SUMMARY REPORT BOWEL CANCER SCREENING PROGRAMME SOUTHERN HUB

Transcription

1 SUMMARY REPORT BOWEL CANCER SCREENING PROGRAMME SOUTHERN HUB Summary Report Bowel Cancer Screening Programme Southern Hub

2 Table of Contents Foreword... 3 Introduction... 4 Hub staff... 6 Hub services... 8 Call and recall... 8 Age extension... 8 Invitation smoothing... 9 Postal and mailing services Helpline Interactions with other Hubs and Screening Centres Indicators of performance Hub finance Commissioning Quality assurance Training and supervision Laboratory services Clinical Pathology Accreditation (CPA) Adverse incident reporting Quality Assurance Reference Centre (QARC) visit Activity analysis Uptake and positivity Programme attrition (dropout rate) Clinical outcomes Patient feedback The future Serving the prison population E-communications with general practitioners Flexible sigmoidoscopy Immunochemical testing Research activities National Awareness of Early Diagnosis Initiative (NAEDI) Appendices Appendix 1: Roles of the Hub (BCSP requirements) Appendix 2: Screening definitions Appendix 3: Data from the Southern Hub Summary Report Bowel Cancer Screening Programme Southern Hub

3 Foreword In May 2006 confirmation was received that the Royal Surrey County Hospital (RSCH) should commence building a Hub facility for a new NHS Bowel Cancer Screening Programme. The confirmation came after many months of anticipation following a ministerial commitment to a National Programme in Torbay Hospital prepared to become the first Screening Centre in the Southern Hub, an endorsement of its wellearned reputation as an endoscopy training centre. On 21 September 2006, four months after the ministerial confirmation, the Bowel Cancer Screening Programme Southern Hub sent the first invitations to residents in the Torbay area. With a partnership between the RSCH and the University of Surrey, supported by Professor Chris Marks and his local Guildford Undetected Tumour Screening (GUTS) charity and a small enthusiastic Hub project team including Norma Patterson and Rachel Avenell, a new and exciting development in healthcare in the south of England had begun. The original Southern Hub project team of three now numbers 45, the first weekly batch of 103 invitations has increased to 21,000 and we now serve 17 Screening Centres in 31 Primary Care Trusts, three Strategic Health Authorities and 1,967 General Practitioner (GP) surgeries. The total population served is 14.4 million. This report is the first of what we hope will become an annual report and which, I trust, will reflect, record, and inform on 12 months of bowel cancer screening in the Southern Hub area. This first report contains elements of the Programme s development since 2006 and shows how much progress we have made in such a short time. The report also highlights our future challenges, including the adoption of immunochemical testing and the first countrywide programme for flexible sigmoidoscopy screening. The value of the Screening Programme to the south of England is exemplified by two statistics; typically each year we will identify 1,200 cancers and 3,500 advanced adenomas. The commitment made by many to achieve this is evident in the pages of this report. We hope this document will prove of interest to the broad spectrum of individuals who have an interest in this important public health venture. My particular thanks go to my able and committed Hub team, managed by Neil Stubbs, and to Michelle Young who has been the editor of this first Annual Report. Professor Stephen P Halloran MBE FRCPath Director, Bowel Cancer Screening Programme Southern Hub Summary Report Bowel Cancer Screening Programme Southern Hub

4 Introduction The Southern Hub, based in Guildford, Surrey, is one of five Hubs in the English NHS Bowel Cancer Screening Programme (BCSP) (Figure 1). This is a national screening programme that invites all men and women aged years who are registered with a GP to complete a guaiac-based faecal occult blood test (gfobt) in the form of a home testing kit every two years. The Programme is now being extended to individuals aged and has reached 50% of the public in this age group. The Southern Hub is hosted by the Royal Surrey County Hospital NHS Foundation Trust (RSCH) and operates as part of the Partnership Pathology Services that encompass pathology services at RSCH and Frimley Park Hospital. This partnership has recently extended and has reconfigured to include Ashford & St Peter s Hospital and will be re-launched in January 2012 as Surrey Pathology Services. England - five Hubs Screening Hub Remit Organisation Invitations and recalls Laboratory tests Freephone Helpline Making Specialist Screening Practitioner (SSP) appointments Statistical monitoring data R&D research/support Midlands & North West 8.1m 13.2m 10.6m 8.8m 14.4m Southern North East Eastern London Figure 1: The five England NHS Bowel Cancer Screening Programme Hubs - population and remit (Source: Quality and Outcomes Framework [QOF] for April March 2011, England) The Southern Hub provides a service to the populations of the South East Coast, South Central and South West Strategic Health Authorities (SHAs). Some 14.4 million people are registered with GPs across this area and the Hub works in partnership with 17 local Screening Centres, 31 Primary Care Trusts (PCTs), the National Office of the NHS Cancer Screening Programmes and 1,967 GP practices to deliver the Screening Programme (Figure 2). The population served by each Screening Centre and the key implementation dates are given in Table 1. Age extension occurs when a Screening Centre has completed at least two years of activity and has met several performance and capacity management criteria as agreed by the National Screening Programme. In October 2011, nine Centres were awaiting approval by the National Office that they meet all necessary criteria to extend the Programme to the population aged years. Summary Report Bowel Cancer Screening Programme Southern Hub

