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REPORT BY THE COMPTROLLER AND AUDITOR GENERALHC 1055 Session 2002-2003: 17 September 2003

Achieving Improvements through Clinical GovernanceA Progress Report on Implementation by NHS Trusts

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REPORT BY THE COMPTROLLER AND AUDITOR GENERALHC 1055 Session 2002-2003: 17 September 2003

Achieving Improvements through Clinical Governance:A Progress Report on Implementation by NHS Trusts

This report has been prepared under Section 6 of theNational Audit Act 1983 for presentation to the Houseof Commons in accordance with Section 9 of the Act.

John Bourn National Audit OfficeComptroller and Auditor General 15 September 2003

The National Audit Office study team consisted of

Karen Taylor, John Step and Guy Munro

This report can be found on the National Audit Officeweb site at www.nao.gov.uk

For further information about the National Audit Officeplease contact:

National Audit OfficePress Office157-197 Buckingham Palace RoadVictoriaLondonSW1W 9SP

Tel: 020 7798 7400

Email: [email protected]

ContentsExecutive summary 1

Part 1

Clinical governance is the centrepiece 11of the quality improvement initiative

Implementation of clinical governance has taken 13place against a background of organisational changes and increased oversight and regulation

We have previously examined aspects of clinical 16governance in England

We are undertaking a series of studies looking 16at aspects of clinical governance in England

Our methodology 16

Part 2

Progress in establishing structures 17and frameworks

Effectiveness of support provided to NHS trusts 17

Progress in putting overall structures, frameworks 17and processes in place

Responsiveness to internal and external 19evaluations of clinical governance and quality

Part 3

The contribution of the individual 21components of clinical governance

Progress in implementing the individual 21components of clinical governance

Part 4

The overall impact of clinical 31governance

Implementing clinical governance has raised the 31profile of quality as an issue for NHS trust boards

Appendices

1. Principles of clinical governance 34

2. Study methodology 35

3. The Commission for Health Improvement's 37clinical governance reviews

4. NHS performance (star) ratings: scoring system 40and indicators, 2001-02

5. Clinical governance in Northern Ireland, 41Scotland and Wales

ACHIEVING IMPROVEMENTS THROUGH CLINICAL GOVERNANCE: A PROGRESS REPORT ON IMPLEMENTATION BY NHS TRUSTS

executivesummary

ACHIEVING IMPROVEMENTS THROUGH CLINICAL GOVERNANCE:

A PROGRESS REPORT ON IMPLEMENTATION BY NHS TRUSTS

Clinical governance plays akey role in efforts to deliverimprovements in the qualityof healthcare

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1 The aim of clinical governance is to secure better quality care from the£54 billion a year spent on healthcare services and, through improvedaccountability, to give patients and the general public greater confidence inNHS services.

2 In 1997, Sir Liam Donaldson, now the Department of Health's Chief MedicalOfficer, drew attention to the fact that quality did not seem to be as high on theagenda of the NHS as financial and workload targets and that approaches toquality were very fragmented and lacked co ordination; and pointed out that themanagement view of quality was very different from the medical view. He calledfor a programme of change and proposed the concept of clinical governance.1

3 The key principles of clinical governance (Appendix 1) are: a coherentapproach to quality improvement, clear lines of accountability for clinicalquality systems and effective processes for identifying and managing risk andaddressing poor performance. It involves putting in place the information,methods and systems to ensure good quality so that problems are identifiedearly, analysed and action taken to avoid any further repetition. TheDepartment of Health (the Department) expects clinical governance tointegrate the previously rather disparate and fragmented approaches to qualityimprovement, such as clinical audit, risk management, incident reporting andcontinuing professional development into a single system and to ally it toaccountability for quality.

4 Clinical governance requires a change in the culture of NHS organisations, toone "where openness and participation are encouraged, where education andresearch are properly valued, where people learn from failures and blame is theexception rather than the rule, and where good practice and new approachesare freely shared and willingly received."2

1 Department of Health website www.doh.gov.uk/cmo/progress/clingov.2 Department of Health website.

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5 In 1997, the Government introduced a 10 year programme to improvecontinuously the overall standard of clinical care; reduce variations inoutcomes of, and access to, services; and ensure that clinical decisions arebased on the most up-to-date evidence of what is known to be effective. 3 4 5 Itintroduced new policies, programmes and structures to support acomprehensive and systematic approach towards assuring and improving thequality of clinical services. Clinical governance was designated the centrepieceof this programme.6

6 The government's strategy has three main strands:

! Establishing clear national standards through National ServiceFrameworks, and the National Institute for Clinical Excellence;

! Ensuring local delivery of those standards through clinical governance,underpinned by lifelong learning and strengthened and modernised systemsof professional self-regulation. Support is provided through: the ClinicalGovernance Support Team, now part of the NHS Modernisation Agency(provides expertise, information, advice and training to clinical andmanagement teams); the National Patient Safety Agency created toimplement a mandatory reporting system to collect and learn from data onadverse incidents, and to develop and implement solutions for improvingpatient safety; and the National Clinical Assessment Authority (provides anexpert advice and assessment service to NHS employers with concerns overthe performance of individual doctors and dentists); and

! Effective monitoring through: The Department's regional offices, untilMarch 2002 and, following the reorganisation implementing the Shiftingthe Balance of Power7 programme, through strategic health authorities; theCommission for Health Improvement, which aims to improve quality byreviewing the care provided and identifying notable practice and areaswhere care could be improved; NHS Performance Assessment (starratings); and the National Survey of Patient and User Experience which isintended to deliver annual feedback on the things that matter to patients,carers and service users.

7 Given the importance of clinical governance to the government's programme formodernisation of the NHS, we examined trusts' progress in putting the requiredstructures in place and progress in improving the quality of patient care. We tookinto account that the introduction of clinical governance has taken place againstthe background of considerable organisational change, particularly since 1997,and an increase in regulation and performance monitoring.

8 We focused this examination on secondary and tertiary care, where systemshave had time to bed in. There are important differences in the implementationof clinical governance in primary healthcare, and because of this and theimpact of major organisational changes from April 2002, including the creationof primary care trusts, we propose to examine that sector later.

3 The New NHS Modern and Dependable: Cm 3807, 1997.4 A First Class Service - Quality in the new NHS, Department of Health, 1998.5 The NHS Plan, Cm 4818 I, 2000.6 Donaldson, L. and Halligan, A. Implementing clinical governance: turning vision into reality.

BMJ, June 2001; 322 1413-1417.7 Shifting the Balance of Power is a programme of change that aims to give locally based primary care

trusts the role of running the NHS and improving health in their areas. This programme has involvedabolishing from March 2002 the Department of Health's regional offices and, from September 2002,the former health authorities; and establishing strategic health authorities.

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9 Early identification and remedying of poor performance of clinicians is anintegral part of clinical governance. Because this component is allied todisciplinary matters and sometimes suspensions, we have examined this aspect- including the contribution of the National Clinical Assessment Authority tothat work - in a separate examination of the management of suspension ofclinicians (to be published in autumn 2003). We are planning to examine in2004 issues surrounding organisational learning as applied to patient safety.

10 The main sources of evidence for this report were a census of NHS acute,mental health and ambulance trusts (working with the Manchester Centre forHealthcare Management, University of Manchester); a survey of boardmembers and senior managers at a representative sample of NHS trusts(conducted on our behalf by the Health Services Management Centre,University of Birmingham); a review of reports published by the Commissionfor Health Improvement; interviews with Department and NHS staff and withother relevant bodies; and through consulting our expert panel. Ourmethodology is set out in more detail at Appendix 2.

11 Given the challenge of changing cultures and embedding new processesthroughout trusts, this is very much a progress report on the implementation ofclinical governance. Our main findings are summarised in paragraphs 12 to 34below, and our recommendations are provided in paragraph 35.

Overall conclusions12 Our examination has confirmed that, while each component predated the

formal introduction of clinical governance, since 1999 the machinery - thestructures and organisational arrangements to make it happen - has been put inplace. Virtually all trusts have the necessary foundations, although thecomponents are not fully embedded within all clinical directorates.

13 The initiative has had many beneficial impacts. Clinical quality issues are nowmore mainstream; there is greater or more explicit accountability of bothclinicians and managers for clinical performance; and there has been a changein professional cultures towards more open, transparent and collaborative waysof working. Moreover there is evidence of improvements in practice and patientcare, though trusts lack robust means of assessing this and overall progress.

14 However, our research and the outcome of the Commission for HealthImprovement's reviews indicate that progress in implementing clinicalgovernance is patchy, varying between trusts, within trusts and between thecomponents of clinical governance. There is, not surprisingly, scope forimprovement in: the support provided to trusts; putting in place overallstructures and processes; communications between boards and clinical teams;developing a coherent approach to quality; and improving processes formanaging risk and poor performance. There is also a need to improve the waythat lessons are learnt both within and between trusts; and to put those lessonsinto practice. Overall, the key features of those organisations that have beenbetter at improving the quality of care are quality of leadership, commitment ofstaff and willingness to consider doing things differently.

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Support in implementing clinical governance15 NHS trusts have found Departmental and regional office guidance and

assistance in implementing clinical governance useful, but many wouldwelcome future support on a wide range of issues, particularly concerning theembedding of clinical governance in healthcare organisations and communitiesand networks. Following the recent organisational changes associated withShifting the Balance of Power, the Clinical Governance Support Team nowexpects to fulfil this role alongside the strategic health authorities.

16 The 43 per cent of NHS trusts that have used the Clinical Governance SupportTeam development programmes have generally found them very useful, andrate them quite highly, particularly those aimed at clinical teams. They report asignificant level of change resulting from their involvement with the Team,though it is not clear how much wider impact the development programmeshave in participating organisations. While many NHS trusts have yet to use theprogrammes, a further 45 per cent indicated that they planned to do so.

Progress in establishing structures andframeworks for clinical governance17 Clinical governance is well established and embedded in the corporate systems

of the vast majority of NHS trusts, with board level executive and non-executive leadership, trust wide committee structures, and a strong executivefunction in the form of a clinical governance department or unit.

18 Clinical governance has delivered a range of achievements, but most NHStrusts still see them in terms of structures and processes - which thoughimportant and very necessary to the objective of improving patient care, are notnecessarily sufficient in themselves to ensure that objective is achieved. Thereare doubts whether there has been sufficient progress in improving systems inclinical areas across trusts. And there is substantial scope for improvement inleadership, particularly in communications between boards and clinical teams,and in collaborating with other agencies.

19 Funding for clinical governance is largely an intra-trust function, with fundinggenerally provided either centrally or at a directorate level. Likewise, theplanning, monitoring and management of clinical governance is also largelytrust-driven with relatively little input from other stakeholders such as healthauthorities and primary care trusts.

20 Because clinical governance is, or should be, an integral part of the way inwhich trusts deliver services it does not lend itself to being costed separately(nor are we suggesting that it should be). There is also ambiguity about whatshould be included in such costing. However, some 30 trusts have attemptedto assess the cost of supporting the implementation, and the average estimate -of around £326,000 per NHS trust a year - suggests the annual cost insecondary and tertiary care is likely to be at least £90 million a year. Thisprobably significantly understates the actual cost because the estimateexcludes clinical and managerial staff time and the cost of the main bodiesestablished to support the implementation of clinical governance, which wassome £60 million in 2002-03.

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Responsiveness to internal and externalevaluations of clinical governance and quality 21 Reviews by the Commission for Health Improvement, the NHS performance (star)

ratings, the Controls Assurance self-assessment process and operation of theClinical Negligence Scheme for Trusts provide an important focus and stimuli forimprovements in clinical governance. Over three quarters of NHS trusts reportedtaking some action to make change happen following an external review, thoughthe scale and significance of the changes is difficult to gauge.

22 NHS trusts acknowledged that the Controls Assurance and Clinical NegligenceScheme for Trusts and the performance (star) ratings have had beneficialimpacts on their performance. But trusts assessed the Commission for HealthImprovement clinical governance reviews as having the greatest impact onthem. While they rarely reveal wholly new information about an organisation,they appear to have the effect of making knowledge about performance moreexplicit and visible, and thus stimulate meaningful changes in NHS trusts.However, many trusts' progress in implementing their Commission for HealthImprovement action plans seems relatively slow. Strategic health authorities,which are now responsible for such follow-up, will need to ensure that truststake timely action.

23 Indeed, the remits of the increasing numbers of inspection bodies that provideexternal evidence of achievements in clinical governance and quality oftenoverlap. The NHS Reviews Co-ordination Group which was set up voluntarily byits members to improve the efficiency of scrutiny in one area, risk management,has identified scope for improved co-ordination. And the joint Department ofHealth/Cabinet Office report on inspection of the NHS8 proposed a HealthcareInspection Concordat. That concordat, to be implemented in December 2003, isintended to reduce unnecessary burdens imposed by the inspection process. Thereforms of the inspection system, with the creation of the new Commission forHealthcare Audit and Inspection and the Commission for Social Care Inspectionshould also address some of these concerns.

The contribution made by the components ofclinical governance24 Most of the individual components of clinical governance are in place in

most NHS trusts, though the coverage of each component within individualtrusts varies from those with less than 20 per cent coverage to ones with over80 per cent. But, for trusts as a whole, there is noticeable progress in thedevelopment of a more co-ordinated, coherent and consistent strategy.

25 On the whole, those functions which serve some statutory or externalrequirement (such as risk management, claims and complaints) appear to bemost robust. Those which are newer, and which though clearly desirable maynot yet be consistently seen as essential (such as patient and publicinvolvement, and knowledge management, including sharing of good practice)are less well developed in many trusts. And, although medical audit wasformally introduced some 14 years ago, clinical audit remains underdevelopedin many trusts. As a result clinical directorates and trusts are not exploiting infull its capacity to drive improvements in the quality of care.

8 Making a Difference - reducing burdens in healthcare inspection and monitoring, Department ofHealth/Cabinet Office, July 2003; available at www.cabinet-office.gov.uk.

