NHS HDL (2006) 3. Develop local implementation plans that will feed into the national plan.

Transcription

1 NHS HDL (2006) 3 abcdefghijklm = eé~äíü=aéé~êíãéåí= = eé~äíü=fãéêçîéãéåí=aáêéåíçê~íé= Dear Colleague BOWEL CANCER SCREENING PROGRAMME This HDL outlines the plan for the implementation of the Bowel Cancer Screening Programme and the roles and responsibilities following roll out. It provides information on the support available to NHS Boards and the steps which NHS Boards need to take to provide investigations and follow-up care for individuals with positive faecal occult blood tests (FOBT). Further detailed information regarding the programme is in the attached Discussion Document. Action NHS Boards should: Nominate individuals with responsibility for co-ordinating the bowel cancer screening programme, which will include Lead Clinician, Public Health Consultant/Specialist and Programme Manager Establish multidisciplinary steering groups locally to take forward planning and implementation. Develop local implementation plans that will feed into the national plan. Develop business cases and identify funding for the investigation and follow up of screen positive cases. 3 rd February 2006 Addresses For action Chief Executives, NHS Boards For information Chief Executives, Special Health Boards Directors of Public Health, NHS Boards Directors of Finance, NHS Boards Chairs, Regional Cancer Advisory Groups Presidents, Royal Colleges Enquiries to: Zak Tuck Scottish Executive Room 2E-S St Andrews House Edinburgh, EH1 3DG Tel: zak.tuck@scotland.gsi.gov.uk Establish robust failsafe mechanisms for all FOBT positive individuals. Ensure that the data required for the monitoring of the screening programme is available.

2 Performance manage the programme and provide data to ISD to produce Key Performance Indicators for the national programme. Ensure the programme quality is delivered and maintained to meet agreed national standards e.g. NHS Quality Improvement Scotland (NHS QIS)). Chief Executives to agree a national overview plan for implementation, identifying the sequence for NHS Boards to be phased in over the period from 2007 to NHS Boards are asked to bring this letter to the attention of all those who will be involved in the implementation of the Bowel Cancer Screening Programme. Yours sincerely PAM WHITTLE Director of Health Improvement

3 Scottish Bowel Cancer Screening Programme BOWEL CANCER SCREENING PROGRAMME Annex Background 1. The incidence of colorectal cancer is high in Scotland; it is the third most common malignancy experienced by the male and female populations and is second only to lung cancer as a cause of cancer death in the combined male and female population. Updated figures state that 3.8% of men in Scotland will develop colorectal cancer by the age of 74 and 2.6% of females in Scotland will develop colorectal cancer by age 74 i. 2. Three randomised controlled trials ii and a Cochrane Review iii provide the evidence for bowel screening, identifying a decrease of 16% mortality from colorectal cancer in the study populations. The Scottish Colorectal Cancer Screening Pilot was established to evaluate the feasibility in the general population, which was confirmed by the Evaluation Report iv. Aim of the Screening Programme 3. The aim of the Bowel Cancer Screening Programme will be to decrease mortality from colorectal cancer in the general population by inviting all eligible men and women aged 50 to 74 years to complete a FOBT kit at home every two years. Programme Scope 4. The screening centre including a call/recall, helpline and central laboratory will be based in a single facility at Kings Cross, Dundee. The call/recall will obtain individuals demographics from the Community Health Index. The centre will issue all invitations and FOBT kits for completion at home. All completed kits will be returned to the central laboratory for testing. Results of the FOBT test will be sent directly from the centre to all participants. Instruction and information leaflets are provided for individuals to allow them to make an informed choice about participation in the programme. 5. Follow up investigations will be carried out by clinical services within local NHS Board areas. All FOBT positive individuals will require a clinical assessment prior to being offered a colonoscopy. If the individual is fit enough and willing to undergo a colonoscopy an appointment is made at their local endoscopy unit. If the colonoscopy is incomplete the individual is referred for a barium enema. 6. Information Services (ISD), NSS, will undertake the overall monitoring and evaluation of the programme. Data capture requirements will be defined in due course. IT System 7. NSD will commission the procurement, development and implementation of the IT system for the call/recall and laboratory within the national screening centre.

4 Scottish Bowel Cancer Screening Programme Impact on Services 8. The impact of the screening programme will mainly affect diagnostic and treatment services including imaging (endoscopy and radiology), pathology, colorectal surgery and oncology. Evidence from the randomised controlled trials and experience from the pilot indicate that this impact will decrease following the prevalent round. 9. The Evaluation Group 4 noted that there was a discernable, albeit modest, impact on Primary Care from the pilot. Information packs on the screening programme will be circulated to Primary Care prior to roll out. GP Practices will be notified of patients with an overall positive FOBT result and can request all results direct from the screening centre. Prior notification lists will not be mandatory. Roles and Responsibilities National Services Division/ NHS National Services Scotland 10. National roll out is scheduled to commence from March 2007; NHS Boards will be phased in between with national coverage achieved by No decisions have yet been taken on the order in which NHS Boards will be phased in. NSD will liaise with planners and other nominated individuals within each NHS Board to commence work on local implementation plans, which will then inform a national plan. NSD will be responsible for the project management of the roll out in collaboration with NHS Boards and Regional Cancer Advisory Groups (RCAGs). 11. NSD will commission the central elements of the programme including the Screening Centre, IT system and test kits. 12. NSD will regularly inform Chief Executives, Regional Planning Groups and RCAGs of progress during the implementation of the programme. Following implementation NSD will continue to inform the Chief Executives on the programme s performance. 13. Following implementation NSD will facilitate an NHS Board screening coordinators group to discuss and disseminate information on the programme. 14. The National Screening Co-ordinator of NHS Scotland Screening Programmes based within NSD, NSS will be responsible for monitoring and co-ordination of the national screening programme. NHS Boards 15. NHS Boards will be responsible for the delivery of investigation and treatment services according to national quality standards (e.g. NHS QIS). NHS Boards will be requested to nominate the following individuals to collaborate with NSD throughout the roll out programme and in particular during phase in of their own

