.
The standard views in a mammography screening programme are:
The cranio-caudal view
The medio-latero-oblique view
Common criteria for image quality assessment are:
Adequate compression
Good technical quality
Symmetrical images
No movement unsharpness
No skin folds
Correct standardized labelling
1-8
The most important criteria for an optimal cranio-caudal view are:

The breast is centrally positioned with the nipple in profile.
One should visualize as much as possible of the breast tissue. The posterior breast tissue should be
pulled forward. A small amount of pectoral muscle is sometimes seen, indicating that the breast has
been positioned as far forward as possible on the film.
The most important criteria for the medio-latero-oblique view are:
The whole breast tissue is imaged.
The pectoral muscle shadow is seen to nipple level.
The nipple should be in profile.
The nframammary angle is clearly shown.
Personal communication
When a pleasant and informative atmosphere is created, the woman is more likely to relax. The radiographer
should answer enquiries and explain the procedure in order to make the woman feel at ease. She should be
friendly, caring and professional. She should treat the woman the way she would like to be treated herself.
Quality Assurance procedures
A technically optimal mammogram is dependent on a number of factors, such as equipment, screen-film
combination, cassettes, processing conditions, darkroom, etc. Image quality standards must be established.
To maintain the highest standard of image quality, a quality assurance programme has to be implemented.
It is the radiographer's duty to carry out quality control procedures, such as performing a phantom image, a
sensitometric stepwedge, etc.
Teamwork
The radiographer should participate in all multidisciplinary team meetings. Feedback is essential to maintain
a high-standard or improve, in particular, regular communication with the radiologist is vital.
Training
Radiographers have a key role in obtaining and maintaining recognized targets for the success of a
mammography screening programme. Training in the various aspects of her work is mandatory.
AUTHORS:
H. Rijken (Nijmegen NL)
J Caseldine (Sheffield UK)
1-9
I -3
T H E R O L E O F T H E R A D I O L O G I S T IN T H E S C R E E N I N G P R O G R A M M E
Introduction
The radiologist is directly involved with the overall quality of service delivery, and in particular all aspects of
interpretation and proper work up so that a woman may be regarded as optimally benefitting from a screening
programme. A sufficient proportion of the radiologist's working time should be spent in breast imaging and
following specialised training, adequate numbers of mammograms must be read in order to preserve skills
and competence. If possible the radiologist should act as clinical director of the programme.
Quality issues
The radiologist must ensure that a satisfactory quality assurance system is in place with sufficient quality
control mechanisms to provide adequate image quality. Recognition must be given to the importance of
optical density of mammograms with regard to small cancer detection rates. Two view mammography is
expected for the woman's first screening attendance, and previous mammograms should be available and
displayed for comparison purposes when a woman has her subsequent (incident) round films read. It is the
responsibility of the radiologist in charge of the screening programme to ensure that failsafe mechanisms are
in place so that women with radiological abnormalities requiring further assessment are not denied suitable
investigations on the basis of a normal clinical examination or failure to inform and communicate with the
woman. He/she should ensure that staff in the screening unit are aware of the concepts of complying with
minimum standards, constantly seeking to maintain and improve skills, and partaking in recognised external
quality assessment(EQA) schemes.
Performance
Required standards (performance indicators) may be regarded as minimum and expected. Expected
standards are scientific estimates of targets required to achieve a mortality reduction of 25% in the target age
group. Minimum standards are set lower than this and should be regarded as a level that must be achieved
by all screening units regardless of statistical variation. Failure to meet minimum standards should be followed
by external investigation as to possible causes. Geographical variation in the incidence of breast cancer may
warrant different target standards for different countries.
One of the key surrogate measures for a radiologist in estimating success of a screening programme in terms
of mortality reduction is the ability to detect small cancers. Tumours of less than 15mms in diameter have
been shown to represent a good prognosis and it is expected that at least 50% of screen detected invasive
cancers will be of such a size. Tumours of less than 10mms in diameter should account for 25% of screen
detected invasive cancers as this size reflects both film quality and radiological performance. It is accepted
than lymph node status, tumour grade and tumour type are also important factors and the radiologist must
ensure that full and adequate recording of such basic histological data is made in the screening programme.
It is believed that removal of ductal carcinoma in-situ (DCIS), particularly of the high grade or risk type,
contributes to long term reduction in mortality. Its detection is also an indicator of image quality, radiologist
prediction and assessment adequacy. It is expected that DCIS should account for at least 15% of screen
detected cancers within a programme.
Assessment
The recall of women from the screening programme for full assessment creates anxiety and it is the
radiologist's responsibility to ensure that sensitivity and specificity are optimal so that women are not
subjected to unnecessary anxiety. At assessment a full range of facilities including ultrasound, micro-focus
magnification and image guided cytological analysis must be available. The radiologist leading the imaging
assessment of a woman referred from the screening programme should also be involved in screen reading
I - 10
and in this way feed back of information is obtained. It is also the responsibility of the assessing radiologist
to ensure that women are suitably assessed in terms of all necessary procedures being performed and that
unnecessary intervention or creation of anxiety is avoided. Short term recall of women with screen detected
abnormalities creates anxiety and should be avoided in all but exceptional circumstances. It is not regarded
as good practice to subject a woman to short term recall following the screening process alone, without clinical
and imaging assessment.
Teamwork
The radiologist should encourage the formation of a skilled multidisciplinary assessment team for women
referred from the screening programme and ensure that regular multidisciplinary review meetings are held
within the programme to provide feedback to involved professionals of a radiological, cytological and
histological nature. Such activity will help minimise the number of benign biopsies performed, which should
be less than the number of cancers detected in the programme.
Interval cancers
It is vital that mechanisms are in place to identify all breast cancers arising in the target screened population,
and that the programme is informed of interval cancers in order to fully assess the quality of programme
performance. In addition the radiologist must ensure that a suitable mechanism exists for the review and audit
of such interval cancers. The radiologist should encourage all surgeons within the locality of a screening
programme to perform mammography prior to treatment in all cases of symptomatic breast cancer.
AUTHORS:
N. Perry (London UK)
A. Kirkpatrick (Edinburgh UK)
I - 11
1-4
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on breast cancer mortality of population based mammography screening programmes. Journal of
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Wald NJ, Murphy P, Major P, Parkes C, Townsend J, Frost C. UKCCCR multicentre randomised
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Nos 1/3
II
Guidelines
&
Protocols
II- A QUALITY ASSURANCE IN THE EPIDEMIOLOGY OF BREAST

CANCER SCREENING
Authors:
Drs. M.J.M. BROEDERS

Vakgroep med.
informatiekunde,
epidemiologie & statistiek
Kapitterweg 54
6500 HB Nijmegen
NEDERLAND
Dr. A. LINOS
Inst, of Preventive Medicine
Enviromental & Occ. Health
227, Kifissias Ave. Anavryta
GR- 14561
KIFISSIA, ATHENS
GREECE
Dr. M. B. CODD
Dept of Epidemiology,
Mater Miseri Cordiae
Hospital
Eccles Street
DUBLIN 7
IRELAND
Dr. N. ASCUNCE
Gobierno de Navarra
Programme Cancer de
Mamma
C/ Condo Uliveto 9 - 30
E-31002
PAMPLONA
ESPAGNE
Prof. A.L.M. VERBEEK

Vakgroep med. informatiekunde,
epidemiologie & statistiek
Kapitterweg 54
6500 HB
Nijmegen
NEDERLAND
Table of contents
QUALITY ASSURANCE IN THE EPIDEMIOLOGY OF BREAST CANCER SCREENING

INTRODUCTION
Completion of tables in the document
BLOCK I - LOCAL CONDITIONS GOVERNING THE SCREENING PROCESS
Table 1.1: Baseline conditions at the start of a breast screening programme
Table 1.2: Screening programme in the national context
Table 1.3: Breast cancer occurrence, rates per 100,000 women per year . .
Table 1.4: Registers available in the screening region/country
Table 1.5: Programme promotion
Table 1.6: Fees paid for the initial screening examination
Table 1.7: Potential conditions for/against screening
BLOCK II - INVITATION SCHEME
Table 11.1: Sources and accuracy of target population data (first round)
Table II.2: Mode of invitation (INITIAL screening)
Table II.3: Mode of invitation (SUBSEQUENT screening)
Table II.4: Potential adjustments (INITIAL screening)
Table II.5: Potential adjustments (SUBSEQUENT screening)
Table II.6: Migration in and out of the screening region
BLOCK III - SCREENING PROCESS AND FURTHER ASSESSMENT
Table III.1: Screening facilities and screening policy
Table III.2A: Screening outcomes (INITIAL screening)
Table III.2B: Screening outcomes: non-invasive investigations (INITIAL screening)
Table III.2C: Screening outcomes: invasive investigations (INITIAL screening)
Table III.3A: Screening outcomes (SUBSEQUENT screening)
Table III.3B: Screening outcomes: non-invasive investigations (SUBSEQUENT screening)
Table III.3C: Screening outcomes: invasive investigations (SUBSEQUENT screening) . . .
BLOCK IV - EVALUATION / OUTCOMES OF SCREENING
Table IV. 1: Adherence to the screening programme
Table IV.2: Parameters by which the performance of a B.S.P is assessed1 - INITIAL screening . . .
Table IV.3: Parameters by which the performance of a B.S.P. is assessed1 - SUBSEQU. screening
Table IV.4: Cancer detection rates: age-specific detection ratios per 5-year age category
Table IV.5: P.P.V. of specific interventions, age category 50-64 (INITIAL screening)
Table IV.6: P.P.V. of specific interventions, age category 50-64 (SUBSEQUENT screening)
Table IV.7: Sensitivity and specificity of the screening test
BLOCK V - DISEASE STAGE OF SCREEN-DETECTED CANCERS
Table V.1A: Size and nodal status of screen-detected cancers (INITIAL screening)
Table V.1B: Disease stage according to the TNM-classification (INITIAL screening)
Table V.2A: Size and nodal status of screen-detected cancers (SUBSEQUENT screening) .
Table V.2B: Disease stage according to the TNM-classification (SUBSEQUENT screening)
DCK VI - TREATMENT OF SCREEN-DETECTED CANCERS

32
Table VI. 1: Treatment of screen-detected ductal CIS breast cancer
32
Table VI.2: Treatment of screen-detected invasive breast cancers according to age at diagnosis
33
Table VI.3: Treatment of screen-detected breast cancers according to stage at diagnosis
34
Table VI.4: Treatment of Breast Cancer diagnosed outside screening according to stage at diagnosis
(OPTIONAL)
35
Table VI.5: Number of days between screening and surgery or screening and final assessment (age group
50 - 64 years) for screen-detected cancers
36
DCK VII - FOLLOW UP AND ASCERTAINMENT OF INTERVAL CANCERS
Table VII. 1: Methods of follow up of the total target population
Suggested classification of interval cancers:
Table VII.2: Interval cancers occurring in the 12 months after previous screening
Table VII.4: Screen-detected cancers at subsequent screens (OPTIONAL)
37
37
38
38
39
39
DCK VIII - IMPACT ON BREAST CANCER MORTALITY
40
KNOWLEDGEMENTS
41
DSSARY OF TERMS
42
Introduction
A breast cancer screening programme is, of necessity, a multidisciplinary undertaking. The effectiveness
of any programme will be directly related to the quality of the individual parts. Success will be judged, not
only on the outcome of the programme and its impact on public health, but also on the organisation,
implementation, execution and acceptability of the programme.
Epidemiology is the fundamental guiding and unifying discipline throughout the entire process of a
screening programme, from the organisational and administrative aspects, through implementation and
execution to evaluation and assessment of impact.
The organisational aspects of a screening programme include (a) identification of the source(s) of data
upon which to base decisions regarding the population to be screened, (b) access to essential
demographic and personal details required for the invitation to screening, administration and scheduling
of the screening process, (c) dissemination of promotional information regarding screening and (d)
attention to the problem of noncompliance. Additional organisational aspects include the dissemination
of the results of screening to participants and appropriate professional staff, maintenance of up-to-date
administrative records and the necessary periodic revisions to screening registers. It is essential to have
epidemiological input into the decisions made in respect of each of these elements, since evaluation of
the outcome and interpretation of the eventual results of the screening endeavour will be intimately
effected by organisational aspects of the programme. Blocks I and II of this document are aimed at
gaining insight into the organisational aspects of a breast screening programme.
Implementation of a breast screening programme from an epidemiological perspective entails more than
simply the execution of the screening process and onward referral for assessment where required. The
particular epidemiological concerns at this phase focus on the complete and accurate recording of all data
pertaining to the participant, the screening test, the outcome of that test, the decisions made as a
consequence and their eventual outcome in terms of diagnosis. A fundamental concern at each step is
the issue of quality assurance. The success of the entire screening programme will be affected by the
quality of every element of the process. Stringent quality control is therefore an integral part of each
component, from the performance of the screening test (both operator and machine-dependent aspects),
to interpretation of the investigation, to classification of findings and recording of results in a standardised
manner. To this end Block III provides detailed guidelines to the data which should be recorded.
The evaluation of a breast screening programme is an epidemiological undertaking of paramount
importance, the components of which are outlined in Block IV. Parameters of performance which describe
the process of screening, and early outcomes of screening are measures of programme quality which
become available early in the lifetime of a screening programme (Blocks IV, V and VI). However, it will
not be possible to calculate these endpoints unless adequate provision has been made in the planning
process for the complete and accurate recording of the data required. A key component of the evaluation
of screening is the ascertainment of interval cancers (Block VII), a process which requires forward
planning and formal links with data sources other than those required for screening. Finally, the ultimate
decision regarding the effectiveness of screening, i.e. its impact on mortality and life-years gained,
demands that follow-up of the screened population continues over an extended period of time, that
information regarding vital status and disease-free status be ascertained and recorded at defined intervals,
and that determination of programme impact be based on sound epidemiological evidence (Block VIII).
It was, therefore, deemed necessary to develop guidelines for Quality Assurance of the epidemiological
aspects of screening for breast cancer. With this in mind the Breast Cancer Screening Pilot Network of
the "Europe Against Cancer" programme established a working group of epidemiologists at its annual
--1
meeting in 1994. The remit of this group was:

(a) to define a functional data set, including tables, for recording organisational aspects and results of a
breast screening programme; and
(b) to draw up an accompanying list of definitions of epidemiological concepts.
Countries represented in the working group were Greece (A. Linos), Ireland (M. Codd), The Netherlands
(M. Broeders, . Verbeek) and Spain (N. Ascunce) with C. De Wolf (E.C.) as facilitator.
These guidelines are not intended as hard and fast rules for the conduct of a screening programme. The
context of screening programmes in regions and/or countries differ, for example the prior existence of a
population register facilitates the issuing of personalised invitations, whereas without a population register
recruitment may be by open invitation. These potential contextual differences are acknowledged in the
recording of Blocks I and II; many of them will explain the outcomes entered in further tables. Since the
tables are designed to accommodate breast screening programmes regardless of context, not all elements
of all tables can be completed by all programmes. The working group would therefore urge caution in
making strict comparisons between programmes on the basis of data in the tables, and emphasise that
the reasons for these guidelines is not so much comparison as standardisation of terminology, definitions
and classifications. The guidelines may further prove to be of value for new (pilot) breast screening
programmes and pilot breast screening programmes in the process of extending to national programmes.
Completion of tables in the document
When absolute numbers are requested in the tables, the numbers should always reflect numbers of
women (not breasts). It is possible however that a woman presents with two lesions suspected for
malignancy. In this situation, data should be recorded in the tables with respect to the worst diagnosis or
the most invasive diagnostic technique used. In case two breast malignancies are diagnosed, the following
order of ranking should be used:
distant metastases > positive axillary lymph nodes > size of the tumour > invasive carcinoma > ductal
carcinoma in situ (DCIS).
Throughout the document, data are generally requested separately for women attending an initial
screening examination (initial screening) or any screening examination following an initial screening
examination (subsequent screening). The terms 'initial' and 'subsequent' thus refer to individual women
regardless of the screening round in which they were screened. Only the first screening examination will
completely consist of women attending for a initial and subsequent screening examinations; all other
screening rounds will constitute a mix of women attending for initial and subsequent screening
examinations. Further, the results regarding a woman attending her first screening examination in the
screening programme, should be regarded as "initial" screening data, regardless of previous invitations
or reminders from the programme that the women may have received.
For purposes of comparability, the last column in a number of tables has been confined to processes and
outcomes in the 50-64 year old age group. Women aged 65 at the time of screening should be excluded
from these analyses. A parallel exclusion is to be made for all five-year age categories in the tables.
II-A-2
Block I - Local conditions governing the screening process

The aim of this block is to describe the situation at the start of a breast screening programme, i.e. the
context in which it is to be or has been established.
Table 1.1 documents baseline conditions with respect to a screening programme. The availability and the
reliability of data on the target population will depend on the existence and accessibility of registers in the
region to be screened. Demographic data on the target population can come from various sources, e.g.
census data, population registers, electoral registers, population surveys, health care data or health
insurance data. For a screening programme to be population-based, every member of the target
population who is eligible to attend (on the basis of pre-decided criteria) must be known to the programme.
The target population of the programme can be a fixed or a dynamic cohort, which will influence the
denominator used in calculating screening outcomes. In some areas, opportunistic screening may be
widespread and possibly dilute the results of a breast screening programme. Please provide your best
estimate of the percentage of your target population that is undergoing screening mammography
(coverage) outside your breast screening programme.
Table 1.1 : Baseline conditions at the start of a breast screening programme
Name of region / country

Year that the programme started
Age group targeted
Target population*
n=
Sources of demographic data*

Population-based*
yes/no
Type of cohort (target population)
fixed cohort*/dynamic cohort*
Proportion of target population covered by

opportunistic screening* (%)
* cf Glossary of terms
Table I.2 A screening programme may exist as part of a national breast screening programme, it may be
one of several pilot projects for breast cancer screening or it may be the only breast screening project in
existence in a country at a certain point in time. To understand the context of your screening programme,
please describe its role on a national level. Please also provide your best estimate of the proportion of the
national target population that is covered by breast screening programmes or by opportunistic screening.
Table I.2: Screening programme in the national context
Proportion of national target population

covered by breast screening programmes (%)
Proportion of national target population
covered by opportunistic screening (%)
II - A - 3
Table 1.3 outlines the background information on breast cancer occurrence in the target population
required to interpret outcome measures of a screening programme. If regional incidence and/or mortality
data are not available, specify the area for which data are presented.
Table 1.3: Breast cancer occurrence, rates per 100,000 women per year
Breast cancer incidence in 19 ...

45-49
/100.000
n=
50-54
/100,000
n=
55-59
/100.000
n=
60-64
/100.000
n=
65-69
/100.000
n=
45-49
/100.000
n=
50-54
/100.000
n=
55-59
/100.000
n=
60-64
/100.000
n=
65-69
/100.000
n=
Breast cancer mortality in 19 ...
Sources of data on breast cancer occurrence

Area for which data on breast cancer are specified
Carcinoma in situ included in incidence rates:
- ductal carcinoma in situ
- lobular carcinoma in situ
yes / no
yes / no
Carcinoma in situ included in mortality rates:

- ductal carcinoma in situ
- lobular carcinoma in situ
yes / no
yes / no
World age-standardised incidence rate* in 19 ..., all ages

World age-standardised incidence rate* in 19 ..., 50-64
World age-standardised mortality rate* in 19 ..., all ages
World age-standardised mortality rate* in 19 ..., 50-64
Incidence and mortality rates are requested for women aged 45-69 in five-year age categories. For
purposes of comparability, world standardised mortality and incidence rates for all ages and for the age
category 50-64 should also be provided. Data on the occurrence of breast cancer may come from vital
statistics registers, cancer registers, review of death certificates, etc. In this respect, it is of interest to
specify whether carcinomas in situ are included in breast cancer incidence and mortality rates.
-A-4
Table 1.4 specifies which of the registers listed are present in the screening region or country, details
whether they are hospital- or population-based, and whether they are accessible to members of screening
programme staff.
Table 1.4: Registers available in the screening region/country
Present
yes/no
Regional/National
(R)
(N)
Hospital (HB) or
Pop.based (PB)
Accessible
yes/no
Cancer register
Pathology
register
Breast cancer
register*
Table 1.5 refers to a variety of modes potentially available to publicise the screening programme.
Depending on the target population and the local geographical, municipal and cultural conditions, the need
and intensity of programme promotion may vary. Please indicate the intensity of the activities that are used
in your screening programme, using a scale of 10 (for the most intensive) to 1 (for the least intensive). Use
'0' when a particular mode is not available or not used at all.
Table 1.5: Programme promotion
Press
Schools
TV
Municipal authorities
Radio
Social clubs
Physician/GP
Other:
Church
II-A-5
Table I.6 A potential determinant of participation in a breast screening programme is whether the
participating woman is required to pay for the initial screening examination. When a consultation with a
family practitioner is required to gain access to the initial screening examination, the costs of this
consultation should be included in the fee paid. In some screening programmes, the fee for the screening
examination will be paid, partly or completely, by a third party. Third party payment may be either through
vouchers available to the woman before screening or through a system in which the woman pays in
advance and gets reimbursed after the screening. Alternatively, a third party may pay the fee directly to
the screening unit or organisation.
Table 1.6: Fees paid for the initial screening examination
Fees paid by the woman herself for the

screening examination (in ECU's)
Fees paid by the woman herself to receive the
results (in ECU's)
Third party payment through voucher(s)
% of costs covered
Third party payment through reimbursement

system
% of costs covered
Third party payment directly to screening unit
% of costs covered
Table 1.7 Many factors can be identified which encourage or impede the setting up of a breast screening
programme. The following are such potential factors: costs, fears, lack of interest, integration into the
existing health care system, data protection legislation. These can also include reasons given for not
responding to the invitation to be screened, and women's attitudes about and knowledge of screening
guidelines.
Table I.7: Potential conditions for/against screening
Please specify any conditions that may have worked for or against screening in your screening
programme:
II-A-6
Block II - Invitation scheme

The aim of this block is to describe the invitation scheme used by a screening programme, i.e. the
processes used to identify and personally invite members of the target population. A number of sources
of data can be used. For each source, information is requested regarding its accuracy.
Table 11.1 lists the sources of demographic data used and the contribution of each to the identification of
the target population in preparation for the first screening round. It is recognised that relative contributions
of these sources will vary and may be difficult to estimate.
Table 11.1: Sources and accuracy of target population data (first round)
% Target
population
identified
Register
accuracy
Register data
Computer/Handhold
(%)
Population register
Electoral register
Organisation register*
Self-registration*
Health insurance
Church register
Other:
cf Glossary of terms
II-A-7
Table II.2 Depending on the programme several types of initial call systems may be used. Invitations may
be by personalised letter, by oral communication or by open invitation, or by a combination of all three.
Those who do not respond to the initial invitation may be issued a reminder, again by any available means
listed below. The time interval (column 5) between initial invitation and reminder will vary by programme.
Some programmes may issue more than one reminder, or reminders by multiple methods. It may not be
possible to ascertain the success of individual types of reminders.
Table II.2: Mode of invitation (INITIAL screening)
Option
Method
LETTER
by mail
Initial invitation
Reminder
Interval to
reminder
at physician/GP
by community leader
other
ORAL/
TELEPHONE
physician/GP
community leader
municipal officers
screening unit
public health nurse
teachers
priests
other
OPEN
public announcement
ORGANISATIONAL:
If the initial invitation is by mail, does the letter provide an appointment for a fixed date and time?
Yes / No
If the letter provides a fixed appointment, is the woman offered an opportunity to change the
appointment?
Yes / No
II-A
Table II.3 details the same information on the invitation scheme for subsequent screening examinations.
Table II.3: Mode of invitation (SUBSEQUENT screening)
Option
Method
LETTER
by mail
Initial invitation
Reminder
Interval to reminder
at physician/GP
by community leader
other
ORAL/
TELEPHONE
physician/GP
community leader
municipal officers
screening unit
public health nurse
teachers
priests
other
OPEN
public announcement
ORGANISATIONAL:
If the initial invitation is by mail, does the letter provide an appointment for a fixed date and time?
Yes / No
If the letter provides a fixed appointment, is the woman offered an opportunity to change the
appointment?
Yes / No
II-A-9
Table II.4 and II.5 In the context of this document, the target population for the breast screening
programme includes all persons eligible to attend for screening on the basis of age, gender and
geographic location. However, each programme may identify additional criteria on the basis of which
women will be excluded from the target population. The remaining group after adjustment will be referred
to as the 'eligible population'. In addition, screening programmes may identify criteria to exclude women
from the results of screening. Potential exclusions from both the target population and results of screening
are listed in table II.4 (initial screening examination) and II.5 (subsequent screening examination). The
ease with which such individuals can be identified and excluded from the target population will vary by
programme; for some programmes it may not be possible to identify any category of potential exclusion
prior to invitation.
Table II.4: Potential adjustments (INITIAL screening)
Target population
n=
Eligible population
n=
Excluded
from target
population
yes/no
Previous breast cancer

Previous mastectomy
- unilateral
- bilateral
Recent mammogram*
Symptomatic women*
Incompetent
- physical
- mental
- other
Deaths
Other, please specify:
II - A -10
Number if
known
Excluded
from
results
yes/no
Number if
known
Table II.5: Potential adjustments (SUBSEQUENT screening)
Target population
n=
Eligible population
n=
Excluded
from target
population
yes/no
Number if
known
Excluded
from
results
yes/no
Number if
known
Previous breast cancer

Previous mastectomy
- unilateral
- bilateral
Recent mammogram*
Symptomatic women*
Incompetent
- physical
- mental
- other
Deaths
Other, please specify:
Table II.6 Each screening programme is confronted with women moving in and out of the region and thus
moving in and out of the target population. Please describe how your screening programme is dealing with
migration and, if possible, provide your best estimate of the number of women concerned.
Table II.6: Migration in and out of the screening region
II-A-
Block III - Screening process and further assessment

The aim of this block is to describe the process of mammographie detection of breast abnormalities
through investigation of those abnormalities, to diagnosis or otherwise of a malignant lesion.
Table III.1 describes the screening facilities available and whether they are dedicated completely to breast
cancer screening. Further details on screening policy of the programme are requested such as: the
screening test used (whether single or two-view mammography, with or without clinical examination), the
interval between screens, the availability of double reading, and the assessment facilities for invasive
investigations (centralised or not).
Table III.1: Screening facilities and screening policy
Screening units*
- static units
- semi-mobile units
- mobile units
- other
n=
n=
=
=
, dedicated* n =
, dedicated* =
, dedicated* =
, dedicated* =
Number of mammography machines
, dedicated* =
Screening test*
- initial screening
- subsequent screening
Screening interval*
Double reading
Centralised assessment (refers to invasive
investigations only)
yes/no
Table III.2 describes the outcomes of initial screening examinations, as well as the additional
investigations which may be undertaken prior to, and including surgery. Initial screening examinations
refer to women who undergo their first screening examination within the screening programme, regardless
of the organisational screening round in which they are screened and regardless of previous invitations
or reminders. The order of investigations as listed does not necessarily imply that each participant will go
through all stages before surgical excision and diagnosis. The table is designed to introduce some
standardisation and comparability of data between programmes. Forali investigations listed the numbers
should reflect women, not breasts. The age category in which the result of an individual woman should
be recorded is to be defined according to the age of the woman at the time of the relevant activity, e.g.
age of a women at invitation, age of a woman at the time of the screening examination. It is thus possible,
that a woman's results will be recorded in different age categories at different points in the screening
process.
I I - A - 12
Table III.2A lists the number of women that are targeted, eligible, invited and finally screened. The result
of the screening examination can be recorded in various categories, that may not all be available in the
screening programme, e.g. a screening programme may not have the option of intermediate
mammography directly following the screening examination. Further assessment includes non-invasive
and invasive investigations for medical reasons.
Table III.2A: Screening outcomes (INITIAL screening)
45-49
50-54
55-59
60-64
65-69
age unk.
50-64
Target population*
Eligible population*
Women invited*
Women screened*
Result of screening
test
- negative
- intermediate
mammogram
following
screening*
- repeat screening
test*
- recommended
- performed
- further
assessment*
- recommended
- performed
- unknown/not
available
*cf Glossary of terms
II-A-13
Table III.2B describes the outcomes of non-invasive investigations directly following the screening
examination. These investigations can be done at the time of screening when facilities are available in the
screening unit or they can be performed on recall, i.e. the woman will have to come back to the screening
unit for that extra examination. As a result of the non-invasive assessment, further clarification of the
perceived abnormality may be required using invasive investigations. It should be realised however, that
a woman may also undergo further assessment by invasive investigations directly following the screening
examination.
Table III.2B: Screening outcomes: non-invasive investigations (INITIAL screening)
45-49
Repeat screening
test*
- at the time of
screening
- done on recall*
Further assessment
by additional imaging
- at the time of
screening
- done on recall*
Types of additional
imaging
- repeat views for
medical reasons
- cranio-caudal view
- other views
- ultrasound
- MRI
Further assessment
by invasive
investigations
- recommended
- performed
- at the time of
screening
- done on recall*
I I - A - 14
50-54
55-59
60-64
65-69
age unk.
50-64
Table III.2C describes the numbers of recommended and/or performed invasive investigations. The
results of the overall screening process are classified in four categories, partly overlapping the results of
the screening test in table III.2A.
Table III.2C: Screening outcomes: invasive investigations (INITIAL screening)
45-49
50-54
55-59
60-64
65-69
age unk.
50-64
Cytology*
- recommended
- performed
Core biopsy*
- recommended
- performed
Open biopsy*
- recommended
- performed
Result of screening
process:
- negative
- intermediate mammog.
required following:
- screening*, including
repeat screening tests
- further assessment*
- malignant tumours
detected:
-DCIS
- invasive cancers
- unknown/not available
Malignant tumours
detected:
- at routine screen
- at intermediate
mammography*
ORGANISATIONAL:
To which organisational screening rounds and time period do the data in tables III.2A, and C refer?
Time period:
Organisational
screening rounds:
I I - A - 15
Table III.3 requests the same information as table III.2 but for subsequent screening examinations.
Subsequent screening examinations refer to all examinations of individual women within the screening
programme following initial screening, regardless of the organisational screening round in which they are
screened.
Table III.3A: Screening outcomes (SUBSEQUENT screening)
45-49
Target population*
Eligible population*
Women invited*
Women screened*
Result of screening test
- negative
- intermediate
mammogram
following screening*
- repeat screening
test*
- recommended
- performed
- recommended
- performed
- unknown/not
available
II - A - 16
50-54
55-59
60-64
65-69
age unk.
50-64
Table III.3B: Screening outcomes: non-invasive investigations (SUBSEQUENT screening)
45-49
50-54
55-59
60-64
65-69
age unk.
50-64
Repeat screening test*

- at the time of screening
- done on recall*
Further assessment by
additional imaging
- done on recall*
Types of additional
imaging
- repeat views for medical
reasons
- cranio-caudal view
- other views
- ultrasound
-MRI
Further assessment by
invasive investigations
- recommended
- performed
- at the time of
screening
- done on recall*
ORGANISATIONAL:
To which organisational screening rounds and time period do the data in tables III.3A, and C refer?
Time period:
Organisational
screening rounds:
I I - A - 17
Table III.3C: Screening outcomes: invasive investigations (SUBSEQUENT screening)
45-49
Cytology*
- recommended
- performed
Core biopsy*
- recommended
- performed
Open biopsy*
- recommended
- performed
Result of screening
process:
- negative
- intermediate Mammogr.
required following:
- screening*, including
repeat screening tests
- malignant tumours
detected:
-DCIS
- invasive cancers
- unknown/not available
Malignant tumours
detected:
- at routine screen
- at intermediate
mammography*
II - A - 1
50-54
55-59
60-64
65-69
age unk.
50-64
Block IV - Evaluation / outcomes of screening

Evaluating the outcome of a screening programme requires considerable input from epidemiology and
statistics. The indicators of performance of interest are as follows (for definitions see Glossary of terms):
PROCESS EVALUATION
- participation rate
- additional imaging rate
- recall rate
- cancer detection rate
- specificity
EARLY OUTCOMES
LATE OUTCOMES
PROGRAMME IMPACT
- positive predictive value

- surgical procedures performed
- benign / malignant biopsy ratio
- invasive cancers < 10 mm in diameter
- stage at diagnosis
- ascertainment of interval cancers
- sensitivity
- case fatality rate
- mortality rates (relative and absolute)
- deaths prevented
- life years gained
-quality of life
- side effects
- cost-effectiveness
Results of a screening programme become available throughout the screening process and afterwards.
Information on participation, recall and cancer detection rates will be available at the end of a screening
round. If one accepts certain assumptions, estimates of specificity and positive (but not negative)
predictive value can also be derived at the end of a round. If surgical and pathological data are complete,
information on surgical procedures, size and types of cancers and on stage at diagnosis will also be
available.
Ascertainment of interval cancers, and consequently estimates of sensitivity and negative predictive value,
cannot be complete until a specified interval since the last women were screened has passed. This is
usually 24 months.
Assessment of late outcomes and impact of the programme takes many years to complete.
Table IV.1 In the evaluation of a breast screening programme, participation is the key indicator which
predicts the overall capacity of the programme to ultimately reduce breast cancer mortality. However, for
these programmes to be really effective, not only the overall participation should be evaluated but also
the adherence to the programme shown by women in later screening rounds.
Adherence to the screening programme can be expressed as the percentage of women in the current
screening round who also attended the previous screening round.
I I - A - 19
Table IV.1 : Adherence to the screening programme

Participation in previous
screening round
Participation in current
screening round
YES
YES
NO
n=
NO
n=
D
C
n=
n=
ADHERENCE = A/ (A+C) =
Table IV.2 and IV.3 In keeping with the staged nature of the availability of outcome measures, the Europe
Against Cancer Programme has outlined those parameters of performance which can be assessed in the
early stages of a programme to provide a yardstick. In comparison to the performance parameters
introduced in first edition of the European Guidelines for Quality Assurance in Mammography Screening,
the following parameters have been added:
(a) participation rate
(b) additional imaging at the time of screening (to be expressed as a percentage of all women undergoing
a screening examination)
(c) total additional imaging procedures, i.e. additional imaging at the time of screening or on recall (to be
expressed as a percentage of all women undergoing a screening examination)
(d) cytology/biopsy procedures with an inadequate result (to be expressed as a percentage of all
cytology/biopsy procedures performed). This parameter is a measure of operator competence and
quality of selection of lesions for sampling.
II - A - 20
Table IV.2 and IV.3 show the acceptable and desirable levels for a number of the above-mentioned
parameters of performance for initial and subsequent screening examinations. Outcomes from your
screening programme for the age category 50-64 should be entered in the last column.
ORGANISATIONAL:
To which organisational screening rounds and time period do the data in Block IV refer?
Time period:
Organisational
screening rounds:
Table IV.2: Parameters by which the performance of a Breast Screening Programme is assessed INITIAL screening
Performance parameter
Acceptable
Desirable
Participation rate
60%
> 75%
Additional imaging
- total
<5%
NG*
< 1%
NG*
Recall rate
<7%
<5%
Cytology/biopsy procedures with an

inadequate result (%)
< 25%
<15%
Total cancer detection rate (per 1000

women screened)***
- invasive cancer detection rate
- in-situ cancer detection rate
3xlR**
>3xlR**
Invasive cancers s 10 mm diameter

(% of inv. cancers detected)
NG*
25%
Benign open biopsy rate (per 1000

women screened)
<5
<4
< 2 to 1
<1 to 1
Benign to malignant biopsy ratio
Screening
programme
50-64
NG = none given
IR = expected incidence rate in the absence of screening
The cancer detection rate per five-year age category is further specified in table IV.4.
II - A - 2 1
Table IV.3: Parameters by which the performance of a Breast Screening Programme is assessed
SUBSEQUENT screening
Acceptable
Desirable
Participation rate
60%
> 75%
Additional imaging
- total
<3%
NG*
<1%
NG*
Recall rate
<5%
<3%
Cytology/biopsy procedures with an

inadequate result (%)
< 25%
< 15%
Total cancer detection rate (per 1000

women screened)***
- invasive cancer detection rate
- in-situ cancer detection rate
1,5x1 R**
NG*
Invasive cancers, s 10 mm diameter

