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Page 1: Clinical Governanace - NHS Wales · governance guidance that was contained in WHC (99) 54. This document is the next step in that it considers the strategic approach that organisations
Page 2: Clinical Governanace - NHS Wales · governance guidance that was contained in WHC (99) 54. This document is the next step in that it considers the strategic approach that organisations
Page 3: Clinical Governanace - NHS Wales · governance guidance that was contained in WHC (99) 54. This document is the next step in that it considers the strategic approach that organisations

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: [email protected]

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: [email protected]

Page 4: Clinical Governanace - NHS Wales · governance guidance that was contained in WHC (99) 54. This document is the next step in that it considers the strategic approach that organisations
Page 5: Clinical Governanace - NHS Wales · governance guidance that was contained in WHC (99) 54. This document is the next step in that it considers the strategic approach that organisations

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 ClinicalGovernance 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 - Supportto 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

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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 CapabilityMembership: Health Care Challenges: Clinical Governance Sub GroupBibliographyWebsites

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Executive Summary

Clinical Governance – Developing A StrategicApproach

This consultation document is aimed at all NHS organisations and theconsultation questions are concerned with ongoing policy developmentthat will support the delivery of clinical governance (See Chapters 5 and 6for details). This document also reaffirms the quality agenda that aims toensure high standards of care, eliminate inequalities and to continuouslyimprove the health service in Wales and it supports the recently launchedNHS Plan Improving Health in Wales. Whilst much of the NHS plan is stillat a developmental stage, this document is timely in that clinicalgovernance must keep moving forward as it sits at the centre of the qualityagenda. Its successful development and delivery is crucial to the overallsuccess of the quality agenda and to the ongoing improvements in quality.It lays out a consistent approach for NHS Wales and provides a means forthe service to monitor improvements.

The approach to strengthening clinical governance is seen asdevelopmental and iterative. Whilst the consultation is underway, theNational Assembly will be analyzing this year’s clinical governance annualreports. The outcome of responses to consultation coupled with theanalysis will help identify any additional issues to be addressed and thesewill be reported back in Spring 2002. At that point, it is hoped that theoutcome of the work of the Task and Finish Groups set up to deliverImproving Health in Wales, can be incorporated into the ongoingdevelopment of this strategic approach to clinical governance.

Quality Care and Clinical Excellence detailed our ten-year plan forimproving the quality of services in Wales. This was followed by the clinicalgovernance guidance that was contained in WHC (99) 54. This documentis the next step in that it considers the strategic approach thatorganisations may wish to develop further. It firstly considers the issuesfacing Boards and Clinical leaders, and goes on to consider thecomponents of clinical governance and how they fit together. The ongoingstrategies being developed in the National Assembly are included toprovide information about work in hand to strengthen clinical governanceand 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 thisdocument. It provides baseline information on NHS organisations andhighlights ways in which clinical governance can be strengthened in Wales.It recognizes that the NHS is continuing to develop clinical governance. Inmany areas organisations are doing well but there are still some areas thatcould be improved. For example, almost all NHS organisations were

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having difficulty in engaging with the public. A lot of activity was reportedbut many had not planned to meet differing needs. This issue and otherkey aspects of clinical governance have been addressed in this documenttogether with some approaches that organisations might wish to follow.

The other strand outlined in this strategic approach is a clinical governancetoolkit produced to aid clinicians at a clinical team level, although this is apractical document that can be used at any level in the organisation. It isthe forerunner to a series of publications that will focus in more detail oneach of the components of clinical governance.

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Chapter 1: Background

Improving Health in Wales – A Plan for the NHSwith its Partners1.1 Improving Health in Wales – A Plan for the NHS with its partnerssignals the renewal of NHS Wales and sets out an ambitious agenda forchange and improvement. The Plan presents challenges that will demandnew approaches. These will be based on new and dynamic partnershipswithin the NHS and between NHS Wales, local government, the voluntaryand independent sectors and the communities they serve. They will needstrong leadership and clear accountabilities at all levels.

1.2 The prime aim of the Plan is to achieve wide scale improvements inpatients’ services and the quality of care. To achieve these, fundamentalchanges are required to deliver a people-centred and participative healthservice 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 NHSWales and its partners, particularly relating to the clinical environment andthe principal health issues facing the people of Wales. These will be tackledthrough a more coordinated approach which seeks to prevent illness andprovide more effective care via better organised programmes. The clinicalgovernance strategy aims to support the process by ensuring an integratedapproach to year on year quality improvement.

1.4 Setting, monitoring and reviewing national standards of care is a keycomponent 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, supportedby clinical guidance from the National Institute for Clinical Excellence. Theyare then adopted in service plans. They aim to significantly improveprimary, secondary and tertiary services for patients and should see an endto unacceptable variations in practice whilst also delivering year on yearclinical quality improvements.

1.5 The future requires that services will be delivered across widegeographical areas in a coordinated, multi-disciplinary and integratedmanner. Services at all levels will need to be developed in a more strategicway and clinical governance needs to be integrated into this approach toensure delivery to the highest levels of quality and a continuousimprovement.

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1.6 The development of managed clinical networks will require clearaccountability arrangements and the development of clinical governancesystems 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 auditof NHS organisations in Wales undertaken by Dr Bernadette Fuge, MedicalDirector and Head of the NHS Quality Division and Jane Farleigh, Head ofthe Clinical Quality Improvement Branch within the NHS Quality Division.The audit took place between October 2000 and March 2001. Thepurpose of the audit was to provide organisations with feedback on theirfirst clinical governance annual reports and to seek clarification oradditional information where required. It also provided an opportunity tohear about innovative practice being carried out, to hear about issuesaffecting the development of clinical governance, and it provided anopportunity for NAW officials to give an update on policy developments.

1.8 A full analysis was undertaken of each organisation and an analysissheet and pen-portrait was produced for each organisation. From thisinformation aggregate data was produced giving the baseline of activityafter the first 12 months. Although the period reported was March 1999-2000, because the visits commenced late in 2000 and into the spring of2001, the information that has been fed into this strategy is quite recent.

1.9 Clinical Governance – the First 12 Months provides more detail of theaudit of clinical governance in Wales and has been published alongside thisdocument. See Annex 1 for an outline of key themes identified during theaudit.

Progress Overall

1.10 Whilst many Trusts were making good progress and had set upappropriate structures, a strategic approach which would ensure theintegration of clinical governance throughout the organisation and acrosspartner agencies had not been adopted. There was lack of integration ofthe various components that would ensure clinical governance wasdelivering continuous quality improvement. Progress on monitoring andevaluation was the most disappointing. However, the audit had alsoidentified many examples of innovative practice. For example, one Trusthad employed a Patient Experience Facilitator whose remit was to ensurethe patients’ perspective was considered at different levels of engagement.

1.11 A problem for many LHGs was being able to engage with allcontractor professions whilst others had managed by a variety of means.Another issue was for LHGs to fully understand what progress had beenmade because of little or no monitoring and evaluation. However,considering the formative stage of LHGs the commitment was clear and

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that progress was demonstrated. Almost all LHGs provided examples ofinnovative practice, for example, one LHG had adapted the British DentalAssociation Clinical Governance Guidance (with permission) as a supportdocument for all professions in the LHG.

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Chapter 2: Developing A StrategicApproach to Clinical Governance2.1 One of the first things the Commission for Health Improvement looksfor at the beginning of a review is whether the organisation has adopted astrategic approach. This is about the leadership of an organisation andhow far this sets a clear overall direction that focuses on patients and howwell 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 theneed to provide an opportunity for the involvement of all staff (clinical andnon-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 theconcept with wide endorsement and support for the strategic approachbeing taken.

Leadership

2.3 ‘The influence of the Board, and particularly the non-executives isparamount in changing attitudes, winning hearts and minds, andaddressing leadership issues. Leaders of clinical governance must be ableto demonstrate a prior commitment to quality initiatives. In addition, theyneed ‘charisma’ and respect amongst their peers to motivate and influencethose who are reluctant to change. As a leader it is important todemonstrate an involvement, commitment and understanding of qualityissues as an example to those working within the organisation’.

From Clinical Governance: key success factors, Anne Williams, Clinician inManagement

2.4 The aim of clinical governance is to ensure that the clinical care,patient’s experiences and outcomes provided by organisations are of thehighest quality. It brings together existing strands of quality initiatives toform a cohesive quality monitoring and improvement programme. Theplanning and delivery of this aim should form part of the organisation’sstrategy.

2.5 When embarking on a strategic approach there are some guidingprinciples all organisations may wish to consider:

• Developing clinical governance as a supporting non-threateningprocess and in an open and transparent way whilst respectingpatient confidentiality and the dignity of patients.

• Planning to ensure successful implementation through asystematic 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

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partnership with each other across the organisation and withpatients.

• Developing the Clinical Governance plan for the organisationthrough both a top down and a bottom up approach.

• Encouraging corporate, directorate and individual endeavourwhich are all vital to clinical quality assurance.

• Addressing shortcomings, mishaps and mistakes in a proactiveway within a culture of ‘no-blame’ as part of a move towardsbecoming 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 LHGBoards.

This should:

• Provide a sense of direction and purpose to the wholeorganisation – the ‘vision’ which should also include coreprinciples and the values the organisation has

• Link activity across the organisation to the wider organisationalaims and goals and those of key stakeholders

• Take account of the environment, needs of others (particularlyservice users), barriers and existing good practice

• Critically assess current work and specify what is needed in termsof developing capacity for the future including resources, skillsand 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 ShouldContain

The example provided includes some of the main headings for a strategicdocument and some information about the issues that might be coveredunder each. This is included as a guide only and is not meant to beprescriptive, each organisation will want to consider their own needs inproducing a strategy.

Purpose of the strategic approach

2.7 This is essential to effective implementation. At each level of theorganisation there needs to be clarity of direction and purpose, what arethe expected benefits, what does it mean at different levels. Ownership of

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the concept and wide endorsement to the principles should be clearlystated and signed up to.

Strategic Context

2.8 Set out a vision, core principles, values and beliefs describing the viewthe organisation has of where it wants to be in 3-5 years time. Perhapsprovide an assessment of overall current performance and key priorities fordevelopment. Include leadership, culture, patient focus, direction,planning, accountability and implementation arrangements. Map how theClinical Governance Strategy fits in with the wider organisation strategyand priorities (internal and external). Outline the strategy for developingthe component parts and integrating them together. Describe the reviewarrangements, outline opportunities for joint working and priority settingwith others.

Wider Context

2.9 Include influencing factors (internal and external) on the clinicalservices the organisation provides e.g. role of the Commission for HealthImprovement, the National Patient Safety Agency, etc, HealthImprovement Programmes and all-Wales priorities, and organisationalchange which may impact on service delivery.

Stakeholders/partners

2.10 Identify those who are involved in working with the organisation andhow this relationship should develop to more effectively deliver ClinicalGovernance. This should include other NHS organisations, communityhealth councils, Local Authority, voluntary sector, education/trainingprovider’s etc.

