Clinical Governanace

Clinical Governanace Enquiries about the content of the document can be made to: Jane Farleigh Head of Clinical Improvement Branch 3rd Floor National Assembly for Wales Cathays Park Cardiff CF10 3NQ Tel: 029 2082 6842 E-mail: jane.farleigh@wales.gsi.gov.uk Further copies of this document are available from: Clinical Quality Improvement Branch 3rd Floor National Assembly for Wales Cathays Park Cardiff CF10 3NQ Tel: 029 2082 5621 E-mail: vanessa.davies@wales.gsi.gov.uk

Contents Executive Summary 1 Chapter 1: Background 3 Improving Health in Wales A Plan for the NHS with its Partners Health Care Challenges Clinical Governance The First 12 Months Progress Overall Chapter 2: Developing a Strategic Approach to Clinical Governance 7 Leadership A Strategic Approach From The Board Example Of What A Strategic Document Should Contain Chapter 3: Making the Connections 11 Resources/People Continuing Professional Development Professional Regulation Clinical Governance Processes Other Processes To Aid A Strategic Approach Standard Setting Monitoring Use Of Information Chapter 4: Measuring Clinical Governance Performance 19 Proposed Clinical Governance Indicators Chapter 5: National Assembly Policy Development - Support to Aid the Development of Clinical Governance 23 Clinical Governance Support And Development Unit Wales Adverse Event Reporting System Public Involvement Strategy Other Patient/Public Involvement Initiatives to Support Clinical Governance Standard Setting Professional Regulation Use Of Information To Support Clinical Governance Future Plans Affordability CPD And Lifelong Learning

Chapter 6: Summary of Consultation Questions 37 Annex 1: 39 Clinical Governance The First 12 Months Key Messages Annex 2: 43 Commission for Health Improvement Clinical Governance Review Annex 3: 45 What Clinicians need from IM&T Annex 4: 49 Centre For Health Leadership Wales Development Of Clinical Governance Capacity And Capability Membership: Health Care Challenges: Clinical Governance Sub Group Bibliography Websites

Executive Summary Clinical Governance Developing A Strategic Approach This consultation document is aimed at all NHS organisations and the consultation questions are concerned with ongoing policy development that will support the delivery of clinical governance (See Chapters 5 and 6 for details). This document also reaffirms the quality agenda that aims to ensure high standards of care, eliminate inequalities and to continuously improve the health service in Wales and it supports the recently launched NHS Plan Improving Health in Wales. Whilst much of the NHS plan is still at a developmental stage, this document is timely in that clinical governance must keep moving forward as it sits at the centre of the quality agenda. Its successful development and delivery is crucial to the overall success of the quality agenda and to the ongoing improvements in quality. It lays out a consistent approach for NHS Wales and provides a means for the service to monitor improvements. The approach to strengthening clinical governance is seen as developmental and iterative. Whilst the consultation is underway, the National Assembly will be analyzing this year s clinical governance annual reports. The outcome of responses to consultation coupled with the analysis will help identify any additional issues to be addressed and these will be reported back in Spring 2002. At that point, it is hoped that the outcome of the work of the Task and Finish Groups set up to deliver Improving Health in Wales, can be incorporated into the ongoing development of this strategic approach to clinical governance. Quality Care and Clinical Excellence detailed our ten-year plan for improving the quality of services in Wales. This was followed by the clinical governance guidance that was contained in WHC (99) 54. This document is the next step in that it considers the strategic approach that organisations may wish to develop further. It firstly considers the issues facing Boards and Clinical leaders, and goes on to consider the components of clinical governance and how they fit together. The ongoing strategies being developed in the National Assembly are included to provide information about work in hand to strengthen clinical governance and to help NHS organisations understand how the various policies fit. The results of an all-wales audit of clinical governance Clinical Governance the First 12 Months (NAW, 2001) has been produced to accompany this document. It provides baseline information on NHS organisations and highlights ways in which clinical governance can be strengthened in Wales. It recognizes that the NHS is continuing to develop clinical governance. In many areas organisations are doing well but there are still some areas that could be improved. For example, almost all NHS organisations were 1

having difficulty in engaging with the public. A lot of activity was reported but many had not planned to meet differing needs. This issue and other key aspects of clinical governance have been addressed in this document together with some approaches that organisations might wish to follow. The other strand outlined in this strategic approach is a clinical governance toolkit produced to aid clinicians at a clinical team level, although this is a practical document that can be used at any level in the organisation. It is the forerunner to a series of publications that will focus in more detail on each of the components of clinical governance. 2