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26 Trusts have made limited progress in involving patients and the public in theNHS. The Department has, however, introduced a number of initiatives toincrease patient involvement in their care and to enable communityinvolvement in their local health services, including the introduction of thePatient Advice and Liaison Service, Independent Complaints AdvocacyServices, Patients' Forums and the Commission for Patient and PublicInvolvement in Health.

27 In contrast, risk management systems have developed substantially since 1999,and are reasonably well established in most trusts. Trusts' performance is takeninto account in reviews by the Commission for Health Improvement, in trusts'Controls Assurance self-assessments, in assessments by the Clinical NegligenceScheme for Trusts and in NHS performance (star) ratings. Since the Committeeof Public Accounts raised concerns about risk management in their hearing onthe Clinical Negligence Scheme in 20019, there has been some progress withmost trusts aiming for a higher rating, but one in five trusts have not achievedany level, and most have yet to move beyond level 1.

28 In 17 per cent of trusts, the proportion of clinical directorates using clinical riskmanagement is still 60 per cent or below. And, while trusts have improved therecording, collating and review of data, training in risk management is stillweak as is performance in moving from identifying risks to taking action toimprove quality.

29 Effective clinical governance requires trusts to generate, identify and use relevantinformation. It involves trusts bringing together information generated by thecomponents of clinical governance, so that they can assess quality andperformance of services; and obtain the information needed to enable evidence-based clinical decision making. It also involves identifying, disseminating andlearning from good practice. A number of recent National Audit Office reportshave concluded that the NHS does not perform well in this respect.

30 The Commission for Health Improvement also has concerns about trusts' use ofinformation, particularly that trust boards did not have the information theyneeded to manage strategically. Furthermore, the failure to share learningacross and between organisations was one of the six most common themesemerging from the Commission for Health Improvement's clinical governancereports, raised at more than 90 per cent of reviews. They also commented atmany organisations on weaknesses in dissemination of national guidance oneffectiveness. Their first annual report on the NHS states - "the NHS was notgood at learning from itself with examples of good practice often not replicatedin the same hospital, let alone the same town".10

31 While there are important sources of information on good practice, such as theCommission for Health Improvement reports, presentations and press releases,the tracking report they maintain is not published, and the examples in it arenot highlighted in a concerted manner that would enable trusts to make gooduse of them. The Clinical Governance Support Team has published a number ofarticles and examples of good practice which are also available on its website(www.cgsupport.org).

9 Committee of Public Accounts 37th report, 2001-02, Handling Clinical Negligence Claims in England. HC280, 2001-02.

10 Getting better? A report on the NHS by the Commission for Health Improvement. May 2003.

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32 To date, few trusts have developed internal indicators of progress inimplementing clinical governance. Trusts generally gain assurance throughregular updates and reports to the board. The Commission for HealthImprovement found that a third of the organisations reviewed had a lack ofconnection between the policies that the board has agreed and what happenson the front-line. The Clinical Governance Support Team is developing a modelform of report that could provide one solution to this issue.

33 The clinical governance strategy has changed the way trusts deal with quality ofcare. To date, most of those changes have been to processes. There are, however,clear indications that there have been changes to the culture of trusts, in thatboards have become more involved in clinical concerns; clinicians have begunto see those concerns as corporate rather than professional and personal; andattitudes of staff within trusts have become less defensive and more open. Thecomponents of clinical governance have been substantially developed and usedmore effectively and as a result trusts have made many changes to patient care.

To maintain the momentum, a number of barrierswill need to be overcome34 Trusts identified a number of barriers that need to be overcome in achieving

further improvements. The most common themes were lack of resources andcultural difficulties. The other main barriers or problems cited were conflictingpriorities, particularly the concentration on short term waiting targets,organisational changes and mergers, the size, spread and heterogeneity of trustsand a lack of organisational direction and impetus for clinical governance. It isdifficult to unpick the relative importance and merits of these barriers, butimproving the rate of progress will require action on all of them.

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A PROGRESS REPORT ON IMPLEMENTATION BY NHS TRUSTS: ACHIEVING IMPROVEMENTS THROUGH CLINICAL GOVERNANCE

35 We therefore make the following recommendations:

The Department of Health should:

! ensure that the Clinical Governance Support Team continues to develop and enhance itsadvice and support function, taking account of the findings of the Judge Institute ofManagement, including how to satisfy the present unmet demand from trusts;

! explore with the Clinical Governance Support Team more effective ways of disseminatinggood practice, including examples identified by the Commission forHealth Improvement;

! in the light of the Department of Health/Cabinet Office reporton inspection, promote the actions and recommendations of the NHS Review Co-ordination Group, to ensure that the opportunities for rationalising the burden of inspectionare maximised;

! evaluate the impact of the various patient empowermentinitiatives and develop a set of good practice guidelines to help trusts make improvements on this issue; and

! consider providing awards to trusts on the theme "doing things better".

The Commission for Health Improvement, or its successorbody, should:

! consider including questions aboutstaff and patient attitudes andexperience of clinical governancein their staff surveys, and identifythe main barriers to furtherprogress and ways of overcomingthese barriers; and

! consider how to build on the workof the NHS Reviews Co-ordinationGroup as part of its proposedleadership of inspection role.

Recommendations


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Trusts should:

! review the information requirements on quality issues required by their board and establishsystems to ensure that such information is provided on a regular basis;

! consider developing with their clinical teams systems of internal reporting on quality on thelines being developed by the Clinical Governance Support Team;

! maximise the benefits to be derived from clinical audit, through developing an annualprogramme based on an agreed trust-wide strategy, endorsed at board level, which includestraining requirements and encourages a multi-professional approach to the audits;

! ensure that there is an open and transparent system of support for continuing professionaldevelopment which ensures that the needs of all staff groups, as identified and endorsed intheir annual performance development plans, are met in an equitable way;

! benchmark key clinical governance initiatives with similar trusts and build on and shareexamples of good practice; and

! ensure that they agree with the trust board an action plan, timetable and priorities forimplementing the findings of inspection reports, such as those of the Commission for HealthImprovement, and allocate clear responsibility for monitoring implementation.

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Part 1



Clinical governance is thecentrepiece of the qualityimprovement initiative

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1.1 This part of our report outlines the key role clinicalgovernance plays in helping to deliver improvements inthe quality of patient care, the arrangements establishedby the Department to implement clinical governanceand the scope and methodology of our examination.

1.2 Clinical governance is the "system through which NHSorganisations are accountable for continuouslyimproving the quality of services and safeguarding highstandards of care by creating an environment in whichexcellence in clinical care will flourish".11 Its purpose isto secure better quality care from the £54 billion a yearspent on healthcare services and, through improvedaccountability, improve patients, and the generalpublic's confidence in NHS services.

1.3 The main principles of clinical governance (Appendix 1)are: a coherent approach to quality improvement, clearlines of accountability for clinical quality systems andeffective processes for identifying and managing riskand addressing poor performance. Clinical governancerequires a change in the culture of NHS organisations,to one where "openness and participation areencouraged, where education and research are properlyvalued, where people learn from failures and blame isthe exception rather than the rule, and where goodpractice and new approaches are freely shared andwillingly received."12

1.4 The main components of clinical governance can begrouped as follows:

! Learning mechanisms (clinical risk management,clinical audit, adverse incident reporting, learningnetworks, continuing professional development);

! Patient empowerment (better information; patientcomplaints, patients' views sought and patientsinvolved throughout the NHS); and

! Knowledge management (information andinformation technology, research and development,education and training).

1.5 Some of these components have been in operation formany years. For example, clinical audit was formallyintroduced into the NHS in 1989-90 and was in use inparts of the NHS well before that time; and we reportedin 1995 that NHS trusts had made progress towardsestablishing it as a routine part of clinical practice.13

1.6 During the 1990s, NHS managers were accountable formeeting targets related to financial and workloadconcerns with quality subsumed under organisationalperformance. However, a number of prominent servicefailures in standards of NHS care, for example thequality failings in cervical smear screening andreporting at Kent and Canterbury Hospital,14 causedpublic and professional concerns and threatened toundermine confidence in the NHS. In response to theseconcerns and concerns that approaches to quality werefragmented and lacked co-ordination and that themanagerial view of quality was different from themedical view, Sir Liam Donaldson, now theDepartment's Chief Medical Officer, introduced theconcept of clinical governance in 1997.

1.7 The government subsequently introduced new policies,programmes and structures to support a comprehensiveand systematic approach towards assuring andimproving the quality of clinical services. This includeda 10 year programme to improve continuously theoverall standard of clinical care; reduce variations inoutcomes of, and access to, services; and ensure thatclinical decisions are based on the most up-to-dateevidence of what is known to be effective.15 16 17

11 Clinical Governance - Quality in the new NHS, NHS Executive, 1999.12 Department of Health website.13 Clinical Audit in England, HC 27 1995-96, December 1995.14 The Performance of the NHS Cervical Screening Programme in England, HC 678 1997-98, April 1998.15 The New NHS Modern, Dependable, Cm 3807 1997.16 A First Class Service - Quality in the New NHS, Department of Health, 1998.17 The NHS Plan, Cm 4818 I, 2000.

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1.8 The government's strategy has three main strands:

! Establishing clear national standards throughNational Service Frameworks, and the NationalInstitute for Clinical Excellence (set up in 1999). Thelatter has the role of providing patients, healthprofessionals and the public with authoritativerobust and reliable guidance on current bestpractice, covering individual health technologiesand the clinical management of specific conditions;

! Ensuring local delivery of those standards throughclinical governance, underpinned by lifelonglearning and strengthened and modernised systems of professional self-regulation. Support isprovided through:

" the Clinical Governance Support Team (1999)now part of the NHS Modernisation Agency,supports the development and profile ofclinical governance, provides information, andcreates, captures and spreads ideas and goodpractice. It provides a number of majorprogrammes - including team development andboard development - and specific support tohelp turn around zero starred trusts. Inaddition, there have been more specificprogrammes in specialist areas including strokeand obstetrics;

" the National Patient Safety Agency (2001)created to implement a mandatory reportingsystem to collect and learn from data onadverse events and near misses. The purpose isto disseminate lessons learnt and reduce therisk of harm to patients, thus improving thequality of care and patient safety; and

" the National Clinical Assessment Authority(2001) to provide a support and expert adviceand assessment service to health authorities,primary care trusts and hospital and communitytrusts that are faced with concerns over the performance of individual doctors. From April 2003, the Authority has also provided aservice for hospital and community dentistry.

! Effective monitoring through:

" the Department's regional offices, whichreviewed all baseline assessments anddevelopment plans prepared in 1999 and untilMarch 2002 development plans and progressagainst them. Strategic health authorities havesince taken over responsibility for performance,managing local services and ensuring thedelivery of safe, high quality services througheffective clinical governance arrangements in

NHS trusts. But they had not taken on that roleat the time of our fieldwork; during thetransitional period (between April andSeptember 2002) NHS resources were putelsewhere, and monitoring was not robust;

" the Commission for Health Improvement,which aims to improve quality by reviewing thecare provided and identifying notable practiceand areas where care could be improved. Itcarries out clinical governance reviews ofindividual trusts and reports publicly on theirprogress. Further details are at Appendix 3. Bythe end of November 2002, the Commissionhad reported on 153 acute and combinedtrusts, 14 mental health trusts, nine ambulancetrusts, six NHS Direct providers, eight primarycare trusts and three health authorities. Thisrepresented over 60 per cent of NHS acute,mental health and ambulance trusts. The results are published on their website(www.chi.nhs.uk.);

" NHS Performance Assessment. The first set ofperformance ratings for 2000-01, presented interms of stars (from none to three), waspublished in September 2001, for acute trustsonly. For the 2001-02 ratings, coveragewidened to include specialist, ambulance andmental health trusts (for the last group,indicative ratings only were given). For acuteand specialist trusts, the performance ratingawarded depends on a combination of theresults of any Commission for HealthImprovement review in the year, andperformance against key targets and a"balanced scorecard" of other measures. Thekey targets are mainly concerned with activityand finance, but the balanced scorecardincludes a number of measures of quality(see Appendix 4); and

" the National Survey of Patient and UserExperience. The White Paper The New NHS,Modern, Dependable18 announced theintroduction from 1998 of annual nationalsurveys of patients' and users' experience. Theresults were to be published nationally andlocally. The results for the 1998, 1999 and 2000surveys were published nationally; thoseundertaken in 2001 and 2002 have not beenpublished, although the Department hassupplied local results to strategic healthauthorities to enable NHS trusts to improvetheir performance.

18 The New NHS, Modern, Dependable, Cm 3807, 1997.

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1.9 Clinical governance was seen as the centrepiece of this strategy. The Chief Medical Officer issuedguidance on clinical governance in March 199919, andimplementation began in 1999-2000. The Departmentdid not earmark additional funding for implementation,but did fund the establishment of new bodies, such asthe National Institute for Clinical Excellence and theCommission for Health Improvement, to support andmonitor its implementation and operation.

1.10 The Department reinforced the priority to be given toquality by introducing a statutory duty for quality of care(Section 18 of the Health Act 1999), which makes NHSchief executives accountable for assuring the quality ofservices provided by their trusts. All NHS organisationshave to submit a Statement on Internal Control as part oftheir audited annual financial statements. Thisacknowledges the trust board's responsibilities forinternal control, and provides assurance that the trusthas attained the required level of control and riskmanagement, or has an action plan to ensure that it willdo so. Trusts gain the assurance necessary to make thatstatement through self-assessment against standards setby the Department. The three core standards focus on(corporate) governance, financial management and riskmanagement. The risk management standard covers allrisks, including clinical risks.

1.11 The guidance on clinical governance also required NHSorganisations to provide a public account in an annualreport of what they are doing to improve and maintainclinical quality. As a minimum, starting with 1999-2000,trusts had to report on where they were at the start of thestrategy, what progress they had made and whatdevelopment plans they had for the coming year. TheDepartment published further details about what shouldappear in trusts' annual reports in November 2002.20

Implementation of clinicalgovernance has taken place againsta background of organisationalchanges and increased oversightand regulation1.12 The introduction of clinical governance has taken place

against a background of substantial organisationalchange (Figure 1).

