CONSOLIDATED GUIDANCE ON STANDARDS FOR THE NHS BREAST SCREENING PROGRAMME

Transcription

1 CONSOLIDATED GUIDANCE ON STANDARDS FOR THE NHS BREAST SCREENING PROGRAMME NHSBSP Publication No 60 (Version 2) April 2005

2 Published by: NHS Cancer Screening Programmes The Manor House 260 Ecclesall Road South Sheffield S11 9PS Tel: Fax: Web site: NHS Cancer Screening Programmes 2005 The contents of this document may be copied for use by staff working in the public sector but may not be copied for any other purpose without prior permission from the NHS Cancer Screening Programmes. ISBN Further copies of this publication are available from the Department of Health Publications Orderline quoting NHSBSP Publication No 60 Tel: Fax: doh@prolog.uk.com Typeset by Prepress Projects Ltd, Perth ( Printed by Duffield Printers

3 CONTENTS Page No PREFACE v GLOSSARY OF TERMS 1 1. INTRODUCTION Aims and objectives for the NHSBSP National standards and quality assurance objectives Organisation of local breast screening programmes 3 2. NATIONAL STANDARDS Revised national standards Background incidence of breast cancer Changes to the invited screening age group Implementation of revised standards Coverage and uptake 5 3. MONITORING NATIONAL STANDARDS Data sources DH Statistical Bulletin NHSBSP Annual Review Monitoring national standards STANDARDS FOR ADMINISTRATION AND INFORMATION TECHNOLOGY Quality assurance guidelines Revised good practice guidance STANDARDS FOR MAMMOGRAPHY Quality assurance guidelines Quality control Staffing STANDARDS FOR RADIOLOGY Quality assurance guidelines Standards for non-operative diagnostic procedures Standards for working practices 18 NHSBSP April 2005 (Version 2) iii

4 7. STANDARDS FOR PATHOLOGY Quality assurance guidelines Pathology reporting STANDARDS FOR SCREENING ASSESSMENT Clinical guidelines STANDARDS FOR SURGEONS IN BREAST CANCER SCREENING Quality assurance guidelines STANDARDS FOR NURSES IN BREAST CANCER SCREENING Quality assurance guidelines STANDARDS FOR EQUIPMENT Standards for mammography equipment Digital mammography Ultrasound equipment Mobile mammography trailers STANDARDS FOR MEDICAL PHYSICS SERVICES Role of medical physics services Standards for medical physics services 31 REFERENCES 32 NHSBSP April 2005 (Version 2) iv

5 PREFACE This publication brings together standards for the NHS Breast Screening Programme (NHSBSP) in a single document. The standards have been developed by different professional quality assurance (QA) groups at different times. Some standards have been revised recently; some are still in the process of being revised. Because of this, there are inconsistencies in terminology and the presentation of standards. In addition, some standards may need to be revised as new techniques (such as digital mammography) come into routine use. This is the first version of this document; the intention is to review it and publish a revised edition when some of these issues have been resolved. NHSBSP April 2005 (Version 2) v

6 NHSBSP April 2005 (Version 2) vi

7 GLOSSARY OF TERMS Assessment Benign biopsy Cancers detected Coverage Criteria Early recall Eligible women Further tests Incident screen Minimum standards Non-operative biopsy Objectives Prevalent screen This is defined as further tests and does not include repeat examinations (see below). A benign surgical biopsy is an open surgical biopsy that results in a benign diagnosis histologically. More than one procedure on one patient at the same assessment visit will be counted as one biopsy. This applies to both invasive and in situ cancers. For this purpose, multiple cancers in one patient are counted as one cancer. If a woman has more than one cancer detected in one screening episode then the details of the most significant/worst should be recorded on the KC62 return. Coverage is defined as the proportion of women resident and eligible for screening who have had a screening mammogram at least once in the previous three years. Women who are ineligible (eg those who have had a bilateral mastectomy) are excluded. These are the parameters by which the achievement of the objective (or not) will be measured. This is now called short-term recall (but the term early recall is still used on the KC62 return). These are women aged years who are included in the call and recall system. These include all second appointments during which further procedures (including further views and/or clinical examination) beyond those normally undertaken at first appointment are carried out. These are women who have had a previous screening episode within the NHSBSP and are now rescreened. These figures represent the levels of performance that are the minimum acceptable for any breast screening unit. Where the minimum standard is shown as greater than or equal to, any level of performance below that standard should be investigated by the QA team. Where the minimum standard is shown as less than or equal to, any level of performance above that standard should be investigated by the QA team. Non-operative biopsy refers to needle core biopsy or fine needle aspiration (FNA). These are the aims of the NHSBSP in its operation in relation to specific quality issues. These are women who are being screened for the first time by the NHSBSP. NHSBSP April 2005 (Version 2) 1

