GUIDE BOOK FOR PROGRAMME HUBS AND SCREENING CENTRES

GUIDE BOOK FOR PROGRAMME HUBS AND SCREENING CENTRES NHS Bowel Cancer Screening Programme Version 1 July 2006 1

PREFACE ACKNOWLEDGEMENTS 1. INTRODUCTION 1.1 Background 1.2 Aims and objectives of the screening programme 1.3 The screening process 1.4 Organisation of the screening programme 1.5 Selection of screening centres 1.6 Screening policy 1.7 National IT system (BCSS) 1.8 Training 1.9 Other national contracts and arrangements 1.10 Information for primary care 1.11 Financial arrangements 1.12 Accountability 1.13 Monitoring programme performance 1.14 Quality assurance 1.15 Audit and evaluation 1.16 Use of patient information 1.17 Advisory Committee 2. SETTING UP A PROGRAMME HUB 2.1 Staffing 2.2 Staff roles 2.3 Staff training 2.4 Accommodation and equipment 2.5 IT site set up 2.6 Setting up the Freephone telephone helpline 2.7 Setting up postal arrangements 2.8 Test kits 2.9 National leaflets 2.10 Stationery for programme hubs 3. COMMUNICATING WITH PARTICIPANTS 3.1 Informed choice 3.2 Confidentiality and data protection 3.3 Telephone helpline 3.4 Letters 3.5 Interpretation and translation 4. PROGRAMME ADMINISTRATION 4.1 Planning the start of screening 4.2 Setting up an implementation plan 4.3 Call 4.4 Controlling the flow of invitations 4.5 Call and recall pathway 4.6 Invitation letters 4.7 Test kit letter and test kits 4.8 Completed test kits 4.9 Result letters 4.10 Spoilt test kits 4.11 Technical failures 4.12 Replacement test kits 2

4.13 Reminder letters 4.14 Non-responders 4.15 Recall 4.16 Individuals who ask to withdraw from the programme (ceasing) 4.17 Opting out of the current screening round 4.18 People who move into the programme 4.19 Self-referral (over-70s) 4.20 People younger than 60 4.21 People who move out of the programme 4.22 Failsafe 5. TEST KIT READING 5.1 Laboratory staff 5.2 CPA accreditation 5.3 Receipt and logging of test kits 5.4 Quality control 5.5 Test kit reading 5.6 Spoilt kits 5.7 Technical failure 5.8 Retention and disposal of test kits 6. SETTING UP A SCREENING CENTRE 6.1 Organisation of screening centres 6.2 Staffing 6.3 Staff roles 6.4 Accountability 6.5 Planning screening centre services 6.6 Administrative support for the screening centre 6.7 Naming of screening centres 6.8 Setting up screening colonoscopy sessions 6.9 Setting up nurse-led clinics 6.10 Data collection 7. NURSE-LED CLINICS 7.1 Booking nurse positive clinic appointments 7.2 Preparing for nurse positive clinics 7.3 During the nurse positive clinic 7.4 Patients who are unfit for colonoscopy 7.5 Patients who decline further investigations 7.6 Patients who do not attend 7.7 Recording clinic outcomes 7.8 Follow up nurse clinic 8. SCREENING COLONOSCOPY SESSIONS 8.1 Endoscopy lists for screening patients 8.2 Standards for colonoscopy 8.3 Links with pathology 8.4 Links with radiology 8.5 Giving patients the results of colonoscopy 8.6 Polyp surveillance 8.7 Referral of patients with suspected cancer 8.8 Referral of patients with other findings 8.9 Completion of datasets GLOSSARY OF TERMS USED IN THE BCSP 3

REFERENCES APPENDIX 1: PROGRAMME HUBS A1.1 Specific tasks for the programme hubs A1.2 Selection criteria for the programme hubs APPENDIX 2: SCREENING CENTRES A2.1 Specific tasks for screening centres A2.2 Selection criteria APPENDIX 3: SITE READINESS APPENDIX 4:FOBT KITS AND NATIONAL LEAFLETS A4.1 Availability and ordering APPENDIX 5 A5.1 Envelope specification APPENDIX 6 A6.1 Setting up arrangements for return of completed FOBt kits APPENDIX 7: SPECIALIST SCREENING PRACTITIONER A7.1 Job description A7.2 Job purpose A7.3 Person specification APPENDIX 8 A8.1 Colonoscopy QA standards 4