1.13 Research demonstrates that NHS reorganisations tend todistract managers from tackling service developmentmatters.21 In addition to the structural changes to theNHS as a whole, 85 new trusts were created throughmergers of 191 former trusts during the periodApril 1999 to July 2002. Those mergers brought togethertrusts that had taken differing approaches toimplementing clinical governance.

Major organisational changes affecting the NHS, 1999-20031

1995-2002

1997-2000

2000

2001

2001

2001

2002

2003

Reconfiguration of acute services involving extensive reorganisation of acute NHS trusts and a succession of mergersand restructuring.

Abolition of General Practitioner fundholding and its replacement initially with primary care groups andsubsequently, in some areas, by primary care trusts. Parallel progressive abolition of NHS trusts in community care asfunctions taken over by primary care groups/trusts. Formation of new mental health NHS trusts and, in some areas,care trusts working across health and social care.

Abolition of the NHS Executive and the incorporation of its functions into the Department of Health.

Abolition of the NHS Executive regional offices, devolution of some functions to new strategic health authorities, andthe creation of four new regional directorates of health and social care in the Department of Health (changes takingeffect from 2002-03).

Reorganisation of health authorities into strategic health authorities, going from around 100 to 28 strategic healthauthorities in England, and the devolution of many responsibilities of health authorities to primary care trusts (changes took effect from 2002).

Creation of primary care trusts in all areas, replacing primary care groups, including some further mergers andrestructuring in community and mental health services, and transfer of responsibilities from health authorities.

Announcement of intention to create new foundation NHS trusts with different legal, governance and financialstructures, initially in acute services but subsequently in other areas of healthcare provision.

Announcement of abolition of the four regional directorates of health and social care.

Source: Walshe, K. Manchester Centre for Healthcare Management

19 Health Service Circular 1999/065 Clinical Governance: Quality in the new NHS.20 Department of Health guidance on reporting on clinical governance November 2002.21 Brown, R.G.S. Reorganising the National Health Service: A case study of administrative change. Oxford: Blackwell 1979.

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1.14 One in six chief executives responding to our survey in 2002 cited organisational change or merger as abarrier to the progress of implementing clinicalgovernance. The Commission for Health Improvementfound that the impact of merger, reconfiguration,rebuilding and site closure on different aspects of theorganisations' activities had sometimes not beenanticipated and managed.22

1.15 There are a large number of regulatory and inspectionbodies whose remits are to examine some or all of thecomponents of clinical governance (Figure 2). Whilemany of these were established after 1999, in responseto the need to ensure local delivery of the nationalquality standards (paragraph 1.9 refers) others have morelong established roles and responsibilities, such as theHealth and Safety Executive and the Audit Commission.Each inspection visit to a trust imposes a burden on trustresources. For example, 45 trusts provided us with anestimate of the costs to them of a Commission for HealthImprovement review. These estimates ranged up to£250,000 with a median value of £50,000.

1.16 The increase in inspection and regulation of the sector has also created a risk of overlap and duplication.For example, examinations of risk management form part of Commission for Health Improvementreviews, performance assessment for star ratings,assessment by the Clinical Negligence Scheme for Trustsand self-assessment for Controls Assurance. However,the star ratings use the Clinical Negligence Scheme forTrusts assessment.

1.17 In recognition of the burden and overlap of inspection,in 2001 the main inspection bodies formed the NHSReviews Co-ordination Group,23 to improve theefficiency and effectiveness of scrutiny by rationalisingreviews of risk management in health bodies, improvingco-ordination and reducing duplication. More generally,they are co-operating to find ways of sharing evidenceand harmonising criteria to reduce the overall burden ofinspection. The Group has:

! agreed and published principles of agreementbetween the reviewing bodies;24

! carried out a survey of NHS bodies and theirreviewers to establish the extent to which theprinciples are applied in practice. The report of thesurvey is expected later in 2003. It will includeactions for each reviewing organisation to takeforward, actions for the Commission for HealthcareAudit and Inspection and actions for the Group as awhole; and

! mapped coverage of infection control by reviewingorganisations. The report is expected by the endof 2003.

1.18 The work of the NHS Reviews Co-ordination Group issupported by the Cabinet Office's Regulatory ImpactUnit. Indeed, the Public Sector Team of the RegulatoryImpact Unit and the Department have conducted a jointproject focusing on healthcare inspection. Its purpose isto help deliver practical changes (actions) that reduce orremove unnecessary or bureaucratic burdens in theNHS caused by inspection, accreditation, or audit. Theirreport25 noted that, while NHS front-line staff andmanagement acknowledged the value added byinspection in driving up standards in healthcare,enhancing public accountability and ensuring patientsafety, they saw several recurring themes as hamperingthe effective delivery of healthcare. They were:

! multiplicity, overlap and lack of co-ordinationbetween reviewing organisations and their functions;

! duplication and inconsistency in requests for dataand information;

! proportionality and transparency of reviews;

! burdens of preparation for reviews;

! benefits of review outputs and quality of reviewreports and action plans; and

! quality of review teams.

1.19 The Cabinet Office agreed a total of 55 actions with theDepartment of Health and other stakeholders to reduceburdens and free up front-line staff to focus onhealthcare standards and patient care. The main actionconcerning inspection was that the Department and theCabinet Office would, by December 2003, facilitatewith stakeholders, including the shadow Commissionfor Healthcare Audit and Inspection, the development ofa draft Healthcare Inspection Concordat, to improve co-ordination between reviewing bodies.

22 Tracking Report: Clinical Governance Reports to November 2002 - A report to the Commission for Health Improvement, December 2002 (unpublished).23 The audit and inspection bodies involved are the Audit Commission, the Commission for Health Improvement, the National Assembly for Wales, the

Department of Health, the Health and Safety Executive, the NHS Litigation Authority and the Welsh Risk Pool.24 Co-ordination of reviews of risk management in England and Wales: Principles of Agreement between Review Organisations, NHS Reviews Co-ordination

Group, 2002. Available from www.chi.nhs.uk.25 Making a difference - reducing burdens in healthcare inspection and monitoring, Department of Health/Cabinet Office, July 2003. Available at

www.cabinet-office.gov.uk.

15

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one


1.20 The decision to unify work under the Commission forHealth Improvement and, later, the Commission forHealthcare Audit and Inspection also has the potential toreduce duplication. In March 2003, the governmentpublished the Health and Social Care (CommunityHealth and Standards) Bill, which includes provisions toestablish a new healthcare inspectorate, the Commissionfor Healthcare Audit and Inspection. They intend thatbody to take on the work carried out by the Commission

for Health Improvement and the national value formoney work of the Audit Commission, along with otherinspection work, such as that of the Mental Health ActCommission and the National Care StandardsCommission (in respect of private and voluntaryhealthcare). Responsibility for performance (star) ratingswas transferred to the Commission for HealthImprovement with effect from the 2002-03 ratings.

Regulatory and support landscape from a NHS trust perspective2

Source: Walshe, K. Manchester Centre for Healthcare Management and National Audit Office

Commission for Health Improvement*

National Institute for Clinical Excellence

Modernisation Agency

National Patient Safety Agency

Health Quality Service and other healthcare accreditation schemes

Medical Royal Colleges

Audit Commission*

Nursing and Midwifery CouncilStrategic health

authority

General Medical Council

National Clinical Assessment Authority

Mental Health Act Commission

NOTE

The inspection bodies marked* are all members of the NHS Reviews Co-ordination Group. The National Audit Office, although not an inspection body, is also represented on the Group as an observer with the aim of working with them where possible to reduce the burden of our audit work.

Health Professions Council

NHS Trust

Health Service Ombudsman

Health Protection Agency

Clinical Negligence Scheme for Trusts* Data Protection Registrar

Department of Health*

Health and Safety Executive*

16

part

one


We have previously examinedaspects of clinical governance in England 1.21 We have previously examined components of clinical

governance, such as our report on clinical audit in199526 and in reports that highlight concerns aboutgovernance, such as those on cervical screening27,hospital acquired infection28, hip replacements29 andwaiting times30. Our report Handling ClinicalNegligence Claims in England (HC 403, 2000-01,May 2001), drew attention to the scale of claims againstthe NHS resulting in part from failures of governanceand quality assurance. The Committee of PublicAccounts' report on the same subject (HC 280 2001-02,June 2002) highlighted the need to reduce the incidenceof negligence; noted the initiatives the Department hadlaunched to improve clinical governance; and stressedthe need for stronger risk management at trusts. A summary of key findings and recommendations fromour earlier work and that of the Committee of PublicAccounts on clinical governance issues is on ourwebsite at www.nao.gov.uk.

We are undertaking a series ofstudies looking at aspects of clinical governance in England1.22 Given our earlier work and the importance of clinical

governance to the government's programme formodernisation of the NHS, we examined trusts' progressin putting the required structures in place and theprogress made in improving the quality of patient care.

1.23 We focused this examination on secondary and tertiarycare, where systems have had time to bed in. There areimportant differences in the implementation of clinicalgovernance in primary healthcare, and because of thisand the impact of major organisational changes fromApril 2002, including the creation of primary care trusts,we propose to examine that sector later. We have notexamined the role of strategic health authorities inrelation to clinical governance in NHS trusts. The AuditCommission has, however, examined the authorities'role, which is essentially one of support andperformance management. The Commission expects topublish its findings later in the year.

1.24 Early identification and remedying of poor performanceof clinicians is an integral part of clinical governance.Because this component is allied to disciplinary mattersand sometimes suspensions, we have examined thisaspect - including the contribution of the NationalClinical Assessment Authority to that work - in aseparate examination of the management of suspensionof clinicians (to be published in autumn 2003). We areplanning to examine in 2004 issues surroundingorganisational learning as applied to patient safety.

1.25 Other healthcare organisations have also introducedclinical governance: the NHS in Northern Ireland,Scotland and Wales, the independent sector in theUnited Kingdom and in other countries (Appendix 5).

Our methodology1.26 The main sources of evidence for this report were a

census of NHS acute, mental health and ambulancetrusts (working with the Manchester Centre forHealthcare Management, University of Manchester); asurvey of board members and senior managers at arepresentative sample of NHS trusts (conducted on ourbehalf by the Health Services Management Centre,University of Birmingham); a review of reportspublished by the Commission for Health Improvement;interviews with staff at the Department of Health and itsregional offices and other relevant bodies; and throughconsulting our expert panel. Summaries of these arepublished on our website www.nao.gov.uk. Ourmethodology is set out in more detail at Appendix 2.

26 Clinical Audit in England (HC 27, 1995-96), December 1995.27 The Performance of the NHS Cervical Screening Programme in England (HC 678, 1997-98), April 1998.28 The Management and Control of Hospital Acquired Infection in Acute NHS Trusts in England (HC 230, 1999-2000), February 2000.29 Hip Replacements: Getting it Right First Time (HC 417, 1999-2000), April 2000.30 Inpatient and Outpatient Waiting in the NHS (HC 221, 2001-02), July 2001.

Part 2

17

part

two

2.1 This part of our report looks at the effectiveness of supportprovided to NHS trusts; progress in developing structuresand frameworks; and trusts' responsiveness to internal andexternal evaluations of clinical governance and quality.

Effectiveness of support provided to NHS trusts2.2 Ninety per cent of trusts reported that the guidance

provided by the Department was fairly, very, orextremely useful. Most trusts indicated that they wouldwelcome further guidance or assistance on a range ofspecific problems or issues - from the safety of medicaldevices to the confidentiality of clinical records anddata. There were some common themes about whereguidance would be helpful, particularly the embeddingor linking of clinical governance within organisationsand between them; the resourcing of clinicalgovernance amid many competing claims on resources;and clarification of the requirements to report onclinical governance through an annual report, to theDepartment of Health, to health authorities, and to theCommission for Health Improvement.

2.3 The Clinical Governance Support Team has beendeveloping a stronger advisory and support role; andplans to meet the demand for support and advice byproviding direct help, through its developmentprogrammes, practical tools and disseminating goodpractice examples. The Department of Health issuedfurther guidance on reporting in November 2002.

2.4 At the time of our survey in autumn 2002, around 20 per cent of trusts had used the Clinical GovernanceSupport Team's board development programme and 40 per cent had sent teams to the team developmentprogramme, with many more planning to do so.However, some trusts (24 per cent in the case of theboard development programme and 12 per cent forteam development) had neither used the programme norhad plans to do so, largely because they did notconsider this to be necessary.

2.5 Most trusts who had used the programmes rated them highly. In particular, 51 per cent saw the clinicalteam development programmes as very or extremelyuseful. Most trusts identified a wide range of changesthat had occurred as a result of their participation. While many were specific improvements to theparticular services or areas of care from which theclinical teams participating had been drawn - anexample of which is at Case Example 1 - other moregeneral improvements included an increase in staffawareness and understanding, greater engagement withthe ideas and processes, and team building andimproved team working.

2.6 The Department has commissioned the Judge Institute ofManagement (part of the University of Cambridge) toevaluate the impact of the clinical governancedevelopment programme on participating organisations.They submitted their interim report31 in July 2002. In it, they highlighted the complexity of the concept of clinical governance and that the understanding ofwhat clinical governance means and involves differedacross and within trusts and teams. They also reportedsome uncertainty about the links between theorganisational and clinical aspects, with some cliniciansseeing it as a managerial agenda and managers asprimarily a clinical matter.

Progress in putting overall structures,frameworks and processes in place2.7 While structures and organisational arrangements do

not of themselves guarantee the progress of clinicalgovernance, they are a necessary foundation. TheDepartment of Health's 1999 guidance required trusts,by April 2000, to identify lead clinicians for clinicalgovernance; set up appropriate structures for overseeingit; and clarify reporting arrangements within boards andproduce annual reports.

Part 2 Progress in establishingstructures and frameworks



31 Evaluating the impact of the NHS Clinical Governance Support Team's Clinical Governance Development Programme, Interim Report: The Judge Institute ofManagement, July 2002.

18

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two


2.8 At the time of our census (July - December 2002) alltrusts had nominated a named executive director withlead responsibility for clinical governance at boardlevel. In most cases this was the medical director (56 per cent) or director of nursing (27 per cent). Inaddition, 87 per cent of trusts had a named lead non-executive director for clinical governance.