8 Proportion of women invited who attend for screening Repeat examinations Screening round length Short-term recall Small cancers Targets Uptake Week The percentage of women who, having been sent an invitation for screening, attend a screening unit and undergo mammography in response to that invitation. No allowance is made for letters returned or refusals. This is calculated from KC62 and represents uptake not coverage. Repeat examinations include both those films repeated with the same view while the woman is still present in the unit, and those occasions when a woman is required to attend a second time to have a film repeated (same view) because of a technical inadequacy. Screening round length is the interval between the date of a woman s previous screening mammogram and the date of her next first offered appointment. A second invitation to attend an assessment clinic at less than the routine (three year) screening interval. The size of the cancer is determined by pathological measurement. These are the quantitative targets that are achievable individually by one-third of units within the NHSBSP. All units should aim to achieve these targets. If the specified cancer detection rates etc are achieved then the programme will be on target to replicate the mortality reduction achieved in trials. The percentage of women who, having been sent an invitation for screening, attend a screening unit and undergo mammography in response to that invitation. No allowance is made for letters returned or refusals. The national standard is for uptake. Uptake is sometimes referred to as acceptance. This is defined as one calendar week (seven calendar days). NHSBSP April 2005 (Version 2) 2

9 1. INTRODUCTION 1.1 Aims and objectives for the NHSBSP The aim of the NHSBSP is to reduce mortality from breast cancer. However, changes in mortality rates take too long to become evident and are compounded by factors outside the screening programme, such as more effective treatment. The NHSBSP has therefore identified operational objectives that can be used to monitor the management of the programme and to measure its effectiveness. The objectives of the NHSBSP are to: identify and invite eligible women for mammographic screening carry out high quality mammography on those women attending for screening provide services that are acceptable to those who receive them follow up all women who are referred for further investigations minimise the adverse effects of screening anxiety, radiation dose and unnecessary investigations diagnose cancers accurately make effective and efficient use of resources for the benefit of the whole population encourage the provision of effective and acceptable treatment that has minimal psychological or functional side effects evaluate the programme regularly and provide feedback to the population served and those working in the programme enable those working in the programme to develop their skills and potential and find fulfilment in their work support audit and research. 1.2 National standards and quality assurance objectives 1.3 Organisation of local breast screening programmes The purpose of this publication is to publish the revised national standards for the NHSBSP and to summarise the more detailed QA and other objectives that have been developed by the national professional QA coordinating groups and the national evaluation group. The NHSBSP national standards are a core set of objectives, criteria, minimum standards and targets that have been developed to measure the processes or outcomes of breast screening. They are shown in Chapter 2. In addition to the national standards, each national professional QA coordinating group in the NHSBSP has developed more detailed QA standards and standards for staffing, resources and working practices. These are summarised in Chapters A detailed discussion of the professional standards can be found in the relevant QA guidelines and other publications, which are given as references. Guidance on the organisation of breast screening programmes is given in Organising a Breast Screening Programme (NHSBSP Publication No 52, 2002). 1 The guidance makes recommendations for the organisation of local breast screening programmes and for the minimum size of population served to ensure that the programme can be properly quality assured and can meet the NHSBSP minimum standards. The minimum size for a breast screening programme is 9000 screening attendances per year of routinely invited women aged years. NHSBSP April 2005 (Version 2) 3

10 2. NATIONAL STANDARDS 2.1 Revised national standards 2.2 Background incidence of breast cancer National standards for the NHSBSP (previously published in NHSBSP Publication No 40) 2 have been reviewed by the national QA coordinating groups and the national evaluation group. The revised standards were agreed by the Advisory Committee on Breast Cancer Screening at its meeting in September The standards table and explanatory notes are shown in Table 1. Changes to the national standards have been made primarily in anticipation of the inclusion of the age group of women in the routine invitation system and in the new KC62 returns. Standards for the prevalent screen are not affected; there will be a marginal change in standards for incident screens. These revised standards are shown in bold type in Table 1. Some standards such as the detection of ductal carcinoma in situ (DCIS), image quality and radiation dose have also been revised to take account of improved scientific knowledge, experience in imaging the typical breast seen in screening, and changes in the clinical use of more advanced x-ray systems. The background incidence of breast cancer may be changing and this could be influencing cancer detection rates. This may explain the high standardised detection ratio (SDR) (1.14 in 1999/2000) being achieved. In the past, substantial changes in the SDR have been related to the change to two views at prevalent screens and to improvements to a small number of large individual programmes. Additional improvements may also be due to standardisation of film density, increasing experience of film readers and more extensive use of double reading in recent years. Any changes in background incidence will need to be incorporated into revised standards but this exercise has been deferred until the programme extension is complete. In order to estimate changes in background incidence in the absence of screening so many years after the start of the national programme, techniques such as age cohort modelling may be needed. Further techniques could include the development of methods to use relative changes in true interval cancer rates but this would need further discussion and considerable work. 2.3 Changes to the invited screening age group 2.4 Implementation of revised standards The aim of the NHSBSP is to reduce mortality from breast cancer in women in the invited screening age group. This age group was originally 50 64, and previous national standards were set based on this age group. The NHS Cancer Plan 3 announced the intention to extend the age range for screening invitation to include women up to and including the age of 70, and all breast screening programmes in England should be inviting women aged inclusive by the end of The revised national standards are based on the assumption that all women in the eligible population have been routinely invited from age 50 upwards. The revised national standards should be applied from 1 April 2004, with the caveat that unless the local programme has been screening women aged for three years then the previous standards for women aged for cancer detection rates (national standards 2 and 3), referral for assessment (national standard 7) and interval cancer rates (national NHSBSP April 2005 (Version 2) 4

