Quality Manual. Folder One

Transcription

1 Section: Front page Bowel Screening Wales Quality Manual Folder One Version 2.0 If printed, this document is only valid for today 05 Page 1 of

2 Section: Contents 1. Introduction Aim and Scope of the Bowel Screening Programme The Aim The Scope The Quality System The Quality and Procedures Manual Quality Assurance Management and Organisational Structure Clinical Governance Policies Standards General Coverage Uptake Call and Recall The Screening Process The Laboratory Process Specialist Screening Practitioner Assessment Colonoscopy Histopathology Referral Pathways Evaluation and Performance Management Risk Management and Incident Reporting Programme Statistics Information, Management & Technology (IM&T) Standards Performance Indicators Key Indicators If printed, this document is only valid for today 05 Page 2 of

3 Section: Contents 6.2 Other Indicators Service Model Pathways Pathway 1 Invitation to Screening and Faecal Occult Blood Test Pathway 2 Referral to Assessment Pathway 3 Colonoscopy Pathway 4 Not Fit for Colonoscopy Pathway 5 Incomplete Colonoscopy Pathway 6 Adenoma Surveillance Pathway 7 Referral to Multidisciplinary Teams Pathway 8 Decline Appendix 1 Terminology Related to Quality Assurance If printed, this document is only valid for today 05 Page 3 of

4 Section: One 1. Introduction The Screening Division of Public Health Wales is responsible for the planning, preparation and delivery of the All Wales Bowel Screening Programme (Bowel Screening Wales). The programme comprises of a home faecal occult blood (FOB) test kit which is sent to eligible people for completion and return to the central laboratory at the Welsh Bowel Screening Centre in Llantrisant. If the test is positive, participants are referred for assessment and offered colonoscopy if considered fit for the procedure. Bowel Screening Wales (BSW) is responsible for the participant up to the point of a diagnosis of cancer. The purpose of the Quality Manual is to set out the scope and processes for delivering and quality assuring the national population based bowel screening programme throughout Wales. If printed, this document is only valid for today 05 Page 4 of

5 Section: Two 2. Aim and Scope of the Bowel Screening Programme 1.1 The Aim The aim of the programme is to reduce mortality from bowel cancer by 15% in the population invited for screening by This will be achieved through adoption and full implementation of Bowel Screening Wales policies, standards and protocols. The quality manual will be subject to ongoing review, in the light of developing evidence. 1.2 The Scope The Bowel Screening programme is responsible up to the point of a diagnosis of cancer and includes: Identifying eligible people to be invited for screening Inviting and recalling eligible people to be screened, ie men and women aged between 50 and 74 years of age Providing testing kits and supporting information Analysing FOB test kits Providing results Referring to a Specialist Screening Practitioner Diagnosis by colonoscopy or radiological investigations Histopathological reporting of samples taken at colonoscopy Referring to multidisciplinary treatment services Providing a surveillance programme for people with intermediate and high risk adenomas BSW is also responsible for: Providing quality standards and protocols, and managing a quality system Raising public and professional awareness of the screening programme Evaluating the programme in Wales and contributing to UK wide evaluation Ensuring staff working within the programme are appropriately trained BSW is not responsible for symptomatic activity, but will collaborate with Health Boards and other agencies to make best use of resources available. If printed, this document is only valid for today 05 Page 5 of

6 Section: Three 3. The Quality System 3.1 The Quality and Procedures Manual The Quality Manual is made up of the following folders: o Folder One Policies, Standards, Performance Indicators and supporting information o Folder Two Service Protocols for the Local Assessment Centres o Folder Three Service Protocols for the administration department of the Welsh Bowel Screening Centre o Folder Four Service protocols for the BSW Regional Nurses Service Protocols for the laboratory department of the Welsh Bowel Screening Centre will be held in the BSW Laboratory and are available upon request. This Quality Manual is a controlled document, which is available electronically. It is a dynamic document and is intended for electronic use. BSW will notify the Local Assessment Centres when new versions are released. The Quality Assurance Group (QAG) is responsible for coordinating the update process, and storing electronic archive copies of each version in line with current policy. Membership of QA Group comprises of: Head of Programme (Chair) Head of Administration Head of Nursing or Regional Nurse QA Manager Information Governance Manager Senior Information Analyst Secretary to Head of Programme QA Advisors All Wales Bowel Screening Manager All Wales Bowel Screening Laboratory Manager Quality Manual Controller The QAG meets regularly to draft amendments and additions. These may arise from: If printed, this document is only valid for today 05 Page 6 of

7 Section: Three Identification of best practice New evidence emerging Changes to BSW policies and procedures Incidents and near-misses Suggestions from staff for improvement of quality Identification of errors and omissions The secretary to the Head of Programme maintains a list of amendments and tracks progress through the various stages of consultation. Draft amendments are submitted to the Senior Management Group (SMG) and Regional Co-ordinating Groups (RCGs) for comment and discussion. Final approval will be given by the All Wales Management Group AWMG. Urgent or minor amendments may be submitted directly to the Director of Screening Division for final approval. If printed, this document is only valid for today 05 Page 7 of