2.9 Over 90 per cent of lead executive directors for clinicalgovernance had this responsibility explicitly stated intheir job descriptions. The median proportion of theirtime spent on this work was 35 per cent, althoughindividuals varied in their commitment from five per centto 100 per cent. Two thirds of trusts considered that thetime spent was sufficient for the director concerned tofulfil their clinical governance responsibilities, but theremainder felt more input was needed.

2.10 Virtually all NHS trusts had a clinical governancecommittee (at the time of the census of trusts, three hadnot) and in line with Departmental guidance all hadconducted a baseline assessment of capability andcapacity for implementing clinical governance andformulated an action plan in the light of that assessment.

2.11 Most clinical governance committees met once everyone or two months (the median was six times a year).But a small minority - about seven per cent - met fewerthan four times a year. All trusts considered that clinicalgovernance committees had brought benefits. Theseincluded bringing about changes to systems orprocesses such as incident reporting, complaintshandling and patient information and communications.They had also led to structural changes within theorganisation, for example restructuring clinicaldirectorates and reorganisation of services. Importantlyfor the strategy as a whole, trusts considered that thecommittees had created corporate commitment,direction and momentum for clinical governance.

2.12 Board members and senior managers rated their viewsof achievement against a set of competencies. Theygenerally confirmed the findings about overallstructures, frameworks and processes, in particular thatstructural changes such as committees and appraisaland complaints systems were now in place. Theyconsidered, however, that there was a shortfall inunderpinning those organisation-wide systems withsystems and nominated leads in clinical areas. They alsoconsidered that insufficient progress had been made inmoving beyond the structural agenda, for example inimproving service quality following reviews of adverseincident data. Overall, they identified a need forongoing support and development if trusts were toprogress further in that direction.

2.13 Although trust board members and senior managersconsidered leadership and collaboration important,their view was that achievement was quite modest. Theyconcluded that there is substantial scope forimprovement, particularly in communications betweenthe board and clinical teams and in collaboration withother agencies.

CASE EXAMPLE 1: South Tees Hospitals NHS Trust - Support from the Clinical GovernanceSupport Team

Situation

The Friarage Hospital in Northallerton was experiencingproblems with long waits for reporting of ultrasoundexaminations. This was causing frustration for patients andstaff. The problem was due to only one of the fourradiologist posts at the hospital being filled. There was anunwritten rule that the radiologist had to report on eachultrasound film, which due to lack of consultant covermeant that films were waiting weeks for a report.

Action taken

The radiography team, along with other teams at the trust,participated in a Clinical Governance Support Teamdevelopment programme, which was held at the trust.With the Support Team's support, and using itsmethodology, the radiography team undertook a servicereview that identified the reporting delays as a seriousissue; and staff collected evidence on the problem. As aresult of this review, the possibility of sonographers doingsome of the reporting was discussed and agreed with theradiologist. A new policy for reporting was presented to,and ratified by, the trust board. Sonographers weretherefore able to issue ultrasound reports on a trial basisfor six months.

Outcome

The trial was a success and provided evidence of reducedwaiting times. Ultrasound reporting times were reducedfrom 10 weeks to two to three days, leading to quickertreatment and reduced anxiety for patients and greater jobsatisfaction for staff. After local negotiations, an interimagreement has been reached to pay sonographers for theirnew role.

Source: South Tees Hospitals NHS Trust

2.14 The Commission for Health Improvement's worksupports this finding, in that three of the six mostfrequently raised themes in their reports relate directlyto leadership and communication issues. It identified atendency for boards to be reactive rather than proactivein clinical governance matters (raised in over 90 per cent of reports); a failure to implement policiesand strategies (also in over 90 per cent of reports); and a lack of communication from strategic to operationallevel (in over 80 per cent). It found that, at a third of theorganisations it had reviewed, there was a lack ofconnection between the policies the board had agreedand what actually happened in wards and clinics.

2.15 In addition, the Commission raised concerns at nearlyevery organisation reviewed about communicationsbetween operational and strategic levels in relation toparticular components of clinical governance and thatwhile the general quality of leadership is good, it isweakened by the difficulties attracting doctors to take uporganisational leadership positions.

2.16 The Department of Health has recognised theimportance of good corporate governance for managinga programme of fundamental improvement andmodernisation. To help strengthen strategic leadership,the Department and the NHS AppointmentsCommission have published a guide for NHS boardmembers.32 The guide aims to draw together the strandsof NHS governance to show how clinical governance,risk management, controls assurance and financial andcorporate governance provide the essential foundationfor good governance.

2.17 Trusts had put considerable resources into supportingclinical governance, but few were able to quantify theannual cost. For the 30 trusts that had estimated theircosts, the median was £326,000 a year, which wouldindicate a cost of some £90 million throughout thesecondary and tertiary care sectors of the NHS. Withinthese trusts the figures varied widely, from a fewthousand pounds to £1.3 million, partly because ofdifferences in organisational size and nature, but alsobecause of definitional differences in the costs that wereincluded. Some included the cost of the clinicalgovernance managers and facilitators, while othersincluded the cost of risk management, complaints,clinical audit and other staff. As a result, the reliability ofany overall cost estimate based on our survey is limited.

2.18 Other relevant costs include the costs of the mainbodies established to support implementation of theclinical governance strategy - the Commission forHealth Improvement, the National Patient SafetyAgency, the Clinical Governance Support Team and theNational Clinical Assessment Authority. In 2002-03, thetotal cost of these bodies was some £60 million. Trustsalso incur costs associated with preparing for andparticipating in inspections and in working with thesupport bodies (paragraph 1.11).

Responsiveness to internal andexternal evaluations of clinicalgovernance and quality2.19 Reviews by the Commission for Health Improvement,

the NHS performance (star) ratings, the ControlsAssurance self-assessment process and the ClinicalNegligence Scheme for Trusts provide an importantfocus and stimuli for improvements in clinicalgovernance. Figure 3 shows that trusts rate reviews bythe Commission for Health Improvement as having thebiggest impact, even though most trusts considered thatthe reviews rarely identified wholly new informationand that the review process had largely confirmed orreinforced their own perceptions of the areas fordevelopment or need for change, or their ownassessment of the position. Relatively few mentionedreceiving positive feedback on their achievements andareas of good practice.

19

part

two


Action taken in response to external assessment3

Source: NAO census of trusts (July to December 2002)

Perc

enta

ge o

f tru

sts

subj

ect

to a

sses

smen

t th

at t

ook

acti

on in

res

pons

e

100

80

60

40

20

0

Commiss

ion fo

r

Health

Impr

ovem

ent

clinic

al go

vern

ance

revie

w

Contro

ls Assu

rance

self-

asse

ssmen

t

Clinica

l Neg

ligen

ce

Sche

me for

Trus

ts ris

k

manag

emen

t asse

ssmen

t

NHS perf

orman

ce

(star)

ratin

gs

32 Governing the NHS, A guide for NHS boards, Department of Health and NHS Appointments Commission, June 2003.

20

part

two


2.20 Trusts had taken, or planned to take, action in responseto the findings of reviews, most commonly reviews orchanges to structures and processes within the trust(such as incident reporting or complaints handling) andto specific service areas like orthopaedics and accidentand emergency. Many indicated that the review hadcaused them to examine the trust's strategic directionand development.

2.21 Trusts are required to prepare an action plan after theCommission's reviews and to agree it with them andwith the strategic health authority. We found thatprogress on those action plans was limited, evenallowing for the fact that many of the reviews wererelatively recent (Figure 4). It is now the strategic healthauthority's responsibility to follow up the action planand monitor whether the trust implements it.

Controls Assurance

2.22 The Department's guidance on clinical governancespecified Controls Assurance as a component formanaging risk and addressing poor performance, andadvocated linking clinical governance and widercontrols assurance. NHS boards must take fully intoaccount clinical governance when signing theirStatement on Internal Control.33

2.23 Trusts' self-assessed average score for risk managementfor 2001-02 was 68 per cent. As this is a self-assessedscore and may not be consistent between trusts, itssignificance lies not in its absolute value, but as ameasure of progress. The 2001-02 score represents animprovement over the average of 54 per cent achievedin the first self-assessments in 1999-2000. The processhelps identify areas that need attention, so that trustsmay deal with them. Following self-assessment in 2001-02, 91 per cent of trusts made changes, mostcommonly in revision or development of their riskmanagement strategies. Others reported changes toprocesses and procedures (such as incident reporting)and introducing or developing risk registers.

33 Department of Health Guidance, Building the Assurance Framework: A practical guide for NHS boards, March 2003.

Trusts' progress in implementing action plans followingreview by the Commission for Health Improvement

4

Source: National Audit Office census of trusts (July to December 2002)

60

50

40

30

20

10

0

Num

ber

of T

rust

s

July-Dec 00 Jan-June 01 July-Dec 01 Jan-June 02

Date of Commission for Health Improvement visit

Action plan not completed

Action plan completed

Part 3



The contribution of theindividual components ofclinical governance

21

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thre

e

3.1 This part of our report looks at the relative progress NHStrusts have made in developing the main components ofclinical governance and the extent to which this hascontributed to improvements in the quality of patientcare. We have not audited those individual components.

Progress in implementing the individual components of clinical governance3.2 The concept of clinical governance brings together a

number of components: clinical audit; clinical riskmanagement; adverse incident reporting includingclinical negligence, and continuing professionaldevelopment (both of which include an element oflearning from these internal information processes);patient and public involvement (including patientcomplaints) which provide the perspective of the serviceusers; and knowledge management.

3.3 We looked at the progress across trusts in putting thestructures and systems in place for the variouscomponents and found that the structural arrangementswere most established for clinical risk management,

adverse incident reporting and patient complaints andleast well established for patient and public involvement(Figure 5). The lack of structures and systems preventsthe components being developed and used effectively.Given that clinical audit has been a requirement fortrusts since the late 1980s the relatively low compliancefor this component of clinical governance is ofparticular concern.

3.4 In order to establish the extent or reach of eachcomponent within each trust we asked trusts to estimatewhat proportion of their clinical directorates ordepartments had arrangements for them in place or wereregularly involved in these activities (Figure 6). Coveragewas best for clinical risk management and adverseincident reporting, but again much less extensive forpublic and patient involvement. Because of themandatory reporting requirements for clinicalnegligence and patient complaints, trusts were not askedabout the extent of their coverage across directorates.Nor was the extent and coverage of continuingprofessional development and knowledge managementcovered as these are perceived as a staff group or wholetrust issue and were therefore addressed separately(paragraphs 3.11 to 3.16 and 3.20 to 3.22 refer).

Proportion of NHS trusts with structures and systems in place5

Proportion of NHS trusts with…

Clinical risk management

Adverse incident reporting

Patient complaints

Clinical audit

Continuing professional development

Knowledge management

Patient and public involvement

Written strategy in place

92%

92%

90%

64%

67%

66%

63%

Trust-wide committee

93%

88%

71%

76%

65%

71%

54%

Named lead person

96%

95%

98%

92%

88%

88%

88%

Source: National Audit Office census of trusts, July to December 2002

22

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e


34 Getting Better? A report on the NHS by the Commission for Health Improvement, May 2003.

Coverage within trusts of some components of clinical governance6

Proportion of NHS trusts with…

Component



Clinical audit


0 to 20 per centcoverage

0

3

2

13


0

5

7

18


3

9

15

29



3

19

24

22

81 to 100 percent coverage

94

64

52

18

Trusts' views on the effectiveness of elements of clinical governance7

Proportion of NHS trusts assessing the effectiveness of components of clinical governance in bringing about change

Component



Patient complaints


Clinical audit

Clinical negligence claims


Knowledge management

Not at alleffective

0

0

0

0

1

2

0

1

Not very effective

8

5

10

9

17

22

16

18

Fairly effective

55

62

57

60

61

52

72

64


Very effective

34

31

29

29

20

21

12

15

Extremelyeffective

3

2

4

2

1

3

0

2

3.5 Trusts' assessment of the effectiveness of the componentsof clinical governance in terms of their contribution tobringing about changes in practice and improvingpatient care showed considerable differences betweencomponents (Figure 7). While most trusts were cautiousin their assessments, with very few using the endpoints ofthe rating scale, the most effective components wereadverse incident reporting, continuing professionaldevelopment and patient complaints. Again, patient andpublic involvement and knowledge management, alongwith clinical negligence and clinical audit, showed thegreatest scope for improvement.

3.6 The Commission for Health Improvement has also foundwide variation in progress between trusts. Figure 8details our analysis of the outcomes of theCommission's reviews of trusts reported on in the yearto November 2002. The average score awarded for allcomponents was 1.92. When applied to an individualtrust, that score would mean that some worthwhileprogress was being made, but not across the wholeorganisation. In its report Getting Better?34 theCommission concluded that the NHS had made a lot ofprogress, but there was a considerable way to go.

3.7 In the following paragraphs, we look in more detail atthe contribution of each of the main components ofclinical governance, including case examples thatdemonstrate how improvements have been achieved.


3.8 Clinical governance aims to change the culture of theNHS, to make it patient centred; The NHS Plansubsequently emphasised the importance of involvingand empowering NHS patients. The Department'sguidance stated that, for clinical governance to besuccessful, all health organisations must demonstrateactive working with patients, users, carers and the public.

3.9 As the previous analyses show (Figures 5 to 7), trustshave made limited progress in this area. This slowerprogress was confirmed by our survey of boardmembers and senior managers who considered thatthere was a shortfall between achievement andimportance in the processes for involving service usersand in having criteria for establishing user involvement.Case Example 2 provides an example of increasedengagement with patients and the public.

23

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3.10 The Department has, however, put in train a number ofchanges to enable patients to be as involved as theywant to be in decisions about their care, and to enablecommunity involvement in their local health services(Figure 9). From October 2002, the Commission forHealth Improvement took over responsibility for patientsurveys; and, subject to the passage of the enablinglegislation, that responsibility will pass to the newCommission for Healthcare Audit and Inspection. Thisarrangement should provide an opportunity to help theNHS obtain an independent and comparable measureof future progress in this area.