(% of inv. cancers detected)
NG*
25%
Benign open biopsy rate (per 1000

women screened)
<3,5
<2
< 1 to 1
< 0,5 to 1
Performance parameter
Benign to malignant biopsy ratio
Screening
programme
50-64
NG = none given
IR = expected incidence rate in the absence of screening
The cancer detection rate per five-year age category is further specified in table IV.4.
- A - 22
Table IV.4 An overall breast cancer detection rate represents the performance of a screening programme
but also reflects the age structure of the population being screened. To provide a more sensitive measure
of performance, table IV.4 allows for the calculation of age-specific detection ratios per 5-year age
category. The incidence rate for breast cancer in the denominator of the formula should reflect the
incidence rate in the year before screening started.
Cancer detection rate in a 5-year age category
Age-specific Detection Ratio =
Breast cancer incidence in that age category
in the year before screening started
Table IV.4: Cancer detection rates: age-specific detection ratios per 5-year age category
Age
category
Initial screening
CDR
BCI
Subsequent screening
ADR
CDR
BCI
ADR
45-49
50-54
55-59
60-64
65-69
CDR
BCI
ADR
= Cancer detection rate (nominator)

= Breast cancer incidence (denominator)
= Age-specific Detection Ratio = CDR/BCI
II - A - 23
Table IV.5 and IV.6 summarise the results of screening in terms of positive predictive values (PPV) of
specific interventions which take place in the course of mammographie screening and in further
assessment of abnormal lesions. Results can be expected to vary between initial and subsequent
screening examinations. PPV is expressed as a proportion. (See Glossary of terms for definition of the
individual PPV's listed in Table IV.5 and IV.6)
Table IV.5: Positive Predictive Values of specific interventions in screening for breast cancer, age
category 50-64 (INITIAL screening)
Breast cancer detected
screening test
no
yes
Outcome of the intervention
Positive
Predictive
Value
positive
negative
additional imaging
positive
negative
recall
yes
no
cytology
positive
negative
recommendation for
open biopsy
positive
negative
POSITIVE PREDICTIVE VALUE = A / (A+B)

Breast cancer
Intervention
A+B
C+D
B+ D
A+C
II - A - 24
Table IV.6: Positive Predictive Values of specific interventions in screening for breast cancer, age
category 50-64 (SUBSEQUENT screening)
Breast cancer detected
yes
Outcome of the intervention

screening test
Positive
Predictive
Value
no
positive
negative
additional imaging
positive
negative
recall
yes
no
cytology
positive
negative
recommendation for
open biopsy
positive
negative
POSITIVE PREDICTIVE VALUE = A / (A+B)

Breast cancer
Intervention
A +B
C +D
B +D
A+C
II-A-25
Table IV.7 A screening test is expected to designate persons with early malignant disease as 'positive'
(sensitivity of the test) and those without as 'negative' (specificity of the test). An acceptable way of
estimating the sensitivity is to follow up the negative screenees for the development of cancer within a
defined time interval. If these interval cancer cases are assumed to have been falsely negative, the
sensitivity can be assessed by relating these interval cancers to the number of cancers detected (true
positives / true positive + false negatives) (1).
To evaluate the specificity of the screening test, it is necessary to know the numbers of false positives.
Assessment of specificity again requires adequate follow up of the negative screenees. It has been shown
however that it is possible to give a close approximation of the specificity without knowledge of the number
of missed cancers. The specificity can thus reliably be estimated soon after the start of the screening
programme. The specificity relates to the number of true negatives to the total number of 'non-cancer'
women. Under the rare disease assumption the specificity is defined as: screening test negatives /
(screened women - true positives)(2).
Table IV.7: Sensitivity and specificity of the screening test
Breast cancer
Screeningtest
A+B
C+D
B+D
A+C
SENSITIVITY = A / (A+C) =
SPECIFICITY = D/(B+D) =
APPROXIMATION OF = (C+D) / (N-A) =
SPECIFICITY
REFERENCES
1 Verbeek ALM. Population screening for breast cancer in Nijmegen; an evaluation of the period 1975-1982 (thesis). Univ. of
Nijmegen. 1985
2 Verbeek ALM, van den Ban MC, Hendriks JHCL. A proposal for short-term quality control in breast cancer screening. Br J
Cancer 1991:63:261-264
II - A - 26
Block V - Disease stage of screen-detected cancers

The aim of this block is to describe the disease stage of screen-detected cancer cases. A prerequisite for
a reduction in breast cancer mortality is a more favourable stage distribution in screen-detected cancers
compared with clinically diagnosed cancers. Tumour size and axillary lymph node involvement for invasive
cancers are of central importance here, and are assessed preferably after surgery (pT and pN). Age
categories in Block V all refer to the age of a woman at diagnosis. Diagnosis refers to the day of surgery
for women undergoing surgery and to the day of final assessment for women not undergoing surgery.
The categorisation for size according to pathological diameter is based on the TNM-classification for
reasons of comparison. It is recommended however to register the size of the tumour on a continuous
scale. This will allow for re-categorisation in the event that consensus is reached on a different prognostic
threshold (e.g. 15 mm).
Primary tumour (T) is classified as follows:
pTx
primary tumour cannot be assessed
pTO
no evidence of primary tumour
pTis
ductal carcinoma in situ
pT1ab
tumour 10 mm in greatest dimension
pT1c
tumour s 20 mm in greatest dimension
pT2
tumour s 50 mm in greatest dimension
pT3
tumour > 50 mm in greatest dimension
pT4
tumour of any size with direct extension to chest wall or skin
Regional lymph node involvement (N) is classified as follows:

Nx
regional lymph nodes cannot be assessed
NO
no regional lymph node metastasis
N1
metastasis to movable ipsilateral axillary lymph node(s)
N2
metastasis to ipsilateral axillary lymph node(s) fixed to one another or to other
structures
N3
metastasis to ipsilateral mammary lymph node(s)
Distant metastasis (M) is classified as follows:
Mx
presence of distant metastasis cannot be assessed
MO
no distant metastasis
M1
distant metastasis (includes metastasis to ipsilateral supraclavicular lymph node(s)
Stage grouping
NO
NO
N1
N1
NO
N1
NO
N2
N2
N2
N1
N2
Stage HIB
Tis
T1
TO
T1
T2
T2
T3
TO
T1
T2
T3
T3
T4
any
Stage IV
any
any
N3
any
Stage 0
Stage I
Stage IIA
Stage MB
Stage IMA
MO
MO
MO
MO
MO
MO
MO
MO
MO
MO
MO
MO
MO
MO
M1
II-A-27
ORGANISATIONAL:
To which organisational screening rounds and time period do the data in tables V.1 and V.2 refer?
Time period:
Organisational
screening rounds:
Table V.1 A: Size and nodal status of screen-detected cancers (INITIAL screening)
45-49
50-54
55-59
60-64
65-69
pTis
pT1ab
NN+
Nx
pT1c
NN+
Nx
pT2
NN+
Nx
pT3
NN+
Nx
pT4
NN+
Nx
pTx
NN+
Nx
TOTAL
NN+
Nx
N- = axillary node negative (NO)
N+ = axillary node positive (any node positive; N1-3)
Nx
= nodal status cannot be assessed (e.g. previously removed, not done)
II-A-28
age unknown
50-64
Table V.1 B: Disease stage of screen-detected cancers according to the TNM-classification (INITIAL
screening)
45-49
50-54
55-59
60-64
65-69
age unknown
50-64
Stage 0
TisNOMO
Stage I
T1N0M0
Stage
IIA
T1N1M0
T2N0M0
Stage
IIB
T2N1M0
T3N0M0
Stage
INA
T1N2M0
T2N2M0
T3N1M0
T3N2M
0
Stage NIB
T4anyNM0
anyTN3M0
Stage
IV
anyTanyNMI
Unknown
TOTAL
II - A - 29
Table V.2A: Size and nodal status of screen-detected cancers (SUBSEQUENT screening)
45-49
50-54
55-59
60-64
65-69
pTis
pT1ab
NN+
Nx
pT1c
NN+
Nx
pT2
NN+
Nx
pT3
NN+
Nx
pT4
NN+
Nx
pTx
NN+
Nx
TOTAL
NN+
Nx
N- = axillary node negative (NO)
N+ = axillary node positive (any node positive; N1-3)
Nx
= nodal status cannot be assessed (e.g. previously removed, not done)
II-A-30
age unknown
50-64
Table V.2B: Disease stage of screen-detected cancers according to the TNM-classification

(SUBSEQUENT screening)
45-49
50-54
55-59
60-64
65-69
age unknown
50-64
Stage 0
TisNOMO
Stage I
T1N0M0
Stage IIA
T1N1M0
T2N0M0
Stage MB
T2N1M0
T3N0M0
Stage IMA
T1N2M0
T2N2M0
T3N1M0
T3N2M0
Stage NIB
T4anyNM0
anyTN3M0
Stage IV
anyTanyNMI
Unknown
TOTAL
II - A - 31
Block VI - Treatment of screen-detected cancers

It is recognised that collecting data on treatment on a regular basis may be a difficult and time consuming
activity, especially in those screening programmes where treatment is not considered to be part of the
screening process. On the other hand, it should be realised that the effect of screening in the long term
will be heavily influenced by the way screen-detected cases are treated. A high-quality screening
programme can only lead to a long-term mortality reduction if the treatment of women detected at
screening is of equally high quality. Thus it is considered of the utmost importance to collect these type
of data.
All women with breast cancer detected at screening, with or without signs of distant metastases, will
receive a form of primary treatment. For ductal carcinoma in situ (CIS) and invasive cancers several types
of treatment are categorised in tables VI.1, VI.2 and VI.3. Women with axillary lymph node metastases
are assumed to receive adjuvant systemic therapy. The treatment options according to disease stage of
breast cancer diagnosed outside screening (interval cancer as well as other 'control' cancers) can be
optionally registered in table VI.4.
Table VI.1: Treatment of screen-detected ductal CIS breast cancer
Breast conserving surgery1
RT45-49
50-54
55-59
60-64
65-69
Unknown
50-64
'
= less than amputation

= treatment refusal or (still) unknown
RT- = without radiotherapy
RT+
= with radiotherapy
RTx = unknown
II-A-32
RT+
Mastectomy
RTx
Remaining2
Table VI.2: Treatment of screer i-detected invasive breast cancers according to age at diagnosis
PRIMARY TREATMENT
Breast conserving surgery1
RT+
RT-
RTx
Chemotherapy
Mastectomy
RT-
RT+
RTx
RT-
RT+
RTx
Radio
therapy
45-49
50-54
55-59
60-64
65-69
Unkn.
50-64
ADJUVANT THERAPY (H=hormonal therapy; C=chemotherapy; B=both therapies; N=no adjuvant therapy)
RT+
RTH
RTx
C
RT-
RT+
RTx
RT-
RTx
H C C C H C H C C C
45-49
50-54
55-59
60-64
65-69
50-64
1
RT+
= less than amputation;2 remaining = treatment refusal or (still) unknown

Radiotherapy: RT- = without radiotherapy; RT+ = with radiotherapy; RTx = unknown
Adjuvant therapy: = hormonal therapy; C = chemotherapy; = both therapies; = no adjuvant therapy
Rem2
Table VI.3: Treatment of screer i-detected breast cancers accord ing te stage at diag nosis
PRIMARY TREATMENT
Breast conserving surgery
RT+
RT-
RTx
Mastectomy
RT-
RT+
Chemotherapy
RTx
RT-
RT+
RTx
Radio
therapy
IIA
IIB
MIA
HIB
IV
Unkn.
RT+
RTH
0
1
IIA
IIB
MIA
HIB
IV
RTx
C
RT-
RT+
RTx
H C C C
RT-
RT+
RTx
H C C C C
Rem2
Table VI.4: Treatment of breast cancers diagnosed outside screening according to stage at diagnosis (OPTIONAL)
PRIMARY TREATMENT
Mastectomy
Breast conserving surgery

RT-
RTx
RT+
RT-
RT+
Chemotherapy
RTx
RT-
RT+
RTx
Radio
therapy
0
1
IIA
IIB
UIA
HIB
IV
Unkn.
0
1
IIA
IIB
IIIA
HIB
IV
RTx
RT+
RT
RT-
RT+
RTx
H C C C
RT-
RT+
RTx
C C C C
Rem2
Table VI.5 reflects the distribution of the number of days between the day of screening and the day of
surgery for those women undergoing surgery as a result of the screening examination. For those women
not undergoing surgery, the interval between the day of screening and the day of final assessment should
be registered.
In case a cancer is detected at intermediate mammography, which is by definition a screen-detected
cancer, the day of screening should be replaced by the day that the intermediate mammogram was
performed.
Table VI.5: Number of days between screening and surgery or screening and final assessment
(age group 50 - 64 years) for screen-detected cancers
Quantizes
5%
25%
50%
75%
Day of screening - day

of surgery
Day of screening - day
of final assessment
ORGANISATIONAL:
To which organisational screening rounds and time period do the data in Block VI refer?
Time period:
Organisational
screening rounds:
II-A-36
95%
Block VII - Follow up and ascertainment of interval cancers

The aim of this block is to describe, as far as is possible, the follow up of the target population of a
screening programme, including ascertainment of interval cancers.
The target population will fall essentially into four groups:
(a) women who have participated in the programme and were dismissed as having a negative screening
test, or were deemed not to have a breast malignancy after further investigation of an abnormality.
Follow up of this group is key to the ascertainment of interval cancers;
(b) women who have participated in the screening programme, and who were identified as having breast
cancer. These patients will be followed clinically, most likely in general practitioner, surgical, oncology
or radiotherapy clinics, for treatment and review of their breast cancer, including evidence of
recurrence. Arguably, follow up of this group does not constitute part of a screening programme.
Nonetheless, the outcome of breast screening in terms of survival, will be determined in large
measure by the clinical course of patients identified with breast cancer;
(c) women who were invited for screening, but did not participate;
(d) members of the target population who were not invited for screening (e.g. due to incomplete or
inaccurate population registers, etc.). It is recognised that it may not be possible to get follow up
information on this group.
Table VII.1 outlines the methods by which the total target population may be followed up for the
occurrence of breast cancer. In general, follow up for ascertainment of interval cancers, or cancer
occurrence in non-screened members of the target population (non-participants and not invited) will
require review of cancer registers, specific pathology registers or records of pathology departments of the
screening contiguous area hospitals, and/or vital statistics/death certificates.
Table VII.1: Methods of follow up of the total target population
Method
yes/no
Participants Negative
Participants Positive
Non - participants
Not invited
cancer register
pathology register
death certificates
other:
Interval cancers (cf Glossary of terms) are a heterogeneous group of cancers, which may be classified
into subgroups. The classification below, assuming mammography is the screening test applied, is based
on:
(a) the occurrence of a clinical breast cancer in a screened woman between two routine screens;
(b) review of the screening mammogram in the knowledge that an interval cancer has occurred; and
(c) the existence, or not, of a mammogram at the time of clinical presentation.
II - A - 3 7
Suggested classification of interval cancers:

Interval cancer
Screening mammogram
Presenting mammogram
True interval
negative
positive
Radiologically occult
negative
negative
Minimal signs
positive (minimal signs)
positive
False negative
positive
positive
Unclassifiable
positive / negative / not

available
not available / not taken
It is recognised that a person presenting with an interval cancer may or may not have a mammogram
performed on presentation. This will depend on the preference of the clinician to whom presented, as well
as the availability of mammographie facilities. When a presenting mammogram has not been taken, or is
unavailable, the interval cancer concerned is unclassifiable.
Table VII.2 and VII.3 contain a suggested method for recording the interval cancers (total and subtypes)
which occur in a defined period following screening. It is usual to report the 12-month and/or 24-month
interval cancer rate of a screening programme, per 1000 women screened. Interval cancers are to be
reported according to 5-year age category and for a limited age range (i.e. 50-64 years). The age referred
to in Tables VI.2 and VI.3 is the age at the time of the screening examination. When comparing interval
cancer rates across screening programmes the rates should be expressed as a proportion of the
underlying (expected) breast cancer incidence rate in the absence of screening.
Interval cancers
True interval
Minimal signs
False negative
Unclassifiable
TOTAL
Interval cancer rate
(per 10,000 women screened)
Incidence rate expected in the
absence of screening
(per 10,000 women)
II - A - 3 8
45-49
50-54
55-59
60-64
65-69
age unk.
50-64
Interval cancers
45-49
50-54
55-59
60-64
65-69
age unk.
50-64
True interval
Minimal signs
False negative
Unclassifiable
TOTAL
Interval cancer rate
(per 10,000 women
screened)
Incidence rate expected in
the absence of screening
(per 10,000 women)
Table VII.4. The suggested classification of interval cancers can also be applied to cancers detected at
subsequent screens, with the exception of the category 'radiologically occult' if mammography is the sole
screening test.
Although radiologic review of cancers mostly focuses on the group of interval cancers, further insight into
the sensitivity and specificity of mammography might be obtained by studying the distribution of subtypes
in screening mammograms as well as in presenting mammograms of interval cancers, and relating the
outcome to diagnosis.
Table VII.4: Screen-detected cancers at subsequent screens (OPTIONAL)
Screen-detected cancers
45-49
50-54
55-59
60-64
65-69
age unk.
50-64
True interval
not applicable
Minimal signs
False negative
Unclassifiable
TOTAL
II - A - 39
Block VIM - Impact on breast cancer mortality

The ultimate objective of every screening programme for breast cancer is to impact favourably on mortality
from the disease, while not adversely affecting the health status of those who participate in the
programme. Several studies, carried out in different countries, over different time periods, using differing
epidemiological approaches, have demonstrated a beneficial effect of mammographie screening on
mortality from breast cancer (1-10).
Estimates of reduction in breast cancer mortality that have been achieved to date in randomised controlled
trials of mammographie screening vary from 4% (4) to 30% (2). E stimates of benefit from case-control
studies could be as high as 52% (8) to 70% (9). For logistic reasons, however, it is not possible for all
screening programmes to embark on a randomised controlled trial or case-control study of mammography.
Nonetheless, every programme, new and existing, will be required to make its own periodic determination
of impact on mortality. While it may be tempting to predict that a programme can achieve a reduction in
mortality of the order of the higher estimates quoted above, recent data examining non-randomised
general population screening suggest that the impact in the non-randomised situation is somewhat
reduced (11). The fore-mentioned study does point out, however, that the better organised the population
programme the more reliable will be the estimate of mortality reduction.
The prediction of mortality reduction achieved by screening has been studied (12). It has been deemed
possible to predict the level of reduction by reference to a number of items which are specific to individual
programmes, and therefore not generalisable. These include the age-specific incidence and mortality rates
from breast cancer, estimates of rates of disease progression, the sensitivity and specificity of the
screening test employed, the therapeutic efficacy of treatment, the age groups chosen for screening and
the expected compliance rate (12).
Ascertainment of impact on mortality demands (a) that follow up of the screened cohorts continues over
extended periods of time, (b) that data on vital status and disease-free interval be vigorously sought and
recorded despite the problems of follow up, and (c) that adequate links exist between programme data
and other relevant data sources, e.g. medical records, pathology registers, death certificate information.
The complexities and variation from region to region of this element of evaluation precludes a detailed
outline of the recording requirements at this time. The purpose of this narrative is to prime the
epidemiologists of new and existing programmes to the need for ongoing evaluation of the impact of
screening on breast cancer mortality.
References
1
Shapiro S, Venet W, Strax , et al. Periodic screening for breast cancer: the Health Insurance Plan project and its sequelae,
1963-1986. Baltimore, MD: Johns Hopkin University Press, 1988.
Tabar L, Fagerberg G, Duffy SW, et al. The Swedish two county trial of mammographie screening for breast cancer: recent
results and calculation of benefit. J Epidemiol Community Health 1989;43:107-14.
UK Trial of Early Detection of Breast Cancer Group. First results on mortality reduction in the UK trial of early detection of
breast cancer. Lancet 1988;2:411-16.
Andersson I, Aspegren K, Janzon L, et al. Mammographie screening and mortality from breast cancer: the Malm
mammographie screening triai. BMJ 1988;297:943-8
Roberts MM, Alexander FE , Anderson TJ, et al.E dinburgh trial of screening for breast cancer: mortality at seven years.
Lancet 1990;335:241-6
Frisell J, Eklund G, Hellstrom L, et al. Randomised trial of mammography screening - preliminary report on mortality in the
Stockholm trial. Breast Cancer Res Treat 1991;18:49-56
Morrison AS, Brisson J, Khalid N. Breast cancer incidence and mortality in the Breast Cancer Detection and Demonstration
Project. JNCI 1988;80:1540-7
II-A-40
Verbeek ALM, Hendriks JHCL, Holland R, et al. Mammographie screening and breast cancer mortality: age-specific effects
in Nijmegen project, 1975-1982. Lancet 1985;1:865-6
Collette HJA, Day NE, Rombach LL, et al. Evaluation of screening for breast cancer in a non-randomised study (the DOM
Project) by means of a case-control study. Lancet 1984;1:1224-6
10
Palli D, Del Turco MR, Buaitti E , et al. A case-control study of the efficacy of a non-randomised breast cancer screening
program in Florence (Italy). Int J Cancer 1986;38:501-4
11
Trnberg S, Carstensen J, Hakuinen T, Lenner , Hatschek T, Lundgren B. E valuation of the effect on breast cancer
mortality of population based mammography screening programmes. J.Med. Screening 1994;1:184-187
12
Knox E G. Evaluation of a proposed screening regimen. BMJ1988;297:650-654
Acknowledgements
The assistance of the European Commission 'Europe against Cancer' programme with Dr. Chris de Wolf
as facilitator is gratefully acknowledged. Drafts of the document were discussed and reviewed at the
annual meeting of the Pilot Network for Breast Cancer Screening in Strasbourg (September 1995) and
a meeting of the epidemiologists from the Pilot Projects (November 1995). Thanks are therefore due to
all those who participated in this review process and whose comments have influenced and helped
improve the document. The authors further wish to thank Anthony McDonnell for his assistance in
preparing the document.
II - A - 41
Glossary of terms
Additional imaging: after evaluation of the screening mammogram, additional imaging may be required
for medical reasons. This may take the form of repeat mammography, specialised views (e.g.
magnification, extended craniocaudal, paddle views), ultrasound or magnetic resonance imaging (MRI).
Additional radiology includes additional views taken at the time of the screening mammogram, as well as
those carried out on recall. It does not include repeat mammograms for technical reasons. It also does
not include intermediate mammograms. On the basis of additional imaging, a woman may be dismissed,
or may be recommended to have cytology or biopsy. Please note the difference between additional
imaging and intermediate mammography.
Additional imaging rate: the number of women who have an additional imaging investigation as a
proportion of all women who have a screening test. This includes additional images taken at the time of
the screening test, as well as imaging for which women are recalled. The additional imaging rate does not
include repeat mammography for technical reasons. It also does not include intermediate mammograms.
Within the group with additional imaging, the rates of individual imaging procedures may be derived.
Adjuvant therapy: women with axillary lymph node metastases are assumed to receive adjuvant
systemic therapy (chemotherapy and/or hormonal therapy).
Age-specific detection ratio: the number of breast cancers detected in a specified age category divided
by the incidence of breast cancer in that same age category in the year before screening started.
Benign/malignant biopsy ratio: the ratio of pathologically-proven benign lesions to malignant lesions
surgically removed in any round of screening. This ratio may vary between initial and subsequent
screening examinations.
Breast cancer register: when a country or region does not have or can not access a pathology register
and/or cancer register, a screening programme may take it upon itself to create a 'breast cancer register'
specifically for the programme.
Cancer: a pathologically-proven malignant lesion which is classified as ductal carcinoma in situ or invasive
breast cancer.
Cancer detection rate: the number of pathologically-proven malignant lesions (both in-situ and invasive)
detected in a screening round per 1000 women screened in that round. This rate will differ for initial versus
subsequent screening examinations. Cancers detected at intermediate mammography should be regarded
as screen-detected cancers and thus be included in the cancer detection rate. Recurrent breast cancers,
detected for the first time at mammographie screening, should also be regarded as screen-detected
cancers since they will be identified and diagnosed in the same way as a primary breast cancer. Cancer
metastases diagnosed in the breast as a consequence of a primary cancer outside the breast should not
be included in the cancer detection rate.
Core biopsy: closed biopsy of a breast lesion providing a histological specimen of breast tissue for
diagnostic purposes.
Cytology: techniques used to extract cells from breast lesions for cytological examination. Cytology can
distinguish between cystic and solid breast lesions. Material from solid lesions can be examined
cytologically for evidence of malignancy. Cytology may be performed with or without radiological
(stereotactic) control. The latter may be referred to as Stereotactic Biopsy (STB) to distinguish it from
- A - 42
cytology performed blindly, as in an outpatient clinic where a surgeon may aspirate a palpable breast lump
for fluid or cells.
Dedicated screening unit: a unit that is used solely for screening examinations.
Dynamic cohort: a cohort, the composition of which is continuously changing allowing for the addition
of new members for screening and follow up, and cessation of screening for those who become older than
the maximum screening age. In order for estimates of screening efficacy to be accurately derived it is
essential to know the denominator of the dynamic cohort at all times.
Eligible population: the adjusted target population, i.e. the target population minus those women that
are to be excluded according to screening policy on the basis of criteria other than age, gender and
geographic location.
Fixed cohort: a cohort into which there are no entries during the study period, including the follow up
period. In a screening programme this means that a specific birth cohort is selected for screening and
follow up. Women entering the age category in subsequent years of the screening programme are not
included in the study cohort.
Further assessment: additional diagnostic techniques (either non-invasive or invasive) that are
performed for medical reasons in order to clarify the nature of a perceived abnormality detected at the
screening examination. Further assessment can take place at the time of the screening test or on recall.
Incidence rate (IR): the number of newly diagnosed cases of disease in a defined population within a
defined time period.
Initial screening: first screening examination of individual women within the screening programme,
regardless of the organisational screening round in which women are screened and regardless of previous
invitations or reminders.
Intermediate mammography following screening: if, as a result of the screening test, a mammogram
is required out of sequence with the screening interval (say at 3, 6 or 12 months), this is referred to as an
intermediate mammogram following screening. Cancers detected at intermediate mammography should
be regarded as screen-detected cancers (not interval cancers).
Intermediate mammography following further assessment: if, as a result of the screening test and
further assessment, a mammogram is required out of sequence with the screening interval (say at 3, 6
or 12 months), this is referred to as an intermediate mammogram following further assessment. Cancers
detected at intermediate mammography following further assessment should be regarded as screendetected cancers (not interval cancers).
Interval cancer: a primary breast cancer which presents between two routine screening examinations,
in a person dismissed as having had a negative screening test, or a 'negative for malignancy' outcome
of further investigation of an abnormality detected at the screening examination.
Interval cancer rate: the number of interval cancers between two rounds of screening per 1000 women
screened in the first of the two rounds.
Open biopsy: refers to surgical removal of a breast lesion.
II - A - 43
Open biopsy rate: the number of women undergoing open biopsy as a proportion of all women who have
a screening examination. This rate may differ for initial versus subsequent screening examinations.
- A - 44
Opportunistic screening: refers to screening which takes place outside an organised or populationbased screening programme. This type of screening may be the result of e.g. a recommendation made
during a routine medical consultation, consultation for an unrelated condition, on the basis of a possible
increased risk of developing breast cancer (family history or other known risk factor).
Organisation register: registers of companies used to help identifying women from the target population
for screening.
Participation rate: the number of women who have a screening test as a proportion of all women who
are invited to attend for screening.
Primary treatment: all women with breast cancer, with or without signs of distant metastases, will receive
a form of primary treatment, e.g. breast conserving surgery, mastectomy, chemotherapy, radiotherapy.
Population-based: a very specific epidemiological term which describes and emphasises the principle
accurate denominator information. For a study to be population-based requires that relevant data be
available for review on every member of the population under study. For a screening programme to be
population-based every member of the target population who is eligible to attend on the basis of predecided criteria must be known to the programme.
Positive predictive value (PPV): refers to the ratio of lesions which are truly positive to those test
positive. It is intimately effected by the prevalence of the condition under study. Thus, with a prevalence
of < 1%, as with breast cancer, one can expect a low positive predictive and a very high negative
predictive value for screening mammography.
PPV of additional imaging: the number of cancers detected as a proportion of the women with positive
results in additional imaging (i.e. suspicion of malignancy). The denominator should include additional
views performed for medical reasons at the time of the screening examination or on recall. Additional
views taken for technical reasons should be excluded. Intermediate mammograms should also be
excluded. In practice, the denominator corresponds to those women who, after additional imaging,
undergo invasive tests for diagnostic confirmation.
PPV of cytology: the number of cancers detected as a proportion of the women with positive cytology
(i.e. suspicion of malignancy). In practice, the denominator corresponds to those women who undergo
biopsy after cytology.
PPV of recall: the number of cancers detected as a proportion of the women who were physically recalled
for further assessment (but excluding those for technical recall).
PPV of recommendation for open biopsy: the number of cancers detected as a proportion of the
women who were recommended for open biopsy. Since biopsy is the 'gold standard', i.e. the test used for
diagnostic confirmation, there is no such thing as a PPV of open biopsy.
PPV of screening test: the number of cancers detected as a proportion of the women with a positive
screening test. In practice, the denominator corresponds to women undergoing further assessment either
at the time of screening or on recall. Further assessment does not include additional mammograms for
technical reasons (repeat screening tests).
II-A-45
Recall: refers to women who are have to come back to the screening unit, i.e. who are physically
recalled, as a consequence of the screening examination for:
(a) a repeat mammogram because of a technical inadequacy of the screening mammogram (technical
recall); or
(b) clarification of a perceived abnormality detected at the screening examination, by performance of an
additional procedure (recall for further assessment).
This group is different from those who may have additional investigations performed at the time of the
screening examination, but who were not physically recalled for that extra procedure.
Recall rate: the number of women recalled for further assessment as a proportion of all women who had
a screening examination.
Recent mammogram: women who had a recent mammogram (either diagnostic or screening) may
potentially be excluded from the target population and/or the results dependent on screening policy.
Repeat screening test: refers to the need to repeat a screening test for technical reasons, either at the
time of the screening examination or on recall. The most common reasons for a repeat screening test are:
a) processing error;
b) inadequate positioning of the breast; or
c) machine or operator errors.
Technical recalls will be reduced considerably, though not necessarily completely eliminated, by on-site
processing taking place before a woman is dismissed.
Screening interval: the fixed interval between routine screens decided upon in each screening
programme dependent on screening policy.
Screening policy: the specific policy of a screening programme which dictates the targeted age and
gender group, the geographic area to target, the screening interval (usually two or three years), etcetera.
Screening test: the test that is applied to all women in the programme. This may be a single or two- view
mammogram with or without clinical examination. The screening test does not include additional imaging
tests carried out at the time of the initial screening examination.
Screening unit: a screening unit refers to a building or facilities where screening examinations take place.
It does not refer to the exact number of e.g. mammography machines within the unit.
Self-registration: women not invited for screening may present themselves and be included in the
screening roster. It is the responsibility of the screening staff to decide whether self-registered women
qualify to become members of the screening roster or not. It would be expected that only women who are
members of the target population and thus eligible to attend would be allowed to self-refer.
Sensitivity: refers to the ratio of histologically-proven malignancies correctly identified at the screening
examination to histologically-proven malignancies identified and not identified at the screening examination
(i.e. true positives/true positives + false negatives). It is clear that to establish the sensitivity of the
screening test in a particular programme there must be a flawless system for identification and
classification of all interval cancers.
Sources of demographic data: demographic data for the purpose of issuing invitations to screening may
come from a population register, an electoral register, other registers, population survey, or census data.
- A - 46
Specificity: refers to the ratio of truly negative screening examinations to those that are truly negative and
falsely positive (i.e. true negatives/true negatives + false positive). To derive an absolutely accurate
estimate of specificity would require that each person dismissed as having a negative screening test is
followed for ascertainment of subsequent negativity, and that those who are recalled for additional
investigation following the screening test are regarded as potentially all having a malignancy. The false
positives are those who have a histologically-proven benign lesion. A note of caution is warranted here,
however, in that, not infrequently, it is known beforehand, on the basis of radiological investigation, that
the offending lesion is benign. The reason for surgery on a benign lesion may be surgeon or patient
preference for excision.
In practice the ascertainment of specificity is frequently made on the basis of the results of initial
mammograms.
Subsequent screening: all screening examinations of individual women within the screening programme
following an initial screening examination, regardless of the organisational screening round in which
women are screened.
Symptomatic women: women reporting breast complaints or symptoms at the screening examination
may potentially be excluded from the target population and/or results according to screening policy.
Target population: all persons eligible to attend for screening on the basis of the following criteria: age,
gender and geographic location (as dictated by the screening policy). This includes special groups such
as institutionalised or minority groups.
Women invited: all women invited in the period to which data refer, even if they have yet to receive a
reminder.
Women screened: all women screened in the period to which data refer, even if results of mammograms
are not yet available.
World age-standardised rate: using 'direct' standardisation, this is the rate which would have occurred
if the observed age-specific rates had operated in the standard world population:
II-A-47
Standard world population used for the computation of age-standardised mortality and incidence rates1:
Age (yrs)
World
015-
2 400
9 600
10 000
101520 25 30 35 40 45 50 55 60 65 70 75 80 85 +
9 000
9 000
8 000
8 000
6 000
6 000
6 000
6 000
5 000
4 000
4 000
3 000
2 000
1 000
500
500
total
100 000
Smith PG (1992) Comparison between registries: age-standardized rates. In: Parkin DM, Muir CS,
Whelan SL, Gao Y-T, Ferlay J, Powell J (eds) Cancer Incidence in Five Continents, Volume VI.
IARC Scientific Publications N-120, Lyon, 865-870
- A - 48
II -
CYTOPATHOLOGY GUIDELINES
produced by the
E.C. WORKING GROUP ON BREAST SCREENING PATHOLOGY
Editor:
Prof. J. Sloane
Content:
Il - CYTOPATHOLOGY GUIDELINES
Introduction
Quality assurance
II - - 1
II - - 2
II - - 3
II - - 5
Introduction
The term fine needle aspiration cytopathology (FNAC) is used throughout
this document although it is recognised that a minority of units do not use
suction for obtaining samples.
The success of FNAC is directly related to the skill and experience of the
aspirator and there is strong evidence that the procedure is most successful
when performed by a limited number of aspirators, who have been properly
trained.
In most circumstances FNAC can be successfully carried out when:
1
easily palpable breast abnormalities are sampled freehand by a

designated experienced clinician who may be a pathologist.
clinically equivocal and impalpable abnormalities are sampled under

image guidance by a radiologist.
The number of aspirators in any one centre should be kept to a minimum

and their performance audited.
Where resources allow it may be appropriate for the pathologist to perform
aspiration him or herself. However, it would be unusual for the pathologist
to have sufficient knowledge of mammography and ultrasound to undertake
image-guided aspiration procedures independently of the radiologist
although it is desirable for the pathologist to be present if resources allow.
The pathologist is most likely to undertake aspiration where the breast
assessment team has decided to provide a same-day cytology service or
where there is a high percentage of inadequate specimens due to
preparation problems or the lack of an experienced clinical aspirator. It is
generally not appropriate for FNAC to be carried out in a separate clinic set
up solely for this purpose. This is likely to be cost-effective only where the
standard of aspiration would otherwise be poor and the pathologist has
other symptomatic breast and non-breast referrals.
The decision about whether to operate on patients with screen-detected
mammographie abnormalities involves the correlation of clinical, radiological
and cytological findings (triple assessment). This is best achieved in
multidisciplinary meetings where the clinician, radiologist and pathologist
discuss these findings and reach a consensus on the management of each
patient following pre-defined protocols.
II-B-1

Information is registered using the standard registration form
Registration Form
BREAST SCREENING CYTOPATHOLOGY
Surname
Forenames . . . .
Screening no
Hospital no . . . .
Date of birth
Centre
Slide
D Right
D Left
Specimen type
D FNA
(solid lesion
D FNA
(cyst)
Nipple discharge
D X-ray guided
Ultrasound guided
Localisation technique D Palpation
Opinion
G 1 Unsatisfactory
Report no
Nipple or skin scrapings
Comment
2 Benign
3 Atypia probably benign
4 Suspicious of malignancy
5 Malignant
PATHOLOGIST
NAME OF ASPIRATOR
DATE
Centre/location
Give the name of the assessment centre, clinic, department etc., where the
specimen was obtained.
Side
Indicate right or left. For specimens from both sides, use a separate form for
each slide.
Specimen type
Please choose one of the following terms:

FNA (solid lesion)
FNA (cyst)
Nipple discharge
Nipple or skin
Localisation technigue

Palpation
Ultrasound guided
X-ray guided
n--2
Fine needle aspiration of a solid lesion

Fine needle aspiration of a cyst subjected to
cytological examination
Cytological preparation of a nipple discharge
Cytological preparation of nipple or skin scrapings
FNA guided by palpation

FNA guided by ultrasound
FNA guided by x-ray examination.
Stereotaxis is included in this category.
Pathologist
The name of the pathologist giving the cytological opinion.
Aspirator
The name of the person performing the fine needle aspiration.
Recording the cytology

opinion
See the reporting categories below. A comment field is included for any extra
information to be recorded in free text.
A definitive diagnosis of malignancy or benignity should be made wherever
possible. The proportion of definitive diagnoses will clearly increase with the
experience of both pathologist and aspirator.
C1 Inadequate
Indicates a scanty or acellular specimen or poor preparation.