11 standard 10) should be used. The previous standards and data sources for monitoring the standards for the age range are given in Chapter 3 (Table 2). Data sources for monitoring the revised standards are given in Table Coverage and uptake The first national standard measures the uptake of the breast screening programme, ie the proportion of women invited for screening for whom a screening test result is recorded. An alternative measure of the performance of the screening programme is coverage. Coverage is defined as the proportion of women eligible for screening who have had a test with a recorded result at least once in the previous three years. Coverage and uptake are illustrated graphically in Figure 1. a b c Figure 1 Coverage and uptake a = Eligible population b = Invited population c = Screened population Coverage = c/a 100% Uptake = c/b 100% The eligible population includes all women in the screening age range who are resident in the primary care organisation (PCO) area. In practice, the best measure of this is the number of women in the age range on the PCO register. The invited population is smaller than the eligible population because it excludes women who are eligible for screening but are not invited because either: they have made their own informed choice that they no longer wish to be invited for breast screening or they are not on the health service register (eg diplomats) or they are not invited within the three year screening round because of slippage in a programme. Women who have had a bilateral mastectomy are excluded from the eligible population. NHSBSP April 2005 (Version 2) 5

12 Table 1 National standards for the NHSBSP (revised September 2003) Objective Criteria Minimum standard Target 1. To maximise the number of eligible The percentage of eligible 70% of invited 80% women who attend for screening women who attend for screening women to attend for screening 2. To maximise the number of cancers detected (a) The rate of invasive cancers detected in eligible women invited and screened (b) The rate of cancers detected which are in situ carcinoma (c) Standardised detection ratio (SDR) 3. To maximise the number of small The rate of invasive cancers invasive cancers detected less than 15 mm in diameter detected in eligible women invited and screened 4. To achieve optimum image quality (a) High contrast spatial resolution (b) Minimal detectable contrast 5 6 mm detail 0.5 mm detail 0.25 mm detail (c) Aim film density 5. To limit radiation dose Mean glandular dose per film for a standard breast at clinical settings 6. To minimise the number of women The number of repeat undergoing repeat examinations examinations 7. To minimise the number of women screened who are referred for further tests 8. To ensure that the majority of cancers, both palpable and impalpable, receive a non-operative tissue diagnosis of cancer 9. To minimise the number of unnecessary operative procedures (a) The percentage of women who are referred for assessment (b) The percentage of women screened who are placed on short-term recall The percentage of women who have a non-operative diagnosis of cancer by cytology or needle histology after a maximum of two visits The rate of benign surgical biopsies Prevalent screen 2.7 per 1000 Incident screen 3.1 per 1000 Prevalent screen 0.4 per 1000 Incident screen 0.5 per Prevalent screen 1.5 per 1000 Incident screen 1.7 per lp/mm 1.2% 5% 8% mgy < 3% of total examinations Prevalent screen < 10% Incident screen < 7% < 0.5% Prevalent screen 3.6 per 1000 Incident screen 4.2 per Prevalent screen 2.0 per 1000 Incident screen 2.3 per % 3% 5% 80% 90% Prevalent screen < 3.6 per 1000 Incident screen < 2.0 per 1000 < 2% of total examinations Prevalent screen < 7% Incident screen < 5% 0.25% Prevalent screen < 1.8 per 1000 Incident screen < 1.0 per 1000 NHSBSP April 2005 (Version 2) 6

13 Table 1 (continued) Objective Criteria Minimum standard Target 10. To minimise the number of cancers in the women screened The rate of cancers presenting in screened women: Expected standard presenting between screening episodes (a) in the two years following a normal screening episode (b) in the third year following a normal screening episode 1.2 per 1000 women screened in the first two years 1.4 per 1000 women screened in the third year 11. To ensure that women are recalled for screening at appropriate intervals 12. To minimise anxiety for women who are awaiting the results of screening 13. To minimise the interval from the screening mammogram to assessment 14. To minimise diagnostic delay for women who are diagnosed nonoperatively 15. To minimise the delay for women who require surgical assessment 16. To minimise any delay for women who require treatment for screendetected breast cancer The percentage of eligible women whose first offered appointment is within 36 months of their previous screen The percentage of women who are sent their result within two weeks The percentage of women who attend an assessment centre within three weeks of attendance for the screening mammogram Proportion of women for whom the time interval between non-operative biopsy and result is one week or less Proportion of women for whom the time interval between the decision to refer to a surgeon and surgical assessment is one week or less The percentage of women who are admitted for treatment within two months of their first assessment visit 90% 100% 90% 100% 90% 100% 90% 100% 90% 100% 90% 100% Standards shown in bold type apply only to programmes in which all women have been fully screened, ie invited for screening from the age of 50 up to and including the age of 70. Until then, the previous standards apply for women invited for screening from the age of 50 up to and including 64. NHSBSP April 2005 (Version 2) 7