Use of information and knowledgemanagement, including sharing good practice

3.11 Effective clinical governance requires trusts to generate,identify and use relevant information. It involves trustsbringing together information generated by the differentcomponents of clinical governance, so that they canassess quality and performance of services and obtainthe information needed to enable evidence-basedclinical decision making. There is also a need to ensurethat trust boards obtain relevant information to see howwell the trust is functioning.

3.12 In response to our census, knowledge management wasrated as one of the least developed of the componentsof clinical governance. Nevertheless, most trustsconsidered that they made information available tothose staff who needed it, and rated their performanceas fairly effective in bringing about changes in practiceand improvements in patient care. Case Example 3shows how Kings College Hospital NHS Trust has

changed its knowledge management processes.However, while board members and senior managersrecognised the importance of identifying and usingresearch evidence and other information on patientincidents, they saw achievement as modest.

3.13 A number of National Audit Office reports havehighlighted the need for trusts to improve their systemsof recording information and dissemination to staff andmanagement boards of the results and learning fromgood practice, including information on patient and staffincidents. These include our reports on clinicalnegligence, waiting lists, hospital acquired infection,prevention of violence and aggression and themanagement of health and safety risks to staff.

CASE EXAMPLE 2: London Ambulance Service NHS Trust -Patient and public involvement

Situation

Because the area the trust serves is large and complex,and it has no premises that are visited by patients,involving patients and the public is not a simple matter.

Action

In 1999-2000, the trust developed a system of feedbackfrom patients called "How did we treat you?", whichinvolved installing in almost all London hospitals adispenser for leaflets enabling patients to feed back theirviews to the trust. It is now following up that initiative bycommissioning the Picker Institute to conduct a majorsocial research project seeking the views of patients andthe public about the London Ambulance Service.

The trust has set up a Patient Advisory and Liaison Service and has established a patient and publicinvolvement group to co-ordinate the process of pilotingpatient and public involvement models to fully engage with London's diverse communities. These modelsreflect the distinct areas of the trust's activities: localcommunity involvement in emergency care, publicengagement in policy development and the provision ofpatient transport services.

Outcome

As a consequence of these developments, the trust is nowreceiving more than 250 enquiries a month from patientsand the public. These contributions have led to manyimprovements to the care afforded to individual patients;and the trust expects patient and public involvement tobecome increasingly effective as the programme matures.

Source: London Ambulance Service NHS Trust

Outcome of Commission for Health Improvement'sreviews of trusts reported on in the year to November 2002

8

Significant areas of weakness

Some Strengths

Many Strengths

Significant Strengths

Source: National Audit Office analysis of Commission for HealthImprovement clinical governance review reports

7 per cent

65 per cent

17 per cent

11 per cent

Overall Finding Percentage of Trusts

NOTES

1. The Commission allocates scores from I to IV for each ofseven aspects. The findings are defined as:

Significant areas of weakness: five or more scores of I

Some strengths: either one or more Is or no IIIs

Many strengths: one or more IIIs and no Is

Significant strengths: three or more IIIs and no Is

2. This analysis draws on reports on 115 trusts.

3.14 The Commission for Health Improvement also hasconcerns about trusts' use of information. A failure toshare learning across and between organisations wasone of the six most common themes emerging from theirclinical governance reports, and was raised in morethan 90 per cent of reviews. It also commented at manyorganisations on weaknesses in dissemination ofnational guidance on effectiveness. A key concernhighlighted in its report of the first three years ofinspection work across NHS organisations is that theydo not make good use of the information they have andthat trust boards do not receive the information theyneed to manage strategically. The Audit Commissionhave also reported that, whilst some trusts have givenhigh priority to improving the accuracy of their data,many trusts needed to improve basic processes.35

3.15 The Department's guidance on clinical governancestates that trusts should use the comparisons with othersto identify good practice; and learn from it so that theirpatients can enjoy the benefits of the enhanced quality.The Commission for Health Improvement identify bestpractice in each clinical governance review reportunder the heading "something that the rest of the NHScan learn from". In their quarterly tracking report, theyanalyse those examples of good practice over thecomponents of clinical governance, patient experience

and strategic capacity. The tracking reports are notpublished and the examples are not highlighted in aconcerted manner for trusts to make use of them. TheCommission does, however, share information with theNHS, for example, through reports such as GettingBetter?, through press releases and by presentations atconferences and other events.

3.16 The Clinical Governance Support Team is fast becomingthe best source of good practice examples. It is part ofits role to capture and spread good practice in clinicalgovernance. It does so through written material, forexample its publication Eurekas and Case Studies36, andits website.

Clinical audit

3.17 While clinical audit was formally introduced in 1993,and medical and nursing and therapy audit predatedthat, Figures 5 to 7 show that clinical audit is not as wellestablished as might be expected, with half of all trustsreporting its use in more than 80 per cent of theirclinical directorates or departments. Most, however,found it fairly effective (or better) in bringing aboutchange. Case Example 4 sets out changes made atMayday Healthcare NHS Trust.

Mechanisms to enable patient and public involvement in NHS trusts

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9

Location and Mechanism

In each NHS trust

A statutory duty on the NHS toconsult and involve patients and the public

Patient Advice and Liaison Service

Independent Complaints Advocacy Services

The NHS complaints procedure

System for clinical negligence

Patients' Forums

At the Centre

Commission for Patient and PublicInvolvement in Health

Change and Purpose

Section 11 of the Health and Social Care Act 2001 places a duty on NHS trusts to makearrangements to involve and consult patients and the public in service planning and operation,and in the development of proposals for changes.

Introduced in place of Community Health Councils. To provide on the spot help andinformation about health services and independent complaints advocacy.

The Health and Social Care Act 2001 places a duty on the Secretary of State for Health tomake arrangements for advocacy services to be provided to people wishing to make acomplaint about their NHS care or treatment. The service was introduced nationally inSeptember 2003.

To be replaced with a more responsive and independent mechanism for dealing with complaints.

The Department of Health are examining ways of reforming the system to ensure disputes areresolved more quickly and more satisfactorily.

To be set up in every NHS trust to influence the day to day management of health services by the trust, and to monitor the effectiveness of the patient advice and liaison service andIndependent Complaints Advocacy Services in their area.

This body was established in January 2003. The Commission is to aggregate and promoteinformation picked up from patients' forums and patient advice and liaison services. It willpublish annual reports to evaluate the system of patient and public involvement, and willreport any issue of concern to patient safety and welfare that it becomes aware of through its analysis of patient experience data.

Source: Department of Health

35 Data Remember - Improving the Quality of Patient-Based Information in the NHS, Audit Commission, 2002.36 Eurekas and Case Studies, NHS Clinical Governance Support Team, 2002.

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CASE EXAMPLE 3: Kings College Hospital NHS Trust - Use ofinformation and knowledge management

Situation

The volume of documents, and the time needed to keep up-to-date with them, led to the trust facing problems ofinformation overload.

Action

The trust appointed a full time guidelines co-ordinator andestablished a sub-committee to oversee a process for clinicalknowledge management. And it now has a formal system inplace for disseminating and monitoring National Institute forClinical Excellence guidelines and an intranet giving accessto local and NICE guidelines.

Outcome

The trust-wide approach to knowledge management has ledto changes in patient care in a number of areas. For example,it ensured that the appropriate clinician was made aware ofa section of the Department of Health's bulletin for chiefexecutives that related to guidelines for management ofintrathecal chemotherapy. Dissemination of the resultinglocally adapted information as a policy now forms part of atraining programme for the appropriate medical staff. Staff donot give intrathecal chemotherapy without having beenthrough this programme and the names of the staff arenotified to the designated clinical areas. This change has ledto risk reduction for patients.

Source: Kings College Hospital NHS Trust

CASE EXAMPLE 4: Mayday Healthcare NHS Trust -Improvements identified as a result of clinical audit

Situation

Before the introduction of clinical governance, clinical auditsat the trust were mostly chosen by clinicians. Their choiceswere influenced by the medical royal colleges, public health,national audits, claims and complaints, research interests andpatterns of clinical activity identified by the trust audit team.Large projects were brought to the trust Audit Committee forapproval and funding.

Action

With the advent of clinical governance and risk management,the trust moved towards integrating clinical audit planninginto the trust annual audit plan, a process that was givenadded momentum following a Commission for HealthImprovement review in 2001. One of the things theCommission highlighted was the fact that the trust was notmeeting existing guidelines for treating patients with fracturedneck of femur. Following the review, the trust strengthened itsFracture of Neck of Femur Team with the appointment of adedicated anaesthetist and an orthopaedic nurse practitioner.It introduced protocols for fast tracking fractured femurpatients in accident and emergency, and an anaestheticprotocol. It also introduced a multiprofessional care plan forfractured hip and audited fractured femur outcome.

Outcome

The operation of a prioritised trust-wide clinical audit planenabled the trust to bring forward the audit and monitorimprovements in patient care. The audit showed that theaverage waiting time for surgery has improved by 50 per cent,and there has been a 20 per cent increase in the number of patients in this group receiving surgery within 24 and 48 hours of admission. There has been a slight reduction inthe length of stay as well. Further improvements are plannedand will be audited.

Source: Mayday Healthcare NHS Trust

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3.18 The Commission for Health Improvement found thatclinical audit was in regular use in less than 60 per centof directorates or departments, and noted that in half oftrusts clinical audit did not involve all relevantclinicians, with adverse consequences for staff andpatients. This suggests that trusts are not fully exploitingthe capacity of clinical audit to drive improvements inquality of care. Our survey also indicated that trainingfor undertaking clinical audit could be improved.

3.19 Ninety eight per cent of trusts reported some degree ofinvolvement in national clinical audits (Figure 10).However, the response by board members and seniormanagers highlights concerns that trusts do not alwaysselect subjects for audit according to clinicalgovernance priorities.


3.20 Continuing professional development underpins thedelivery of good quality service, by ensuring thatprofessional staff continue to improve their skills andknowledge. Our census suggested that, while trustscould do more to put written strategies in place andshow greater leadership through a trust-wide committee,in practice continuing professional development wasfairly or very effective in bringing about change. This wasconfirmed by the Commission for Health Improvement'sreviews: in the year to November 2002, education,training and continuing professional development wasthe highest marked component. The difference fromother components was not great, though; and theaverage score reflects only worthwhile achievement insome areas. The Commission for Health Improvementhas also expressed concern that some professionalgroups, frequently doctors and nurses, are better coveredthan others, such as therapists. Our survey of boardmembers and senior managers suggested thatperformance in carrying new skills gained through toclinical practice was only moderate.

3.21 The Audit Commission drew attention to disparities infunding of continuing professional developmentbetween trusts and that access to education, trainingand development opportunities varies between trusts,between directorates within trusts and between staffgroups.37 The Committee of Public Accounts Report onEducating and training the future health professionalworkforce (20th Report, Session 2001-02)38 drewattention to the Audit Commission's finding. In responsethe Department stressed the need for continuingprofessional development in its framework for lifelong learning for the NHS and in 2002-03 and 2003-04 has made significant additional resourcesavailable to support improvements in this area.39

3.22 The Workforce Development Confederations areresponsible for working with local employers in drawingup clear links between investment in the learningenvironment and achieving national priorities.40


3.23 The Department's guidance identified a need for asystematic assessment of clinical risk, with programmesin place to reduce risk. Board members and seniormanagers told us that risk management was a highlyimportant component of clinical governance, secondonly to corporate accountability, and trusts rated it as oneof the more effective components in terms of itscontribution to bringing about changes in practice andimprovements in patient care. However, while riskmanagement is reasonably well established, being usedregularly in more than 80 per cent of clinical directoratesand departments at two thirds of all trusts, there was asizeable minority of trusts - one in six - where theproportion of clinical directorates regularly using clinicalrisk management was 60 per cent or below.

3.24 Although board members and senior managersconsidered their trusts had performed well in terms ofrecording, collating and reviewing data, in their viewperformance was weak as regards training in the use ofrisk management and, importantly, in moving fromidentifying measures to improve quality to taking action.This mirrors the finding of our examination of health andsafety in the NHS41 where we found that most trusts hadimproved their overall approach to risk management butthat only 12 per cent of trusts provided inductiontraining in risk management. The Commission for HealthImprovement has also commented on poor attendanceby some staff groups at mandatory training in over athird of trusts.

37 Hidden Talents: Education, Training and Development for Healthcare Staff in NHS Trusts, Audit Commission, 2001.38 HC 609, 2001-02.39 Working Together, Learning Together - A framework for lifelong learning in the NHS, Department of Health, 2001.40 Treasury Minute Response to the 20th Report of the Committee of Public Accounts Session, 2001-02.41 HC 623, 2002-03 A Safer Place to Work: Improving the management of health and safety risks to staff in NHS Trusts.

Participation in national clinical audits 10

Many national clinical audits

Some national clinical audits

A few national clinical audits

None

Source: National Audit Office census of NHS trusts (July to December 2002)

37

37

24

2

Trusts participate in: Proportion of NHS trusts (per cent)

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3.25 Our census highlighted that the major barriers toeffective risk management were a lack of resources (attwo thirds of trusts); the culture, behaviour, or attitudesof staff of the organisation (at a third of trusts); and a lackof strategy, processes, or co-ordination (a quarter). TheCommission for Health Improvement also commentedthat some organisations had a culture that was notconducive to reporting risks.

3.26 The Clinical Negligence Scheme for Trusts encouragesgood quality risk management arrangements at trusts.Since 1997, this risk pooling scheme administered bythe NHS Litigation Authority has set standards formembers (all NHS trusts are members of the Scheme) toensure that risk management is conducted in a focusedand effective fashion, and thus to make a positivecontribution towards the improvement of patient care.

3.27 The Scheme assesses trusts' performance against thestandards and, depending on their level of attainment,assigns them to one of three levels. Level 1 representsbasic elements of risk management that should be easilyattainable; and levels 2 and 3 are assessed progressivelywhen a trust has been notified that it has achieved theprevious level. Those meeting the standards are alloweddiscounts against their subscription to the Scheme,according to the level achieved. The level of achievementagainst Clinical Negligence Scheme for Trusts standards isalso used by the NHS performance ratings.