The designation of an aspirate as 'inadequate' is to a certain extent a
subjective matter and may depend on the experience of the aspirator and/or
the interpreter.
Poor cellularity (usually less than five clumps of epithelial cells) is sufficient
to declare an aspirate inadequate. Preparative artefacts or excessive blood
may also be reasons for rejecting an aspirate as inadequate.
Preparative artefacts include:
1.
Crush, when too much pressure is used during smearing.
2.
Drying, when dry smears are allowed to dry too slowly or when wetfixed smears have been allowed to dry out before fixation.
3.
Thick smears, when an overlay of blood, protein-rich fluid or cells

obscurs the picture, making assessment impossible.
It is often helpful to make a comment as to the cause of the inadequate

specimens in the Comment box on the form.
C2 Benign
Indicates an adequate sample showing no evidence of malignancy.

The aspirate in this situation is often poorly to moderately cellular and tends
to consist mainly of regular duct epithelial cells. These are generally
arranged as monolayers and the cells have the characteristic benign
cytological features. The background is usually composed of dispersed
individual and paired naked nuclei. Should cystic structures be a component
of the aspirated breast, then a mixture of foamy macrophages and regular
apocrine cells may be part of the picture. Fragments of fibrofatty and/or fatty
tissue are common findings.
A positive diagnosis of specific conditions, for example: fibroadenoma, fat
necrosis, granulomatous mastitis, lymph node, etc., may be suggested if
sufficient features are present to establish the diagnosis with confidence.
II-B-3
C3 Atypia probably
benign
All the characteristics of a benign aspirate may be seen as described above.

In addition, there are certain features not commonly seen in benign
aspirates, including any of the following, alone or in combination:
1 nuclear pleomorphism
2 some loss of cellular cohesion
3 nuclear and cytoplasmic changes resulting from hormonal influence
(pregnancy, contraceptive pill, HRT) or treatment effects.
Increased cellularity may accompany the above features.
As thus defined, this group would be expected to contain approximately 20%
of cases which were subsequently proven to be malignant.
C4 Suspicious of
malignancy
The pathologist's opinion is that the material is suggestive but not diagnostic
of malignancy. There are three main reasons:
1)
the specimen is scanty, poorly preserved or poorly prepared, but
some cells with features of malignancy are present.
2)
the sample may show some malignant features without overt
malignant cells present. The degree of abnormality should be more
severe than in the previous category.
3)
the sample has an overall benign pattern with large numbers of
naked nuclei and/or cohesive sheets of cells, but with occasional
cells showing distinct malignant features.
As thus defined, this group would be expected to contain approximately 80%
of cases which were subsequently proven to be malignant.
C5 Malignant
Indicates an adequate sample containing cells characteristic of carcinoma,

or other malignancy.
The interpreter should feel at ease in making such a diagnosis. Malignancy
should not be diagnosed on the basis of a single criterion but on a
combination of features.
Calcification
It is very useful for the radiologist if the pathologist reports the presence of
calcification within specimens taken from stereotactic or perforated plate
guided FNAC when the abnormality is one of mammographie
microcalcification. If calcification is present in these circumstances, the
radiologist or multidisciplinary team can be more certain that the lesion has
been sampled accurately and that the likelihood of a false negative due to an
aspiration miss is lower. This may allow the team to advise with greater
confidence that the woman be routinely recalled or rescreened early rather
than subjected to biopsy. It is desirable to specify the type of calcification
(hydroxyapatite or weddellite).
Calcification alone does not discriminate between benign and malignant
conditions.
II--4
Quality assurance
Definitions
The following calculations are intended to reflect the quality of the FNAC
service as a whole rather than the laboratory component alone. Inadequate
FNAC results are not, therefore excluded from the calculations as in some
publications. Cytologists wishing to evaluate purely their own accuracy in
diagnosis may wish to calculate the figures differently.
Absolute sensitivity (C5)
The number of carcinomas diagnosed as such

(C5) expressed as a percentage of the total
number of carcinomas aspirated.
Complete sensitivity
(C3, 4 and 5)
= The number of carcinomas that were not

definitely negative or inadequate on FNAC
expressed as a percentage of the total number of
carcinomas aspirated.
Specificity
= The number of correctly identified benign lesions

(the number of C2 results minus the number of
false negatives) expressed as a percentage of
the total number of benign lesions aspirated.
Positive predictive value = The number of correctly identified cancers

of a C5 diagnosis
(numbers of C5 results minus the number of
false positive results) expressed as a percentage
of the total number of positive results (C5).
Positive predictive value = The number of cancers identified as suspicious
of a C4 diagnosis
(number of C4 results minus the number of false
suspicious results) expressed as a percentage of
the total number of suspicious results (C4).
Positive predictive value = The number of cancers identified as atypia
of a C3 diagnosis
(number of C3 results minus the number of
benign atypical results) expressed as a
percentage of the total number of atypical results
(C3).
Negative predictive
= The number of benign cases (including those
value of a C2 diagnosis
with no histology) expressed as a percentage
of the total number of C2 diagnoses.
False negative case
A case which subsequently turns out (over the

next 2 years) to be carcinoma having had a
negative cytology result. (This will by necessity
include some cases where the cancer was
missed rather than misinterpreted in the smears.
Furthermore, the interval may vary from one
programme to another depending on the
screening interval).
- -5
How to calculate these

figures
False positive case
A case which was given a C5 cytology result but

which turns out at open surgery to have a benign
lesion (including atypical hyperplasia).
False negative rate
The number of false negative results expressed

as a percentage of the total number of
False positive rate
The number of false positive results expressed

as a percentage of the total number of
Inadequate rate
The number of inadequate specimens expressed

as a percentage of the total number of cases
aspirated.
Suspicious rate
The number of C3 and C4 diagnoses expressed

as a percentage of the total number of cytology
results.
It is intended that a computer system will be able to calculate these figures

automatically from the data in the database cross-referencing with the
histology or subsequent outcome and a report derived for quality assurance
purposes.
CYTOLOGY QA STANDARD REPORT
Total cases screened in period
Total assessed
Total FNAC performed
Cytology
Histology
C5
C4
C3
C2
C1
Total
Total malignant
Box 1
Box 2
Box 3
Box 4
Box 5
Box 6
Invasive
Box 7
Box 8
Box 9
Box 10
Box 11
Box 12
Non-invasive
Box 13
Box 14
Box 15
Box 16
Box 17
Box 18
Total benign
Box 19
Box 20
Box 21
Box 22
Box 23
Box 24
No histology
Box 25
Box 26
Box 27
Box 28
Box 29
Box 30
Total C results
Box 31
Box 32
Box 33
Box 34
Box 35
Box 36
II-B-6
Each box (numbered 1 to 36) of the above table is calculated from the number
of FNAC with a C code (C1, C2, etc.) cross-referenced with the worst histology
diagnosis. The table and calculations (see below) should be produced for all
FNAC tests (headed ALL TESTS) and also for all patients (headed ALL
PATIENTS) where if two FNAC records are present the highest C number is
taken. Only closed episodes should be used.
From the above table the sensitivity and specificity are then calculated in
percentages for each of the categories in the cytology document. (The numbers
correspond to BOX NUMBERS in the above table.)
1 ABSOLUTE SENSITIVITY
- 1 ^ x 100
6 + 25
(This assumes that all unbiopsied C5 results are

carcinomas treated non surgically.)
2. COMPLETE SENSITIVITY
1+2+3+25 x 100
6+25
3 SPECIFICITY
(biopsy cases only)
22
* 100
22 28
4 SPECIFICITY (full)
(This assumes that all cases of atypia (C3) which
are not biopsied are benign.)
24 27 ,28+29
5 POSITIVE PREDICTIVE VALUE

(C5 diagnosis)
(C4 diagnosis)
(C3 diagnosis)
8 NEGATIVE PREDICTIVE VALUE
(C2)
11 INADEQUATE RATE
100
2
32-26
100
3
33
100
34-4
34
100
mn
9 FALSE NEGATIVE RATE

(This EXCLUDES inadequate results)
10 FALSE POSITIVE RATE
31-19
31
6 + 25
^ - * 100
6 + 25
=
35
x 100
36
II - - 7
12 INADEQUATE RATE FROM CANCERS
13 SUSPICIOUS RATE
6+25
x 100
32 + 33
100
36
It is recognized that the specificities are approximate and will be more accurate
the longer the follow up.
Suggested minimum
standards where
therapy is partially
based on FNAC
> 60%
Absolute sensitivity (AS)
> 80%
Complete sensitivity (CS)
> 60%
Specificity (SPEC)
(including non-biopsied cases)
(as calculated above)
> 98%
Positive predictive value (C5) (+PV)
<5%
False negative rate (F-)
<1%
False positive rate (F+)
< 25%
Inadequate rate (INAD)
Inadequate rate in samples taken from carcinomas
< 10%
< 20%
Suspicious rate
These figures will obviously depend on aspiration techniques and the experience
and care of the aspirator and will vary widely between units. The figures are
interrelated and strategy to improve one figure will affect others. Thus attempts
to reduce the inadequate rate will often increase the number of suspicious
reports and attempts to improve the specificity will increase the false negative
rate and so on. Also, reducing the benign biopsy rate by not sampling the
majority of lesions with benign cytology will reduce the specificity where this is
based on cases with benign histology rather than on the total.
A high proportion of impalpable cases aspirated in any series is likely to make
the figures worse as there is more chance of missing a small area of
microcalcification leading to a false negative or inadequate result and more
likelihood of aspirating atypical hyperplasia, radial scars and tubular carcinomas,
leading to a high level of suspicious or atypical reports. In screening with
aspiration of impalpable lesions the results are likely to reveal lower values than
those achieved in the symptomatic setting.
n--8
II - C QUALITY ASSURANCE GUIDELINES FOR PATHOLOGY

IN MAMMOGRAPHY SCREENING
produced by the
E.C. WORKING GROUP ON BREAST SCREENING PATHOLOGY
Editor:
Prof. J. Sloane
Content:
Il - C Quality Assurance Guidelines for Pathology in Mammography
Screening
INTRODUCTION
ll-C-1

Biopsy Specimens
-C-1

Introduction
-C-
TABLE 1. DISTINCTION OF PAPILLOMA FROM ENCYSTED PAPILLARY CARCINOMA

-C-1
-C-2
-C-
-c-e
-C-
-C-7
I -C-
l-C-12
TABLE 2. COMPARISON OF HISTOLOGICAL FEATURES OF DUCTAL HYPERPLASIA AND DCIS I - C - 1 TABLE 3. DISTINCTION OF ATYPICAL LOBULAR HYPERPLASIA FROM LOBULAR C.I.S
l-C- V
CLASSIFYING MALIGNANT NON-INVASIVE LESIONS

Mixed Types
I-C-1
TABLE 4. DISTINCTION OF DUCTAL FROM LOBULAR CARCINOMA IN SITU

Paget's disease
l-C-1/
RECORDING PROGNOSTIC DATA
I-C-1
REFERENCES
I - C - 2'
INDEX FOR SCREENING OFFICE PATHOLOGY SYSTEM
I - C - 2(
l-C -3
I-C-1
I-C-1
I-C-1
l-C-K
l-C-K
I-C-1
i-c-1
I-C-1
I - C - 1
II-C
INTRODUCTION
The success of a breast screening programme depends heavily on the
quality of the pathological service. Specimens from screened women provide
pathologists with particular problems of macroscopic and histological
examination; the former principally result from identifying impalpable
radiological abnormalities and the latter from classifying borderline lesions
which are encountered with disproportionate frequency.
Accurate
pathological diagnoses and the provision of prognostically significant
information are important to ensure that patients are managed appropriately
and that the programme is properly monitored and evaluated. A standard set
of data from each patient, using the same terminology and diagnostic criteria
is essential to achieve the latter objective. The opinions expressed represent
the consensus view of the EC. Working Group on Breast Screening
Pathology and other pathologists who made written or verbal comments on
this document and the United Kingdom document on which it is based. We
hope that European pathologists involved in breast screening will find the
guidance useful and the method of recording data convenient.

Biopsy Specimens
Optimal handling
Palpable lesions
Confirming excision of
radiological abnormality
Biopsies of mammographically detected lesions may provide especial

difficulty in histological interpretation and consequently require optimal
fixation and careful handling. Sometimes a photographic record of the sliced
specimen, with the guide wire in position may be necessary to maximize the
value of case discussions with clinical and radiological colleagues. Provision
for macroscopic photography must, therefore, be borne in mind, especially
for difficult cases.
The surgeon should be discouraged from cutting the specimen before
sending it to the pathologist and should ideally mark it with sutures in order
to obtain proper orientation. Sutures are preferable to metal staples which
often retract into the specimen, thus becoming impossible to recognize, and
may obscure microcalcifications. A code of orientation for the sutures needs
to be established and indicated on the request form.
Palpable lesions detected in the screening programme may be dealt with by
conventional methods and there is no especial virtue in specimen
radiography, assuming that there is no doubt that the radiological and
palpable lesions are one and the same.
After excision, the intact specimen - with guide wire in situ - must be x-rayed.
Ideally this procedure is carried out by the staff of the radiological
department, so that the radiologist or surgeon can determine whether the
relevant lesion has been resected. It may be necessary on medico-legal
grounds for centres to name consultants responsible for confirming that
mammographie lesions have been removed. Ideally those consultants
should be the radiologists who interpreted the clinical mammograms. A good
working relationship between pathologists, surgeons and radiologists is
essential. Two copies of the specimen radiograph at this time could be taken
with benefit, one for the department of radiology and one for the pathologist.
II - c - 1
If mammographie
abnormality not
identified
Fresh specimens
Frozen sections
Fixation
Excision margins
Clearly there will be a few occasions when the mammographie abnormality

cannot be identified in the specimen. This may result from the excision of a
lesion producing only architectural change in the clinical mammogram or from
unsuccessful surgical localization. Detailed pathological examination should
still be undertaken even in the latter case and the findings communicated to
the surgeon. Clinical mammography can subsequently be repeated to
determine if the lesion is still present in the breast.
Specimens should be examined within 2-3 hours if received fresh. Samples
for oestrogen receptor determination should be snap frozen in liquid nitrogen
within 30 minutes of excision if a ligand binding assay is used. It should be
remembered, however, that oestrogen receptor status can adequately be
determined on standard formalin-fixed, paraffin-embedded sections.1,2
Rapid frozen sectioning is generally inappropriate in the assessment of
clinically impalpable lesions. Rarely, however, it may be justified to enable
a firm diagnosis of invasive carcinoma to be made in order to allow definitive
surgery to be carried out in one operation. Three essential criteria, however,
must be fulfilled:
1) the mammographie abnormality must be clearly and unequivocally
identified on macroscopic examination
2) it must be large enough (generally at least 10mm) to allow an adequate
proportion of the lesion to be fixed and processed without prior freezing
3) it must have proved impossible to make a definitive diagnosis pre
operative^.
The intact specimen may be examined in the fresh state or after fixation.
Good fixation is very important to preserve the degree of morphological detail
needed to diagnose borderline lesions and report features of prognostic
significance, particularly grade and vascular invasion. Small specimens may
be fixed whole but larger ones should be examined and sliced within 2-3
hours of excision, if possible, to allow adequate penetration of fixative.
In order to demonstrate adequacy of excision, the entire surface of the
specimen should be painted with India ink, radiolucent pigments, dyed gelatin
or other suitable material. An appropriate period of drying must be allowed
if spread of the chosen reagent is to be avoided.
Naked eye examination
After determining its weight (and size if required), the specimen is then
serially sliced at intervals of up to 4mm. The cut surfaces are examined by
careful visual inspection. Palpation may also be informative. The maximum
diameter, contour, colour and consistency of any macroscopic lesion are
recorded. The size of lesions measured macroscopically should be checked
later on histological sections as the true extent of the abnormality is not
always appreciated by macroscopic inspection alone. If different, the
histological dimensions should be accepted as the true size. In the case of
malignant lesions, adequacy of excision should be assessed by naked eye
and later by microscopic examination.
Specimen radiography
Unless a lesion obviously accounting for the radiological abnormality is

identified, a second radiograph of the sliced specimen should be performed.
It is desirable for the pathologist to give a brief description of the abnormality
in the specimen radiograph during macroscopic examination. Blocks should
then be taken from the areas corresponding to the mammographie
abnormalities and any other macroscopically suspicious zones. This method
allows precise correlations to be made between the radiological and
histological appearances and may serve as a reference map for orientation
- c -2
Histological
characterization of
mammographie
changes
Choice of specimen
mammography
equipment
Extent of sampling
Large blocks
and reconstruction purposes. It is thus the favoured method of specimen

radiography. It has been found, however, to be too time-consuming for some
laboratories to undertake. A number of shorter, one stage, methods have
been reported. For reviews see Anderson and Armstrong & Davies.34
Whichever method is adopted, pathologists must satisfy themselves that the
pathological changes responsible for mammographie abnormalities have
been identified in the histological sections; it may be necessary to consult
with radiologists to be certain of this. If not, the residual unblocked tissue
and/or blocks should be re-x-rayed. Any residual tissue should be stored
until the mammographie changes have been characterized histologically.
It is not recommended that tissue is simply taken from around a guide wire
introduced pre-operatively which may not necessarily be very close to the
mammographie abnormality.
Although it is possible to prepare adequate mammographs of specimens
using a clinical mammography machine, this approach may present logistical
difficulties. There are several dedicated specimen mammography cabinets
on the market. Their characteristics, mode of operation and the use of
accessories have been described in a recent publication by the English
Department of Health.5
The precise number of blocks to be taken cannot be stated dogmatically and
clearly depends on the size and number of lesions present. With small
biopsies, all the tissue should be blocked and examined. For malignant
tumours in excess of 20mm, about 3 blocks of the tumour are desirable.
Where possible, at least one block should include the edge of the tumour and
the nearest excision margin to enable measurement of this distance, in mm.,
on the histological sections.
For larger biopsies which cannot be blocked in toto, some sampling of
radiologically and macroscopically normal breast should be undertaken in
order to increase the detection of small occult cancers (particularly in situ
change) and atypical proliferative lesions. The frequency with which such
lesions are detected incidentally in unscreened women depends on the
number of blocks taken.6 The extent of sampling of biopsies containing
benign screen-detected mammographie abnormalities should be decided
locally and will depend, amongst other things, on the extent of local
resources. Additional sampling is more effective if restricted to fibrous
parenchyma, ignoring the adipose tissue.
Large blocks and sections are used in some laboratories where they are
found to be of value in identifying screen-detected lesions as well as in
determining their size, extent of spread and adequacy of excision. They
facilitate orientation by obviating the need for mental reconstruction of the
overall picture from several separate sections. They also reduce the number
of blocks required.7 Other workers, however, have encountered problems in
achieving adequate fixation and good cytological detail in addition to the
technical difficulties of cutting large sections and the problems in storing
them. These drawbacks can be overcome, but large blocks, although of
value, are not regarded as essential for examining specimens from screened
women and their use should depend on local preference.
Naked eye examination
Mastectomy specimens should be dealt with within 2 hours of removal and

either examined in the fresh state or incised before fixation to allow adequate
li-c-3
penetration of fixative. The favoured method of examination is by slicing the

breast from the deep surface in the sagittal plane after measuring the
dimensions or recording the weight. The slices should be about 10mm thick
and may be left joined by the skin or separated completely and arranged in
order. The maximum diameter of the main lesion should be measured and
the distance from the nearest margin of excision determined as for biopsies
(see earlier).
Sampling
Sampling
-C -4
Blocks of tumour (the number depending on tumour size as above) should

be taken to include the edges and should always be sufficient to represent
the maximum extent of the lesion noted macroscopically. Blocks of the
nearest excision margin should be taken. Painting with India ink or pigments
may be helpful as in local excision specimens. If the tumour has been
removed, then 3-4 blocks should be taken from the cavity wall. The breast
slices should be examined by careful naked eye inspection and palpation.
Blocks should be taken from any suspicious areas, noting the quadrant in
which they are located. At least one block should be taken from each
quadrant and ideally two from the nipple - one in the sagittal and one in the
coronal plane through the junction with the areola.
Axillary contents received with mastectomy or biopsy specimens should be
examined carefully to maximize lymph node yield. This is usually achieved
by cutting the specimen into thin slices which are then examined by careful
inspection and palpation. The use of clearing agents or Bouin's solution may
increase lymph node yield but are time-consuming and expensive of reagents
and not regarded as essential. The axillary contents can be divided into
three levels if the surgeon has marked the specimen appropriately.
Pathological examination should be performed on all lymph nodes received
and the report should state the total number and the number containing
metastases. A representative complete section of any grossly involved
lymph node is adequate. For nodes greater than 5mm in maximum
dimension, three slices should be taken and processed in a single block.
Nodes less than 5mm should be embedded in their entirety. They can be
processed in groups and are ideally examined at two levels.
EUROPEAN BREAST SCREENING

HISTOPATHOLOGY
Surname
Forenames
Date of birth
Screening no
Hospital No
Side:
PATHOLOGIST
Date of reporting
Report No
Histological calcification
D Absent
Specimen radiograph seen? D YesD No

Specimen type
D Benign
D Malignant
Mammographie abnormality present in specimen
D Localisation biopsy D Open biopsy
Specimen Weight
D RIGHT
Size
Both
D Yes
D Segmental excision G Mastectomy

mm
mm
o LEFT
G No
Both
Wide bore
needle core
mm
BENIGN LESION PRESENT

G Complex sclerosing lesion/radial scar
G Periductal mastitis/duct ectasia
Fibroadenoma
D Fibrocystic change
Other (please specify)
Multiple papilloma
Solitary papilloma
G Sclerosing adenosis
Solitary cyst
EPITHELIAL PROLIFERATION
Present with atypia (ductal)
Present with atypia (lobular)
Not present
Present without atypia
MALIGNANT LESIONS NON-INVASIVE
G Not present
G Ductal, high grade
Growth pattern(s) .
G Paget's
D Lobular
MICROINVASION
Ductal, other
Cell type/pattern
SIZE (Ductal only)
Present
D Not present
Possible
INVASIVE
Mucinous carcinoma
D Tubular carcinoma
D Mixed (please tick component types present)
D Not assessable
Not present
Ductal / no specific type (NST)
Lobular carcinoma
Medullary carcinoma
D Other primary carcinoma (please specify)

Other malignant tumour (please specify) .
MAXIMUM DIAMETER OF INVASIVE TUMOUR
mm
WHOLE SIZE OF TUMOUR (to include DCIS extending >1 mm beyond invasive area)
AXILLARY NODES PRESENT
OTHER NODES PRESENT
D Yes
Yes
No
No
Number positive
Number positive
Total number
Total number
Site of other nodes

EXCISION MARGINS
D Reaches margin
Uncertain
D Does not reach margin (nearest. . . .mm)
GRADE
Dl
all
Gill
DISEASE EXTENT
D Localised
D Multiple
Not assessable
VASCULAR INVASION (blood or lymphatic)
Present
G Not assessable
Not seen
COMMENTS/ADDITIONAL INFORMATION
HISTOLOGICAL DIAGNOSIS
D NORMAL
G BENIGN
G MALIGNANT
II - C - 5

Introduction
This section gives guidance on how to use the histopathology form and
provides definitions of the terms used. The aim is not to replace standard
texts on breast histopathology but to focus on diagnostic criteria for including
lesions in the various categories and therefore help to achieve maximum
uniformity of reporting.
The guidance in this section is drawn from standard textbooks of breast
pathology and other published data. Reporting forms can be obtained from,
or may be computer-generated in, screening offices. It is not necessary to
use the form as it appears in this document. It may be found desirable to
undertake modifications locally, particularly if the form is also to function as
the definitive pathology report to be entered in patients' notes and laboratory
records. It is, of course, essential to record all the information requested by
the form for submission to screening offices using exactly the same
terminology. Evaluation of breast screening programmes depends upon
provision of accurate pathology data.

Side:
Pathologist:
Date:
Histological
calcification:
Specimen radiograph
seen?
Mammographie
abnormality present in
specimen?
Specimen type
Indicate left or right. For specimens from both sides, use one form for each
side.
The pathologist should enter their name.
Enter the date the specimen was reported.
Indicate if calcification observed radiologically is seen in histological sections
and, if so, whether it is present in benign or malignant changes or both.
Please indicate if you have seen a specimen radiograph.
Are you satisfied that the mammographie abnormality is present in the
specimen? This may necessitate consultation with the radiologist responsible
for examining the specimen radiograph. It is worth remembering that breast
calcification is occasionally due to oxalate salts (Weddelite) which can only be
detected satisfactorily in histological sections using polarized light.8
- Localization biopsy
Specimen weight
II-C-6
Biopsy of impalpable lesion identified by

radiologically guided marking.
Non-guided biopsy/excision, lumpectomy, tylectomy,
Open biopsy
dochectomy.
Segmental excision
Include: wedge excisions, partial mastectomies and
re-excision specimens for clearance of margins.
Mastectomy
Where specimen includes all or nearly all of the
breast parenchymal tissue. Include: subcutaneous
mastectomy, total glandular mastectomy, simple
mastectomy, extended simple mastectomy, modified
radical mastectomy, radical mastectomy, Patey
mastectomy, supra-radical mastectomy.
Pre-operative diagnostic needle biopsy, e.g. trucut,
- Wide bore needle
screw, etc.
core
Please record the weight and/or size of all biopsy and segmental excision
specimens. Weight is a more reproducible method of estimating the size of
a specimen than 3 dimensional measurements to determine volume, even
taking into account the different densities of fat and fibrous tissue, which form
varying proportions of breast specimens

Fibroadenoma
A benign malformation composed of connective tissue and epithelium

exhibiting a pericanalicular and/or intracanalicular growth pattern. The
connective tissue is generally composed of spindle cells but may rarely also
contain other mesenchymal elements such as fat, smooth muscle, osteoid or
bone. The epithelium is usually double-layered but some multilayering is not
uncommon. Changes identical to those found in lobular epithelium elsewhere
in the breast (e.g. apocrine metaplasia, sclerosing adenosis, blunt duct
adenosis, hyperplasia of usual type, etc.) may occur in fibroadenomas but
need not be recorded separately unless they amount to atypical hyperplasia
or in situ carcinoma.
Sometimes individual lobules may exhibit increased stroma producing a
fibroadenomatous appearance and occasionally such lobules may be loosely
coalescent. These changes are often called fibroadenomatoid hyperplasia or
sclerosing lobular hyperplasia but may be recorded as fibroadenoma on the
reporting form if they produce a macroscopically visible or palpable mass.
Consequently, fibroadenomas need not be perfectly circumscribed.
Old lesions may show hyalinization and calcification (and less frequently
ossification) of stroma and atrophy of epithelium. Fibroadenomas are
occasionally multiple.
For the purposes of the screening form, tubular adenomas can be grouped
under fibroadenomas.
Fibroadenomas should be distinguished from phyllodes tumours. The high
grade or 'malignant' phyllodes tumours are easily identified by their
sarcomatous stroma. The low grade variants are more difficult to distinguish
but the main feature is the more cellular stroma. Phyllodes tumours may also
exhibit an enhanced intracanalicular growth pattern with club-like projections
into cystic spaces and there is often overgrowth of stroma at the expense of
the epithelium. Adequate sampling is important as the characteristic stromal
features may be seen only in parts of the lesion. Although phyllodes tumours
are generally larger than fibroadenomas, size is not an acceptable criterion
for diagnosis; fibroadenomas may be very large and phyllodes tumours small.
For purposes of convenience, low grade phyllodes tumours should be
specified under 'other benign lesions' and high grade under 'other malignant
tumour' although it is recognized that histological appearance is often not a
good predictor of behaviour.
Papilloma
A papilloma is defined as a tumour with an arborescent, fibrovascular stroma

covered by epithelium generally arranged in an inner myoepithelial and outer
epithelial layer. Epithelial hyperplasia without cytological atypia is often
present and should not be recorded separately. Atypical hyperplasia is rarely
seen and, when present, should be recorded separately under 'Epithelial
Proliferation'. Epithelial nuclei are usually vesicular with delicate nuclear
membranes and inconspicuous nucleoli. Apocrine metaplasia is frequently
observed but should not be recorded separately on the reporting form.
Squamous metaplasia is sometimes seen, particularly near areas of infarction.
Sclerosis and haemorrhage are not uncommon and where the former involves
the periphery of the lesion, may give rise to epithelial entrapment with the
false impression of invasion. The benign cytological features of such areas
II-C-7
should enable the correct diagnosis to be made.

The term 'intracystic papilloma' is sometimes used to describe a papilloma
in a widely dilated duct. These tumours should simply be classified as papil
loma on the form. (For distinction from encysted papillary carcinoma, Table
1.)
Papillomas may be solitary or multiple. The former usually occur centrally
in sub-areolar ducts whereas the latter are more likely to be peripheral and
involve terminal duct lobular units. The distinction is important as the multiple
form is more frequently associated with atypical hyperplasia and ductal
carcinoma in situ, the latter usually of low grade type which should be
recorded separately. This malignant change may be restricted to small foci
and extensive sampling may be required to detect it. Some sub-areolar
papillomas causing nipple discharge may be very small and extensive
sampling may be required to detect them.
Lesions termed ductal adenoma exhibit a variable appearance which
overlaps with other benign breast lesions. They may resemble papillomas
except that they exhibit an adenomatous rather than a papillary growth
pattern. These cases should be grouped under papilloma on the form.
Indeed, some tumours may exhibit papillary and adenomatous features.
Some ductal adenomas may show pronounced central and/or peripheral
fibrosis and overlap with complex sclerosing lesions (see 10).
The condition of adenoma of the nipple (sub-areolar duct papillomatosis)
should not be classified as papilloma in the screening form but specified under
'Benign Lesions, Other'.
Diffuse microscopic papillary hyperplasia should be recorded under 'Epithelial
Proliferation' in the appropriate box depending on whether atypia is present
or not.
II - c
TABLE 1. DISTINCTION OF PAPILLOMA FROM ENCYSTED PAPILLARY CARCINOMA
Histological features Papilloma encysted papillary carcinoma
Usually broad and extend throughout
the lesion
Very variable, usually fine and ma

be lacking in at least part of the
lesion
a) basal
Myoepithelial layer always present
Myoepithelial cells usually absent

but may form a discontinuous lay
b) luminal
Single layer of regular luminal

epithelium OR features of regular
usual type hyperplasia
1) Fibrovascular cores
2) Cells covering papillae
Cells often taller and more

monotonous with oval nuclei, the
long axes of which lie perpendicul
to stromal core of papillae. Nude
may be hyper-chromatic. Epitheli
multi-layering frequent, often
producing cribriform and
micropapillary patterns of DCIS
overlying the papillae or lining the
cyst wall.
3) Mitoses
Infrequent with no abnormal forms
More frequent; abnormal forms m

be seen
4) Apocrine metaplasia
Common
Rare
5) Surrounding tissue
Benign changes may be present

including regular epithelial
hyperplasia
Surrounding ducts may show due

carcinoma in situ
6) Necrosis and haemorrhage
May occur in either. Not a useful

discriminating feature.
7) Periductal and intratumoural

fibrosis
May occur in either. Not a useful

discriminating feature.
NB: All the features of a lesion should be taken into account when making a diagnosis. No criterion is reliable alon
Sclerosing adenosis
Sclerosing adenosis is an organoid lobular enlargement in which increased

numbers of acinar structures exhibit elongation and distortion. The normal
two cell lining is retained but there is myoepithelial and stromal hyperplasia.
The acinar structures may infiltrate adjacent connective tissue and
occasionally nerves and blood vessels, which can lead to an erroneous
diagnosis of malignancy. Early lesions of sclerosing adenosis are more
cellular and later ones more sclerotic. Calcification may be present.
There may be coalescence of adjacent lobules of sclerosing adenosis to
n-c-9
form a mass detectable by mammography or macroscopic examination.