14 Notes to specific standards 1. The expected effectiveness of the NHSBSP is based on the minimum standard uptake of 70% of eligible women being screened. Current national data indicate that this standard is being achieved across the UK. However, it is recognised that in some localities this will prove very difficult to attain. Indeed, even in those regions that do attain well over 70% uptake, there may be PCOs or GP practices within PCOs where to achieve considerably less than 70%, for example 50%, may still be regarded as an achievement. In these cases it could be considered that the objective of maximising the number of eligible women attending for screening in that GP practice has been achieved. This minimum standard and target relates to women aged called or recalled for screening as part of the NHSBSP. 2. The criterion used to measure whether the number of cancers detected is being maximised is the rate of invasive cancers detected in women both invited and screened, every three years, in the age group. Microinvasive disease is excluded. The number of in situ carcinomas expected includes DCIS, lobular carcinoma in situ and microinvasive disease. There is a geographical variation in the incidence of breast cancer, although no consistent pattern has emerged which would allow different standards to be set for different parts of the country. The SDR measures a unit s performance and takes into consideration variable age distributions between screening units. For investigative purposes it can be corrected for the geographical variations in background incidence. The minimum standard and the target are a guide to the levels to be achieved, based on the underlying incidence and the average age of the women screened. If a high DCIS rate is reported, the overall cancer detection rate and pathology reporting should be investigated. 3. This standard refers to the number of invasive cancers measuring less than 15 mm in diameter. Microinvasive carcinoma is excluded. Size is determined by pathological measurement. These figures are 55% of the total invasive cancer rate. 4. For a full discussion of the assessment of image quality, refer to the latest version of IPEM Report No The following points should be noted. i. The measurement of image quality is subjective and due allowance should be made for observer variability. Ideally, measurement data should be based on more than one film and more than one observer. ii. The standards specified are guidelines based on current knowledge and may need to be revised in the light of future developments. iii. Test films should be evaluated under appropriate viewing conditions, with the use of ocular aids when necessary. iv. These standards were derived from experience with film screen systems and are not appropriate for digital mammography systems. New standards and testing procedures for digital mammography systems in the UK are in preparation. 5,6 4a. The value given refers to the limiting high contrast resolution that would be obtained by radiographing a high contrast resolution grating placed on top of approximately 4 cm Perspex and approximately 6 cm from the chest wall edge. The value given should be met in directions both parallel and perpendicular to the tube axis. The measured high contrast resolution in the direction perpendicular to the tube axis will normally be greater than that parallel to the tube axis. The test film should have a sufficient dwell time in the cassette prior to exposure to ensure good screen film contact (the time will depend on the type of cassette but will often be at least five minutes). The film should be evaluated under appropriate conditions with the aid of a high power magnifier. 4b. The figures given for threshold contrast are based on measurements with the TOR(MAS) or TOR(MAX) test object placed on top of 4 cm Perspex and the contrast values are those quoted by the manufacturer (nominal radiation contrast calculated at 28 kvp using a molybdenum target and filter). To estimate the number of details that should be detected to meet the standard using the TOR(MAX) test object, the user should refer to the contrast specifications from the supplier for the specific version used. Because the contrast steps in some test objects (eg (TOR(MAX)) are relatively large and arbitrary, very precise measurements may not be possible, and due allowance should be made for this in interpreting measurements and comparison with the rounded numbers in the standards. The threshold contrast limits can be applied NHSBSP April 2005 (Version 2) 8

15 using different makes of test object, provided that due allowance is made for the different definitions of contrast used by the manufacturer and the amount of scatter material used. 4c. Each screening centre should operate with a specified aim film density in the range of In this context, film density is taken to mean the gross optical density measured 4 cm from the chest wall edge on the midline of a radiograph of a 4 cm thick Perspex block exposed using the automatic exposure control (AEC) at the current clinical settings. The aim film density for a unit should be chosen taking into account local factors such as system contrast and the AEC calibrated to achieve this aim density. The measured film density will fluctuate slightly from day to day, and the quality control system should confirm that it always lies within ± 0.2 of the chosen aim density. 5. The standard applies for a measurement of the mean glandular dose for a 53 mm thick standard breast simulated with a 45 ± 0.5 mm thick Perspex phantom exposed at the conditions used clinically (ie as selected by the automatic AEC system using the usual clinical settings). For definitions and methods of dose measurement, refer to IPEM Report No Image quality should be investigated if dose values are lower than 1.0 mgy. A more complete estimate of doses for a mammography system can be obtained by a dose survey in which the mean glandular doses are determined for a sequential sample of 50 or 100 screened women. These data can be used to determine that the appropriate diagnostic reference level (DRL) for mammography is not being exceeded. 6. Repeat examinations should be avoided both to minimise radiation dose and, particularly when second appointments are needed, to minimise anxiety. The decision to repeat a film while the woman is present in the unit is generally the radiographer s decision. The decision to recall a woman for a second appointment in order to repeat a film is the film reader s decision. Both types of repeat examination need to be monitored, and the combined rate of both types of repeat examination should be less than 3% of total examinations. 7. The minimum standards and targets for the number of women referred for assessment relate to women aged called or recalled for screening as part of the NHSBSP. 8 & 9. If a particularly low benign biopsy rate is reported, this might be due to a high non-operative diagnosis rate in the context of an on-target cancer detection rate. If this is not the case then further investigation would be needed, particularly looking at cancers detected amongst women placed on short-term recall. This target relates to women aged called or recalled for screening as part of the NHSBSP. 10. The criterion for measuring whether the number of cancers presenting between screening episodes is being minimised is the rate of cancers that presents in screened women in the first 24 months subsequent to screening. It is recognised that these will not all be false negatives; some will have developed in the interval since screening and some will be mammographically occult cancers. In addition, it is recognised that some false negative cancers will present in the third year after screening. As interval cancers are an expected part of breast screening, and have to be considered over either a number of years or on a regional, large population basis, no minimum or target level is given. 11. The long term effectiveness of the screening programme is dependent on women in the target age group continuing to be screened at regular intervals. Currently, the screening interval is 36 months. Women should be offered an appointment that ensures that they are screened at an interval of not more than 36 months. In order to keep women within their screening batch, this may on occasion necessitate a screening interval of less than 36 months. 15. Many programmes are able to assess all women within a week by having the surgeon attend part of the assessment clinic or by holding a simultaneous clinic nearby. 16. The total period between first attendance for assessment and admission for any resulting definitive treatment should be no longer than two months, irrespective of whether an open biopsy has been carried out or not. 14, 15 & 16. When the recommended intervals detailed in the standards are not achieved, this should be drawn to the attention of the appropriate hospital managers and steps taken to improve the situation. NHSBSP April 2005 (Version 2) 9