3.28 In their report Handling Clinical Negligence Claims inEngland, the Committee of Public Accounts noted that,by March 2000, almost a quarter of all NHS trusts hadnot achieved the basic risk management standards setby the Clinical Negligence Scheme for Trusts, and afurther two thirds had not achieved more than basicstandards; that the Scheme remained voluntary; and thatthe Department "hoped" that a majority of Schememembers will achieve strong standards by 2003-04.

The Committee recommended that the Departmentshould make membership of the Scheme mandatory,and should set each trust a clear target of raising its riskmanagement standards to the minimum level and thento the highest level.

3.29 Trusts have made some progress since May 2001, butone in five have not achieved any level, and most haveyet to move beyond level 1 (Figure 11). However, 81 per cent of trusts reported that they made changesfollowing their Clinical Negligence Scheme for Trusts riskmanagement assessment. Almost half had changedpolicies and procedures, such as incident reporting andequipment maintenance. Others made changes in areaslike health records management (20 per cent) and patientconsent procedures (10 per cent); and had increasedtraining and development activity particularly related torisk management (24 per cent). About a quarter wereworking towards the next higher level of assessment.


3.30 One of the aims of clinical governance is to change theculture of the NHS from one of blame to one oflearning. This purpose was underlined within the reportOrganisation with a Memory42 and in the reportsdealing with its implementation, Building a Safer NHSfor Patients43 and Doing Less Harm44. The NationalPatient Safety Agency (paragraph 1.5), establishedfollowing consultation on Organisation with a Memory,has a key role in this process. The Department'sguidance requires reporting of adverse incidents so thatthey might be identified and openly investigated; andlessons are learnt and applied promptly. Adverseincident reporting is practised widely: almost all trustsreport that it is operating regularly in over 80 per cent oftheir clinical directorates or departments. Howeverdissemination of the results and learning from them areless well developed.

42 Organisation with a Memory-Report by the Chief Medical Officer, June 2000.43 Building a Safer NHS for Patients, Department of Health, 2001.44 Doing Less Harm, Department of Health and National Patient Safety Agency, 2001.

Trusts' level of achievement against Clinical Negligence Scheme for Trusts standards11

Proportion of trusts (per cent)Level of achievement against ClinicalNegligence Scheme for Trusts standards

No level achieved

Level 1

Level 2

Level 3

Reported in May 2001

24

66

10

0

Achievement by March 2003

20

64

15

1

Source: NHS Litigation Authority

3.31 Over 90 per cent of trusts consider that adverseincident reporting is fairly effective or better, atcontributing to changes in practice or improvements inpatient care. Board members and senior managersconfirmed that reviewing and acting on the lessonslearnt is highly important.

3.32 To be fully effective, learning from adverse incidentsrequires a culture where staff feel able and are willingto report adverse incidents, and trusts develop actionplans that improve quality. While board members andsenior managers ranked the need for an open and fairculture third in importance out of the 54 propositionsput to them, they considered that achievement of thoseelements needed to make adverse incident reportingeffective lagged some way behind. More than half of thetrusts responding to our census saw cultural difficultiesas being the greatest barrier preventing effectiveimplementation of reporting and learning from adverseincidents. Barts and the London NHS Trust was awarethat some clinicians were reluctant to report suchincidents; and that there was a belief that no changesresulted from doing so. In response, the Trust promoteda fair and just culture at all levels; provided guidancefor staff on what to report and how; and increasedfeedback to those who report incidents. The outcomewas that the number of reports received increased by 40per cent between 2001-02 and 2002-03. And CaseExample 5 presents an instance where an ambulancetrust has tackled cultural features that limited willingnessto report adverse incidents.

3.33 The National Patient Safety Agency has been chargedwith developing a new national patient incidentreporting system. Following on from piloting this systemin 28 hospital and primary care units, the reporting andlearning system underwent further testing anddevelopment in 2003. The Agency expects it to beimplemented across the NHS from late in 2003.

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CASE EXAMPLE 5: Greater Manchester Ambulance ServiceNHS Trust - Adverse clinical incidents

Situation

A high percentage of adverse clinical incidents in theService resulted in disciplinary action, as there were noalternative options available for managers to progresssuch issues. Therefore incidents had a very negative effecton team morale. Managers felt that many less seriousincidents were not being reported. There was noprocedure in place for learning from reported incidents.

Action taken

The trust decided to explore the handling of clinicalincidents with the Clinical Governance Support Team;and a team from the trust joined the developmentprogramme in February 2001. It became clear that a movetowards a 'fair blame' culture was required, where allincidents could be learnt from. The Trust Board has nowapproved and introduced an 'Untoward Incident Policy'which includes a Trust Review Panel deciding on theappropriate course of action to take and an eight-stage de-brief procedure designed to take staff through thestages of the incident and identify what could be done toprevent such incidents recurring. Staff are provided withthe option of peer support throughout the de-brief.

Outcome

Staff are now far more comfortable reporting incidents.More incidents are being reported and lessons are beinglearnt from them so that the service can be improved. Forexample, a paramedic in the field terminated aresuscitation for 'humane' reasons. This contravenedprocedure and could previously have led to disciplinaryproceedings. However, de-briefing confirmed that,although procedures should be adhered to at all times, theaction taken was justified and changes to the policy arenow being reviewed. Senior staff felt that with the new de-brief procedure staff morale has improved.

Source: Greater Manchester Ambulance Service NHS Trust

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CASE EXAMPLE 6: Barnsley District General Hospital NHS Trust- Clinical negligence claims

Situation

Although some lessons were learnt on an individual basis,the trust made little use of clinical negligence claims as asource of lessons about good practice.

Action

With the launch of clinical governance, and furtherencouraged by their Commission for Health Improvementreview and Clinical Negligence Scheme for Trusts riskmanagement assessments, the Trust has become more activein drawing on the lessons to be learnt from claims. There hasbeen improvement to the governance structure resulting in achange of culture. Clinicians respond more promptly andpositively and are prepared to review cases more openlywithin directorate forums to avoid recurrence of incidentsand to provide impetus to service improvements and patientsafety. Those reviews are, increasingly, bringing aboutchanges in practice.

Outcome

This more vigilant and active approach has led to improvedpatient safety through, for example:

! revising clinical protocols (for example on swabcounting, lumbar punctures and psychiatric referral);

! liaising with specialist centres on guidelines, for examplefor aortic aneurisms and the process for radiology andmagnetic resonance imaging reports; and

! upgrading the computed tomography scanner.

And changes have been made to the information provided topatients by:

! improving advice and consent procedures; and

! producing patient information leaflets.

Source: Barnsley District General Hospital NHS Trust

3.34 The Chief Medical Officer's report, An Organisationwith a Memory, also noted that data from litigationclaims represent a potentially rich source of learningfrom failure. We found however, that trusts consideredsuch claims only moderately useful in leading to changeor improvement. Case Example 6 shows how a NHStrust has made increasing use of clinical negligenceclaims as a source of good practice lessons.

Patients' complaints

3.35 Properly accountable and learning NHS organisationsneed to have complaints systems that are accessible topatients; and to learn lessons from complaints and takeaction to avoid recurrences. Trusts see patients'complaints as a good source for lessons: 90 per cent ratedtheir systems as fairly effective, or better, at leading tochanges in clinical practice and patient care. Trust boardmembers and senior managers confirmed that complaintsprovide useful information, but were less optimistic aboutthe extent to which reviews led to improvements inquality. Case Example 7 provides an example of how onetrust deals with the causes of justified complaints.

3.36 The NHS Complaints procedure currently operated bytrusts was introduced in 1996. An independentevaluation commissioned by the Department of Healthresulted in a report in 2001 that pointed to slowness,poor communication and lack of independence, and inhis 2001-02 annual report the Health ServiceOmbudsman reached similar findings. The NHS Plancommitted the Department to act on the result of theindependent evaluation, and the new Commission forHealthcare Audit and Inspection will have among itsresponsibilities the independent scrutiny of complaints.The Department are now considering what this role willentail and how it will fit in the context of wider reformto the complaints procedure.

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CASE EXAMPLE 7: Basildon & Thurrock University Hospitals NHS Trust - Patients' complaints

Situation

The Trust has always had a proactive mechanism to ensure that action is taken to reduce the risk of repetition of incidents thatled to patients' justified complaints.

Action

Where appropriate, the chief executive requires an action plan to deal with the causes of justified complaints to be submittedalongside the draft letter to the complainant. Quality management staff monitor performance against those plans; and, in the caseof more serious complaints, the action required appears on the risk register until that action is taken.

Outcome

This active approach to dealing with the causes of complaints has led to better communications with patients when adverseincidents occur and to improved patient safety through, for example:

! undertaking urgent computed tomography scans within 48 hours;

! immediately referring to a senior doctor any patients returning to the Accident and Emergency department within six weeks;

! purchasing buffers for cot sides in the Accident and Emergency department;

! including on the children's head injury card an instruction to guardians that the child should be woken every two hours; and

! amending the insulin regime for children undergoing surgery.

Source: Basildon and Thurrock University Hospitals NHS Trust

Part 4



The overall impact of clinical governance

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Implementing clinical governancehas raised the profile of quality asan issue for NHS trust boards4.1 This part of our report looks at the overall impact so far

of the clinical governance strategy and the barriers that need to be overcome if further improvements are tobe made.

The impact so far

4.2 The launch of the clinical governance strategy and theintroduction of board accountability for quality haveunderlined the need for trust boards to be engaged inquality of care. On average, clinical governancefeatured as a formal board agenda item six times a year,with boards receiving written reports on its progress ateach of these meetings. Chief executives consider thatthe strategy had led to boards being better informedabout quality of care, and to greater corporateownership and management of quality issues.

Implementation of clinical governance hasled to culture changes

4.3 While cultural difficulties form one of the major barriersto implementing clinical governance, the strategy hascontributed to changes in culture within trusts. Oneconsequence of boards' involvement in quality issues isthat they now see clinicians as being more accountableto them. Chief executives considered that clinicalgovernance had brought about positive changes inorganisational culture, with closer working betweenclinicians and managers, greater "buy-in" to clinicalgovernance from clinicians and a shift to see clinicalissues as corporate, and not professional and personal.In turn, clinical governance leads noted that it had ledto less defensive and more open attitudes, with someimprovement in the degree of staff and patientinvolvement in decision taking.

Trusts have made improvements to thecomponent parts of clinical governance

4.4 All of the components of clinical governance predatedthe launch of the strategy, but in almost all of them trustsreported two key changes since 1999:

! an increasing systematisation of methods andprocesses, aligning and co-ordinating activity acrossthe trust; and

! a growing acceptance by staff of the purpose andnature of the components and their place inhealthcare organisations.

4.5 In addition, many trusts reported component-specificchanges, for example the development of greater in-house capacity to plan and provide continuingprofessional development, changes to systems andprocesses to disseminate information and increasedaccess to information.

There are examples of changes being madeto clinical care

4.6 The central purpose of clinical governance is to deliverimproved care to patients. About three quarters of trustsidentified specific improvements in care as an outcomeof their implementing the strategy.

4.7 Trusts provided many examples of changes. Thesechanges included actions to improve the quality ofpatients' experience. For example, one trust instancedalleviating patients' anxiety by introducing contactcards so that they could raise any concerns they hadafter treatment; another had improved facilities forparents on children's wards. They had also madechanges to the medical care provided, such asintroducing 24 hour recovery nurse care in theatres, andimproving responses to the problem of pressure sores.

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4.8 Although progress has been made in improving patientcare, our census of trusts and survey of board membersand senior managers confirmed the scope for furtherimprovement. For example, while 57 per cent of chiefexecutives said the number of unjustified variations inclinical practice had fallen, only a third consideredthere had been a reduction in the use of ineffectiveinvestigations and treatments. Few chief executivesconsidered that patients would yet have noticed thechanges: 29 per cent judged that patient satisfaction hadincreased and 14 per cent that they had received fewerpatient complaints as a result of clinical governance. Inits report on the first three years of its inspections, theCommission for Health Improvement said that theimprovement in NHS services was not yet affectingfront-line delivery of services on a large enough scale toimpact on most members of the public.45

4.9 For each trust that participated in our survey of boardmembers and senior managers, the Health ServicesManagement Centre calculated the average score out of10 for each of the aspects measured (corporateaccountability, risk management, performanceimprovement, leadership and collaboration and qualityimprovement). The results were aggregated, giving eachtrust a score out of 50. Figure 12 shows the scores,ranked from lowest to highest, achieved by the 100trusts surveyed. Most scores fell between 26 and 37,indicating considerable room for improvement.

Barriers to further improvement

4.10 Our census of trusts asked chief executives what werethe main barriers preventing or impeding the successfulimplementation of clinical governance; and it askedclinical governance leads what were the main barriers toestablishing and using each of the components ofclinical governance. Two problems featured at the headof both lists: lack of resources and cultural difficulties.Other major barriers cited by chief executives includedthe size of the priorities agenda and conflicts within it,organisational changes and mergers, and the size, spreadand heterogeneity of the trust. Clinical governance leadsalso found lack of strategy and lack of expertise in theparticular component impeded progress.

4.11 Lack of time and resources was by a substantial marginthe most frequently cited barrier. Trusts were concernedabout direct shortages, such as of clinical andadministrative support staff; and shortage of time arisingfrom patient care taking priority over and thus crowdingout clinical governance activities. Resource constraintsalso resulted from conflicting priorities. Trusts reportedthat the pressures of the wider agenda, and focus onnational targets and performance indicators, led toclinical governance components being seen as less of apriority. As noted in part 3, our survey, and Commissionfor Health Improvement reviews, found barriers to

45 Getting Better? A report on the NHS by the Commission for Health Improvement, May 2003.

Survey of trust board members and senior managers - trusts' ranked aggregate scores for achievement12

Source: Health Services Management Centre, University of Birmingham: analysis of results of survey conducted on behalf of the National Audit Office

50

45

40

35

30

25

20

15

10

5

0

Agg

rega

ted

scor

e (0

to

50)

Corporate accountability

Risk management

Perfomance improvement

Leadership and collaboration

Quality improvement

1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 67 70 73 76 79 82 85 88 91 94 97 100

Trusts

NOTE

This graph shows the scores for each of the 100 trusts participating in the survey.