The term 'adenosis tumour' has been used to describe such lesions.9 It is
recommended that sclerosing adenosis is not entered on the screening form
if it is a minor change detectable only on histological examination. Although
sclerosing adenosis often accompanies fibrocystic change (see below), this
is not always the case and the two changes should be recorded separately.
Occasionally apocrine metaplasia is seen in areas of sclerosing adenosis
(apocrine adenosis). It can produce a worrying appearance and should not
be mistaken for malignancy.10
Complex sclerosing
lesion/radial scar
Rarely, the epithelium in sclerosing adenosis may show atypical hyperplasia

or in situ carcinoma. In such cases, please record these changes
separately on the reporting form.
The differential diagnosis of sclerosing adenosis includes tubular carcinoma,
microglandular adenosis and radial scar. In tubular carcinoma, the
infiltrating tubules lack basement membrane, myoepithelium, a lobular
organoid growth pattern and exhibit cytological atypia. Ductal carcinoma in
situ is a frequent accompaniment. Microglandular adenosis differs from
sclerosing adenosis in lacking the lobular organoid growth pattern and being
composed of rounded tubules lined by a single layer of cells lacking
cytological atypia. The glandular distortion of sclerosing adenosis is lacking.
Radial scar is distinguished from sclerosing adenosis by its characteristic
floret-type growth pattern with ducto-lobular structures radiating out from a
central zone of dense fibro-elastotic tissue. Furthermore, the compression
of tubular structures associated with myoepithelial and stromal hyperplasia
is lacking.
Under this heading are included sclerosing lesions with a pseudoinfiltrative
growth pattern which have been called various names including infiltrating
epitheliosis, rosette-like lesions, sclerosing papillary proliferation, complex
compound heteromorphic lesions, benign sclerosing ductal proliferation,
non-encapsulated sclerosing lesion, indurative mastopathy and proliferation
centre of Aschoff.
The radial scar is generally 10mm or less in diameter and consists of a
central fibro-elastotic zone from which radiate out tubular structures which
may be two-layered or exhibit intra-luminal proliferation. Tubules entrapped
within the central zone of fibro-elastosis exhibit a more random, non
organoid arrangement. Lesions greater than 10mm are generally termed
complex sclerosing lesions. They have all the features of radial scars and,
in addition to their greater size, exhibit more disturbance of structure, often
with nodular masses around the periphery. Changes such as papilloma
formation, apocrine metaplasia and sclerosing adenosis may be
superimposed on the main lesion. Some complex sclerosing lesions give
the impression of being formed by coalescence of several adjacent
sclerosing lesions. There is a degree of morphological overlap with some
forms of ductal adenoma.
If the intra-luminal proliferation exhibits atypia or amounts to in situ
carcinoma, it should be recorded separately under the appropriate heading
on the screening form.
The main differential diagnosis is carcinoma of tubular or low grade 'ductal'
type. The major distinguishing features are the presence of myoepithelium
and basement membrane around the tubules of the sclerosing lesions.
Cytological atypia is also lacking and any intra-tubular proliferation
II - C - 10
Fibrocystic change
Solitary cyst
Periductal
mastitis/ectasia
(plasma cell mastitis)
Other (specify)
resembles hyperplasia of usual type unless atypical hyperplasia and/or in

situ carcinoma are superimposed (see above). Tubular carcinomas
generally lack the characteristic architecture of sclerosing lesions.
This term is used for cases with several to numerous macroscopically visible
cysts, the majority of which are usually lined by apocrine epithelium. The
term is not intended for use with minimal alterations such as fibrosis,
microscopic dilatation of acini or ducts, lobular involution, adenosis and
minor degrees of blunt duct adenosis. These changes should be indexed
as normal.
It is not intended that cystic change or apocrine metaplasia occurring within
other lesions such as fibroadenomata, papillomata or sclerosing lesions
should be coded here.
Apocrine metaplasia occurring in lobules without cystic change may produce
a worrisome appearance, occasionally mistaken for carcinoma. This
change should be specified as 'apocrine adenosis' under other benign
lesions.
Papillary apocrine hyperplasia should be indexed separately under epithelial
proliferation with or without atypia, depending on its appearance. It should
be noted, however, that apocrine cells usually exhibit a greater degree of
pleomorphism than is seen in normal breast cells. Hyperplasia should
therefore be regarded as atypical only when the cytological changes are
significantly more pronounced than usual.
This term should be used when the abnormality appears to be a solitary
cyst. The size is usually greater than 10mm and the lining attenuated or
apocrine in type. The latter may show papillary change which should be
indexed separately under epithelial proliferation of appropriate type. If
multiple cysts are present, it is better to use the term 'fibrocystic change' as
above. Intra-cystic papillomas and intra-cystic papillary carcinomas should
not be entered here but under papilloma or carcinoma.
This process involves larger and intermediate size ducts, generally in sub
duct areolar location. The ducts are lined by normal or attenuated
epithelium, filled with amorphous, eosinophilic material and/or foam cells
and exhibit marked periductal chronic inflammation, often with large
numbers of plasma cells. There may be pronounced periductal fibrosis.
The inflammatory infiltrate may contain large numbers of histiocytes giving
a granulomatous appearance. Calcification may be present. The process
may ultimately lead to obliteration of ducts leaving dense fibrous masses.
Persistence of small tubules of epithelium around the periphery of an
obliterated duct result in a characteristic garland pattern. Duct ectasia is
often associated with nipple discharge or retraction.
Cysts are distinguished from duct ectasia by their rounded rather than
elongated shape, tendency to cluster, lack of stromal elastin, frequent
presence of apocrine metaplasia and less frequent presence of eosinophilic
material or foam cells in the lumina.
Mammary duct fistula (recurring sub-areolar abscess) should be coded
under'Benign, Other'.
This category is intended for use with less common conditions which form
acceptable entities but cannot be entered into the categories above, e.g. fat
necrosis, lipoma, adenoma of nipple, low grade phyllodes tumours. The
index at the end of the booklet should help as a reference for lesions difficult
to place in any of the above categories.
- c -11
Not present
Present without
atypia
Present with atypia

(ductal)
II-c
This section is for recording intra-luminal epithelial proliferation in terminal

duct lobular units or nter-lobular ducts.
This should be ticked if there is no epithelial multilayering (apart from that
ascribed to cross-cutting) or if there is slight multilayering without atypia, not
exceeding 4 cells in thickness.
This term is used to describe all cases of intra-luminal proliferation showing
no or only minor atypia where the epithelial cells are more than 4 thick. The
change may involve terminal duct lobular units or inter-lobular ducts. The
major features which distinguish hyperplasia from ductal carcinoma in situ
of low nuclear grade are summarized in Table 2.
Hyperplasia of usual type should be recorded if it occurs alone or in
association with cystic change or other benign lesions, but not if it is
confined to fibroadenomas, adenomas, papillomas or radial scars/complex
sclerosing lesions. The term should be used for cases where there is no
atypia or atypia of only minor degree, insufficient to raise the possibility of
DCIS.
If a diagnosis of atypical ductal hyperplasia (ADH) is contemplated, then
extensive sampling should be undertaken to search for evidence of
unequivocal DCIS with which it frequently co-exists.
ADH is a rare lesion often co-existing with fibrocystic change, a sclerosing
lesion or a papilloma. Its current definition rests on identification of some
but not all features of ductal carcinoma in situ. Most of the difficulties are
encountered in distinguishing ADH from the low grade variants of DCIS.
The main features of low grade DCIS are
I
a uniform population of cells
II
even cellular placements
III
smooth geometric spaces between 'rigid' bars or micropapillary
formations
IV
hyperchromatic nuclei
ADH has some but not all of the features described above. A diagnosis of
DCIS should be reserved for lesions having all these features present in at
least two or more duct spaces.
Table 2 provides more details of features which serve to distinguish ADH
from usual type hyperplasia and ductal carcinoma in situ.
Useful rules of thumb to distinguish atypical ductal hyperplasia from ductal
carcinoma in situ are:
1)
restrict the diagnosis of ADH to cases where the diagnosis of DCIS
is seriously considered but in which the features are not sufficiently
developed for a confident diagnosis.
2)
DCIS usually extends to involve multiple duct spaces and is rarely
under 2-3mm in extent. In any lesion where the process with the
above features extends widely, a diagnosis of atypical ductal
hyperplasia should be questioned.
For further guidance, the reader is referred to Page & Rogers.11
TABLE 2. COMPARISON OF HISTOLOGICAL FEATURES OF DUCTAL HYPERPLASIA AND DCIS*

Histological
features
Usual type ductal

hyperplasia
Atypical ductal hyperplasia
Low nuclear grade DCIS
Size
Variable size but rarely

extensive unless associated
with other benign processes
such as papilloma or radial
scar
Usually small (less than 23mm) unless associated with

other benign processes such
as papilloma or radial scar
Rarely less than 2-3mm an

may be very extensive
Cellular
composition
Mixed. Epithelial cells and

spindle-shaped cells**
present. Lymphocytes and
macrophages may also be
present. Myoepithelial
hyperplasia may occur
around the periphery
May be uniform single

population but merges with
areas of usual type
hyperplasia within the same
duct space. Spindle-shaped
cells may be intermingled
with the proliferating cells
Single cell population.

Spindle-shaped cells not
seen. Myoepithelial cells
usually in normal location
around duct periphery but
may be attenuated
Architecture
Variable
Micropapillary, cribriform or
solid patterns but may be
rudimentary
Well developed micropapillary cribriform orso

patterns
Lumina
Irregular, often ill-defined

peripheral slit-like spaces
are common and a useful
distinguishing feature
May be distinct, well formed

rounded spaces in cribriform
type. Irregular, ill-defined
lumina may also be present
Well delineated, regular

punched out lumina in
cribriform type
Cell orientation
Often streaming pattern with

long axes of nuclei arranged
parallel to direction of
cellular bridges which often
have a tapering' appearance
Cell nuclei may be at right

angles to bridges in cribriform
types, forming 'rigid'
structures
Micropapillary structures
with indiscernible fibrovascular cores or smootl
well-delineated geometri
spaces. Cell bridges 'rigi
in cribriform type with
nuclei orientated toward;
the luminal space
Nuclear spacing
Uneven
May be even or uneven
Even
Epithelial/tumour
cell character
Small ovoid but showing

variation in shape
Small uniform or medium

sized monotonous cell
populations present at least
focally
Small uniform
monotonous cell
population
Nucleoli
Indistinct
Single small
Single small
Mitoses
Infrequent with no abnormal

forms
Infrequent, abnormal forms

rare
Infrequent, abnormal form:

rare
Necrosis
Rare
Rare
If present, confined to sma

particulate debris in
cribriform and/or luminal
spaces
Major diagnostic features are shown in bold type.

* See Page & Rogers11
**These cells are usually called myoepithelial cells but immunohistological studies have shown that they have characte
of basal keratin type epithelial cells12
II - C - 1 3
Present with
atypia (lobular)
This change is characterized by proliferation within terminal duct lobular

units of characteristic small rounded cells similar to those seen in lobular
carcinoma in situ. The major points of distinction from the latter are
summarized in Table 3. Like the ductal variety, atypical lobular hyperplasia
occurs in about 2% of non-cancer containing biopsies from unscreened
women.
TABLE 3. DISTINCTION OF ATYPICAL LOBULAR HYPERPLASIA FROM LOBULAR CARCINOMA IN

SITU
Histological features
Atypical lobular hyperplasia
Lobular carcinoma in situ
Cellular composition
Polymorphic. Cells similar to

those seen in LCIS
accompanied by spindleshaped cells, leucocytes and
other epithelial cells
Monomorphic proliferation of
chracteristic small rounded
cells with granular or
hyperchromatic nuclei,
inconspicuous nucleoli and
high nucleo-cytoplasmic ratio
Cell cohesion
Usually good
Often poor
Cell spacing
Irregular
Regular
Luminal occlusion
Partial
Complete
Lobular distension
Slight
Moderate to marked
Pagetoid spread into

interlobular ducts
Very uncommon
Common
NB: All the features of a lesion should be taken into account when making a
diagnosis. No criterion is reliable alone.
II - C - 14
Classifying Malignant Non-Invasive Lesions

Ductal carcinoma
in situ
Ductal carcinoma in situ (DCIS) is defined as a proliferation of epithelial

cells with cytological features of malignancy within parenchymal structures
of the breast and is distinguished from invasive carcinoma by the absence
of stromal invasion across the basement membrane.
DCIS varies in cell type, growth pattern and extent of disease and may thus
represent a group or spectrum of related in situ neoplastic processes.
Classification has traditionally been according to growth pattern but has
been carried out with little enthusiasm given a perceived lack of clinical
relevance. More recently, evidence has emerged that lesions composed of
cells of high nuclear grade are more aggressive.13,14 There is currently no
generally accepted method of classifying DCIS but distinction between
common histological subtypes is of value for correlating pathological and
radiological appearances, improving diagnostic consistency, assessing the
likelihood of invasion and determining the probability of recurrence after
local excision. Despite the name, most DCIS is generally considered to
arise from the terminal duct lobular units. The main points of distinction from
lobular carcinoma in situ are summarized in Table 4.
For measurement of size see p. 19.
The nuclear grading system adopted below is derived from that employed
by Hollandetal.15.

This is composed of cells with pleomorphic, irregularly-spaced and usually
large nuclei exhibiting marked variation in size, irregular nuclear contours,
coarse chromatin and prominent nucleoli. Mitoses are frequently present
and abnormal forms may be seen.
High nuclear grade DCIS may exhibit several different growth patterns. It
is often solid with central, comedo-type necrosis which frequently contains
deposits of amorphous calcification. This is the easiest pattern to recognize.
Sometimes a solid proliferation of malignant cells fills the duct without
necrosis but this is relatively rare and is usually confined to nipple ducts in
cases presenting with Paget's disease. High nuclear grade DCIS may also
exhibit micropapillary and cribriform patterns frequently associated with
central, comedo-like necrosis. Unlike low nuclear grade DCIS, there is
rarely any polarization of cells covering the micropapillae or lining the
intercellular spaces.

This is composed of monomorphic, evenly-spaced cells with roughly
spherical, centrally-placed nuclei and inconspicuous nucleoli. The nuclei are
usually, but not invariably, small. Mitoses are few and there is rarely
individual cell necrosis.
The cells are generally arranged in micropapillary and cribriform patterns
which are frequently present within the same lesion, although the latter is
more common and tends to predominate. There is usually polarization of
cells covering the micropapillae or lining the intercellular lumina. Less
frequently, low nuclear grade DCIS has a solid growth pattern. When
terminal duct lobular units are involved, the process can be very difficult to
distinguish from lobular carcinoma in situ. Features in favour of DCIS are
II - C - 15
greater cellular cohesion and lack of intracytoplasmic lumina. Occasionally,

however, there may be a combination of both processes.

Some cases of DCIS cannot be assigned easily to the high or low nuclear
grade categories. The nuclei show mild to moderate pleomorphism which
is less than that seen in high grade DCIS but they lack the monotony of the
small cell type. The nucleus:cytoplasm ratio is often high and one or two
nucleoli may be identified.
The growth pattern may be solid, cribriform or micropapillary and the
cells usually exhibit some degree of polarization covering papillary
processes or lining intercellular lumina although this is not as marked as in
low nuclear grade DCIS.
Mixed Types
A proportion of cases of DCIS exhibit features of more than one histological
subtype. One of the advantages of classifying DCIS according to nuclear
grade is that, although variations of growth pattern are frequent, there is
usually a dominant cell type and the lesion is fairly easily classified into one
of the above main groups.
Rarely, cells of different nuclear grade may be seen within a single lesion.
This should be recorded but the case should be classified according to
the highest nuclear grade observed.
Lobular carcinoma
in situ
I I - C - 16

The main features of encysted papillary carcinoma are listed in Table 1
(see p. 9 ).
Ductal carcinoma in situ of signet ring cell, pure apocrine cell, cystic
hypersecretory and neuroendocrine types have been described and may
be classified separately. For further details of these rare variants, the
reader is referred to recent standard textbooks of breast pathology.
The histological features of lobular carcinoma in situ are compared with
those of atypical lobular hyperplasia in Table 3 and with ductal carcinoma
in situ in Table 4. To maximize consistency of diagnosis, it is recommended
that the term lobular carcinoma in situ be used when the characteristic
uniform cells comprise the entire population of the lobular units, that there
are no residual lumina and that there is expansion and/or distortion of at
least one half the acini in the lobule. Otherwise the lesion should be
classified as atypical lobular hyperplasia.
TABLE 4. DISTINCTION OF DUCTAL FROM LOBULAR CARCINOMA IN SITU

Histological features
Ductal carcinoma in situ
Lobular carcinoma in situ
Cells
Variable, depending on nuclear grade

(see p. 15)
Small, rounded with granular or

hyperchromatic nuclei,
inconspicuous nucleoli and high
nucleo-cytoplasmic ratio
Intracytoplasmic lumina
Rare
Common
Growth pattern
Very variable, e.g. solid, comedo, papillary,

cribriform
Diffuse monotonous with

complete luminal obliteration
Cell cohesion
Usually good
Usually poor
Degree of distension of
involved structures
Moderate to great
Slight to moderate
Pagetoid spread into

interlobular ducts
Absent
Often present
Necrosis
Common with high nuclear grade, uncommon

with low nuclear grade
Absent
Mitoses
Common with high nuclear grade, uncommon

with low nuclear grade
Infrequent
Abnormal mitoses
Common with high nuclear grade, rare with

low nuclear grade
Rare
Calcification
Common
Rare
NB: All the features of a lesion should be taken into account when making a diagnosis. No criterion is reliable alom
Paget's disease
In this condition, there are adenocarcinoma cells within the epidermis of the
nipple. Cases where there is direct epidermal invasion by tumour infiltrating
the skin should be excluded. Paget's disease should be recorded
regardless of whether or not an underlying in situ or invasive carcinoma is
identified. The underlying carcinoma should be recorded separately.
A microinvasive carcinoma is defined for the purposes of the reporting form
as a tumour in which the dominant lesion is DCIS but in which there are one
or more clearly separate foci of infiltration of non-specialized interlobular or
interductal fibrous or adipose tissue, none measuring more than 1 mm (about
2 hpf - see later) in maximal diameter. This definition is very restrictive and
tumours fulfilling the criteria are consequently very rare. If there is sufficient
doubt about the presence of invasion, the case should be classified as
DCIS. Where the evidence is equivocal, tick the 'Microinvasion - Possible'
box on the reporting form. Possible microinvasion includes separate islands
of appropriately abnormal epithelium which are embedded in periductal
fibrosis or inflammation, where the true boundary of the specialized
periductal or lobular stroma is not clear. The term 'possible' microinvasion
completely excludes merely ultrastructural evidence of basement membrane
breach, histochemical or immunohistochemically identified basement
membrane discontinuities and lesions in which there is demonstrable
continuity in a 5pm section with the parent DCIS. Microinvasion is largely
restricted to high nuclear grade types of DCIS, mainly of comedo type.
Cases of apparently pure comedo DCIS should thus be extensively sampled
II - C - 17
to exclude invasion. Microinvasive carcinomas should likewise be

extensively sampled in order to exclude the possibility of larger invasive foci.
Where such foci are found, the lesion should be classified as an invasive
carcinoma and the approximate number and size range of the invasive foci
stated under 'Comments/Additional Information'. Small invasive carcinomas
without an in situ component are classified as invasive.
'Ductal' - no specific
type (Ductal-NST)
Infiltrating lobular
carcinoma
Tubular carcinoma
(including cribriform
carcinoma)
Medullary carcinoma
II - C - 18
Typing invasive carcinomas has established prognostic value.16,17 Some

caution should be exercised in typing carcinomas in inadequately fixed
specimens or if they have been removed from patients who have been
treated primarily by chemotherapy or radiotherapy. The more common
types are described below.
This group contains infiltrating carcinomas which cannot be entered into any
type other category on the form, or classified as any of the less common
variants of infiltrating breast carcinoma. Consequently, invasive ductal
carcinomas exhibit great variation in appearance and are the most common
carcinomas, accounting for up to 75% in most series.
Infiltrating lobular carcinoma is composed of small regular cells identical to
those seen in the in situ form. In its classical form, the cells are dissociated
from each other or form single files or targetoid patterns around uninvolved
ducts. Several variants have been identified in addition to this classical form
but in each case the cell type is the same:
a)
the alveolar variant exhibits small aggregates of 20 or more cells;18
the solid variant consists of sheets of cells with little stroma;19
b)
the tubulo-lobular type exhibits microtubular formation as part of
c)
the classical pattern.20
Tumours that show mixtures of typical tubular and classical lobular
carcinoma should be classified as mixed (see below),
the pleomorphic variant is uncommon and exhibits the growth
d)
pattern of classical lobular carcinoma throughout but the cytological
appearances are more pleomorphic.
Mixtures of above.
e)
At least 90% of the tumour should exhibit one or more of the above patterns
to be classified as infiltrating lobular.
Tubular carcinomas are composed of round, ovoid, or angulated single
layered tubules in a cellular fibrous or fibro-elastotic stroma. The neoplastic
cells are small, uniform and may show cytoplasmic apical snouting. At least
90% of the tumour should exhibit the classical growth pattern to be classified
as tubular. If the co-existent carcinoma is solely of the invasive cribriform
type, however, then the tumour should be typed as tubular if the tubular
pattern forms over 50% of the lesion.
Invasive cribriform carcinoma is composed of masses of small
regular cells similar to those seen in tubular carcinoma. The invasive
islands, however, exhibit a cribriform rather than a tubular appearance.
Apical snouting is often present. More than 90% of the lesion should exhibit
the cribriform appearance except in cases where the only co-existent
pattern is tubular carcinoma when over 50% must be of the cribriform
appearance in order to be so classified. If a diagnosis of cribriform
carcinoma is preferred, then tick the 'tubular' box and make the appropriate
comment under 'Comments/ Additional Information'.
These rare tumours are composed of syncytial interconnecting masses of
large pleomorphic cells with vesicular nuclei and prominent nucleoli; they
are of histological grade 3. The stroma may be sparse but always contains
large numbers of lymphoid cells. The border of the tumour is well-defined.
The whole tumour must exhibit these features to be typed as medullary.
Surrounding in situ elements are very uncommon.
The term atypical medullary carcinoma may be specified under 'other
primary carcinoma' for lesions which do not fulfil all the criteria for medullary
carcinoma. The atypical medullary group has been defined by both Fisher
et al.21 and Ridolfi et al.22 These tumours show less lymphoid infiltration,
less circumscription or areas of dense fibrosis while still having the other
features of a medullary carcinoma. A well circumscribed tumour is also
classified as atypical medullary if up to 25% is composed of 'ductal' type
and the rest comprises classical medullary carcinoma. If in doubt, classify
as 'Ductal-NST'.
Mucinous carcinoma
Mixed tumours
Other primary
carcinoma
Other malignant
tumour
Not assessable
This type is also known as mucoid, gelatinous or colloid carcinoma. There

are islands of uniform small cells in lakes of extracellular mucin. An in situ
component is uncommon. At least 90% of the tumour must exhibit the
mucinous appearance to be so classified.
Tubular or cribriform mixed carcinomas have a usually central tubular or
cribriform zone, which amounts to 75-90% of the area, with a ductal-NST or
infiltrating lobular component usually at the periphery accounting for the
remainder.23 Such tumours have a good prognosis but less so than the pure
types. The mixed NST and mucinous carcinomas include any mixtures of
mucinous with ductal NST where the former accounts for 10-90%. In mixed
NST and lobular carcinomas distinct and separate ductal NST and lobular
elements must be present; the former occupies between 10% and 90% of
the tumour area. These tumours are regarded as biphasic and are distinct
from mixed and pleomorphic lobular carcinomas (see above). Mixtures of
NST and specific types not listed on the form should be classified as 'other
primary carcinoma'.
Other primary breast carcinomas should be entered under this heading and
will include variants such as atypical medullary, spindle cell, infiltrating
papillary, argyrophil, secretory, apocrine, etc.
Please include non-epithelial tumours and secondary carcinomas in this
category. For purposes of convenience, all high grade phyllodes tumours
should be recorded here.
This category should be ticked only if an invasive carcinoma cannot be
assigned to any of the previous groups for technical reasons, e.g. the
specimen is too small or poorly preserved.
Recording Prognostic Data

Maximum diameter
All lesions should be measured in the fresh or fixed state and on the
histological preparation. If the two measurements are discrepant then that
obtained from histological examination should be recorded where tumours
are small enough to be visualized in cross-section. This may give a small
underestimation of size due to shrinkage of the tissue in processing. It is
considered, however, that the slight but consistent underestimation in the
size of all tumours is preferable to the larger and less predictable errors that
may result from measuring poorly delineated tumours macroscopically.
Clearly, sufficient blocks should be taken from the periphery of larger
II-c
tumours to allow accurate estimates of their size to be made from combined

histological and macroscopic examination. The largest dimension should
be recorded to the nearest millimetre.
For non-invasive carcinomas, the maximum diameter should be entered in
the 'Non-Invasive' section only where the tumour is of ductal type; lobular
carcinoma in situ is not measured. For invasive carcinomas, the invasive
component only needs to be recorded unless accompanying ductal
carcinoma in situ extends more than 1mm beyond the periphery of the
infiltrative component, when the size of the infiltrative component and the
overall size should be stated in the appropriate spaces of this section. This
is to allow the identification of invasive carcinomas, where the in situ
component forms a significant proportion of the lesion and may be important
in determining the risk of recurrence after local excision. The largest
dimension, to the nearest millimetre, is recorded in each case. The
diagrams below illustrate whole and invasive tumour measurements in a
variety of circumstances. Foci of lymphatic and blood vascular invasion are
not included in the whole tumour measurement.
aae
Invasive Tumours
= Ductal Carcinoma in Situ
I = Invasive Tumour Measurement

W = Whole Tumour Measurement
In E the satellite focus of invasive tumour is not included in the measurement

In F the best estimate of the total size of the invasive components is given
II - C - 20
Lymph nodes
Excision
Grade
If a carcinoma (either infiltrative or ductal in situ) is insufficiently delineated

to measure reliably, make an appropriate comment in the
'Comments/Additional Information' section and give an approximate estimate
of the maximum dimension of the area over which the changes extend. It
may be necessary to use combined histological, macroscopic and
radiological information to make a reliable estimate.
All lymph nodes should be examined histologically.
The use of
immunohistology is most appropriate in cases where there is doubt about the
presence of small metastases. The clinical relevance of metastases detected
solely by this means remains controversial. Please record data from axillary
nodes separately from nodes from other sites.
The presence of
extracapsular spread can be noted under 'Comments/Additional Information'.
For infiltrative tumours, the distance from the nearest resection margin should
be recorded and checked from the histological sections. Other margins can
be reported if required. This normally refers to the infiltrative component but,
if associated ductal carcinoma in situ extends nearer to the margin than the
infiltrative component, then enter its distance from the margin and state in the
'Comments' section that this measurement refers to the in situ component.
The information should be related to orientation markers if used.
For pure ductal carcinoma in situ, the distance from the nearest excision
margin should be recorded if the lesion is sufficiently delineated. If not, make
a comment under 'Comments/Additional Information'. The presence of non
neoplastic breast parenchyma between the DCIS and the margin is usually
associated with adequate excision. The specimen radiograph is also a useful
adjunct in assessing surgical clearance. In cases where the adequacy of
excision is uncertain, please tick the relevant box and state the reason for
uncertainty under 'Comments/Additional Information'.
See earlier for guidance on macroscopic examination.
Grading can provide powerful prognostic information. It requires some
commitment and strict adherence to a recommended protocol. The following
protocol is based on that described by Elston & Ellis.24 The method involves
the assessment of three components of tumour morphology: tubule
formation, nuclear pleomorphism and frequency of mitoses. Each is scored
from 1-3. Adding the scores gives the overall histological grade as shown
below.
Tubule
1)
2)
3)
formation
majority of tumour (greater than 75%)
moderate amount (10-75%)
little or none (less than 10%)
Nuclear pleomorphism
1)
nuclei small, with little increase in size in comparison with normal
breast epithelial cells, regular outlines, uniform nuclear chromatin,
little variation in size.
2)
cells larger than normal with open vesicular nuclei, visible nucleoli
and moderate variability in both size and shape.
3)
vesicular nuclei, often with prominent nucleoli, exhibiting marked
variation in size and shape, occasionally with very large and bizarre
forms.
II - C - 21
Mitoses
The size of high power fields is very variable and hence it is necessary to
standardize the mitotic count using the graph below. In order to determine
the mitotic count for an individual microscope, the following procedure should
be adopted:
Graph of mitotic counts by field diameter
Mitotic count
28
26
24
22
20
18
16
14
12
10
8
6
4
2
0
CQI
Seo-2
0.44
0.46
0.48
1.
2.
3.
4.
0.50
0.52
S^oreh

0.54
0.56
i'-
0.58
i
i
i
:
I
;
'
;
0.60
0.62
Field diameter
measure the field diameter of the microscope with a graticule.

plot this value on the vertical axis of the graph.
draw a vertical line at this value.
read off the value a on the horizontal axis where the line intersects
the lower bold line.
5.
read of the value b on the horizontal axis where the line intersects
the upper bold line.
6.
the count is then
Score Count
3
>b
2
between a+1 and b
1
Oto a
For example, for a field diameter of 0.48, a=6, b=12 from graph - therefore
Score 3 = >12 mitoses/1 Ohpf
Score 2 = 7-12 mitoses/1 Ohpf
Score 1 = 0-6 mitoses/1 Ohpf
This needs to be done only once for each microscope.
n - c - 22
Disease extent
Vascular invasion
Overall grade
The scores for tubule formation, nuclear pleomorphism and mitoses are then
added together and assigned to grades as below:
Grade 1 = score 3-5
Grade 2 = score 6-7
Grade 3 = score 8-9
It is recommended that grading is not restricted to invasive carcinoma NST
but is undertaken on all histological subtypes. There are two major reasons
for this recommendation:
1) there are occasionally problems in deciding whether to classify a tumour
as NST or some other type
2) there may be significant variation within certain subtypes, e.g. invasive
lobular carcinoma.
Tick 'Not assessable' if for any reason the grade cannot be determined,
e.g. specimen poorly preserved or too small.
It must be clearly stated if a grading system other than that described above
is used.
The term 'localized' is used to describe a single focus of tumour with
defined borderlines of any size. It should also be used where the exent of
the tumour cannot accurately be defined although all of it appears to be part
of a single lesion.
The term 'multiple' is used to describe multiple foci of in situ or infiltrating
carcinoma which are widely separated (at least 40mm) and present in
quadrants or segments other than that of the main tumour. 'Multiple' is
preferred to 'multifocal' or 'multicentric' as there is currently a lack of
agreement on how these terms should be used.
Tick 'Not assessable' if the extent of the disease cannot be determined or
if it is not clear whether the tumour is localized or multiple.
The presence of unequivocal tumour in vascular spaces should be recorded.
If there is doubt about diagnosing vascular invasion, please tick the 'not
seen' box. The difficulty in identifying small blood vessels as blood or
lymphatic precludes accurate recording of their type and specification of
lymphatic or venous invasion is not required. Ideally, a clear rim of
endothelium should be identified around the tumour before vascular invasion
is recorded. The use of immunostaining for endothelial markers may be
helpful in confirming vascular invasion in difficult cases but is not
recommended on a routine basis. Morphological features which may be
helpful when diagnosing vascular invasion are:
1)
Comments/
Additional
information
clumps of tumour in spaces outside the main tumour mass are more
likely to indicate vascular invasion.
2)
nests of tumour separated from the stroma by shrinkage artefact
usually conform better to the shape of the space in which they lie.
3)
the proximity of larger veins and arteries in the diagnosis of
lymphatic invasion.
4)
the presence within the space of erythrocytes and/or thrombus.
Any relevant additional information may be entered here as free text.
Please also state if any further special investigations have been undertaken,
e.g. steroid hormone receptor determination, oncogene analysis, etc.
II-C-23
Histological
diagnosis
If normal, tick the normal box and do not complete the rest of the form.
'Normal' includes minimal alterations such as fibrosis and microscopic
dilatation of acini or ducts, lobular involution and enlargement and blunt duct
adenosis.
If malignant and benign changes are found, tick only the malignant box.
Tick the benign box when the breast is neither normal nor exhibits
malignancy.
References
1.
Andersen J, Poulsen HS. Immunohistochemical oestrogen receptor determination in paraffinembedded tissue: prediction of response to hormonal treatment in advanced breast cancer.
Cancer 1989;64:1901-1908.
2.
Snead DRJ, Bell JA, Dixon AR, Nicholson RI, Elston CW, Blarney RW, Ellis IO. Methodology of
immunohistological detection of oestrogen receptor in human breast carcinoma in formalin-fixed,
paraffin-embedded tissue: a comparison with frozen section methodology. Histopathology
1993;23:233-238.
3.
Anderson TJ. Breast cancer screening: principles and practicalities for histopathologists. Recent
Advances in Histopathology No. 14, 43-61, Churchill Livingstone 1989.
4.
Armstrong JS, Davies JD. Laboratory handling of impalpable breast lesions: A review. J. Clin.
Pathol. 1991;44:89-93.
5.
Department of Health Medical Devices Directorate. Evaluation of specimen radiography cabinets:

reports and guidance notes. Blue book (MDD/91/13) London: Department of Health, 1991, 1-33
and 1-13.
6.
Schnitt SJ, Wang HH. Histologic sampling of grossly benign breast biopsies: how much is enough?
Am J Surg Pathol 1989;13:505-512.
7.
Gad A. Pathology in breast cancer screening: A 15-year experience from a Swedish programme.
In: Breast Cancer Screening in Europe. A. Gad & M. Rosselli del Turco (eds), Springer-Verlag
1993,87-101.
8.
Frappait L, Boudeulle M, Boumendil J et al. Structure and composition of microcalcifications in

benign and malignant lesions of the breast. Human Pathol 1984;15:880-889.
9.
Nielsen BB. Adenosis tumour of the breast - a clinicopathological investigation of 27 cases.