5 SC SC SC SC SC SC SC Southern Hub (Guildford) SC SC SC SC Colonoscopy Site Screening Centres (17) Colonoscopy Site Clinic Sites Clinic Sites Clinic Sites SC SC SC SC SC Screening Centre activities Available clinics for Hub Pre-colonoscopy clinics Colonoscopy Surveillance Administration Centre Health promotion Figure 2: Relationship between the Southern Hub, Screening Centres and sites Screening Centre Centre Start Population Age extension (70-74) roll-out South Devon 21/09/2006 * 637,660 September 2008 Gloucestershire 31/01/2007 * 607,818 January 2010 Solent & West Sussex 30/03/2007 * 903,784 April 2010 Dorset 03/03/2008 * 833,367 April 2010 Hampshire 17/03/2008 * 961,270 April 2010 Somerset 31/03/2008 * 535,953 April 2010 Berkshire 08/05/2008 * 997,424 May 2010 Surrey 01/10/2008 * 1,514,806 October 2010 Sussex 17/11/2008 * 1,214,401 Bristol & Weston 01/12/2008 * 910,484 Bath, Swindon, Wiltshire 17/02/2009 * 864,186 East Kent 07/04/2009 * 659,989 North & East Devon 04/06/2009 * 539,328 West Kent & Medway 08/07/2009 * 1,106,392 Buckinghamshire 05/10/2009 * 731,039 Cornwall 11/10/2009 * 537,552 Oxford 22/01/ ,151 * Completed roll-out to the population aged years (phase 1) Table 1: 2009 Quality Management and Analysis System (QMAS) population data used for 2010/11 service level agreements Summary Report Bowel Cancer Screening Programme Southern Hub

6 Hub staff The staffing structure shown in Figure 3 was correct at 3 October All staff work in multifunctional roles and these include our Screening Assistants, who perform both test kit analysis and answer telephone calls through the Helpline. All staff receive Connecting for Health and additional local training. Screening Officers and Senior Screening Officers have previously occupied more junior positions in the Hub and have acquired the relevant experience to support their supervisory role. We have two Data Analysts; one has extensive experience in working with another large NHS population database the General Practice Research Database (GPRD) and the other supported the analysis of the BCSP pilot data. The Hub team includes six individuals with extensive laboratory experience and practical scientific skills. Two Research Assistants are employed on a National Institute for Health Research (NIHR) grant and collaborate with Imperial College and University College London. In October 2011 we appointed a Research Fellow to work with the Hub Director to develop local research activities and an MSc in Cancer Screening. The Hub Manager has extensive senior management experience within other areas of the NHS. The Director is a university professor with many scientific interests and an enthusiasm and record of achievement in bowel cancer screening. The Deputy Director for the Southern Hub is the Director for Midlands and North West Programme Hub and acts as deputy when the Southern Hub Director is not available. Table 2 shows the number and band of staff working within the Southern Hub expressed as whole time equivalents (WTEs) at the end of each year from 2006 and monthly for Band December December December December January February March April May June July August September October November December Table 2: Southern Hub staffing (WTEs) Summary Report Bowel Cancer Screening Programme Southern Hub

7 Summary Report Bowel Cancer Screening Programme Southern Hub Senior Screening Officer Training Officer Administration Assistant/PA to Director Figure 3: Southern Hub staff reporting structure Principal Clinical Scientist Research Assistants Administration Lead Administration Assistant Hub Director University Professor Hub Manager Senior Screening Officer Laboratory and Quality Lead Principal Data Analyst Data Analyst Research Fellow University post Deputy Director (Director Midlands and North West) Senior Screening Officer Screening Officers Screening Officers Screening Officers Screening Officers Screening Officers Screening Officers 7 Screening Assistants Screening Assistants Screening Assistants Screening Assistants Screening Assistants Screening Assistants Screening Assistants Screening Assistants Screening Assistants Screening Assistants Screening Assistants Screening Assistants

