Part 1 Overview of clinical governance Clinical governance the concept 1-3

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1 Page Part 1 Overview of clinical governance Clinical governance the concept 1-3 Purposes 1-3 Why clinical governance 1-3 The evolution to accountability for patient care quality and safety 1-4 The concept of clinical governance 1-5 Standards relating to clinical governance 1-9 Implications of Equity and excellence: Liberating the NHS 1-11 Evidence on organizational factors associated with quality improvement 1-12 Recognition of the key factors 1-14 Assessing your organization s progress on governance 1-15 References 1-21 Part 2 Understanding clinical governance components Clinical audit 2-3 Purposes 2-3 Why do clinical audit 2-3 Clinical audit defined 2-4 The clinical audit process 2-4 Rapid-cycle approach to clinical audit 2-7 Clinical survey versus clinical audit 2-8 Clinical audit and research 2-9 Expectations for clinical audit 2-11 How to design a clinical audit 2-12 How to select subjects for clinical audit 2-12 Quality impact analysis 2-13 Using a quality impact analysis 2-16 How to develop a clinical audit objective 2-20 How to consider stakeholders 2-22 How to think about the number of cases to include and how they 2-22 will be selected How to decide on a population or a sample 2-22 How to select a sampling technique 2-24 How to decide on sample size 2-26 How to decide on a data collection strategy 2-30 Designing a clinical audit 2-31 Clinical audit measure defined 2-33 How to draw up a clinical audit measure 2-33 i

2 ii How to convert a clinical audit objective to a clinical audit measure 2-35 How to define a standard 2-36 Templates for clinical audit measures 2-37 For audits on access (measured in time) 2-38 For audits on appropriateness 2-39 For audits on effectiveness 2-40 For audits on efficiency 2-41 For audits on acceptability (patient and carer experience) 2-42 For audits on efficacy (benefits or outcomes) 2-43 Types of clinical audit measures 2-44 How to evaluate a clinical audit design and measures 2-44 Evaluating clinical audit designs and measures using SAMBA 2-45 Developing measures for a clinical audit 2-54 Preparing for data collection 2-57 What data collection involves 2-58 How to collate preliminary findings and calculate preliminary compliance 2-59 The importance of careful review of preliminary findings of a clinical audit 2-60 How to review individual cases 2-61 How to calculate final compliance 2-62 How to display and analyse variation in clinical audit findings 2-62 Types of variation 2-64 Common cause variation 2-65 Special cause variation 2-66 How to determine the type of variation 2-67 How to act on variation 2-70 Analysing run charts to identify special cause variation 2-71 How to identify problems and their causes and act 2-77 Problems and causes 2-77 Fishbone (cause and effect) diagramming 2-78 Asking why five times 2-81 Finding the causes of a problem 2-82 How to plan action 2-85 How to plan repeat measurement 2-85 How to carry out follow up 2-86 Standards relating to clinical audit 2-88 NHS Litigation Authority (NHSLA) Risk Management Standards 2-89 Strategy, structure, culture and technical support 2-90 Strategy 2-91 Structures and systems 2-92 Culture 2-93 Technical support 2-94 References Quality improvement 3-1 Purposes 3-1 The quality improvement process 3-1 Stages in team development 3-5 Team requirements 3-6 Quality improvement techniques and tools 3-6 ClinicalGovernance Manual