16 3. MONITORING NATIONAL STANDARDS 3.1 Data sources Activity and outcomes from local breast screening programmes (breast screening unit) are collected annually on the Department of Health KC62 return. The KC63 return summarises call and recall activity and is generated by primary care organisations (PCOs) from the population database. Quality assurance reference centres (QARCs) collate KC62 and KC63 data from local screening programmes on a regional basis and check their validity before they are used beyond local programme level. They also collect data about the performance of programmes from other sources. Most QARCs produce a range of reports that include analysis and commentary. This includes comparison of the performance of local screening programmes against the NHSBSP national minimum standards, and comparisons of the performance of programmes within a region or with other programmes nationally. The reports produced by QARCs are primarily intended to enable evaluation of the quality of the breast screening process. In addition, QARCs may also provide information on activity and quality to other organisations in their own regions; for example, the Regional Director of Public Health, strategic health authorities, primary care trusts (PCTs) and cancer networks. Care should be taken when using data from different reports to understand the basis on which they have been compiled. 3.2 DH Statistical Bulletin 3.3 NHSBSP Annual Review 3.4 Monitoring national standards The Breast Screening Programme Statistical Bulletin produced annually by the Department of Health (DH) Statistics Division is a summary of statistics for the NHSBSP (England only) derived from KC62 and KC63 returns. The purpose of this return is to report activity (eg numbers of women screened, numbers of cancers detected, etc) in the NHSBSP. Although the bulletin includes some selected outcome measures, these are not necessarily calculated on the same basis as the outcome measures used to evaluate the quality of the NHSBSP and should not be used to compare the performance of programmes against national standards. Details of the current breast screening bulletin tables and the data sources are available from the DH Statistics Division. The NHSBSP Annual Review includes selected statistics on activity and outcomes for the breast screening programmes across the UK compiled by the Cancer Screening Evaluation Unit (CSEU) from KC62 and KC63 returns and equivalent in Northern Ireland, Wales and Scotland. Details of the data sources are available from the CSEU. The purpose of monitoring national standards is to evaluate the quality of the NHSBSP. Data for monitoring several of the standards are derived from the KC62 returns. The source tables and calculations for age ranges and are given in Tables 2 and 3. More detailed explanations are given in the footnotes. NHSBSP April 2005 (Version 2) 10

17 Table 2 Summary of KC62 source tables and age groups to be used in the calculation of standards (50 64) Objective Criteria Calculation Minimum standard Target 1. To maximise the number The percentage of eligible Tables: A, B, C1, C2 70% of invited women to attend for 80% of eligible women who attend for screening* women who attend for screening Age: screening 2. To maximise the number of cancers detected* (a) The rate of invasive cancers detected in eligible women invited and screened Prevalent screen 2.7 per 1000 Incident screen 3.0 per 1000 Prevalent screen 3.6 per 1000 Incident screen 4.0 per To maximise the number of small invasive cancers detected* 7. To minimise the number of women screened who are referred for further tests* 8. To ensure that the majority of cancers, both palpable and impalpable, receive a nonoperative tissue diagnosis of cancer* 9. To minimise the number of unnecessary operative procedures (b) The rate of cancers detected which are in situ carcinoma (c) Standardised detection ratio (SDR) The rate of invasive cancers less than 15 mm in diameter detected in eligible women invited and screened (a) The percentage of women who are referred for assessment (b) The percentage of women screened who are placed on short-term recall The percentage of women who have a non-operative diagnosis of cancer by cytology or needle histology after a maximum of two visits Table: A Age: Table: C1 Age: Table: A Age: Table: C1 Age: Tables: A and B Age: Table: C1 Age: Tables: A, B and C1 Age: Table: A Age: Table: C1 Age: Table: A Age: Table: C1 Age: Table: T Age: Table: T Age: The rate of benign biopsies Table: A Age: Table: C1 Age: Prevalent screen 0.4 per 1000 to 0.9 per 1000 Incident screen 0.5 per 1000 to 1.0 per 1000 Prevalent screen 0.75 Incident screen 0.75 Overall 0.75 Prevalent screen 1.5 per 1000 Incident screen 1.65 per 1000 Prevalent screen < 10% Incident screen < 7% < 1.0% Prevalent screen 1.0 Incident screen 1.0 Overall 1.0 Prevalent screen 2.0 per 1000 Incident screen 2.2 per 1000 Prevalent screen < 7% Incident screen < 5% 0.25% 80% 90% Prevalent screen < 3.6 per 1000 Incident screen < 2.0 per 1000 Prevalent screen < 1.8 per 1000 Incident screen < 1.0 per 1000 NHSBSP April 2005 (Version 2) 11