PREFACE This guide book is based on the experience of the UK Colorectal Cancer Screening Pilot, in particular the English pilot site, and is intended to assist the national roll out of the NHS Bowel Cancer Screening Programme (BCSP). It sets out definitive policies and procedures for the programme. Initially, the guide book will help potential programme hubs and screening centres to assess the resources and processes that they would need to be able to put in place if they wish to be considered for selection. The guide book will also serve as a guide for designated programme hubs and screening centres to ensure that they operate to a common set of protocols and procedures. The guide book will be published on the BCSP website (www.bcsp.nhs.uk), and will be developed as experience of running the national programme becomes available. In particular, standard operating procedures will be written as soon as the first programme hub and screening centres have practical experience of using the national bowel cancer screening IT system (the BCSS). The guide book should be used in conjunction with the BCSS User Guide and other BCSS documentation. ACKNOWLEDGEMENTS The guide has been compiled by Sue Gray. Thanks to members of the pilot management team: Sue Elwell, Sara Lee, Margaret Ofield, Ron Parker, Pat Ramsell and Steve Smith. Thanks also to Paul Ryder and Gordon Crosthwaite of Beaumont Colson, to Nikki Fish and John Doherty of NHS Connecting for Health and to Julietta Patnick, Lynn Coleman, Richard Winder, TJ Day and Claire Nickerson from the national office of the NHS Cancer Screening Programmes for their contributions. 5

1. INTRODUCTION 1.1 Background Bowel cancer is a major public health problem. It is the second most common cause of cancer death in the United Kingdom. 1 Research undertaken in Nottingham 2 and Funen 3 in the 1980s showed that screening men and women aged 45 74 for bowel cancer using the faecal occult blood test (FOBt) could reduce the mortality rate from bowel cancer by 15% in those screened. An independently evaluated pilot in Coventry and Warwickshire, and in Scotland showed that this research can be replicated in an NHS setting. 4 In September 2000, the NHS Cancer Plan 5 stated that a national bowel cancer screening programme would be introduced subject to evidence of the effectiveness of the pilot. Based on the final evaluation report of the pilot and a formal options appraisal, 6 the Secretary of State for Health announced in October 2004 that the NHS Bowel Cancer Screening Programme (NHS BCSP) would begin in April 2006. Advice to the NHS was issued by the Department of Health in July 2005. 7 The programme will begin by inviting men and women aged 60 69 in order to achieve full national coverage with available and expanding capacity. Once national coverage has been achieved, the programme can be expanded to offer FOB testing in a wider age group, or by implementing new screening technologies. The White Paper Our Health, Our Care, Our Say: a New Direction for Community Services 8 reaffirmed the Government s commitment to rolling out a screening programme for bowel cancer from April 2006. The roll out of the national programme is being phased over three years, with the intention that the whole eligible population will be covered by 2009. 1.2 Aims and objectives of the screening programme The aim of the NHS BCSP is to reduce mortality from bowel cancer in the population covered. The objectives of the programme are to: identify and invite eligible men and women for screening enable people to make an informed choice about whether or not to participate in the screening programme provide clear information quickly to people with either normal or abnormal FOBt results diagnose a significant proportion of cancers at an early stage minimise anxiety among participants in the programme make the best use of screening resources maintain minimum standards of screening and continually strive for excellence involve and give feedback to the population covered by the programme develop the staff who deliver the screening service continue research into screening for and diagnosis and treatment of colorectal cancer. 1.3 The screening process The NHS BSCP offers screening to men and women aged 60 69 every two years using a guaiac based faecal occult blood test (FOBt). People aged 70 or over can request an FOBt kit. Most people who participate in the NHS BCSP will not see a health professional. They will have a normal test result and will be invited to participate again in two years time. Participants with an abnormal FOBt result are invited to see a nurse at a local screening 6

centre. They are offered colonoscopy as the investigation of choice. 1 Depending on the findings of colonoscopy, they are offered screening again in two years time, entered into the polyp surveillance programme or referred for treatment at a local hospital. A flowchart of the screening process is shown in Figure 1. Estimated numbers of referrals for colonoscopy are shown in Table 1. 1 Note that people who are sent an FOB test kit are referred to as participants. People who have an FOB test result that is not normal are referred to as patients. The BCSS uses the terminology screening subject. See Glossary. 7

Figure 1 The screening pathway. 8

Table 1 Expected referrals for screening colonoscopies Population covered by each programme hub (up to 20 screening centres) Resident population per screening centre About 10% of this population is aged 60 69 and will be invited for screening Half the invitations will be sent out in year 1 of the screening round and the remainder in year 2 The anticipated uptake for the first round of screening is 60% About 2% of kits returned will be abnormal Number of nurse clinic appointments per year to each screening centre Most people referred to the nurse clinic will be referred for colonoscopy Assuming four patients are seen in each colonoscopy clinic and clinics run for 40 weeks per year After the first round of screening, provision needs to be made for surveillance colonoscopies Assuming five patients are seen in each clinic and clinics run for 40 weeks per year 1.4 Organisation of the screening programme 10 million people 500 000 people 50 000 people eligible 25 000 invitations per year 15 000 kits returned per year 300 abnormal test results per year 300 nurse clinic referrals per year 300 screening colonoscopies per year 1 or 2 colonoscopy clinics per week 600 colonoscopies per year Three colonoscopy clinics per week 1.4.1 Programme hubs The NHS BCSP is being organised around five programme hubs. Each programme hub covers the same geographical area as the NHS Connecting for Health regional clusters and relates to one local service provider (LSP 2 ). The main tasks for each programme hub are to: manage call and recall for the screening programme provide a telephone helpline for people invited for screening dispatch and process test kits send test result letters and notify GPs book the first appointment at a nurse-led clinic for patients with an abnormal test result coordinate quality assurance activities. The detailed specification of the tasks for programme hubs is given in Appendix 1. Operational details about setting up and running programme hubs are described in Chapters 2 5. 1.4.2 Screening centres Up to 20 screening centres will be linked to each programme hub when the programme is fully rolled out. The main tasks for each screening centre are to: provide nurse-led clinics for patients with an abnormal test result arrange colonoscopy appointments for patients with an abnormal test result arrange alternative investigations for patients in whom colonoscopy has failed ensure appropriate follow-up or treatment for patients after colonoscopy. Other tasks for screening centres are to: 2 See www.connectingforhealth.nhs.uk/regions. The programme hubs are Eastern, London, North East, Midlands & the North West, and Southern. 9