Chapter 1: Background Improving Health in Wales A Plan for the NHS with its Partners 1.1 Improving Health in Wales A Plan for the NHS with its partners signals the renewal of NHS Wales and sets out an ambitious agenda for change and improvement. The Plan presents challenges that will demand new approaches. These will be based on new and dynamic partnerships within the NHS and between NHS Wales, local government, the voluntary and independent sectors and the communities they serve. They will need strong leadership and clear accountabilities at all levels. 1.2 The prime aim of the Plan is to achieve wide scale improvements in patients services and the quality of care. To achieve these, fundamental changes are required to deliver a people-centred and participative health service which is designed to be: Simpler for patients to understand; Accountable for the actions it takes and the services it delivers; and A stronger democratic voice in the way it is governed. Health Care Challenges 1.3 Improving Health in Wales outlines the major challenges faced by NHS Wales and its partners, particularly relating to the clinical environment and the principal health issues facing the people of Wales. These will be tackled through a more coordinated approach which seeks to prevent illness and provide more effective care via better organised programmes. The clinical governance strategy aims to support the process by ensuring an integrated approach to year on year quality improvement. 1.4 Setting, monitoring and reviewing national standards of care is a key component of our strategic approach to improving quality. In Wales, standards are set through a variety of means including Colleges, professional bodies and of course National Service Frameworks, supported by clinical guidance from the National Institute for Clinical Excellence. They are then adopted in service plans. They aim to significantly improve primary, secondary and tertiary services for patients and should see an end to unacceptable variations in practice whilst also delivering year on year clinical quality improvements. 1.5 The future requires that services will be delivered across wide geographical areas in a coordinated, multi-disciplinary and integrated manner. Services at all levels will need to be developed in a more strategic way and clinical governance needs to be integrated into this approach to ensure delivery to the highest levels of quality and a continuous improvement. 3

1.6 The development of managed clinical networks will require clear accountability arrangements and the development of clinical governance systems which will integrate with those of the component organisations. Clinical Governance the First 12 Months 1.7 The strategic approach is based on the outcome of an all Wales audit of NHS organisations in Wales undertaken by Dr Bernadette Fuge, Medical Director and Head of the NHS Quality Division and Jane Farleigh, Head of the Clinical Quality Improvement Branch within the NHS Quality Division. The audit took place between October 2000 and March 2001. The purpose of the audit was to provide organisations with feedback on their first clinical governance annual reports and to seek clarification or additional information where required. It also provided an opportunity to hear about innovative practice being carried out, to hear about issues affecting the development of clinical governance, and it provided an opportunity for NAW officials to give an update on policy developments. 1.8 A full analysis was undertaken of each organisation and an analysis sheet and pen-portrait was produced for each organisation. From this information aggregate data was produced giving the baseline of activity after the first 12 months. Although the period reported was March 1999-2000, because the visits commenced late in 2000 and into the spring of 2001, the information that has been fed into this strategy is quite recent. 1.9 Clinical Governance the First 12 Months provides more detail of the audit of clinical governance in Wales and has been published alongside this document. See Annex 1 for an outline of key themes identified during the audit. Progress Overall 1.10 Whilst many Trusts were making good progress and had set up appropriate structures, a strategic approach which would ensure the integration of clinical governance throughout the organisation and across partner agencies had not been adopted. There was lack of integration of the various components that would ensure clinical governance was delivering continuous quality improvement. Progress on monitoring and evaluation was the most disappointing. However, the audit had also identified many examples of innovative practice. For example, one Trust had employed a Patient Experience Facilitator whose remit was to ensure the patients perspective was considered at different levels of engagement. 1.11 A problem for many LHGs was being able to engage with all contractor professions whilst others had managed by a variety of means. Another issue was for LHGs to fully understand what progress had been made because of little or no monitoring and evaluation. However, considering the formative stage of LHGs the commitment was clear and 4

that progress was demonstrated. Almost all LHGs provided examples of innovative practice, for example, one LHG had adapted the British Dental Association Clinical Governance Guidance (with permission) as a support document for all professions in the LHG. 5

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Chapter 2: Developing A Strategic Approach to Clinical Governance 2.1 One of the first things the Commission for Health Improvement looks for at the beginning of a review is whether the organisation has adopted a strategic approach. This is about the leadership of an organisation and how far this sets a clear overall direction that focuses on patients and how well clinical governance is integrated throughout the Trust (or HA/LHG) (Commission for Health Improvement 2001). 2.2 It is about planning to deliver continuous quality improvement and the need to provide an opportunity for the involvement of all staff (clinical and non-clinical) across the organisation. At each level within the organisation, there must be clarity about what it means for individuals and clinical teams, where responsibilities and accountabilities lie, to gain ownership of the concept with wide endorsement and support for the strategic approach being taken. Leadership 2.3 The influence of the Board, and particularly the non-executives is paramount in changing attitudes, winning hearts and minds, and addressing leadership issues. Leaders of clinical governance must be able to demonstrate a prior commitment to quality initiatives. In addition, they need charisma and respect amongst their peers to motivate and influence those who are reluctant to change. As a leader it is important to demonstrate an involvement, commitment and understanding of quality issues as an example to those working within the organisation. From Clinical Governance: key success factors, Anne Williams, Clinician in Management 2.4 The aim of clinical governance is to ensure that the clinical care, patient s experiences and outcomes provided by organisations are of the highest quality. It brings together existing strands of quality initiatives to form a cohesive quality monitoring and improvement programme. The planning and delivery of this aim should form part of the organisation s strategy. 2.5 When embarking on a strategic approach there are some guiding principles all organisations may wish to consider: Developing clinical governance as a supporting non-threatening process and in an open and transparent way whilst respecting patient confidentiality and the dignity of patients. Planning to ensure successful implementation through a systematic and a whole system approach. Considering patients as people and not a number or a disease. Ensuring clinicians and managers (including non-clinical) work in 7