8 Section: Three 3.2 Quality Assurance Principles Quality assurance depends on effective management to design, document, implement, maintain and review a quality system. Quality assurance relies on all staff working in, or for, the screening programme complying with the requirements of the quality system; one such requirement is that any deficiencies in the system are reported and remedied. The quality assurance system documented in the BSW quality manual supports all staff working within the bowel screening programme in Wales in meeting their responsibilities under clinical governance. Each individual must understand his or her contribution to quality and must be sufficiently trained, motivated and enabled to make that contribution effectively. The system is constantly improved by the feedback mechanism and every individual has an important part to play in achieving quality. Please see appendix 1 for terminology relating to quality assurance. Quality Policies BSW is committed to total quality management in order to attain, maintain and continuously improve the quality of the service. Quality issues are integral to every aspect of the organisation. It is accepted that there will be exceptional circumstances when clinical judgement indicates that there should be a departure from a standard and/or operational procedure/protocol, as outlined in the Quality Manual. All such departures must be documented and notified to the BSW Head of Programme or the Director of Screening Division, so that: Any quality and/or risk management issues may be identified Future policy can be considered The documentation in this manual can be reviewed If printed, this document is only valid for today 05 Page 8 of

9 Section: Three 3.3 Management and Organisational Structure Organisational Status Bowel Screening Wales (BSW) is part of the Screening Division of Public Health Wales. BSW is a single organisation providing the bowel screening programme throughout Wales. Public Health Wales is responsible for the clinical governance of all elements of the bowel screening programme. BSW monitors the quality of the service provided for each element of the programme, including those elements provided by other Health Boards (HBs). BSW commissions colonoscopy, histopathology and radiology services from the HBs. Long Term Agreements (LTAs) specify that each HB service complies with the relevant elements of the BSW Policy, Standards and Protocols outlined in the Quality Manual. Lines of Accountability Director BSW is headed by the Director of Screening Division, who has overall responsibility for the management, quality assurance and evaluation of all aspects of the bowel screening programme including those which are provided by other HBs in Wales and Trusts in England. The Director is managerially accountable to the Chief Executive of Public Health Wales NHS Trust. There are line management relationships linking the Director with all directly employed staff. The Head of Programme for BSW, Head of Administration, Head of Information, Finance Manager and Head of Nursing are all directly managerially accountable to the Director or Deputy Director. The Head of Business and Service Development is accountable to the Director but line managed by the Director of Operations and Service Development for Public Health. Head of Programme, Bowel Screening Wales The Director is supported in planning, delivering, monitoring and developing the bowel screening programme by the Head of Programme for BSW. The BSW Head of Programme is directly managerially accountable to the Director. The Head of Programme has managerial responsibility for the Head of Laboratory Services, Screening Division as illustrated in figure one. The Director of Laboratory Services, Screening Division has managerial responsibility for the Laboratory Manager. Other Managerial Responsibilities The Head of Administration has managerial responsibility for the All Wales Bowel Screening Manager. The All Wales Bowel Screening Manager is responsible for all administration, clerical and helpline staff in the Welsh If printed, this document is only valid for today 05 Page 9 of

10 Section: Three Bowel Screening Centre. The Head of Nursing has managerial responsibility for the Regional Nurses. Figure 1 Director of Screening Services Head of Laboratory Services Head of Programme Head of Administration Head of Nursing Laboratory Manager All Wales Bowel Screening Manager Regional Nurses Deputy Laboratory Manager Centre Co-ordinator Laboratory Screeners Screening Administrators All Wales Bowel Screening Secretary Supplies Officer Accountable To Line Managed By Management Groups The BSW management structure comprises of an All Wales Management Group, a Senior Management Group and three Regional Coordinating Groups as illustrated in Figure 2. Page 10 of If printed, this document is only valid for today 05

11 Figure 2 Management Groups Section: Three All Wales Management Group Senior Management Group Regional Co-ordinating Group South East Regional Co-ordinating Group South West Regional Co-ordinating Group North All Wales Management Group (AWMG) The AWMG provides advice and support to the Director of Screening Division on policy, strategic and management issues. The AWMG is a management and the main decision-making body dealing with strategic issues at an all Wales level. The AWMG will normally meet quarterly, unless more frequent meetings are required. Membership of the group will include: Director of Screening Division/Deputy (Chair) Head of Programme, BSW Business Manager Head of Nursing Head of Information Head of Administration Finance Manager All Wales QA Medical Advisor Colonoscopist All Wales QA Medical Advisor Histopathologist All Wales QA Medical Advisor Biomedical Scientist All Wales QA Medical Advisor Surgeon All Wales QA Medical Advisor Radiology Regional Nurse Information Governance and Evaluation Manager Trust Board representative PA to Director (minutes) Page 11 of If printed, this document is only valid for today 05