Structure for Management and Delivery of Clinical Governance

2.11 Outline the clinical governance committee structures and how theyrelate to one another. Include arrangements for identifying and sharinggood practice and for poor performance. State who has leadaccountability and responsibility and how this is devolved within theorganisation. Provide links with external agents. Describe processes to befollowed/developed e.g. CHI, NPSA, NICE, NSFs, NationalAudits/confidential enquiries, accreditation/inspection reports, localpolicies 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 Organisationalstructure – from Board level to individually and collectively throughcommittee structures and plot how they relate to one another. Providesummaries of terms of reference and membership of key committees.Include reporting arrangements between structures and ensure all

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components are covered. Remember to Include individual clinicians’responsibilities.

Components of Clinical Governance

2.13 The component parts of clinical governance need to be supportedand developed. At Chapter three there are examples of things to considerbut in summary these are: arrangements for standard setting (e.g. NICE,NSFs) and implementation if not included elsewhere; Public/patientconsultation; clinical risk management; complaints; clinical audit; researchand effectiveness; collection and use of information to support clinicalgovernance; staff management and development. There should be anassessment of current performance and key priorities for developmentwithin each component if not included elsewhere.

Financial Resourcing

2.14 There needs to be a summary of financial resources, including issuesand plans regarding clinical governance. This will involve the identificationof resources already available, an evaluation of effectiveness to recognisegaps and of priorities for the future.

Evaluation and Monitoring

2.15 Include clinical governance performance monitoring targets, criticalincident reporting, clinical audit activities (including re-audit followingrecommended change in practice), education/training/CPD activities. Itneeds to be clear who receives what information and what use is made ofit, this is particularly important at board level to ensure Board ownershipand awareness of issues.

Key Challenges

2.16 The future challenges and emerging developments. What effect willthey 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 implementationand monitoring.

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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 maincomponents of clinical governance and explains how organisations mightbenefit from adopting a strategic approach. It is aimed at clinical leadswith a clinical governance responsibility.

Resources/People

3.2 The staff providing services within NHS Wales are fundamental inensuring a continuously improving quality of healthcare service is deliveredto all patients and clients. It is essential that a high quality, competentworkforce that is highly motivated can be developed across the service.‘Delivering for Patients’, the NHS Wales Human Resources Strategyencourages NHS organisations to develop appropriate individual trainingand development strategies through focussed Continuing ProfessionalDevelopment (CPD) and Personal Development Plans (PDPs). It recognisesthat a supporting performance management system will be essential to thedelivery of the organisation’s responsibility for Clinical Governance. TheHuman Resources Strategy provides the foundation on which NHSorganisations can build a climate of employment in which appropriatelevels of staff are employed in a flexible and safe working environment, andwhere they are encouraged to develop their skills and adopt best practicein the working place.

Continuous Professional Development

3.3 Lifelong learning is vital to the continuous personal and professionaldevelopment of all staff. Opportunities must be available to every memberof staff at all levels and health organisations must safeguard sufficient fundseach year to enable this to happen. A ‘skills escalator’ approach should beencouraged so that all staff gaining core levels of skills and competenciesmay progress to higher levels of responsibility with appropriateremuneration. Learning opportunities must be flexible enough to copewith the needs of those with specific responsibilities such as carers.

3.4 Health organisations will develop individual approaches throughCPD. PDPs for all staff will identify and balance their personal, educationaland professional development needs with those of the organisation.

3.5 CPD must remain a key component of the training and education ofhealth professional staff. A CPD website will provide all staff with directaccess to learning materials, occupational standards, guidance onappraisals, PDPs, mentorship, professional body guidance and educationalopportunities.

3.6 A systematic approach to CPD is an essential component of clinicalgovernance. CPD needs to meet organisational as well as personal needs.It is vital that it is part of the integrated approach to clinical governance.

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For example, the results of clinical audit or of an investigation into a clinicalincident may highlight training and development issues, as may theintroduction of NSFs or NICE guidance.

Professional Regulation

3.7 Developing a framework for managing professional performance inthe NHS is a key component in maintaining public confidence in our healthservice. The ‘Maximising Clinical Performance Consultation Document’issued in October 2000 set out proposals to maintain the clinical excellenceof doctors in Wales. The announcement in the NHS Plan for England ofthe establishment of a new Special Health Authority, the National ClinicalAssessment Authority, takes this a step forward and the Assembly iscurrently considering its applicability for the service in Wales. Details ofongoing developments in this area included in Chapter 5. A new Nursingand Midwifery Council (NMC) is being established to undertake theregulatory functions relating to Nurses, Midwives and Health Visitors thathad once been carried out by the UKCC and the Welsh National Board forNurses, Midwives and Health Visitors. The NMC will be in place on 1 April2002. The Health Professions Council (HPC) will also come into place on 1April 2001, taking over the regulatory functions for the allied healthprofessions.

3.8 Appraisal has been around in various forms for a range of NHSprofessional groups for many years especially for nurse and non-clinicalmanagers. In April 2001 appraisal was introduced for Medical Consultants.Several consultants have already undergone the appraisal process andthere is an on-going training programme.

Clinical Governance Processes

Clinical Risk Management

3.9 Risk management is a way of reducing risks and clinical riskmanagement is about reducing the risks of adverse clinical eventshappening. 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 ofhigh-risk specialties.

3.11 The reasons for problems can be due to a number of factors, it maybe due to poor channels of communication between the various parties,poor processes such as the absence of clinical guidelines, unclear lines ofresponsibility and these are just some examples. It must not be forgottenthat positive feedback needs to be recorded and used.

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3.12 A strategic approach to risk management should help organisationsby using the steps outlined in the bullet points above. There are a numberof publications that go into this in more detail but use of incident reportingto identify risks, use of complaints and claims information can helporganisations to assess the level of risk and good information managementand reporting systems should support the review and prevention of risk.The introduction of care pathways can assist in this process because theanalysis of variations is a useful component. The pathway could contain achecklist of potential adverse events, variances from the pathway or if anevent on the checklist occurs, could be reported promptly to managementfor analysis and action.

Adverse Clinical Incidents

3.13 An open, sharing and learning culture needs to be driven from thehighest levels of the health service. Professionals must feel safe to examinepractice and admit mistakes. The approach to clinical governance must befuelled by a desire to improve practice, to learn from error and to supportprofessionals to get it right in future (Improving Health in Wales, The futureof primary care, NAW 2001).

3.14 It must also be recognised that the great majority of care is of a veryhigh clinical standard and by comparison to the amount of care provided,the number of serious failures are uncommon. Unfortunately, when theydo occur they can often result in extremely distressing consequences forpatients and their families. What is widely known is that many of the moreserious 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 approachto 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 reportingmechanisms and ensuring a feedback of the outcomes of incidents to theteams involved. They should share the results of internal inquiries with therest of the organisation and ensure that CPD, audit and complaintsmonitoring 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 toadmit their errors.

3.16 The biggest learning often comes from identifying near misssituations and these can also give early warnings of serious problems, yetthis 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

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misses was 1:29:300. Near miss reporting should therefore be developedat 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 canargue that conversely, a compliment is any expression of satisfaction thathas been relayed to the organisation. In addition, information fromcomplaints and compliments should be seen as free feedback about yourservice as this is the best form of market research you can get. It makessense therefore to make sure that whilst organisations are dealing withcomplaints appropriately they must also utilise this free feedback to itsfullest extent.

3.18 As outlined above, information from the analysis of complaints cangive insight into risk assessment and risk management and give anindication of potential risks. A thorough analysis of complaints will provideopportunities for improved services and this should be shared across theorganisation (and wider if applicable) to ensure lessons are learnt. Theanalysis should also feed into the CPD programme; it might be that theorganisation needs to think about its communication, public involvement,customer care, improved quality of clinical care etc. Likewise, a record ofcompliments and analysis of these can highlight areas of good practice inthe organisation which should also be shared with others.

Patient and Public Involvement

3.19 A strategy for public involvement needs to provide coherence anddirection for the work and represent a meaningful blueprint for action andessential tool for management. It should be a living document – onewhose set of objectives and priorities gets worked on and monitoredcontinuously, revisited often, and updated when necessary. A strategyshould:

• Have relevance and links to wider organisational goals andobjectives

• Have relevance to wider community and partner interests andpriorities

• 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)

* Cabinet Office guidance on handling complaints

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Clinical Audit

3.20 Clinical audit is a key component that will ensure the qualityframework meets the aim of continuous quality improvement. Becauseclinical standard setting is at the top of the agenda, it is inevitable that thefocus of attention will move to clinical audit. NICE is developing its auditmethodologies to accompany guidance (This is outlined in Chapter 5).The concept of a multi-disciplinary approach to clinical audit provides areal opportunity for quality improvement because it centres onprofessionals together examining their practice, understanding thevariances and making change happen through a structured approach,evidenced through repeat audit. NICE guidance and NSFs provide a usefulvehicle for this to happen.

3.21 Evidence-based standards will be determined, and through clinicalaudit, organisations will have a clear idea of how they need to develop orchange practice to meet those standards. Clinical audit will also highlightissues that must be addressed as a priority. NICE guidance and NSFs alsoprovide opportunities for organisation-wide audits and Health Economywide audits. There are good examples in Wales of these happening inprimary and secondary care. However, in some cases there is still adominance of medical audit. There will undoubtedly be cases where uni-professional audit will be appropriate and cases where the topics chosenare not part of the national standard setting programme, but the focusshould be on an organisational strategy for clinical audit that encompassesorganisational aspirations that are linked to new national standards andmost of these audits should be multi-disciplinary. Multi-professionalclinical audit is seen as an essential component of clinical governancebecause it directs attention to patient’s needs rather than those of theindividual professions, it helps avoid duplication of effort and waste ofvaluable resources, it improves teamwork and communication betweenclinicians and more increasingly between clinicians and managers.

3.22 The committee responsible for the organisation’s clinical auditprogramme needs to report clearly on how this programme is improvingthe quality of services, in other words it must clearly define the areas ofimprovement that have come about as a result of the audit. The reportshould also provide signposts for future CPD activity identified as a resultof the audit. There is a real opportunity for a well-defined clinical auditstrategy to be the key to evidence based quality improvement.Furthermore, the clinical audit committee should include people outsideclinical areas such as managers because they have a key role in theplanning, delivering and prioritising of quality improvement programmes.The group should also extend beyond the immediate organisation toinclude other partners in the community to ensure the patient experienceis improved across those boundaries.

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Other Processes to aid a Strategic Approach

Benchmarking

3.23 Benchmarking is about comparing oneself with others, continuousimprovement and finding and implementing best practice. AlthoughBenchmarking has been around for many years, it was perhaps a littleahead of its time because it is now, more than ever before, thatorganisations need to know how well they are doing and need to adoptthe staged implementation of moving from current performance to betterand eventually best practice.

