enhancing patient care

A l a n W o l f f • S a l l y T a y l o r

ENHANCINGPATIENT CARE

The Wimmera quality improvement and risk management model

Enhancing Patient Care

A practical guide to improving quality and safety in hospitals

Alan Wolff • Sally Taylor

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Alan Wolff, MB BS, MD, MBA, DipRACOG. FRACGP, FACHSE, MRACMA Director of Medical Services and Director of Emergency Department.' and Adjunct Associate Professor^Sally Taylor, RN, RM. BN, HDNC, MAppMgt(Health) Clinical Risk Manager1

1 Wimmera Health Care Group. Horsham. Victoria • 2 School of Medicine. Flinders University Adelaide Sooth Australia

First published in 2009 by MJA BooksAustralasian Medical Publishing Company Limited (AMPCo) ACN 000 005 854

AMPCo House 277 Clarence Street Sydney NSW 2000 AustraliaLocked Bag 3030 Strawberry Hills NSW 2012 AustraliaTel +61 2 9562 6666 • Fax +61 2 9562 6699 • Email [email protected]

This book is copyright. Apart from any fair dealing for the purposes of research or study, criticism or review, as permitted under the Copyright Act 1968, no part may be reproduced by any process without written permission. All enquiries should be addressed to the publisher.

National Library of Australia cataloguing-in-publication data

Enhancing patient care: a practical guide to improving quality and safety in hospitals

Bibliography.

Includes index.

ISBN 978 0 9775786 6 5

(pbk ). I. Wolff, Alan II. Taylor,

Sally

1 Hospital - Safety measures.2 Hospital care - Quality control.3 Hospital patients - Care - Quality control.

Dewey Number: 362.11

© Text: Wimmera Health Care

Group © Design and Typography:

AMPCo

mailto:[email protected]

Foreword

As the title indicates, this is a "practical guide" to enhancing patient care through the improvement of quality and safety in hospitals.

A clear understanding of the key concepts of patient safety, risk management and quality improvement is critical to providing the care that we, as individuals and as a community, expect from our health system. Despite well trained, enthusiastic health care professionals trying to deliver the very best care possible, the system often fails them by a lack of support, encouragement and resources to colled the data, implement the processes and teach the methods that will help to deliver the very best care possible. This practical guide to implementation will help managers, and health professionals at all levels, achieve their goals in safety and quality.

Implementation of processes and methods that are known to work is likely to be the most cost-effective way of improving care. This guide takes the best information about implementation available from the literature and adds the authors' practical knowledge, which has been gained from almost 20 years of hands-on experience at their local hospital in rural Victoria. Their successes have been well publicised and are a credit to them.

Improving quality, addressing risk and providing the safest possible care is not an easy task, with many barriers and some resistance from busy doctors and nurses. Through their own experiences, the authors clearly understand the clinician's point of view, which should help reduce resistance to change. The long-term demonstration and evaluation of successful improvement in an Australian hospital using established methods from health care and other industries gives the guide considerable authority. It is easily accessible, well organized, clearly and simply written and is well referenced.

The authors have set out to produce "an integrated set of quality improvement and risk management modules that can be used individually or in various combinations" and "a practical,

step-by-step approach to implementing and maintaining an effective clinical quality and safety program*. In my view, they have achieved their goal and have, in so doing, provided great help and a marvellous resource document for everyone who is actively trying to improve care delivery.

Bruce Barraclough, AO President. Internationa) Society tor OuaMy in HmM Cam

"tmir Hit- Tnilti 'fifnln' riiniriil TirnHnnr* ..................

Contents

Foreword.....................................................................................................................................................................................™

Acknowledgements.......................................................................................................................................................................B

Preface........................................................................................................................................................................................™*

Introduction.................................................................................................................................................................................™

1 An overview of clinical governance.......................................................................................*

1.1The roles, structures and processes of health care management...................................1

1.2Governance....................................................................................................................2

1.3Clinical governance........................................................................................................3

1.4The components of a clinical governance program.........................................................5

1.5Reporting the results of the clinical governance program...............................................II

1.6Accountability for the clinical governance program in health services..........................11

1.7A health service's role with the major components of a clinical governance program. .12