12 Section: Three The AWMG will be responsible for: Determination of strategic policy Approval of operational policy Consideration of clinical governance and risk management Determination of performance indicators Consideration of quality issues highlighted by BSW audit Financial monitoring Final approval of policies Ratification of changes to policy Changes and additions to standards and protocols Consideration of National, health board and BSW issues Consideration of information governance issues Consideration of clinical governance issues Receipt of detailed quarterly reports on all aspects of the screening programme Receipt of reports from National Conferences Consideration of programme plans When the AWMG is considering routine reports on the performance of individuals, the data will be anonymised. Senior Management Group (SMG) The SMG provides operational management, planning and delivery of the bowel screening programme. The SMG is a sub-group of AWMG and is a management and representative group responsible for operational management and programme planning. The SMG will report to AWMG and will meet monthly. Membership of the group will include: Head of Programme Bowel Screening Wales (Chair) Head of Laboratory Services Business Manager Finance Manager All Wales QA Medical Advisor Biomedical Scientist All Wales Bowel Screening Manager Bowel Screening Laboratory Manager Information Governance Manager Administration representative Information representative Personnel Representative Head of Nursing Lead Screening Promotion Officer Risk Management representative Regional Nurses The SMG will be responsible for: Page 12 of If printed, this document is only valid for today 05

13 Section: Three Determination of operational policy Consideration of clinical governance and risk management issues Review of performance against standards and identification of actions Receipt, review and agreement of draft, new and updated documents for referral to AWMG Receipt of financial reports and consideration of financial issues Consideration of issues identified at AWMG, RCGs and health board Groups Consideration of programme plans Consideration of health promotion issues Consideration of information governance issues Consideration of staffing requirements and recruitment The SMG will be attended by the Director of Screening Division as required. Regional Co-ordinating Groups (RCGs) There are three RCGs to provide regional co-ordination of the bowel screening programme. The remit of the RCGs is to co-ordinate the bowel screening programme across the three regions in Wales. The RCG provides advice to local multidisciplinary groups, providing a forum for discussion and sharing of knowledge. The RCGs ensure local ownership and understanding of the bowel screening programme. The RCGs reports to the SMG and will meet biannually. Membership of the RCG includes: Screening Division Regional Co-ordinator (Chair) Regional Nurse Screening Colonoscopist Specialist Screening Practitioner Lead Endoscopy Nurse Administration representative Pathology Laboratory representative Radiology representative Colorectal Surgery representative MDT co-ordinator Information Technology representative The RCG will be responsible for: Facilitating and monitoring implementation of all-wales policy, standards and protocols at a regional and local level Contributing to policy development and update Solving policy implementation problems at a local level Facilitating the sharing of good practice between local services Providing advice to the SMG on all aspects of the programme Page 13 of If printed, this document is only valid for today 05

14 Section: Three Providing a forum for multidisciplinary discussion and user representation Receiving regular reports on all aspects of the service from the Health Boards Consideration of clinical governance and risk management issues at a local level Co-ordination of the provision of and evaluation of staff training Consultation on the development and updating of public and professional information Undertaking specific projects on behalf of the programme as invited by the SMG The Head of Programme and regional nurse will attend RCG meetings and the Director of Screening Division may delegate one or more members of the AWMG to attend RCG meetings if appropriate for communication and feedback. Additionally, an annual meeting of the RCG sub-group meets to discuss operational issues, local progress and to plan development. It also reviews activity and capacity. Membership of this group includes: Regional Nurse (Chair) Head of Programme BSW Screening Colonoscopist (one from each unit) Specialist Screening Practitioners Professional Responsibilities Individual clinicians within the bowel screening programme are expected to adhere to the current BSW policies, standards and protocols. The QA Advisors are accountable to the Head of Programme for work undertaken on behalf of the bowel screening programme. QA Role of the Director The Director has overall responsibility for the quality of all aspects of the bowel screening programme provided by BSW. The Director or Head of Programme also represents BSW on the NHS Bowel Cancer Screening Programme (NHSBCSP) Quality Assurance Directors Group. QA Advisors The QA advisors for each professional group have specific responsibility for ensuring that quality is maintained in line with BSW policy, standards and protocols QA advisors are responsible for: Reviewing the quality of the service provided within their professional remit in BSW Local Assessment Centres Page 14 of If printed, this document is only valid for today 05