provide information about the screening programme for the local health community promote the screening programme to the general public in their locality provide information and support for local people in completing the FOB test (on referral from the programme hub) ensure that data are collected to enable audit and evaluation of the screening programme. The detailed specification of the tasks for screening centres is given in Appendix 2. Operational details about setting up and running a screening centre are described in Chapters 6 8. An example of the possible configuration of programme hub, screening centres and treating hospitals is shown in Figure 2. MDT at treating hospital MDT at treating hospital Screening centre Programme hub (relates to up to 20 screening centres) MDT at treating hospital Screening centre Screening centre MDT at treating hospital Figure 2 Configuration of programme hubs, screening centres and multidisciplinary teams (MDTs). 1.5 Selection of screening centres First wave screening centres have now been selected by the national office of the NHS Cancer Screening Programmes. Second wave screening centres will be selected in due course. A number of criteria need to be satisfied before a screening centre can become operational. The minimum criteria are: 10

endoscopy global rating scale (GRS) scores for timeliness are at level A for all sites where screening colonoscopies are offered a satisfactory Joint Advisory Group (JAG) on gastrointestinal endoscopy visit that has given the endoscopy unit full or conditional accreditation. In addition, the screening centre must have a minimum of two colonoscopists who have successfully completed the process for accreditation for screening colonoscopists. The organisation of JAG visits to potential screening centres will be organised through the JAG office at the Royal College of Physicians, London. The national office of the NHS Cancer Screening Programmes will provide the JAG office with a list of endoscopy units to be visited and approximate dates for the visits. An explanation of the endoscopy GRS, accreditation of colonoscopists and JAG accreditation of endoscopy units are given in NHS BCSP Implementation Guides 2, 3 and 4. 9,10,11 The guides can be found on the NHS BCSP website (www.bcsp.nhs.uk). Details of the JAG accreditation process can be found on the JAG website (www.thejag.org.uk). Details of how to apply for accreditation as a screening colonoscopist are on the BSCSP website (www.bcsp.nhs.uk). 1.6 Screening policy 1.6.1 Age range The NHS BCSP offers biennial FOB test screening to people in the age range 60 69. People aged 70 and over have the option to self-refer, although they will not be invited routinely for screening and will have to make a new request for screening every two years. People under the age of 60 cannot be included in the programme under any circumstances. 1.6.2 Criteria for inclusion in invitations Invitations to participate in the screening programme are sent without any prior knowledge of an individual s medical history, but recipients are invited to telephone the programme hub with queries if screening may not be appropriate (see below). The criteria for inclusion in invitations to participate are: men and women aged 60 69 registered with the NHS. 3 An FOB test or colonoscopy carried out in the private sector does not affect a person s entitlement to participate in the BCSP. However, individuals may be advised that screening is inappropriate if they have had a recent colonoscopy. 1.6.3 Criteria for exclusion (ceasing) The criteria for exclusion from the national screening programme are if the person: 3 This generally means registered with a GP, but there may be some individuals registered with the NHS who do not have a GP. People who are not registered with a GP cannot currently be included in call and recall. This issue will be addressed at a later stage. 11

has undergone total removal of the large bowel is already in a colonoscopy surveillance programme (eg for Crohn s disease) has signed a request that no further contact be made by the NHS BCSP at any stage. 1.6.4 Equal access for people with disabilities The NHS Cancer Screening Programmes is currently updating its guidance on consent issues in cancer screening programmes, and this will include guidance specific to the bowel cancer screening programme. 1.7 National IT system (BCSS) A national IT system - the bowel cancer screening system (BCSS)- has been designed and built by NHS Connecting for Health to support the bowel cancer screening programme. The system offers a range of functions that enable programme hubs and screening centres to manage the programme. These functions include: selection of screening subjects call and recall logging receipt of test kits and test kit results booking nurse clinic appointments letter production reporting programme activity. Full details of the functions available in the BCSS and how to use them are given in the BCSS User Guide. 12 This will be made available online to system users as part of the site set-up for programme hubs and screening centres. Detailed guidance on site set-up and accessing the system is given in the Site Set Up Pack 13 that will be available to programme hubs and screening centres when these have been selected. A guide to site readiness is at Appendix 3. NHS Connecting for Health will provide training in using the BCSS for staff in programme hubs and screening centres as part of their preparations for beginning screening. Connecting for Health will also provide a helpdesk for BCSS users. The helpdesk will refer any problems that require clinical input to the programme hub director and the screening centre clinical lead to decide on immediate action for the participant or patient. The problem should also be referred to the national office to consider whether there are any implications for programme policy. The helpdesk will refer any problems that have implications for IT policy direct to the national office. When the BCSS is operational, any requests for changes to the system will be considered by the BCSS User Group and approved by the BCSS Programme Board. Programme hubs and screening centres will be represented on these groups. 1.8 Training Arrangements are being made for the first programme hub (based in Rugby) to run a series of induction sessions for staff from new programme hubs and screening centres. More formal professional or technical training is being developed for programme hub laboratory staff and for screening centre nurses. For further details, see Chapters 2 and 6. 1.9 Other national contracts and arrangements National contracts and arrangements are in place for the supply of the following: 12