partnership with each other across the organisation and with patients. Developing the Clinical Governance plan for the organisation through both a top down and a bottom up approach. Encouraging corporate, directorate and individual endeavour which are all vital to clinical quality assurance. Addressing shortcomings, mishaps and mistakes in a proactive way within a culture of no-blame as part of a move towards becoming a learning organisation. Building on and extended existing good practice. Ensuring public participation in the development and monitoring of Clinical Governance. Consider the workforce and financial resources available. Identify cross links with other organisations. A Strategic approach from the Board 2.6 In this context, the board refers to Trust, Health Authority and LHG Boards. This should: Provide a sense of direction and purpose to the whole organisation the vision which should also include core principles and the values the organisation has Link activity across the organisation to the wider organisational aims and goals and those of key stakeholders Take account of the environment, needs of others (particularly service users), barriers and existing good practice Critically assess current work and specify what is needed in terms of developing capacity for the future including resources, skills and effort Identify clear objectives, measurement targets and practical, achievable actions Ensure there is a realistic plan for action and implementation Example of What a Strategic Document Should Contain The example provided includes some of the main headings for a strategic document and some information about the issues that might be covered under each. This is included as a guide only and is not meant to be prescriptive, each organisation will want to consider their own needs in producing a strategy. Purpose of the strategic approach 2.7 This is essential to effective implementation. At each level of the organisation there needs to be clarity of direction and purpose, what are the expected benefits, what does it mean at different levels. Ownership of 8

the concept and wide endorsement to the principles should be clearly stated and signed up to. Strategic Context 2.8 Set out a vision, core principles, values and beliefs describing the view the organisation has of where it wants to be in 3-5 years time. Perhaps provide an assessment of overall current performance and key priorities for development. Include leadership, culture, patient focus, direction, planning, accountability and implementation arrangements. Map how the Clinical Governance Strategy fits in with the wider organisation strategy and priorities (internal and external). Outline the strategy for developing the component parts and integrating them together. Describe the review arrangements, outline opportunities for joint working and priority setting with others. Wider Context 2.9 Include influencing factors (internal and external) on the clinical services the organisation provides e.g. role of the Commission for Health Improvement, the National Patient Safety Agency, etc, Health Improvement Programmes and all-wales priorities, and organisational change which may impact on service delivery. Stakeholders/partners 2.10 Identify those who are involved in working with the organisation and how this relationship should develop to more effectively deliver Clinical Governance. This should include other NHS organisations, community health councils, Local Authority, voluntary sector, education/training provider s etc. Structure for Management and Delivery of Clinical Governance 2.11 Outline the clinical governance committee structures and how they relate to one another. Include arrangements for identifying and sharing good practice and for poor performance. State who has lead accountability and responsibility and how this is devolved within the organisation. Provide links with external agents. Describe processes to be followed/developed e.g. CHI, NPSA, NICE, NSFs, National Audits/confidential enquiries, accreditation/inspection reports, local policies and procedures. Say how activities such as induction, appraisal, job descriptions etc support delivery. Roles and Responsibilities 2.12 State where accountability and responsibility lie in the Organisational structure from Board level to individually and collectively through committee structures and plot how they relate to one another. Provide summaries of terms of reference and membership of key committees. Include reporting arrangements between structures and ensure all 9

components are covered. Remember to Include individual clinicians responsibilities. Components of Clinical Governance 2.13 The component parts of clinical governance need to be supported and developed. At Chapter three there are examples of things to consider but in summary these are: arrangements for standard setting (e.g. NICE, NSFs) and implementation if not included elsewhere; Public/patient consultation; clinical risk management; complaints; clinical audit; research and effectiveness; collection and use of information to support clinical governance; staff management and development. There should be an assessment of current performance and key priorities for development within each component if not included elsewhere. Financial Resourcing 2.14 There needs to be a summary of financial resources, including issues and plans regarding clinical governance. This will involve the identification of resources already available, an evaluation of effectiveness to recognise gaps and of priorities for the future. Evaluation and Monitoring 2.15 Include clinical governance performance monitoring targets, critical incident reporting, clinical audit activities (including re-audit following recommended change in practice), education/training/cpd activities. It needs to be clear who receives what information and what use is made of it, this is particularly important at board level to ensure Board ownership and awareness of issues. Key Challenges 2.16 The future challenges and emerging developments. What effect will they have and how they will be addressed. Action/Development Plan 2.17 A more detailed development plan (possibly a separate document) comprising aims and (SMART) objectives with clear time scales, targets/improvements and identified responsibilities for implementation and monitoring. 10