15 Section: Three Informing the Director and/or Head of Programme about performance issues in BSW Local Assessment Centres Highlighting quality deficiencies to the Director and/or Head of Programme Recommending corrective action as necessary and verifying the outcome of any action taken Providing feedback on quality to colleagues Advising colleagues on methods to improving quality Convening meetings of relevant professional groups Encouraging continuous professional development of colleagues Co-ordinating the introduction of agreed policies, standards and protocols Ensuring representation of BSW on national committees within the NHSBCSP Feeding back information from the NHSBCSP to AWMG Further Guidance Page 15 of If printed, this document is only valid for today 05

16 Section: Three 3.4 Clinical Governance BSW are committed to continual review and improvement of service delivery within the programme. Clinical governance structures are incorporated into all aspects of the programme and include: Participant focussed care Clinical practice improvement System improvement and accountability Risk management Risk management Central to risk management is the recording, investigation and analysis of clinical incidents and complaints. Health Inspectorate Wales (HIW) sets policy for risk management within NHS Wales. As part of its responsibilities, HIW formulates and audits risk management standards and issues guidance to inform and educate staff on the benefits of proper risk management. Adherence to the Healthcare Standards for Wales and controls assurance standards helps determine Public Health Wales Welsh Risk Pool excess levels. The Screening Division Risk Management Group oversees risk management of the Screening Division. Membership of this group includes: Director of Screening Division Head of Administration Programme Managers (all programmes) Head of Nursing Head of Business and Service Development Risk, Health, Safety and Clinical Governance Manager Associate Director for NBHSW Information Governance Manager Hazards arising from clinical risks and Health and Safety have been considered throughout the BSW quality system. Any deviation from them (or near miss ) must therefore be reported and assessed following the PHW incident and accident reporting procedures. The concept of acceptable risk is inherent in the organisational framework of BSW. The ethical considerations of screening are such that, unlike the acute services, BSW cannot accept any risk other than those considered in the programme framework, which is already set within the parameters of national screening policy. All recognised risks are, therefore, managed and monitored throughout the BSW quality system. Page 16 of If printed, this document is only valid for today 05

17 Section: Three Even relatively trivial incidents may have the potential for serious consequences as they have the potential to be inflated by media interest, or of re-occurring due to the high level of activity within the screening programme. Whistle blowing procedure The Screening Division whistle blowing procedure relates to concerns where the interests of others, and/or those of the health board are at risk and is designed to encourage staff to raise concerns about malpractice at an early stage. Complaints procedure The Screening Division complaints procedure outlines the process of complaints handling within BSW which is in line with the Public Health Wales policy. All Health Boards in Wales who contract with BSW for colonoscopy and laboratory services must inform the Director immediately, both verbally and in writing, of any complaint or legal correspondence received by the health board which relates to any services covered by the LTA. Further Guidance Page 17 of If printed, this document is only valid for today 05

18 Section: Four 4. Policies Eligible Population When fully implemented men and women aged between 50 and 74 years of age will be invited for bowel screening. People will not be able to self refer into the screening programme, although this will be reviewed when the programme is fully implemented. People under the age of 50 cannot be included in the programme. Genetics Services for people with a significant family history of colorectal cancer (i.e. one first degree relative with colorectal cancer aged less than 45 years, and/or two or more first degree relatives with the disease) will be provided by the All Wales Genetic Service. The initial mailing will include a leaflet advising eligible people meeting these criteria to call the helpline or contact their GP. Frequency of Invitation When fully implemented, eligible people will normally be invited for screening for the first time during the year in which they have their 50 th birthday. Invitations will be sent every 2 years up to and including the year in which the person is 74 years old. Inclusion Criteria Initial invitations for screening and test kits with support information will be dispatched without prior knowledge of the person s medical history or mental capacity. A telephone helpline number is included for people to call with queries about their suitability for screening. Criteria for inclusion when fully implemented are that the person is: Aged between 50 and 74 years of age Resident in Wales Exclusion Criteria The criteria for exclusion from the bowel screening programme in Wales are that the person: Has undergone total removal of the colon and rectum Has a permanent ileostomy and no functioning colon and rectum remains Is already on a colonoscopy surveillance programme which monitors the entire colon and rectum Has signed a request that no further contact be made by the programme Has any other medical condition which would make screening inappropriate Page 18 of If printed, this document is only valid for today 05