8 Hub services The main tasks for each of the five Programme Hubs are: Despatch and analyse test kits Provide call and recall services for the Screening Programme Provide a telephone Helpline for the Programme Send test result letters and notify GPs (by letter and electronically) Book the first appointment at a Specialist Screening Practitioner (SSP)-led clinic for patients with an abnormal test result Ensure the Hub Programme is provided in accordance with national standards Produce performance monitoring information as requested by Screening Centres, Commissioners and Quality Assurance Reference Centres Support agreed BCSP Research & Development activities A more detailed list of tasks for Programme Hubs is given in Appendix 1 (page 35). Call and recall The first invitation to participate in the BCSP requires that an individual is registered with a GP, aged years and that a Screening Centre is available. This is unlike the breast screening programme in which participants of the eligible age are called only when screening is due for the GP practice with which they are registered. After individuals have completed the first screening (prevalent) round of screening, subsequent invitations are determined by the date of closure of their previous episode or, if they did not respond, the two year anniversary of their last invitation. The population data on eligibility on the Bowel Cancer Screening Services (BCSS) database are refreshed each night from the National Health Authority Information System (NHAIS) by Connecting for Health. Roll-out of the Screening Programme was planned in three phases: Phase 1 (ages 60 69), Phase 2 (ages 70 74) and Phase 3, which would address the age group below 60 years. The planned introduction of a once-only flexible sigmoidoscopy examination at age 55 will fulfil Phase 3 (see page 30). During initial roll-out of the Screening Programme, subjects could either be invited at age 60 or 61. Subsequent incident round invitations always start at age 60 and this disparity from the initial odd and even ( ) invitation strategy causes yearly fluctuations in the number of invitations, thus creating issues for the age extension programme. These are now addressed by a process of manually smoothing the invitation rate (page 9). The current call and recall system does not invite all age-eligible participants, for example if an individual is not registered with a GP. Such individuals may include prisoners or care home residents. The Southern Hub is currently progressing ways to promote the Screening Programme within the prison population and this is discussed in detail in The future (page 30). Age extension In July 2011, 49% of the population served by the Southern Hub was supported by Screening Centres that are offering a service to people up to 75 years of age. Eight Centres now offer an age-extended service and nine more are expected to follow. Screening Centres that progressed to age extension after two years have experienced a surge in workload for reasons that include the anticipated increase in positivity Summary Report Bowel Cancer Screening Programme Southern Hub

9 associated with screening an older population. Figure 4 illustrates the effect of age extension roll-out during 2010 on uptake and positivity. Whilst there was the anticipated increase in positivity, uptake did not appear to increase with age extension. Uptake (%) by month Positivity (%) by month Uptake (%) Positivity (%) Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 0.0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Month Month Figure 4: Southern Hub uptake (%) and positivity (%) by month in 2010 Invitation smoothing The Hub agrees implementation plans with the National Office and the Screening Centres to identify the GP surgeries that are to be served and to decide a start date to manage the invitations during programme roll-out. In the first two years of an implementation plan, the date of invitation to eligible participants is determined by an individual s date of birth. Incident screening due dates are determined not by the date of birth but by the two year anniversary of their episode closure. The flow of returned kits to the Hub fluctuates and is markedly influenced by public holidays, summer holidays and local and national health publicity, therefore the consequent pattern of re-invitations is uneven. To moderate the impact of these effects on Screening Centre workload in incident rounds, the Hub smoothes the invitations it sends out. For each Screening Centre, the Hub produces a report from the BCSS entitled Estimate of subjects to be invited for screening. This report provides a BCSP view of the invitations expected during the next 20 months. An average weekly invitation rate is determined from these data. Where a Centre is currently behind or ahead of their screening due date, this information is used to adjust the weekly average invitation rate. The Hub agrees with the Screening Centre the invitation rate for the next 12 months. This information can be used to estimate the number of appointments that are going to be made. If the average weekly invitation rate is to be used as the basis for a capacity plan, the number of appointments initiated by a positive test must be adjusted further to allow for attendance rate, rebooking (voids), and repeat scopes. All of these parameters can be obtained from OBIEE (Online Business Intelligence Enterprise Edition). The Hub revisits this calculation at two-monthly intervals and adjusts the invitation rate as required. Should a significant backlog have developed then this is addressed following discussion with the Screening Centre. During the first half of 2011 it became apparent that the endoscopy capacity for Dorset and Gloucestershire was becoming overstretched. A decision was taken by the Summary Report Bowel Cancer Screening Programme Southern Hub

10 National Office and QARC to reduce the invitations in Gloucestershire by 75%. Both Centres have now returned to normal invitation rates including removal of the accumulated backlog. Postal and mailing services Currently the Southern Hub despatches over 3.5 million letters every year. The Southern Hub management decided that this service should be out-sourced to specialist mailing providers and the London Hub and Eastern Hub (Nottingham) adopted the same arrangements. Under an Office of Government and Commerce framework agreement a contract for the preparation of screening packs and letters was tendered and awarded to Real Digital International (RDI) based in Croydon. The vast majority of letters despatched by the three Hubs is produced by RDI and these encompass a variety of letters: S1 Pre-invitation letter S9 Initial test kit letter S10 Reminder letter S2 Normal result letter S19 GP discharge non-response S158 GP discharge normal result. The downstream mailing service was commissioned from DHL between 2007 and March DHL delivered the letters to a Royal Mail sorting office for them to deliver to the last mile. Data sent to RDI from BCSS are encrypted before being transferred and protocols are in place for the identification, receipt confirmation and destruction of data batches once letters have been produced. In 2011, a new tender resulted in a contract for mailing services being awarded to RDI and UKMail with effect from 4 April These two providers are located adjacent to each other on an industrial estate in Croydon and this minimises the costs and environmental impact of transferring post between them. Improved delivery times, five days per week transfer, better tracking information and cost reductions have been achieved. Helpline On average, the Helpline receives 600 calls each day and deals with a variety of issues including anxious individuals who wish to know why they have or have not been invited for screening and people who need extra guidance on how to complete the test kit, want to change an appointment or have a medical query. Staff who answer Helpline calls are not medically trained but have received training on common diseases of the colon. Helpline staff have two days BCSS training, perform test kit analysis, call and recall and have a sound knowledge of the screening process. Any complex queries are passed to the management team, the Director or to the caller s Screening Centre. The number of calls received by the Helpline fluctuates throughout the week and throughout the year as illustrated in Figure 5. Changes in Helpline activity can be a result of publicity, news articles or public holidays. During the Christmas season, the number of callers declines and the majority of the calls received relate to postponing participation in the Screening Programme until the New Year; this is also reflected in the reduced number of completed test kits received over the Christmas period and the marked increase in January (Figure 6). Summary Report Bowel Cancer Screening Programme Southern Hub