5 Scottish Bowel Cancer Screening Programme NHS Board: NHS Board Co-ordinator (either Consultant in Public Health Medicine or Public Health Specialist), a designated Lead Clinician (clinician who has credibility within colorectal services, e.g. colorectal surgeon/gastroenterologist/pathologist) and a designated programme manager. 16. Local implementation will be facilitated through multidisciplinary steering groups chaired by either one of these three individuals. Decisions on the frequency and structure of these groups will be agreed locally and must address local needs. 17. Throughout the implementation period the above individuals will meet NHS Scotland Screening Programmes staff regularly to review monitoring data and disseminate quality and performance information. NHS Boards will assist in ensuring an appropriate infrastructure is put in place that supports a screening programme co-ordinated in parallel with the symptomatic services. 18. Business Cases should be developed locally to identify the diagnostic and treatment needs of the Screening Programme and associated funding requirements. 19. NHS Boards will assure programme quality is delivered; by ensuring data capture is sufficient to support performance management (of the programme). See also paragraph Failsafe mechanisms must be agreed prior to commencement of the programme to ensure that outcomes of screening referrals can be identified. 21. On completion, the national overview plan (identifying the sequence NHS Boards will be phased in) will be submitted to the Chief Executives for final agreement and provided to the RCAGs for information. Information Services, NHS National Services Scotland 22. Information Services (ISD), NSS, will undertake the overall monitoring and evaluation of the programme. ISD will also have a role in reporting and publishing national data. NHS Quality Improvement Scotland 23. NHS QIS will have responsibility in developing and publishing quality standards for the screening programme taking account of the existing pilot standards and for conducting future peer reviews. NHS Health Scotland 24. NHS Health will have an ongoing responsibility for developing, publishing and reviewing national information material for the programme. This will be similar to that used by the breast and cervical screening programme and based on the existing pilot information.

6 Scottish Bowel Cancer Screening Programme NHS Education Scotland 25. Additional funding will be available to expand endoscopy training. NHS Boards will bid for funding to provide education and training for medical and non medical (nurse) training. NHS Education Scotland (NES) will establish a group to oversee how the funding is utilised and report back to SEHD on a national overview. This investment combined with service redesign will substantially increase the provision of endoscopy and alleviate the burden of additional colonoscopies generated by the screening programme. Funding Requirements and Commissioning Arrangements 26. When national coverage is in place it is estimated that the total cost of the programme will be approximately 9 million per year. Approximately one third of the cost will be covered under the top-slicing arrangements from NHS Boards and provided to NSD, NSS, to commission the national screening centre in Dundee and the IT system. The remaining two thirds estimates the total cost of investigations, treatment and follow up procedures incurred by NHS Boards. 27. NHS Boards will need to provide resources to investigate all FOBT positive patients. Local and regional planning and funding arrangements will need to take account of any additional needs including nurses and other health professionals to assess FOBT positive patients, additional workload on endoscopy, pathology, radiology and surgery as the programme rolls out in line with the agreed national implementation plan. 28. Approximately 10% of all positive FOBT patients will have cancer and approximately 30% will require surveillance for adenomas identified through the programme. Based on the randomised controlled trials and evidence from the pilot assessments of the potential impact are set out in the Discussion Document attached. However, these are estimates only and NHS Boards/Regional Planning Groups as appropriate will need to undertake more detailed local assessments based on their local populations, expected demand and service capacity.

7 Scottish Bowel Cancer Screening Programme CONTACTS AND FURTHER INFORMATION National Services Division Carol Colquhoun National Screening Co-ordinator NHS Scotland Screening Programmes National Services Division NHS National Services Scotland Gyle Square 1 South Gyle Crescent EDINBURGH EH12 9EB carol.colquhoun@nsd.csa.scot.nhs.uk Tel: Fax: Carole Morton Project Manager (Bowel Screening) National Services Division NHS National Services Scotland Gyle Square 1 South Gyle Crescent EDINBURGH EH12 9EB carole.morton@nsd.csa.scot.nhs.uk Website: Tel: Fax: Programme Director Professor R.J.C. Steele Professor of Surgical Oncology Department of Surgery and Molecular Oncology Ninewells Hospital and Medical School Dundee DD1 9SY r.j.c.steele@dundee.ac.uk Tel: Fax: REFERENCES i ii Hardcastle JD, Chamberlain JO, Robinson MHE, Moss SM, Amar SS, Balfour TW et al. Randomised controlled trial of faecal occult blood screening for colorectal cancer. Lancet 1996, 348; ii Kronborg O, Fenger C, Olsen J, Jorgensen OD, Sondergaard O. Randomised study of screening for colorectal cancer with faecal occult blood test. Lancet 1996; 348; ii Mandel JS, Bond JH, Church JR, Snover DC, Bradley GM, Schuman LM et al. Reducing mortality from colorectal cancer by screening for faecal occult blood. N Engl J Med 1993; 328; iii Towler BP, Irwig L, Glasziou P, Weller D, Kewenter J. Screening for colorectal cancer using the faecal occult blood test, Hemoccult (Cochrane Review). The Cochrane Library, Chichester, UK: John Wiley & Sons, Ltd. Issue 3, 2004.] iv The UK CRC Screening Pilot Evaluation Team (2003) Evaluation of UK Colorectal Cancer Screening Pilot Final Report.

