European guidelines for quality assurance in mammography screening

European Commission Directorate-General For Employment Social Affairs And Inclusion

Description

Health policy

Sujets

• Cancer
• Medical diagnosis
• Preventive medicine

Informations

• Publié par: EUROPEAN-COMMISSION-DIRECTORATE-GENERAL-FOR-EMPLOYMENT_SOCIAL-AFFAIRS-AND-INCLUS
• Nombre de lectures: 33
• Langue: English
• Poids de l'ouvrage: 4 Mo

Extrait

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' χ 7'8" (243.9 χ 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 -1
2. European network of reference centres (EUREF) -2
3. Key organisational aspects -2
Conditions for breast cancer screening -2
Objectives -2
-3 4. QA programme
Identification of the target population -3
-4 Data-administrative System
-4 Screening age groups and intervals:
-4 The Screening Examination:
-4 Professional communication:
-4 Radiation Protection Considerations:
-5 Cost-effectiveness calculations:
-5 Training:
-5 Performance Indicators:
-6 5. Quality Maintenance
-7 6. Assessment Process
I - 2. THE IMPORTANCE OF THE RADIOGRAPHER IN MAMMOGRAPHY SCREENING -8
Compression -8
-8 Positioning
Personal communication -9
-9 Quality Assurance procedures
-9 Teamwork
-9 Training
I - 3 THE ROLE OF THE RADIOLOGIST IN THE SCREENING PROGRAMME -10
Introduction -10
Quality issues -10
Performance -10
-10 Assessment
Teamwork -11
-11 Interval cancers
I - 4 BIBLIOGRAPHY 1-12
GUIDELINES AND PROTOCOLS
II- A QUALITY ASSURANCE IN THE EPIDEMIOLOGY OF BREAST CANCER SCREENING
Introduction II - A -1
Block - Local conditions governing the screening process II - A - 3
BlockI - Invitation schemeI - A - 7
Block III - Screening process and further assessmentI - A -1
BlockV - Evaluation / outcomes of screeningt - A -19
Block V - Disease stage of screen-detected cancersI - A - 27
Block VI - Treatment ofd cancersI - A - 32
Block VII - Follow up and ascertainment of interval cancersI - A - 37
Block VIM - Impact on breast cancer mortality II - A - 40
Acknowledgements II - A - 41
Glossary of termsI - A - 42
II-Β CYTOPATHOLOGY GUIDELINES
IntroductionI - Β -1
Registering basic information II-B-2
Reporting categoriesI - Β - 3
Quality assuranceI - Β - 5 Il - C QUALITY ASSURANCE GUIDELINES FOR PATHOLOGY IN MAMMOGRAPHY SCREENING
INTRODUCTION II-C-1
MACROSCOPIC EXAMINATION OF BIOPSY AND RESECTION SPECIMENS -C-1
Biopsy Specimens -C-1
Mastectomy Specimens -C-3
Axillary Dissection Specimens -C-4
USING THE HISTOPATHOLOGY REPORTING FORM -C-6
Introduction -C-6
Recording Basic Information -C-6 g Benign Lesions -C-7
C-12 Classifying Epithelial Proliferation
CLASSIFYING MALIGNANT NON-INVASIVE LESIONS II C-15
High Nuclear Grade DCIS IC-15
Lowre DCISC-15
Intermediate Nuclear Grade DCISI - C -16
Mixed TypesI - C -16
Other histological typesI - C -16
Paget's diseaseI - C -17
Diagnosing MicroinvasionI - C -17
Classifying Invasive CarcinomaI - C -18
Invasive cribriform carcinomaI - 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
Il - D- 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 thes -D
-D 2.1 X-ray generation and control
-D 2.1.1 X-ray source
-D Focal spot size
-D Focal spot size: star pattern method
-D Focal spot size, slit camerad
-D Focal spot size, pinhole method
-D Source-to-image distance
-D Alignment of X-ray field/image receptor
-D-7 Radiation leakage
Tube output -D-7
2.1.2 Tube voltage -D-8
Reproducibility and accuracy -D-8
Half Value Layer -D-8
2.1.3 AEC-system -D-9
Optical density control setting: central value and difference per step -D-9 Guard timer II D-9
I- D-10 Short term reproducibility
Long termy D-10
D-10 Object thickness compensation
Tube voltagen D-10
D-10 2.1.4 Compression
Compression force D- 11
D - 11 n plate alignment
D-12 2.2 Bucky and image receptor
D-12 2.2.1 Anti scatter grid
D-12 Grid system factor
D-12 Grid imaging
D-12 2.2.2 Screen-film
D-12 Inter cassette sensitivity and attenuation variation
D-12 Screen-film contact
D-14 2.3 Film processing
D-14 2.3.1 Base line performance processor
D-14 Temperature
D-14 Processing time
D-14 2.3.2 Film and processor
D-14 Sensitometry
D-15 Daily performance
D-15
Artifacts
D-15
2.3.3 Darkroom
D-15
Light leakage
D-16
Safelights
D-16
Film hopper
D-16
Cassettes
D-17
2.4 Viewing conditions
D-17
2.4.1 Viewing box
D-17
Luminance
D-17
Homogeneity
D-18
2.4.2 Ambient light
D-18
Level I-
D-19
2.5 System properties
D-19
2.5.1 Dosimetry
D-19
Entrance surface air kerma
D-19
2.5.2 Image Quality
D-19
Spatial resolution
D-20
Image contrast
D-20
Threshold contrast visibility
D-20
Exposure time
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
I - D - 33 Appendix 1: Calculation of film-parameters
I - D - 34 Appendix 2: A method to correct for the film curve
I - D - 35 Appendix 3: Typical values for other spectra and densities
I - D - 37 Appendix 4: Sample Data Sheets ANNEXES
ANNEX 1:
RECOMMENDATIONS OF THE COMMITTEE OF CANCER EXPERTS ON BREAST CANCER
SCREENING Ill -1
ANNEX 2:
EUREF PROTOCOLl - 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."