19 Section: Four The following incidental findings will lead to the person being referred to an appropriate clinician and being excluded from the programme if it is considered appropriate: Crohn s Colitis Ulcerative Colitis Other Mental Capacity Act Participants with mental capacity issues or their carers will be given the opportunity to discuss completion of the test kit with a regional nurse on an individual basis as documented in folder four. Health Boards will follow local procedures for the Mental Capacity Act in line with current legislation. Informed Choice People who are offered screening must be given enough information in an appropriate format to enable an informed choice to be made. Information on the benefits and limitations of screening must be given. A telephone help line and advice service is available for people with additional queries. Information is available in different formats for people with sensory impairment. The information is also available in different languages. Screening Test Bowel screening test kits are sent to eligible people for completion at home and returned to the screening laboratory. Kits are tested for Faecal Occult Blood (FOB) and results communicated to participants and the General Practitioner. Physical Capacity Participants with physical capacity issues or their carers will be given the opportunity to discuss completion of the test kit with a regional nurse on an individual basis as documented in folder four. Referral Participants with positive screening test results will be asked to contact the Central Administration Department who will arrange a telephone assessment with the Specialist Screening Practitioner. Colonoscopy will be offered at a local assessment centre if the participant is considered fit. Participants who are assessed as unfit for colonoscopy will be offered radiological investigations if clinically appropriate. This is outlined in more detail in folder three. Page 19 of If printed, this document is only valid for today 05

20 Section: Four Evaluation Ongoing evaluation of the programme will gauge the impact of screening on colorectal cancer incidence and mortality, and will monitor the quality of the service delivered by the bowel screening programme. Agreed key performance indicators will be used. Further Guidance Page 20 of If printed, this document is only valid for today 05

21 Section: Five 5. Standards 5.1 General Standard An effective bowel screening programme is available and offered to all eligible people resident in Wales. Rationale There is evidence that population based screening can lead to a reduction in mortality from bowel cancer. Essential Criteria 5.1.a. There are clearly defined arrangements for managing the bowel screening programme in Wales. Overall management responsibility lies with the Director of Screening Division, Public Health Wales NHS Trust, supported by an all Wales management team and the Head of Programme 5.1.b. There is a designated team and lead clinician for the bowel screening programme in each Health Board. The team should comprise of representation from the following services: Colonoscopy Pathology Radiology Management Colorectal Surgery Nursing and Specialist Screening Practitioner IT Administration 5.1.c. Each health board has a responsibility for meeting criteria specified by the screening programme 5.1.d. Each health board must collect a minimum data set as requested by Bowel Screening Wales (BSW) 5.1.e. Each health board must comply with All Wales policies, standards and protocols 5.1.f. Data will be collected to populate the All Wales performance management framework 5.1.g. BSW will monitor effectiveness of the programme Page 21 of If printed, this document is only valid for today 05

22 Section: Five Further Guidance Page 22 of If printed, this document is only valid for today 05

23 Section: Five 5.2 Coverage Standard All eligible people resident in Wales will be offered bowel screening every two years. The number of individuals responding to bowel screening is maximised within the principles of informed choice. At least 60% of eligible people will participate in the screening programme after 2 ½ years. Rationale There is evidence that the mortality rate from bowel cancer can be reduced by a high level of participation in a population based bowel screening programme. Essential Criteria 5.2.a. There is a planned period for phased implementation of the programme 5.2.a. The programme should offer recall (further invitations) to all eligible residents every two years after each screening or invitation even if no test was returned previously Further Guidance Page 23 of If printed, this document is only valid for today 05

24 Section: Five 5.3 Uptake Standard All eligible people resident in Wales will be offered bowel screening every two years. The number of individuals responding to bowel screening is maximised within the principles of informed choice. At least 60% of invited people will participate in the screening programme after 2 ½ years. Rationale There is evidence that the mortality rate from bowel cancer can be reduced by a high level of participation in a population based bowel screening programme. Essential Criteria 5.3.a. There is a plan to maximise informed uptake, with particular attention to the local population profile and vulnerable groups such as people from deprived communities, prisons, long stay institutions and those who are homeless Further Guidance Page 24 of If printed, this document is only valid for today 05

25 Section: Five 5.4 Call and Recall Standard Effective call and recall arrangements are in place to ensure 100% of all eligible individuals are invited for screening according to All Wales protocols. Rationale Effective call and recall systems will improve coverage and uptake. There is evidence that population based bowel screening amongst the age range years leads to a reduction in mortality from bowel cancer. Essential Criteria 5.4.a. Within a year of the programme being fully implemented 100% of the eligible population are sent their first invitation for screening before the birthday following the year in which they become eligible for screening 5.4.b. Within a year of the programme being fully implemented 100% of the eligible population are recalled for screening within 24 months of their previous result being validated, or of their previous invitation if they didn t respond to screening 5.4.c. There are mechanisms to identify non responders and offer them a further opportunity to respond within the screening round 5.4.d. There are mechanisms in place to cease or suspend people from the programme 5.4.e. There are mechanisms in place to ensure people who do not attend assessment appointments are offered an early recall to assessment appointment 5.4.f. There are failsafe procedures in place, appropriate to the outcome of the screening episode Further Guidance Page 25 of If printed, this document is only valid for today 05