Chapter 3: Making the Connections 3.1 Following on from the last chapter which gave the big picture view, this chapter moves down to the next level, it considers some of the main components of clinical governance and explains how organisations might benefit from adopting a strategic approach. It is aimed at clinical leads with a clinical governance responsibility. Resources/People 3.2 The staff providing services within NHS Wales are fundamental in ensuring a continuously improving quality of healthcare service is delivered to all patients and clients. It is essential that a high quality, competent workforce that is highly motivated can be developed across the service. Delivering for Patients, the NHS Wales Human Resources Strategy encourages NHS organisations to develop appropriate individual training and development strategies through focussed Continuing Professional Development (CPD) and Personal Development Plans (PDPs). It recognises that a supporting performance management system will be essential to the delivery of the organisation s responsibility for Clinical Governance. The Human Resources Strategy provides the foundation on which NHS organisations can build a climate of employment in which appropriate levels of staff are employed in a flexible and safe working environment, and where they are encouraged to develop their skills and adopt best practice in the working place. Continuous Professional Development 3.3 Lifelong learning is vital to the continuous personal and professional development of all staff. Opportunities must be available to every member of staff at all levels and health organisations must safeguard sufficient funds each year to enable this to happen. A skills escalator approach should be encouraged so that all staff gaining core levels of skills and competencies may progress to higher levels of responsibility with appropriate remuneration. Learning opportunities must be flexible enough to cope with the needs of those with specific responsibilities such as carers. 3.4 Health organisations will develop individual approaches through CPD. PDPs for all staff will identify and balance their personal, educational and professional development needs with those of the organisation. 3.5 CPD must remain a key component of the training and education of health professional staff. A CPD website will provide all staff with direct access to learning materials, occupational standards, guidance on appraisals, PDPs, mentorship, professional body guidance and educational opportunities. 3.6 A systematic approach to CPD is an essential component of clinical governance. CPD needs to meet organisational as well as personal needs. It is vital that it is part of the integrated approach to clinical governance. 11

For example, the results of clinical audit or of an investigation into a clinical incident may highlight training and development issues, as may the introduction of NSFs or NICE guidance. Professional Regulation 3.7 Developing a framework for managing professional performance in the NHS is a key component in maintaining public confidence in our health service. The Maximising Clinical Performance Consultation Document issued in October 2000 set out proposals to maintain the clinical excellence of doctors in Wales. The announcement in the NHS Plan for England of the establishment of a new Special Health Authority, the National Clinical Assessment Authority, takes this a step forward and the Assembly is currently considering its applicability for the service in Wales. Details of ongoing developments in this area included in Chapter 5. A new Nursing and Midwifery Council (NMC) is being established to undertake the regulatory functions relating to Nurses, Midwives and Health Visitors that had once been carried out by the UKCC and the Welsh National Board for Nurses, Midwives and Health Visitors. The NMC will be in place on 1 April 2002. The Health Professions Council (HPC) will also come into place on 1 April 2001, taking over the regulatory functions for the allied health professions. 3.8 Appraisal has been around in various forms for a range of NHS professional groups for many years especially for nurse and non-clinical managers. In April 2001 appraisal was introduced for Medical Consultants. Several consultants have already undergone the appraisal process and there is an on-going training programme. Clinical Governance Processes Clinical Risk Management 3.9 Risk management is a way of reducing risks and clinical risk management is about reducing the risks of adverse clinical events happening. It involves: Identification of risk Systematic assessment Review and prevention or management 3.10 Organisations need to understand their high-risk areas, for example, it is well documented that A&E, Anaesthetics, Obstetrics are examples of high-risk specialties. 3.11 The reasons for problems can be due to a number of factors, it may be due to poor channels of communication between the various parties, poor processes such as the absence of clinical guidelines, unclear lines of responsibility and these are just some examples. It must not be forgotten that positive feedback needs to be recorded and used. 12