FOBt kits national leaflets (Bowel Cancer Screening The Facts and Bowel Cancer Screening The Colonoscopy Investigation) information packs for GPs posters. Details of availability and ordering are given in Appendix 4. 1.10 Information for primary care The intention of the screening programme is to keep the primary care workload to a minimum. However, screening centres are responsible for disseminating information about the screening programme to primary care teams, eg through PCTs, practice visits, or regular GP/practice manager meetings. Once screening has begun, some people receiving invitations and test kits may want the opportunity to discuss the screening process with their GPs. An information pack is being prepared to assist GPs in dealing with their patients queries and concerns. Posters and leaflets will also be available for screening centres to use in providing information about the NHS BCSP for local primary care or health promotion teams (see Appendix 4 for details of availability and ordering). 1.11 Financial arrangements For 2006/7, funding for programme hubs and screening centres will be routed via the national office of the NHS Cancer Screening Programmes. There will be an service level agreement between the national office and each programme hub or screening centre that will specify: the range of services to be provided indicative activity levels the value of the agreement payment terms. Details of financial arrangements for 2007/8 and subsequent years are still to be determined. 1.12 Accountability Staff working in the NHS BCSP will be expected to work to national programme protocols and standards. However, they will be subject to the local clinical governance arrangements of their host trust. 1.13 Monitoring programme performance The BCSS provides a series of strategic reports that give statistics about programme activity (eg count of letter types sent, FOB test results count). Programme hubs will be expected to report regularly to the national office on programme activity. For further details, see the BCSS User Guide. 12 Programme hubs and screening centres will be required to work towards meeting the national standard for cancer waiting times (the 62 day wait) for patients who are diagnosed with bowel cancer through the screening programme. A national statistical return (a KC return) is being developed by the NHS Health and Social 13

Care Information Centre. 1.14 Quality assurance Initial process quality standards have been developed based on the process measures in the screening trials and elsewhere in the literature. These will be subject to constant review, revision and augmentation throughout the roll out period. Regular review of performance against these standards and revision of the standards will be a feature of the operation of the bowel cancer screening programme in the longer term. Arrangements for quality assurance are being developed as programme hubs and screening centres become operational. National professional coordinating groups will be set up and the intention is that a QA Director will be appointed for each cluster, ie each programme hub and associated screening centres. 1.15 Audit and evaluation Screening centres and programme hubs are expected to be able to report final outcomes on all patients screened by the programme. In particular, screening centres will have to liaise with a number of treating hospitals in order to ascertain the tumour characteristics for all patients referred for cancer treatment. Details of data collection activities by screening centres are given in Chapter 6. The Department of Health has made arrangements with the Cancer Screening Evaluation Unit (CSEU) at the Institute of Cancer Research to evaluate the outcome of the programme in the longer term. Guidance on the audit of bowel cancers in patients who have been screened will be developed. Data collection for this purpose will require extensive liaison between programme hubs and cancer registries. 1.16 Use of patient information All programme hubs and screening centres must comply with the requirements set by the national office of the NHS Cancer Screening Programmes for the confidentiality and security of patient information. The national office will check annually to ensure that programme hubs and screening centres comply with the requirements of the Patient Information Advisory 14, 15 Group (PIAG) for the use of patient information in cancer screening programmes. 1.17 Advisory Committee An Advisory Committee on Bowel Cancer Screening is being set up to advise ministers and the Department of Health on the development of the NHS Bowel Cancer Screening Programme, to monitor its effectiveness and to advise on the implications of research evidence as and when it becomes available. 14