26 Section: Five 5.5 The Screening Process Standard Written information will be sent to all eligible people with the test kit and invitation letter. The information will give a full explanation of the screening process, and provide balanced information on the benefits and risks of screening. Rationale There is an obligation to provide accurate information about screening tests and diagnostic investigations in order to allow informed choice and informed consent. Essential Criteria a. All Wales written information will be given to all eligible people explaining the benefits and risks of screening and the significance of positive and negative results b. All individuals invited for screening are given appropriate all Wales information explaining how to undertake the screening test and return it to the Welsh Bowel Screening Centre c. All individuals invited for screening are given appropriate all Wales information explaining that a colonoscopy or other appropriate test will be offered if their screening test result is positive d. Information is made available in different formats and languages appropriate to the needs of the individual Further Guidance Page 26 of If printed, this document is only valid for today 05

27 Section: Five Standard Written information will be sent to all people who have returned a Faecal Occult Blood test kit (FOBt). The information will give a full explanation of the meaning of results and the screening pathway. Rationale There is an obligation to provide accurate information about screening tests and diagnostic investigations in order to allow informed choice and informed consent. Essential Criteria a. Information is made available in different formats and languages appropriate to the needs of the individual on request b. Individuals receiving a negative result are informed of the limitations of the screening test. Individuals are advised to be observant of and report relevant symptoms to their GP c. The letter sent to individuals with a positive screening test result will be accompanied by an all Wales information leaflet to explain the significance of a positive result in terms of further investigation and possible outcome d. The letter sent to individuals with an equivocal screening test result will be accompanied by an all Wales information leaflet to explain the significance of an equivocal result and an immunochemical test kit e. The letter sent to individuals with a spoilt screening test result contains all Wales information to explain the significance of a spoilt result and a further test kit f. The letter sent to individuals with a positive screening test result asks participants to phone a central appointments line to arrange an appointment for assessment by the Specialist Screening Practitioner Further Guidance Page 27 of If printed, this document is only valid for today 05

28 Section: Five Standard There is an adequately staffed helpline for all individuals receiving an invitation to participate in bowel screening. Rationale Evidence from the screening programme in Scotland and England indicates that a number of individuals require verbal clarification or extra information regarding aspects of the screening process. Essential Criteria a. The free-phone telephone helpline is staffed Monday to Friday, excluding bank holidays b. Outside working hours a recorded message advises callers of the hours the helpline is staffed and acts as a signpost to NHS Direct Wales if the call is urgent and to the BSW website c. All staff involved with the screening helpline receive relevant training before undertaking unsupervised work d. All staff involved with the screening helpline undertake regular update training provided by Bowel Screening Wales e. audited The time taken to answer calls to the telephone helpline is f. Calls to the helpline will be recorded for quality assurance and training purposes and the participants will be informed g. Individual staff members activity will be audited including the number of calls taken and the duration of calls h. The call volume, nature, date, time of day will be logged and audited to ascertain if the helpline is staffed appropriately Further Guidance Page 28 of If printed, this document is only valid for today 05

29 Section: Five Standard The time between returning the screening test and receiving the result is minimised. At least 95% of individuals returning a screening test are sent a result letter within seven calendar days of receipt of the test by the screening centre. Rationale There is evidence that waiting for a screening test result can cause anxiety. Essential Criteria a. All test kits received by the screening laboratory are tested within 2 working days of receipt in the laboratory b. 100% of positive results will be validated within working day of being tested c. The administration department are notified of a positive result on the day of validation d. Positive results letters are normally posted first class within one working day of validation Further Guidance Page 29 of If printed, this document is only valid for today 05

30 Section: Five 5.6 The Laboratory Process Standard The laboratory providing bowel screening test analyses meets recognised professional standards. Rationale There is evidence that laboratories accredited and working towards agreed standards achieve the required high level of performance. Accreditation is regarded as a key element in ensuring good clinical governance. Essential Criteria a. All bowel screening laboratory staff receive relevant training before undertaking unsupervised work b. All bowel screening laboratory staff undertake regular training provided by the programme and undertake appraisal and continuous professional development c. The screening laboratory holds or is working towards accreditation from Clinical Pathology Accreditation (UK) Ltd Further Guidance BSW Laboratory Standard Operating Procedures Page 30 of If printed, this document is only valid for today 05

31 Section: Five Standard The quality of the bowel screening laboratory test analyses is continually assessed and monitored, and there is evidence of internal quality control, external quality assessment and quality assurance. Rationale Quality control, assessment and assurance are essential to provide independent assessments of the performance of the laboratory. Essential Criteria a. Internal quality control procedures are undertaken and documented b. The laboratory demonstrates overall satisfactory performance in an accredited independent national External Quality Assessment Scheme (EQAS) c. The laboratory demonstrates overall satisfactory performance in an accredited independent national Technical Quality Assessment Scheme (TQAS) d. The designated quality manager conducts annual audits to ensure continuing compliance with relevant ISO standards Further Guidance BSW Laboratory Standard Operating Procedures Page 31 of If printed, this document is only valid for today 05