8 Discussion Document Proposal for Scottish Bowel Cancer Screening Programme NHS Scotland Screening Programmes National Services Division NHS National Services Scotland October 2005 V5

9 Contents 1 Purpose & Scope of Document Background Evidence UK National Screening Committee UK Pilot Programme Overview Implementation Objective Programme Scope Estimated Target Population Pattern of Service Call/Recall Laboratory Colorectal Service Monitoring and Evaluating Method of Approach Deliverables Bowel Screening Manual Implementation Plans Quality Standards Communications Constraints National Funding NHS Board Funding Capacity Workforce Training Quality Assurance and Clinical Audit Waiting Lists Roles & Responsibilities Scottish Executive Health Department National Services Division, NHS National Services Scotland NHS Boards Regional Advisory Cancer Networks Information Services, NHS National Services Scotland NHS Quality Improvement Scotland NHS Health Scotland NHS Education Scotland Regional Planning Plan

10 Tables Table 1 Predictions for years... 7 Figures Figure 1 Initial Project Plan Appendices Appendix I Dukes Stage Comparisons Appendix II - Summary of 1 st Round Key Performance Indicators Appendix III Proposed Screening Pathway Appendix IV Scotland Wide Estimated Costs Appendix V Projected Numbers per 100,000 target population Appendix VI Organisational Structure for Implementation

11 1 Purpose & Scope of Document This discussion document provides a general overview of the requirements for implementation of the NHS Scotland Bowel Screening Programme. The document provides the background and scope of the screening programme and who should be involved in managing the implementation of the programme together with their roles and responsibilities. Detailed work will be required with each NHS Board to formulate and agree local implementation plans. On completion of local plans, a national overview plan will be developed and agreed by the Scottish Bowel Screening Programme Board (SBSPB). This document does not provide actual timescales but Section 8 provides an initial project plan for rollout. Further detailed guidance will be developed to provide Boards with comprehensive information to facilitate rollout. In this document national refers to a Scotland-wide programme. Following consultation with all NHS Boards the discussion document will be revised and provide the basis for the programme specification. The IT requirements for a call/recall and laboratory system will not be discussed in this paper; a specification has been developed. It is anticipated that the IT system will be fully functional prior to rollout. 2 Background The Health Minister announced the rollout of the screening programme on 30 August Evidence The incidence of colorectal cancer is high in Scotland; it is the third most common malignancy experienced by the male and female populations and is second only to lung cancer as a cause of cancer death in the combined male and female population. Updated figures state that 3.8% of men in Scotland will develop colorectal cancer by the age of 74 (in other words, for males the risk of getting colorectal cancer by the age 74 is 1 in 27) and 2.6% of females in Scotland will develop colorectal cancer by age 74 (in other words, for females, the risk of getting colorectal cancer by age 74 is 1 in 38) 2. There have been three randomised controlled trials (RCT) undertaken which provide the evidence base for screening with guaiac faecal occult blood tests (FOBT) for colorectal cancer from England 3, Denmark 4 and the US 5. In summary, the RCT and a Cochrane Hardcastle JD, Chamberlain JO, Robinson MHE, Moss SM, Amar SS, Balfour TW et al. Randomised controlled trial of faecal occult blood screening for colorectal cancer. Lancet 1996, 348; Kronborg O, Fenger C, Olsen J, Jorgensen OD, Sondergaard O. Randomised study of screening for colorectal cancer with faecal occult blood test. Lancet 1996; 348; Mandel JS, Bond JH, Church JR, Snover DC, Bradley GM, Schuman LM et al. Reducing mortality from colorectal cancer by screening for faecal occult blood. N Engl J Med 1993; 328;