3.12 A strategic approach to risk management should help organisations by using the steps outlined in the bullet points above. There are a number of publications that go into this in more detail but use of incident reporting to identify risks, use of complaints and claims information can help organisations to assess the level of risk and good information management and reporting systems should support the review and prevention of risk. The introduction of care pathways can assist in this process because the analysis of variations is a useful component. The pathway could contain a checklist of potential adverse events, variances from the pathway or if an event on the checklist occurs, could be reported promptly to management for analysis and action. Adverse Clinical Incidents 3.13 An open, sharing and learning culture needs to be driven from the highest levels of the health service. Professionals must feel safe to examine practice and admit mistakes. The approach to clinical governance must be fuelled by a desire to improve practice, to learn from error and to support professionals to get it right in future (Improving Health in Wales, The future of primary care, NAW 2001). 3.14 It must also be recognised that the great majority of care is of a very high clinical standard and by comparison to the amount of care provided, the number of serious failures are uncommon. Unfortunately, when they do occur they can often result in extremely distressing consequences for patients and their families. What is widely known is that many of the more serious failures are not isolated but have happened somewhere else before. For example, the statistics show that many failures occur from: Medical device problems Serious adverse reactions to drugs; and Suicides committed by people in recent contact with mental health services 3.15 In chapter five there is an outline of the National Assembly s approach to an all Wales adverse event monitoring system. In addition to this work, which will be developed and rolled out over the next couple of years, organisations need to continue working on improving their reporting mechanisms and ensuring a feedback of the outcomes of incidents to the teams involved. They should share the results of internal inquiries with the rest of the organisation and ensure that CPD, audit and complaints monitoring are geared towards making sure the failure does not reoccur. This must all be delivered in a no blame culture so that people feel safe to admit their errors. 3.16 The biggest learning often comes from identifying near miss situations and these can also give early warnings of serious problems, yet this appears to be the least developed area. Heinrich in a study in industry (1941) concluded that the ratio of major injury to minor injury to near 13

misses was 1:29:300. Near miss reporting should therefore be developed at a local level and built into the organisation s reporting systems. Complaints and Compliments 3.17 Complaints occur in all types of organisations and have been defined* as any expression of dissatisfaction that needs a response and one can argue that conversely, a compliment is any expression of satisfaction that has been relayed to the organisation. In addition, information from complaints and compliments should be seen as free feedback about your service as this is the best form of market research you can get. It makes sense therefore to make sure that whilst organisations are dealing with complaints appropriately they must also utilise this free feedback to its fullest extent. 3.18 As outlined above, information from the analysis of complaints can give insight into risk assessment and risk management and give an indication of potential risks. A thorough analysis of complaints will provide opportunities for improved services and this should be shared across the organisation (and wider if applicable) to ensure lessons are learnt. The analysis should also feed into the CPD programme; it might be that the organisation needs to think about its communication, public involvement, customer care, improved quality of clinical care etc. Likewise, a record of compliments and analysis of these can highlight areas of good practice in the organisation which should also be shared with others. Patient and Public Involvement 3.19 A strategy for public involvement needs to provide coherence and direction for the work and represent a meaningful blueprint for action and essential tool for management. It should be a living document one whose set of objectives and priorities gets worked on and monitored continuously, revisited often, and updated when necessary. A strategy should: Have relevance and links to wider organisational goals and objectives Have relevance to wider community and partner interests and priorities Be founded in a sound and thorough diagnosis Have clear priorities and targets, with milestones for achievement Embrace an understanding of the dimensions of public and patient involvement Consider resource and capacity issues Be realistic and achievable Be widely endorsed and supported internally and externally (Reproduced from Signposts A guide to public and patient involvement in Wales - OPM, 2001) 14 * Cabinet Office guidance on handling complaints

Clinical Audit 3.20 Clinical audit is a key component that will ensure the quality framework meets the aim of continuous quality improvement. Because clinical standard setting is at the top of the agenda, it is inevitable that the focus of attention will move to clinical audit. NICE is developing its audit methodologies to accompany guidance (This is outlined in Chapter 5). The concept of a multi-disciplinary approach to clinical audit provides a real opportunity for quality improvement because it centres on professionals together examining their practice, understanding the variances and making change happen through a structured approach, evidenced through repeat audit. NICE guidance and NSFs provide a useful vehicle for this to happen. 3.21 Evidence-based standards will be determined, and through clinical audit, organisations will have a clear idea of how they need to develop or change practice to meet those standards. Clinical audit will also highlight issues that must be addressed as a priority. NICE guidance and NSFs also provide opportunities for organisation-wide audits and Health Economy wide audits. There are good examples in Wales of these happening in primary and secondary care. However, in some cases there is still a dominance of medical audit. There will undoubtedly be cases where uniprofessional audit will be appropriate and cases where the topics chosen are not part of the national standard setting programme, but the focus should be on an organisational strategy for clinical audit that encompasses organisational aspirations that are linked to new national standards and most of these audits should be multi-disciplinary. Multi-professional clinical audit is seen as an essential component of clinical governance because it directs attention to patient s needs rather than those of the individual professions, it helps avoid duplication of effort and waste of valuable resources, it improves teamwork and communication between clinicians and more increasingly between clinicians and managers. 3.22 The committee responsible for the organisation s clinical audit programme needs to report clearly on how this programme is improving the quality of services, in other words it must clearly define the areas of improvement that have come about as a result of the audit. The report should also provide signposts for future CPD activity identified as a result of the audit. There is a real opportunity for a well-defined clinical audit strategy to be the key to evidence based quality improvement. Furthermore, the clinical audit committee should include people outside clinical areas such as managers because they have a key role in the planning, delivering and prioritising of quality improvement programmes. The group should also extend beyond the immediate organisation to include other partners in the community to ensure the patient experience is improved across those boundaries. 15