Sharing Good Practice

3.24 There is an emerging theme coming out of the reports of clinicalgovernance reviews produced by CHI, namely, that where there is evidenceof good practice in organisations, it is often not shared across the rest ofthe organisation or beyond it.

3.25 Sharing good practice often saves other parts of the organisationfrom ‘reinventing the wheel’ and perhaps being able to use the goodpractice from other areas to address and overcome difficulties. Good useof information and communication streams may be the best way ofensuring that good practice is shared and organisations should considerhow to do this as part of its quality improvement strategy. Examples mightbe through newsletters and Websites.

Standard Setting

National Institute for Clinical Excellence

3.26 The National Institute for Clinical Excellence (NICE) is an England andWales body established to assist health professionals in providing NHSpatients with the highest attainable quality of clinical care. This is based ona rigorous analysis and assessment of the available evidence; it is based onboth clinical and cost effectiveness; is robust and authoritative guidance onthe best clinical practice for patients and health professionals.NICE inissuing appraisals and guidelines sets the standards for clinical care.Organisations need to ensure they are implementing these in a structuredcoordinated way that includes audit and re-audit to ensure the standardsare being met. CPD for individuals may need to reflect appropriatetraining and development that might arise out of NICE guidance.

National Service Frameworks

3.27 National Service Frameworks for client groups or disease or topicareas are being underpinned by the standards set by NICE. They like NICEsignal the Assembly’s aim to ensure ineffective practices are discontinuedand that unacceptable variations in care are targeted. They are alsotargeted at the Assembly’s priority areas for action based on the health

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needs of the people in Wales. A programme of evidence-based NationalService Frameworks will set out what patients can expect to receive fromthe health service.

Monitoring

Commission for Health Improvement

3.28 The Commission for Health Improvement is a statutory England andWales body that commenced its work in April 2000. The Regulationsgoverning Wales are ‘The Commission for Health Improvement (Functions)(Wales) Regulations 2000’ and these are available on the NationalAssembly Internet site http://www.wales-legislation.hmso.gov.uk/legislation/wales/w-2000.htm. They provide for CHI to undertake clinicalgovernance reviews in all NHS organisations in Wales. CHI will alsoundertake an investigation where there is evidence of a serious failureresulting from poor systems and processes. CHI also undertakes nationalreviews of NSF subject areas although the first review was of cancerservices because the Calman Hine Report was seen as a forerunner to NSFs.As CHI develops and increases its knowledge from the reviews it undertakesit will also provide good practice advice to support organisations in takingclinical 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 2there is an outline of the Clinical Governance Review process together withan explanation of the role of the Assembly.

Use of Information

3.30 Clinical governance covers the organisation’s systems and processesfor 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 appropriatelyavailable to patients and clinicians (e.g. work of NICE, Health ofWales Information Service, National Electronic Library for Health,NHS Direct Online)

• Making available the information systems which support cliniciansin individual patient management

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• Accessing existing information sources such as libraries• Making available the equipment, be that desktop computers,

portables, printers or telecommunications devices, which can linkto information sources and run operational systems

• Enabling clinicians and clerical staff to capture data about patientpromptly and accurately

• Involving patients by making available information about theirhealth and healthcare and enabling their contribution to theprocess

• Ensuring that information for audit, research and servicemonitoring is available as a by-product from operational systems

• Ensuring clinicians, managers, information/IT personnel andadministrative staff have the health informatics education andtraining necessary to use health information effectively

3.32 Thus, at the core of clinical governance is the requirement to ensurethat clinicians have the tools necessary to provide, assess and seekcontinuously to improve the quality of care to their patients. Informationand information systems should be recognised as major components ofsuch a toolset. One aspect of the availability of such ‘information’ tools, forexample, will be the ability to capture, share and analyse the informationneeded to support the implementation of National Service Frameworks.

* At annex 3 there is more information about what clinicians need from IM &T

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Chapter 4: Measuring ClinicalGovernance Performance

4.1 The NHS plan indicates that there is a need to enhance existingperformance management arrangements to meet the changing objectivesof the service and the needs of the communities it serves. The objective isfor consistent assessment and improvement to drive up performance, sothat NHS Wales can assuredly stand comparison with the best. For thispurpose, a performance measurement framework is being developed andthe main aim is to "build organisational capacity for performancemanagement, to help leaders develop effective systems and achieve thenecessary supporting cultural change" (Improving Health in Wales, NAW2001).

4.2 The new performance framework has 6 key principles:

• Clarity of purpose – it is important to understand who will useperformance information, and how and why the information willbe used

• Focus – the information must be focused on priorities, coreobjectives and service areas in need of improvement

• Alignment – there must be links between the performanceindicators used by management for operational purposes, andthe indicators used to monitor corporate performance

• Balance – the overall set of indicators must give a balancedpicture of NHS Wales’ performance, reflecting current priorities

• Robust performance indicators – must be used and must beintelligible for their intended use

• Independent scrutiny – whether internal or external, helps toensure that the systems for producing the information are sound

4.3 New accountability arrangements for the NHS in Wales will be issuedshortly and further strengthened with the structural changes signalled inthe plan. Clinical governance performance arrangements need to beincluded as part of these.

4.4 This process requires a degree of flexibility and the clinicalgovernance performance arrangements will develop over the comingmonths. They will also be influenced by the outcome of the analysis of thisyear’s clinical governance annual reports.

4.5 The work has commenced and detailed below is the work so far andthe outcomes of that work.

4.5.1 Members of the Health Care Challenges Clinincal GovernanceSub group held a facilitated workshop where the principles ofwhat was to form part of the clinical governance performancearrangements were discussed. The group agreed thatmeasuring clinical governance needed to encompass something

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about quality inmprovement whch was more than merelyoutcome measures.

4.5.2 The group agreed that there needed to be a bridge betweenprimary and secondary care and examples were produced of thecriteria and processes for selection of performance indicatorsthat might be used as follows:

Table 1: Performance Measures Focus Group

4.5.3 It was agreed that a trawl would be carried out to determinewhat other NHS organisations were using for performanceindicators/measures and that a ‘focus group’ would be set up totake this work forward. The focus group included NAW policyleads with an interest in performance together with invitedothers including a representative from the Performance Taskand Finish Group.

4.5.4 The focus group received the results of the trawl, whichprovided limited information but established that many NHSorganisations in England and Wales were themselves attemptingto determine what to measure and how to manage this process.

4.5.5 The focus group agreed the principles that clinical governanceneeded to be measured by products that really demonstratedcontinuous quality improvement and that using the samecriteria that CHI uses in a clinical governance review could be agood start point. In other words, for the first year the indicatorswould consider the process issues and would not address all ofthe components outlined in table 1. There are eight key themesthat CHI asks the organisation to describe as follows:

Inputs People: numbers, skillsMoneyTechnology: equipment, drugs

Process Protocols, NSFs, NICEStaff trainedSupporting systems:Risk Management,public involvement etc

Outputs Patients ‘cured’, patients cared forConditions preventedCarers reassured

Outcomes Mortality loweredMorbidity lowered

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1. Strategic capacity, (patient focus, leadership, direction andplanning)

2. Consultation and patient involvement 3. Clinical risk management4. Clinical audit5. Research and effectiveness6. Staff and staff management7. Education, training and CPD8. Use of information to support clinical governance

4.6 A balance needs to be struck between quality assurance (thegovernance aspects) and continuous quality improvement. In consideringthe above elements, this might be possible, or at least it is a good startpoint. A major factor that will have an impact on the performancearrangements for clinical governance will be the Government and NationalAssembly’s response to the Kennedy Report of the BRI Inquiry. This clearlyoutlines a series of recommendations, of great significance.

4.7 Recognising the evolving world described above, theindicators/measures outlined below are a first stab at what must be adevelopmental and iterative approach. The outcome of consultation,together with the outcome of policy development will no doubt influencethis process.

Proposed Clinical Governance Indicators

Strategic Capacity

4.8 Describe your three main priorities for developing clinical governanceover the next three years and explain how the board intends to monitorprogress.

4.9 Describe the development plans for the components of clinicalgovernance in your organisation and how they fit together.

Consultation and Patient Involvement

4.10 Provide three examples of consultation with patients/the public at aplanning level.

4.11 Give three examples of ways in which staff are encouraged to engagein patient involvement.

Clinical Risk Management

4.12 Give three examples of improvements identified and implemented asa result of the WRP assessment for 2000/01

Clinical Audit

4.13 Give five examples of multi-disciplinary clinical audit that hasimproved quality of care in your organisation.

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4.14 How are clinical audit priorities set?

Research and Effectiveness

4.15 Give a minimum of three examples of how the outcome of researchand 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 into practice, evaluating through audit the outcome).

Staff and Staff Management

4.17 How is your HR strategy linked to the organisation’s qualityimprovement programme?

4.18 What is the average monthly percentage of locum or bank basedstaff.

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 thenext 12 months.

4.22 What clinical information is routinely received at Board level and whatuse is made of it?

Consultation Questions

Q.1. Does the suggested approach meet the needs of yourorganisation or can you suggest other ways of measuringperformance that might be more useful?

Q.2. Are the proposed indicators suitable for all NHSorganisations or should they differ for Trusts, HealthAuthorities and LHGs and if so can you providesuggestions?

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Chapter 5: National Assembly PolicyDevelopment – Support to aid thedevelopment of clinical governance

5.1 This chapter outlines some of the policy development work that iscurrently underway that impacts on clinical governance. It also outlinesAssembly work that will directly support clinical governance such as thatprovided by the new Clinical Governance Support and Development Unit.It includes some consultation questions for you to consider and these arerepeated at Chapter five for ease of reference. In addition, at Annex 4 thework of the Centre for Health Leadership has been included in the contextof what is being provided to underpin clinical governance.

Clinical Governance Support and DevelopmentUnit - Wales

Background

5.2 Improving Health in Wales announced the Assembly’s intention toestablish a unit to support the implementation and development of clinicalgovernance in Wales. The need for the unit has been identified as a resultof previous work by the Clinical Effectiveness Support Unit – Wales (CESU),a stock take of activity undertaken by NHS Quality Division betweenSeptember 2000 – March 2001 and review of the clinical governanceannual reports completed by NHS organisations in Wales during 2000.This new unit is called the Clinical Governance Support and DevelopmentUnit - Wales (CGSDU) and it is established an executive arm of the NHSQuality Division headed by Dr Bernadette Fuge.

Purpose of CGSDU

5.3 The role of the unit is to provide leadership, support and clarity ofdirection on clinical governance issues.

5.4 Its aim is to support the further implementation and development ofclinical governance through improving the strategic and operationalcapacity 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 beinformed by regular needs assessment including feedback from the service.