12 Review 6 identified a decrease of 16% mortality from colorectal cancer in the research populations. In the screened population the decrease in mortality is 23%. Appendix I provides a comparison of the cancer registrations, complete to the 31st December 2001, by Dukes' staging, of those NHS Boards piloting bowel cancer screening in year olds and those NHS Boards not piloting screening. The charts highlight an increase of approximately 10% in the registration of early stage cancers (Dukes' A) in the boards piloting screening in the first year following screening implementation. In the Cancer Scenarios document 7 it was estimated that once the programme was established 75 deaths per year for each sex would be prevented, in comparison to the breast screening programme which prevents 40 deaths per year and cervical screening prevents 60 cases per year and 26 deaths. It has been calculated that screening by FOBT costs about 5,900 per life year saved, which is well below the threshold most European countries are willing to pay, and therefore is a cost effective intervention 8 & UK National Screening Committee Following review of the evidence from the three RCT and other published work, the UK National Screening Committee (NSC) recommended to Health Ministers that screening for colorectal cancer should be piloted in the first instance to assess the feasibility, acceptability and practicality of a national programme for the general population. Requests for bids to undertake the pilot work were requested in England and Scotland 10. Following evaluation of the bids, a consortium of Grampian, Tayside and Fife Health Boards was successful in Scotland and in England, Coventry and Warwickshire. 2.3 UK Pilot The colorectal cancer screening pilot in Scotland commenced in April 2000 in Tayside, Grampian and Fife. All men and women registered with a GP Practice in these three areas aged between years were invited to participate. The last invitations for the first (prevalent) cycle of the colorectal cancer screening pilot were sent out in October 2002; follow-up investigations were completed by March Following the Options and Implications report 11 to the Scottish Executive Health Department (SEHD) early 2002, funding was provided through the National Services Division (NSD) for a second cycle of the pilot to gather further information. The second (incidence) cycle of the pilot commenced in December 2002 which provided additional information to assist in planning for rollout. A third round in Tayside, 6 Towler BP, Irwig L, Glasziou P, Weller D, Kewenter J. Screening for colorectal cancer using the faecal occult blood test, Hemoccult (Cochrane Review). The Cochrane Library, Chichester, UK: John Wiley & Sons, Ltd. Issue 3, 2004.] 7 Scottish Executive Health Department (2001). Cancer Scenarios: An aid to planning cancer services in Scotland in the next decade. Edinburgh: The Scottish Executive. 8 Steele RJC, Gnauck R, Hrcka R, Kronborg O, Kuntz C, Moayyedi P, et al (2004) Methods and economic considerations, Report from the ESGE/UEGF workshop on colorectal cancer screening. Endoscopy; 36, Tengs TO, Adams ME, Pliskin JS, Safran DG, Siegel JE, Weinstein MC et al (1995) Five hundred life-saving interventions and their cost-effectiveness. Risk Analysis; 15, NHS MEL(1998)62. Screening for Colorectal Cancer 11 Implications and Options Colorectal Cancer Screening, National Services Division, Common Services Agency, Feb

13 Grampian and Fife commenced in May 2005 for a further 2 years; this will be regarded as Phase I of the programme. A comprehensive evaluation of the first round of the pilot has been undertaken to assess the feasibility of rolling out screening to a National programme. The Evaluation Group s report was published in Spring and the evaluation noted that the UK Pilot has demonstrated that key parameters of test and programme performance observed in randomised studies of FOBT screening can be repeated in population based pilot programmes. A summary of the results of the first round have also been published 13. Appendix II provides a summary of the Key Performance Indicators (KPIs) from the first round. 3 Programme Overview 3.1 Implementation Objective The aim is to plan and implement a national bowel screening programme. The project needs to achieve national rollout across Scotland using FOBT kits as the screening test and colonoscopy as the first line investigation. 3.2 Programme Scope The Scottish Bowel Cancer Screening Programme will invite all men and women between the ages of years registered with a General Practice. Other eligible individuals who are not registered with a General Practice such as prisoners, armed forces, homeless, and individuals in long-stay institutions will also be able to participate following organisational and local agreements. Arrangements will be made for individuals who transfer in or out of Scotland who are undertaking, but have not completed, the screening pathway, see Appendix III. All individuals will be sent a guaiac FOBT (gfobt) in the first instance. If the overall result is positive the individual will be referred to hospital for assessment and offered a colonoscopy, if appropriate. Robust plans for referral and failsafe procedures will be agreed and implemented for each NHS Board. The National Screening Co-ordinator based within NHS Scotland Screening Programmes, NSD, NSS will have a responsibility to monitor and co-ordinate the screening programme. However, the screening programme will be integrated with the existing colorectal service to ensure equity for all patients. The NHS Boards will have a responsibility to ensure the quality and performance of care for the patients within their Board area referred for further investigation and treatment. 12 The UK CRC Screening Pilot Evaluation Team (2003) Evaluation of UK Colorectal Cancer Screening Pilot Final Report 13 UK Colorectal Cancer Screening Pilot Group (2004) Results of the first cycle of a demonstration pilot of screening for colorectal cancer in the United Kingdom. British Medical Journal, doi: /bmj c ( published 5 July 2004) - 6 -

14 3.3 Estimated Target Population Table 1 provides the estimated target population: Table 1 Predictions for years Year Males 658, , ,000 Females 721, , ,000 Taking into consideration the projected numbers, the national programme would require inviting 689,500 individuals each year rising to 822,000 by The Council of the European Union - Proposal for a Council Recommendation on cancer screening stated that screening tests which fulfil the requirements of the recommendation include FOBT screening for colorectal cancer in men and women age Pattern of Service The pattern of the service will include call/recall, laboratory, investigations/treatment and monitoring Call/Recall Scotland will require one screening centre; this will consist of the call/recall office, helpline and laboratory. The current unit based at Kings Cross in Dundee will be expanded to provide all of these aspects for a national rollout. The call/recall office will download the target population from the Community Health Index (CHI) in the first instance. The CHI will be the key patient identifier throughout the screening episode. The individual will be called every two years based on their age. The office will also liaise with the NHS Boards to agree numbers of invitations and number of referrals for further investigations. The office will provide each NHS Board with regular reports on area-specific statistics. The number of invitations to each Board area will be pre-determined by the number in the target population requiring invitation over a 2 year period; however, it will be necessary to have the facility to vary the rate of call/recall if difficulties are encountered for a short-term. In these circumstances it is important for close communication between the NHS Board and screening centre. The office will provide a helpline facility for individuals to contact with queries regarding any aspect of the screening programme. This has proved to be a valuable service in the pilot using a local call rate number. The office will also issue results to individuals within 10 working days of receipt of their test kit and refer to the relevant local colorectal service for further investigations. The office will provide Information Services (ISD), NSS with a regular download of individuals and the result of their FOBT for further analysis. 14 The Council of the European Union Proposal for a Council Recommendation on cancer screening, Brussels, 25 November 2003, 15026/03-7 -