2 Quality improvement — measuring clinical performance and closing gaps in clinical care.17

2.1 Defining quality improvement......................................................................................17

2.2 Deciding the clinical areas in which quality improvement activities should be undertaken

18

2.3 Components of a quality improvement program..........................................................19

2.4 Quality improvement collaborates................................................................................26

2.5 Whole-of-practice audits...............................................................................................27

2.6 Clinical indicators.........................................................................................................29

3 Risk management — why do adverse events happen to patients?.....................................37

3.1 Health care delivery as a system..................................................................................37

3.2 The extent of adverse events.......................................................................................38

3.3 The reasons why errors occur.......................................................................................39

3.4 Errors and adverse events...........................................................................................

3.5 The response to errors..................................................................................................41

3.6 The basic risk management process.............................................................................43

3.7 The basic risk management process in health care......................................................43

3.8 Characteristics of an ideal quality improvement and risk management system...........44

3.9 The Wimmera quality improvement and risk management model................................44

4 Dctccting adverse events and risk.....................................................................................49

4.1 Methods of detecting adverse events and risk............................................................ 494.2 Reactive risk management — detecting adverse events..............................................50

4.2.1 Direct observation............................................................................................... 50

4.2.2 Legal claims..........................................................................................................50

4.2.3 Medical record review...........................................................................................51

4.2.4 Clinical incident reporting.....................................................................................63

4.2.5 Sentinel event reporting... ...................................................................................71

4.2.6 General practitioner feedback..............................................................................74

4.2.7 Clinical pathways and variance analysis...............................................................76

4.2.8 fetieni satisfaction................................................................................................77

4.3 Proactive risk management — detecting risks..............................................................78

4.3.1 Consultative councils and committees..................................................................78

4.3.2 Coronial reports....................................................................................................78

4.3.3 Information from insurers.....................................................................................79

4.3.4 Statewide and national databases of clinical incidents.........................................80

4.3.5 Media reports........................................................................................................83

4.3.6 Clinical journals.....................................................................................................84

4.3.7 Pharmaceutical and equipment alerts...................................................................84

4.3.8 Inquiries into individual health services or specific clinical areas in health services.

85

4.4 Additional proactive risk management methods...........................................................86

4.5 Systematic review of external information about risk...................................................88

5 Analysing adverse events and prioritising action................................................................95

5.1 Managing a patient who has experienced an adverse event.........................................96

5.2 Managing a stafT member who has been involved in an adverse event........................97

5.3 Analysis of adverse events............................................................................................98

5.4 Prioritising adverse events for action..........................................................................103

5.5 The surveillance committee........................................................................................105

5.6 Principles for prioritising action to prevent adverse events recurring..........................109

6 Taking action to close gaps in care and prevent adverse events recurring — evidence and theory119

6.1 Determinants of implementing a change within a health service................................121

6.2 Theories relevant to the implementation of change and their practical implications for

change in health care..................................................................................................126

6.3 Approaches to change................................................................................................141

6.4 Developing change strategies....................................................................................141

6.5 The evidence about change strategies.......................................................................144

6.6 Change strategies commonly used at the Wimmera Health Care Group.....................145

6.7 Actions commonly taken to prevent adverse events that are generally ineffective...........................................149

7 A practical framework to close gaps in patient care and reduce risks to patients.............155

7.1 A practical framework.................................................................................................155

7 2 Motivating doctors to participate in quality and safety programs...............................177

7 3 The framework in action — clinical pathways.............................................................179

*8 Reporting the activities and results of the clinical governance program.............................W

9 A quality improvement and patient safety culture...............................................................I"

9.1 Types of organisational culture...................................................................................'91

9.2 Components of an informed culture..........................................................................192

9.3 Types of safety cultures.............................................................................................194

9.4 The safety spectrum in health services — from resilience to vulnerability.................195

9.5 Measuring the patient safety culture.................. .....................................................198

10 Eighteen practical steps to implementing a clinical risk management program in j health service ... 203

11Implementing a clinical risk management program in a small hospital...........................217

11.1Problems unique to small hospitals that want to undertake a clinical risk

management program.............................................................................................217

11.2Modifications required for programs in small hospitals.............................................217

11.3Screening and medical review..................................................................................218

11.4Obtaining the support of small hospitals..................................................................218

11.5The logistics of screening and medical Teview.........................................................218

11.6Reference panel recommendations..........................................................................219

11.7Small hospital clinical risk management manual......................................................220

11.8Introduction of the program across rural Victoria.....................................................220

11.9...................................................................................Changes to the screening criteria

221

12.............................................................................Important messages................................223

12.1Health care as a system...........................................................................................223

12.2........................................................................................................Clinical governance

223

12.3......................................................................................................Quality improvement

224

12.4Detection of adverse events and risk.......................................................................224

12.5...................................................................................Analysing adverse events..........