5.5 The unit will use frameworks developed by the Commission forHealth Improvement (CHI), National Patient Safety Agency (NPSA) andothers related to Clinical Governance to develop its work programmeensuring consistency of message and approach. It will establish a reflectiveand learning environment in its own work, identifying and deliveringagainst clear and measurable targets.

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5.6 The objectives of the Unit are to:

• Develop the strategic and operational capacity of the NHS in Walesto deliver a strategic approach to clinical governance.

• Work with individual organisations in the NHS in Wales on specificissues e.g. helping deliver against CHI recommendations post-review/investigation, delivering against future clinical governanceperformance measures.

• Act as an advocate for the NHS in Wales with organisations likeCHI, 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 thisprogramme. This will particularly include the NAW based PerformanceManagement Division – patch managers, Innovations in Care team andPublic Involvement strategy work; Human Resources Division – HRInnovation Teams; HIM&T Division for clinical information issues;promoting inter-professional education (IPE) and overseeing the review ofcontinuous professional development (CPD) arrangements in primary care.

Activities of the CGSDU

5.8 The work programme that falls out of the objectives can besummarised as:

• Develop a Board Support Programme: creating the vision ofwhat clinical governance should look like, integrating thecomponent parts, spreading across the whole organisation in amulti-professional way, incorporating cross-sector andpublic/patient views, learning lessons from e.g. critical incidents,complaints.

• Deliver a Clinical Governance Development Programme inWales to support clinical team working aimed at implementationof priority areas (e.g. National Service Frameworks, clinicalnetworks). This will build on the training delivered by the ClinicalGovernance Support Team in England, led by Professor AidanHalligan.

• Establish a Clinical Governance Learning Network – supportingclinical governance leads, facilitators and others through a web-site, newsletter, query answering service/help line, resource file &topic specific support, CD-ROM, networks, skills directory,training/skills development events. Identifying, developing anddisseminating useful tools, techniques etc.

• Work with specific NHS organisations for specific issues – e.g.implementing CHI, NPSA recommendations, progressing activityagainst clinical governance performance measures.

• Provide direct training and information e.g. to CHI review teamsto help them understand what is different about Wales.

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Adverse Event Reporting System

5.9 The NHS Plan outlines proposals for the introduction of an adverseevent monitoring system in Wales. The new National Patient SafetyAgency provides an ideal opportunity for joint working and we are aboutto conclude discussions on a partnership agreement between the Agencyand NAW. Below is some information about the agency and of how NAWintends to engage with it

National Patient’s Safety Agency

5.10 The new National Patient’s Safety Agency represents a significantdevelopment in the programme of improving healthcare. Reducing errorby promoting patient safety is the prime purpose of the Agency. Its workwill focus on two key areas:

• Developing and implementing a national adverse event and "nearmiss" reporting system; and,

• Disseminating learning throughout the NHS

5.11 The new national reporting system will help provide the evidence tochange practice or behaviour to reduce the potential for adverse eventsrecurring by sharing the evidence and knowledge across the NHS. Thispresents the NHS with the opportunity to create a unique learningenvironment across the UK.

5.12 Another important aspect of the Agency’s work will be to agreenational and international standards and definitions of adverse events and"near misses". This will enable the Agency to provide information ontrends and highlight the issues that the NHS need to address.

The Agency in Wales

5.13 Development work has begun to address how the Agency will workwith the NHS and in particular, how Wales will work with the Agency. Tohelp this, we are supporting an implementation project in Wales, whichincludes funding a project manager from the service to work closely withthe NHS on implementation. The person has been seconded to theNational Assembly (October 2001) and is working in the NHS QualityDivision’s Clinical Quality Improvement Branch for a 12-month period.

Consultation Questions

Q1. Does the proposed work programme meet the needsof your organisation?

Q2. Is there anything else you would like the Unit tocover?

Q3. How would you like the Unit to link with your organisation/network?

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Wales will also be taking part in two pilot studies to test the reportingsystem, these will take place at Swansea Local Health Group andPembrokeshire and Derwen NHS Trust.

The Implementation Project

5.14 The project will be managed by a Board chaired by Mr Gren Kershaw,nominated by the National Assembly and All Wales Chief Executive Group(NACE). Board members are currently being nominated by the NHS andwill comprise of representatives from various sectors of the NHS Wales andof a suitable patient representative body who collectively will haveknowledge and expertise in clinical risk management, the handling ofadverse clinical events and of complaints.

5.15 The aim of the project will be to support the implementation of thenew reporting system in Wales and to provide expert advice to theNational Assembly.

Public Involvement Strategy

Complaints

5.16 A two-year UK-wide evaluation of the NHS complaints proceduresuggests a number of improvements to the way that complaints arehandled, both at the local resolution stage and the independent reviewstage. Whilst the first stage of the process (local resolution) is felt to workreasonably well, the independence of the second stage (independentreview) is widely questioned.

5.17 The report makes 27 suggestions for changes to improve theprocedure. These will be going out for widespread consultation inSeptember. The suggestions include: better training and support for front-line NHS staff in dealing with complainants; an alternative approach to thehandling of family health service complaints; and a strengthening of theindependent review process to ensure that it is more independent andimpartial.

Consultation Questions

Q1. What do you think about the approach outlined above? Do you consider there to be a different way (s),which would more effectively encourage and facilitateNHS participation in the development andimplementation work?

Q2. Are there any other key tasks, which would be essentialto initial implementation?

Q3. Do you have any general views or comments about the Agency’s work and or our proposed approach?

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5.18 Improving Health in Wales commits the Assembly to act on theoutcome of the evaluation and to reform the complaints procedure tomake it more effective by 2002.

Health and Social Care Guide

5.19 The Health and Social Care Guide has been developed as a result ofwide consultation with the NHS, local authorities, voluntary organisations,professional organisations and the public. It will replace the Patient’sCharter for Wales which was published in 1996. There was widespreadsupport that the document should be called a 'guide' to services asopposed to a 'charter'.

5.20 Key messages emerging from the consultation were, that the guideshould contain a small number of core standards to allow benchmarkingbetween organisations, and that it should cover priority areas such ashospital waiting times, access to GP's and other practitioners and dischargefrom hospital.

5.21 The new guide will be launched during the autumn of 2001. It setsout what users of health and services can expect from both current andfuture services as improvements are made. It also explains how to get moreinformation about services. Health and social care organisations will berequired to publish an annual report to describe progress in meeting thestandards in the new guide.

Modernising Patient Advocacy and Support

5.22 A key commitment in Improving Health in Wales is to give patients andthe public more say in the running of NHS services. In practice this meansputting patients first and gearing services around their needs. The NHSwill need to work closely with patients, their families and carers, and thepublic to look for ways to improve and develop services. When using NHSservices patients often need an identifiable person they can turn to forinformation or to have their concerns dealt with quickly and sensitively onthe spot.

5.23 A programme of "pathfinder" schemes to test out patient support andadvocacy across Wales has been agreed. This will include six patientsupport managers and two complaints advocates to be based in NHS andCommunity Health Council settings. The scheme will operate for one yearafter which the impact on the NHS and on patients/public will bethoroughly evaluated by an independent organisation.

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Patient and Public Involvement

5.24 Improved patient and public involvement is a key element ofImproving Health in Wales. Involving patients and the public in the design,delivery and monitoring of health services is central to service planning andprovision and a major driver for service improvement.

5.25 Included in the NHS Plan is a requirement for NHS trusts and LocalHealth Groups to undertake a baseline assessment of arrangements todeliver public and patient involvement, and produce annual plans forpublic involvement beginning in 2002. Chief executives will be heldaccountable for the implementation of these plans.

5.26 The Assembly will produce a resource guide to help support thisprocess. The guide will provide practical help to those developing publicand patient involvement plans and strategies. It will also provide them withtools, techniques and tips to successful involvement and signposts tofurther sources of support.

Other Patient/Public Involvement Initiatives toSupport Clinical Governance

5.27 There are a number of other initiatives which will support the clinicalgovernance agenda, these include:

• A network of 'expert patients' to be established to supportindividual patients in the treatment of specific conditions.

• Patients will have the right to copies of correspondence betweenclinicians about themselves.

• All patients leaving hospital will be invited to record their viewson the care received.

• Trusts and Local Health Groups will publish an account of theviews received from patients and action taken as a result.

• A framework for best practice in the provision of healthinformation for the public will be produced.

• A skills training programme will be in place to enable NHS staffand managers to acquire skills and expertise they need to makebest use of public involvement techniques.

Consultation Question

Q. How can we ensure that effective and lasting patientand public involvement is put centre stage by NHSorganisations?

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Standard Setting

NICE

5.28 The Assembly partners the Department of Health in its sponsorship ofthe National Institute for Clinical Excellence (NICE), with the aim ofensuring that patients in Wales have the benefits of treatments and servicesdeveloped by robust evidence based clinical guidance. The Assembly playsa full part in setting the NICE agenda, based on Welsh priorities.

5.29 The National Institute for Clinical Excellence provides robustevidence based advice to assist health professionals in England and Walesin providing patients with the highest attainable quality of clinical care. Itissues appraisals and guidelines identified through a set and transparentprocess.

5.30 As part of the development of clinical governance, the Assembly inconsultation with key players, proposes to organise a programme whichwill provide advice, guidance and support the whole range of interestedparties to develop proposals to be put forward to NICE as part of theagenda setting process.

5.31 As part of the implementation of NICE guidance, auditmethodologies are being developed for NICE guidance and the NationalPrescribing Centre has been commissioned to produce guidance onimplementation (launched on 7 August).

National Service Frameworks

5.32 NICE guidance underpins National Service Frameworks. TheAssembly, as part of the work on the implementation of Improving Healthin Wales, has set up an NSF sub group as part of the Health Challenges Taskand Finish Group. The sub group is working on the development of criteriafor NSFs, and a process pathway for their development andimplementation. The recommendations will form advice to assist the NHSand its partners in the implementation of NSFs.

Professional Regulation

5.33 Developing a framework for managing professional performance inthe NHS is a key component in maintaining public confidence in our healthservice. The Maximising Clinical Performance Consultation Documentissued in October 2000 set out proposals to maintain the clinical excellenceof doctors in Wales. The announcement in the NHS Plan for England ofthe establishment of a new Special Health Authority, the National ClinicalAssessment Authority, takes this a step forward and the Assembly iscurrently considering its applicability for the service in Wales.

5.34 We know from the Commission for Health Improvement that thequality of services and the mechanisms for ensuring high standards canvary widely, even within individual hospitals, and in a small minority of

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cases patients receive their care from clinicians whose practice is poor ordangerous. The NCAA represents a new approach to the problem ofpoorly performing doctors and is one of the central planks of the NHSagenda for quality improvement. Its aim is to provide a support service toemployers who are faced with concerns over the performance of anindividual doctor. It is there to provide support to doctors in difficulty andto boost patient confidence in the NHS.

5.35 Together with a reformed GMC and changes to disciplinaryprocedures the new system will also be able to deal with the genuinelydangerous doctors much more quickly and effectively, before patients areharmed.