32 Section: Five 5.7 Specialist Screening Practitioner Assessment Standard The interval between receiving a positive Faecal Occult Blood test (FOBt) result and Specialist Screening Practitioner assessment is minimised. The time interval between a participant contacting the screening programme following a positive result and the first offered assessment appointment is within 14 calendar days for at least 95% of individuals. Rationale There is evidence that the time interval between receiving a positive result and assessment can result in significant anxiety. Essential Criteria a. There are arrangements to identify all individuals who do not respond to positive letters and offer a further appointment b. Individuals with a positive result are asked to contact a central appointments telephone line. They are offered an appointment for Specialist Screening Practitioner telephone assessment at a time and location convenient to participants c. The first available appointment and chosen appointment must be documented for audit purposes d. If telephone assessment is not acceptable or appropriate to the participant a clinic appointment must be arranged to see the Specialist Screening Practitioner Further Guidance BSW Quality Manual - Folder 2 Local Assessment Centre Protocols BSW Quality Manual - Folder 3 Bowel Centre Administration Protocols Page 32 of If printed, this document is only valid for today 05

33 Section: Five Standard Individuals with a positive result are offered assessment by a Specialist Screening Practitioner. They are given appropriate information, and an explanation of why, how and when colonoscopy or other investigations could be undertaken. Rationale There is evidence that providing information about tests, preparation and investigations reduces anxiety and encourages participation. Essential Criteria a. All individuals with a positive FOBt result are offered an assessment to ascertain fitness for colonoscopy, a full explanation of the process of colonoscopy, the possible risks and the possible outcomes are given. The opportunity to discuss any concerns is provided at this stage b. Assessment of fitness for colonoscopy is carried out by a Specialist Screening Practitioner with appropriate skills and knowledge using an all Wales pro-forma c. The Specialist Screening Practitioner must have undertaken training specified by Bowel Screening Wales and maintain competence in line with BSW protocols d. Clear and appropriate pathways are followed for individuals with a positive FOBt result who do not proceed for colonoscopy e. 100% of participants deemed fit and who consent to colonoscopy are offered a date for the procedure at the assessment appointment f. Written information on colonoscopy and bowel preparation will be sent or given to participants who have been deemed fit and have accepted the offer of colonoscopy g. Bowel preparation medication will be prescribed and distributed according to local protocol h. Information on colonoscopy or other appropriate tests is available in other formats Further Guidance Page 33 of If printed, this document is only valid for today 05

34 Section: Five Standard The time between notification of a positive Faecal Occult Blood test (FOBt) and colonoscopy is minimised. In at least 95% of cases, the interval between the Specialist Screening Practitioner (SSP) assessment appointment and the first date offered for colonoscopy is within 14 calendar days. Rationale There is evidence that waiting for colonoscopy creates anxiety. Essential Criteria a. The first available colonoscopy appointment will be offered to the participant b. A record of the first available appointment and the chosen appointment for colonoscopy must be captured on the Bowel Screening Information Management System c. Consent for colonoscopy must be captured using Bowel Screening Wales standardised postal consent form Further Guidance Page 34 of If printed, this document is only valid for today 05

35 Section: Five 5.8 Colonoscopy Standard The time between notification of a positive FOBt and colonoscopy is minimised. In at least 95% of cases, the interval between the notification of the positive screening result and the date offered for colonoscopy is within 28 days. Rationale There is evidence that waiting for colonoscopy creates anxiety. Essential Criteria a. The first available colonoscopy appointment will be offered to the participant b. A record of the first available appointment and the chosen appointment for colonoscopy must be captured on the Bowel Screening Information Management System c. Consent for colonoscopy must be captured using BSW standardised postal consent form Further Guidance Page 35 of If printed, this document is only valid for today 05

36 Section: Five Standard Screening colonoscopy is only undertaken by colonoscopists who have been assessed and approved by Bowel Screening Wales. Rationale Colonoscopy can cause discomfort and complications and there is a small mortality rate associated with the procedure. Failure to complete colonoscopy or incomplete visualisation of the colonic mucosal surface may result in significant neoplasia being missed. Essential Criteria a. Screening colonoscopists are expected to satisfy the following criteria prior to being accepted for assessment: Minimum 120 colonoscopies performed or directly supervised per year (equivalent to one training list per week for 40 weeks of the year); Lifetime undertaking of more than 750 colonoscopies; Lifetime perforation rate for diagnostic colonoscopy less than one in 1,000; Pathology adjusted caecal intubation rate of at least 90% Adenoma retrieval rate of at least 15% b. Potential screening colonoscopists are assessed by BSW assessors using an approved model comprising of multiple choice questions, lesion recognition testing and a directly observed procedure skills assessment (DOPS) c. Screening colonoscopists access regular update sessions provided by BSW d. Individual colonoscopists must submit colonoscopy reports and audit data as required by BSW e. Screening colonoscopists will be expected to undertake a minimum of 150 total colonoscopy procedures per annum, of which at least 50 should be screening colonoscopies. They must maintain experience undertaking screening colonoscopy as required by BSW and continue to satisfy all eligibility criteria for screening colonoscopists f. There is a system for collection of data on individual colonoscopists g. Screening colonoscopists participate in local and regional multidisciplinary education sessions and management meetings Page 36 of If printed, this document is only valid for today 05