Histopathology 1987;11:1259-1275.
10.
Simpson JF, Page DL, Dupont WD. Apocrine adenosis: a mimic of mammary carcinoma. Surg
Pathol 1990;3:289-299.
11.
Page DL, Rogers LW. Combined histologic and cytologic criteria for the diagnosis of mammary
atypical ductal hyperplasia. Human Pathol 1992, 23, 1095-1097.
II - C - 24
12.
Bcker W, Bier B, Freytag G, Brmmelkamp B, Jarasch E-D, Edel G, Dockhorn-Dworniczak B,

Schmid KW. An immunohistochemical study of the breast using antibodies to basal and luminal
keratins, alpha-smooth muscle actin, vimentin, collagen IV and laminin. Part I: normal breast and
benign proliferative lesions. Virchows Archiv A Pathol Anat 1992;421:315-322.
13.
Lagios MD. Duct carcinoma in situ. Surg Clin N Am 1990, 70, 853-871.
14.
Bellamy COC, McDonald C, Salter DM, Chetty U, Anderson TJ. Noninvasive ductal carcinoma of
the breast: the relevance of histologic categorization. Human Pathol 1993;24:16-23.
15.
Holland R, Peterse JL, Millis RR, Eusebi V, Faverly D, van de Vijver MJ, Zafrani B. Ductal
carcinoma in situ: a proposal fora new classification. Semin Diagn Pathol 1994;11:167-180.
16.
Page DL, Anderson TJ. Diagnostic Histopathology of the Breast, 1987, pp. 193-268. Churchill
Livingstone, Edinburgh, London, Melbourne and New York.
17.
Ellis IO, Galea M, Broughton N, Locker A, Blarney RW, Elston CW. Pathological prognostic factors
in breast cancer. II. Histological type. Relationship with survival in a large study with long term
follow-up. Histopathology 1992;20:479-489.
18.
Martinez V, Azzopardi JG. Invasive lobular carcinoma of the breast: incidence and variants.
Histopathology 1979;3:467-488.
19.
Fechner RE. Histologic variants of infiltrating lobular carcinoma of the breast. Human Pathol
1975;6:373-378.
20.
Fisher ER, Gregorio RM, Redmond C, Fisher B. Tubulolobular invasive breast cancer: a variant
of lobular invasive cancer. Human Pathol 1977;8:679-683.
21.
Fisher ER, Gregorio RM, Fisher B, Redmond C, Vellios F, Sommers SC and co-operating
investigators. The pathology of invasive breast cancer: a syllabus derived from findings of the
National Surgical Adjuvant Breast Project (Protocol No 4). Cancer 1975;36:1-84.
22.
Ridolfi RL, Rosen PP, Port A, Kinne D, Mike V. Medullary carcinoma of the breast: a
clinicopathologic study with 10-year follow-up. Cancer 1977;40:1365-1385.
23.
Pari FF, Richardson LD. The histological and biological spectrum of tubular carcinoma of the
breast. Human Pathol 1983;14:694-698.
24.
Elston CW, Ellis IO. Pathological prognostic factors in breast cancer. I. The value of histological
grade in breast cancer: experience from a large study with long term follow up. Histopathology
1991;19:403-410.
II - C - 25
Index for screening office pathology s y s t e m

Term
A
Abscess
Adenocarcinoma (no special type)
Adenoid cystic carcinoma
Adenoma, apocrine
Adenoma intraduct
Adenoma of nipple
Adenoma, pleomorphic
Adenoma, tubular
'Adenomyoepithelioma'
Adenosis, NOS
Adenosis, apocrine
Adenosis, apocrine (atypical)
Adenosis, blunt duct
Adenosis, microglandular
Adenosis, sclerosing
with atypia
Adnexal tumours
Alveolar variant of lobular carcinoma
Aneurysm
Angiosarcoma
Apocrine adenoma
Apocrine adenosis
Apocrine carcinoma (in-situ)
Apocrine carcinoma (invasive)
Apocrine metaplasia
(multilayered/papillary)
Argyrophil carcinoma
Arteritis
Atypical blunt duct adenosis
Place to classify on form

Other benign pathology (specify)
Invasive ductal n.s.t.
Other primary carcinoma (specify)
Enteras papilloma
Fibroadenoma
OR
Histology normal
Epithelial proliferation-atypia (ductal)
Histology normal
Sclerosing adenosis
Atypical ductal hyperplasia

Atypical epitheliosis (ductal)
Atypical lobular hyperplasia
Epithelial proliferation atypia ductal or lobular

Invasive lobular
Other malignant tumour (specify)
Non-invasive malignant, ductal (specify)
Other primary carcinoma (if pure) or ductal n.s.t.
Fibrocystic change
Epithelial proliferation present
Fibrocystic change
Epithelial proliferation-atypia
Epithelial proliferation-atypia (lobular)
B-cell lymphoma
Benign phyllodes tumour
Blunt duct adenosis
Blunt duct adenosis (atypical)
Breast abscess

Histology normal
n - C - 26
Calcification (benign)
Calcification (malignant)
Carcinoma, apocrine (in-situ)
Carcinoma, apocrine (invasive)
Carcinoma, clear cell
Carcinoma, colloid
Carcinoma, comedo-in-situ
Carcinoma, cribriform (in-situ)
Carcinoma, cribriform (invasive)
Carcinoma, ductal in-situ
Carcinoma, lobular in-situ
Carcinoma, lobular (invasive)
Carcinoma, lobular variant
Carcinoma, medullary
Carcinoma, metastatic
Carcinoma, mixed
Carcinoma, mucinous
Carcinoma, papillary
Carcinoma, signet ring
Carcinoma, spindle cell
Carcinoma, squamous
Carcinosarcoma
Cellular fibroadenoma
Clear cell carcinoma
Clear cell hidradenoma
Clear cell metaplasia
Collagenous spherulosis
Comedocarcinoma
Comedocarcinoma invasive
Complex sclerosing lesion
Cribriform carcinoma (in-situ)
Cribriform carcinoma (invasive)
Cyclical menstrual changes
Cyst, epidermoid
Cyst, single
Cyst, multiple
Cystic disease
Cystic mastopathia
Cystic hypersecretory hyperplasia
Cystic hypersecretory carcinoma
Calcification present, benign

Calcification present, malignant
Non-invasive malignant, ductal (specify type)
Other primary carcinoma (if pure) or ductal n.s.t.
Invasive mucinous carcinoma
Invasive tubular or cribriform
Non-invasive malignant, ductal (specify sub-type)
Non-invasive malignant, lobular
Invasive lobular
Invasive lobular
Invasive medullary
Other primary carcinoma (specify types)
Fibroadenoma
Non-invasive malignant, ductal
Complex sclerosing lesion/radial scar
Histology normal
Solitary cyst
Fibrocystic change
Enter components
Enter components
Ductal carcinoma in-situ

Ductal carcinoma invasive
Ductal hyperplasia (regular)
Ductal hyperplasia (atypical)
Duct ectasia
Duct papilloma
Dysplasia, mammary

Epithelial proliferation present without atypia
Epithelial proliferation, atypical (ductal)
Periductal mastitis/duct ectasia
Papilloma, single
Enter components
II - C - 27
Eccrine tumours
Epidermoid cyst
Epitheliosis (regular)
Epitheliosis (atypical)
Epitheliosis (infiltrating)

Epithelial proliferation, atypical (ductal)
Fat necrosis
Fibroadenoma
Fibroadenoma, giant
Fibroadenoma, juvenile
Fibrocystic disease
Fibromatosis
Fistula, mammillary
Focal lactational change
Foreign body reaction
Other benign pathology

Fibroadenoma
Fibroadenoma
Fibroadenoma
Enter components
Histology normal
Galactocoele
Giant fibroadenoma
Glycogen-rich carcinoma
Grading of carcinomas
Granulomatous mastitis

Fibroadenoma
See page
H
Haematoma
Haemangioma
Hamartoma
Hyaline epithelial inclusions
Hyperplasia, ductal (regular)
Hyperplasia, ductal (atypical)
Hyperplasia, lobular (= adenosis)
Hyperplasia, lobular (atypical)

Histology normal
I
Infarct
'Inflammatory carcinoma'
Invasive carcinoma
Invasive comedocarcinoma
Involution

Specify by type (usually ductal n.s.t.)
Specify by type
Histology normal
Juvenile fibroadenoma
Juvenile papillomatosis
Fibroadenoma
n - c - 28
(specify)
(specify)
(specify)
(specify)
L
Lactation
Lactational change, focal
Lipoma
Lipid-rich carcinoma
Lobular carcinoma in-situ
Lobular carcinoma invasive
Lobular hyperplasia (= adenosis)
Lobular hyperplasia (atypical)
Lymphoma
M
Malignant phyllodes tumour
Mammary duct ectasia
Mammillary fistula
Mastitis, acute
Mastitis, granulomatous
Mastitis, plasma cell
Mastopathia, cystic
Medullary carcinoma
Menopausal changes
Metaplasia, apocrine (single layer)
Metaplasia, apocrine
(multilayered/papillary)
Metaplasia, clear cell
Metaplasia, mucoid
Metaplasia, squamous
Metastatic lesion
Microcysts
Microglandular adenosis
Microinvasive carcinoma
Micropapillary change
Mixed carcinoma
Mondar's disease
Mucinous carcinoma
Mucoele-like lesion
Mucoid metaplasia
Multiple papilloma syndrome
Multiple papilloma
syndrome with atypia
Myoepithelial hyperplasia
N
Necrosis, fat
Nipple adenoma
Nipple - Paget's disease
Normal breast
Histology normal
Histology normal
Non-invasive malignant, lobular
Invasive lobular
Histology normal
Enter components
Invasive medullary
Histology normal
Fibrocystic change
Fibrocystic change
Histology normal
Code by in-situ component and specify
microinvasion present
Other primary carcinoma (specify types)
Papilloma, multiple
Papilloma, multiple

Non-invasive malignant Paget's disease
Histology normal
II - C - 29
Paget's disease of nipple

Non-invasive malignant, Paget's disease
Panniculitis
Papillary carcinoma (in-situ)
Papillary carcinoma (invasive)
Papilloma, duct
Papillomatosis
Papillomatosis, juvenile
Papillomatosis, sclerosing
Phyllodes tumour (low grade)
Phyllodes tumour (high grade)
Pregnancy changes
Non-invasive malignant, Paget's disease

Papilloma
Epithelial proliferation (with or without atypia)
Specify under other benign pathology as adenoma
of nipple
Histology normal
R
Radial scar
Regular hyperplasia

Sarcoidosis
Sarcoma
Sclerosing adenosis
Sclerosing adenosis
with atypia
Sclerosing subareolar proliferation
Squamous carcinoma
Squamous metaplasia
Spindle cell carcinoma
Scar, radial

Sclerosing adenosis
Sclerosing adenosis
Epithelial proliferation-atypia
Specify under other benign pathology as adenoma
of nipple
Invasive malignant, other (specify)
Invasive malignant, other (specify)
Trauma
Tuberculosis
Tubular adenoma
Tubular carcinoma

Fibrodenoma
Invasive malignant, tubular or cribriform
W
Wegener's granulomatosis
II-C-30

Chairman: Prof. J.P. Sloane, University of Liverpool, United Kingdom.
Dr. I. Amendoeira, Institute of Molecular Pathology and Immunology of the University of Porto,
Porto, Portugal.
Dr. N. Apostolikas, Hellenic Anticancer Institute, Athens, Greece.
Professor J.P. Bellocq, Hpital de Hautepierre, Strasbourg, France.
Dr. S. Bianchi, Italian Breast Screening Programme and Istituto di Anatomia e Istologia Patologica,
Firenze, Italy.
Professor W. Bcker, Gerhard-Domagk-Institut fr Pathologie, Mnster, Germany.
Professor G. Bussolati, Istituto di Anatomia e Istologia Patologica, Torino, Italy.
Dr. CE. Connolly, Associate Professor of Pathology, University Colige Hospital, Galway, Ireland.
Dr. C. De Miguel, Hospital Virgen del Camino, Pamplona, Spain.
Professor P. Dervan, The Eccles Breast Screening Project, Mater Hospital and University College, Dublin,
Ireland.
Dr. R. Drijkoningen, Pathologische Ontleedkunde 1, Leuven, Belgium.
Dr. CW. Elston, City Hospital, Nottingham, United Kingdom.
Dr. D. Faverly, Projet Bruxellois de Dpistage du Cancer du Sein and CM.P. Laboratory, Bruxelles,
Belgium.
Dr. A. Gad, Falun Hospital, Falun, Sweden.
Dr. R. Holland, National Expert and Training Centre for Breast Cancer Screening, Nijmegen, The
Netherlands.
Dr. J. Jacquemier, Institut Paoli Calmette and Breast Histological Registry, Marseille, France.
Dr. M. Lacerda, Centro de Oncologia de Coimbra, Coimbra, Portugal.
Dr. A. Lindgren, University Hospital, Uppsala, Sweden.
Dr. J. Martinez-Peuela, Hospital de Navarra, Pamplona, Spain.
Dr. J.L. Peterse, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Dr. F. Rank, Bispebjerg Hospital and Danish Cancer Society, Copenhagen, Denmark.
Dr. V. Tsakraklides, Hygeia Hospital, Athens, Greece.
Dr. C de Wolf, European Commission, Luxembourg.
Dr. B. Zafrani, Institut Curie, Paris, France.
II - C - 31
European Protocol for the

QUALITY CONTROL
of the Physical and Technical Aspects
of Mammography Screening
Appendix to
"European Guidelines for Quality Assurance

in Mammography Screening"
JUNE 1996
EUROPEAN COMMISSION
Europe Against Cancer Programme Radiation Protection Actions
The European Protocol for the

Quality Control of the Physical and Technical Aspects
EUROPEAN COMMISSION
DG V F.2 Europe Against Cancer

DG XI C.1 Radiation Protection Actions
DG XII F.6 Radiation Protection Actions
Authors:
Martin A.O. Thijssen, Nijmegen NL
Kenneth C. Young, Guildford UK
Sander van Woudenberg, Nijmegen NL
Revisors:
KR. Bijkerk, Nijmegen, NL
A. Ferro de Carvalho, Lisbon,
M. Fitzgerald, London, UK
A. Flioni-Vyza, Athens, GR
R. Van Loon, Brussels, BE
revision: JUNE 1996
In collaboration with the

Study Group on Quality Control in Mammography:
D.R. Dance, London UK
A. Ferro de Carvalho, Lisbon,
A. Flioni Vyza, Athens, GR
M. Gambaccinl, Ferrara, I
W. Leltz, Stockholm, S
C. Maccia, Cachan, F
B.M. Moores, Liverpool, UK

H. Schibilla, Brussels, EC
F.E. Stieve, Neuherberg, D
D.H.A.P. Teunen, Luxembourg, EC
M.A.O. Thijssen, Nijmegen, NL
E. Vano, Madrid, E
J. Zoetelief, Rijswijk, NL
This document is the first revision of chapter 4, "Technical Aspects" in the "European Guidelines for
Quality Assurance in Mammography Screening", published in 1993 (EUR 14821, ISSN 1018-5593).
Original authors: Johan M. Lindeijer, NL t . Remko Bijkerk, NL Martin A. O. Thijssen, NL
Contents
D- THE EUROPEAN PROTOCOL FOR THE QUALITY CONTROL OF THE PHYSICAL AND TECHNICAL
ASPECTS OF MAMMOGRAPHY SCREENING
Executive summary
1. Introduction to the measurements
Description of the measurements
2.1.1 X-ray source
Focal spot size
Radiation leakage
Tube output
2.1.2 Tube voltage
Half Value Layer
2.1.3 AEC-system
Guard timer
2.1.4 Compression
Compression force
Grid system factor
Grid imaging
2.2.2 Screen-film
Inter cassette sensitivity and attenuation variation
Screen-film contact
2.3 Film processing
Temperature
Processing time
Sensitometry
Daily performance
Artifacts
2.3.3 Darkroom
Light leakage
Safelights
Film hopper
Cassettes
D-1
D-3
-D
I -D
I -D
I -D
I -D
I -D
I -D
I -D-7
I -D-7
I -D-7
I -D-7
I -D-8
I -D-8
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2.4 Viewing conditions

2.4.1 Viewing box
Luminance
Homogeneity
2.4.2 Ambient light
Level
2.5 System properties
2.5.1 Dosimetry
2.5.2 Image Quality
Spatial resolution
Image contrast
Exposure time
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3. Daily and weekly QC tests
II - D - 21
4. Definition of terms
II - D - 22
5. Tables
II - D - 26
6. Bibliography
II - D - 29
Appendix 1 : Calculation of film-parameters
II - D - 33
Appendix 2: A method to correct for the film curve
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Appendix 4: Sample Data Sheets
II - D - 37
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T H E E U R O P E A N P R O T O C O L FO R T H E Q U A L I T Y C O N T R O L O F T H E
PHYSICAL AND TECHNICAL ASPECTS O F MAMMO GRAPHY SCREENING

Executive summary
A prerequisite for a successful screening project is that the mammograms contain sufficient diagnostic
information to be able to detect breast cancer, using as low a radiation dose as is reasonably achievable
(ALARA). This quality demand holds for every single mammogram. Quality Control (QC) therefore must
ascertain that the equipment performs at a constant high quality level.
In the framework of "Europe Against Cancer" (EAC), a European approach for mammography screening
is chosen to achieve comparable high quality results for all centres participating in the mammography
screening programme. Within this programme, Quality Assurance (QA) takes into account the medical,
organizational and technical aspects. This section is specifically concerned with the quality control of
physical and technical aspects and the dosimetry.
The intention of this part of the guidelines is to indicate the basic test procedures, dose measurements
and their frequencies. The use of these tests and procedures is essential for ensuring high quality
mammography and comparison between centres. This Document is intended as a minimum standard for
implementation throughout the EC Member States and does not reduce more comprehensive and refined
requirements for QC that are specified in local or national QA Programmes. Therefore some screening
programmes may implement additional procedures.
Quality Control (QC)
Mammography screening should only be performed using modern dedicated X-ray equipment and
appropriate image receptors.
QC of the physical and technical aspects in mammography screening starts with specification and
purchase of the appropriate equipment, meeting accepted standards of performance. Before the system
is put into clinical use, it must undergo acceptance testing to ensure that the performance meets these
standards. This holds for the mammography X-ray equipment, image receptor, film processor and QC test
equipment. After acceptance, the performance of all equipment must be maintained above the minimum
level and at the highest level possible.
The QC of the physical and technical aspects must guarantee that the following objectives are met:
1. The radiologist is provided with images that have the best possible diagnostic information obtainable
when the appropriate radiographic technique is employed. The images should at least contain the
defined acceptable level of information, necessary to detect the smaller lesions (see CEC Document
EUR 16260).
2. The mage quality is stable with respect to information content and optical density and consistent with
that obtained by other participating screening centres.
3. The breast dose is As Low As Reasonably Achievable (ALARA) for the diagnostic information required.
QC Measurements and Freguencies
To attain these objectives, QC measurements should be carried out. E ach measurement should follow
a written QC protocol that is adapted to the specific requirements of local or national QA programmes. The
European Protocol for the Quality Control of the Physical and Technical Aspects of Mammography
Screening gives guidance on individual physical, technical and dose measurements, and their
frequencies, that should be performed as part of mammography screening programmes.
II-D-
Several measurements can be performed by the local staff. The more elaborate measurements should
be undertaken by medical physicists who are trained and experienced in diagnostic radiology and
specifically trained in mammography QC. Comparability and consistency of the results from different
centres is best achieved if data from all measurements, including those performed by local technicians
or radiographers are collected and analyzed centrally.
Image quality and breast dose depend on the equipment used and the radiographic technique employed.
QC should be carried out by monitoring the physical and technical parameters of the mammographie
system and its components. The following components and system parameters should be monitored:
X-ray generator and control system;
Bucky and image receptor;
Film processing;
System properties (including dose);
Viewing conditions
The probability of change and the impact of a change on image quality and on breast dose determine the
frequencies at which the parameters should be measured.
The protocol gives also the basic and desirable limiting values for some QC parameters. The basic values
indicate the minimal performance limits. The desirable values indicate the limits that are achievable. New
equipment must meet the desirable limits. Limiting values are only indicated when consensus on the
measurement method and parameter values has been obtained.
The necessary QC equipment for both the basic and desirable level of QC is listed also, together with the
appropriate tolerances.
Methods of dosimetry are described in the "European Protocol on Dosimetry in Mammography"
(EUR16263). It provides accepted indicators for breast dose, both by measurements on a group of women
and by phantom measurements. The summary of this document is listed in annex.
The first (1992) version of this document (REF: EUR 14821) was produced by a Study Group, selected
from the contractors of the CEC Radiation Protection Actions. This revised (1996) version is based on a
critical review of recent QA and QC literature and includes the experience gained by users of the
document and comments from manufacturers of equipment and film-screen systems (see literature and
reference list, Chapter 6, bibliography). Communication on this protocol can be directed to the EUREF
Coordinating Office, National Expert and Training Centre for Breast Cancer Screening, PO-box 9101, NL6500 HB Nijmegen, The Netherlands, Tel: +31-(0)24-3617515.
II - D - 2
European Guidelines for Q UALITY ASSURANCE in Mammography Screening 2nd edition (JUNE 1996)
1 Introduction to the measurements

This protocol is intended to provide the basic techniques for the quality control (QC) of the physical and
technical aspects of mammography screening. It is based on other existing protocols (see chapter 6,
bibliography) and the experience of groups performing Q C of mammography equipment. Since the
technique of mammographie imaging and the equipment used are constantly improving, the protocol
needs to be updated regularly.
Many measurements are performed using an exposure of a test object or phantom. All measurements are
performed under normal working conditions: no special adjustments of the equipment are necessary.
Two types of exposures need to be mentioned:
- The reference exposure is intended to provide the information of the system under defined
conditions, independent of the clinical settings.
- The routine exposure is intended to provide the information of the system under clinical conditions,
dependent on the settings that are clinically used.
For the production of the reference or routine exposure, a plexiglass phantom is exposed and the machine
settings are as follows (unless otherwise mentioned):
tube voltage
compression device
plexiglass phantom
anti scatter grid
source-to-image distance
phototimer detector
automatic exposure control
optical density control
Reference exposure:
Routine exposure:
28 kV
in contact with phantom
45 mm
present
matching with focused grid
in position closest to chest wall
on, central density step
central position
clinical setting
in contact with phantom
45 mm
present
matching with focused grid
clinical setting
on
clinical setting
The optical density (OD) of the processed image is measured at the reference point, which lies 60 mm
from the chest wall side and laterally centred. The reference optical density is 1.0 OD, base and fog
excluded. Therefore the aim of the measured OD value in the reference point is: 1.0 0.1 + base + fog
(OD). The routine OD may be different.
All measurements should be performed with the same cassette to rule out differences between screens
and cassettes.
Limits of acceptable performance are given, but often a better result would be desirable. Both the
acceptable and desirable limits are given in chapter 5, table 1. Occasionally no limiting value is given, but
only a typical value as an indication.
The measurement frequencies indicated in the table are the minimum required. When problems occur,
additional measurements should be performed to determine the origin of the observed problem and
appropriate actions should be taken to solve the problem.
For guidance on the specific design and operating criteria of suitable test objects; see the Proceedings
of the CEC Workshop on Test Objects (see chapter 6, Bibliography). The definition of terms, like the
reference point and the reference density are given in chapter 4. The evaluation of the results of the QC
measurements can be simplified by using the completion forms provided in appendix 4.
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Staff and equipment

Several measurements can be performed by the local staff. The more elaborate measurements should
be undertaken by medical physicists who are trained and experienced in diagnostic radiology and
specifically trained in mammography QC. Comparability and consistency of the results from different
centres is best achieved if data from all measurements, including those performed by local technicians
or radiographers are collected and analyzed centrally.
The staff conducting the daily/weekly QC-tests will need the following equipment" at the screening site:
-
Sensitometer
Densitometer
Thermometer
PMMA plates**
Daily QC test object
Reference cassette
The medical physics staff conducting the other QC-tests will need the following additional equipment":
- Dosemeter
- kVp-meter
- Exposure time meter
- Light meter
- QC test objects
- Aluminium sheets
- Focal spot test device + stand
- Stopwatch
- Film/screen contact test device
- Tape measure
- Compression force test device
- Rubber foam
- Lead sheet
- Aluminium stepwedge
The specifications of the listed equipment are given, where appropriate, in chapter 5, table 2.
PMMA (polymethylmethacrylate) is commercially available under several brandnames, e.g. Lucite,
plexiglass and perspex.
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2 Description of the measurements

2.1.1 X-ray source
The measurements to determine the focal spot size, source-to-image distance, alignment of X-ray field
and image receptor, radiation leakage and tube output, are described in this section.
Focal spot size

The measurement of the focal spot size is intended to determine its physical dimensions at installation or
when resolution has markedly decreased. For routine quality control the evaluation of spatial resolution
is considered adequate.
The focal spot dimensions can be obtained by using one of the following three methods.
star pattern method; a convenient method (routine testing);
slit camera; a complex, but accurate method for exact dimensions (acceptance testing)
pinhole camera; a complex, but accurate method to determine the shape (acceptance testing)
A magnified X-ray image of the test device is produced using a non-screen cassette. This can be achieved
by placing a black film (OD ;> 3) between screen and film. Select the focal spot size required, 28 kV tube
voltage and a focal spot charge (mAs) to obtain an optical density between 0.8 and 1.4 OD base and fog
excluded (measured in the central area of the image). The device should be imaged at the reference point
of the image plane, which is located at 60 mm from the chest wall side and laterally centred. Remove the
compression device and use the test stand to support the test device. Select about the same focal spot
charge (mAs) that is used to produce the standard image of 45 mm PMMA, which will result in a optical
density of the starpattern image: 0.8<OD<1.4.
According the IEC/NEMA norm, an 0.3 focal spot is limited to a width of 0.45 mm and a length of 0.65 mm.
An 0.4 focal spot is limited to 0.60 and 0.85 mm respectively. No specific limiting value is given here: the
measurement of imaging performance of the focal spot is incorporated in the limits for spatial resolution
at high contrast, (see 2.5.2)
The focal spot dimensions can be estimated from the 'blurring diameter' on the image (magnification
2.5 to 3 times) of the star pattern. The distance between the outermost blurred regions is measured
in two directions: perpendicular and parallel to the tube axis. Position the cassette on top of the bucky
(no grid).
The focal spot is calculated by applying formula 2.1, which can also be found in the completion form.
r
v
1 =
*
180
blur
(2.1)
(Ms(ar-1)
where is the angle of the radiopaque spokes, and Db!ur is the diameter of the blur.
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The magnification factor (Mstar) is determined by measuring the diameter of the star pattern on the
acquired image (D,mage) and the diameter of the device itself (Dstar), directly on the star, and is
calculated by:
Mstar=DmageAtar
Limiting value
Frequency
Equipment
(22)
None
At acceptance and when resolution has changed.
Star resolution pattern (spoke angle 1 orO. 5) and appropriate test stand.

To determine the focal spot dimensions (f) with a slit camera, a 10 pm slit is used. Produce two
magnified images (magnification 2.5 to 3 times) of the slit, perpendicular and parallel to the tube axis.
Remove the compression device and use the test stand to support the slit.
The dimensions of the focal spot are derived by examining and measuring the pair of images
through the magnifying glass. Make a correction for the magnification factor according to f=F/MS|it,
where F is the width of the slit image. The magnification factor (5,) is determined by measuring
the distance from the slit to the plane of the film (dsliWo.fiim) and the distance from the focal spot to the
plane of the slit (dfoca, spoMo.slit). Mslit is calculated by:
Mslit
dsiit-to-film'dfocal SDot-to-slit
(2.3)
Note: Mslit = Mimage - 1

Remark: The method requires a higher exposure than the star pattern and slit camera methods.
Limiting value
Frequency
Equipment
None
Slit camera (10 m slit) with appropriate test stand and magnifying glass (5-1 Ox),
having a built-in graticule with 0.1 mm divisions.

To determine the focal spot dimensions (f) with a pinhole, a 30 pm gold/platinum alloy pinhole is used.
Produce a magnified image (magnification 2.5 to 3 times) of the pinhole.
The dimensions of the focal spot are derived by examining the images through the magnifying glass
and correcting for the magnification factor according to f=F/Mpinh0|e, where F is the size of the imaged
focal spot. The magnification factor (Mpjnh0ie) is determined by measuring the distance from the pinhole
to the plane of the film (dpinhote.to.fi|m) and the distance from the focal spot to the plane of the pinhole (dfoca,
spot-to-pinhoie)- M pinhole is c a l c u l a t e d by:
'^'pinhole - ^pinhole-to-film ' Sfocai spot-to-pinhole
(2-4)
Remark: The method requires a higher exposure than the star pattern method.
Limiting value
None.
Frequency
Equipment

Pinhole (diameter 30 pm) with appropriate test stand and magnifying glass (5-1 Ox),
having a built-in graticule with 0.1 mm divisions.
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Measure the distance between the focal spot indication mark on the tube housing and the top surface
of the bucky. Add distance between bucky surface and the top of the image receptor.
Limiting value
Frequency
Equipment
The source-to-image distance should conform to the manufacturers' specification and

typically is > 600 mm.
Only initially.
Tape measure.

The alignment of the X-ray field and image receptor at the chest wall side can be measured with two
loaded cassettes and two X-ray absorbers, e.g. coins.
Place one cassette in the bucky tray and the other on top of the breast support table. Make sure the
second cassette has a film loaded with the emulsion side away from the screen. It must extend beyond
the chest wall side about 30 mm. Mark the chest wall side of the bucky by placing the absorbers on top
of the cassette. Automatic exposure will result in sufficient optical densities. Reposition the films on a
light box using the imaged absorbers as a reference. The misalignment between film and X-ray field
can be measured.
Note 1: The lateral edges of the X-ray field should at least expose the mage receptor. A slight
extension beyond any edge of the image receptor is acceptable.
Note 2: If more than one field size or focal distance is used, the measurement should be repeated for
each diaphragm or distance.
Limiting value
Frequency
Equipment
Thorax-side: X-rays must cover the film by no more than 5 mm outside the film.
Lateral sides: X-rays must cover the film to the edges
Yearly.
X-ray absorbers -e.g. coins, tape measure.
Radiation leakage
The measurement of leakage radiation comprises two parts; firstly the location of leakage and
secondly, the measurement of its intensity.
Position a beam stopper [e.g. lead sheet) over the end of the diaphragm assembly such that no primary
radiation is emitted. Enclose the tubehousing with loaded cassettes and expose to the maximum
kilovoltage and a high mAs (several exposures). Process the films and pin-point any excessive
leakage. Next, quantify the amount of radiation at the "hot-spots" at a distance of 50 mm of the tube
with a suitable detector. Correct the readings to mGy/h (free in air) at the distance of 1 m from the focal
spot at the maximum rating of the tube.
Limiting value
Frequency
Equipment
Not more than 1 mGy in 1 hour at 1 m from the focus at the maximum rating of the
tube averaged over an area not exceeding 100 cm2, and according to local regulations.
Initially and after intervention on the tube housing.
Dose meter and appropriate detector.
Tube output
The specific tube output (pGy/mAs) and the output rate (mGy/s) should both be measured on an axis
passing through the reference point, in the absence of scatter material and attenuation (e.g. due to the
compression plate). An mAs similar to that required for the reference exposure should be used for the
measurement. Correct for the distance from the focal spot to the detector and calculate the specific
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output at 1 metre and the output rate at a distance equal to the focus-to-film distance (FFD).
Limiting values acceptable: >30 pGy/mAs; desirable: 40-75 pGy/mAs at 1 metre
acceptable: > 7.5 mGy/s; desirable: 10-30 mGy/s at a distance equal to the FFD
Frequency
Every six months and when problems occur.
Equipment
Dose-meter, exposure timer
Note:
A high output is desirable for a number of reasons e.g. it results in shorter exposure times,
minimising the effects of patient movement and ensures adequate penetration of large/dense
breasts within the present back-up time. In addition any marked changes in output require
investigation.
2.1.2 Tube voltage

The radiation quality of the emitted X-ray spectrum is determined by tube voltage, anode material and
filtration. Tube voltage and Half Value Layer (i.e. beam quality assessment) can be assessed by the
measurements described below.
A tube voltage check over the whole used kV-range at 1 kV intervals should be performed. The
reproducibility is measured by repeated exposures at one fixed tube voltage that is normally used
clinically (e.g. 28 kV). A digital kVp-meter (specially designed for mammography) is presently the most
suitable for this purpose.
Note: consult the manufacturers' instruction manual for the correct positioning.
Limiting value
Frequency
Equipment
Accuracy for 25-31 kV: < 1 kV, reproducibility <0.5 kV.

Every six months.
Digital kVp-meter
Half Value Layer

The Half Value Layer (HVL) can be assessed by adding thin aluminium (Al) filters to the X-ray beam
and measuring the attenuation.
Position the exposure detector at the reference point (since the HVL is position dependent) on top of
the bucky. Place the compression device halfway between focal spot and detector. Select 28 kV tube
voltage and an adequate focal spot charge (mAs-setting), and expose the detector directly. The filters
can be positioned on the compression device and must intercept the whole radiation field. Use the
same mAs setting and expose the detector through each filter. For higher accuracy (about 2%) a
diaphragm, positioned on the compression paddle, limiting the exposure to the area of the detector may
be used (see the protocol on dosimetry).
The HVL is calculated by applying formula 2.5.
X^InC1)-X 2 x|n(1)
HVL TL_
h_
The direct exposure reading is denoted as Y0; Y, and Y2 are the exposure readings with added
II - D - 8
(2 5)
aluminium thicknesses of X, and X2 respectively.

Note 1: The purity of the aluminium a 99.0% is required. The thicknesses of the aluminium sheets
should be measured with an accuracy of 1%.
Note 2: For this measurement the output of the X-ray machine needs to be stable.
Note 3: The HVL for other (clinical) energies and other target materials and filters may also be
measured for assessment of the mean glandular dose (see appendix 1 and the protocol on
dosimetry).
Note 4: Alternatively a digital HVL-meter can be used, but correct these readings under extra filtration
following to the manufacturers' manual.
Limiting value
Frequency
Equipment
For 28 kV Mo/Mo the HVL must be over 0.30 mm Al equivalent.

Typically readings are< 0.40 mm Al. For typical readings for other kV's, targets and
filters, see appendix 3.
Yearly.
Dosemeter, aluminium sheets 0.30 and 0.40 mm.
2.1.3 AEC-system
The performance of the Automatic Exposure Control (AEC) system can be described by the
reproducibility and accuracy of the automatic optical density control under varying conditions, like
different object thicknesses and tube voltages. An essential prerequisite for these measurements is
a stable operating film-processor and the use of the reference cassette.
To compensate for the long term variations in mean density due to system variations the central optical
density setting and the difference per step of the selector are assessed. To verify the adjustment of the
optical density control, produce exposures with a 45 mm PMMA phantom with varying positions of the
optical density control selector.
A target value for the mean optical density should be established according to local preference. Once
the target is agreed, any deviations must be monitored.
Limiting value
Frequency
Equipment
The optical density (base and fog included) at the reference point should remain within
0.15 OD to the target value. Target value is typical in the range: 1.3- 1.8 OD, base
and fog included.
The desirable quantity for the smallest optical density control step-size is 0.10 OD; <.
0.20 OD per step is acceptable. Adjustable range > 1.0 OD.
Stepsize: every six months
Central density or mAs-value: daily
PMMA 45 mm thick block, densitometer
Guard timer
The AEC system should also be equipped with a guard timer which will terminate the exposure in case
of malfunctioning of the AEC system. Measure the mAs at which the system terminates the exposure.
W a r n i n g : since an incorrect functioning of the guard timer could seriously

damage the tube, this measurement should be performed under the
responsibility of the manufacturer.
II - D - 9

position the dosemeter in the x-ray beam but without covering the AEC-detector. The short term
reproducibility of the AEC system is calculated by the deviation of the exposure meter reading often
routine exposures (45 mm PMMA).
Limiting value
Frequency
Equipment
Note:
The deviation of the mean value of exposures must be < 5%, desirable would be <
2%.
Every six months.
PMMA 45 mm thick block, dosemeter.
For the assessment of the reproducibility, also compare the results from the short term
reproducibility with those from the thickness and tube voltage compensation and the optical
density control setting at 45 mm PMMA and 28 kV. Any problem will be indicated by a
mismatch between those figures.

The long term reproducibility can be assessed from the measurement of optical density and mAs
resulting from the exposures of a PMMA-block or the QC phantom in the daily quality control. Causes
of deviations can be found by comparison of the daily sensitometry data and mAs recordings (see
2.3.2)
Limiting value
Frequency
Equipment
<0.20 OD acceptable; < 0.15 OD desirable from the target OD.

Daily
PMMA 45 mm thick block or QC phantom, densitometer

Compensation for object thickness is measured by exposures of PMMA plates in the thickness range
20 to 70 mm, using the clinical setting for the AEC.
Limiting value
Frequency
Equipment
All optical density variations must be within the range 0.15 OD, with respect to the
target optical density. Desirable: 0.10 OD.
Weekly.
PMMA: plates 10x180x240 mm3, densitometer.

Compensation for tube voltage is measured over the clinical range of kV, filters and target materials
used.
Limiting value
Frequency
Equipment
All optical density variations must be within the range 0.15 OD, with respect to the
target optical density. Desirable: 0.10 OD.
Every six months.
PMMA 45mm, densitometer.
2.1.4 Compression
The compression of the breast tissue should be firm but tolerable. There is no optimal value known for the
force, but attention should be given to the applied compression and the accuracy of the indication.
I I - D - 10
Compression force
The compression force can be adequately measured with a compression force test device or a
bathroom scale (use compressible material e.g. a tennisball to protect the bucky and compression
device). When compression force is indicated on the console, it should be verified whether the figure
corresponds with the measured value.
Limiting value
Frequency
Equipment
Maximum automatically applied force: 130 - 200 N. (~ 13-20 kg)

Yearly.
Compression force test device.

The alignment of the compression device at maximum force can be visualized and measured when a
piece of foam-rubber is compressed. Measure the distance between bucky surface and compression
device on each corner. Ideally, those four distances should be equal. Misalignment normal to the chest
wall side is less disturbing than in the parallel direction. The upright edge of the device must be imaged
outside the receptor area and optimally within the chestwall side of the bucky.
Limiting value
Frequency
Equipment
Minimal misalignment is allowed, < 15 mm is acceptable for asymmetrical load and in

the direction towards the nipple, < 5 mm for symmetrical load.
Annually.
Foam rubber, tape measure.
II-D- n
2.2 Bucky and i m a g e receptor

The anti scatter grid is composed of alternating strips of lead and cotton fibre interspace material mainly
and is designed to absorb scattered photons. The grid system is composed of a cassette holder, breast
support table and a mechanism for moving the grid, to prevent grid lines on the image.
Grid system factor
The grid system factor can be measured with a dosemeter. Produce two images, one with and one
without the grid system. Use manual exposure control to obtain images of about unit optical density.
The first mage is made with the cassette in the bucky tray (with grid system) and PMMA on top of the
bucky, and the second with the cassette on top of the bucky (without grid system) and PMMA on top
of the cassette. The grid system factor is calculated by dividing the exposures, corrected for the inverse
square law and optical density differences.
Limiting value
Frequency
Equipment
Grid system factor s 3.