Other Processes to aid a Strategic Approach Benchmarking 3.23 Benchmarking is about comparing oneself with others, continuous improvement and finding and implementing best practice. Although Benchmarking has been around for many years, it was perhaps a little ahead of its time because it is now, more than ever before, that organisations need to know how well they are doing and need to adopt the staged implementation of moving from current performance to better and eventually best practice. Sharing Good Practice 3.24 There is an emerging theme coming out of the reports of clinical governance reviews produced by CHI, namely, that where there is evidence of good practice in organisations, it is often not shared across the rest of the organisation or beyond it. 3.25 Sharing good practice often saves other parts of the organisation from reinventing the wheel and perhaps being able to use the good practice from other areas to address and overcome difficulties. Good use of information and communication streams may be the best way of ensuring that good practice is shared and organisations should consider how to do this as part of its quality improvement strategy. Examples might be through newsletters and Websites. Standard Setting National Institute for Clinical Excellence 3.26 The National Institute for Clinical Excellence (NICE) is an England and Wales body established to assist health professionals in providing NHS patients with the highest attainable quality of clinical care. This is based on a rigorous analysis and assessment of the available evidence; it is based on both clinical and cost effectiveness; is robust and authoritative guidance on the best clinical practice for patients and health professionals.nice in issuing appraisals and guidelines sets the standards for clinical care. Organisations need to ensure they are implementing these in a structured coordinated way that includes audit and re-audit to ensure the standards are being met. CPD for individuals may need to reflect appropriate training and development that might arise out of NICE guidance. National Service Frameworks 3.27 National Service Frameworks for client groups or disease or topic areas are being underpinned by the standards set by NICE. They like NICE signal the Assembly s aim to ensure ineffective practices are discontinued and that unacceptable variations in care are targeted. They are also targeted at the Assembly s priority areas for action based on the health 16

needs of the people in Wales. A programme of evidence-based National Service Frameworks will set out what patients can expect to receive from the health service. Monitoring Commission for Health Improvement 3.28 The Commission for Health Improvement is a statutory England and Wales body that commenced its work in April 2000. The Regulations governing Wales are The Commission for Health Improvement (Functions) (Wales) Regulations 2000 and these are available on the National Assembly Internet site http://www.wales-legislation.hmso.gov.uk/ legislation/wales/w-2000.htm. They provide for CHI to undertake clinical governance reviews in all NHS organisations in Wales. CHI will also undertake an investigation where there is evidence of a serious failure resulting from poor systems and processes. CHI also undertakes national reviews of NSF subject areas although the first review was of cancer services because the Calman Hine Report was seen as a forerunner to NSFs. As CHI develops and increases its knowledge from the reviews it undertakes it will also provide good practice advice to support organisations in taking clinical governance forward. 3.29 All NHS Wales organisations will be reviewed over a four-year period. Some may be reviewed more than once during this period. At Annex 2 there is an outline of the Clinical Governance Review process together with an explanation of the role of the Assembly. Use of Information 3.30 Clinical governance covers the organisation s systems and processes for monitoring and improving services, including: Consultation and patient involvement Clinical risk management Clinical audit Research and effectiveness Staffing and staff management Education, training and continuing personal and professional development The use of information about the patients experience, outcomes and processes 3.31 In information terms, this translates into: Making the knowledge, evidence base and standards appropriately available to patients and clinicians (e.g. work of NICE, Health of Wales Information Service, National Electronic Library for Health, NHS Direct Online) Making available the information systems which support clinicians in individual patient management 17

Accessing existing information sources such as libraries Making available the equipment, be that desktop computers, portables, printers or telecommunications devices, which can link to information sources and run operational systems Enabling clinicians and clerical staff to capture data about patient promptly and accurately Involving patients by making available information about their health and healthcare and enabling their contribution to the process Ensuring that information for audit, research and service monitoring is available as a by-product from operational systems Ensuring clinicians, managers, information/it personnel and administrative staff have the health informatics education and training necessary to use health information effectively 3.32 Thus, at the core of clinical governance is the requirement to ensure that clinicians have the tools necessary to provide, assess and seek continuously to improve the quality of care to their patients. Information and information systems should be recognised as major components of such a toolset. One aspect of the availability of such information tools, for example, will be the ability to capture, share and analyse the information needed to support the implementation of National Service Frameworks. * At annex 3 there is more information about what clinicians need from IM &T 18