5.36 In order to help doctors in difficulty, the NCAA will provide advice,take referrals and carry out targeted assessments where it is deemednecessary. The NCAA’s assessment will involve trained medical and layassessors. Once an objective assessment has been carried out, the NCAAwill advise employers on the appropriate course of action. The NCAA hasbeen established as an advisory body and the NHS employer organisationwill remain responsible for resolving the problem once the NCAA hasproduced its assessment. The NCAA also sees it as centrally important thatkey stakeholders at all levels are thoroughly consulted throughout all stagesof the work of the organisation. Consultation with key stakeholders willlead to a more productive relationship and will ensure that proceduresdeveloped by the NCAA are fair, effective and transparent.

5.37 The Authority will endeavour to provide the doctor with a supportiveenvironment while he or she is undergoing assessment and will strive to benon-stigmatising. The focus will be very much on problem-solving andwhere a problem with the doctor’s performance is found, on answering thequestion ‘what practical steps need to be taken so that this doctor canreturn to practice without risk to patients’. The employer will takeresponsibility for implementing the findings of the NCAA in each casewhich will address the original concerns and deliver practical solutions.Strong links and involvement with the postgraduate dean and clinicaltutors will be developed so that tailored education and training solutionsto the clinical problems can be delivered.

5.38 Prototype assessments will commence in primary, hospital andcommunity care based on referrals taken from October 2001 onwards.Twenty assessments will be undertaken by March 2002.

5.39 The NCAA are currently developing guidance which will explain theprocedures for referral to the NCAA and the creation and development oflocal services under the auspices of the Authority will be developed as aresult of experience of the prototype phase of assessments. This willinfluence the Assembly’s thinking on the Wales assessment service and theother changes which will have an effect on the model we adopt i.e.:

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• the introduction of appraisal systems for medical staff;• the proposed abolition of the NHS Tribunal and the

consequential regulatory changes to the contractualarrangements between employers and doctors in primary care;

• the further development of the GMC’s fitness to practiceprocedures.

5.40 Wales will become part of a network of local services which willprovide an accessible source of expertise to advise employers faced withconcerns at individual practice.

Use of Information to support Clinical Governance

5.41 A number of initiatives supporting the information management andinformation technology requirements of clinical governance are currentlyin place. A selection of these are described below.

5.42 Access to the knowledge: The Health of Wales Information Service isbeing developed as the primary source of electronic information abouthealth in Wales for health professionals, NHS partners, voluntary sector,patients and the public. Existing evidence-bases and research will beextended to provide reliable, easy as access to the knowledge base ofhealth care.

5.43 HOWIS will provide access to information about the delivery of thehealth care exploiting, improving and integrating current and new datacollections. This will provide a reliable and consistent resource for theplanning, monitoring and development of services. The corporateresources made available in this way will support all performancemanagement, benchmarking, public health, clinical governance andpublic involvement.

5.44 Underpinning the development of HOWIS is the need for goodquality, accurate, and timely information. The National Assembly is fundingaccreditation programmes in health record management and data qualitywhich will drive up the quality of information. In addition a review ofInformation Quality in the NHS has been undertaken and any futureinformation Plan will take forward the recommendations.

Consultation Questions

Q1. What kind of Welsh regional presence do we need toestablish to channel concerns about the performance ofindividual doctors?

Q2. What arrangements do we need to establish to reachagreement with the NCAA on collaborative working?

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5.45 Available Information systems: £18million has been made availablefor the ICT Foundation Programme for General Medical Practices. Thisfunding comes equally from the Assembly and the NHS. Over the nextthree years, all practices will be upgraded to modern, Windows-basedpractice systems. They will operate over local computer networks andcommunicate with the others in the NHS and beyond through connectionto the strategic telecommunications network for Wales. They will also haveemail and web browsing services available to them. This investment willbe underpinned by an extensive education and training programme toensure that a high level of patient, clinician and broader NHS benefits arerealised.

5.46 The Clinical Records Structure and Contents Programme hasmade £80k available to a small number of projects to explore the issuesinvolved in moving from unstructured paper-based systems to structured,standards-based, electronic clinical systems.

5.47 Equipment: the entire telecommunications infrastructure is beingupgraded to a high capacity managed service provided by British Telecom.Over time, all organisations will have connections to this network. InGeneral Medical Practices, the Foundation Programme will ensure that allmembers of the team do have access to high-specification, networkedworkstations.

5.48 Patient involvement: SCIPiCT (Sharing Clinical Information in aPrimary Care Team) is a key demonstrator project. Its vision is to promotea patient focus, based on one multi-professional electronic clinical recordmaintained in partnership with the patient, who is thereby informed andinvolved in their own care planning. The Patient Liaison group hasdeveloped an open working relationship with members of the primary careteam and clear requirements for information have been identified. Thelearning from this work will be widely disseminated across Wales andbeyond.

5.49 Information for primary and secondary purposes: In primary careI3PC (Improving Information and IM&T in Primary Care) is providingfacilitators and analysis services to enable GP practice members to improvethe quality of the data they capture in practice systems. The GP MorbidityDatabase Review project is exploring how data from operational practicesystems, can be extracted, aggregated and used to inform patient care,practice development, service planning, health needs analysis andepidemiological studies. Really Useful Read (a structured approach toRead coding) which started in Iechyd Morgannwg Health Authority isbeing tested and extended and should be made available across PrimaryMedical Care. This will have benefits for both the breadth of datacollection and the depth required to support National Service Frameworks.In secondary care, the Information Quality programme is supportingdata accreditation and health record accreditation programmes, as well as

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work to identify areas for improvement in current data collection andanalysis processes.

5.50 Education: The Developing Information Systems for Clinicians -Education and Training Group (DISCET) has already identified thelearning needs of clinicians and endorsed the principles laid out in’Learning to Manage Health Information’. They will be working withthe wider education and training programme to develop a corporateapproach to meeting these needs and those required by professionalstandards. This programme will engage with NHS bodies, Academicinstitutions and professional bodies. It aims to give all health careprofessionals, at whatever stage of their career, the required skills. Inaddition the group will be working with Information systems developmentprojects to ensure education and training needs are fully considered andaddressed.

5.51 Educational Development in Information & CommunicationsTechnology – the wider education and training programme, will beaddressing the ICT needs of other staff groups. It will also includecontinuing professional development of ICT staff themselves and thetraining required to support the flexible working required of informationprofessionals.

5.52 It is important to stress that while basic computer skills are importantin allowing access to information, EDICT is not exclusively, nor even largelyconcerned with these basic skills. It will be primarily concerned with useand management of health information to deliver high quality care andservices.

Future Plans

5.53 In December 2001, the National IM&T Development Plan will bepublished. The Plan will address the roles, responsibilities andorganisational change required to request, produce, analyse and useinformation to underpin all aspects of healthcare. It will describe acohesive migration path towards the vision outlined in Annex 3. It willinclude targets in relation to implementation of standards, culture change,education and training, as well as infrastructure development. As outlinedin Improving Health in Wales key development areas will include

• electronic patient records: as clinical networks develop, the needto transfer patient information becomes paramount. In order forthis to be achieved, common standards and systems compatibilitymust be developed;

• links between primary and secondary care: investment in GP[practice] connectivity will provide a foundation for developinglinks between primary and secondary care supporting a range ofelectronic health business. Results reporting and booking systems

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will be early candidates;• clinical information systems: with the advent of clinical

governance, clinical information systems will be central to theperformance of activity within NHS Wales. Administrative andother data should flow from clinical systems and investment shouldallow the quality of clinical services to be appropriately measured;

• electronic access to information: health professionals must haveaccess to a networked electronic workstation at their point ofpractice if the benefits of information and communicationstechnologies are to be realised. They must be adequately trainedin the use of the technology and the management of theinformation which they can record and/or access through theirworkstation;

• performance management: if performance management is tooperate effectively within NHS Wales, then the availability of goodquality comparative information is critical. Existing informationflows will need revision and extension;

• National Service Frameworks: as each NHS is introduced,information will be required locally and nationally to ensure theservice is developing as planned. Implementation plans mustexplicitly take account of this requirement

• more effective procurement: information systems procurement isexpensive and complex. It is increasingly an area for PPP. Everyopportunity should be taken for organisations to work together, toreduce procurement overheads, and to benefit from theadvantages of greater standardisation of information systems."

Affordability

5.54 Investment in information systems and services is essential to supportbetter quality, safer and more clinically effective health care, i.e. to ‘deliver’clinical governance. Improving Health in Wales identifies the need toincrease the revenue spend on IM&T to 2% within five years. The NationalIM&T Developmnt Plan will include progress towards this target as a keyperformance indicator.

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CPD and Lifelong Learning

5.55 The National Assembly and health organisations will improve accessto IT systems and clinical information for all appropriate staff. Progress willbe reviewed annually by the National Assembly. Education on core topicswill be provided each year by every Trust for all appropriate staff. Annualreports of compliance will be provided to the Trust Board and the NationalAssembly.

5.56 By April 2003, all health organisations will have in place careerdevelopment and succession planning programmes includingsecondment, shadowing and networking opportunities.

5.57 Clinical supervision will be offered to all qualified nurses and healthvisitors and an annual report will be provided to Trust Boards. The TrustBoards will also receive an annual report of midwifery supervision andstandards.

5.58 All PMS pilots must seek to improve access, quality and flexibility ofservices to high clinical standards. There will also be opportunities to pilotnew arrangements for delivering services that would give differentprofessionals greater scope and opportunities.

Consultation Questions

Q1. It will take some time for robust clinical informationsystems to be procured, implemented and exploited, doyou feel more help is needed in the meantime on how toaddress the information requirements of clinicalgovernance?

Q2. Do colleagues feel they have sufficient knowledge,experience and expertise to specify robust clinicalinformation systems?

Q3. Do colleagues feel they are aware of all relevant healthinformatics developments (e.g. SNOMED Clinical Terms,Headings for Communicating Clinical Information,‘Learning to Manage Health Information’)?

Q4. Given the activities that are currently in place, havecolleagues any suggestions on other work required todevelop information support for clinical governance?

Q5. What are your views on involving clinicians in theproduction ofthe National IM&T Development Plan? If so,what mechanisms do you think would be most effective?

Q6. Would you like to get involved in the production of theNIDP: if so how?

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5.59 The National Assembly funds a range of initiatives aimed at careerprogression for support staff who, in providing a valuable service to GPs,nurses, therapists and many others, are vital to the success of healthorganisations in Wales. The Healthcare Support Worker Initiative allowsNursing Assistants to access pre-registration nursing courses by providingfinancial support to employers during their training.

5.60 As support workers must be able to perform a more fulfilling range ofduties to enable them to develop to their full potential - and in turn releaseprofessional staff to help meet the health service targets in Wales - similarprovision will have been made by health organisations for support staff inother areas of work by December 2003.