2. SETTING UP A PROGRAMME HUB 2.1 Staffing The staffing of a programme hub includes an administration team to undertake the call and recall process and a laboratory team to process the FOBt kits. Both teams need to work closely with each other, and they should work in a location that allows this to happen as easily as possible. The staff roles at the programme hub are likely to include: a programme hub director (who may also fulfil one of the other roles) a programme hub manager a programme hub lead nurse a programme hub lead clinical biochemist. The administration team should include staff to produce and dispatch letters and to answer the telephone helpline. The laboratory team includes staffing to process test kits and enter test results. In the pilot site, the laboratory staff also dispatched test kits, but consideration is being given to outsourcing this when the national programme is fully operational. 2.2 Staff roles The roles of programme hub staff are summarised below. Note that, in the BCSS, user roles are defined to determine different levels of access to functions and reports. It is for each programme hub manager to determine the user roles of individual staff at programme hubs and screening centres; some staff may have more than one user role. Details of user roles are given in the BCSS User Guide. 12 2.2.1 Programme hub director The programme hub director: is responsible for the management and smooth running of the programme hub provides advice and support to the programme manager and programme hub lead nurse ensures close liaison with associated screening centres leads quality assurance (QA) activities at the hub (both laboratory and administrative aspects) provides advice to the national office of the NHS Cancer Screening Programmes. 2.2.2 Programme hub lead clinical biochemist The programme hub lead clinical biochemist: directs the laboratory activities of the programme hub participates in laboratory QA activities provides advice to the programme hub director and lead nurse on issues arising from the processing of FOB test kits contributes to the development of alternative testing methods. 15

2.2.3 Programme hub manager The programme hub manager: plans, in conjunction with local screening centres, the roll out of the screening programme sets up implementation plans to bring the selected population into the programme manages, in conjunction with local screening centres, the flow of patients to colonoscopy clinics manages the activities of the programme hub administrative team, including provision of the telephone helpline, production and dispatch of letters, booking nurse clinic appointments and production of activity reports manages the activities of the laboratory team monitors the activities of screening centres coordinates QA activities at the programme hub and screening centres. 2.2.4 Programme hub lead nurse The programme hub lead nurse: provides advice and support for programme hub staff answering the telephone helpline helps screening centres to manage the flow of patients referred from screening to colonoscopy clinics provides professional support to screening centre nurses ensures that screening centres collect patients data for quality assurance and programme evaluation. 2.2.5 Programme hub administration team The programme hub administration team: produces and dispatches letters arranges for test kits to be dispatched books appointments for nurse-led clinics answers the telephone helpline orders supplies of test kits produces reports of programme activity. Production of letters and reports are manages using the BCSS. Full details are given in the BCSS User Guide. 12 2.2.6 Programme hub laboratory team The programme hub laboratory team: receives and logs test kits processes test kits and enters test results. Logging of test kits and entering test results are managed using the BCSS. Full details are given in the BCSS User Guide. 12 2.3 Staff training 16

The first programme hub (based in Rugby) will provide training and support for new programme hubs. Additional training in office and laboratory procedures for programme hub staff is under consideration. NHS Direct may be able to provide local training for programme hub staff who answer the telephone helpline. The host trust is responsible for providing training to ensure compliance with trust policies (eg health and safety or data protection). Training in the use of the BCSS will be provided by NHS Connecting for Health. Once programme hubs have begun work, training will be available on an on-going basis to deal with system updates and new members of staff. 2.4 Accommodation and equipment Programme hubs activities involve printing and handling large volumes of letters and test kits on a daily basis. In addition to normal office and laboratory requirements, sufficient space is required to ensure that this can be carried out in a safe and efficient manner. Table 2 shows estimates of the numbers of letters and kits that will be handled when programme hubs are fully operational. The national office is considering the possibility of outsourcing the bulk printing and mailing activities. However, the process would still need to be managed by the programme hub. The issues being considered include: printing of invitation letters, test kit letters and normal result letters overprinting of test kits with bar codes mailing of test kit letters and test kits. Accommodation for the programme hub administration team needs to be suitable in terms of working space and (lack of) background noise. Each member of staff who is anserwing the telephone helpline needs an adjacent dedicated PC to be able access the BCSS during a call. In the laboratory, sufficient space is needed for the daily receipt, opening and sorting of test kits. Each test kit reader who is at work logging and processing test kits needs bench space with a bar code reader and an adjacent dedicated PC. Office space is also required for the laboratory team manager. Storage space is needed to retain the processed kits for one month. Sufficient storage space at the programme hub is needed for a supply of leaflets, other stationery and test kits, although the bulk will be held elsewhere and can be called off as required (see Appendix 4). Table 2 Estimated numbers of letters and kits handled by programme hubs when fully operational Minimum Maximum Invitation letters sent per annum 360 000 630 000 Invitation letters sent per day 1250 3000 Test kit letters and test kits sent per day 1250 3000 Test kits returned per day (assuming 60% uptake) 780 1850 Normal result letters sent per day 764 1813 Normal GP notifications sent per day 764 1813 Abnormal test results per day 16 37 Nurse clinic letters sent per day 16 37 Abnormal GP notifications sent per day 16 37 17