37 Section: Five h. A lead Screening Colonoscopist is responsible for local Health board co-ordination of the screening programme Further Guidance Page 37 of If printed, this document is only valid for today 05

38 Section: Five Standard Colonoscopy is performed in a local assessment centre that satisfies Bowel Screening Wales criteria for local assessment centres. Rationale Participants must receive an equitable high quality service across Wales. Essential Criteria a. A Local Assessment Centre screening plan must be maintained and a copy available in the screening unit b. All Local Assessment Centres must comply with Bowel Screening Wales policies, standards and protocols c. All Local Assessment Centres must submit data requested by Bowel Screening Wales d. All Local Assessment Centres must participate in Health Inspectorate Wales Audits if appropriate e. All Local Assessment Centres are expected to participate in Joint Advisory Group (JAG) visits f. All Local Assessment Centres will facilitate visits from Bowel Screening Wales when necessary and requested Further Guidance Page 38 of If printed, this document is only valid for today 05

39 Section: Five Standard If colonoscopy is incomplete further investigation is carried out to ensure the entire large bowel has been visualised. Rationale Failure to complete colonoscopy may result in significant neoplasia being missed. Essential Criteria a. Repeat colonoscopy should be considered if the initial procedure was limited by suboptimal bowel preparation b. Radiological investigation is offered depending on local protocol and participant suitability c. Whenever possible radiological investigations should be performed within 24 hours of the incomplete colonoscopy except when polypectomy has been undertaken d. A date for a radiological investigation is given within 24 hours of the day of the incomplete colonoscopy e. Following incomplete colonoscopy further investigation will be undertaken within 31 days for 100% of participants f. A record of the first available appointment and the chosen appointment for further investigation must be captured on the Bowel Screening Information Management System g. Radiological investigations must be reported by named individuals who can demonstrate that they are appropriately trained h. Radiological reports will be sent to GPs and SSPs within seven calendar days i. Participants will receive the results of all investigations within seven calendar days of the final procedure j. SSPs to update Bowel Screening Information Management System within 48 hours of receiving results Further Guidance Page 39 of If printed, this document is only valid for today 05

40 Section: Five Standard If a participant is not deemed fit for colonoscopy by a Screening Colonoscopist, an individual management plan must be developed. Radiological investigations should be considered and if appropriate the first available appointment offered for an alternative investigation is within 14 calendar days of the Screening Colonoscopist s decision. Rationale Failure to visualise the large bowel may result in significant neoplasia being missed. Essential Criteria a. All participants deemed unfit for colonoscopy, must have an individual management plan. This should be developed and agreed by the Screening Colonoscopist and participant b. Where appropriate radiological investigation should be offered with appropriate information to enable participants to make an informed choice c. 100 % of participants who are deemed fit for radiological investigation and who consent, are given a date for the procedure on the day they are deemed unfit for colonoscopy d. Radiological investigations must be reported by named individuals who can demonstrate that they are appropriately trained e. Radiological reports will be sent to GPs and SSPs within seven calendar days f. Participants will receive the results of all investigations within seven calendar days of the final procedure g. A record of the first available appointment and the chosen appointment for further investigation must be captured on the Bowel Screening Information Management System h. SSPs to update Bowel Screening Information Management System within 48 hours of receiving results Further Guidance Page 40 of If printed, this document is only valid for today 05

41 Section: Five 5.9 Histopathology Standard Histopathology must be reported in a timely manner using recognised professional standards. Rationale Subsequent management of individuals with screen detected neoplasia must be based on accurate histopathology. Essential Criteria a. Histopathology reports include a clear indication of the main diagnosis, in accordance with the Royal College of Pathologists guidelines b. Histology should be reported using standardised proformas when available c. Histopathology reports for at least 80% of specimens submitted from colonoscopy are authorised and relayed to referrer within seven calendar days of receipt of the specimen in the laboratory d. A development standard will be that 95% of specimens submitted from colonoscopy are authorised and relayed to referrer within seven calendar days of receipt of the specimen in the laboratory e. Histopathology reports will be sent to SSPs and Screening Colonoscopist within seven calendar days f. Participants will receive the results of all investigations within seven calendar days of the procedure g. SSPs to update Bowel Screening Information Management System and finalise management proforma within 2 working days of receiving results Further Guidance Page 41 of If printed, this document is only valid for today 05