5.61 Nurse, midwife and health visitor consultant posts provide a newcareer opportunity that will help retain experienced and expertpractitioners in clinical practice. It is intended that 50% of consultants’time will be devoted to providing direct care to patients, clients orcommunities. The posts will strengthen leadership within the professionsand improve services and the quality of care. In contributing to theachievement of Health Improvement Programmes, in which the principlesof social inclusion and equality of opportunity are fundamental, postholders will be involved in complex cross-boundary and inter-agencycollaboration.

5.62 By April 2004, health organisations in Wales will have introducedindividual training accounts for all support staff.

5.63 In order to provide similar opportunities to PAMs, therapy consultantswill be introduced during 2003 and throughout the other appropriateprofessions in the following year.

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Chapter 6: Summary of ConsultationQuestions

The consultation questions from the Chapters 4 & 5 are summarised belowfor ease of reference. We welcome your comments and responses to theconsultation questions posed. Please send your replies to NHS QualityDivision, Clinical Quality Improvement Branch, National Assembly forWales, Cathays Park Cardiff by Friday 4 January 2002.

1. Measuring Clinical Governance Performance

Q1. Does the suggested approach meet the needs of your organisation or can you suggest other ways of measuring performance that might be more useful?

Q.2. 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?

2. CGSDU

Q3. Does the proposed work programme meet the needs of your organisation?

Q4. Is there anything else you would like the Unit to cover?

Q5. How would you like the Unit to link with your organisation?

3. Adverse Clinical Incidents

Q6. What do you think about our planned approach? Do you considerthere is a different way, which would more effectively encourage andfacilitate NHS participation in the development and implementationwork?

Q7. Are there any other key tasks, which would be essential to initial implementation?

Q8. Do you have any general views or comments about the Agency’s work and or our proposed approach?

4. Public Involvement Strategy

Q9. How can we ensure that effective and lasting patient and publicinvolvement is put centre stage by NHS organisations?

5. Professional Regulation

Q10. What kind of Welsh regional presence do we need to establish to channel concerns about the performance of individual doctors?

Q11. What arrangements do we need to establish to reach agreement with the NCAA on collaborative working?

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6. Use of Information

Q12. It will take some time for robust clinical information systems tobeprocured, implemented and exploited, do you feel more help isneeded in the meantime on how to address the informationrequirements of clinical governance?

Q13. Do colleagues feel they have sufficient knowledge, experience andexpertise to specify robust clinical information systems?

Q14. Do colleagues feel they are aware of all relevant health informaticsdevelopments (e.g. SNOMED Clinical Terms, Headings forCommunicating Clinical Information, ‘Learning to Manage HealthInformation’)?

Q15. Given the activities that are currently in place, have colleagues anysuggestions on other work required to develop informationsupport for clinical governance?

Q16. What are your views on involving clinicians in the production ofthe National IM&T Development Plan (NIDP)? If so, whatmechanisms do you think would be most effective?

Q17. Would you like to get involved in the production of the NIDP: if sohow?

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Annex 1

Clinical Governance – The First 12 Months KeyMessages

This annex only includes the key messages of the all Wales auditundertaken by Dr Bernadette Fuge and Jane Farleigh between October 200and March 2001. The full report, Clinical Governance – the First 12Months, includes information about issues raised by the each organisationvisited, and more importantly, includes examples of innovative practice.

A) Trusts

Summary

Whilst many Trusts were making good progress and had set up appropriatestructures, a strategic approach which would ensure the integration ofclinical governance throughout the organisation and across partneragencies had not been adopted. There was lack of integration of thevarious components that would ensure clinical governance was deliveringcontinuous quality improvement. Progress on monitoring and evaluationwas the most disappointing. However, the audit also identified manyexamples of innovative practice for example one Trust had employed aPatient Experience Facilitator whose remit was to ensure the patient’sperspective was considered at different levels of engagement. The keyfindings were as follows;

Structures

Some Trusts had set up quite complex clinical governance sub-groupswhere the links were difficult to maintain across other Trust sub-groups, forexample, risk management or audit might be separate sub-groups outsidethe clinical governance sub-group as they cover non-clinical elements aswell as clinical. One Trust had given this a lot of thought and hadestablished a governance sub-group but for others it was still anoutstanding issue.

Board level engagement and understanding – some Trusts told us they didnot think the whole board were engaged with clinical governance.

Evidence Based Decision Making

Evidence based practice was recognised as an important aspect of clinicalgovernance by all Trusts and there was evidence in some trusts of goodprogress with the systems used to implement NICE and NSFs.

Ward based access to evidence based practice was recognised as a need forsome Trusts and they were trying to implement ward based IT as part oftheir IM&T strategy.

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Integrated Planning

12 out of 14 Trusts recognised that integrated planning for quality (withlinks to HIPs and NSFs) was an issue for them. 2 Trusts had made noreference at all. Only 6 Trusts provided evidence of good progress beingmade.

CPD

Whilst all Trusts referred to CPD in only 3 cases reference was made to aCPD strategy. In 8 Trusts reference was made to CPD plans. All Trustsreferred to uni-professional CPD with medical and nursing CPD being thecommonest. One Trust referred to a shortfall in CPD for Allied HealthProfessions and in only 5 cases was reference made to multi-professionalCPD.

There was a need for a more strategic approach to CPD that includesmultidisciplinary and integrated CPD and a need to ensure that CPD meetsthe needs of the organisation as well as the individual.

Clinical Audit Activity

Most Trusts planned clinical audit activity, although only three had an auditstrategy and almost all had a clinical audit committee. Half said theyproduced an annual audit report. Many referred to multi-professionalaudit. 3 Trusts referred to having more than one audit committee was apre-merger situation that still prevailed. One Trust commented that auditactivity was medically dominated. There was not a lot written about‘closing the loop’ i.e. implementing change as a result of audit activity andre-auditing, although during the visits some Trusts referred to how they didthis.

There was clearly a need for a more strategic approach to audit includingmore multi-disciplinary clinical audit and evidence of ‘closing the loop’.

Issues and Shortfalls

Clinical risk management was referred to by 8 out of 14 Trusts, IM&T by 7and time for clinical governance by 4. Issues affecting 3 Trusts (not thesame ones) were public involvement, patient experience, NSF/NICE/HIPs,quantity versus quality, adverse incidents and financial resources.

Public Involvement

Only 4 Trusts had a clear public involvement strategy but 6 Trusts hadplans of how to engage with the public. All trusts reported some progressin this and recognised the need to continue doing so. Whilst someinnovative schemes had been identified, these were not always part of astrategic approach but often due to historical practice.

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Learning the Lessons

11 Trusts had development plans in place to ensure lessons can be learntfrom mistakes. 9 made specific reference to learning lessons but 5 madeno reference at all. 13 had adverse incidents systems and 9 Trusts referredto complaints procedures.

There was insufficient evidence of organisations linking up the differentcomponents and ensuring the lessons were being learnt.

B) LHGs

Summary

Considering the formative stage of LHGs the commitment was clear andthat progress was demonstrated. Almost all LHGs provided examples ofinnovative practice, for example, one LHG had adapted the British DentalAssociation Clinical Governance Guidance (with permission) as a supportdocument for all professions in the LHG. However, a problem for manyLHGs was being able to engage with all contractor professions whilstothers had managed by a variety of means. Another issue was for LHGs tofully understand what progress had been made because of little or nomonitoring and evaluation. Below is a summary of the findings from theaudit.

Structures

20 of the 22 LHGs had clinical governance facilitators in post but some haddual responsibilities such as clinical governance and chronic diseasemanagement.

Evidence Based Decision Making

Only 1 LHG made no reference to this issue nor did the LHG refer to NICEor NSFs. 4 had referred to current progress with evidence-based decision-making and it was in the development plans of 17 LHGs. 9 LHGs providedinformation on progress of dealing with NSFs and a further 9 had plans todo so. 8 LHGs had dealt with NICE guidance and 3 had future plans to doso.

Integrated Planning

The need to integrate planning with links to HIPs NICE and NSFs wasrecognised by all LHGs.7 were at the planning stage, 2 had made someprogress, 13 had made good progress and 13 had made considerableprogress. Some of the examples provided were excellent and many werevery good.

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CPD

Whilst progress on CPD was generally quite good for General MedicalPractitioners it was not so for the other contractor professions. In 4 casesthe LHG had made little or no reference to CPD at all. Only 7 LHGsreferred to multi-professional CPD.

The inclusion of other contractor professions and multi-disciplinaryworking needs further development.

Clinical Audit Activity

20 LHGs reported on clinical audit activity but again this was mostly forgeneral medical practices only. Some were part of HA wide audits or LHGwide audits whilst others seemed to be practice based only. 4 LHGs haddeveloped a strategic approach that included all contractor professionsand 2 of these had multi-professional (different contractor professions) aswell as multi-disciplinary (different professions within a contractorprofession).

There is a need to include all contractor professions and multi-disciplinaryaudit.

Issues and Shortfalls

15 LHGs quoted IM&T, 13 quoted clinical audit, and clinical riskmanagement and 12 quoted CPD and professional development as issues.9 LHGs quoted public involvement, 8 NICE/NSF/HIPs and 7 quotedadverse incidents. 7 LHGs also quoted performance and prescribing asissues.

Public Involvement

2 LHGs made no reference to public involvement at all but 14 had madeprogress or had plans in place and 6 had made good progress by adoptinga strategic approach.

Learning the Lessons

11 LHGs had embarked on a clinical and non-clinical risk managementtraining programme, 9 had complaints procedures and 3 had adverseevents systems. Whilst there were some mechanisms most LHGs did notreport on how they were learning lessons from mistakes and this is an areathat requires further development.

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Annex 2

Commission for Health Improvement ClinicalGovernance Review

A CHI review looks at the effectiveness of the NHS organisation's clinicalgovernance arrangements, that is, it will assess the management, provisionand quality of service provided by the organisation. CHI will identify bestpractice which it will share with the rest of the NHS and areas forimprovement. A review has three stages: preparation, visit and report andtakes about 24 weeks.

To ensure that the process runs as smoothly as possible, the Trust is askedto nominate a member of staff to coordinate the review process on theirbehalf and act as a focal point. This will be the Trust Co-ordinator.

Requests for information

CHI will request various types of data and reports to prepare for its site visitin week 16. This information is analysed and assists in identifying specificareas the review team will look at during its visit. This information isessential to the success of the review and requires the NHS organisation todo some preparatory work.

Requests for local opinion

CHI will actively seek the opinions of patients, staff, relatives of patients andlocal organisations interested in the NHS organisation being reviewed. Thisinformation will help draw together themes of public opinion and will beconsidered as part of the review.

Early in the review process, the trust coordinator may wish to start collatinga list of stakeholder names, addresses and contact numbers and possiblenon-hospital based, accessible stakeholder meeting venues.