Chapter 4: Measuring Clinical Governance Performance 4.1 The NHS plan indicates that there is a need to enhance existing performance management arrangements to meet the changing objectives of the service and the needs of the communities it serves. The objective is for consistent assessment and improvement to drive up performance, so that NHS Wales can assuredly stand comparison with the best. For this purpose, a performance measurement framework is being developed and the main aim is to "build organisational capacity for performance management, to help leaders develop effective systems and achieve the necessary supporting cultural change" (Improving Health in Wales, NAW 2001). 4.2 The new performance framework has 6 key principles: Clarity of purpose it is important to understand who will use performance information, and how and why the information will be used Focus the information must be focused on priorities, core objectives and service areas in need of improvement Alignment there must be links between the performance indicators used by management for operational purposes, and the indicators used to monitor corporate performance Balance the overall set of indicators must give a balanced picture of NHS Wales performance, reflecting current priorities Robust performance indicators must be used and must be intelligible for their intended use Independent scrutiny whether internal or external, helps to ensure that the systems for producing the information are sound 4.3 New accountability arrangements for the NHS in Wales will be issued shortly and further strengthened with the structural changes signalled in the plan. Clinical governance performance arrangements need to be included as part of these. 4.4 This process requires a degree of flexibility and the clinical governance performance arrangements will develop over the coming months. They will also be influenced by the outcome of the analysis of this year s clinical governance annual reports. 4.5 The work has commenced and detailed below is the work so far and the outcomes of that work. 4.5.1 Members of the Health Care Challenges Clinincal Governance Sub group held a facilitated workshop where the principles of what was to form part of the clinical governance performance arrangements were discussed. The group agreed that measuring clinical governance needed to encompass something 19

about quality inmprovement whch was more than merely outcome measures. 4.5.2 The group agreed that there needed to be a bridge between primary and secondary care and examples were produced of the criteria and processes for selection of performance indicators that might be used as follows: Table 1: Performance Measures Focus Group Inputs Process Outputs Outcomes People: numbers, skills Money Technology: equipment, drugs Protocols, NSFs, NICE Staff trained Supporting systems: Risk Management, public involvement etc Patients cured, patients cared for Conditions prevented Carers reassured Mortality lowered Morbidity lowered 4.5.3 It was agreed that a trawl would be carried out to determine what other NHS organisations were using for performance indicators/measures and that a focus group would be set up to take this work forward. The focus group included NAW policy leads with an interest in performance together with invited others including a representative from the Performance Task and Finish Group. 4.5.4 The focus group received the results of the trawl, which provided limited information but established that many NHS organisations in England and Wales were themselves attempting to determine what to measure and how to manage this process. 4.5.5 The focus group agreed the principles that clinical governance needed to be measured by products that really demonstrated continuous quality improvement and that using the same criteria that CHI uses in a clinical governance review could be a good start point. In other words, for the first year the indicators would consider the process issues and would not address all of the components outlined in table 1. There are eight key themes that CHI asks the organisation to describe as follows: 20

1. Strategic capacity, (patient focus, leadership, direction and planning) 2. Consultation and patient involvement 3. Clinical risk management 4. Clinical audit 5. Research and effectiveness 6. Staff and staff management 7. Education, training and CPD 8. Use of information to support clinical governance 4.6 A balance needs to be struck between quality assurance (the governance aspects) and continuous quality improvement. In considering the above elements, this might be possible, or at least it is a good start point. A major factor that will have an impact on the performance arrangements for clinical governance will be the Government and National Assembly s response to the Kennedy Report of the BRI Inquiry. This clearly outlines a series of recommendations, of great significance. 4.7 Recognising the evolving world described above, the indicators/measures outlined below are a first stab at what must be a developmental and iterative approach. The outcome of consultation, together with the outcome of policy development will no doubt influence this process. Proposed Clinical Governance Indicators Strategic Capacity 4.8 Describe your three main priorities for developing clinical governance over the next three years and explain how the board intends to monitor progress. 4.9 Describe the development plans for the components of clinical governance in your organisation and how they fit together. Consultation and Patient Involvement 4.10 Provide three examples of consultation with patients/the public at a planning level. 4.11 Give three examples of ways in which staff are encouraged to engage in patient involvement. Clinical Risk Management 4.12 Give three examples of improvements identified and implemented as a result of the WRP assessment for 2000/01 Clinical Audit 4.13 Give five examples of multi-disciplinary clinical audit that has improved quality of care in your organisation. 21