15 3.4.2 Laboratory The laboratory will take receipt of the test kit, undertake the analyses, and provide the office, via the IT system, with the results of all test kits received. The laboratory will direct guidance to individuals who have problems completing the test kit. The laboratory will be accredited under the ISO based scheme conducted by Clinical Pathology Accreditation (UK) Ltd as required in HDL(2003)45 and therefore will be consultant-led. It will be independently assessed at regular intervals with regard to Health and Safety and other requirements. The laboratory will participate in a UK-wide CPA accredited External Quality Assessment Scheme and maintain rigorous internal quality control and assurance techniques. Kits will be tested within 5 working days of receipt in the laboratory Colorectal Service The screening programme should be integrated with the existing colorectal service within NHS Boards. This will require expansion in capacity and resources to cope with the impact. Any patient with an overall positive FOBT result will be referred into the existing care pathway for patients with colorectal symptoms. The screening programme should be viewed as an additional urgent high risk referral route and not a separate service. The only exception to this will be that all referrals from the screening programme should be investigated by colonoscopy in the first instance. Referral to colonoscopy should be agreed within local protocols that ensure that the quality standards set for the programme (e.g. waiting times) are met. All individuals with a positive FOBT result will be referred from the screening office to the colorectal service for pre-assessment prior to being offered a colonoscopy. This assessment can be completed in existing pre-assessment clinics if available. The nurses undertaking the assessment should be part of the endoscopy or colorectal cancer team and have undergone appropriate training. The reason for the pre-assessment is that these individuals will not have had any contact with health care professionals at this stage and will require further advice, reassurance and explanation of the risks of colonoscopy as well as the benefits and identification of any co-morbidity. Informed consent will also be obtained for colonoscopy, as this is the first opportunity for individuals to receive the information they need to make an informed choice regarding further investigations. Following assessment, if the patient is fit and meets the criteria set for the programme, they will be provided with an appointment for colonoscopy. If the colonoscopy is incomplete, then referral for a barium enema will be provided. As with all patients, regardless of the route of referral, following the result of the colonoscopy, they will either be referred to another specialty or treated accordingly in the existing care pathways. Colorectal services in NHS Boards will require to quality assure the service that is provided and this should be integral with existing QA procedures and must meet the programmes nationally set clinical standards Monitoring and Evaluating NSD will have a responsibility in implementing the national rollout in conjunction with NHS Boards. On completion of rollout, NSD will continue to monitor the effectiveness of - 8 -

16 the programme and will nationally commission the screening centre. NSD will provide secretariat to the NHS Board Co-ordinators Group. The Acute Divisions will require collating additional fields, which will provide a failsafe for screened referrals (an essential part of any screening programme) and the completion of the national minimum dataset for colorectal cancer. Arrangements will be agreed with each Board on the identification of the information needed to identify individuals who have slipped through the system but also the lines of responsibility and communication for resolving any problems. ISD will analyse the data from the screening centre and the colorectal cancer minimum dataset on a regular basis to produce the Key Performance Indicators for the programme. NHS Boards will collate additional data on their screened patients which will be generated, collated and analysed locally to assist the NHS Board Co-ordinators in their role of local performance monitoring. 4 Method of Approach The implementation of the national programme should be project managed using a recognised project management methodology such as PRINCE2 for all stages of the project. To limit risk and to allow for flexibility within NHS Boards, a staged implementation over one or two screening cycles should be planned (that is, national rollout to be phased over four years). The SBCFG has been established by the SEHD and a sub-group SBSPB will oversee the implementation of the programme. The Screening Programme Board following agreement from the SBCFG will sign off all plans. Consultation with all key stakeholders will be an ongoing process throughout implementation. NHS Boards will be requested to nominate a NHS Board Co-ordinator (either Consultant in Public Health Medicine or Public Health Specialist), a designated Lead Clinician (clinician who has credibility within the colorectal service, colorectal surgeon/gastroenterologist/pathologist) and a Programme Manager. Local implementation will be facilitated through multidisciplinary steering groups chaired by either one of the three key stakeholders. Decisions on the frequency and structure of these groups will be agreed at a later stage and must address local needs. The Screening Lead Clinician role could be combined with the Colorectal Cancer Lead Clinician if this individual was willing to fulfil both roles. If this is not the set-up it will be necessary for both clinicians to liaise closely. NSD will be responsible for the project management of the rollout in collaboration with NHS Boards and Regional Cancer Advisory Networks