11 The Helpline is run through an automated system that distributes the calls between the Helpline staff and monitors the number of calls that the Hub receives by day and time, the calls we miss or are sent to our answer phone machine service, and the number of calls received outside normal working hours. The monitoring service helps the management team to determine an optimum allocation of staff to Hub activities and allows us to evaluate the need for extended hours and weekend working, should it be required. Number of calls 5,000 4,000 3,000 2,000 Monday Tuesday Wednesday Thursday Friday Total 1, /04/10 25/04/10 16/05/10 06/06/10 27/06/10 18/07/10 08/08/10 29/08/10 19/09/10 10/10/10 31/10/10 21/11/10 12/12/10 02/01/11 23/01/11 13/02/11 06/03/11 27/03/11 Figure 5: The number of calls received by the Helpline according to day of the week over a 12 month period (2010/2011) 25,000 20,000 Test kits in Phone calls Volume 15,000 10,000 5, /10/10 11/10/10 18/10/10 25/10/10 01/11/10 08/11/10 15/11/10 22/11/10 29/11/10 06/12/10 13/12/10 20/12/10 27/12/10 03/01/11 10/01/11 17/01/11 24/01/11 Figure 6: The Christmas holiday effect on test kits and calls received Summary Report Bowel Cancer Screening Programme Southern Hub

12 Helpline responsiveness Telephone calls received by the Helpline can be categorised as: Calls offered: Total number of calls offered in the designated hours of the Helpline. Calls handled: Total number of calls answered by a member of the Helpline team. Calls abandoned: A call that is ended before any conversation occurs. These could be wrong numbers, repeat callers or, in the case of the long abandoned, an individual who has held on the line for over six seconds before hanging up. The number of calls received and handled by the Helpline in 2010 is given in Table 3. Activity month (2010) Calls offered Calls handled % Calls abandoned % Calls handled January February March April May June July August September October November December Total Table 3: Telephone calls offered, handled, answered or abandoned in 2010 Interactions with other Hubs and Screening Centres The BCSP Hub Quality Assurance Group meets three times a year. It is chaired by the NHS Cancer Screening Programme Director, Julietta Patnick, and brings together Hub directors and managers and senior members of the national team. We have an Annual Meeting of the Hubs that includes scientific presentations and an opportunity to discuss important issues relating to the effectiveness of the national programme. The meeting is open to staff members and each Hub takes its turn to host. The meeting took place in London in 2010 and then in Nottingham in June We look forward to attending the meeting in 2012 hosted by Rugby. The Southern Hub hosts its own Annual Conference - this year s will be held on Wednesday 30 November We invite an international speaker to give an understanding of a screening programme outside the UK. In 2010 we were delighted to welcome Leo van Rossum from the Netherlands who gave an excellent presentation on the immunochemical faecal occult blood test. This year we are delighted that Alan Smith from the BCSP in Ireland has agreed to speak. Additionally we will have speakers discussing some highly topical issues NAEDI 1 and capacity management - and we will present an overview of our current collaborative research activity. 1 National Awareness of Early Diagnosis Initiative Summary Report Bowel Cancer Screening Programme Southern Hub

13 The Quality Assurance Reference Centres (QARC) hold regular meetings and a Southern Hub representative attends whenever possible. The Southern Hub has a strong working relationship with the QARCs to support and address issues and problems as they arise. The Hub plays a particular role in providing information at the time of QARC visits. The Southern Hub Director has been part of the QARC team visiting the London, the Eastern and the Midland and North West Hubs. In addition there are separate meetings for the Hub managers, data analysts, administration leads, and research staff. The Southern Hub maintains regular telephone communication with the Screening Centres facilitating the combined monitoring of service provision and assessment of waiting lists. Such close working relationships between the Hub and Centres have been particularly important over recent months when both the Dorset and Gloucestershire Screening Centres have had serious issues regarding colonoscopy waiting times. We are continuing to work together to address these problems and regularly reassess the situation. Summary Report Bowel Cancer Screening Programme Southern Hub