225

12.6Prioritising gaps and risks.........................................................................................225

12.7.....................................................................................Closing gaps and reducing risks

225

12.8......................................................................................................................Conclusion

227

Appendix 1: Wimmcra Health Care Group Adverse Event - Analysis Form...........................229

Appendix 2: Clinical risk management executive summary.................................................232

Index...................................................................................................................................235

Acknowledgements

Fortunately, in 1987, Duncan Stuart introduced adversfe event screening to Australia after visiting the United States to find a suitable clinical risk management program for Royal North Shore Hospital. His work influenced health professionals in other hospitals, and he generously organised seminars to explain the Medical Management Analysis model. The Wimmera clinical risk management model was established after one such seminar. Without Duncan's contribution to Australian quality and safety, the Wimmera model would not have been developed and this book would probably not have been written.

For a quality improvement and clinical risk management program to flourish jn a health service for 20 years requires the suppon of many dedicated individuals working together as a team. Most critically; the culture at the Health Care Group has supported the provision of high-quality, safe care, which has allowed the program to develop, with the benefits to patients always being paramount in any discussion Wr thank all the staff at the Health Care Group, Medical Staff Group, Executive and Board of Management for their support of the program over many years.

Over the years, the members of the Patient Care Committee have generously given their time to participate in the program; in panicular, Ian Campbell, a visiting surgeon, and David Leembruggen, a visiting general practitioner, enthusiastically panicipated in the program from day one. They have

reviewed a huge number of medical records and contributed enormously to robust discussions in Patient Care Committee meetings, and supported the program and its recommendations to senior medical staff. Gram Phelps and Edward Janus, both visiting physicians, were long-term contributors.

Jo Bourke worked tirelessly as the first clinical risk manager in what was largely uncharted territory. She gained the respect of medical staff, which allowed nursing staff to participate in formal discussion of adverse events, helping us formulate comprehensive strategies and take action to prevent these events recurring. After it became clear that many adverse events clustered around patients with panicular diagnoses, Janeue McCabe became the driving force in establishing the clinical pathway program, which resulted in dramatic improvements in the quality of care for many patients.

The success of a comprehensive medical record review program depends on the strong suppon of Health Information Services. We thank Cathy Dooling, the former manager of the service, for developing and introducing the medical record screening process in her department, and Briana Farr, the current manager, and their staff for their continuing suppon. Kieran Loughran and his stafT have provided excellent information technology suppon over many years.

Rob Irvine very generously provided facilities at the Horsham campus of Ballarat University that were most conducive for writing. Shirley Mewett, our librarian, found every reference that we have required, however obscure the journal, which assisted greatly with the book's literature review and references

James Dunbar, John Christie, Caroline Brand, Les Reti, Karen Dunn, Mane Aitken and Alicia McGrath most kindly agreed to review the manuscript and made many very helpful suggestions for improvement. Graeme Exell kindly proofread the final draft. We are grateful for the lime they took and effort they made to provide valuable feedback about our work.

The generous suppon of the Victorian Department of Human Services, initially with Ginical Risk Management Pilot programs, and then the Limited Adverse Occurrence Screening program, has been much appreciated.

The book would not have been possible without the magnificent suppon and expenise of Rivqa Bcrgcr. our editor at MJA Books, and the guidance of Ruth Armstrong, Deputy Editor of the Mcdical

Journal of Australia, and Glenn Carter, Production Manager, and Peter Humphries, Production Coordinator

Finally, our thanks go to our spouses Yvonne Cymbalist and Peter Taylor for their suppon during the lengthy process of writing and editing.

Preface

Small ideas and beginnings can have large ripple effects. Wimmera Health Care Group, where this

clinical quality improvement and risk management model was developed, is 300 km north-west of

Melbourne and has approximately 10 000 admissions a year. Over 19 years, we have developed a

tew basic ideas into an efficient quality improvement and clinical risk management model.