17 5 Deliverables In addition to the information provided in this document, the following will be developed in collaboration with the service: 5.1 Bowel Screening Manual This will include the following and be available to all areas prior to commencement of the programme: Programme Specification Policy Evidence & Results from the Pilot Roles & Responsibilities National Information Leaflets Overview of IT system National Minimum Dataset & Local Minimum Dataset Key Contact Details Monitoring & Evaluation Quality Standards Key Performance Indicators Quality Assurance and Clinical Audit Protocols Consent & Data Protection Protocols Administrative Protocols & QA procedures Laboratory Protocols & QA procedures Failsafe Procedures Procedure for dealing with patients with physical incapacity or consent difficulties Clinical Protocols Escalating Procedures for incidents 5.2 Implementation Plans A number of project plans will be developed to ensure that all stakeholders are aware of the elements of the screening programme and the estimated timescales for implementation. The national plans will include: I. Overall National Implementation Plan to be agreed with the National Steering Group. II. Implementation Plan for the screening centre including procurement of test kits, equipment and potential capital build or refurbishment. III. Plan for IT system including procurement, design, development and implementation. IV. Plan for reporting and monitoring the effectiveness of the programme

18 The National Plan will result from the local plans and will be worked in collaboration with and agreed with each NHS Board prior to sign off by the SBSPB and agreement from SBCFG. 5.3 Quality Standards Comprehensive quality standards will be developed for the screening programme. 5.4 Communications National information material will be developed in collaboration with NHS Health, similar to the established screening programmes. Additional information for NHS Scotland personnel and the media will also be produced in the first instance nationally with guidance issued for ongoing production. The screening centre would be best placed to continue review and circulation of guidance on an annual basis following consultation with the Boards, NSD and ISD. 6 Constraints 6.1 National Funding National funding will be provided for the Scottish Bowel Screening Centre that includes the call/recall facility, helpline, office and laboratory. The central elements will be covered under the top-slicing arrangements from Health Boards and provided to NSD, NSS to commission the national facility in Dundee and the IT system. The monitoring of the programmes effectiveness will be provided by and co-ordinated by NSD and ISD. Appendix IV provides Scotland-wide costs and target population numbers for each NHS Board. 6.2 NHS Board Funding Local funding arrangements will need to take account of the consequent increases to the following services: Pre-assessment clinics or nurse clinics to assess patients prior to colonoscopy Colonoscopy sessions Barium enema sessions and/or CT colography (dependent on availability/resources) Pathology Surgery Oncology Follow-up/Surveillance Out-patient clinics Audit, monitoring and evaluation Approximate numbers of individuals requiring the above services can be extrapolated from the algorithm in Appendix V for each 100,000 target population

19 6.3 Capacity As noted in the Mapping Exercise of Diagnostic Services for colorectal cancer undertaken by NSD in , unused capacity did exist in the endoscopy services. However, lack of staff and equipment were the main constraints to utilising the existing capacity. The survey also highlighted the substantial vacancies in pathology and radiology. The impact on radiology for barium enema provision has however been minimal within the pilot; in contrast the impact on pathology has been substantial. 6.4 Workforce Adequate workforce is required for a national rollout including administrative staff, laboratory staff, nursing and clinical staff. As previously noted recruiting to pathology posts can be problematic and the number of unfilled vacancies in pathology departments needs to be addressed. There are also considerable problems with recruitment and retention of biomedical scientists, currently being addressed Training A skilled workforce requires adequate training. As noted in the Colonoscopy Training Report 17, the recommendation was that training for colonoscopy should be integrated with all endoscopy training. The report also noted that on a Scotland-wide basis a standardised programme for colonoscopy training should be developed and implemented in stages to meet the needs of reaching accreditation standards, and to increase the pool of medical and non-medical endoscopists. Retraining and updating of staff for revalidation will also be essential and the inability to recruit adequate numbers of appropriately trained clinical staff may well be a rate-limiting step for the rollout of bowel screening in some board areas. NHS Education Scotland have submitted a business case for endoscopy training in Scotland, this will increase the numbers of nurse endoscopists and also provide a Train the Trainers course. 6.6 Quality Assurance and Clinical Audit The existing clinical audit departments will require collating a number of additional fields for the screening programme. The majority of data required is already collated within the hospitals system. There are stand alone endoscopy systems available that would allow collation of data to monitor QA of the procedure, but this may not be available in all sites and QA of the procedure should be collated on all patients (not just screened patients). There may also be a lack of IT facilities in pathology as additional information on adenomas has been collected throughout the pilot and this has proved to be extremely valuable. The forthcoming Royal College of Pathology minimum datasets which will include limited cancer excisions including polyp cancers will assist with the completeness of data on the screened patients. 15 Diagnostic Services for colorectal cancer in Scotland, NHSScotland Screening Programmes, National Services Division 16 HDL(2004)28: The recruitment, training and retention of medical laboratory scientific officers (biomedical scientists) 17 Colonoscopy Training Recommendations, National Services Division, Common Services Agency,