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continuing professional development, largely caused byworkload or organisation of working commitments,which conflict with training.

4.12 Cultural constraints largely arose from inhibitions aboutreporting and learning from incidents and being openabout poor performance. For example, there wereconcerns about the tendency on the part of the media,public and government to apportion blame, and aboutthe threat of litigation. Senior managers considered an open and fair culture for reporting adverse incidentshighly important but that achievement failed to matchthat importance. There were also difficulties in fullyengaging staff in the clinical governance strategy.

4.13 Clinical governance leads considered the lack ofstrategy or direction for components of clinicalgovernance was an important barrier. They instanced alack of a cohesive agenda for clinical teams anddepartments, fractured approaches to priority setting forclinical audit, and fracturing of systems for "clinical" and"non-clinical" risk management.

4.14 Most trusts do not have internally generated indicatorsof progress in implementing clinical governance. Trustsgenerally gain assurance through regular updates andreports to the board.

4.15 The Clinical Governance Support Team is developing amodel form of report that could provide one solution.The report would entail measuring performance againsta small number of meaningful targets or indicators. It isplanned that this model will augment the quantitativetargets that feature in performance assessments withspecialty-specific quality indicators.

Main Components of Clinical Governance1 Clear lines of responsibility and accountability for the

overall quality of clinical care through:

! The NHS trust chief executive carries the ultimateresponsibility for assuring the quality of servicesprovided by the trust

! A designated senior clinician responsible forensuring that systems for clinical governance are inplace and monitoring their continued effectiveness

! Formal arrangements for NHS trust and primary care trust boards to discharge their responsibilitiesfor clinical quality, through a clinical governancecommittee

! Regular reports to NHS boards on the quality ofclinical care given the same importance as monthlyfinancial reports

! An annual report on clinical governance.

2 A comprehensive programme of quality improvementactivities which includes:

! Full participation by all hospital doctors in auditprogrammes, including specialty and sub-specialtynational audit programmes endorsed by theCommission for Health Improvement

! Full participation in the current four NationalConfidential Inquiries

! Evidence-based practice is supported and appliedroutinely in everyday practice

! Ensuring the clinical standards of National ServiceFrameworks and National Institute for ClinicalExcellence recommendations are implemented

! Workforce planning and development (i.e.recruitment and retention of appropriately trainedworkforce) is fully integrated within the NHSorganisation's service planning

! Continuing professional development: programmesaimed at meeting the development needs ofindividual health professionals and the service needsof the organisation are in place and supported locally

! Appropriate safeguards to govern access to andstorage of confidential patient information asrecommended in the Caldicott Report on the Reviewof Patient-Identifiable Information

! Effective monitoring of clinical care with highquality systems for clinical record keeping and thecollection of relevant information

! Processes for assuring the quality of clinical care arein place and integrated with the quality programmefor the organisation as a whole

! Participation in well-designed, relevant researchand development activity is encouraged andsupported as something which can contribute to thedevelopment of an "evaluation culture".

3 Clear policies aimed at managing risks:

! Controls Assurance, which promotes self-assessmentto identify and manage risks

! Clinical risk systematically assessed with programmesin place to reduce risk.

4 Procedures for all professional groups to identify andremedy poor performance, for example:

! Critical incident reporting ensures that adverseevents are identified, openly investigated, lessonsare learnt and promptly applied

! Complaints procedures, accessible to patients andtheir families and fair to staff. Lessons are learnt andrecurrence of similar problems avoided

! Professional performance procedures, which takeeffect at an early stage before patients are harmedand which help the individual to improve theirperformance whenever possible, are in place andunderstood by all staff

! Staff are supported in their duty to report anyconcerns about colleagues' professional conductand performance, with clear statements from theboard on what is expected of all staff. Clearprocedures for reporting concerns so that earlyaction can be taken to remedy the situation.

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Appendix 1 Principles of Clinical Governance

1 Most of the evidence used in this report was collected in2002 through:

! A census of NHS acute, mental health and learningdisability and ambulance trusts;

! A survey of trust board members and senior managers;

! Interviews and examination of documents at theDepartment of Health and its former regional offices;

! Drawing on the work of the Commission for HealthImprovement (Appendix 3); and

! Consulting experts and other stakeholders.

Census of NHS trusts2 We obtained data and information from trusts through

a postal census, using a questionnaire. Trust clinicalgovernance leads completed most sections, but weprovided for input from chief executives. Chiefexecutives, who are trusts' accountable officers, signedoff the questionnaires as a whole. We identified 270 eligible trusts, all of which responded - almost allbetween July and December 2002. We commissionedthe Manchester Centre for Healthcare Management toundertake the census on our behalf. In addition tohandling the administration, the Centre provided advice on the content and format of the questionnaireand on interpretation of the results; and wrote a reporton the findings.

3 The areas covered in the census were support provided to trusts to implement clinical governance; theestablishment of structures and frameworks; resourcesand processes; external evaluations; and chief executives'comments. The results are used throughout this report.

Survey of trust board members andsenior managers4 The University of Birmingham Health Services

Management Centre conducted on our behalf a surveyof board members and senior managers of trusts. Thesurvey was carried out between May and July 2002. The Centre used a questionnaire they had alreadydeveloped. Up to 10 board members and 10 directoratelevel managers/clinical governance leads from each of astratified sample of 100 NHS trusts (68 acute, 21 mentalhealth/learning disability and 11 ambulance) wereinvited to complete questionnaires. In total, 1,177 (61.4 per cent) responded. Details of the results of thissurvey are on our website.

Interviews and examination ofdocuments at the Department ofHealth and its former regional offices5 We interviewed key staff at the Department of Health; at

the NHS Modernisation Agency (Clinical GovernanceSupport Team) and three of the former regional offices(South East, Trent and West Midlands). We alsoreviewed work carried out by the regional offices onbaseline assessments and development plans.

Drawing on the work of theCommission for Health Improvement 6 The Commission for Health Improvement commission

"tracking reports" that analyse the findings from theirclinical governance reviews. We used those as a sourceof evidence of trusts' progress in implementing clinicalgovernance. Details of their clinical governancereviews, and of the main themes emerging from them,are at Appendix 3. We also maintained contact with theCommission throughout the study, to draw on anyrelevant information they had, and to minimise theextent of any duplication. And we have includedcomments from their report Getting Better? - A report onthe NHS, published in May 2003.


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Appendix 2 Study Methodology

Consulting experts and other stakeholders7 We had the benefit of an expert panel, who advised us

on the scope, findings and conclusions of ourexamination. And we consulted other people andorganisations in the course of our work.

8 We are grateful to the following members of our expertpanel who advised us during our study:

Mr Andrew Barker, Director of Corporate Affairs, TheLondon Clinic

Mr David Bawden, Development Manager, Commissionfor Health Improvement

Miss Helen Davis, Senior Lecturer in Orthoptics, Royal Hallamshire Hospital - representing the HealthProfessions Council

Professor David A Haslam, Chairman, the Royal Collegeof General Practitioners

Professor David Hatch, Chairman of the Committee onProfessional Performance, General Medical Council

Professor Sir John Lilleyman, President of the RoyalCollege of Pathologists and Vice-Chairman of theAcademy of Medical Royal Colleges - representing theAcademy of Medical Royal Colleges

Mr Bill Murray, Chief Executive, South Tees HospitalsNHS Trust

Ms Sue Osborn and Mrs Susan Williams, Joint ChiefExecutives, National Patient Safety Agency

Ms Susan Savage, formerly with the Nursing andMidwifery Council

Dr Alastair Scotland, Chief Officer and Medical Directorof the National Clinical Assessment Authority

Mr Mike Stone, Chief Executive, the Patients' Association

Dr Jose Westgeest, formerly with BUPA, representing theIndependent Healthcare Association

Mr Julian Brookes (then with the Department of Health),Mr Stuart Emslie (then with the Department of Health),Dr Aidan Halligan (now Department of Health, thenHead of the Clinical Governance Support Team) and Ms Susan Went (then with the Department of Health)who acted as observers.

9 We are also grateful to the following people whoprovided us with information and advice:

Ms Jocelyn Cornwell, Commission for HealthImprovement

Professor Sandra Dawson and Mr Tom Smith, the JudgeInstitute of Management, University of Cambridge

Mr Stephen Eastham, Boots the Chemists Ltd.

Mr Joseph Farrington-Douglas, Regulatory Impact Unit,Cabinet Office

Professor Jenny Firth-Cozens, University of Northumbriaat Newcastle

Mrs Elizabeth Fradd, Commission for HealthImprovement

Mr Roger Goss, Patient Concern

Ms Sheila Leatherman, University of North Carolina atChapel Hill and University of Cambridge

Ms Katrina Neal, formerly with the Nursing andMidwifery Council

Professor Ellie Scrivens, Keele University and Director ofthe Controls Assurance Support Unit

Dr Jonathan Secker Walker, University Hosptial of Wales

Ms Hilary Scott, formerly Deputy Health ServiceOmbudsman

Ms Helen Sheldon, College of Health

Professor Peter Spurgeon, Health Services ManagementCentre, University of Birmingham

Dr Grace Sweeney, University of Exeter

Miss Sally Taber, Independent Healthcare Association

Professor Brian Toft, Marsh Risk Consulting Practice

Dr Kieran Walshe, Manchester Centre for HealthcareManagement, University of Manchester

Ms Jo H Wilson, Marsh Healthcare Services

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1 The Commission for Health Improvement uses asystematic framework for assessing clinical governancein trusts. It aims thus to ensure that the judgements madein reports of reviews are reliable, fair and consistent;and that consistent messages are given to trusts aboutclinical governance. It developed the assessmentframework in consultation with the National ClinicalGovernance Support Team in England and the ClinicalGovernance Support and Development Unit in Wales.

Scope2 The Commission for Health Improvement evaluates

clinical governance by exploring three key areas:

! Strategic capacity: how far does the trust'sleadership set a clear overall direction that focuseson patients? How well is it integrated throughout the trust?

! Resources and processes: how robust are itsprocesses for achieving quality improvement, suchas consultation and patient involvement and clinicalaudit? How effective are the trust's arrangements forstaff management and development?

! Information: what information is available about thepatient experience, outcomes, processes andresources, and how does the trust use it strategicallyand at the level of patient care?

3 Each of these areas comprises a number of componentsthat the Commission for Health Improvement examinesin every trust. The Commission has so far identifiedseven components of 'Resources and processes' and'Use of information' (Figure 13). It is carrying out workto identify the components of 'Strategic capacity'.

4 The Commission for Health Improvement's reviewteams assess how well clinical governance is workingthroughout the trust by making enquiries about each ofthese seven components at corporate and directoratelevels and in clinical teams. This involves collectinginformation systematically about review issues that havebeen defined for each component. The Commissionpropose to introduce similar methods to assessinformation collected about components of strategiccapacity in future rounds of reviews.


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Appendix 3 The Commission for HealthImprovement's ClinicalGovernance Reviews

Components of clinical governance - resources and processes and use of information13

Component

Resources and Processes

(i) Processes for quality improvement Patient and public involvement

Clinical audit

Risk management

Clinical effectiveness programmes

(ii) Staff focus Staffing and staff management

Education, training and continuing professional and personal development

Use of information Use of information to support clinical governance and health care delivery

Source: Commission for Health Improvement

Scoring5 There is wide variation within trusts in progress made in

developing the component parts of clinical governance.At this stage of development, the Commission believe itis most useful to trusts to assess each componentseparately to help them prioritise their development ofclinical governance and will not make judgements toproduce an overall rating for a trust. On the basis of theevidence collected, the Commission's reviewers assesseach component against a four point scale:

1 - Little or no progress at strategic and planning level,or at operational level

The lack of strategy and implementation means thatthe organisation does not have the systems andprocesses for it to be sure that adequate quality ofcare and services are (or are not) being achieved.Systems for improving the quality of care andservices through systematic learning do not exist orare underdeveloped. There may be isolatedexamples of strategy development or where progresshas been made implementing elements of clinicalgovernance often the result of an individual'senthusiasm and initiative, rather than part oforganisational development.

2 - Worthwhile progress and development at strategicand planning levels but not at operationallevel/Worthwhile progress and development atoperational level but not at strategic and planninglevels/Worthwhile progress and developments atstrategic and planning levels and at operationallevel but not across the whole organisation

The organisation does not have comprehensivesystems and processes for it to be sure that adequatequality of care and services are (or are not) beingachieved. Systems for improving the quality of careand services through systematic learning are not fullydeveloped. However, there will be examples where:

! a coherent strategy has been developed but whereimplementation of it has not yet occurred; or

! parts of the organisation have implementedsound systems and processes but these are notconnected to strategy development; or

! there is co-ordinated strategy development andimplementation, but not covering all aspects ofthe component of clinical governance or notinvolving all parts of the organisation.

3 - Good strategic grasp and substantial implementation.Alignment across the strategic and planning level, andthe operational level, of the trust

The activity is explicitly part of the organisation'sstrategy for clinical governance and systems and processes are implemented in most parts of the organisation.

The organisation's systems provide it withinformation that the quality of care and services are(or are not) being achieved in most parts of theorganisation. There are systems for identifying andcorrecting deficiencies and for taking preventativemeasures to ensure that they do not recur, thoughsystems for improving the quality of care andservices through systematic learning may not befully developed.

4 - Excellence - co-ordinated activity and developmentacross the organisation and with partnerorganisations in the local health economy that isdemonstrably leading to improvement. Clarityabout the next stage of clinical governance

There is good understanding across the organisation- at board, executive team and clinical team levels -about the place that the activity plays insafeguarding and improving the quality of care andservices. There is co-ordinated development acrossthe organisation and with partner organisations inthe local economy, for example other NHSorganisations, local authorities, voluntary groups.

Systems and processes are mature such that there issystematic learning from them that has led tostrengthening of patients' safety and toimprovements in the quality of care and services.