2.5 IT site set up A Site Set up Pack 13 is available for the site set up of the BCSS. This includes the specification for equipment and connectivity, including: PCs and printers for the programme office PCs and bar code readers for the laboratory. A guide to site readiness is at Appendix 3. Details of the process for setting up the BCSS, including staff training and access to the system, will be included as part of the training and support provided by NHS Connecting for Health as each programme hub is set up. 2.6 Setting up the Freephone telephone helpline Telephone calls to the helpline will be via a single national Freephone number (0800 707 60 60). Calls will then be routed automatically to the relevant programme hub. They can be routed to any designated telephone provided that that phone has a direct connection to the public telephone network. Calls to the helpline must be answered directly by programme administration staff (ie not via a switchboard). The telephone system at the hub needs to be set up so that if one designated telephone is engaged the call is routed to one of at least two other telephones and then to an answerphone system. The answerphone system should be available as a back up if programme hub administration staff are engaged on other calls. It should also be used to provide an out of hours service. Details on staffing and running the telephone helpline are given in Chapter 3. Initially, all calls to the helpline will be answered by the first programme hub (based in Rugby). As each of the other programme hubs becomes operational, calls from anywhere within their region will be routed automatically to that hub. Each hub needs to contact BT to ensure that the correct network connections are set up. Contact details are available from the national office of the NHS Cancer Screening Programmes. 2.7 Setting up postal arrangements 2.7.1 Envelopes for sending out programme letters and test kits All programme letters and test kits and must be sent out from the programme hub in NHS identified envelopes (ie with the NHS logo top left). The envelopes must have a window to ensure that the participant s address is clearly visible. The detailed specification is at Appendix 5. Programme hubs need to order the envelopes from a local supplier. 2.7.2 Envelopes for returned test kits Completed test kits will be returned to the hubs via specially designed prepaid envelopes. These envelopes need to be ordered from the kit supplier, and must conform to specifications laid down by the Royal Mail. These prepaid envelopes operate under the Business Reply Plus service from Royal Mail. The procedure for setting up Business Reply Plus envelopes for returning kits is as follows: programme hub agrees address format with national office programme hub applies to Royal Mail for Business Reply Plus code for that address 18

programme hub informs the national office of the designated code the national office generates PDF files of the address to include the NHS logo, and returns the files to the hub the programme hub sends the PDF files to the kit supplier, who then prints and supplies the required stocks of envelopes. Details of the procedure are in Appendix 6. 2.7.3 Collection and delivery of mail Programme hubs will need to make their own arrangements locally with Royal Mail with regards to the delivery and collection of mail. Delivery of returned kits should be direct to laboratories wherever possible, to allow processing on the day they are received at the hub. Hubs will also need to make arrangements with Royal Mail for undelivered letters. 2.8 Test kits A national contract has been negotiated by the NHS Purchasing and Supply Agency (PASA) on behalf of the NHS Cancer Screening Programmes for the supply of test kits. Each programme hub can call off this contract according to its needs and taking account of the fact that kits have an expiry date. The test kit supplier will provide: the test kits cardboard sticks to use with the test kits envelopes for the return of the test kits buffer solutions for processing the test kits. Details of how to order test kits are given in Appendix 4. The national office will provide a PDF of the instruction leaflet on how to use the test kit. This is a double sided A4 document which needs to be folded twice (into C6 format). Programme hubs will need to order supplies form a local printer. 2.9 National leaflets Two national leaflets are available: Bowel Cancer Screening The Facts Bowel Cancer Screening The Colonoscopy Investigation As a first priority, black and white PDF text versions of the national leaflets will be available in the 10 or so most commonly requested languages for translations of health information. Subsequently, full colour PDF and printed versions of the leaflets will be available in the five most commonly requested languages. The printed versions will be available to order from the Department of Health (DH) Publications Orderline. Hubs will be notified of the relevant order codes as the leaflets become available. The text PDFs and full colour PDFs of the leaflets will be available to download from the Bowel Cancer Screening Programme website at www.bcsp.nhs.uk. Audio versions of the two leaflets will be available on CD in English and the five most 19

commonly requested languages. These will be available to order from the DH Publications Orderline. Hubs will be notified of the relevant order codes as the CDs become available. Braille versions will be available in due course. Other communications for blind or partially sighted participants, including instructions on how to use the kits and invitation and result letters, is under consideration. Details of how to order leaflets are given in Appendix 4. 2.10 Stationery for programme letters All correspondence from the programme hub to participants will be sent out on preprinted headed paper. The heading consists of the NHS Cancer Screening Programmes logo, bowel cancer screening programme title, hub address and Freephone contact number. The programme director s name should also be preprinted on the letters. The reverse of letters that enclose one of the national leaflets can be preprinted with advice in other languages about how to obtain information if the recipient is not able to read the leaflet. A CD is available for programme hubs to use to select the relevant languages. Print ready PDFs for the letters are available from the national office of the NHS Cancer Screening Programmes for programme hubs to have these letters printed locally. 20