20 Taking both endoscopy and pathology data into consideration, it will be necessary to discuss this information gap at the SBSPB, to agree if this should be taken forward at a national or NHS Board level. 6.7 Waiting Lists Current waiting times in the majority of NHS Boards are out with the current national waiting lists targets 18. Waiting lists for endoscopy, radiology and surgery are significant in many Board areas. NHS Boards are already working towards meeting national targets, and it is assumed that boards will have waiting lists under control prior to commencing screening. Local plans will need to reflect the services views of when and how they think they can achieve this but it will be necessary to have an overall timescale for the completion of the rollout. 7 Roles & Responsibilities The national screening programme must be organised within current NHS Scotland structures. NHS Scotland Screening Programmes currently have responsibility for all national screening programmes within Scotland and will provide a leading role in national co-ordination. 7.1 Scottish Executive Health Department Provision of policy on screening programme and provision of funding to NSD and Boards. 7.2 National Services Division, NHS National Services Scotland The National Screening Co-ordinator of NHS Scotland Screening Programmes based within NSD, NSS will have a responsibility to monitor and co-ordinate the screening programme. NSD will also continue to commission the national screening centre. 7.3 NHS Boards Co-ordination at a national level should be fully integrated with the co-ordination at NHS Board level. NHS Boards will be required to appoint a designated NHS Board Coordinator. Lead Clinician and Service Co-ordinator to lead the process locally. The boards will be responsible for the delivery of adequate, high quality investigation and treatment services. The co-ordinators will meet NHS Scotland Screening Programmes regularly to discuss the programme and review monitoring data. NHS Boards will also be called on to help to facilitate the implementation of an appropriate infrastructure to support a co-ordinated screening programme within their Board. 7.4 Regional Advisory Cancer Networks The Cancer Networks will have a continued role in collating, analysing and circulating data on bowel cancer which will include patients referred from the screening programme. The Networks would also have a role in contributing to or commenting on the local 18 Audit Scotland (2005) A review of bowel cancer services, An early diagnosis, Audit Scotland, Edinburgh

21 implementation plans and ensuring that services within their region can cope with the impact of screening. The Managed Clinical Network for Bowel Cancer will collate data and continue to have an active role in auditing clinical practice and programme standards. 7.5 Information Services, NHS National Services Scotland ISD will have responsibility to collate the national data for colorectal cancer and perform analysis on the screening population data. This will include data on the performance of the screening programme. ISD will also have a role in publishing national data. 7.6 NHS Quality Improvement Scotland NHS QIS will have a role in developing and publishing quality standards for the screening programme based on the existing pilot standards. NHS QIS will undertake regular review of the service. 7.7 NHS Health Scotland Developing and reviewing on an ongoing basis national patient information material similar to the breast and cervical screening programmes based on the existing pilot information. 7.8 NHS Education Scotland NHS Education Scotland will co-ordinate the expansion of an Endoscopy Training Network across Scotland to increase the number of Nurse Endoscopists and ensure that a Training the Trainers programme is in place. This will substantially increase the numbers of qualified endoscopists which will alleviate the burden of additional colonoscopies generated by the screening programme. 7.9 Regional Planning This will be agreed when the regional planning structure is fully integrated. The relationships with the local, regional and national components of the screening programme will be clearly stated. The organisational structure for the implementation is in Appendix VI highlighting the groups involved

22 8 Plan The following provides an initial project plan with provisional timescales. Depending on compliance with waiting list targets the phased rollout could be extended to Year 6. The earliest the screening programme would commence national rollout is 2007, following completion of the 3 rd round of the screening pilot. The rollout will be phased with one NHS Board being brought on at a time; this would take between 6 weeks to 4 months depending on the size of the target population. The phasing in of all Boards will take approximately 2½ years. A number of criteria will be identified to ensure that Boards are in a state of readiness before commencing. Figure 1 Initial Project Plan

23 Appendix I Dukes Stage Comparisons CRC Registrations by Dukes' Staging broken down for health boards piloting colorectal cancer screening and those not piloting screening Males and Females: Aged CRC Registrations by Dukes' Staging for health boards piloting screening: Scotland: Males and Females, aged CRC Screening Pilot implemented April % 13% 21% 23.2% 15.3% 18.9% Percentage (%) 80% 60% 40% 31.4% 30.8% 30.3% 30.3% 28% 24.8% 26.5% 25.1% 28% 25.7% D - Distant metastases (e.g. liver) C - Regional lymph nodes +ve B - Tumour inv MP/ peritoneum but regional lymph nodes -ve A - Tumour lim muscularis propria, regional lymph nodes -ve 9 - Not known 20% 13.7% 12.2% 12.4% 22.5% 17.6% 0% 11.1% 8.5% 9.2% 10.6% 9.8% 1997/ / / / /2002* Financial Year *Data for 2001/2002 considered to be approx. 75% complete (i.e. complete to 31 December 2001) CRC Registrations by Dukes' Staging for health boards not piloting screening: Scotland: Males and Females, aged CRC Screening Pilot not implemented (April 2000) 100% 18% 22.9% 18.7% 23.6% 21.1% Percentage (%) 80% 60% 40% 30% 25.2% 30.2% 28.6% 29.5% 28.7% 27.6% 25.1% 27.2% 28.1% D - Distant metastases (e.g. liver) C - Regional lymph nodes +ve B - Tumour inv MP/ peritoneum but regional lymph nodes -ve A - Tumour lim muscularis propria, regional lymph nodes -ve 9 - Not known 20% 15% 15.3% 13.5% 12.6% 13.5% 0% 6.8% 8% 9.6% 11.1% 10.1% 1997/ / / / /2002* Financial Year *Data for 2001/2002 considered to be 75% complete (i.e. complete to 31 December % Breakdown of Dukes' Staging in the Screen-detected Population Scotland: Males and Females aged Date of colonoscopy April December 2001 CRC Screening Pilot implemented (April 2000) 80% 25.8% 20.2% Percentage (%) 60% 40% 20% 17.2% 31.7% 54.7% 47.1% Tis (Carcinoma in situ) D - Distant metastases (e.g. liver) C - Regional lymph nodes +ve B - Tumour inv MP/ peritoneum but regional lymph nodes -ve A - Tumour lim muscularis propria, regional lymph nodes -ve 9 - Not known 0% 1997/ / / / /2002* Financial Year *Data for 2001/2002 considered up to 31 December 2001 to be comparable to available registration d