Findings6 The Commission's tracking reports contain a summary

of themes emerging to date. Figure 14 sets out thosethemes, together with the average mark awarded foreach component over the year to November 2002.

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Main themes identified by the Commission for Health Improvement and average scores in the year to November 200214

Component

Education, training and continuingprofessional development

Research and effectiveness

Risk management

Staffing and staff management

Clinical audit


Use of information

Average score1

2.19

2.01

1.94

1.93

1.90

1.77

1.71

Main themes emerging from 193 reviews2

In some NHS organisations, education, training and continuingpersonal and professional development do not reflect clinicalgovernance priorities or draw on other clinical governance componentssuch as audit, complaints and patient surveys, or staff surveys. Theycalled on nearly half of the organisations reviewed to address pooropportunities for training for some staff groups compared to others.

There were barriers to access for training in some organisations,caused by workload and organisation of working commitments, whichcan conflict with training.

It asked 171 NHS organisations to address concerns abouteffectiveness or research. It expressed concern about the disseminationof national guidance on effectiveness in many organisations.

It called for action in 188 NHS organisations. Most concerns raisedrelated to approaches to risk management that were reactive ratherthan proactive (for example a failure to monitor and learn fromincidents); or policies not being implemented or formulated. Someorganisations had a culture that was not conducive to reportingpotential risk. The Commission asked over a third of organisations toaddress poor attendance by some staff groups at mandatory training.

It asked 187 NHS organisations to address concerns about staffing andstaff management:

! Many organisations had not approached workforce planningsystematically, involving all disciplines and ideally the whole localhealth community; and

! There are problems in recruitment and retention in manydisciplines throughout the NHS, and few organisations areattempting creative approaches to these problems locally.

It called for action in 180 organisations. It had three major concerns:

! Organisations do not always select audit topics according toclinical governance priorities;

! In some organisations audit was not linked to other clinicalgovernance components such as risk management and research; and

! In at least half of reviewed organisations audit was not planned orconducted with the involvement of all relevant disciplines, withconsequences for staff and patients.

It asked 184 NHS organisations to take action about consultation andpatient involvement. It noted that some did not encourage patient andpublic input to service development.

It urged action to be taken on the use of information in 188 of theorganisations reviewed. It was particularly concerned that boards oftendid not receive and disseminate the information from clinicalgovernance and service activities that allowed them to be proactiveand strategic. It also found the recording systems for components suchas managing audit were inadequate.

NOTES

1. The figures here are averages for reports on acute, mental health and learning disability and ambulance trusts published in the year toNovember 2002.

2. These themes were based on the 193 clinical governance reviews the Commission had reported on to November 2002.

Source: Commission for Health Improvement Tracking Report, November 2002 (unpublished) and National Audit Office analysis of Clinical GovernanceReview reports

Figure 15 sets out the targets and indicators used in assessing performance ratings. Commission for Health Improvement reviewsare taken into account for those acute and specialist trusts where a report has been published since the last ratings werecalculated. (For 2002-03 this approach was extended to mental health trusts, but not ambulance or primary care trusts). If thereview shows significant weaknesses against five or more of the seven components of clinical governance, the trust is awardedno stars. Those trusts that pass this stage are assessed on their performance against the key targets. Performance against thebalanced scorecard is used to refine the judgement on the ratings.

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Appendix 4 NHS Performance Ratings: ScoringSystem and Indicators, 2001-02

Targets and indicators used in assessing performance ratings15

Key targets No patients waiting more than 18 months for inpatient treatment

Fewer patients waiting more than 15 months for inpatient treatment

No patients waiting more than 26 weeks for outpatient treatment

Fewer patients waiting on trolleys for more than 12 hours

Less than one per cent of operations cancelled on the day

No patients with suspected cancer waiting more than two weeks to be seen in hospital

Improvement to the working lives of staff

Hospital cleanliness

A satisfactory financial position

"Balanced scorecard" indicators: Risk of clinical negligence

Clinical Focus Deaths within 30 days of surgery for patients admitted on an unplanned basis

Deaths within 30 days of a heart bypass operation

Emergency re-admissions to hospital following discharge

Emergency re-admissions to hospital following discharge for children

Emergency re-admission to hospital following treatment for a fractured hip

Emergency re-admission to hospital following treatment for a stroke

Returning home from hospital following treatment for a fractured hip

Returning home from hospital following treatment for a stroke

"Balanced scorecard" indicators: Inpatients waiting less than six months for treatment

Patient Focus Total inpatient waits

Outpatients seen within 13 weeks

Total time in accident and emergency

Cancelled operations not admitted within a month

Heart operation

Breast cancer

Delayed discharges

Inpatient survey of patients - co-ordination of care

Inpatient survey of patients - environment and facilities

Inpatient survey of patients - information and education

Inpatient survey of patients - physical and emotional needs

Inpatient survey of patients - prompt access

Inpatient survey of patients - respect and dignity

"Balanced scorecard" indicators: Data quality as measured by the hospital inpatient activity data

Capacity and Capability Focus Staff satisfaction as measured by the staff opinion survey

Compliance with the New Deal on junior doctors' hours (working a maximum 56 hour week)

Compliance with targets on confidentiality and information governance

The sickness/absence rate for directly employed NHS staff

Source: Department of Health

1 Northern Ireland, Scotland and Wales also have clinicalgovernance strategies. This appendix summarises theapproach each country has taken.

Northern Ireland2 The Northern Ireland Department of Health, Social

Services and Personal Safety issued guidance on clinicaland social care governance - Governance in the Healthand Personal Social Services - in January 2003. Thatguidance described clinical and social care governanceas: "a framework within which Health and PersonalSafety Service organisations are accountable forcontinuously improving the quality of their services andsafeguarding high standards of care and treatment.Clinical and social care governance is aboutorganisations taking corporate responsibility forperformance and providing the highest possiblestandard of clinical and social care."

3 The guidance recognised that many organisations wouldhave developed their own systems based on the earlierguidance for England, Scotland and Wales, but soughtto bring consistency to the work already begun. Itrequired the appointment of a senior professional atboard level to provide leadership in relation to clinicaland social care arrangements and processes; thedesignation of a committee to be responsible for theclinical and social care governance of the organisation;an evaluation of the current clinical and social caregovernance arrangements in the organisation toestablish the baseline from which the developmentsmust begin; the formulation of a plan for thedevelopment and maintenance of clinical and socialcare governance arrangements; and a system to deliverroutine progress reports to the board and a formalprogress report within the organisation's annual report.It also underlined a proposed statutory duty of qualityand explicitly linked clinical and social care governanceand controls assurance. The statutory duty of quality wassubsequently commenced on 25 April 2003. It places arequirement on Health and Personal Safety Serviceorganisations to put and keep in place arrangements forimproving and monitoring the quality of health andsocial care services they provide to individuals.

4 A clinical and social care governance support team willbe established following an analysis of the results of abaseline assessment exercise undertaken by Health andPersonal Safety Service organisations. The Department ofHealth, Social Services and Personal Safety will work withthe service to develop the structure and role of the team.

5 The new Health and Personal Social Services Regulationand Improvement Authority will conduct reviews ofclinical and social care governance arrangements;independently scrutinise the arrangements developed tosupport, promote and deliver high quality services; andwill support health and personal social servicesorganisations in the delivery of high quality, safeservices for the user.

Scotland6 The Chief Executive, Chief Medical Officer and Chief

Nursing Officer of the Scottish NHS issued Guidance on Clinical Governance in November 1998. Thatguidance described clinical governance as "corporateaccountability for clinical performance…making qualityof care an integral part of the NHS governanceframework"; and stated that, from April 1999, thecorporate governance of all NHS bodies in Scotlandwould encompass both financial and quality issues.

7 The guidance made the trust chief executives beresponsible to the trust board for delivery; and requiredtrusts to establish clinical governance committeesresponsible for the oversight of the clinical governanceof the trust so as to assure the board that thearrangements are working and to bring to the full boardregular reports on the operation of the system andspecific reports on any problems that emerge. Trusts arealso required to include a specific section in theirannual report giving a full account of their activitiesrelated to clinical governance. Trusts have a statutoryresponsibility for quality of care.


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Appendix 5 Clinical Governance in NorthernIreland, Scotland and Wales

8 The Clinical Standards Board for Scotland had the remitto develop and run a national system of qualityassurance of clinical services. In partnership withhealthcare professionals and members of the public, itset standards for clinical services, assessed performancethroughout NHS Scotland against those standards andpublished the findings. Two rounds of visits to each trustto assess performance against generic - clinicalgovernance - standards have been completed. FromJanuary 2003, the Board was incorporated in the NHSQuality Improvement Scotland, a special health board.That Board is also developing a capacity to providesupport and good practice information to trusts.

Wales9 The Welsh Office issued guidance on clinical

governance - Quality Care and Clinical Excellence - inMarch 1999. That guidance described clinicalgovernance in the same terms as those used in England:"a framework through which NHS organisations areaccountable for continuously improving the quality oftheir services and safeguarding high standards of care bycreating an environment in which excellence in clinicalcare will flourish".

10 The guidance required trusts and local health groups toidentify a senior clinician to lead the implementation ofclinical governance; establish a clinical governancecommittee of the board responsible for overseeingclinical governance within the trust; conduct a baselineassessment of the capability and capacity forimplementing clinical governance; formulate an actionplan in the light of that assessment; and publish anannual report on progress. It also underlined trusts'statutory duty of quality and linked clinical governanceand controls assurance.

11 There is a Clinical Governance Support andDevelopment Unit for Wales, located within theAssembly for Wales.

12 The Commission for Health Improvement carries outclinical governance reviews covering all NHS trusts andhealth authorities in Wales.

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Reports Reports by the Comptroller andAuditor General, Session 2002-2003

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The Comptroller and Auditor General has to date, in Session 2002-2003, presented to the House of Commons the followingreports under Section 9 of the National Audit Act, 1983:

Agriculture

Reaping the Rewards of Agricultural Research ........HC 300Fisheries Enforcement in England ............................HC 563

Cross-Government Reports

The Invest to Save Budget ..........................................HC 50Using call centres to deliver public services ............HC 134Progress in making e-services accessible to all -

encouraging use by older people ..........................HC 428Developing effective services for Older People ........HC 518Improving service delivery:! The Veterans Agency ........................................HC 522! The Forensic Science Service ..........................HC 523! The Food Standards Agency ............................HC 524! The role of Executive Agencies ........................HC 525

Getting the evidence: Using research in policy making ........................HC 586-I

Getting the evidence: Using research in policy makingAn international review on Governments' researchprocurement strategies........................................HC 586-II

Purchasing and Managing Software Licences ..........HC 579

Culture, Media and Sport

Community Fund: Review of grants made to the National Coalition of Anti-Deportation Campaigns ..................................HC 519

Film Council: Improving access to, and education about themoving image through the British Film Institute ....HC 593

Progress on 15 major capital projects funded byArts Council England ............................................HC 622

The English national stadium project at Wembley....HC 699

Defence

Major Projects Report 2002 ......................................HC 91Ministry of Defence: The Construction of Nuclear

Submarine Facilities at Devonport ..........................HC 90Through-Life Management ......................................HC 698Ministry of Defence: Compensation claims ............HC 957

Environment

Protecting the Public from Waste ............................HC 156Warm Front: Helping to combat fuel poverty ..........HC 769

Europe

The European Court of Auditors report for the year 2001 ..................................................HC 701

Housing

Improving social housing through transfer ..............HC 496

Inland Revenue

Tackling Fraud against the Inland Revenue ..............HC 429

Law, Order & Central Institutions

Community Legal Service: the introduction of contracting ..........................................................HC 89

New IT systems for Magistrates' Courts:the Libra project ....................................................HC 327

Modernising procurement in the Prison Service ......HC 562

National Health Service

Facing the Challenge: NHS Emergency Planningin England ..............................................................HC 36

Innovation in the National Health Service - the acquisition of the Heart Hospital ..................HC 157

Safety, quality, efficacy: regulating medicinesin the UK ..............................................................HC 255

Ensuring the effective discharge of older patients from NHS acute hospitals ......................................HC 392

Safer Place to Work: Protecting NHS staff fromviolence and aggression ........................................HC 527

A Safer Place to Work: Improving the managementof health and safety risks to staff in NHS trusts ......HC 623

Hip replacements: an update ..................................HC 956Achieving Improvements through Clinical Governance:

A Progress Report on Implementation by NHS Trusts ..........................................................HC 1055

Overseas affairs

Maximising impact in the water sector ....................HC 351

Public Private Partnership

The PFI Contract for the redevelopment ofWest Middlesex University Hospital ........................HC 49

PFI: Construction Performance ................................HC 371PPP in practice: National Savings and Investments' deal

with Siemens Business Services, four years on ......HC 626Northern Ireland Court Service

PFI: The Laganside Courts ......................................HC 649The Operational Performance of PFI Prisons ............HC 700PFI: The New Headquarters for the Home Office ....HC 954Government Communications Headquarters

(GCHQ): New Accommodation Programme..........HC 955

The Comptroller and Auditor General has to date, in Session 2002-2003, presented to the House of Commons the followingreports under Section 9 of the National Audit Act, 1983:

Reports Reports by the Comptroller andAuditor General, Session 2002-2003

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Printed in the UK for The Stationery Office Limitedon behalf of the Controller of Her Majesty's Stationery Office

153552 09/03 77240

Regulation

The Office of Fair Trading: Progress in ProtectingConsumers' Interests ..............................................HC 430

Department of Trade and Industry:Regulation of weights and measures ......................HC 495

The New Electricity Trading Arrangements in England and Wales ................................................HC 624

The Office of Telecommunications: Helping consumers benefit from competition in the telecommunications market ........................HC 768

Social Security

Tackling Pensioner Poverty: Encouraging Take-upof Entitlements ........................................................HC 37

Department for Work and Pensions: Tackling Benefit Fraud ..........................................HC 393

Improving service quality: Action in responseto the Inherited SERPS problem ............................HC 497

Trade and Industry

The Department for Trade and Industry:Regional Grants in England ..................................HC 702

Transport

Highways Agency: Maintaining England'sMotorways and Trunk Roads..................................HC 431

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