Open lines of communication

CHI will be as open and accessible as possible to ensure a successful reviewprocess. It will meet with the management teams at the organisation beingreviewed to explain the review process and answer questions.

After the visit, the review team drafts a report of their findings. The reportis discussed with the NHS organisation being reviewed which commentson its factual accuracy.

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Weeks 1 - 15: Pre visit preparationWeek 16: Site visitWeeks 17 - 24: Production of report

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The final summary and report is published and is available to the publicand on CHI's web site. It contains CHI's key findings and identifies bestpractice as well as areas for improvement.

Follow up

In the final stages of the review process, the NHS organisation will beginto work on its action plan. After the publication of the report, CHI will assistthe organisation to set objectives to take forward improvements needed.

The Role of the National Assembly

The National Assembly for Wales takes a vital role in approving the actionplan because there is a statutory requirement for the National Assembly forWales to sign it off in consultation with CHI. The National Assembly forWales also has a responsibility to monitor progress with implementationthereafter. After the objective setting day, which National Assembly forWales officials are happy to attend and be a part of, the draft plan shouldbe sent to the National Assembly for Wales who will comment. Thecomments are aimed at ensuring the organisation is meeting the aims ofthe report. The final draft should be sent to the National Assembly forWales who will then consult with CHI. The National Assembly for Wales willask the organisation for progress through the performance monitoringarrangements. The new National Assembly NHSD Clinical GovernanceSupport and Development Unit will contact organisations to provide themwith support following a review by CHI. Furthermore, the NationalAssembly NHSD Patch Managers will also support the process bydiscussing progress with the implementation of actions resulting from thereview. It is also likely that organisations will be asked for progress reportsas part of the new performance accountability reviews.

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Annex 3

What clinicians need from IM&T

Clinicians require two main sources of information to be available to them.The first is evidence-based, reference, research and guidelines informationand the second is patient-specific information. The evidence-base willinfluence the actual care given; the clinical record will capture the actualcare given. Analysis of the record will enable review and change, which inturn will add to the evidence base.

In relation to the first of these, clinicians suffer from a high level ofinformation overload. They require good quality information to bepresented to them when and where it is needed. Organisations such asNICE contribute to this in their systematic reviews. Clinicians also needaccess to the latest opinion wherever they are. This means that theinformation should be available in electronic form and should be accessibleto the clinician. Further work is required on integrating access toinformation within operational systems.

In relation to the second, currently clinicians largely have to rely on paperrecords. These records fail to provide adequate support for clinicians inindividual patient management as they:

• are not Available - anywhere, anytime • do not contain Comprehensive data on problems, symptoms,

observations, diagnoses, actions and results in an easilyretrievable form

• are not Used by all professionals; to create a sequential storywithout gaps

To put this right requires IM&T developments to address two key aspectsof the problem, namely:

• Automating the processes which surround the record, and• Constructing a structured core for data collection in a form that

can be stored, communicated and analysed

The various components of both the processes and the structured core aredescribed below.

Automated processes

Current processes require repeated entry of data on a range of differentpaper forms, often involving a large number of individuals usingunconnected information systems. As a result, clinicians are not providedwith the information they need when and where it is required. Examplesof clinicians’ requirements are as follows:

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• scheduling - on line booking when patients are seen, or bypatients themselves

• test ordering - on line where patients are seen• results reporting - on line where patients are seen• prescribing - electronically, with decision support• communications - summaries, letters, referrals, etc• reminders & alerts - to reduce errors• access to knowledge - at the point of care• telecommunication - with colleagues and patients

Structured core

It is not sufficient to define a clinician’s IM&T needs in terms of theprocesses that must be automated. There is also a requirement to link suchautomated processes, through the information they generate, to astructured core. The components and justification for such a core is set outbelow:

• coded clinical data capture - so that data can be validated,aggregated and analysed

• free text - where structured data capture is not enough• longitudinal individual records - to build up a complete picture

over time• multi-item measures - to capture quality of life, severity scores

and disability measures, and monitor these over time; to assesstreatment and procedure risk

• structured clinical messaging - to simplify communication• simple data retrieval and analysis - for secondary purposes

Once systems are in place which support both these sets of requirements,then information will be available for a range of secondary purposes. Fromthe clinical governance perspective, these will include the ability to:

• monitor the activity if all professionals• monitor performance of professionals and organisations• identify areas of risk• provide information to patients in support of decision making• support audit• facilitate research• provide an evidence base for service planning• inform consultant and other staff appraisal, including the

identification of educational needs• support policy decisions

Standards

Although data captured in these operational ‘clinical information systems’will be used for these secondary purposes, the primary purpose will remainto support individual patient management. This will mean the ability tobuild up a longitudinal picture of an individual patient’s health and

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healthcare which may be accessed, subject to appropriate patient consent,by a range of different clinicians and others at different times and indifferent locations

Given this objective, it is essential to ensure that the data and informationcontained within the record have a single, shared and understoodmeaning from the point of capture to the point of use. This will requiresystems to conform to a range of robust standards currently beingdeveloped for the Service. These include:

• Clinical language: SNOMED Clinical Context of Care• Headings for Communicating Clinical Information • Definition of Episodes

Close working between policy makers, clinicians, informaticians, ITspecialists and suppliers will be required to translate these standards intocomponents of operational clinical information systems.

Education and Training

However, it is not sufficient merely to provide clinicians with such systems,clinicians require considerable education and training support in a range ofareas in order to be able to manage healthcare information to support theirclinical activities. ‘Learning to Manage Health Information’ identifies - thatthe care of patients/clients is dependent upon:

• the availability, quality and accuracy of information• the ability of health care professionals to produce, access use,

and manage information about individuals• access to, and use of information management tools for Evidence

Based Care, to enhance the effectiveness of clinical practice andthe delivery of services to those in need

• effective systems for communication and good communicationskills

• ensuring safe, secure, ethical and confidential handling of dataand information

Learning expectations to meet this stated need must cover the full rangeof health informatics components from:

• authoring and reading health records• clinical language and the roles of coding and terming• team working• knowledge management• data quality and management• principles and implementation of confidentiality• knowledge of secondary uses of clinical data and information• clinical and service audit• critical reading skills for research and information• working clinical systems available to support patient care• telemedicine and telecare

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The task of ensuring that this education and training agenda is part ofcareer long learning, starting at pre-qualification level, forms the basis ofthe work of the DISC-ET (Developing Information Services for Clinicians –Education and Training) steering group. The development of their workprogramme and the objectives to be achieved in this area will be outlinedin the National IM&T Development Plan.

Confidentiality & Security

There is much existing legislation and common law governing the accessto, sharing and storage of confidential patient-identifiable information.This includes the work of Caldicott, the Data Protection Act 1998, Health& Social Care Bill 2001 and the Common Law Duty of Care inter alia.Further work is required on the various forms of, and requirements for,patient consent. As such work develops, it will be essential for clinicalinformation systems to be able to support patient wishes on sharing oftheir information. This must include issues concerned with limiting accessto what might be deemed irrelevant information for the purposes of thecurrent episode. It should also address the need for better sharing ofrelevant information with other clinicians and those involved in supportingpatient care. It will include the need for a range of appropriate views onindividual patient records by members of the clinical team and others.Although these requirements are equally applicable to existing papersystems, much tighter control over the sharing of information will bepossible with electronic systems.

The word "secure" is often used as an alternative to "confidential".However, whilst ensuring data is kept confidential, security addresses theneed for that information to remain unchanged, and uncorrupted, so thatquality is maintained. Data must be available in a timely manner, and theinformation source must be guaranteed and trusted. IT security, andencryption only cover part of the problem, and wider issues such asmanual processes, and awareness, should be included in any securitypolicy.

Patients Needs & Expectations

It is commonly accepted that patients are becoming more aware of theirown role and responsibility in relation to the diagnosis and treatment oftheir health problems. This will, of course, vary significantly across thepopulation. In order to support this, patients should be given access toinformation about their problems, the treatments for those problems, theservices available to them and the management of their healthcaredelivery. Similarly, information collected by patients about their healthcare problems and needs should be available to clinicians.

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Annex 4

Centre for Health Leadership Wales -Development of Clinical Governance Capacity andCapability

The Centre for Health Leadership Wales (CHLW) is responsible forfacilitating the development of

• Health leadership, in all disciplines, and at every level in the healthservice

• Health organisations in primary, secondary and tertiary care, andacross the NHS/ Local Authority interface

A significant part of this role is involved with building clinical governancecapacity and capability. Set out below are examples of current and futureservices being provided by the Centre.

Boards and Executive Directors

Many good examples exist of clinical governance development work inLHGs and Trusts. This activity has developed an understanding amongstclinicians and managers of the concepts and operational practicalities ofclinical governance. This strategy seeks to bring together the best of thisgood practice and to integrate it into a strategic understanding andapproach across NHS Wales.

• Boards and their executive teams will need to be thoroughlybriefed on the strategic approach being presented in this strategyand be given opportunities to explore their responsibilities in thisregard. CHLW is experienced at facilitating such developmentactivity with Boards and Executive Teams, and also has networks ofexpertise that can be utilised for such development. It is importantthat Boards and executive teams create opportunity, not only todevelop strategic responsibility for clinical governance, but also todocument their commitments in their own organisational clinicalgovernance strategy, and to pro-actively drive progressthroughout the whole organisation

• It will be important that the new LHGs give early consideration tothe implications of this strategy, and CHLW are able to providesupport and organisation for such board-level learning

Facilitation

• Development of Change Agents – there are a number of LearningNetworks being launched that are supporting clinicians andmanagers who have key roles within this strategy. The aim of theselearning networks is to provide training in key skills, to supportchange agents in sharing expertise and learning, and to speed thespread of innovation and quality improvements. CHLW is able to

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support groups of Clinical Governance Leads at all-Wales or locallevel in developing their own responses to this strategy

• Development of care pathways is one of the strategic actionshighlighted in this strategy. CHLW is able to support ‘wholesystem’ teams in pathway redesign and the development ofintegrated patient records

• In primary care, there is a huge need for practice level support,both for the development of practice-based clinical governanceleads and for the development of clinical governance systemswithin the practice teams. LHGs are using the CHLW to supportthem in developing their practices in a range of ways, such aspractice and professional development planning (PPDP),facilitation of professional forums for practice-based CGLs,collaborative improvement projects addressing care pathwayredesign, facilitating health needs assessment based oncommunity oriented primary care models, and so on

• A specific Learning Network is being created for those who are, orwish to be, involved in this practice-based development work

Organisational Reviews

• CHLW provides a service to Trusts and general practices toestablish their ‘fitness for purpose’. This entails using quantitativeand qualitative measures in preparing a report for the topmanagement or the Partnership, to help them view theirorganisation in the light of current and future challenges, includingclinical governance and performance management. Numbers oforganisations have found such a review an ideal mechanism toprepare them for ‘external’ review by the Commission for HealthImprovement.