The model has now been adopted by many hospitals, ranging in size from tertiary centres in capital

cities to rural hospitals with one doctor on staff. These hospitals implemented the model because a

person, or group of people, had a commitment to and passion for providing high-quality care, and

continually improving that standard of care. This drive may come from a board member, a senior

executive, a quality or clinical risk manager, a clinical champion for quality or, ideally, a group of

such people.

Strong motivation and dedication are necessary, because, sooner rather than later in the process of

implementing and maintaining a quality improvement and clinical risk management program,

adversity will strike. It is probably the response to things when they go wrong that most determines

whether the program will be successful. Many people will feel threatened (for various reasons) by

the issues raised by such programs and the changes required to implement and maintain them. The

temptation will frequently be to give up and claim that it is just too difficult to achieve the required

change. But health care is complex, and perfect solutions to problems are unlikely to exist. Most

decisions that attempt to change complex systems will result in unintended negative events. What

is required when things go wrong — and they most certainly will — is for you to pick yourself up,

dust yourself off, reaffirm your beliefs about what is required, and return to the battle the wiser for

the experience.

So when applying the principles provided in this book, allow for the complexity of health care

delivery systems and human nature, and continue on through the turbulence. After 19 years of the

program at Wimmera Health Care Group, it has become easier. We are reminded daily of the many

obstacles to achieving change, but also of the significant improvements we have made in the

quality and safety of patient care through the dedication of staff members. Our vision is to continue

this pathway of improvement to achieve the safest and best health care for all in the Wimmera.

We wish you the best for your endeavours during this exciting journey and would be pleased to

receive feedback from readers via our website (www.whcg.org.au).

Alan Wolff and Sallv Tavlor

Introduction

Health care is primarily about improving the quality of patients' lives, but its delivery can be a complicated process that requires the use of many complex systems. The treatments available tor providing patient care are becoming increasingly more effective and complex, with an increased risk at errors occurring. Demand for health services is usually high, and advances in knowledge and technology are rapidly and continuously being made, while the resources available to provide

http://www.whcg.org.au/

services remain limited. As well as "a complex environment with multiple stakeholders, [there are) conflicting objectives and considerable restraints".'

Much of the care provided to patients is not supported by scientific evidence. There is wide variation in the treatment being given to patients with the same clinical conditions, and a significant proportion of the care recommended for the leading causes of death and disability are not being provided.2 Further, some care that is provided causes preventable harm to patients,3 and most errors are thought to be undetected and unreported.11 Considerable cost is being incurred and valuable resources expended in providing suboptimal care.

There is an expectation by the community that health care will be of high quality, that people receiving health care will be safe while it is being delivered, and that errors in providing care are "neither acceptable nor inevitable".4 Consequently, if the anticipated outcome of care is not achieved, retribution is often sought; hence, litigation by patients against clinicians and health services is increasing.4 At the same time, health professionals and management are being held increasingly accountable for the quality and safely of the care they provide, not only by patients and their relatives, but also by governments and regulatory and funding bodies. Despite these conditions, the management of many health services still predominantly emphasises the service's financial situation and patient throughput targets, rather than the quality of care and the level of patient safety within the health service.

In our experience, most health care professionals want to provide the best possible care for their patients. However, even with the very best of intentions and the greatest vigilance, suboptimal care and errors in patient management occur frequently. Given the conditions under which health care is currently provided, how can health services and the professionals working within them ensure that they consistently provide a high-quality, safe service to their patients? The structures, processes and systems of health care delivery are created under the influence of leadership. Culture and performance need to be effectively monitored, and systems appropriately changed in response to the quality and safety of the care that is being provided.

There is now a great deal written about the quality of care provided to patients and the level of patient safety in health services. Twenty years ago, the occasional anicle about quality or safety would appear in major clinical journals. Now, whole journals are devoted to these topics, and the volume of literature is considerable. The terminology used in these publications has expanded, and

can be confusing. There has been much activity being undenaken aimed at improving the quality and safety of clinical care, but there are still significant gaps in the quality of care provided to patients, and the number of adverse events experienced by patients while receiving care is still substantial. Health services need a simple, clear-cut and practical approach to delivering high-quality and safe health care to assist with their quality improvement and risk management programs.