3. COMMUNICATING WITH PARTICIPANTS 3.1 Informed choice Effective communication is a central part of any screening programme. People who are offered screening must be given enough information to allow them to make an informed choice based on a full appreciation of both the potential benefits and the risks and limitations of screening. A copy of the national leaflet Bowel Cancer Screening The Facts must be sent to every individual who is invited to participate in the programme. The leaflet gives an overview of the screening process, explains what will happen to the test kit, and contains other information for the individual who decides to participate in the screening programme. If a test kit is returned, this is accepted as valid consent to participation in the screening programme. 3.2 Confidentiality and data protection Participation in the screening programme following receipt of the mandatory national leaflet also includes consent to the use of information for audit of the screening programme. A publication about consent to cancer screening is in preparation. 16 Programme hubs and screening centres must comply with NHS Cancer Screening Programmes policies on confidentiality and data security. 14,15 The programmes have PIAG support for exemption under Section 60 of the Health and Social Care Act 2001, but this is dependent on compliance with these policies. PIAG reviews its support of the programmes exemption every year. 3.3 Telephone helpline The telephone helpline provides a source of accurate advice and information for the general public on the screening process, and practical advice on completing the test kits for all those taking part in the screening programme. All members of the programme hub administration team must be trained in telephone answering techniques. The helpline must be staffed during normal office hours. Staff answering the helpline should have easy access to a list of responses for common queries. Complex queries, for example about programme policy or those requiring clinical judgement, should be referred to the programme hub manager or the programme hub lead nurse. Some queries may need to be referred to the appropriate screening centre. A guide to frequently asked questions is being prepared by the national office. 17 An answerphone must be available as a backup if all staff are engaged on other calls or for calls outside normal working hours. The BCSS can be used to look at the screening subject s status and amend his or her details during a call to the helpline. 3.4 Letters A suite of standard letters is included in the BCSS. These must be used for all correspondence to participants in the screening programme. There is some limited provision for programme 21

hubs to include additional lines of text or to produce supplementary letters. An example might be to include local information about the location of a nurse-led clinic. There is also provision for ad hoc letters to individuals. However, programme hubs cannot alter the wording of standard letters which has been agreed nationally. Any request for changes must be made through the BCSS User Group (see section 1.7). Arrangements for participants who are blind or partially sighted are under consideration. For further details, see the BCSS User Guide. 12 3.5 Interpretation and translation Programme hubs should seek advice from their screening centres on which any additional languages are likely to be needed locally. Screening centres should make use of the local interpretation services provided by their trust as they may be able to translate instructions about completing the test kit or to attend screening centre appointments with patients. Consideration should be given to the provision of a telephone interpretation service similar to that provided by Cancerbackup if there is sufficient need. 22

4. PROGRAMME ADMINISTRATION This chapter is about managing the progress of screening participants along the screening pathway. The tools for doing this are provided by the BCSS. Full details about how to use the BCSS are given in the BCSS User Guide. 12 Standard working procedures for programme administration are being developed and will be shared across programme hubs. 4.1 Planning the start of screening Each programme hub will need to work closely with public health professionals, lead PCTs and each screening centre to agree the roll out of the NHS BCSP across its geographical area. Uptake of screening will vary, and the local public health profession will be able to advise on how to ensure a smooth flow of participants into the programme. The hub will invite people at a rate and in an order to match the availability of colonoscopy sessions at the screening centre and the capacity of the colorectal cancer MDTs at treating hospitals to accept patients referred from the screening programme. 4.2 Setting up an implementation plan An implementation plan is set up jointly with a screening centre by agreeing the population to be invited for screening and establishing the date on which the screening centre will be operational. Each screening centre can have any number of implementation plans so that screening can be implemented in a series of phases, or all at once, as required. There will be a separate implementation plan corresponding to each site at which screening colonoscopies are undertaken, so that the flow of patients into clinic sessions can be controlled by adjusting the rate at which people are invited to participate in the screening programme. The BCSS allows the implementation plan to be designed across the full age range to ensure that all people who are eligible for screening are invited to participate, and to ensure that demand for colonoscopy is as evenly spread as possible. Invitation due dates can be spread across all age groups - demand for further investigation, following positive tests, is highest in the oldest age groups. The implementation planning tool also contains an in-built report that indicates the numbers, by week, that will arise from the plan as it has been entered. For further details on setting up an implementation plan, see BCSS User Guide. 12 4.3 Call When an implementation plan has been entered on the BCSS, the programme hub is able to examine the report of expected numbers and either edit or accept the plan. As soon as the plan is activated, everybody within it, ie everyone of the appropriate age who is registered with the selected GP practices covered by the implementation plan, will then have a screening due date set on their birthday in either the first or the second year of implementation. All 69 year olds screening due dates will be set 13 weeks prior to their birthdays in year 1, ensuring that they 23

are all given at least one written invitation to participate before they reach the upper age limit for automatic inclusion in the screening programme. Screening due dates will correspond with individuals birthdays. However, they will not necessarily receive their first invitation on this date; depending on how invitation numbers are spread, they may be invited earlier or later than this date. 4.4 Controlling the flow of invitations Based on the numbers contained in the implementation plan report, the programme hub can control the issue of invitations and generate managed peaks and troughs in numbers to coincide with working practices and public holidays. This degree of control can be exercised in two ways: the system can be asked to generate a batch based on the number of invitation letters required or to produce a batch of invitations up to and including a chosen calendar date. 4.5 Call and recall pathway The call and recall pathway is shown in Figure 3. The BCSS provides the means of managing the flow of individuals along the pathway and of generating letters and GP notifications at the appropriate times. Full details are given in the BCSS User Guide. 12 24