18 Table 3 Summary of KC62 source tables and age groups to be used in the calculation of standards (50 70) Objective Criteria Calculation Minimum standard Target 1. To maximise the number of 80% eligible women who attend for screening* 2. To maximise the number of cancers detected* 3. To maximise the number of small invasive cancers detected* 7. To minimise the number of women screened who are referred for further tests* 8. To ensure that the majority of cancers, both palpable and impalpable, receive a nonoperative tissue diagnosis of cancer* 9. To minimise the number of unnecessary operative procedures The percentage of eligible women who attend for screening (a) The rate of invasive cancers detected in eligible women invited and screened (b) The rate of cancers detected which are in situ carcinoma (c) SDR The rate of invasive cancers less than 15 mm in diameter detected in eligible women invited and screened (a) The percentage of women who are referred for assessment (b) The percentage of women screened who are placed on short-term recall The percentage of women who have a non-operative diagnosis of cancer by cytology or needle histology after a maximum of two visits Tables: A, B, C1, C2 Age: Table: A Age: Table: C1 Age: Table: A Age: Table: C1 Age: Tables: A and B Age: Table: C1 Age: Tables: A, B, C1 Age: Table: A Age: Table: C1 Age: Table: A Age: Table: C1 Age: Table: T Age: Table: T Age: The rate of benign biopsies Table: A Age: Table: C1 Age: % of invited women to attend for screening Prevalent screen 2.7 per 1000 Incident screen 3.1 per 1000 Prevalent screen 0.4 per 1000 Incident screen 0.5 per 1000 Prevalent screen 0.85 Incident screen 0.85 Overall 0.85 Prevalent screen 1.5 per 1000 Incident screen 1.7 per 1000 Prevalent screen < 10% Incident screen < 7% < 0.5% Prevalent screen 3.6 per 1000 Incident screen 4.2 per 1000 Prevalent screen 1.0 Incident screen 1.0 Overall 1.0 Prevalent screen 2.0 per 1000 Incident screen 2.3 per 1000 Prevalent screen < 7% Incident screen < 5% 0.25% 80% 90% Prevalent screen < 3.6 per 1000 Incident screen < 2.0 per 1000 Prevalent screen < 1.8 per 1000 Incident screen < 1.0 per 1000 NHSBSP April 2005 (Version 2) 12

19 Footnotes to Tables 2 and 3 The national standards refer to invited women only (not eligible women). Part 4 of each table of the KC62 is a summary of outcome measures. These measures apply only to the cohort of women included in each table and should not be used for comparison with the national standards unless specified in Tables 2 and 3. Uptake *The calculation excludes women in Table D because women on short-term recall are not invited to the screening clinic. The calculation should be run for women aged until the programme has completed a full screening round of women aged Cancer detection rates *Table A includes all women aged and screened for the first time in the NHSBSP. It is possible that some Age trial women aged are included in Table B. These women will have been non-responders to previous invitations but attend for the first time aged These women are excluded from the calculation as being a special case. Table C2 women are excluded from the calculation because they have a screening interval of more than three years. The standards for the incident screen cancer detection rates are based on the assumption of a three year screening interval. No standards are set for a screening interval of more than 36 months. If a programme has significant slippage, incident screen women may be counted on Table C2. Cancer detection rates for a programme that has had round length slippage should be interpreted with caution and the impact of the extended round length should be taken into account. Assessment rates *Table A includes all women aged and screened for the first time in the NHSBSP. It is possible that some Age trial women aged are included in Table B. These women will have been non-responders to previous invitations but attend for the first time aged These women are excluded from the calculation as being a special case. Table C2 women are excluded because they have a screening interval of more than three years. The standards for the incident screen assessment rates are based on the assumption of a three year screening interval. No standards are set for a screening interval of more than 36 months. If a programme has significant slippage, incident screen women may be counted on Table C2. Assessment rates for a programme that has had round length slippage should be interpreted with caution and the impact of the extended round length should be taken into account. NHSBSP policy is that women can only be referred to short-term recall following assessment (in other words, not on the basis of a screening mammogram only). Therefore, column 6 on the KC62 should be zero. It is recommended that the KC62 should be audited to identify any cases that may have been entered as early recall as an outcome of an initial screen. Non-operative diagnosis *An NBSS Crystal report is being developed to monitor the number of visits required before a non-operative diagnosis is reached. If the standard for the overall non-operative diagnosis rate is not met, then QARCs may wish to look at rates for individual cohorts (ie rates for Tables A, B, C1 and C2). NHSBSP April 2005 (Version 2) 13