Initially and when dose or exposure time increases suddenly.
Dosemeter, PMMA 45 mm thick block and densitometer.
Grid imaging
To assess the homogeneity of the grid in case of suspected damage or looking for the origin of artefacts,
the grid may be imaged by automatic exposure of the bucky at the lowest position of the AEC-selector,
without any added PMMA. This in general gives a good image of the gridlines.
2.2.2 Screen-film
The current image receptor in screen-film mammography consists of a cassette with one intensifying
screen in close contact with a single emulsion film. The performance of a stock of cassettes is described
by the inter cassette sensitivity variation and screen-film contact.
Inter cassette sensitivity and attenuation variation and optical density range
The relative sensitivity of the screens can be assessed with the reference exposure (chapter 1). Select
an AEC setting (should be the normal position) to produce an mage having about the clinically used
mean optical density on the processed film. Repeat for each cassette using films from the same box
or batch. Make sure the cassettes are identified properly. Measure the exposure (in terms of mGy or
mAs) and the corresponding optical densities on each film at the reference point.
Limiting value
Frequency
Equipment
The exposure, in terms of mGy (or mAs), must be within 5% for all cassettes.
The maximum difference in optical density between all cassettes:0.20 OD is
acceptable, 0.15 OD is desirable.
Initially (including manual exposures), yearly, and after introducing new screens.
PMMA 45 mm or phantom, dosemeter, densitometer.
Screen-film contact
Clean the inside of the cassette and the screen. Wait for at least 5 minutes to allow air between the
screen and film to escape. Place the mammography contact test device (mesh: about 40 wires/inch,
II - D - 12
1.5 wires/mm) on top of the cassette and expose to produce a film optical density of about 2 OD at the
reference point. Regions of poor contact will be blurred and appear as dark spots in the image. Reject
cassettes only when they repeatedly show the same spots.
Limiting value
Frequency
Equipment
No significant areas of poor contact are allowed in the diagnostically relevant part of
the film.
Initially, yearly and after introducing new screens.
Mammography screen-film contact test device and densitometer.
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2.3 Film processing

The performance of the processor greatly affects image quality. The best way to measure its performance
is by sensitometry. Measurements like temperature and processing time are performed to establish a
base-line performance. No limiting values are given, since temperature and processing time are set to
adapt to the requirements of the sensitometry.
Temperature
To establish a base-line performance of the automatic processor, the temperature of developer and
fixer are measured. Take care that the temperature is measured at a fixed point, as recommended by
the manufacturers. The measured values can be used as background information when malfunction
is suspected.
Limiting value
Frequency
Equipment
None.
Initially and when problems occur.
Thermometer (digital or alcohol, no mercury allowed)
Processing time
The total processing time can be measured with a stopwatch. Insert the film into the processor and
start the timer when the signal is given by the processor. When the processed film is available, stop
the timer. When malfunction of the processor is suspected, measure this processing time exactly the
same way again and check to see if there is any difference.
Limiting value
Frequency
Equipment
None.
Initially and when problems occur.
Stopwatch.

The films used in mammography should be specially designed for that purpose and should comply with
the given figures under "Limiting value". Light sensitometry is a suitable method to measure the
performance. Disturbing processor artifacts should be absent on the processed image.
Sensitometry
Use a sensitometer to expose a film with light and insert the exposed side into the processor first.
Before measuring the optical densities of the step-wedge, a visual comparison can be made with a
reference strip to rule out a procedure fault, like exposure with a different colour of light or exposure
of the base instead of the emulsion side.
From the characteristic curve (the graph of measured optical density against the exposure by light) the
values of base and fog, maximum density, speed and mean gradient can be derived. These
parameters characterize the processing performance. A detailed description of these ANSI-parameters
can be found in appendix 1, calculation of film parameters.
Limiting value
Frequency
I I - D - 14
The required values for these parameters are:

base and fog: <. 0.20 OD
contrast: MGrad: 2.8-3.2
Daily.
Equipment
Note:
Sensitometer, densitometer.
There is no clear evidence for the optimal value of MGrad; the range is based on theory and
current experience. A higher value of MGrad might lead to under- and over exposure of parts
of the image and therefore reduce the information content. Only in stable conditions with very
low variability of the parameters could it further improve image quality.
Daily performance
The daily performance of the processor is assessed by sensitometry. After the processor has been
used for about one hour each morning, perform the sensitometry as described above. The variability
of the parameters can be calculated over a period of time e.g. one month (see calculation of film
parameters in appendix 1).
Limiting value
Frequency
Equipment
Note:
Variability for all parameters acceptable: < 10%, desirable < 5%.
Daily and more often when problems occur.
Sensitometer, densitometer.
A more practical approach to the assessment of variations can be found in the use of the
following table, where the limiting percentages are expressed as a range of limiting values
(Max value - Min value):
base+fog:
max. density:
speed:
mean gradient:
acceptable:
<0.03
<0.30
<0.05
<0.20
desirable
<0.02
<0.20
<0.03
<0.10
Artifacts
The mage of the PMMA block obtained daily, should be inspected. This should show a homogeneous
density, without scratches, shades or other marks indicating artifacts.
Limiting value
Frequency
Equipment
No artifacts.
Daily.
PMMA block 45 mm or plates 40-60 mm, viewing box
2.3.3 Darkroom
Light tightness of the darkroom should be verified. It is reported, that about half of darkrooms are found
to be unacceptable. Cassettes and film hopper should also be light tight. Extra fogging by the safelights
must be within given limits.
Light leakage
Remain in the darkroom for a minimum of five minutes with all the lights, including the safelights, turned
off. Ensure that adjacent rooms are fully illuminated. Inspect all those areas likely to be a source of light
leakage. To measure the extra fog as a result of any light leakage or other light sources, a pre-exposed
film of about 1.2 OD is needed. This film can be obtained by a reference exposure of a uniform PMMA
block. Always measure the optical density differences in a line perpendicular to the tube axis to avoid
influence of the heel effect.
II - D - 15
Open the cassette with pre-exposed film and position the film (emulsion up) on the (appropriate part
of the) workbench. Cover half the film and expose for four minutes. Position the cover also
perpendicular to the heel effect, to avoid the influence of this inhomogeneity in the measurements.
Measure the optical density difference of the background (Dbg) and the fogged area (Dfogged). The extra
fog (AD) equals:
AD = D f o g g e d - D b g
Limiting value
Frequency
Equipment
(2.6)
Extra fog: ADs 0.02 OD in 4 minutes.

Initially, every six months and when light leakage is suspected.
Film cover, densitometer.
Safelights
Perform a visual check that all safelights are in good working order (filters not cracked). To measure
the extra fog as a result of the safelights, repeat the procedure for light leakage but with the safelights
on. Make sure that the safelights were on for more than 5 minutes to avoid start-up effects.
Limiting value
Frequency
Equipment
Extra fog: ADs 0.10 OD in 4 minutes.

Initially, every six months and every time the darkroom environment has changed.
Film cover, densitometer.
Film hopper
Fogged edges on unexposed (clear) films may indicate that the film hopper is no longer light tight.
Place one fresh sheet of film in the hopper. Leave it there for several hours with full white light
illumination in the darkroom. Inspect the processed film for light leakage of the hopper.
Limiting value
Frequency
No extra fogging.
This test should be performed initially and when light leakage is suspected.
Cassettes
Dark edges on radiographs indicate a need to perform light leak tests on individual cassettes. Reload
the suspect cassette with a fresh sheet of film and place it in front of a viewing box for several hours.
Making sure that each side of the cassette is exposed to bright light by turning it over. Inspect the
processed film for dark edges due to light leakage of the cassette.
Limiting value
Frequency
II - D - 16
No extra fogging.
This test should be performed initially and when light leakage is suspected.
2.4 V i e w i n g conditions
Since good viewing conditions are important for the correct interpretation of the diagnostic images, they
must be optimised. Although the need for relatively bright light boxes is generally appreciated, the level
of ambient lighting is also very important and should be kept low. In addition the film should be masked
to minimise stray light.
As regards light levels the procedures for photometric measurements and the values required for optimum
mammographie viewing are not well established. However there is general agreement on the parameters
that are important. The two main measurements in photometry are luminance and illuminance. The
luminance of viewing boxes is the amount of light emitted from a surface measured in candela/m2.
Illuminance is the amount of light falling on a surface and is measured in lux (lumen/m2). The illuminance
that is of concern here is the light falling on the viewing box, i.e. the ambient light level. (An alternative
approach is to measure the light falling on the film readers eye by pointing the light detector at the viewing
box from a suitable distance with the viewing box off.) Whether one is measuring luminance or illuminance
one requires a detector and a photometric filter. This combination is designed to provide a spectral
sensitivity similar to the human eye. The collection geometry and calibration of the instrument is different
for luminance and illuminance. To measure luminance a lens or fibre-optic probe is used, whereas a
cosine diffuser is fitted when measuring illuminance. Where the only instrument available is an illuminance
meter calibrated in lux it is common practice to measure luminance by placing the light detector in contact
facing the surface of the viewing box and converting from lux to cd/m2 by dividing by n. This approach
makes assumptions about the collection geometry, therefore a correctly calibrated luminance detector is
preferred.
There is no clear consensus on what luminance is required for viewing boxes. It is generally thought that
viewing boxes for mammography need to be higher than for general radiography. In a review of 20 viewing
boxes used in mammographie screening in the UK, luminance averaged 4500 cd/m2 and ranged from
2300 to 6700 cd/m2. In the USA the ACR have recommended a minimum of 3500 cd/m2 for
mammography. However some experts have suggested that the viewing box luminance need not be very
high provided the ambient light is sufficiently low and that the level of ambient light is the most critical
factor. The limiting values suggested here seem a reasonable compromise until clearer evidence is
available.
2.4.1. Viewing box
Luminance
Measure the luminance close to the centre of the illuminated area using a luminance meter calibrated
in cd/m2. An upper limit is included to minimise glare where films are imperfectly masked.
Limiting value Luminance should be in the range 2000-6000 cd/m2.
Frequency
Yearly.
Equipment
Luminance meter.
Homogeneity
The homogeneity of a single viewing box is measured by multiple readings of luminance over the
surface of the illuminator, compared with the mean value of readings in the middle of the viewing area.
Readings very near the edges (e.g. within 5 cm) of the viewing box should be avoided. Gross mismatch
between viewing boxes or between viewing conditions used by the radiologist and those used by the
radiographer should be avoided. If a colour mismatch exists, check to see that all lamps are of the
I I - D - 17
same brand, type and age. To avoid inhomogeneities as a result of dust, clean the light boxes regularly
inside and out.
Limiting value
Frequency
The uniformity of luminance across a single light box is typically within 30%. The
intensity of different light boxes at one department is suggested to be within 15%
(measured in the middle of the viewing area).
Yearly.
Equipment
Luminance meter.
2.4.2. Ambient light

Level
When measuring the ambient light level (illuminance), the viewing box should be switched off. Place
the detector against the viewing area and rotate away from the surface to obtain a maximal reading.
This value is denoted as the ambient light level.
Limiting value Ambient light level < 50 lux.
Frequency
Yearly.
Equipment
Illuminance meter
I I - D - 18
2.5 S y s t e m properties
The quality of any X-ray image is defined by its ability to transfer the information, necessary to make the
right diagnosis, from the tissues examined to the radiologist. This information is proffered by X-ray quanta
that are not absorbed by the tissues and reach the detector. The differences in absorption by the different
tissues make them discernable. The better the differences are defined, the better the information can be
visualised, be it by blackening of the processed film or intensities on a monitor of a digital system. A better
separation of the imaged tissues can be achieved by a larger difference between the OD's representing
those tissues, and/or by a better definition of the differences in absorption.
The first improvement is achieved by manipulating the X-ray spectrum, either by the choice of a
lower kV or of appropriate target and filter materials. It increases the difference in mean value of the
OD's of the imaged tissues at the film and by that, the contrast between the tissues.
The second improvement is achieved by increasing the system dose. Without affecting the mean
values it improves the definition of those values by lowering the standard deviation of their
distributions and by that, giving less noise in the imaged tissues.
Both ways to improve image quality are at the cost of a higher patient dose either by more absorption due
to the lower energies or by more irradiation to compensate for a less sensitive imaging system.
The success of a screening programme is dependent on the proper information transfer and therefore on
the image quality of the mammogram. Decreasing the dose per image for reasons of radiation protection
is only justified when the information content of the image remains sufficient to achieve the aim.
2.5.1 Dosimetry
The measurement of exposure and the calculation of the mean glandular dose in mammography are
described in detail in the European Protocol on Dosimetry in Mammography.(see chapter 6, Bibliography)
Only the measurement of entrance surface air kerma is described here for convenience.
This measurement is performed under reference conditions either with AEC or manual exposure.
Produce two exposures of a PMMA block with an optical density under and over 1.0 OD
respectively. The corresponding entrance surface dose should be measured as close to the
reference point as possible. The value for the entrance surface air kerma at 1.0 OD (base and fog
excluded) can be interpolated linearly from these data.
Limiting value
Frequency
Equipment
10 mGy for 40 mm PMMA,

12 mGy for 45 mm PMMA,
20 mGy for 50 mm PMMA.
(Limiting values for other OD's: see appendix 3)
Yearly.
Dose meter, PMMA block 150x240 mm2, densitometer.
2.5.2 Image Quality

Although the information content of an image may best be defined in terms of just visible contrasts and
details, characterised by its contrast-detail curve, the basic conditions for good performance and the
constancy of a system can be assessed by some physical measurements.
Spatial resolution
One of the parameters which determine image quality is the system spatial resolution. It can be
adequately measured by imaging two resolution lead bar patterns, up to 20 line pairs/mm each.
They are placed either between PMMA plates to measure the resolution in the tissue, or on top of
I I - D - 19
PMMA plates with a total thickness of 45 mm, to measure worst-case resolution. Image the patterns
at the reference point both parallel and perpendicular to the tube axis, and measure these
resolutions.
Note: The resolution measured at different heights between 25 and 50 mm from the tabletop does
not differ much, since geometric blur is largely compensated by magnification for small focal spot
sizes. The distance from the chest wall edge is critical, but the position parallel to the thorax side
is not critical within 5 cm from the reference point. Resolution is generally worse parallel to the
tube axis due to the asymmetrical shape of the focal spot.
Limiting value
Frequency
Equipment
> 12 Ip/mm acceptable, > 15 Ip/mm desirable at the reference point

Weekly.
PMMA plates 150x240 mm, resolution pattern(s) up to 20 Ip/mm, densitometer.
Image contrast
Since image contrast is affected by various parameters (like tube voltage, film contrast etc.) this
measurement is an effective method to detect a range of system faults.
Make a reference exposure of an aluminium stepwedge and measure the optical density of each
step in the stepwedge. Draw a graph of the readings at each step against the stepnumber. The
graph gives an impression of the contrast.
Since this graph includes the processing conditions, the film curve has to be excluded to find the
radiation contrast, see Appendix 2.
Remark: The value for image contrast is dependent on the whole imaging chain, therefore no
absolute limits are given.
Limiting value
Frequency
Equipment
10% to baseline is suggested.

Weekly.
PMMA or aluminium stepwedge, densitometer.

This measurement should give an indication of the lowest detectable contrast of "large" objects
(diameter > 5 mm). Therefore a selection of low contrast objects have to be embedded in a PMMA
phantom to mimic clinical exposures. There should be at least two visible and two non-visible
objects. Note, that the result is dependent on the mean OD of the image.
Produce a routine exposure and let two or three observers examine the low contrast objects. The
number of visible objects is recorded.
Limiting value
Frequency
Equipment
<1.3% contrast for a 6 mm detail is suggested.

Weekly.
Test object with low contrast details plus PMMA plates, to a thickness of 45 mm,
densitometer.
Exposure time
Long exposure times can give rise to motion unsharpness. Exposure time may be measured by
some designs of kVp- and output meters. Otherwise a dedicated exposure timer has to be used.
The time for a routine exposure is measured.
Limiting value
Frequency
Equipment
II - D - 20
Acceptable: < 2 sec; desirable: <1.5 sec.

Yearly and when problems occur.
Exposure time meter, PMMA 45x150x240 mm.
3 Daily and weekly QC tests.

There is a number of items that should be checked daily or weekly. For this purpose, a dedicated QCphantom or set of test objects must be available. The procedure must facilitate the measurement of some
essential physical quantities, and it should be designed to evaluate:
-
AEC reproducibility
tube output stability
reference optical density
spatial resolution
mage contrast
threshold contrast visibility
homogeneity, artifacts
sensitometry (speed, contrast, gross fog)
Note: The reproducibility of the AEC system should be tested daily, using a 40 - 50 mm PMMA block
phantom. Its constancy of response to thin and to thick compressed breasts should be tested
weekly using PMMA plates covering the range 20 - 70 mm thick.
Practical considerations:
Ideally the sensitometric stepwedge should be on the same film as the image of the test object, to
be able to correct optimally for the processing conditions.
To improve the accuracy of the daily measurement, the phantom should be designed in such a way
that it can be positioned reproducibly on the bucky.
The shape of the phantom does not have to be breast-like. To be able to perform a good
homogeneity check, the phantom should at least cover the normally imaged area (150x240 mm)
on the image receptor (180x240 mm).
For testing the AEC reproducibility, the PMMA phantom may comprise several layers of PMMA, 10or 20-mm thick. It is important that the correct thicknesses are known, since commercially available
plates are neither identical nor correct in thickness.
II - D - 21
Definition of terms
Note that the definitions given here may not be universally applicable but do express the
meaning of the terms as used in this document.
Accuracy represents unbiased and precise results. It is the closeness of an observed value of a quantity to
the true value. Its value is: the percentage of difference between measured value (m) and true value
(t) according: (m/t -1) 100%
Air kerma: The quotient of dEtrby dm, measured in Gray, where dEtr is the sum of initial kinetic energies of
all the charged ionising particles liberated by uncharged ionising particles in a mass of air dm (adapted
fromlCRU 1980)
Automatic exposure control (AEC) system: A mode of operation of an X-ray machine by which the tube
loading is automatically controlled and terminated when a pre-set radiation exposure to the image
receptor is reached. Also the tube potential (kV) may or may not be automatically controlled.
Average glandular dose: Reference term (ICRP 1987) for radiation dose estimation from X-ray
mammography i.e. the average absorbed dose in the glandular tissue (excluding skin) in a uniformly
compressed breast of, e.g., 50% adipose, 50% glandular tissue composition. The reference breast
thickness and composition should be specified.
Baseline value: The value that is used for comparison when no absolute limiting value is present.
Breast compression: The application of pressure to the breast during mammography so as to immobilize
the breast and to present a lower and more uniform breast thickness to the X-ray beam.
Compression paddle: An approximately rectangular plate, positioned parallel to and above the breast table
of a mammography X-ray machine, which is used to compress the breast.
Deviation ( %): The percentage of difference between measured value (m) and prescribed value (p)
according: (m/p -1) 100% .
Dmin, Dmax: see appendix 1: "Calculation of film-parameters"
Entrance surface air kerma (ESAK): The air kerma measured free-in-air (without backscatter) at a point
in a plane corresponding to the entrance surface of a specified object e.g., a patient's breast or a
standard phantom.
Entrance surface dose (ESD): The absorbed dose in air, including the contribution from backscatter,
measured at a point on the entrance surface of a specified object e.g., a patient's breast or a standard
phantom.
II - D - 22
Grid: A device which is positioned close to the entrance surface of an image receptor to reduce the quantity
of scattered radiation reaching the receptor.
Half-value layer (HVL): The thickness of aluminium absorber which attenuates the air kerma of a collimated
X-ray beam by half
Heel effect: The non-uniform distribution of air kerma rate in an X-ray beam in a direction parallel to the
cathode-anode axis.
Inverse sguare law: The physical law which states that the X-ray beam intensity reduces in inverse
proportion to the square of the distance from the point of measurement to the X-ray tube focus.
Image Quality: Information content of the image in terms of just visible contrasts and details.
Laterally centred: Centred on a line perpendicular to the kathode-anode axis, not necessarily in the middle
of the image.
Limiting value: A value of a parameter which, if exceeded, indicates that corrective action is required,
although the equipment may continue to be used clinically. Limiting values for dose or air kerma are
derived differently from reference values, i.e., reference ESD is based on third quartile values derived
during surveys whereas limiting values of other parameters are derived from standard good practice.
Mammography: The X-ray examination of the female breast. This may be undertaken for health screening
of a population (mammography screening) or to investigate symptoms of breast disease (symptomatic
diagnosis).
MGrad: see appendix 1: "Calculation of film-parameters"
Net optical density: Optical density excluding base and fog.
Optical density (OD): The logarithm of the ratio of the intensity of perpendicularly incident light (lo) on a film
to the light intensity (I) transmitted by the film: OD=log(lo/l). Optical density differences are always
measured in a line perpendicular to the tube axis to avoid influences by the heel-effect.
Patient: Any woman attending a facility for mammography whether for screening or for symptomatic
diagnosis.
Patient dose: A generic term for a variety of radiation dose quantities applied to a (group of) patient(s).
Phantom: Test object, often a series of PMMA-plates or a PMMA-block with various embedded measuring
devices.
PMMA: The synthetic material polymethylmethacrylate. Trade names include Lucite, Perspex and Plexiglass.
Precision: The variation (usually relative standard deviation) in observed values.
Quality Assurance as defined by the WHO (1982): "All those planned and systematic actions necessary to
provide adequate confidence that a structure, system or component will perform satisfactorily in service
(ISO 6215-1980). Satisfactory performance in service implies the optimum quality of the entire
diagnostic process-i.e., the consistent production of adequate diagnostic information with minimum
exposure of both patients and personnel."
II-D-23
Quality Control as defined by the WHO (1982): "The set of operations (programming, coordinating, carrying
out) intended to maintain orto improve [. . . ] (ISO 3534-1977). As applied to a diagnostic procedure,
it covers monitoring, evaluation, and maintenance at optimum levels of all characteristics of
performance that can be defined, measured, and controlled."
Radiation detector: An instrument indicating the presence and amount of radiation.
Radiation dose: A generic term for a variety of radiation quantities.
Radiation dosemeter: A radiation detector, connected to a measuring and display unit, which has a
geometry, size, energy response and sensitivity suitable for measurements of the radiation generated
by an X-ray machine.
Radiation output: The air kerma measured free-in-air (without backscatter) per unit of tube loading at a
specified distance from the X-ray tube focus and at stated radiographic exposure factors.
Radiation guality: A measure of the penetrating power of an X-ray beam, usually characterised by a
statement of the tube potential and the half-value layer (HVL).
Range: The absolute or relative difference of minimum and maximum values of measured quantities.
Reference cassette: The identified cassette that is used for the QC tests.
Reference exposure: The exposure of the phantom to provide an image at the reference optical density.
Reference optical density: The optical density of 1.0 OD, base and fog excluded, measured in the reference
point.
Reference phantom: A phantom similar to the standard phantom, but of a specifically stated thickness.
Reference point: A measurement position in the plane occupied by the entrance surface of a 45 mm thick
phantom, 60 mm perpendicular to the chest wall edge of the table and centred laterally.
Reference value (for dose): The value of a quantity obtained for patients which may be used as a guide to
the acceptability of a result. In the 1996 version of the "European Guidelines on Quality Criteria for
Diagnostic Radiographic Images" it is stated that the reference value can be taken as a ceiling from
which progress should be pursued to lower dose values in line with the ALARA principle. This objective
salso in line with the recommendations of ICRP Publication 60 (1991) that consideration be given to
the use of "dose constraints and reference or investigation levels" for application in some common
diagnostic procedures.
Reproducibility indicates the reliability of a measuring method or tested equipment. The results under
identical conditions should be constant.
Resolution (at high or low contrast) describes the smallest detectable detail at high or low contrast to a given
background.
Routine exposure: The exposure of the phantom under the conditions that would normally be used to
produce a mammogram. It is used to determine image quality and dose under clinical conditions.
Speed: see appendix 1: "Calculation of film-parameters"
II - D - 24
Standard breast: A model used for calculations of glandular dose consisting of a 40 mm thick central region
comprising a 50% : 50% mixture by weight of adipose tissue and glandular tissue surrounded by a 5
mm thick superficial layer of adipose tissue. The standard breast is semicircular with a radius 80 mm
and has a total thickness of 50 mm. (see: Standard phantom)
Standard phantom: A PMMA phantom to represent approximately the average breast (although not an exact
tissue-substitute) so that the X-ray machine operates correctly under automatic exposure control and
the dosemeter readings may be converted into dose to glandular tissue. The thickness is 45 0.5 mm
and the remaining dimensions are either rectangular a 150 mm 100 mm or semi-circular with a radius
of 100 mm.
Target OD: The optical density (OD) at the reference point of a routine exposure, choosen by the local staff
as the optimal value, typically in the range 1.3-1.8 OD, base and fog included.
Test object: see phantom
Threshold contrast: The contrast that produces a just visible difference between two optical densities.
Tube-current exposure-time product (mAs): The product of the X-ray tube current (milliampere, mA) and
the radiographic exposure time (second, s)
Tube loading: The tube-current exposure-time product (mAs) that applies during a particular exposure.
Tube potential: The potential difference (kilovolt, kV) applied across the anode and cathode of the X-ray tube
during a radiographic exposure.
Typical value: The value of a parameter that is found in most facilities in comparable measurements. The
statement of such a value is an indication of what to expect, without any limits attached to that.
X-ray spectrum: The distribution of photon energies in an X-ray beam.
II - D - 25
TABLE 1. Radiographic technique parameters

frequency of Quality Control, measured and limiting values.
to
ON
freq.
typical
acceptable
- focal spot size

- source-to-image distance
- alignment of x- ray field/image receptor
- radiation leakage
* output
* output rate
i
i
12
i
6
6
0.3
600
IEC/NEMA
- reproducibility
- accuracy (26 - 30 kV)
-HVL
6
6
12
AEC
* central opt. dens control setting (1)

- opt. dens, control step
* short term reproducibility
* long term reproducibility
- object thickness compensation
- tube voltage compensation
6
6
6
6
w
6
1.3-1.8
0.15
compression
- compression force
- compression plate alignment, asymm.
- compression plate alignment, symm.
12
12
12
130-200

X-ray source
tube voltage
desirable
unit
40-75
10-30
<5
<1
>30
>7.5
>40
> 10
mm
mm
mGy/hr
pGy/mAs
mGy/s
0.3-0.4
<0.5
< 1.0
>0.3
<0.5
<1.0
system dep.
kV
kV
mm Al
<0.15
<0.20
<5%
<0.20
<0.15
<0.15
< 0.15
<0.10
<2%
< 0.15
<0.10
<0.10
OD
OD
mGy
OD
OD
OD
< 15
<5
< 15
<5
N
mm
mm
<3
<3
< 5%
<0.20
< 5%
<0.15
<5

anti scatter grid
* grid system factor
screen-film
* inter cassette sensitivity variation (mAs)

* inter cassette sensitivity variation (OD range)
- screen-film contact
i = initially; d = daily; w = weekly; 6 = every 6 months; 12 = every 12 months

* standard measurement conditions
(1) total optical density is indicated, base and fog are included.
=> This table is continued on next page.
i
12
12
12
mGy
OD
TABLE 1, continued. Radiographic technique parameters

frequency and limiting values.
2.3 film processing
freq
typical
processor
- temperature
- processing time
i
i
34-36
90
film
- sensitometry:
base and fog

speed
contrast
- daily performance
- artifacts
d
d
d
d
d
> 0.15
darkroom
light leakage (extra fog in 4 minutes)

safelights (extra fog in 4 minutes)
film hopper
cassettes
acceptable
desirable
unit
C
s
OD
< 0.20(1)
< 0.20(1)
>2.6
< 10%
2.8-3.2
<5%
12
12
i
i
< +0.02 (2)

<+0.10 (2)
<+0.02 (2)
<+0.10 (2)
OD
OD
12
12
12
12
2000 - 6000
< 30 %
<50
2000 - 6000
< 30 %
< 15%
<50
cd/m2
cd/m2
cd/m2
lux
<12
> 12
< 10%
< 10
> 15
< 10%
mGy
Ip/mm
<2
< 1.5
2.4 viewing conditions

viewing box
environment
- brightness
- homogeneity
- difference
- ambient light level
2.5 system properties

reference dose
image quality
* entrance surface dose; 45 mm phantom

* spatial resolution, reference point
* image contrast variation
* threshold contrast visibility
* exposure time
12
w
w
w
12
i = initially; d = daily; w = weekly; 6 = every 6 months; 12 = every 12 months

* standard measurement conditions
(1) for standard blue based films only
(2) at net optical density 1.00 OD
IO
=> End of table 1.
QC eguipment
(O
co
sensitometer
densitometer
dosemeter
thermometer
kVp-meter for mammographie use
exposure time meter
light meter
phantoms, PMMA
compression force test device
aluminum filters (purity 2 99,5%)
focal spot test device
stopwatch
film/screen contact test tool
tape measure
rubber foam for compression plate alignment
(lead sheet)
accuracy
reproducibility
unit
_
2 % at 1.0 OD
5%
0.3
2%
5%
10%
2%
10%
2%
1%
1%
0.1
1%
1%
5%
5%
OD
OD
mGy
C
kV
s
klux
mm
N
6. Bibliography
CEC-Reports
1
Technical an Physical Parameters for Quality Assurance in Medical Diagnostic Radiology;

Tolerances, Limiting Values and Appropriate Measuring Methods
1989: British Institute of Radiology; BIR-Report 18, CEC-Report EUR 11620.
Optimization of Image Quality and Patient Exposure in Diagnostic Radiology

1989: British Institute of Radiology; BIR-Report 20, CEC-Report EUR 11842.
Dosimetry in Diagnostic Radiology

Proceedings of a Seminar held in Luxembourg, March 19-21, 1991.
1992: Rad. Prot. Dosimetry vol 43, nr 1-4, CEC-Report EUR 14180.
Test Phantoms and Optimization in Diagnostic Radiology and Nuclear Medicine

Proceedings of a Discussion Workshop held in Wuertzburg (FRG), June 15-17, 1992
1993: Rad. Prot. Dosimetry vol 49, nr 1-3; CEC-Report EUR 14767.
Quality Control and Radiation Protection of the Patient in Diagnostic Radiology and Nuclear
Medicine
1995: Rad. Prot. Dosimetry vol 57, nr 1-4, CEC-Report EUR 15257.
European Guidelines on Quality Criteria for Diagnostic Radiographic Images

1996: CEC-Report EUR 16260, in press.
Protocols
1
The European Protocol for the Quality Control of the Technical Aspects of Mammography
Screening.
1993: CEC-Report EUR 14821
European Protocol on Dosimetry in Mammography.

1996: CEC-Report EUR 16263 in press.
Protocol acceptance inspection of screening units for breast cancer screening, version 1993.
National Expert and Training Centre for Breast Cancer Screening, University Hospital Nijmegen
(NL)
1996 (translated in English).
LNETI/DPSR: Protocol of quality control in mammography (in English)

1991.
ISS: Controllo di Qualit in Mammografia: aspetti technici e clinici.

Instituto superiore de sanit (in Italian),
1995: ISTASAN 95/12
IPSM: Commissioning and Routine testing of Mammographie X-Ray Systems - second edition
The Institute of Physical Sciences in Medicine, York
1994: Report no. 59/2.
II-D-29
American College of Radiology (ACR), Committee on Quality Assurance in Mammography:

Mammography quality control.
1994, revised edition
American Association of Physicists in Medicine (AAPM): Equipment requirements and quality

control for mammography
1990: report No. 29
Publications
1
Chakraborty D.P.: Quantitative versus subjective evaluation of mammography accreditation

phantom images.
1995: Med. Phys. 22(2):133-143
Wagner A.J.: Quantitative mammography contrast threshold test tool.

1995: Med. Phys. 22(2): 127-132
Widmer J.H.: Identifying and correcting processing artifacts.

Technical and scientific monograph
Health Sciences Division
Eastman Kodak Company, Rochester, New York
Caldwell C.B.: Evaluation of mammographie image quality: pilot study comparing five methods.
1992: AJR 159:295-301
Wu X.: Spectral dependence of glandular tissue dose in screen-film mammography.

1991: Radiology 179:143-148
Hendrick R.E.: Standardization of image quality and radiation dose in mammography.

1990: Radiology 174(3):648-654
Baines C.J.: Canadian national breast screening study: assessment of technical quality by external
review.
1990: AJR 155:743-747
Jacobson D.R.: Simple devices for the determination of mammography dose or radiographic
exposure.
1994: Z.Med. Phys. 4:91-93
Conway B.J.: National survey of mammographie facilities in 1985, 1988 and 1992.
1994: Radiology 191:323-330
10
Farria D.M.: Mammography quality assurance from A to Z.

1994: Radiographics 14: 371-385
11
Sickles E.A.: Latent image fading in screen-film mammography: lack of clinical relevance for batchprocessed films.
1995: Radiology 194:389-392
12
Sullivan D.C. : Measurement of force applied during mammography.

1991: Radiology 181:355-357
II-D-30
13
Russell D.G. : Pressures in a simulated breast subjected to compression forces comparable to those
of mammography.
1995: Radiology 194:383-387
14
Faulkner K. : Technical note: perspex blocks for estimation of dose to a standard breast - effect of
variation in block thickness.
1995: Br. J. Radiol. 68:194-196
15
Faulkner K.: An investigation into variations in the estimation of mean glandular dose in
mammography.
1995: Radit. Prot. Dosimet. 57:405-407
16
Young K.C. : Mammographie film density and detection of small breast cancers.
1994: Clin. Radiol. 49:461-465
17
Tang S.: Slit camera focal spot measurement errors in mammography.

1995: Med. Phys. 22:1803-1814
18
Hartmann E.: Quality control of radiographic illuminators and associated viewing equipment.
Retrieval and viewing conditions.
1989: BIR report 18:135-137
19
Haus A.G.: Technologic improvements in screen-film mammography.

1990: Radiology 174(3):628-637
20
L.K. Wagner, B.R. Archer, F. Cerra; On the measurement of half-value layer in film-screen
mammography.
1990: Med. Phys. (17):989-997.
21
J.D. Everson, J.E. Gray: Focal-Spot Measurement: Comparison of Slit, Pinhole, and Star Resolution
Pattern Techniques.
1987: Radiology (165):261-264.
22
J. Law: The measurement and routine checking of mammography X-ray tube kV.
1991: Phys.Med.Biol. (36): 1133-1139.
23
J. Law: Measurements of focal spot size in mammography X-ray tubes.

1993: Brit. J. Of Radiology (66):44-50
24
M. Thijssen et al: A definition of image quality: the image quality figure.

1989: Brit. Inst. Radiology, BIR-report 20: 29-34
25
R. L. Tanner: Simple test pattern for mammographie screen-film contact measurement.

1991: Radiology (178):883-884.
Other reports
1
International Electrotechnical Commission (IEC), Geneva, Switzerland: Characteristics of focal

spots in diagnostic X-ray tube assemblies for medical use
1982: IEC-Publication 336.
II-D-31
Quality assurance in mammography - quality control of performance and constancy

1990: Series of Nordic Reports on radiation Safety No. 1, Denmark, Finland, Iceland, Norway and
Sweden.
Socit franaise des physiciens d'hpital, Nancy: Contrle de qualit et mesure de dose en
mammographie - aspects thoriques et pratiques (in French)
1991.
Department Health & Social Security, Supplies Technology Division (DHSS): Guidance notes for
health authorities on mammographie equipment requirements for breast cancer screening
1987: STD:87:34
Department of Radiodiagnostic Radiology, University of Lund, Sweden: Quality Assurance in

Mammography
1989.
Sicherung der Bildqualitt in rntgendiagnostischen Betrieben - Filmverarbeitung (in German)

1985: DIN 6868 teil 2: Beuth Verlag GmbH, Berlin.
American Association of Physicists in Medicine (AAPM): Basic quality control in diagnostic radiology
1978: report No. 4
ECRI: Special issue: Mammography Units;

1989: Health Devices:Vol.18:No.1:Plymouth Meeting (PA)
ECRI: Double issue: Mammography Units;

1990: Health Devices:Vol.19:No.5-6:Plymouth Meeting (PA)
10
Siemens Medical Systems Inc., New Yersey: Mammography QA - Doc.# 54780/up

1990
11
ANSI: Determination of ISO speed and average gradient.

American National Standards Institute (ANSI).
1983: Nr. PH2.50.
12
Sicherung der Bildqualitt in rntgendiagnostischen Betrieben - Konstantzprfung fr die

Mammographie (in German)
1989: DIN-1:6868 teil 7:Beuth Verlag GmbH, Berlin.
13
Sicherung der Bildqualitt in rntgendiagnostischen Betrieben - Abnahmeprfung

Mammographie-Einrichtungen (in German)
1989: DIN-2:6868 teil 52: Beuth Verlag GmbH, Berlin.
14
ICRP Publication 52, including the Statement from the Como Meeting of the ICRP.
1987: Annals of the ICRP 17 (4), i-v, Pergamon Press, Oxford, UK.
15
ICRP Publication 60, 1990 Recommendations of the ICRP.