14 Indicators of performance At the monthly Hub Management Meetings several key performance indicators (KPIs) are reported and discussed. These include: 1. Hub staffing capacity The ratio of employed staff hours to population served calculated by allowing 1.5 working time equivalents (WTE) per 1.5 million of the population plus 40% to accommodate the work for the age-extended population. 2. Sickness absence The aim is to achieve below 3% of the working week lost through staff absence because of sickness. There has been a marked improvement over the last year and we are now within target. 3. Timeliness of results The proportion of test kits logged and tested on the day of receipt. 4. Helpline responsiveness The percentage of answer phone messages cleared by the end of the day. The aim is to achieve <5% long abandoned calls. 5. Timeliness of letter production Daily confirmation that RDI have received letter batches. 6. Timeliness of first appointments with SSP The date of a first appointment with an SSP should be scheduled to take place within 14 days of a positive FOBt result. This is monitored for the Screening Centres served by the Southern Hub. 7. Post For a timely service we require post to be delivered before 9am and collected after 4pm by Royal Mail. This is usually the case and requires maintaining a good relationship with the local Royal Mail office. 8. Incidents The criteria for signing off any incidents and preventative actions by the Hub management are being met. 9. GP results We are encouraging GP practices to receive results from the BCSP electronically and we monitor the proportion of practices that now receive electronic results only, both electronic and paper results or that have agreed a start date to move across to electronic receipt. This is a temporary KPI to monitor progress in electronic communication with GPs as described in more detail later (page 30). 10. Personal Development Reviews We monitor the number of outstanding staff Personal Development Reviews and aim to complete all reviews in a timely manner. 11. Diagnostic test wait to FOBt positive assessment The time between a FOBt positive assessment with an SSP and the first offered diagnostic test should be fewer than 14 days. This is monitored by the Southern Hub. 12. RDI Wrecks A wreck includes both a scheduled interval check and all unplanned stoppages of the production run of the S9 initial test kit letter. Reported production wrecks from RDI should be <1%. The criteria for signing off any incidents and preventative actions by the Hub management are being met. Summary Report Bowel Cancer Screening Programme Southern Hub

15 Hub finance The pie chart in Figure 7 summarises Hub expenditure in The areas of highest expenditure were postage and packing costs and staff salaries. In addition to the overheads shown and an allocation taken by RSCH & Frimley Park Hospital, the Hub pays 1% of its income to Partnership Pathology Services for services provided by pathology. ( Other expenditure includes staff training and travel, office equipment, maintenance, computers and hospitalities.) Pay Kits & laboratory Printing & stationery Postage & packing Telecom Rents Other Figure 7: Summary of Hub expenditure in 2010 Commissioning Since April 2010 the Hub service has been commissioned by both the National Cancer Screening Programme and by the 31 PCTs that operate in the three SHAs in the south of England. The service for people aged is commissioned by the PCTs and the age extended service (ages 70-74) is commissioned by the National Office. Payments are made on the basis of the registered population using the previous June s QMAS data. The population dataset is that recommended by the Department of Health for the Programme. The data are provided by the National Office and ensure consistency in the funding formula for the and age groups. The service is tightly specified (Quality assurance arrangements for the NHS BCSP Version 2.1 December 2010) and a standard Service Level Agreement (SLA) has been developed by the National Office in consultation with commissioners. This ensures that service levels and monitoring data are provided consistently to all commissioners. The current remuneration formula is 49p for all subjects in the population served (the cost of 48p when the Programme commenced in 2006 increased to 49p in 2009 when the kit price increased due to marked changes in the dollar/pounds sterling exchange rate). All other price increases including staff costs have been absorbed by the Hub. The SLA is for a three-year period with an opportunity to review the arrangement if required by the Hub or commissioners. This minimises the resources required each year to renegotiate and ensures consistency of arrangements across PCTs. Summary Report Bowel Cancer Screening Programme Southern Hub

16 Quality assurance Training and supervision The induction process for new members of staff covers all relevant areas such as health and safety, security and housekeeping. Staff attend a two-day training course in the use of the BCSS, either provided in-house or at a training centre. In addition, a representative from the test kit supplier gives test kit reading training to new staff who will be reading test kits. When a new member of staff starts in the laboratory they are supervised by a Senior Screening Officer or Screening Officer. In the laboratory, 500 kits are read under oneto-one supervision and then another 500 are read whilst a Senior Screening Officer or Screening Officer is sitting adjacent to the new member of staff. At the end of this period, individuals who have developed the appropriate skills are signed off as competent to read test kits. Helpline training for new staff is initiated using a training headset whereby the trainee can listen to calls taken by an experienced member of staff. When new members of staff begin to take calls, a Senior Screening Officer or Screening Officer sits with them to give advice and help with difficult calls. Only when the senior member of staff is happy with their performance is the trainee signed off as competent. At all stages, both in the laboratory and on the Helpline, new members of staff use the Standard Operating Procedures (SOPs) for each process and sign to say that they have read and understood them and will work accordingly. Laboratory services Reading Time Our staff read test kits for one hour only before taking a 20 minute break from reading. This is to ensure that concentration is maintained and to prevent fatigue. Staff may transfer to the Helpline during the 20 minute break or use the time for other Programme-related activities such as logging the test kits. Reader positivity Analysis of reader positivity across the five English Hubs has revealed significant differences in reader positivity rates, accuracy and precision (Figure 8). Reader positivity is monitored weekly at the Southern Hub. Positivity rates below 1% or above 4% are scrutinized to ascertain whether the positivity may be attributable to the number of first, second or third kits read. If there is no obvious reason for an aberrant positivity rate the reader is monitored. The chart in Figure 9 is an example of a reader positivity plot from the Southern Hub. The black dots represent positivity over the last week, red dots represent positivity for weeks 2 to 4, orange dots represent positivity for weeks 5 to 8 and green dots represent positivity for weeks 9 to 26. Summary Report Bowel Cancer Screening Programme Southern Hub