4.14 How are clinical audit priorities set? Research and Effectiveness 4.15 Give a minimum of three examples of how the outcome of research and effectiveness has improved the quality of care in the organisation. 4.16 What is the % of staff trained in core skills of evidence based practice (e.g. accessing the evidence, appraising the evidence, putting evidence in to practice, evaluating through audit the outcome). Staff and Staff Management 4.17 How is your HR strategy linked to the organisation s quality improvement programme? 4.18 What is the average monthly percentage of locum or bank based staff. Education Training and CPD 4.19 What percentage of staff for each discipline have CPD plans? 4.20 What percentage of staff for each discipline have appraisals? Use of Information 4.21 Outline 3 key priorities for improving clinical information over the next 12 months. 4.22 What clinical information is routinely received at Board level and what use is made of it? Consultation Questions Q.1. Q.2. Does the suggested approach meet the needs of your organisation or can you suggest other ways of measuring performance that might be more useful? Are the proposed indicators suitable for all NHS organisations or should they differ for Trusts, Health Authorities and LHGs and if so can you provide suggestions? 22

Chapter 5: National Assembly Policy Development Support to aid the development of clinical governance 5.1 This chapter outlines some of the policy development work that is currently underway that impacts on clinical governance. It also outlines Assembly work that will directly support clinical governance such as that provided by the new Clinical Governance Support and Development Unit. It includes some consultation questions for you to consider and these are repeated at Chapter five for ease of reference. In addition, at Annex 4 the work of the Centre for Health Leadership has been included in the context of what is being provided to underpin clinical governance. Clinical Governance Support and Development Unit - Wales Background 5.2 Improving Health in Wales announced the Assembly s intention to establish a unit to support the implementation and development of clinical governance in Wales. The need for the unit has been identified as a result of previous work by the Clinical Effectiveness Support Unit Wales (CESU), a stock take of activity undertaken by NHS Quality Division between September 2000 March 2001 and review of the clinical governance annual reports completed by NHS organisations in Wales during 2000. This new unit is called the Clinical Governance Support and Development Unit - Wales (CGSDU) and it is established an executive arm of the NHS Quality Division headed by Dr Bernadette Fuge. Purpose of CGSDU 5.3 The role of the unit is to provide leadership, support and clarity of direction on clinical governance issues. 5.4 Its aim is to support the further implementation and development of clinical governance through improving the strategic and operational capacity of the service. This will be achieved through providing leadership, support and direction, influencing attitudes, developing knowledge, understanding and skills about clinical governance at all levels and will be informed by regular needs assessment including feedback from the service. 5.5 The unit will use frameworks developed by the Commission for Health Improvement (CHI), National Patient Safety Agency (NPSA) and others related to Clinical Governance to develop its work programme ensuring consistency of message and approach. It will establish a reflective and learning environment in its own work, identifying and delivering against clear and measurable targets. 23

5.6 The objectives of the Unit are to: Develop the strategic and operational capacity of the NHS in Wales to deliver a strategic approach to clinical governance. Work with individual organisations in the NHS in Wales on specific issues e.g. helping deliver against CHI recommendations postreview/investigation, delivering against future clinical governance performance measures. Act as an advocate for the NHS in Wales with organisations like CHI, NPSA helping them to understand what is different in Wales. 5.7 It is important for the CGSDU to link with the work of international, national (UK) and all-wales initiatives and policies in driving forward this programme. This will particularly include the NAW based Performance Management Division patch managers, Innovations in Care team and Public Involvement strategy work; Human Resources Division HR Innovation Teams; HIM&T Division for clinical information issues; promoting inter-professional education (IPE) and overseeing the review of continuous professional development (CPD) arrangements in primary care. Activities of the CGSDU 5.8 The work programme that falls out of the objectives can be summarised as: Develop a Board Support Programme: creating the vision of what clinical governance should look like, integrating the component parts, spreading across the whole organisation in a multi-professional way, incorporating cross-sector and public/patient views, learning lessons from e.g. critical incidents, complaints. Deliver a Clinical Governance Development Programme in Wales to support clinical team working aimed at implementation of priority areas (e.g. National Service Frameworks, clinical networks). This will build on the training delivered by the Clinical Governance Support Team in England, led by Professor Aidan Halligan. Establish a Clinical Governance Learning Network supporting clinical governance leads, facilitators and others through a website, newsletter, query answering service/help line, resource file & topic specific support, CD-ROM, networks, skills directory, training/skills development events. Identifying, developing and disseminating useful tools, techniques etc. Work with specific NHS organisations for specific issues e.g. implementing CHI, NPSA recommendations, progressing activity against clinical governance performance measures. Provide direct training and information e.g. to CHI review teams to help them understand what is different about Wales. 24