(Adopted by the Commission in November 1990);
1991: Annals of the ICRP 21 (1-3), Pergamon Press, Oxford, UK.
II-D-32
an
Appendix 1: Calculation of film-parameters

The film curve can be characterized by a few parameters. Most important items are contrast, sensitivity
and base and fog. There are different methods to calculate the film parameters. Existing normalizations
differ so much that the following method is suggested, derived from the Dutch protocol (1991), which is
based on the ANSI (1983) norm.
Dmin
Base and fog; the optical density of a non exposed film after developing. The minimum
optical density can be visualized by fixation only of an unexposed film. The extra fog is a
result of developing the (unexposed) emulsion.
MGrad
Mean Gradient; the property which expresses the filmcontrast in the diagnostic range. MGrad
is calculated as the slope of the line through the points D^Dmin+0.25 OD and D2=Dmin+2.00
OD. Since the film curve is constructed from a limited number of points, D: and D2 must be
interpolated. Linear interpolation of the construction points of the film curve will result in
sufficient accuracy.
Speed
Sensitivity; the property of the film emulsion directly related to the dose. The Speed is
calculated as the x-axis cut-off at optical density 1.00+Dmin, also called 'Speedpoint'. The
higher the figure Speed, the more dose is needed to obtain the right optical density.
Since the film curve is constructed from a limited number of points, the Speed must be
interpolated. Linear interpolation will result in sufficient accuracy.
Two other methods are available for the determination of film contrast, both less precise and less
reproducible but easier.
Contrast Index 1:
The difference in density found between the step nearest to the speedpoint (density 1.0 OD, base
and fog excluded) and the one with a 0.6 loglt (factor 4) higher light exposure (normally 4 density
steps) (ACR).
Contrast Index 2:
The difference in density steps found between the step nearest to the speedpoint and the step
nearest to a density at 2.0 OD, base and fog excluded (IPSM, see bibliography).
D-:
Appendix 2: A method to discriminate between processing and

exposure variations by correction for the film-curve
The optical density of a film is the result of X-ray exposure and processing.
The film is mainly exposed by light emitted by the intensifying screen. The light-emission of the screen is
proportional with the incident X-ray exposure. Primary X-rays only contribute up to 5% of the total
exposure. The developing process determines the optical density of the exposed area.
When an optical density in any given film is measured, the corresponding exposure is unknown. However,
the film curve (measured with light-sensitometry) describes the relation between light-exposure and optical
density. Any measured optical density can be converted into a relative log(light-exposure) or log(l') by
interpolation of the film curve. This figure log(l') is a relative value and strongly depends on the
sensitometer used. But still it is a useful value, closely related with the radiation dose applied and is
therefore suitable to calculate the mass attenuation coefficient of an arbitrary step wedge.
When the optical density of several images, taken under identical conditions, are measured, there will be
a range of optical densities. This can either be the result of a change in exposure or a change in
developing conditions. By calculating the relative figure log(l') we are able to distinguish between
processor faults and tube malfunctions.
Approximation of X-ray contrast

To assess the X-ray contrast, correct the OD-readings of an Al-stepwedge for the processing conditions
by converting the optical densities into a fictional "exposure", log(l'), according the film curve. Now, a graph
of the stepwedge number against "exposure" will result in an almost straight line. The slope of this line is
a measure for the X-ray contrast.
II - D - 34

Other spectra
The techniques used to produce a mammographie image are constantly optimized. New anode materials,
in combination with filters of different composition and thicknesses, may be explored to improve image
quality orto reduce patient dose. Some of these new techniques are used in mammography screening.
The typical values of the HVL of some of these combinations are listed below (IEC ).
Anode and filter materials
HVL at 25 kVp
m m Al
HVL at 28 kVp
m m Al
Mo + 30 pm Mo
0.28
0.32
Mo + 25 pm Rh
0.36
0.40
W + 60pm Mo
0.35
0.37
W + 50 pm Rh
0.48
0.51
W + 40pm Pd
0.44
0.48
Rh + 25 pm Rh
0.34
0.39
Other densities
The mean optical density of a mammogram affects the dose imparted in the tissue. Applying a different
mean OD in the mammogram changes the exposure and the glandular dose. An indication of the changes
expected in respect to the reference exposure (28 kV) are listed below as adaptation of the limiting value
for the Entrance Surface Air Kerma (ESAK) and standard Average Glandular Dose (sAGD). The film is
expected to fulfill the limiting value by having a MGrad of 3.0 (see the European Protocol on Dosimetry
in Mammography, 1996).
net film density (OD)
0.8
1.0
1.2
1.4
1.6
1.8
ESAK (mGy)
9.8
12.0
14.2
16.5
18.7
20.9
standard AGD (mGy)
1.6
2.0
2.4
2.8
3.1
3.5
-D-35
Appendix 4: Sample data sheets for QC reporting
QC report
based on
The European Protocol for the

Quality Control
of the Physical and Technical Aspects
Version: June 1996
Date:
Contact:
Institute:
Address:
Telephone:
Conducted by:
II-D-37
E u r o p e a n Guidelines for Q U A L I T Y A S S U R A N C E in M a m m o g r a p h y S c r e e n i n g 2 n d edition ( J U N E 1996)
2.2
X - r a y generation and control
2.1.1 X-ray source

Focal spot size
Class (large) focal spot:
(IEC)
star pattern method

diameter star pattern
spoke angle
diameter magnified star image
diameter first MTF zero AC axis
diameter first MTF zero / / AC axis
Dmag
Mstar
mm
mm
mm
Dblur / /
slit-to-film
^focus-to-slit-
- film
_ mm
mm
mm J.
mm//
Fx:
F/l:
; f
M
focus - slit
slit
method
diameter pinhole
distance pinhole-to-film
distance focus-to-pinhole
C^pinhole-to-filmC^focus-to-pinhole
diameter pinhole AC axis

diameter pinhole / / AC axis
pinhole '
Focal spot size
II-D-38
(Mst -1)
__ p m
slit
pinhole
Dblur
180
slit
^mag
Dblur J-
width slit image j . AC axis

width slit image / / AC axis
. mm
f=H^x
Dstar
slit camera method

width slit
distance slit-to-film
distance focus-to-slit
Dstar:
:
f =
ill =
mm
mm
mm
mm//
F_L:
Fll:
pinhole - film
.
focus - pinhole
pm
mm
mm
F
""pinhole
Accepte
Nominal value :
Measured value :
Focus indication to bucky
Bucky to cassette :
Total focus-film distance :
mm
mm
mm
mm
Alignment of X-ray field / image receptor

Deviation at chest wall side film:
inside/outside image receptor: left
middle:
right :
mm, in /out
mm, in / out
mm, in /out
Accepted: yes / no
Deviation at the short edges of film:

beam reaches at the left hand side onto the film edge:
beam reaches at the right hand side onto the film edge:
yes/no
yes/no
Accepted: yes/ no
Radiation leakage
Description of position of 'hot spots'
1
2
3
detector surface area :
distance from tube:

and surface area:
nr:
1.
2.
3.
mm2
measured:
50 mm
mm2
calculated for
1000 mm,
100 cm2:
mGy/hr
mGy/hr
mGy/hr
Accepted: yes/ no
Tube output
focus detector distance:
surface air kerma:
focal spot charge:
specific tube output at 1 m
output rate at FFD
mm
mGy
mAs
pGy/mAs
mGy/s
Accepted: yes / no
D-39
2.1.2 Tube voltage

Preset mAs:
Clinically most relevant kV:
mAs
kV
Accuracy
Setting
25
27
26
28
29
30
kV
31
Measured
kV
Deviation
kV
Accepted: yes / no
Reproducibility at the clinically most relevant value

Measured value:
1.
5.
kV
Reproducibility (max deviation from the mean ):
kV
Accepted: yes / no
Half Value Layer

Measured tube voltage:
kV
Preset mAs value:
mAs
Filtration:
0.0
0.30
0.40
Exposure:
Yo
Yi
Y2
1.
mGy
2.
mGy
3.
mGy
Average exposure:
HVL
mm/ 1
mGy
2V
2Y
2
0.3 ln( -) - 0.4 * ln(1)
Yn
y.
mmAI
ln()
HVL:
Variation exposure at 0 mm Al
mm Al
%
Accepted: yes / no
II - D - 40
2.1.3 AEC-system
Target density value:
Settin
OD
Exposure
mAs
Density
Density incr.
mGy
mAs
OD
OD
-3
-2
-1
0
1
9
3
Accepted: yes / no
Density range:
OD
Accepted: yes / no
Optical density control setting for D = 1.0 -1.2 OD

Optical density control setting for target density:
Guard timer
Exposure terminates by exposure limit
Alarm or error code :
Exposure :
Delivered mAs value :
yes/no
yes/no
mGy
mAs
II - D - 41

Optical density control setting:
Exp. #
Exposure
mAs
1
2
3
4
5
6
7
8
9
10
Variation in mAs:
% (= 100 (max-min)/mean )
Accepted: yes / no

Thickness
Exposure
mAs
Density
[cm]
[mGy]
[mAs]
[OD]
2.0
3.0
4.0
5.0
6.0
7.0
Variation in optical density:
OD
Accepted: yes / no
II - D - 42

Tube volt.
Exposure
mAs
Density
[kV]
[mGy]
[mAs]
[OD]
25
26
27
28
29
30
31
Variation in optical density:
OD
Accepted: yes / no
2.1.4 Compression
Compression force
Force-indication:
Measured compression force:
Compression force after 1 min.
N
N
N

attachment compression plate : in order / out of order
Symmetric load
Thickness indication
cm
Height of compression plate above the bucky at full compression:

left
Front :
Rear :
Difference(f/r)
right
difference(l/r)
cm
cm
cm
Accepted: yes / no
II-D-43
Asymmetric load left-right

left
right
Front :
Rear :
difference(l/r)
cm
cm
cm
Difference(f/r)
Accepted: yes / no
Asymmetric load front-rear

left
right
Front :
Rear :
difference(l/r)
cm
cm
cm
Difference(f/r)
Accepted: yes / no

2.2.1.
Anti scatter grid
Grid system factor

Bucky
exposure
[mGy]
deliv.mAs
[mAs]
Present:
Absent:
Bucky factor:
density
[OD]
Accepted: yes / no
Grid imaging
Additional grid images made:
#
added PMMA
1.
yes/no
description of artefacts
yes/no
3.
yes/no
Accepted: yes / no
II - D - 44
2.2.2.
Screen-film
Inter cassette sensitivity and attenuation variation and optical density range
AEC setting: _
(Manual mAs:
Cassette id
)
exposure
[mGy]
deliv.mAs
[mAs]
density
[OD]
density (manual)
[OD]
1
2
3
5
6
7
8
9
10
11
12
mAs
%
Average values:
Variation:
OD
OD
OD
OD
Reference cassette :
Accepted: yes / no
Screen-film contact
Cassette id:
Description of artefacts:
Accepted: yes/ no
2.3
Film processing
2.3.1.
Base line performance of the processor
Temperature
Point of measurement in bath:
Developer
Fixer
reference/nominal:
thermometer.
reference
local:
console:
Process time
Time from processor signal to film available:
-D-45
2.3.2.
Film and processor
Sensitometry
Daily performance
Artifacts
2.3.3.
Darkroom
Light leakage
Fog (after 4 min.) of a pre-exposed film on the workbench:
point:
1 2
3
4
5
D(point)
D(background):
Deviation:
OD
Average deviation:
OD
OD
OD
Accepted: yes / no
Positions of light sources and leaks in the darkroom:
Safelights
Type of lighting:
, direct/indirect
ca.
Height :
metre above workbench
Setting:
Filter condition :
insufficient/good/not checked
Fog (after 4 min.) of a pre-exposed film on the workbench:

point:
D(point)
OD
D(background):
OD
Deviation:
OD
Average deviation:
OD
Accepted: yes / no
Film hopper
Fogging due to lightleakage in film hopper is absent: yes/no
Accepted: yes/ no
Cassettes
The following cassettes show lightleakage:
Cassette id:
leaking position
Accepted: yes / no
II-D-46
2.4
Viewing conditions
2.4.1.
Viewing box
Viewing box luminance

Reading from the luminance metre (detector at the centre of the image plane) :
Cd/m2
Homogeneity
Cover the view box pane with mammography films, measure the luminance (remove films first)
at all centre positions of these films.
Position
Top
Bottom
Homogeneity:
% ( = 100% .(Lmax - Lmin) / L0

Accepted: yes / no
2.4.2.
Ambient light level

Reading from the illuminance metre (detector at the image plane, box is off) :
Lux
Accepted: yes / no
2.5
System properties
2.5.1
Dosimetry

exposure
[mGy]
deliv.mAs
[mAs]
Exposure for D = 1.00 OD+b+s
density
[OD]
mGy
Accepted: yes / no
II-D-47
2.5.2
Image Quality
Spatial resolution
Position of the centre of the pattern:
Hight above the bucky surface:
Distance from thorax side of the bucky:
Distance from AC axis:
Resolution
_ mm
_mm
_ mm
R AC-axis
R iAC-axis
image 1
image 2
image 3
image 4
Accepted: yes / no
Image contrast
image
mAs
#1
#2
#3
#4
#5
#6
#7
#8
#9
#10
1
2
3
4
5
Graph(s) attached
Observer
# objects identified
1
2
3
Accepted: yes / no
Exposure time
AEC setting for a routine image:
mAs number obtained:
exposure time:
mAs
s
Accepted: yes / no
II-D-48
III
ANNEXES
ANNEX 1:
RECOMMENDATIONS OF THE COMMITTEE OF CANCER EXPERTS

ON BREAST CANCER SCREENING
6 APRIL 1992
The Committee recommends that the following criteria be respected by any project intending to implement
a breast screening programme:
1.
Before initiating large-scale campaigns, pilot schemes (town, district) should be undertaken to obtain
the necessary experience, with a view to implementation of national screening programmes before
the year 2000 taking into account the costs, the benefits and the effects
2.
The ideal frequency for mammography should be two to three years.
3.
Action in this area should cover a long period, and long-term follow-up over ten years should be
ensured.
Support by the national and/or local health authorities should be assured not only in the screening
part, but also in the further investigations which are needed for definite diagnosis, and for the
treatment, whenever is necessary, which will inevitably be increased in the pilot area during the
lifetime of the experiment. Hence the Committee recommends accepting only those projects which
will be officially supported by the national and/or regional health authorities.
4.
With respect to selection of age groups, the Committee recommends that the age limit should be the
one specified in the tenth rule of the European Code, i.e. 50 years of age, since up to now scientific
evidence of the public benefits of screening is limited to women aged 50 to 69 years of age.
At present there is no statistical evidence that population screening under the age of 50 will reduce
mortality from breast cancer. Mammographie screening under the age of 50 should be discouraged
until the results of ongoing controlled trials become available.
5.
Special attention should be paid to the organization of the call and recall system and follow-up of
women with suspicious radiological lesions. Quality control measurements should be included in the
protocol and be implemented.
6.
Adequate staff training (radiologists, technicians as well as physicist) is mandatory.
7.
With regard to assessment, the regions to be selected should ideally be towns or districts where a
cancer register exists. Where this is not the case, the Committee recommends that the pilot project
be selected only if there is a commitment to create simultaneously a breast cancer incidence register.
8.
Two view mammography is recommended in the first year of a programme while radiological
experience is still being gained. Some experts are of the opinion that two view mammography should
be performed on all women attending their first (prevalent) round screen in order to maximise the
detection of small cancers and minimise the number of women recalled for further investigation.
9.
The Committee stresses that double reading should be the general rule. Furthermore, the schemes
should include a continuous statistical monitoring of the quality (sensitivity and specificity) to limit the
number of errors, whether positive or negative.
10. An acceptable figure for malignant : benign biopsy ratio is 1 : 1. It is understood that it may be difficult
to achieve this in the first year of a programme. In subsequent years it should be possible to
substantially improve on this figure with the use of cytology.
11. Education and information of the public is necessary not only before, but also during the experience.
12. The criteria of the reduction in mortality should also be complemented by criteria relating to effects
on the quality of life (stage of diagnosis, conservative treatment instead of mastectomy, numbers of
patients recalled and patients treated for preclinical disease, beneficial and detrimental psychosocial
effects and dosimetry) when assessing the results of screening campaigns. Special continuous
studies on this aspect should be encouraged.
13. The benefits of a screening programme will be optimized by the formation of good teamwork between
the staff at expert centres and those in other units involved. The professional team should include a
radiologist, surgeon, cyto/histopathologist and oncologist.
14. Either opportunistic screening or organized screening taking place outside the confines of a national
programme should be subject to the same standards of quality control as the national programme.
15. It is agreed that cost-efficiency is an integral part of quality assurance. Adequate documentation of
any screening programme and its results is essential in evaluating the programme and demonstrating
its safety and benefit to the population being screened. The same methodology in documenting such
data is recommended for accurate comparison.
m-2
ANNEX 2:
EUREF PROTOCOL
This protocol and its recommendations with relation to the EUREF programme is time limited to the current
Action Plan of Europe Against Cancer.
Confidentiality with regard to findings and reports by EUREF and its associate personnel will be respected
between the boards of EUREF, the EAC Subcommittee on Cancer Screening and the European
Commission.
Status
The Europe against Cancer Subcommittee on Cancer Screening is committed to ensuring that the pilot
breast screening projects funded by it achieve sufficient quality and expertise to function as Quality
Assurance Reference Centres in their own country. To this end, EUREF is charged with the responsibility
of responding to and coordinating a quality assurance training requirement in a given programme. The
nature of this response would be to facilitate contacts and training activities between the pilot study
concerned and the source of expertise seen most suitable by the EAC Subcommittee on Cancer
Screening. EUREF should further monitor the progress of the programme in question to the point where
a satisfactory outcome has been achieved.
In such a way EUREF fulfils its intended function as a European Network of Reference Centres for Breast
Cancer Screening.
Guidelines for European Training/Reference Centres have already been introduced and agreed by the
Subcommittee on Cancer Screening. Such guidelines should be used as a basis upon which to promote
or strengthen programmes in their own countries or within the European Network.
Eventually it is hoped that the pilot projects will reach the sufficient standard to
act as reference centres for each of the member states, having suitable political backing from the relevant
Departments of Health. The support from EUREF for these projects will vary and diminish in time
according to their requirements before they become fully established. There may also be some additional
activity between EUREF and external purchasers of the specialist knowledge
incorporated into the EUREF network but this must be assessed on the basis of future needs and approval
by the board of EUREF and the Subcommittee on Cancer Screening.
In summary EUREF have a major responsibility for quality system support to the pilot breast screening
projects. These programmes and EUREF are funded by Europe Against Cancer. EUREF is responsible
to the EAC Subcommittee on Cancer Screening for carrying out its duties and the primary authority
remains with the Subcommittee on Cancer Screening. The activities of the EUREF Programme will be
supervised and recommended by the Advisory Board which can be regarded as an associate sub-group
of the Subcommittee on Cancer Screening. This Advisory Board will be composed of relevant members
of the Subcommittee on Cancer Screening, representatives of the Pilot network and also representatives
of the coordinating centre at Nijmegen.
The EUREF programme is physically based in Nijmegen with some professional specialist input from the
staff at the Nijmegen training centre. The activities and experts it coordinates will be more widely based
throughout Europe. Individual experts and centres providing training will be approved by the Advisory
Board.
m-3
Site visits will be performed by members of the EAC Subcommittee on Cancer Screening. These visits
will take the form of fact finding missions and status evaluation. They will assess the current state of
Quality Assurance within a programme and will make specific recommendations as to structural and
organisational needs as well as training requirements. These visits will maintain liaison between the pilot
programmes and the Subcommittee on Cancer Screening. Training visits are defined as those visits to
a pilot programme made by personnel recommended by the Scientific Committee to provide training in
the individual disciplines required.
Visits by pilot programme personnel to recognised training centres or individuals may take two forms.
Firstly, a visit to a recognised individual or screening programme in order to gain a general and broad
based experience of structure, organisation and methodology within a screening programme. Secondly,
a specific secondment to a recognised training centre by individual scientific personnel connected with
the pilot programme.
Purposes
1.
To act as an advisory body and provide support to the EAC pilot projects by coordinating the
necessary training of relevant personnel by recognised reference and training centres or individual
experts.
2.
To provide the pilot projects with information on necessary technical and professional quality
assurance programmes and to support them in implementing these.
3.
Support should be given to a wider allocation of training centres.
4.
To provide support in epidemiological evaluation of the pilot projects.
5.
A pilot screening programme may be considered suitable for accreditation following the
recommendation of EUREF and its visiting teams. The form and manner of accreditation should be
decided by the member state concerned.
6. Visits by representatives from the Subcommittee on Cancer Screening to the pilot projects will be
maintained, at least once every 2 years, to oversee activities, training needs and act as a liaison with
the local teams. Written reports on programme status specifying required actions will be provided to
the programme concerned and the European Commission.
7.
EUREF should encourage coordinated research within the screening programmes.
Ill-4
ANNEX 3:
Population screening Act ( The Netherlands).

ACT of 29 October 1992 containing rules relating to population screening
(Population Screening Act)
We, Beatrix, by the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc.
Whereas, we have considered that it is desirable for the purpose of protecting the population to institute a system
of authorisation for population screening programmes which may endanger the health of the persons to be
examined, and that separate provisions concerning chest radiography to screen for tuberculosis, as laid down in the
Tuberculosis Screening Act (Bulletin of Act, Orders and Decrees[Staatsblad] 1951, 288), are no longer required;
On the advice of the Council of State and in consultation with the Dutch Parliament, have approved and decreed
the following:
CHAPTER I
Definitions
Article 1
In this Act and in the provisions issued under it, the following definitions shall apply:
a) Our Minister: the Minister for Welfare, Health and Cultural Affairs;
b) the Health Council: the Health Council referred to in Article 21 of the Health Act (Bulletin of Act, Orders and
Decrees 1956,51);
c) population screening: medical examination of persons performed for the purpose of implementing an offer
made to the whole population or a section thereof and aimed at detecting specific diseases or risk indicators
for the benefit, or in part for the benefit, of the persons examined.
CHAPTER II
Population screening for which an authorisation is required
Article 2
1.
Population screening involving the use of ionising radiation, population screening for cancer and population
screening for serious diseases or disorders which cannot be treated or prevented shall be subject to the
safeguards referred to in Article 3.
2.
If, on account of the nature of the screening method to be used or on account of the disease or risk indicator
to be detected, Our Minister considers that provisions to protect public health are required immediately, he may
designate the screening programmes that are to be subject to the safeguards referred to in Article 3.
3.
A bill regulating the matters covered by a decree issued under 2 shall be introduced in the Lower House of the
Dutch Parliament within 12 months of the entry into force of such a decree. If the bill is withdrawn or rejected
by one of the Houses of the Dutch Parliament, the decree shall be immediately revoked.
Article 3
1. It is forbidden to carry out screening programmes as referred to in Article 2(1) or designated under Article 2(2)
without the authorisation of Our Minister.
Ill-5
2.
Rules designed to protect the persons to be examined against the risks associated with the screening
programmes referred to in Article 2(1) or with the screening programmes designated under Article 2(2) may
be laid down in regulations. Such rules may differ according to the various types of screening programme
involved.
3.
In the case of the screening programmes referred to in Article 2(1 ) and screening programmes designated under
Article 2(2) that are partly carried out for medical research purposes, a regulation may be issued laying down
rules concerning the manner in which permission is to be given and in which the individuals involved are to
be informed about the purpose, nature and consequences of the screening programme and about protection of
privacy for the persons to be examined.
4.
An authorisation may be granted subject to restrictions or with requirements attached, solely in sofar as is
necessary having regard to the nature of the screening programme for which authorisation is granted, the
purpose in either case being to protect the persons to be examined against the risks or to ensure adequate
benefit from the screening programme in question.
5.
In the case of a designation as referred to in Article 2(2), Our Minister may impose rules as referred to in
Article 3(2) and (3); these rules, if not revoked earlier, shall lapse 12 months after they enter into force.
Article 4
1.
a)
b)
c)
d)
e)
An application for authorisation as referred to in Article 3(1) shall contain a detailed description of:
the methods of examination to be used;
the diseases or risk indicators to be detected;
the population category to be examined;
the organisation of the screening programme;
the quality assurance measures to be taken in respect of the screening programme.
2.
Rules concerning other information to be submitted with an application may be laid down in regulations. Such
rules may differ according to the various types of screening programme involved.
Article 5
Repealed.
Article 6
Our Minister shall consult the Health Council before taking a decision on an application.
Article 7
1. An application shall be rejected if:
a) the screening programme is scientifically unsound;
b) the screening programme does not conform to statutory provisions governing medical practice;
c) the anticipated benefits of the screening programme are outweighed by the attendant risks to the health of the
persons examined.
2.
In the case of the screening programmes referred to in Article 3(3), an authorisation may be rejected if such
an examination is not required for public health purposes.
3.
In the case of population screening for serious diseases or disorders that cannot be treated or prevented, an
authorisation shall be issued only in special circumstances.
Article 8
1. The inspectors referred to in Article 10 shall be informed of the decision on the application in sofar as they
exercise authority in the locality concerned.
Ill-6
2.
The decision shall also be announced in the Netherlands Government Gazette (Staatscourant).
Article 9
1. An authorisation may be withdrawn only if:
a) the information submitted in order to obtain the said authorisation proves to be incorrect or inadequate to the
extent that a different decision on the application would have been taken if the true circumstances had been
fully known when the application was assessed;
b) a restriction subject to which the authorisation has been granted is contravened;
c) a requirement attached to the authorisation is not complied with;
d) a different decision on the application would have been taken if subsequent scientific knowledge concerning
the screening programme for which authorisation has been granted had been known when the application was
assessed;
e) a medical research study is added to the screening programme after authorisation has been granted and a
different decision on the application would have been taken if this had been known when the application was
assessed.
2.
In cases where an authorisation may be withdrawn, restrictions or requirements may be added to it or the
restrictions or requirements attached to it may be amended instead.
3.
Our Minister shall consult the Health Council before giving effect to paragraphs 1 or 2.
CHAPTER III
Further provisions
Article 10
The public health inspectors designated for the purpose by Our Minister and the officials of the Public Health
Supervisory Service acting on their instructions shall be responsible for monitoring compliance with the provisions
of this Act and those issued pursuant to it.
Article 11
1. The persons referred to in Article 10 shall be authorised to request information and to demand access to
documents and take copies thereof in sofar as such actions can reasonably be deemed necessary for the
performance of their duties.
2.
All persons shall be obliged to lend the persons referred to in Article 10 any assistance that may reasonably
be deemed necessary for the performance of their duties.
Article 12
Repealed.
Article 13
1. Persons contravening
a) the provisions of Article 3(1),
b) provisions issued pursuant to Article 3(2), (3) or (5),
c) a requirement attached to an authorisation pursuant to Article 3(4),
d) the provisions of Article 11(2),
shall be liable to a class four fine.
2.
The punishable actions referred to in (1) constitute offences.
Article 14
III-7
1.
Persons who on the date on which this Act or a decree issued under Article 2(2) enters into force are already
carrying out a screening programme for which an authorisation is required under Article 3(1) shall not be
required to comply with Article 3(1) and the provisions issued under Article 3(2), (3) or (5) for 13 weeks
following the above date, provided that an application for the necessary authorisation has been submitted
within that period, or for four weeks after the order containing the decision on that application enters into force.
2.
If in his judgment immediate steps have to be taken in the interests of public health, Our Minister may stipulate
that the time limits set out in paragraph 1 shall not apply to the persons referred to in the said paragraph who
are already carrying out a screening programme.
Article 15
Within five years of the entry into force of this Act, Our Minister shall submit a report on its implementation to both
Houses of the Dutch Parliament.
Article 16
The Tuberculosis Screening Act (Bulletin of Act, Orders and Decrees 1951, 288) is repealed.
Article 17
This Act shall enter into force on a date to be determined by Royal Decree.
Article 18
This Act may be cited as the Population Screening Act.
We order and command that this Act shall be published in the Bulletin of Act, Orders and Decrees (Staatsblad), and
that all ministerial departments, authorities, bodies and officials whom it may concern shall diligently implement
it.
Done at The Hague, 29 October 1992
Beatrix
The State Secretary for Welfare, Health and Cultural Affairs
H.J. Simons
Published on 1 December 1992
The Minister for Justice
E.M.H. Hirsch Ballin
III
DECREE of 1 August 1995 laying down regulations pursuant to Articles 3(3) and 4(2) of the Population
Screening Act (Population Screening Decree)
We, Beatrix, by the grace of God, Queen of the Netherlands, Princess of Orange Nassau, etc.
On the recommendation issued by the Minister for Health, Welfare and Sport on 11 April 1995 (PAO/GZ-952378);
Taking account of Articles 3(3) and 4(2) of the Population Screening Act;
Having obtained the opinion of the Health Council (opinion of 7 September 1994);
Having consulted the Council of State (opinion of 27 June 1995, No W13.95.0195);
Having seen the more detailed report of the Minister for Health, Welfare and Sport, dated 14 July 1995
(NoPAO/GZ/95-6771);
Have approved and decreed the following:
Article 1
In this Decree "the Act" means "the Population Screening Act".
Article 2
1. The examination of a person as part of a screening programme as referred to in Article 3(3) of the Act may
only be carried out:
a) where the person to be examined has come of age and subsection c) does not apply: with the written consent
of the person concerned;
b) where the person to be examined is a minor who is at least 12 years old and subsection c) does not apply: with
the written consent of the person concerned together with the written consent of the parents who are effectively
responsible for him or of his guardian;
c) where the person to be examined is at least 12 years old and is unable to exercise reasonable judgment in the
matter: with the written consent of the parents who are effectively responsible for him or of his guardian, or
if he is of age, of his legal representative, spouse or other partner;
d) where the person to be examined has not yet reached the age of 12: with the written consent of the parents who
are effectively responsible for him or of his guardian.
2.
If the person referred to in paragraph 1(c) and (d) apparently objects to a procedure being performed on him,
it shall be deemed that the consent referred to in paragraph 1(c) has not been given.
3.
Persons who have given their consent may withdraw it at any time without indicating the reasons. Such a
withdrawal shall not entail the payment of any compensation.
Article 3
1. Before any consent is requested, the persons in charge of the screening programme shall ensure that the person
whose consent is required is informed in writing of the following:
a) the purpose, type and duration of the examination;
b) the risks of the screening programme to the health of the person undergoing the examination;
c) the risks to the person who is to be examined arising from discontinuating the screening programme,
d) the inconvenience or other adverse effects associated with undergoing the examination.
2.
The information referred to in 1 shall be provided in such a way that it may reasonably be assumed that the
person concerned has understood its contents. The latter shall be given sufficient time to enable him, on the
basis of this information, to reach a carefully considered decision concerning the consent that has been
requested.
Ill-9
3.
If the person to be examined is not yet 12 years old or is unable to exercise reasonable judgment in the matter,
the person carrying out the examination shall ensure that the individual concerned is given information in a
manner appropriate to his ability to understand.
Article 4
Without prejudice to the provisions of Article 4(1) of the Act, applications for an authorisation as referred to in
Article 3(1) of the Act shall include:
a) the dates on which the screening programme will commence and end;
b) a detailed description of the purpose of the programme;
c) a detailed description of the potentially detrimental effects of the screening programme;
d) a description of the type and layout of the areas or rooms where the screening is to take place.
Article 5
1. Where application is made for an authorisation concerning a screening programme in which X-ray equipment
is used and where the use of such equipment requires an authorisation under the Nuclear Energy Act, a copy
of the latter authorisation or of the application for such an authorisation shall be submitted.
2.
Where application is made for an authorisation concerning a screening programme for a serious disease or
disorder which cannot be treated or prevented, the said application shall contain a description of the special
circumstances justifying the programme in question.
Article 6
This Decree shall enter into force on a date to be determined by Royal Decree.
Article 7
This Decree may be cited as the Population Screening Decree.
We order and command that this Decree together with the relevant explanatory memorandum shall be published
in the Bulletin of Act, Orders and Decrees (Staatsblad).
The Hague, 1 August 1995
Beatrix
The Minister for Public Health, Welfare and Sport
E. Borst-Eilers
Published on 5 September 1995
The Minister for Justice

W. Sorgdrager
III- 10
ANNEX 4:
COUNCIL OF EUROPE , COMMITTEE OF MINISTERS

RECOMMENDATION No. R (94)11
ON SCREENING AS A TOOL OF PREVENTIVE MEDICINE
I I I - 11
COUNCIL OF EUROPE
COMMITTEE OF MINISTERS
RECOMMENDATION No. R (94) 11
OF THE COMMITTEE OF MINISTERS TO MEMBER STATES

ON SCREENING AS A TOOL OF PREVENTIVE MEDICINE
(Adopted by the Committee of Ministers on 10 October 1994
at the 518th meeting of the Ministers' Deputies)
The Committee of Ministers,

Considering that the aim of the Council of Europe is to achieve a greater unity between its members and that this aim may
be pursued, inter alia, by the adoption of common action in the public health field;
Noting that chronic diseases are the major causes of death and a high social and economic burden in developed countries;
Considering that screening for the early detection of some of these diseases could, in principle, provide a method for their
control;
Considering that, as yet, there is no absolute proof of the value of screening and early treatment in most diseases;
Considering that few, if any, diseases can at the present time be regarded as fulfilling all the desirable criteria for screening,
and that the recommended evaluative procedures are not often carried out in full;
Recognising that the implementation of widespread screening programmes raises major ethical, legal, social, medical,
organisational and economic problems which require initial and ongoing evaluation;
Taking into account the provisions of the Europe an Convention on Human Rights and of the European Social Charter;
Bearing in mind the Convention for the protection of individuals with regard to automatic processing of personal data of
28 January 1981, as well as the provisions of Recommendation No. R (81) 1 on regulations for automated medical banks and
Recommendation No. R (83) 10 on the protection of personal data used for purposes of scientific research and statistics,
Recommends to governments of member states that they take account in their national health planning regulations and
legislation of the conclusions and recommendations set out in the appendix to this recommendation.
Ill-12
Appendix to Recommendation No. R (94) 11

/. Introduction
1.1. For the purposes of this recommendation, screening means applying a test to a defined group of persons in order to identify
an early stage, a preliminary stage, a risk factor or a combination of risk factors of a disease. In any case it is a question of
detecting phenomena, which can be identified prior to the outbreak of the disease.
1.2. The object of screening as a service is to identify a certain disease or risk factor for a disease before the affected person
spontaneously seeks treatment, in order to cure the disease or prevent or delay its progression or onset by (early) intervention.
1.3. The value of existing forms of screening for infectious diseases is fully acknowledged but these established methods are
not considered in detail in this recommendation. Emphasis is made on screening for chronic degenerative non-communicable
disorders.
1.4. Screening is only one method of controlling disease. It should be viewed in the whole context of reducing the burden of
ill health to the individual and the community by, for example, socio-economic, environmental measures, health education and
improvement of existing health care and disease prevention systems.
1.5. Environmental factors are recognised as important contributors to disease, but inherited factors may also play an important
role. With the advent of new genetic knowledge, an increasing number of genetic diseases and genetic risk factors for disease
will be identified and offer the possibility for new screening procedures. As the procedures for genetic screening are not fully
established nor fully evaluated, they have not been included in this recommendation.
1.6. The present position is that the implementation of screening in European countries is fragmentary, with few national
screening programmes for the total population but many screening schemes restricted to population groups.
1.7. Because there are differences in health needs and health services, as well as in ethical values and in legal norms and rules
between countries, the decision to implement a particular screening programme should be taken in cooperation with the medical
profession by each country. Nevertheless there are common general principles and problems which are equally relevant to all
systems.
1.8. Screening is a tool which is potentially capable of improving the health of the population but it also has adverse effects.
Constant care should be taken to ensure that in any screening programme the advantages prevail over the disadvantages.
1.9. The general benefits of screening are often described. It is, however, also important to be aware of the adverse effects which
can be:
- stigmatisation and/or discrimination of (non) participants;
- social pressure to participate in the screening and undergo the intended treatment/intervention;
- psychological distress where there is no cure for the disease or where the treatment and/or intervention is morally
unacceptable to the individual concerned;
- exposure to physical and psychological risks with limited health gains;
- creation of expectations which probably cannot be fulfilled;
- individuals who are positively screened might experience difficulties such as access to insurance, employment, etc.;
- severe side effects of invasive clinical diagnosis of false positives;
- delay in diagnosing false negatives ;
- unfavourable cost-benefit relationship of a screening programme.
1.10.
The various problems which are encountered in the introduction and provision of screening interrelated. Nevertheless,
a distinction may be made between those concerned with:
i. ethical and legal issues;
ii. selection of diseases (medically) suitable for screening;
iii. economic aspects and evaluation of screening ;
v. quality assurance;
v. organisation of a screening programme ;
vi. scientific research.
Ill- 13
2. Ethical and legal values