20 4. STANDARDS FOR ADMINISTRATION AND INFORMATION TECHNOLOGY 4.1 Quality assurance guidelines 4.2 Revised good practice guidance Quality assurance standards for administrative and clerical staff working in screening offices are published in Quality Assurance Guidelines for Administrative and Clerical Staff (NHSBSP Publication No 47, 2000). 7 These guidelines are currently being revised to take account of the extension of routine invitations to women up to and including the age 70, changes to the organisation of primary care in the NHS and the introduction of the new national breast screening computer system (NBSS). The standards are summarised in Table 4. Standards that are included in the national standards table (Table 1) are highlighted. Detailed guidance on good practice for administrative processes is also being reviewed. This will be included in the revised NHSBSP Good Practice Guides 8 14 or in the new NBSS User Manual 15 as appropriate. Table 4 Quality assurance standards for administration Objective Measure Minimum standard Target To ensure timely and accurate exchange of information between the screening office and PCOs The number of open episodes displayed in Table A2 on KC63 expressed as a percentage of the total eligible population 0.25% 0% To ensure that all women aged are invited once every three years To invite all eligible women for screening once every three years To ensure that all women receive their first invitation for screening before their 53rd birthday To enable women aged 70 and over to attend for screening if requested To ensure that women are recalled for screening at appropriate intervals (national standard 11) The number of unscreened women less the number of unavailable or ineligible women expressed as a percentage of the total eligible population using AJ- BCSI* The number of uninvited women expressed as a percentage of the total eligible population using AJ- BCNS KC63. The percentage of eligible population invited for screening within the previous three years KC62, Table A. The sum of column 1, lines 1, 2 and 3, expressed as a percentage of column 1, line 9 KC62, Tables E, F1 and F2. The sum of column 3, lines 6 and 7, expressed as a percentage of column 3, line 9 The percentage of eligible women whose first offered appointment is within 36 months of their previous screen The percentage of the eligible population screened within the previous three years (coverage) 0.5% 0.5% 0.1% 0.1% 85% 100% 90% 100% 2% 4% 90% 70% 100% 70% NHSBSP April 2005 (Version 2) 14

21 Table 4 (continued) Objective Measure Minimum standard Target To enable GPs and The percentage uptake for each practice screened 70% 70% PCTs to promote breast screening effectively to their eligible patients To ensure that an appropriate, timely and accessible screening invitation is sent to all eligible women The percentage of screening invitation letters giving at least two weeks notice of the appointment date The percentage of women requiring a technical recall appointment invited within one month of their original screen 95% 95% 100% 100% To enable women who do not respond to a first invitation to have a further opportunity to attend To minimise anxiety for women who are awaiting the results of screening (national standard 12) To minimise the interval from the screening mammogram to assessment (national standard 13) To enable the service to produce accurate outcome measures The percentage of women recontacted in writing within one month of failing to attend their initial appointment The percentage of women who are sent their result within two weeks The percentage of women who attend an assessment centre within three weeks of attendance for their screening mammogram Number of open episodes on KC62, Part 5, Table T, KC62 Percentage data incompleteness in all columns 95% 100% 90% 100% 90% 100% *Analysis job AJ-BCSI is the breast screening integrity checker. Analysis job AJ-BCNS provides a list of all those women not screened during the regular call and recall process. Information about the NHSBSP is collected on two Department of Health returns. Local screening programmes report the process and outcomes of the call and recall system on return KC62, and primary care organisations report population coverage on return KC63. 0 < 1% 0 0% NHSBSP April 2005 (Version 2) 15

22 5. STANDARDS FOR MAMMOGRAPHY 5.1 Quality assurance guidelines 5.2 Quality control 5.3 Staffing The current Quality Assurance Guidelines for Radiographers (NHSBSP Publication No 30, 2002) 16 are being revised to take account of the introduction of mammography practitioners and other developments in the screening programme. Mammography practitioners may include both radiographers and support workers. Table 5 provides a summary of the QA objectives for mammography practitioners. Standards that are included in the national standards table (Table 1) are highlighted. A minimum standard and target have been set for some objectives, whereas others are statements of good practice. A full explanation of these objectives will be included in Quality Assurance Guidelines for Mammography, 17 which will replace the current radiography guidelines. Details of routine quality control tests undertaken by mammography practitioners are given in the Radiographic Quality Control Manual for Mammography (NHSBSP Publication No 21, 1999). 18 This is currently being revised and will be incorporated in the new Quality Assurance Guidelines for Mammography. Mammography practitioners should ensure that all routine quality control tests are performed and that appropriate action is taken when test results are outside standard tolerances. Mammography practitioners (radiographers and non-radiographers) should be sufficiently involved in breast screening/assessment to maintain their competence to practice for their particular role. National occupational standards for mammography should be adhered to whoever performs the tasks. 19 Mammographic training may be through an in-house course (NVQ) or via a national training centre. Table 5 Quality assurance standards for mammography Objective Criterion Minimum standard Target 1. To achieve optimum image 12 lp/mm quality (national standard 4) 2. To limit radiation dose (national standard 5) 3. To minimise the number of women undergoing repeat examinations (national standard 6) High contrast spatial resolution Minimal detectable contrast: 5 6 mm detail 0.5 mm detail 0.25 mm detail Aim film density Mean glandular dose per film for a standard breast at clinical settings The number of repeat examinations 1.2% 5% 8% mgy < 3% of total examinations 0.8% 3% 5% < 2% of total examinations NHSBSP April 2005 (Version 2) 16