17 Positivity (%) Precision Accuracy Reader identity Figure 8: Reader positivity all Hubs monthly average 2009 (each point represents >500 kits read) 10 9 Black dots: last week 1 Red dots: weeks 2-4 Orange dots: weeks 5-8 Green dots: weeks Mean weekly spot positivity (%) Reader identity Figure 9: Southern Hub reader positivity February 2011 August 2011 Summary Report Bowel Cancer Screening Programme Southern Hub

18 Quality control All test kit readers have to develop and enter the correct results from a quality control (QC) kit before the system will allow them to read test kits. External quality assurance (EQA) The BCSP Southern Hub is registered with the Yorkshire External Quality Assurance Scheme (YEQAS) for guaiac-based FOBt. The material has been designed to mirror the natural matrix as closely as possible and is fortified with human blood of a known concentration. Fifty samples per year are distributed in six batches at two monthly intervals; the samples are stored at -20 C, analysed weekly, and the results are returned fortnightly. Samples with a concentration of <0.15mg Hb/g matrix are designated as negative results and those with a concentration of >0.9mg Hb/g are positive. Since the beginning of 2009 the Hub has analysed 114 samples. The Hub is shortly to participate in a pilot of a new EQA scheme run by Birmingham Quality. Each member of staff will register with the scheme and will be sent three preloaded test kits per month to read and log results. The reports will adopt a traffic light presentation for performance and should be available within 48 hours of the final submission date. Clinical Pathology Accreditation (CPA) In addition to working closely with the QARC and satisfying their quality requirements, the Southern Hub BCSP also comes under inspection from CPA as it forms part of the Biochemistry Department within Partnership Pathology Services. CPA is designed particularly for assessing pathology laboratories. The Biochemistry Department has satisfied CPA standards. Adverse incident reporting One aspect of robust quality assurance in the BCSP is handling and learning from adverse incidents. The Hub aims to ensure that incidents are reported openly and reviewed appropriately. Every incident provides an opportunity for learning and improvement for the Hub s systems, other Hubs and for individuals. In order to help achieve this, it is important to have an incident reporting system that identifies, manages and ensures learning from near-misses, mistakes and incidents. The Hub categorises incidents into three distinct categories: Internal mistakes that are identified by quality checking processes and resolved before completion of the task and rectified without impacting on the service to the public Errors and incidents resulting from mistakes that were not picked up as part of normal quality checking processes Serious incidents that, for the purposes of national screening programmes, can include incidents that have potential to undermine public confidence in, and therefore cause great damage to, the reputation and delivery of screening programmes or injury to participants. Serious incidents are rare and may require full root-cause analysis by an external high level investigatory team. The Hub has a robust method of incident reporting and appropriate escalation. Internal mistakes are brought to the attention of the Laboratory and Quality Lead for laboratory issues, to the Administration Lead for non-laboratory mistakes and to the Hub Manager when appropriate. Errors and incidents are reported as appropriate to the Director, to Summary Report Bowel Cancer Screening Programme Southern Hub

19 the RSCH, the National Office and to all three QARC directors. Whenever a serious incident has occurred, it is escalated by the Hub Manager (or Director) to: Hub Director if not aware/directly involved Relevant senior members of RSCH National Office for NHS Cancer Screening Programmes QARC Screening Lead within PCT(s) affected. The adverse incident reporting system is currently under review by the National Office. An electronic copy is kept of all incidents. Between April 2009 and April 2011 the Southern Hub recorded two serious incidents and 14 incidents. The serious incidents involved activation of an incorrect implementation plan and sending out an erroneously high number of invitations for Solent and West Sussex for three weeks. All incidents and serious incidents have been dealt with in the appropriate way and closed. Summary Report Bowel Cancer Screening Programme Southern Hub