Integrated Development Framework

• CHLW is creating a system to identify, nurture and utilise leadershippotential across all disciplines in NHS Wales. This will provideparticipants with career development support and access tosecondments and other learning opportunities. It is clear thatthose involved in clinical governance leadership and change agentroles are likely to be ideal candidates for inclusion in the IntegratedDevelopment Framework. Such involvement will give them accessto development resources that will support them in clinicalgovernance, innovation, leadership and other changetechnologies.

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Research and Development

• The National Assembly has commissioned CHLW to complete areview of continuing professional development amongst thoseclinicians who are directly represented on LHGs (doctors, dentists,pharmacists, optometrists, district nurses, health visitors, practicenurses, midwives and community psychiatric nurses). This reviewis looking at the current mechanisms and funding of CPD for thevarious disciplines and will make recommendations on how CPDcan further support the clinical governance agenda in primary carein Wales.

• The General Practice Maturity Matrix is a tool being developed byUWCM and CAPRICORN for the use by primary health care teamsto look at their clinical governance systems. An occupationalpsychologist from CHLW has been awarded research funding fromthe DoH to work with UWCM on the development and validationof this tool.

Whole Systems Thinking and Modelling

• CHLW has initiated the use of tools for mapping and modellingwhole systems and pathways of care. The dynamic nature ofcomplex health systems lends itself to such approaches. Thissystem modelling approach is ideal as an ‘executive learning tool’,for use with executive teams who wish to gain systemic insight intothe behaviour of a particular system of interest.

CPD Website

• CHLW is also developing a web site for NHS managers which hasbeen funded by the National Assembly, which aims to develop elearning and to provide access to CPD support materials, includingmaterials and workshops on accessing and understanding the useof evidence.

Selection and Development

• CHLW provides a specialist service, using occupational psychologyexpertise, for the running of selection and development centres forstaff in NHS Wales. If you are selecting key staff in the field ofclinical governance, or wish to look at the development needs ofindividuals or groups involved with clinical governance, thenCHLW is able to design and deliver such a service.

The Centre for Health Leadership Wales is a service-driven organisation,and is always willing to work with colleagues who have responsibility forclinical governance, to support them in addressing personal andorganisational development needs.

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LHG Multi-professional CPD Project

A project is being developed in partnership with the University of WalesCollege of Medicine and the National Assembly for Wales and is beingmanaged by CHL Wales.

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Health Care Challenges – ClinicalGovernance Sub-Group

Membership:

Mr Ian Lane (Chair) Medical Director, Cardiff & Vale NHS Trust

Ms Fiona Peel (Chair of the Health Care Challenges Group)Chairman, Gwent Health Authority

Dr Kurt Burkhardt Clinical Governance Lead, Rhondda Cynon Taff LHG

Mrs Wendy Chatham Manager, Clinical Governance Support and Development Unit Wales

Mrs Carol Condren Trust Clinical Governance Facilitator, Conwy & Denbighshire NHS Trust

Mr Ben Cope OptometristMrs Marion Evans General Manager, Monmouth LHGMs Jane Farleigh Head of Clinical Quality Improvement

Branch, National Assembly for WalesDr Bernadette Fuge Medical Director & Head of Quality

Division, National Assembly for WalesMrs Jane Jeffs Chief Officer, Association of Welsh CHCsMr Chris Martin Pharmacist, St David’s PharmacyMiss Charlette Middlemiss Trust Co-ordinator, Bro Morgannwg

NHS TrustDr Stephen Monaghan Clinical Governance Lead, Bro Taf Health

AuthorityMrs Hilary Pepler Chief Executive, North East Wales NHS

TrustDr David Prichard Medical Director, North West Wales TrustDr Jenny Wainwright GP & CME Tutor, University Hospital of

WalesMr Chris Willswood Dentist, SwanseaMrs Gill Graham National Council Voluntary Action Wales

Secretariat:

Vanessa Davies Clinical Quality Improvement Branch, National Assembly for Wales

Freda Lewis Clinical Quality Improvement Branch, National Assembly Wales

Karen Martin Project manager to Health Care ChallengeTask and Finish Group

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Bibliography:

A Guide to Developing Effective User Involvement Strategies in the NHS.Kelson M. College of Health 1997.A Review of Continuing Professional Development in General Practice.Calman K, Chief Medical Officer DOH London 1998.An Organisation with a Memory. Report of an expert group on learningfrom adverse events in the NHS chaired by the Chief Medical Officer.Stationery Office 2000.Better Information – Better Health. Information Management andTechnology for Health Care and Health Improvements in Wales. AStrategic Framework 1998 to 2005. Welsh Office 1998.Barriers and Strategies. Jenny Firth-Cozens. Pub: Northern and YorkshireRegion.Citizens jury: a forum for health debate. Coote A. BMJ Update 18-3-99 485(editorial).Clinical Audit Action Pack. National Centre for Clinical Audit (1997),Version 2. London: NCCA.Clinical Audit in the NHS. Using Clinical Audit in the NHS: A PositionStatement. NHS Executive (1996), Leeds.Clinical Governance a Practical Guide for Primary Care Teams. Roland M,Baker R. National Primary Care Research and Development Centre,University of Manchester. Clinical Governance Research & DevelopmentUnit, University of Leicester.Continuing Professional Development in Primary Care. Wakley G,Chambers R, Field S. Radcliffe Medical Press 2000.Culture, Leadership, and Power: the Key to Changing Attitudes andBehaviours in Trusts. Clinician in Management 1999 8:27-32.Effective Health Care. Getting Evidence into Practice. Feb 1999 Vol 5(1).University of York, NHS Centre for Reviews and Dissemination.Evidence-based Medicine. Sackett D, Richardson W, Rosenberg W, HaynesB. Churchill Livingstone 1997Evidence-based Healthcare. Muir Gray JA. Churchill Livingstone 1997Evidence-based Healthcare. A Practical Guide for Therapists. Butterworth-Heineman. London 1998Experience, Evidence and Everyday Practice. Dunning M, Abi-Aad G,Gilbert D, Hutton H and Brown C 1998. Kings Fund London.Getting Evidence into Practice. Effective Health Care Bulletin No. 5. RoyalSociety of Medical Press 1999.Getting Research Findings into Practice. Haines A and Donald A (eds)(1998). BMJ Books London."Guidance to Clinical Governance Systems for Primary Care Practices" inRhondda Cynon Taff Local Health Group. Winter 2000 Edition. RhonddaCynon Taff Local Health Group.Healthcare Quality Quest (1997), Getting Audit Right to Benefit Patients.Romsey: Health Quality Quest.Health Informatics Competency Profiles for the National Health ServiceNHS Information Authority 2000How to Read a Paper. Trisha Greenhalgh. BMJ Publishing Group 1997Implementing Change with Clinical Audit . Baker R, Hearnshaw H,Robertson N (Eds). John Wiley & Sons Ltd Chester 1998.

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Involving Patients and the Public. Chambers R. Radcliffe Medical PressOxford 1999In Partnership with Patients. National Consumer Council. NationalConsumer Council London 1995.Implementing Evidence-Based Changes in Healthcare. Smith L,McClenahan J eds Evans D Haines A. 2000 Radcliffe Oxon.Improving Health in Wales. A Plan for the NHS with its Partners. NationalAssembly for Wales. January 2001.Learning to Manage Information. NHS Executive 1999Clinical Governance: Making it Happen. Hobbs S in Lugon M Secker-Walker J 1999 RSM Press London. Making Clinical Governance Work for You. Chambers R , Wakely G.Radcliffe Medical Press 2000Managing Teams : Why they Succeed or Fail. Belbin, M (1981).HeinemannManaging Change. Burnes, B (1992). PitmanManaging Change in Organisations. Carnall, C. (1995). Prentice-HallManaging Organisations. Wilson D and Rosenfeld RH (1996).National Centre for Clinical Audit (1997), Clinical Audit Action Pack.Version 2. London: NCCA.Organisational Transitions: Managing Complex Change. Beckhard, R &Harris, RT (1987). Addison-WesleyOrganisation Development : Behavioural Science Interventions forOrganisations Improvement. French, W & Bell, JR (1990). Prentice-HallPutting Patients First. Welsh Office 1998.Quality Care and Clinical Excellence. Welsh Office. July 1998Quality Systems for Dental Practice. BDA. April 2000 first editionReference Manual for Public Involvement 2nd edition. Barker J, Bullen M,De Ville J. Bromley Health 1999.Risk Management Problems in General Practice. Medication Errors MedicalDefence Union 1996.Self Assessment Manual and Standards - Clinical Standards in GeneralDental Practice. Advisory Board in General Dental Practice. 1991The Essence of Audit. The National Working Group on Clinical Audit inCommunity Dental Practice. 1992The Clinical Audit Handbook Improving the Quality of Healthcare. MorrellC, Harvey G. RCN (Bailliere Tindall) 1999The Good CPD Guide. Grant J, Chambers E, Jackson G. Reed HealthcareSutton 1999The Patients Perspective on Clinical Governance. Julia Neuberger. BritishJournal of Clinical Governance Vol4 No2 1999. MCB University PressEnglandThe Quality Gurus - Managing in the 90s. DTI URN 95/657.Understanding Systems Failures. Bignall V, Fortune J. Manchester UniversityPress 1984Ward Leadership Project: a journey to patient-centred leadership. RCNLondon 1997(WHC(99)54). Clinical Governance: Quality Care and Clinical Excellence.Welsh Office, 1999. WHC(2000) 57. Corporate Governance in the NHS in Wales: ControlsAssurance Statements for 1999-2000 and the introduction of Welsh RiskManagement Standards.

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Websites:

Bandolierhttp://www.jr2.ox.ac.uk/bandolier/Best Evidence 4 databasehttp://www.bmjpg.com/template.cfm?name=specjou_be#best_evidenceCochrane Library. via the National electronic Library for Health:http://www.nhs.uk/nelh/ orhttp://www.update-software.com/cochrane/cochrane-frame.htmlCommission for Health Improvementhttp://www.chi.nhs.uk/Database of Abstracts of Reviews of Effectiveness (DARE)http://www.york.ac.uk/inst/crd/Effective Health Care Bulletinshttp://www.york.ac.uk/inst/crd/ehcb.htm.Health of Wales Information System (HOWIS)http://howis.wales.nhs.ukNational Assembly for Waleshttp://www.assembly.wales.gov.ukNational Electronic Library for Health (NeLH)http://www.nhs.uk/nelh/National Institute for Clinical Excellencehttp://www.nice.org.ukNetting the Evidencehttp://www.shef.ac.uk/~scharr/ir/nettingNHS Centre for Reviews and Disseminationhttp://www.york.ac.uk/inst/crdTRIP databasehttp://www.tripdatabase.com/WISDOM Centre (this site has an extensive bibliography listing variousjournal articles on clinical governance)http://www.shef.ac.uk/uni/projects/wrp/cgbiblio

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