23 Table 5 (continued) Objective Criterion Minimum standard Target 4. To provide women with accurate messages about breast The percentage of women provided with information about: 100% of women screening the screening test how they will receive their results organisation of the screening programme harms and benefits of screening i m p o r t a n c e o f b r e a s t awareness 5. To provide women with comprehensive explanations about the mammographic examinations 6. To ensure that all health and safety legislation and safe working practices are adhered to 7. To ensure that client confidentiality is maintained 8. To ensure professional development takes place 9. To ensure participation in performance appraisal The percentage of women provided with explanations about: the use of compression mammographic views examination times The percentage of incidents reported to the National Coordinating Centre for the Physics of Mammography (NCCPM) The percentage of critical incidents reported to the Medicines and Healthcare products Regulatory Agency (MHRA) The percentage of staff who have read and understood the requirement for confidentiality The percentage of mammography practitioners involved in continuing professional development (CPD) The percentage of mammography practitioners with a personal development plan The percentage of staff involved in annual appraisal < 7% of women surveyed will find the examination painful 100% of women > 95% of women are examined within 30 minutes of their appointment time 100% 100% 100% 100% 100% 100% NHSBSP April 2005 (Version 2) 17

24 6. STANDARDS FOR RADIOLOGY 6.1 Quality assurance guidelines 6.2 Standards for nonoperative diagnostic procedures 6.3 Standards for working practices Quality assurance standards for the radiological aspects of breast screening are published in Quality Assurance Guidelines for Radiology (NHSBSP Publication No 59). 20 These guidelines have been revised to take account of the extension of the age range to 70 for invited women, improvements in the screening programme as a result of increasing experience of film readers, standardisation in film density, and improvements in equipment reliability. The quality standards primarily relate to monitoring at local programme level. They are divided into three separate tables (Tables 6, 7 and 8) and relate to women aged who are called or recalled for screening as part of the NHSBSP. Table 6 shows the core radiological quality standards. These standards relate to cancer detection, and achieving them is fundamental to the aim of the NHSBSP in reducing mortality. General radiological quality standards are shown in Table 7. Table 8 shows service quality standards. All these standards are included in the national standards table (Table 1). A non-operative diagnosis of malignancy is highly desirable. A national standard has been set (national standard 8 in Table 1, radiological standard 4 in Table 7). More detailed standards for non-operative diagnostic procedures are summarised in Table 9. Detailed guidance is given in Guidelines for Non-operative Diagnostic Procedures and Reporting in Breast Cancer Screening (NHSBSP Publication No 50, 2001). 21 Radiologists involved in breast screening should have completed a multidisciplinary course at a recognised training centre and be involved in continuing medical education (CME). Film readers may be trained clinicians, radiographers or surgeons as well as radiologists. All film readers should have successfully completed a recognised course of study. They should read mammograms from a minimum of 5000 screening and/or symptomatic cases annually. They should also be involved in assessment, multidisciplinary meetings, review of interval cancers and should be encouraged to participate in the PERFORMS TM self assessment programme. NHSBSP April 2005 (Version 2) 18

25 Table 6 Core radiological QA standards Objective Criteria Minimum standard Target 1. To maximise the number of cancers detected (national standard 2) 2. To maximise the number of small invasive cancers detected (national standard 3) (a) The rate of invasive cancers detected in eligible women invited and screened (b) The rate of cancers detected which are in situ carcinoma (c) Standardised detection ratio (SDR) The rate of invasive cancers less than 15 mm in diameter detected in eligible women invited and screened Prevalent screen 2.7 per 1000 Incident screen 3.1 per 1000 Prevalent screen 0.4 per 1000 Incident screen 0.5 per Prevalent screen 1.5 per 1000 Incident screen 1.7 per 1000 Prevalent screen 3.6 per 1000 Incident screen 4.2 per Prevalent screen 2.0 per 1000 Incident screen 2.3* per 1000 *The target is shown incorrectly as > 2.5 per 1000 in the Quality Assurance Guidelines for Radiology (NHSBSP Publication No 59) Table 7 General radiological quality standards Objective Criteria Minimum standard Target 3. To minimise the number of women screened who are referred for further tests (national standard 7) 4. To ensure that the majority of cancers, both palpable and impalpable, receive a non-operative tissue diagnosis of cancer (national standard 8) 5. To minimise the number of unnecessary operative procedures (national standard 9) (a) The percentage of women who are referred for assessment (b) The percentage of women screened who are placed on short-term recall The percentage of women who have a non-operative diagnosis of cancer by cytology or needle histology after a maximum of two visits The rate of surgical benign biopsies Prevalent screen < 10% Incident screen < 7% < 0.5% 80% 90% Prevalent screen < 3.6 per 1000 Incident screen < 2.0 per 1000 Prevalent screen < 7% Incident screen < 5% 0.25% Prevalent screen < 1.8 per 1000 Incident screen < 1.0 per 1000 NHSBSP April 2005 (Version 2) 19