Programme hub and screening centre identify PCTs and GP practices for inclusion in the screening programme Programme hub liaises with screening centre and sets up an implementation plan(s) Invitation letter and The Facts leaflet sent Ceased Opt out of this screening round Recall in 2 years Test kit letter and test kit, instruction leaflet, sticks and return envelope sent No kit returned after 4 weeks Reminder letter sent No kit returned after 13 weeks Test kit returned and tested in the screening laboratory Recall in 2 years Normal result Unclear result Spoilt kit or technical fail Abnormal result Recall in 2 years Second kit sent out Second kit sent out (several more kits may be required) Letter to individual inviting them to attend a nurse clinic (GP also informed) Kit returned to laboratory for testing At nurse clinic, offered colonoscopy Normal result Decline colonoscopy Accept colonoscopy Normal result Third kit sent to individual for completion Figure 3 The call and recall pathway. Letter to individual closing this episode. GP informed. Invite again in 2 years Treatment/surveillance as required. GP informed. Invite again or cease when and if appropriate 25

4.6 Invitation letters An invitation letter is sent to everyone eligible for bowel cancer screening. The content includes a small amount of information on the screening programme, what will happen next and details of the Freephone helpline for any queries. A copy of the national leaflet Bowel Cancer Screening The Facts must be included with every invitation letter. The invitation letter asks people to contact the Freephone number if they: have had a colonoscopy or a barium enema plus a sigmoidoscopy within the last 2 years are on a bowel polyp surveillance programme are currently being treated for bowel cancer have had their large bowel removed are currently being treated for ulcerative colitis or Crohn s disease are currently awaiting bowel investigations arranged by their GP. They are also asked to contact the Freephone number if they do not wish to participate in the screening programme or if they have any other queries. The invitation letters are sent using second class post (see Appendix 5 for envelope specification). 4.7 Test kit letter and test kits One week after the invitation letter has been sent, everyone who has not declined the offer of screening is sent a test kit letter and test kit. The test kit letters are sent using second class post (see Appendix 5 for envelope specification). The contents of the envelope are: test kit letter FOBt kit instruction leaflet for completing the test kit sticks for collecting stool samples return envelope for completed test kit (see Appendix 6). The test kit letter is produced by the BCSS. The test kits are printed with the participant s name and NHS number and a bar code that identifies the test kit number for ease of data entry when the kits are returned. A specialised printer connected to the BCSS prints these details directly onto the kits. 4.8 Completed test kits These are opened and processed by the laboratory staff. Test kits must be logged on to the BCSS on the day of receipt by the laboratory. The test kit results are entered on the BCSS by laboratory staff when the test kits are processed. This need not be on the date of receipt (but see timescales below for results). Test kit logging is facilitated by using barcode readers. Further details are given in Chapter 5. 26

4.9 Result letters For details of how to print result letters and GP notifications, see the BCSS User Guide. 12 Participants will be told that they will receive a results letter within two weeks of the laboratory processing their test kit. This means that programme hubs should aim to print and dispatch result letters to participants within a week of the kits being logged on the BCSS. This allows time for unforeseen delays. 4.9.1 Abnormal or unclear result letters Participants with an abnormal or unclear test result must be offered an appointment date, which is within one week from the date of the result letter, to see a specialist nurse at the screening centre to discuss the possibility of further investigations. The programme hub manager must monitor the demand for nurse clinic appointments closely to ensure that there are sufficient appointments available at the screening centres within the timescale of one week from the date of the result letter. If there are insufficient slots available, the hub must slow down or stop sending out test kits until the backlog has been cleared. It is expected that there will be close liaison between the programme hub and the screening centres about available dates for nurse-led clinics. The BCSS supports this process by allowing screening centre nurses to record their availability and the programme hubs to fill available appointment times. If necessary, a programme hub can book a nurse clinic appointment in any of the nationally available screening centre slots. The letter to the participant should be sent using first class post. A copy of the leaflet Bowel Cancer Screening The Colonoscopy Investigation must be enclosed with every nurse clinic appointment letter. Abnormal or unclear result letters should not be sent to arrive on a weekend or a bank holiday when support from the GP or programme hub may not be available. The result notification to the participant s GP must be printed and dispatched at the same time as the letter for the patient. It should also be sent using first class post so that the GP is prepared if the participant telephones for advice. For details of how to set up and allocate clinic appointments, see the BCSS User Guide. 12 4.9.2 Normal test results Result letters to participants with a normal FOBt result must be printed and dispatched within one week (seven days) of the date of receipt of the test kit. The letter to the participant should be sent using second class post. The result notifications for GPs are printed and dispatched in batches. 4.10 Spoilt test kits If a participant has not completed the test kit correctly, a spoilt kit letter must be printed and dispatched within one week (seven days) of the date of receipt of the test kit. The letter includes a list of possible reasons why the test kit might be spoilt - the programme hub can select the relevant one. 27