3 Agreeing on a quality improvement 3-7 Testing commitment 3-8 Establishing the baseline 3-8 Analysing processes and relationships 3-9 Finding evidence of how things work elsewhere 3-9 Using quantitative techniques 3-10 Using qualitative techniques 3-11 Analysing practice and acting to make improvements 3-11 Solving problems 3-11 Planning action 3-12 Measuring again 3-13 Assessing your interest and readiness to support quality improvement 3-14 How to use consensus-building techniques for quality improvement 3-16 Brainstorming 3-16 Nominal group process 3-18 Delphi process 3-21 Multivoting 3-23 Using consensus-building techniques 3-26 How to test commitment 3-27 Force field analysis 3-28 Readiness for change rating 3-30 Using a testing commitment technique 3-33 Standards relating to quality improvement 3-34 The future for quality improvement 3-34 Strategy, structure, culture and technical support 3-36 Strategy 3-36 Structures and systems 3-39 Culture 3-40 Technical support 3-40 References Evidence-based practice 4-1 Purposes 4-1 The background to evidence-based practice 4-1 Evidence-based practice 4-3 The clinical effectiveness process 4-4 Why do critical appraisal 4-6 Critical appraisal 4-6 Key terms in critical appraisal 4-8 Randomized controlled trials 4-9 How to critically appraise a research study 4-10 How to critically appraise the findings in a research study 4-12 Appraising an individual research study 4-12 Scoring the quality of research 4-16 Risk of harm or benefit 4-17 Formulas 4-18 Using calculations to decide on clinically effective practice 4-22 Systematic reviews 4-24 The importance of the search strategy and inclusion criteria 4-25 iii

4 Meta-analysis 4-26 How to critically appraise a systematic review or meta-analysis 4-30 Critically appraising a systematic review or meta-analysis 4-31 Grading evidence 4-32 Clinical considerations 4-33 Implementation of evidence-based practice 4-33 Standards relating to clinical effectiveness 4-34 The future for clinical effectiveness 4-36 Strategy, structure, culture and technical support 4-37 Strategy 4-38 Structures and systems 4-39 Culture 4-39 Technical support 4-40 References Patient experience 5-1 Purposes 5-1 Why patient experience and involvement 5-1 Patient and public involvement 5-2 Systems for patient involvement 5-3 Systems for public involvement 5-4 Patient experience 5-5 Systems for patient experience 5-7 National patient experience systems 5-7 Patient experience systems at local organizational level 5-10 The future for patient experience and involvement 5-11 Involving patients in quality improvement 5-12 Involving patients in clinical audit 5-13 Mechanisms in the NHS to enable patient and public involvement 5-14 Standards relating to patient focus 5-17 Assessing patient involvement and experience systems 5-19 Strategy, structure, culture and technical support 5-21 References 5-25 iv 6 Clinical risk assessment and management 6-1 Purposes 6-1 The incidence of adverse events in clinical practice in hospitals 6-1 The incidence of adverse events in primary care 6-4 Risk management processes 6-7 Assessing the effectiveness of current reporting and analysis systems 6-10 The role of risk assessment 6-12 Risk assessment defined 6-12 Identifying risks 6-13 Incident reporting 6-14 Observation 6-14 Asking patients 6-15 Screening data sources 6-18 Types of events or situations to identify 6-19 ClinicalGovernance Manual

5 Hospital settings 6-19 Primary care settings 6-22 Other clinical risk areas 6-25 Identifying hazards, events, situations or other potential risks 6-27 The risk assessment process 6-28 Determining consequence 6-29 Determining likelihood 6-31 Judging significance 6-31 Assessing the risk of identified hazards, events or situations 6-32 How to evaluate the risks 6-34 Action and accountability for significant risks 6-34 How to document the risks 6-35 Purpose of analysing clinical risks and adverse events 6-37 Types of failures and errors 6-37 Types of failures 6-38 Types of errors 6-39 Benefits of using root cause analysis 6-41 Root cause analysis terms and questions 6-44 Root cause analysis stages 6-45 Seeking all the facts 6-46 People to get information from 6-46 What to ask 6-47 Organizing the facts into a chronology 6-48 Obtaining and preserving materials and data 6-49 Seeking facts and obtaining materials related to an incident 6-50 Learning the processes 6-53 Top-down process map 6-54 Detailed process map 6-55 Cross-functional process map 6-58 Workflow or layout process map 6-58 Learning the processes related to an incident 6-62 Validating analysis of causes of breakdowns 6-68 Fishbone diagramming 6-68 Asking why five times 6-71 Tree diagramming 6-73 Contributing factors 6-75 Validating root causes and contributing factors of an incident 6-76 Establishing and implementing action 6-81 Confirm the improvement 6-82 Identify the types of changes 6-83 Mobilize opinion to get ready for change 6-84 Match change strategies to types of change 6-85 Determining the effectiveness of actions taken 6-87 Types of measures of the effectiveness of RCA actions 6-88 Model for measures of the effectiveness of actions 6-88 Deciding on a safety improvement 6-89 Establishing an action plan and planning implementation for an incident 6-90 Determining the effectiveness of action as part of an RCA 6-92 Purposes and approaches to monitoring clinical risks and adverse events 6-93 Shortcomings of root cause analysis 6-94 v