This book has been written to assist the many health care professionals and health services who arc strongly committed to providing high-quality, safe care to their patients, and who arc searching for the best way to provide such care. It is written from the perspective of a health service that independently wishes to improve the quality of care it provides for its patients and raise the level of patient safety in their facility, without these requirements being imposed on the service by external regulatory, accreditation and funding bodies. We have found that in most health services, there are individual clinicians and managers with a genuine passion and internal drive to provide the best care possible for their patients — without having this forced upon them as a requirement of their senior management or from external bodies.

Much of what is written about quality of care and patient safety is theoretical, and the evidence — especially about the effective implementation of quality and safety strategies — is limited. Relatively tittle is written of practical value to individual health services tTying to satisfactorily address these important issues in their facilities. The task can be overwhelming for clinicians charged with the responsibility of developing, implementing and maintaining a quality and safety program for their individual health services Without clear overall direction from a comprehensive organisation-wide quality and safety program, individual health services may move in many directions simultaneously, with little overall integration and coordination. The next practical steps that individual health services should undertake in their quality and safety programs are often not clearly visible.

To fill this gap, we describe a simple and practical framework that can act as a signpost for health services wishing to establish a quality and safety program (or enhance an existing program) to effectively monitor and improve quality and safety in all the clinical areas of their health service. The framework is:

■ logical

■ fully integrated■ easy to understand■ based on relevant theory, evidence, and 19 years of practical experience in designing and

implementing a comprehensive clinical quality improvement and risk management program at the Wimmera Health Care Group in Horsham, Victoria.

We describe in detail an integrated set of quality improvement and risk management modules that can be used individually or in various combinations. A practical, step-by-step approach to implementing and maintaining an effective clinical quality and safety program will also be described, together with practical examples outlining how each component of the program can be used in practice.

References

1 Res V. Sutherland K. Organisational change: a review tor health care managers, professionals and researchers. London: National Co-ordinating Centre for NHS Service Delivery and Organisation R & 0.2001.2 McGtyrm EA. Asch SM. Adams J. et al. The quality of health care delivered to adults in the United States. N Eng J

Med2003: 348: 2635-2645.

3 Brenoan TA. Leape LL. Laird NM. et al. Incidence of adverse events and negligence in hospitalised patients.

N Eng J Med 1991; 324: 370-3764 Bion JF. HeffnerJE Challenges in the care of the acutely

ill. Lancet 2004; 363; 970-977. □1 An overview of clinical governance

This chapter wMf:

■ Discuss the organisation of health care management■ Define clinical governance■ Describe the major components of clinical governance■ Discuss accountability for clinical governance■ Describe the role of health services in establishing and maintaining effective clinical

governance.

1.1 The roles, structures and processes of health care management

Management has four main roles in any organisation, including health services — planning, organising, leading and regulating. Regulating involves monitoring and evaluating the health service's performance and determining whether activities are being carried out as planned, thereby allowing the health service to achieve its goals. In essence, regulation involves determining the performance required within the organisation to achieve a particular goal, monitoring the actual performance of the organisation towards achieving the goal, and, if there is a significant deviation between the desired and actual performance, taking appropriate corrective action. The

organisation's goals should also be achieved using the resources the organisation has available — both efficiently (with a minimum of waste) and effectively (ensuring the right things are being done).

Organisations usually have a distinct purpose for their existence or a main goal they wish to achieve through their activities. For health services, this goal usually involves providing their communities with the best range and quality of health care possible with the available resources.

To help meet such goals, health services are provided with resources to construct buildings, employ skilled staff and purchase appropriate equipment. Most health services have developed strategic plans that include the range and level of clinical services they will provide. The delivery of these clinical services is usually supported by a number of structures, including policies and procedures detailing how work is to be undertaken in the organisation, job descriptions, and lines of authority from the board of management through to executive staff, department heads and all other staff

A committee structure is usually in place to aid decision making and to review activities occumng within the health service. For example, a pharmacy committee decides which medications are approved for use by medical stall. A medical appointments committee appoints all senior medical staff and determines the range of clinical services, including the operations and procedures each senior doctor can provide within the service. The standards against which health services are assessed by national health care accreditation bodies will, among other things, detail the structures that should be in place in each service and how the structures should be assessed to determine whether they are functioning effectively.