24 Dukes Stage Comparisons (continued) Numbers of Colorectal Cancer Registrations by Dukes' Stage By Financial Year (Year before screening and first year of screening) Males and Females Aged Screened Health boards Dukes' D 23.2% Dukes' C 30.3% Dukes' Unknown 9.2% Dukes' A 12.4% Dukes' B 24.8% Dukes' C 26.5% Dukes' D 15.3% Dukes' Unknown 10.6% Dukes' A 22.5% Dukes' B 25.1% 1999/ Before screening commenced 2000/ First year after screening implemented Numbers of Colorectal Cancer Registrations by Dukes' Stage By Financial Year (Year before screening and first year of screening) Males and Females Aged Non-Screened Health boards Dukes' D 18.7% Dukes' Unknown 9.6% Dukes' A 13.5% Dukes' D 23.6% Dukes' Unknown 11.1% Dukes' A 12.6% Dukes' C 29.5% Dukes' B 28.7% Dukes' C 27.6% Dukes' B 25.1% 1999/ /

25 Appendix II - Summary of 1 st Round Key Performance Indicators COLORECTAL SCREENING PILOT Key Performance Indicators Data extract taken April 2005: Complete First Round Data Results reported for invitations sent 29/03/2000 to 31/03/2003 Males Females Overall 1 Overall uptake of screening (%) Time between appointment with specialist nurse and colonscopy % in 4 weeks 3 Proportion of people found FOBt positive (per 1000 screened) 4 Crude cancer detection rate (per 1000 screened) 5 % of people with screened detected cancers 5.1 Dukes Stage A Dukes Stage B Dukes Stage C Dukes Stage C Dukes Stage D High risk adenoma detection rate (per 1000 screened) 7 Rate of colonoscopic complications (requiring admission) 8 Percentage of polyp cancers (% of people with polyp cancers out of all those with cancer) 9 Polyp cancer detection rate (per 1000 screened) 10 Positive Predictive Value of FOBT to cancer

26 Appendix III Proposed Screening Pathway `~ää=í~êöéí éçéìä~íáçå=rmjsv Ñêçã=`ef mêáçê=kçíáñáå~íáçå=iáëí=íç=dm Ñçê=ÅäÉ~åáåÖ Eçéíáçå~äF ^ãéåç=fq=ëóëíéã péåç=ñáêëí áåîáí~íáçåë qéëí=âáí=klq êéíìêåéç=ïáíüáå=s ïééâë péåç=êéãáåçéê äéííéê kç=êéëéçåëé oéíìêå=íç=äáëí=íç=äé áåîáíéç=áå=o=óé~êë oéíìêå=íç=äáëí=íç=äé ëåêééåéç=áå=o óé~êë kéö~íáîé=oéëìäí qéëí=âáí=êéíìêåéç oééé~íl oééä~åéãéåí =íéëí=âáí=ëéåí oééä~åéãéåí=íéëí âáí=êéèìéëíéç p`obbkfkd `bkqob lîéê~ää mçëáíáîé=oéëìäí oéñéêê~ä=íç=_ç~êç oééé~í=íéëíáåö êéèìáêéç kç=êéëéçåëé oéãáåçéê=c=íéëí âáí=ëéåí kç=êéëéçåëé dm=áåñçêãéç ^ééçáåíãéåí=ñçê éêéj~ëëéëëãéåí ÅäáåáÅ `lilob`q^i=pbosf`b péåç=~åçíüéê ~ééçáåíãéåí aáç=kçí=^ííéåç ^ííéåç=éêéj ~ëëéëëãéåí=åäáåáå ^ëëéëë=ñçê=ñáíåéëë Ñçê=ÅçäçåçëÅçéó oéñéê=ñçê ÅçäçåçëÅçéó `çäçåçëåçéó ìåçéêí~âéå aáç=kçí=^ííéåç `çãéäéíé fååçãéäéíé oéñéê=ñçê=_~êáìã båéã~ fåñçêã=dm=c `äáåáåá~å kéö~íáîé líüéê=m~íüçäçöó `~ååéê=pìëééåíéç mçäóéë _~êáìã=båéã~ ééêñçêãéç få~ééêçéêá~íé=ñçê ÅçäçåçëÅçéó oéñéê=íç=åäáåáåá~å Ñçê=~ëëÉëëãÉåí fåñçêã=é~íáéåí =C=dm oéñéêê~ä=íç ~ééêçéêá~íé ëééåá~äáíó m~íüçäçöó cçääçïjìé pfdk=dìáçéäáåéë kéö~íáîé pìëéáåáçìë=çñ `~ååéê líüéê=m~íüçäçöó `çåñáêãéç dm=áåñçêãéç oéñéêê~ä=ñçê=ëìêöéêó oéñéêê~ä=íç ~ééêçéêá~íé ëééåá~äáíó fåñçêã=dm=c líüéê=`äáåáåá~å fåñçêã=é~íáéåí =C=dm oéñéê=ñçê=ëìêöéêól çååçäçöó oéíìêå=íç=äáëí=íç=äé áåîáíéç=áå=o=óé~êë oéíìêå=íç=äáëí=íç=äé áåîáíéç=áå=o=óé~êë