6 FMEA 6-95 Carrying out an FMEA 6-99 Standards relating to patient safety The future for patient safety Strategy, structure, culture and technical support for clinical risk management Strategy Structures and systems Culture Technical support References Appraisal and continuing development of staff competence 7-1 Purposes 7-1 The role of appraisal and continuing development in clinical governance 7-1 Key principles of appraisal and development planning 7-2 Roles 7-4 Standards, indicators or criteria for assessing performance 7-4 Competences 7-5 Occupational standards 7-6 Local performance indicators 7-9 Performance profile 7-10 The generic appraisal process 7-11 Pitfalls in traditional approaches to performance appraisal 7-11 Revalidation of healthcare professionals 7-12 Standards relating to staff competence 7-14 Strategy, structure, culture and technical support 7-19 Strategy 7-19 Structures and systems 7-20 Culture 7-21 Technical support 7-21 References 7-22 vi Part 3 Understanding clinical governance as a system Organizational strategy, structure, systems, culture 8-3 and support for clinical governance Purposes 8-3 The strategy, structural, cultural and technical support issues 8-3 A quality and safety strategy 8-5 Evidence on leadership for quality and safety improvement 8-5 A quality and safety structure 8-12 Dissemination systems 8-14 Options for disseminating good practice 8-15 Policies and procedures 8-15 Ethics review of a clinical audit or quality improvement project proposal 8-15 Oversight of clinical audit or quality improvement projects 8-16 Confidentiality 8-17 Security 8-18 Documentation 8-18 ClinicalGovernance Manual

7 Student or trainee projects 8-19 Evidence on assessing an organization s culture 8-21 Clinical governance climate questionnaire 8-23 Competing values framework 8-24 Organizational culture inventory 8-25 Organization ideology questionnaire 8-26 Hospital culture questionnaire 8-26 Techniques and key findings 8-26 Theories on changing organizational culture 8-27 Patient safety culture 8-29 Best practices 8-29 Applying best practices 8-31 References Accounting for the quality and safety of patient care 9-1 Purposes 9-1 The importance of good reporting systems 9-1 Types of reports 9-4 Specifications for reports 9-4 Guidelines for selecting types of reports 9-5 for a report on an individual clinical audit 9-6 for a summary report on clinical audit 9-14 Purpose and contents for a report on a root cause analysis of an incident 9-16 Report requirements 9-18 Approaches to reporting on governance progress 9-20 National clinical audit and confidential enquiries performance 9-20 Implementation of national guidance and standards 9-21 Patient experience in the organization 9-22 High risks 9-22 Significant untoward or adverse events 9-23 Quality Accounts 9-29 Reporting on governance progress 9-33 References Acting to improve governance components or systems 10-1 Purposes 10-1 How to plan the further implementation of clinical governance 10-1 using a tree diagram Using a tree diagram to plan a governance-related outcome 10-4 How to identify the critical points, products and people 10-6 Critical points 10-6 Products and time frames 10-6 Matching the team and the resources to the work 10-8 Communicating about the work programme 10-9 Identifying the critical points and milestones and making the matches Acknowledgments vii

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