20 Quality Assurance Reference Centre (QARC) visit Summary taken from the report prepared by the South Central, South East Coast and South West Bowel Cancer Screening Quality Assurance Reference Centres Dr Linda Garvican, QA Director South East Coast The first QA visit to the Southern Hub took place on 18th October 2010, and I am pleased to report that the team found a well-run service which appears to be delivering several areas of good practice. Most of the national standards are being met - others cannot yet be assessed. Prior to the visit the three Quality Assurance Reference Centres (QARCs) had undertaken a survey of all the 31 PCTs and 17 Bowel Screening Centres across the three Strategic Health Authorities (SHAs) served by the Hub. All reported satisfaction with the service received and no issues were identified, which is a great credit to the Hub team. The Hub has faced the challenge of a continuously expanding workload as the programme was initially rolled out across the South; and then the implementation of the age extension, which is ongoing. In the future there are likely to be further changes as we move to a programme which includes flexible sigmoidoscopy. We recognise that there is no robust business continuity plan but this is a national challenge. We have made several recommendations in this report. Most of these are of a relatively minor nature, with the intention of improving the service still further. The visiting team felt it was important to demonstrate that the governance arrangements with the host Trust were tight. The mailing aspect of the Hub s operation is outsourced to Real Digital International (RDI), in conjunction with two other Hubs. We did not visit this organisation but understand that it is providing a good service and the Hub regularly monitors performance. We were concerned however that a new contract with the mailing house be put in place as soon as possible, but after due process of tendering. The Hub could be vulnerable to challenge as there are other potential providers of this service. The Hub was established before the three QARCs became involved in bowel screening, and the data analysis function in the QARCs has been poorly developed until very recently. The Hub has therefore fulfilled an important role in providing Screening Centres with data on their activity and a breakdown by PCT and even GP practice. Now, however, programme monitoring of both Hub and Screening Centres is the responsibility of the QARCs, which are accountable to the Department of Health (DH) for screening data collection and transfer. To that end it is important that routine reports sent from the Hub to Screening Centres are copied to the relevant QARC. We would like to thank the Hub Director and his team for their cooperation on this visit. Summary Report Bowel Cancer Screening Programme Southern Hub

21 Activity analysis The data available through the Southern Hub are part of its monitoring service. A Quarterly Report is generated by the Hub and includes data on uptake and positivity stratified by PCT, sex, age, episode and postcode. Core Report Outcomes are also generated for each Screening Centre stratified by age (70+ and under 70). Data for the previous year and up to the end of the last quarter are provided. The data can be imported into Microsoft MapPoint for illustrative mapping. Figure 10 shows an overview of the Southern Hub activity during the roll-out of the BCSP from September 2006 until 2010 across the 17 Screening Centres. The marked increase in the number of letters sent per week in 2010 reflects the effect of age extension roll-out. Figure 10: Southern Hub Activity September 2006 to 2010 S. Devon (p1) Gloucestershire S. Devon (p2) Solent Dorset Hampshire Somerset 3/08 Berkshire Wiltshire Surrey Sussex (p1) Bristol & Weston Bath E. Kent Sussex (p2) N. & E. Devon W. Kent & Medway Cornwall Buckinghamshire Oxford Swindon & IOW 09/ Uptake and positivity A breakdown of the screening invitations sent annually between stratified by the three SHAs served by the Southern Hub (South Central, South East Coast and South West) and by PCT is given in Appendix 3 (page 37). In-keeping with national statistics, the percentage uptake of screening invitations by females is greater than for males for all ages across the Southern Hub (Figure 11). Summary Report Bowel Cancer Screening Programme Southern Hub

22 Uptake (%) Male: Male: Male: >69 Female: Female: Female: >69 Sex and age (years) Figure 11: Southern Hub percentage uptake by age and sex ( ) Uptake, for those aged 60-69, is defined as the proportion of invitees who were sent a standard invitation letter (excludes self-referrals) and completed the screening process to either a positive or negative FOBt result (adequately FOBt screened). The percentage increase in uptake with age is more marked for males. The percentage uptake across the three SHAs and the 17 Screening Centres from is in Appendix 3 (page 37). The positivity rate for males in the Southern Hub is markedly higher than for females in all age groups (Figure 12) Positivity (%) Male: Male: Male: >69 Female: Female: Female: >69 Sex and age (years) Figure 12: Southern Hub positivity (%) by age and sex ( ) Summary Report Bowel Cancer Screening Programme Southern Hub

23 The average uptake and positivity data derived for the population of the Southern Hub masks trends in postcode variability in areas defined by sector and the index of multiple deprivation. Slough (circled in top right-hand corner of Figure 13), a region with areas of deprivation, shows a lower uptake (illustrated by the larger proportion of yellow in the pie charts) and a high positivity (illustrated by the dark green shading). Conversely, in a more affluent area, such as Winnersh and Earley, there is a higher uptake and lower positivity. Positivity Low High Figure 13: Uptake and positivity in two areas of contrasting affluence covered by the Southern Hub ( ) Uptake (%) Figure 14 below shows the difference in uptake across a spread of postcode sectors. There are extremes of overall percentage uptake (blue) and the graph illustrates two different areas; Gloucestershire, in yellow, where uptake is generally very good as compared with Berkshire, in red, where there is a broader spectrum of uptake. Figure 14: Southern Hub uptake by postcode sector ( ) Summary Report Bowel Cancer Screening Programme Southern Hub

24 Positivity (%) Similarly, positivity by postcode sector reveals a range in positivity rates (Figure 15). Uptake (%) Figure 15: Southern Hub positivity by postcode sector ( ) Figure 16: Southern Hub uptake by episode ( ) As the screening programme progresses from the prevalent round to the first and second incident rounds, data analysis reveals the relationship between episode and uptake (Figure 16). Summary Report Bowel Cancer Screening Programme Southern Hub