2.1. Effectiveness is a necessary prerequisite for the screening to be ethical. It should none the less be kept in mind that
screening can be effective and still unethical.
2.2. Advantages and disadvantages of screening for the target population and the individual must be well balanced, taking into
account social and economic costs, equity as well as individual rights and freedoms.
2.3. Failure to make known information on the positive and negative aspects of the screening is unethical and infringes the
autonomy of the individual.
2.4. The decision to participate in a screening programme should, be taken freely. The diagnoses and treatments which may
follow the screening should also require a free and separate consent. No pressure should be used to lead somebody to undergo
any of these procedures.
2.5. The right to privacy requires that the results of the tests as a general rule are not communicated to those who do not wish
to be informed, are collected, stored, and handled confidentially, and adequately protected. It is preferable not to screen
individuals who do not wish to be informed of the results of the screening.
2.6. Neonatal screening can only be justified if the intervention is of direct health benefit to the child. Otherwise screening
should be postponed until the child can decide for itself.
2.7. No personal data derived from the screening should be communicated to third parties unless the data subject has given
consent to it or in accordance with national law.
2.8. When a screening programme is provided as a service and conducted also for research purposes, the decision to make
available personal medical data stemming from the screening programme for research purposes should be taken freely, without
undue pressure.
The decision not to take part in the research should not in any way prevent the individual from participating in the
screening programme.
3. Criteria for selecting diseases suitable for screening
3.1. The disease should be an obvious burden for the individual and/or the community in terms of death, suffering, economic
or social costs.
3.2. The natural course of the disease should be well-known and the disease should go through an initial latent stage or be
determined by risk factors, which can be detected by appropriate tests. An appropriate test is highly sensitive and specific for
the disease as well as being acceptable to the person screened.
3.3. Adequate treatment or other intervention possibilities are indispensable. Adequacy is determined both by proven medical
effect and ethical and legal acceptability.
3.4. Screening followed by diagnosis and intervention in an early stage of the disease should provide a better prognosis than
intervention after spontaneously sought treatment.
4. Economic aspects
4.1. The increasing financial burden of health care makes it necessary to assess the economic aspects of screening. However
these aspects should not be the overriding consideration. In all screening programmes human consideration regarding the value
and quality of life, life expectancy as well as respect for individual rights are of prime importance.
4.2. Economic assessments are necessary to enable rational decisions to be made on the priority to be given to alternative ways
of using health resources.
4.3. Measurement of the economic aspects of screening is not fully mastered. Early detection and treatment may be less
expensive than late treatment. However, available studies relate only to present screening costs and further work is necessary
to determine possible cost control in the long term.
4.4. Non systematic screening or spontaneous screening results in high marginal costs. Only systematic screening is able to
provide means for controlling cost. Therefore, constant care should be taken to ensure that in any screening programme the
allocated resources are used in an optimal way.
5. Quality assurance
5.1. Screening should aim at the highest possible standards of quality from the medical and organisational point of view.
5.2. Because of the expectations that screening creates as well as its adverse effects, screening should meet the highest quality
assurance standards in all its aspects.
Ill- 14
5.3. An assessment of the scientific evidence of the effectiveness of screening in the control of a disease should be made by
experimental studies before introducing a screening programme as a service. The practical arrangements for a mass screening,
which are directly linked to the health structures and systems, should obtain the same effectiveness as that obtained in the
randomised trial.
5.4.
Having implemented a screening programme, it should be subjected to continuous independent evaluation.
Evaluation will facilitate adaptation of the programme, correction of deficiencies noted and verification of achievement of
objectives. The adverse effects of the screening programme should not be ignored in the evaluation which should be carried out
by independent public health experts.
5.5. If quality assurance standards are not met in the long term it should be possible for the screening programme to be
corrected, and, if this is not possible, stopped.
5.6. The programme must evaluate participation, and the percentage of people screened in the target population, the technical
quality of testing and the quality of diagnosis and treatment provided as a follow-up for persons with a positive test result.
Severe side effects of false positives should be revealed and evaluated.
5.7. There is a need for more teaching of medical students in epidemiology and its application to measuring the effects of
screening. Similarly post-graduate education in this field is also needed to enable practising doctors to understand the principles
and evaluation of screening. .
5.8. Provision of screening programmes requires that training in techniques and interpretation of screening tests is included in
undergraduate and post-graduate medical teaching programmes.
5.9. A screening programme requires resources in both staff and technical facilities for carrying out the screening tests. In many
instances tests can be performed by non medical staff. Provision should be made for initial and further training of the medical
and technical staff who will be involved in performing the screening tests and interpreting their results. Technical methods,
including automated techniques, are useful in screening for some diseases. Quality of screening methods should be monitored.
6. Organisation
6.1. The organising body of a screening programme should be held responsible throughout the programme. The organisation
of a screening programme should comply with what is described in national guidelines and protocols.
6.2. Within the organisational framework the target population should be defined (by age or otherwise) as well as the frequency
of screening tests and the general and specific objectives and quality assurance guidelines.
6.3. It must be stressed that screening cannot succeed without co-operation between preventive and curative systems.
Organisation must be tailored to the structures of the health system. If appropriate structures in the curative health care system
arc lacking, screening should not be implemented until they are developed (pilot programmes, for example). There are various
degrees to which screening services may be integrated with curative services or develop as a separate speciality. The advantages
and disadvantages of these should be assessed separately in different health care systems.
6.4. Provisions should be made for the financing of the pro me, the cost of organising and evaluating the structure, the cost of
testing, the cost of quality assessment and monitoring, and the cost of the follow-up care of those people who screen positively.
6.5. Process and outcome indicators should be constantly evaluated.
6.6. Systematic collection of data is required in screening programmes to serve the needs of the individual and of the health
service. To that end, data should be collected on the target population, on persons screened (with dates and the results of the test
carried out), and on the results of eventual diagnostic examinations. Access to a morbidity register considerably facilitates
evaluation.
6.7. Adequate protection of all data collected by means of a screening programme should be guaranteed.
6.8. Participation of the public in screening programmes is determined by personal factors (for example attitudes, motivation
and anxiety) and by situational factors (waiting time and efficient organisation, for example). These can be influenced for
instance by health education and by good organisation of the screening procedure,
6.9. In order to ensure optimal participation by the target population, the best possible information should be widely provided
and awareness-raising and education programmes should be organised for both the target population and the health professionals.
6.10.
Invitations should be accompanied by written information on the purposes and effectiveness of the programme, on
the test, on potential advantages and disadvantages, on the voluntary nature of participation and on how data will be protected.
An address should be provided for those who require further information.
6.11.
Participants should be informed on how, when and where their test results will be available or will be communicated
to them.
Ill- 15
6.12.
The positive results found at screening should always be confirmed by subsequent diagnostic tests before commencing
a treatment/intervention, unless the screening test is a diagnostic test. It is absolutely essential that adequate diagnostic facilities
are available to confirm or reject the screening finding as soon as possible. Similarly, treatment facilities must be available and
easily accessible to the confirmed cases. The work load placed on the health services by screening can be very large, especially
since most screening programmes also lead to incidental pathological findings unrelated to the disease at which the programme
is aimed.
6.13.
Combining screening for several diseases into a multiple screening procedure may seem to be convenient to the
individual and economic to the programme, but such a "package deal" may negatively influence the extent to which most of the
criteria for screening including age limit and frequency would be met.
7. Research
7.1. Research into new, more effective, screening tests must be encouraged and the long-term effects of the various methods
of treatment and provision for positive subjects studied. Research must be further developed to answer the numerous social,
ethical, legal, medical, organisational and economic questions as well as psychological problems raised by screening, on which
evidence is incomplete.
7.2. Quality assurance concerning research programmes should be conducted into the effectiveness of the various screening
tests, the practical arrangements for screening, the measures to increase participation, the means of improving test efficiency,
follow-up to and provisions for those screened positive, an assessment process and all the economic aspects.
7.3. Information gathered during screening should be available for the purpose of scientific research, for the improvement of
health services, and for the benefit of future screening, taking into account full respect of autonomy and confidentiality and the
protection of personal privacy.
8. General remarks
8.1. It is particularly important that political decision-makers and target groups should be kept informed of the current state of
knowledge about the value of screening for particular diseases. Improved communication should be encouraged.
8.2. Governments should promote the research and evaluation necessary for assessing the value of both new and existing
programmes. This form of research necessarily means large-scale research which, in some instances, may be designed as
international collaborative studies. Scientific evaluation is the only way in which the positive and negative effects of screening
can be assessed in order that a rational decision can be taken on whether a screening programme should be implemented and
what resources should be allocated.
Quality assurance (as defined by World Health Organization) .
" All those planned and systematic actions necessary to provide adequate confidence that a structure, system or component will
perform satisfactorily in service (ISO 6215- 1980). Satisfactory performance in service implies the optimum quality of the entire
diagnostic process i.e., the consistent production of adequate diagnostic information with minimum exposure of both patients
and personnel."
Quality control (as defined by World Health Organization) :
"The set of operations (programming, co-ordinating, carrying out) intended to maintain or to improve [...] (ISO 3534-1977).
As applied to a diagnostic procedure, it covers monitoring, evaluation and maintenance at optimum levels of all characteristics
of performance that can be defined, measured, and controlled."
Ill
ANNEX 5:
(EXECUTIVE SUMMARY OF EUR 16263)
J. Zoetelief, M. Fitzgerald2, W. Leitz3, M. Sbel4
TNO Centre for Radiological Protection and Dosimetry

P.O. Box 9034
6800 ES Arnhem
The Netherlands
The Radiological Protection Centre
St. George's Hospital
Blackshaw Road
London SW17 OQT
United Kingdom
Statens Strlskyddinstitut
17116 Stockholm
Sweden
Klinik fr Frauenheilkunde der Universitt
Universittsstrasse 21/23
D 91054 Erlangen
Germany
Advisors
D.R. Dance, London, UK
M. Gambaccini, Ferrara, I
J.T.M. Jansen, Rijswijk, NL
C. Maccia, Cachan, F
B.M. Moores, Liverpool, UK
H. Schibilla, Brussels, EC
M.A.O. Thijssen, Nijmegen, NL
December 1995
III- 17
EXECUTIVE SUMMARY
Application of the general principles of radiation protection to medical diagnostic radiology implies that
each procedure using X rays or radionuclides is justified and optimized. For diagnostic radiology, including
mammography, optimization means that the radiation exposure of the patient should be kept as low as
possible, but compatible with the image quality necessary for an adequate diagnosis.
The purpose of the European Protocol on Dosimetry in Mammography is to provide dosimetric methods
which can serve to increase the awareness of the dose variations due to differences in technique and/or
equipment and facilitate the comparability of dose values reported according to national protocols. For
countries where national guidance and protocols are not yet available the present protocol provides
consistent methods of dose measurement and assessment. The present protocol is also intended to
supplement the European Protocol for the Quality Control of the Technical Aspects of Mammography
Screening.
The present protocol includes several dosimetric approaches reflecting the various reasons why dosimetry
is necessary and the different methods given in national and European protocols and working documents:
1.Measurement on patients (Chapter 1, Appendix A1). This covers determination of Entrance surface
air kerma (ESAK) for patients employing either thermoluminescent dosemeters (TLDs), issued and read
out by a central laboratory, or calibration of tube output with an appropriate dosemeter.
2.Measurements with a standard phantom (Chapter 2, Appendix A2). ESAK is determined for a standard
phantom using TLDs from a central laboratory or through the calibration of tube output with an
appropriate dosemeter.
3.Determination of average glandular dose (Chapter 3, Appendix A3). Average glandular dose (AGD)
is calculated from ESAK using conversion factors as a function of measured half-value layer (HVL). This
can be achieved using either the standard phantom or a representative selection of patients.
Although differences between entrance surface dose (ESD) and ESAK are for mammography, in the order
of about 10 per cent at maximum, determination of the ESAK is preferred since almost all national protocols
include the determination of ESAK.
Chapters 1, 2 and 3 on the various methods of dose assessment should be of interest to doctors,
radiologists, radiographers and screening managers. For situations where dose measurements cannot be
provided locally, the readers are referred to Sections 1.1 and 2.1 for the determination of ESAK for patients
and the standard phantom, respectively. When dosimetry is locally accessible, either through special
training of staff and/or availability of a physicist, Sections 1.2 and 2.2 are relevant for determination of
ESAK for patients or the standard phantom, respectively. The determination of AGD (Chapter 3) enables
a more direct assessment of the potential radiation risk.
Each type of measurement has its own "stand alone" protocol. The most appropriate method for a specific
user can be derived from the flow diagram presented in the section on "Guidance on use of the document".
The appendices corresponding to the measurement methods are intended to provide additional information
on the dosimetric approaches. Appendix A4 provides a summary of dosimetric methods recommended in
national protocols and tables to convert results according to national protocols into values according to the
European Protocol. Appendices A5 and A6 are mainly intended for those interested in additional scientific
information.
The present protocol is directly linked to the European Working Document on Quality Criteria for Diagnostic
Radiographic Images and related Trials (Section 1.1), the European Guidelines for Quality Assurance in
Mammography Screening including the European Protocol for the Quality Control of the Technical Aspects
of Mammography Screening (Section 2.2) and existing national protocols (Appendix A4).
For those performing mammography, the present protocol is intended to increase the awareness
concerning general radiation protection principles, needs for quality control of dosimetric aspects of
mammography and optimization of day-to-day practice.
m-18
FOREWORD
Mammography as a radiological technique for breast cancer detection is receiving particular attention by
several programmes and initiatives of the Commission of the European Communities. Special efforts for
its optimization are supported by the programmes "Europe against Cancer" and "Regulatory Aspects and
Research Actions in Radiation Protection", as well as by "VALUE" which is the specific programme for the
dissemination and utilization of scientific and technological research results.
Various actions were taken in the 1990-1994 period:
strategies for optimizing of the functioning of mammography screening centres were developed, giving
rise to the definition of reference centres for guidance in quality assurance and quality control;
the concept of quality criteria was set up, dealing with image criteria, image details, parameters of good
radiographic techniques, and criteria for radiation dose to the patient, including reference dose values;
trials were carried out in nearly all European countries on the practical application of the quality criteria;
workshops were organized for the discussion of more standardized quality control tools and methods,
for specifying the requirements oftest phantoms for mammography and for assessing the perspectives
of digitization in mammography.
For the effective implementation of the conclusions of these actions, the "European Guidelines for Quality
Assurance in Mammography Screening" were published, including a European Protocol for the Quality
Control of the Technical Aspects of Mammography Screening.
During the elaboration of these European Guidelines it became evident that dose measurement is a crucial
part and requires special definitions and guidance for a standardized approach. Thus the present protocol
specifies some of the most practicable methods and levels of possible accuracy of dose measurements in
mammography. It should allow for comparability and evaluation of dose data that will be acquired from now
on, whilst increasing at the same time the awareness of the need for periodical quality control and radiation
protection measures.
Mrs. S. Blanco
Dr. H. Eriskat
Europe against Cancer Radiation Protection
DGV 1
DGXI 1
Directorates-General involved:
DG V:
DG XI:
DG XII:
DG XIII:
Dr. C. Gitzinger
VALUE
DGXIII 1
Dr. J. Sinnaeve
Radiation Protection Research
DG XII1
Employment, Industrial Relations and Social Affairs

Environment, Nuclear Safety and Civil Protection
Science, Research and Development
Telecommunications, Information Market and Exploitation of Research
III- 19
INTRODUCTION
The general radiation protection principle of the International Commission on Radiological Protection (ICRP)
postulates that all exposures "should be kept as low as reasonably achievable". In the case of medical
radiology this implies that each procedure is justified and optimized (ICRP 1977, ICRP 1991). The 1977
recommendations of the ICRP formed the basis of the radiation protection policy of the Commission of the
European Communities (CEC) as formulated, e.g., in the Council Directive 84/466/Euratom of 3 September
1984 laying down basic measures for the radiation protection of persons undergoing medical examination
or treatment" (CEC 1984). For diagnostic radiology, optimization means that the radiation dose to the
patients should be kept as low as possible, but still providing images compatible with the clinical
requirements. The CEC Directive states explicitly in Article 3 that "all (radiological) installations in use must
be kept under strict surveillance with regard to radiological protection and the quality control of appliances".
According to these principles, an assessment of the dose to the breast constitutes an important part of
quality control for mammography, including symptomatic women and those involved in screening
programmes. The method of dose evaluation must be carefully defined in order to allow comparisons of
radiation exposure and the assessment of carcinogenic risk.
Since the introduction of the molybdenum anode X-ray tube equipped with a molybdenum K-edge filter in
1969 there has been a growing interest in the evaluation and comparison of absorbed doses in
mammography. Early dosimetric investigations concerned mainly the determination of entrance surface
dose (including backscatter) for (mostly small) samples of patients as well as for breast phantoms.
Measurements on patients yielded information about the variation of radiation exposure and its dependence
on breast thickness and tissue composition. The use of phantoms facilitated the comparison of different
mammographie techniques and studies on the influence of technical aspects on absorbed dose.
At the beginning there was some uncertainty concerning the thickness and chemical composition of a
phantom which should represent the average breast, i.e. produce a value of entrance surface dose which
was approximately the same as the mean value of an unselected larger sample of patients. Especially in
relation to quality control, polymethylmethacrylate (PMMA) phantoms with a thickness ranging from 40 to
50 mm were proposed. As a compromise, in this protocol a 45 mm thick PMMA phantom ("the standard
phantom") is assumed to represent approximately the average breast (Chapter 2) with regard to attenuation
and scatter properties of the incident ionizing radiation.
When it became evident that mammographie screening could be an effective tool to reduce breast cancer
mortality, there was increasing interest in the assessment of radiation risk. It was obvious that entrance
surface dose could be used as an indicator of radiation exposure in certain simple comparison cases, but
that this quantity was a poor indicator of carcinogenic risk. Presently, it is largely accepted that the average
dose to the glandular tissue, most usefully characterizes the risk of carcinogenesis. This dosimetric quantity
is recommended e.g. by the International Commission on Radiological Protection (ICRP 1987), the British
Institute of Physical Sciences in Medicine (IPSM 1989, IPSM 1994), the Netherlands Commission on
Radiation Dosimetry (NCS 1993) and the United States National Council on Radiation Protection and
Measurements (NCRP 1986). It is also adopted in this protocol.
Average glandular dose cannot be measured directly, but is generally calculated under certain assumptions
(concerning mainly the tissue composition of the breast) from dose quantities determined at the position
of the entrance surface of the breast (Chapter 3). In this context entrance surface air kerma (ESAK)
free-in-air (i.e. without backscatter) has become the most frequently used quantity. To avoid confusion,
III-20
efforts are made in this protocol to differentiate between ESAK (without backscatter) and entrance surface
dose (ESD, including backscatter), both quantities using air as the reference material.
The preceding more historical remarks already demonstrate the need of a harmonizing European protocol
on dosimetry in mammography. The following reasons emphasize this necessity:
A project for the establishment of quality criteria for diagnostic radiographic images was initiated by the
CEC in 1987. The main objective of this project was to contribute to a standardization of quality criteria
and to the production of comparable radiographs throughout Europe. After an initial trial (Maccia et al
1989) for six common examinations, including mammography, a working document on "Quality Criteria
for Diagnostic Radiographic Images" (CEC 1990) was issued and circulated among professional radiology
associations. In order to validate and demonstrate the usefulness of this document a second trial was
carried out in 1991. A first evaluation of this trial (Maccia et al 1993) shows excessively high doses in a
number of cases, thus demonstrating that serious problems exist. When local expertise or resources are
lacking, the accessability of dosimetry provided by a central laboratory will be of help to detect
unnecessarily high doses and indicate follow-up actions.
The "European Guidelines for Quality Assurance in Mammography Screening" (CEC 1993) contain as
an appendix a "European Protocol for the Quality Control of the Technical Aspects of Mammography
Screening". The protocol however does not include detailed information on the determination of the dose
to the breast. The "European Protocol on Dosimetry in Mammography" will supplement the quality control
protocol and contribute an answer to some of the points raised.
Mainly in relation to mammographie screening different national protocols exist, which deal in varying
extent with the evaluation of absorbed dose as a part of quality assurance; examples are the protocols
of Germany (DGMP 1986), France (GIM 1993), the United Kingdom (IPSM 1989, IPSM 1994), the
Netherlands (NCS 1993), the Nordic countries (NRPA 1991), Spain (SEFM/SEPR 1993) and Italy (ISS
1995). For these countries a European Protocol can serve to facilitate the comparability of the reported
dose values. For other countries the present protocol provides consistent methods of dosimetry.
Concerning the assessment of doses in diagnostic radiology, the "1990 Recommendations of the ICRP"
state that "periodic measurements should be made to check the performance of equipment and to
encourage the optimization of protection" (ICRP 1991, para. 272), and that "consideration should be given
to the use of dose constraints, or investigation levels, selected by the appropriate professional or
regulatory agency" (ICRP 1991, para. S34). The present protocol can help to comply with these
recommendations and to establish reference or limiting dose values as a criterion for good mammographie
practice.
The present protocol includes several dosimetric approaches reflecting the various reasons why dosimetry
is necessary and the different methods given in national and European protocols and working documents:
1. Measurements on patients
2. Measurements with the standard phantom
3. Determination of average glandular dose
To allow facilities where expertise and local resources are lacking, the possibility to obtain an impression
of the radiation exposure associated with their mammographie technique, most appropriate methods using
dosemeters provided by a central laboratory are presented. Dosemeters from a central laboratory can be
applied for a sample of patients (Section 1.1 ) or a phantom (Section 2.1). The dosimetric approach in the
case of mammography screening will be the measurement of ESAK with the standard phantom, which is
described in Section 2.2. When dosimetric equipment and expertise is not accessible in-house, ESAK for
III - 21
the standard phantom can be obtained through dosemeters provided by a central laboratory (Section 2.1).
For screening it is desirable to determine the average glandular dose (Chapter 3).
Each type of measurement is presented in a separate section and is self contained. The most appropriate
method for a specific user can be derived from the flow diagram presented in the section on "Guidance on
use of the document".
The three approaches of dose determination are described in Chapters 1 to 3 of this protocol; these
chapters should be of interest to doctors, radiologists, radiographers and screening managers. Additional
information to these dosimetric methods is given in the Appendices A1 to A4; which are mainly intended
for those interested in the scientific background to the chapters (primarily physicists) and to highlight
available scientific information and existing problems. Appendices A5 and A6 provide more general
background information on technical parameters influencing absorbed dose and on the carcinogenic risk
of mammography. The protocol also includes a definition of terms and references to the scientific literature.
Since the techniques of mammographie imaging and the methods of dose evaluation are subject to further
improvement, the protocol has to be updated regularly.
Those facilities performing mammography, especially in screening programmes, that have not yet
established routine dose assessment procedures are strongly encouraged to follow this protocol.
Ill - 22
ANNEX 6:
In December 1994 the European Commission funded a European consensus Conference on the role
of General Practitioners in cancer screening in order to clarify some of the issues involved and to
seek the opinion of General Practitioners on their role in cancer screening. The following are the
conclusions of this conference.
EUROPEAN CONSENSUS ON THE ROLE OF GENERAL PRACTITIONERS IN WOMEN'S CANCER

SCREENING
FLORENCE, 2nd - 3rd DECEMBER 1994
At the Second European Conference on the role of GP's in women's cancer screening in Florence, 2nd 3rd December 1994, the following comments were made summarising the recommendations made at The
Hague (Satellite Conference of WONCA Congress - June 1993).
Primary Health Care should always be involved from the beginning when organizing Secondary Preventive
programmes, which should themselves (where possible) be developed in the context of national preventive
programmes, including Primary Prevention.
The general practitioner, as a front-line doctor has a special role in counselling patients on all individual
preventive and health issues. Screening for specific diseases should therefore always be considered in the
context of comprehensive family medicine (which involves previous knowledge of the patient including
physical, psychological and social aspects).
The key role of the GP includes facilitating aspects of patient care. His involvement in setting up screening
programmes is however influenced by the different health care systems in various countries which fall
broadly into the two groups shown below.
1.
2.
General Practitioners function as the point of access to the system (including access to specialist
care), and registration of patient at primary care level is required.
There are some differences in detail between these systems in different countries including the
distribution of tasks for the GP.
In this type of system direct access to specialists without referral is possible and there is no formal
need for registration with a general practitioner. This will be referred to in this document as "open"
system.
An essential element for the organisation of screening programmes is the centralisation of Individual medical
data to allow adequate coordination of care and to favour provision of information and counselling whenever
needed by the women. Steps should therefore be taken to ensure that all patients' medical data are
summarised and stored at primary physician level, so appropriate individual comprehensive personal
counselling can be obtained from the general practitioner.
SETTING UP OF SCREENING PROGRAMMES

Screening programmes should be set up in all European countries in accordance with the guidelines of the
III-23
Europe Against Cancer programmes, taking into account all local circumstances. Sufficient financial sources
for the setting up (planning phase) as well as the accomplishment of the programme must be available prior
to the start in order to ensure that all those in the target group can take part, including the socially deprived;
In principle screening should be free of charge.
Programmes should involve a Steering Committee truly representative of local General Practitioners and
all other professionals involved in the screening process. Within this committee a consensus should first
be reached concerning all issues of screening, in accordance with national and international guidelines. If
national consensus exists, it should be thoroughly discussed and made applicable to local situations.
This consensus should, In particular relate to following points:
- Target population
- Frequency and access
- Programme and organisation
- Task definition and task distribution (programme, GP's, specialist care, health administration)
- Practice organisation and support
- Assessment and therapeutic protocols
- Follow up
- Training and CME of GP and other personnel
- Public education
- Monitoring and feedback to GP
- Quality assurance
In accordance with accepted ethical principles, adequate treatment facilities must be available before
implementation of screening programmes
The role of GP can be promoted by:
- Involvement of GP representatives in consensus development
- Development of both general and practice guidelines
- Setting realistic targets at programme and practice level
- Setting up networks involving GP
- Specific educational programmes (CME) relating to all aspects of screening
- Provision of educational material (practice and public)
- Clear statements to the public by the profession and health authorities that the GP has a central role In
screening in all systems of health care where GP's should Ideally be involved before the screening and
always after mammography
- Economic incentives (adequate remuneration for technical act and administration)
-Always involving GP representatives in the design of the screening programmes from the beginning
AIMS AND TASKS
A number of specific alms, requirements and tasks were identified. The responsibility for these tasks is
different according to the healthcare system. An indicative table was set up for Cervical and Breast
Screening. (See annexe 1)
As Breast Cancer Screening differs from Cervical Cancer Screening in detection of cancer instead of
precancerous lesions, the following differences should be kept In mind:
1.
The GP is not performing the screening test.
2.
The GP's orientation is towards ensuring participation and providing counselling rather than
m - 24
carrying out technical procedures.

It should be noted that nothing In this document Implies that, In particular in open systems, Individual
patients should not be referred for mammography or colposcopy.
GENERAL RECOMMENDATIONS FOR CERVICAL AND BREAST CANCER SCREENING

Organised programmes for Breast and Cervical Cancer Screening should be set up in accordance with the
"Europe against Cancer" guidelines
Such programmes must have a clearly defined systematic population approach (invitation, public health
education).
Educational materials (leaflets) should be specifically designed for the programme and be sufficiently
accessible potential to participants.
When possible, invitations and reminder letters should be sent and signed by the GP himself and lists of
non-attenders should be flagged.
Assessment and therapeutic protocols should be available and accepted by consensus between all
professionals involved.
A fail safe mechanism to ensure adequate work-up is the responsibility of the programme. When a woman
fails to attend, the GP should be Informed. The GP should cooperate with this system.
Task definition and description should help GPs to plan their activity. An acceptable task definition and task
distribution should be part of any programme. Task distribution and task definition are essential in relation
to practice staffing. Training of paramedical and other assistants of general practice in a practice based
prevention approach, are beneficial.
Feed back about practice performance in relation to set principles is essential to permit improvement In the
overall process. The Public should be informed about the role in screening defined for primary health care
and learn how to use the services provided.
Public health education and community involvement is useful in changing the professional attitude towards
a more proactive and systematic preventive approach.
Organizational support of practices from programme level Is a definite need. Direct practice support should
be further investigated.
Where possible, systematic screening should be used but there are circumstances in which an opportunistic
approach may be necessary. Opportunistic preventive testing In daily general practice needs further study.
Studies should be organized on the best ways of reducing the psychological side effects of screening,
including those associated with reporting abnormal findings.
Practical training in a pro-active approach to patients seems feasible and Is recommended.
Practical support strategies within programmes should:
- Actively use continuous medical education facilities
- Involve GP teachers for peer groups
- Organize co-ordination between specialists and GPs
- Involve the media actively in discussing the role of GPs and creating a preventive environment of
- Involve members of the Public in presenting the results of their own experience as a means of promoting
screening
- Plan adequate financial sources
III - 25
- Stimulate practice automation

- Set realistic targets
Costs and benefits of different approaches should be evaluated to define priorities for local action.
PROPOSAL FOR FURTHER EUROPEAN ACTIONS
Due to the complexity, and the number of problems involved, and the time needed to come to a
representative and real European consensus on General Practitioners involvement and support in Cervical
and Breast Cancer Screening Programmes, the conference participants request the European Community
to support further meetings of a group of delegates from cancer screening projects, general practitioners'
associations and health general administrations. Their aim should be and to fine tune and officially adopt
the different principles regarding collaboration between General Practice, Screening Programmes and
Health Administrations.
It is suggested that a small expert group be set up to provide updating and advice about GP involvement
in cancer screening projects.
Constant updating of guidelines is required to take account fresh epidemiological and statistical data and
other studies (e.g. quality of life Issues, patient satisfaction, counselling experiences)
Research into the cost/effectiveness of using General Practitioners (where appropriate) rather than
specialists, In screening programmes, is required.
Ill-26
European Commission
European Guidelines for Quality Assurance in Mammography Screening
(2nd edition, June 1996)
Editors: Dr C. J. M. de Wolf and Dr N. M. Perry
Luxembourg: Office for Officiai Publications of the European Communities
1996 208 pp. 21 29.7 cm
ISBN 92-827-7454-6
Breast cancer is the commonest cause of cancer death among women. Of the women
currently affected by breast cancer approximately 75% are aged 50 or over. The
number of breast cancer deaths has doubled in absolute terms since 1960, the increase
being almost wholly accounted for by the growth in the size of the population and the
increasing age of the population.
Population screening for breast cancer is a major public health intervention and
experience shows that suitable performance parameters can only be achieved through
strict adherence to quality assurance guidelines. Since screening is targeted essentially
at asymptomatic women, the narrow balance between benefits and undesirable effects
is completely dependent on programme quality. Achievement of the objective, mortality
reduction, is inevitably long term. There are, however, important early performance
indicators which can predict outcome and which therefore must be accurately
documented. High quality data are essential.
The first edition of the European Guidelines for Quality Assurance in Mammography
Screening which was published in 1993 received considerable attention. The concept
of quality assurance of a medical intervention in a public health context was recognised
The Guidelines also gave a new impulse to the European Network of Breast Cancer
Screening to strive for higher quality of the pilot projects and initiated international
comparison and exchange of knowledge.
Revision of the guidelines has become necessary in the light of the experience gained
from the operation of screening programmes in Europe. For this second edition, full
guidelines for epidemiology and pathology are included.
The second edition of the European Guidelines for Quality Assurance in Mammography
Screening summarizes the current state of knowledge on systematic breast cancer
screening. The Guidelines are applicable to all units providing a breast screening
service but should also be observed by any mammographie facility involved in the
provision of symptomatic breast care.
* *
ISBN
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OFFICE FOR OFFICIAL PUBLICATIONS

OF THE EUROPEAN COMMUNITIES
L-2985 Luxembourg
9 789282"774540 l >

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EUROPEAN COMMISSION

EUROPEAN GUIDELINES FOR

EUROPE AGAINST CANCER

Cataloguing data can be found at the end of this publication

EUROPEAN GUIDELINES FOR QUALITY ASSURANCE IN MAMMOGRAPHY SCREENING

THE IMPORTANCE OF THE RADIOGRAPHER IN MAMMOGRAPHY SCREENING

THE ROLE OF THE RADIOLOGIST IN THE SCREENING PROGRAMME

GUIDELINES AND PROTOCOLS

QUALITY ASSURANCE IN THE EPIDEMIOLOGY OF BREAST CANCER SCREENING

QUALITY ASSURANCE GUIDELINES FOR PATHOLOGY IN MAMMOGRAPHY SCREENING

MACROSCOPIC EXAMINATION OF BIOPSY AND RESECTION SPECIMENS

USING THE HISTOPATHOLOGY REPORTING FORM

CLASSIFYING MALIGNANT NON-INVASIVE LESIONS

RECORDING PROGNOSTIC DATA

INDEX FOR SCREENING OFFICE PATHOLOGY SYSTEM

MEMBERSHIP OF WORKING GROUP

1. Introduction to the measurements

2. Description of the measurements

3. Daily and weekly QC tests.

Appendix 1: Calculation of film-parameters

Appendix 2: A method to correct for the film curve

Appendix 3: Typical values for other spectra and densities

Appendix 4: Sample Data Sheets

Quality Assurance as defined by the WHO (1982):

Quality Control as defined by the WHO(1982):

2. European network of reference centres (EUREF)

3. Key organisational aspects

To identify and invite eligible1 women for mammography screening.

See epidemiology glossary for full definition

Issue all invitations to screening

Issue reminder letters to non-attenders.

Issue appointments for assessment of screen detected abnormalities.

all exposures shall be kept as low as reasonably achievable;

appropriate dose constraints shall be applied;

Crude Cancer Detection Rate

Small Cancer Detection Rate

Interval Cancer Rate

Positive Predictive Value of Recommendation for Open Biopsy

Number of women invited.

Structure and Monitoring of QA

Technical Quality Control

To minimise the number of women

Onward referral to assessment.

To minimise the number of false

In the prevalent round the number of invasive

To maximise the number of cancers

In the prevalent round the number of invasive

To maximise the number of small

In the prevalent round the number of invasive

To minimise the number of

Benign to malignant biopsy ratio.

The most important criteria for an optimal cranio-caudal view are:

Eckardt S, Badellino F, Murphy GP. UICC meeting on breast-cancer screening in pre-menopausal

Frisell J, Eklund G, Hellstrm L, Lidbrink E, Rutqvist L-E, Somell A. Randomized study of

Kopans DB. Mammography screening for breast cancer. Cancer 1993;72:1809-1812.

Lidbrink E, Frisell J, Brandberg Y, Rosendahl I, Rutqvist L-E. Nonattendance in the Stockholm

Shapiro S. Screening: assessment of current studies. Cancer 1994;74:231-238.

Trnberg S, Carstensen J, Hakulinen T, Lenner , HatschekT, Lundgren B. Evaluation of the effect

II- A QUALITY ASSURANCE IN THE EPIDEMIOLOGY OF BREAST

Drs. M.J.M. BROEDERS

Prof. A.L.M. VERBEEK

QUALITY ASSURANCE IN THE EPIDEMIOLOGY OF BREAST CANCER SCREENING

DCK VI - TREATMENT OF SCREEN-DETECTED CANCERS

fixed cohort/dynamic cohort