25 The percentage uptake in the incident round (episode 2) is substantially higher than in the prevalent round suggesting that those who have undergone screening in episode 1 are keen to continue participating in future screening rounds. Perhaps the most interesting data are for the prevalent round in episode 2; understanding the reasons why this group decides to participate in episode 2 but not episode 1 may be key to increasing uptake of the Programme nationally. The fall in uptake in the prevalent round reflects the increasing proportion of 60-year-olds for whom uptake is lower than for older subjects. Uptake and positivity in the incident and prevalent rounds are shown in Figures 17 and 18. The data from prevalent round 2 have been omitted since the data available to date are limited and do not give a true representation Uptake (%) Episode 1 Episode 2 Episode 3 Prevalent all Prevalent 1 Prevalent 2 Incident all Incident 1 Incident 2 Figure 17: Southern Hub uptake Positivity (%) Episode 1 Episode 2 Episode 3 Prevalent all Prevalent 1 Prevalent 2 Incident all Incident 1 Incident 2 Figure 18: Southern Hub positivity Summary Report Bowel Cancer Screening Programme Southern Hub

26 Programme attrition (dropout rate) Whilst the uptake of the screening test is well-characterised, the number of subjects who commence screening but do not complete the process either to a laboratory or clinical outcome is less well described. Data analysis performed in 2009 by ScHARR (School of Health and Related Research, Sheffield) on data from the Southern Hub indicated that 7.1% of subjects commence screening by returning a test kit but fail to continue to a definitive positive or normal test result; 4% fail to return a second kit and 3.1% fail to return a third kit. A further 12.3% of participants who are referred following a positive test result fail to attend a Specialist Screening Practitioner clinic. These statistics are of concern because each of these subjects is at a significantly higher risk of developing bowel pathology. The English screening algorithm is demanding with three samples required for each kit and a substantial number (>6%) of participants needing repeat sampling. The adoption of a single immunochemical test in the future will go a long way to address this problem. Summary Report Bowel Cancer Screening Programme Southern Hub

27 Clinical outcomes The following ring diagrams compare the screening outcomes from episode 1 (inner circle) and episode 2 (outer circle) of the Screening Programme for the Southern Hub (Figure 19) and for the whole of England (Figure 20). The percentage of cancers, high risk polyps and intermediate risk polyps detected in the second episode is lower than in the first, both at a national and local level. This reduction reflects successful detection of lesions in the first episode. Data for the Southern Hub are similar to those for England overall. Figure 19: Episodes 1 and 2 screening outcomes Southern Hub, March 2011 Figure 20: Episodes 1 and 2 screening outcomes England, March 2011 Summary Report Bowel Cancer Screening Programme Southern Hub

28 The pie chart illustrated in Figure 21 shows the percentage of cancers, high risk, medium risk and low risk polyps, other diagnoses or no abnormality detected at colonoscopy in the Southern Hub since The data also separate each outcome into the three gfobt criteria currently used to define a positive test tests can be deemed overall positive at the first, second or third test kit. Cancer No Abnormality Detected (NAD) NAD 2nd NAD 3rd Cancer 1st Cancer 2nd Cancer 3rd High Risk 1st High Risk 2nd High Risk NAD 1st High Risk 3rd Med. Risk 1st Other Diagnoses Other 3rd Other 2nd Med. Risk 2nd Medium Risk Other 1st Med. Risk 3rd Low Risk 3rd Low Risk 1st Low Risk 2nd Low Risk 11,887 colonoscopy outcomes: Devon, Gloucestershire, Solent & West Sussex, Hampshire, Berkshire, Somerset, Dorset, Surrey, Sussex, Bristol, Wiltshire, Kent, Cornwall, Buckinghamshire. Updated 30/6/2010 Figure 21: Colonoscopy outcomes Southern Hub since 2006 The bar chart in Figure 22 shows that the majority of definitive results is obtained after a second kit has been completed. Data analysis is ongoing to assess whether the current referral algorithm for guaiac FOB testing could be improved. 3,500 3,000 3rd Kit Positive 2nd Kit Positive 1st Kit Positive 2,500 Number of outcomes 2,000 1,500 1, Cancer High Risk Med Risk Low Risk Other Diagnosis No Abnormality Detected Figure 22: Relationship between outcome and positivity determinant Southern Hub since 2006 (11,887 colonoscopies) Summary Report Bowel Cancer Screening Programme Southern Hub

29 Patient feedback Questionnaires Following colonoscopy, individuals are asked to complete a questionnaire on their experiences and perception of the Screening Programme service. Questions address experience at all stages, from the initial invitation to take part in bowel cancer screening, to an individual s level of comfort during the colonoscopy procedure. The first four questions on the questionnaire are relevant to the Hub: A01: Was the invitation letter to take part in the bowel cancer screening easy to understand? A02: Did you contact the freephone number on the letter? A03: Did you receive a satisfactory reply? A04: Did you find the information booklets useful? The results obtained for questionnaires completed in 2010 are given in Table 4. Question Answer Hub Total Hub % A01 Was the invitation letter to take part in the bowel cancer screening easy to understand? No Not sure Yes No response A02 Did you contact the freephone number on the letter? A03 Did you receive a satisfactory reply? A04 Did you find the information booklets useful? No Not sure Yes No response No Not sure Yes No response Not sure Not useful Quite useful Very useful Non responder Table 4: Results from questionnaires completed in Summary Report Bowel Cancer Screening Programme Southern Hub