Using these structures, a number of systems (or sequences of processes) of care are then created to provide specific clinical services to patients. For example, when an individual presents to a health service's emergency department, how will the urgency of presenting problem be determined? Which nurses and doctors will assess the patient's clinical condition and provide clinical care for them? If the patient requires investigations, how will they be requested, and how will the results be communicated to medical staff? If the patient requires admission, what administrative and clinical processes will need to be followed for the patient to be transferred from the emergency department to a ward? Using these

Enhancing patient care

systems, health care is provided to patients and clinical activity occurs within the health service. The culture, leadership and education programs in the health service influence these systems. The process is represented in

Figure 1.1.From a management perspective, clinical care is usually regarded as the health service's output. As with other industries, one of management's functions and responsibilities is to regulate the output of the areas of the organisation for which they are responsible. Such regulation will need to be applied over the volume and quality of the organisation's output.

1.2 Governance

Another term for the activity of regulation in organisa-tions and the framework used to achieve it is govern-

ance. In business, the principles of corporate governance include the oversight of management, the

appropriate breadth and depth of expenise of organisation's directors, the directors' independence, ethical and responsible decision making, integrity of

financial reponing, monitoring and management of risk, maintenance of full-time internal audit, encouragement of enhanced performance within the

organisation, and protection of the shareholders' interests.1-2 Major tenets of corporate governance include fairness, transparency and ethical business practices.1

Previously, governance in health care organisations focused primarily on Financial governance. About 90% of board of management meeting agendas comprise financial items, and only 10% of items are clinical in nature.4 Discussions at board of management meetings often focus on issues such as whether:■ the service can meet its financial obligations adequately and in a timely manner■ external financial audits are being undertaken regularly, and whether their results are satisfactory■ areas of financial concern detected by these audits have been properly addressed■ revenue obtained from private patients utilising the health service has been maximised■ the health service's expenditure in areas such as pharmaceuticals, diagnostic services or

ambulance transpon are within the allocated budget for these areas.

Although these areas of the health service are clearly important, it is equally important that "the quality and safety of patient care is not pushed from the |

board| agenda by immediate operational issues", but is placed "at the heart of the board agenda".4

More recently, there has been a move to extend the regulatory function of management in health services to include regulation of the health service's clinical output. Clinical output refers not only to the numbers and types of patients being treated, but also the quality of clinical care that patients receive and the level of safety they experience while receiving that care. Regulation of the quality of care that is provided and the level of patient safety in clinical areas in health services is referred to as "clinical governance"

Rgw* 1.1 Tha structure and procMsas of health car* IMRi^tfMllt

1 An overview of cinicalgowemeno*

1.3 Clinical governance

Clinical governance has been defined differently by health systems in various countries; there is no single agreed definition. The term was first used in the Ufiited Kingdom and was defined as "a system through which [National Health Service] organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish".5 In Australia, clinical governance has been defined as "the system by which the governing body, managers and clinicians share responsibility and are held accountable for patient care, minimising risks to consumers and for continuously monitoring and improving the quality of clinical care".6 The World Health Organization has divided clinical governance into four aspects: professional performance review, resource use, risk management and patient satisfaction.7 Clinical governance "should consist of an integrated system of different types of activity all aimed at improving quality of care" 4

In a practical and operational sense, clinical governance has also been described as

doing the right thing, at the right time, by the right person — the application of the best evidence to a patient's problem, in the way the patient wishes, by an appropriately trained and resourced individual or team ... working within an organisation that is accountable for the actions of its staff, values its staff (appraises and develops them), minimises risk and learns from good practice and indeed mistakes.8

Clinical governance aims to create a system to continuously improve the quality and safety of patient care. As corporate governance concentrates on the activities of the board of management and executives and financial and business issues, clinical governance focuses on what occurs at the bedside and in wards, specialist units and clinics where health services are provided.9 The principles and activities that make up a clinical governance program are not fundamentally new,10 but have previously been used in "a disparate and fragmented"11 manner with each component having operated as a "silo" within the organisational structures of health services over many years.12 This disjointed approach often meant that decisions in one area of clinical governance were made in isolation from key issues in other related areas.4

What has been missing from these clinical governance activities has been a framework to systematically incorporate and integrate all these related activities into one comprehensive program to most effectively improve the quality of patient care and the level of patient safety.Put simply, clinical governance has two major com-ponents — quality of care provided the patients and patient safely (Figure 1.2).13

1.3.1 Quality of careThe Institute of Medicine in the United Slates defines quality of health care as "the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge."14 In basic terms, quality of patient carc can be defined as ensuring lhai ihe nght things happen lo patients more often 13 The quality of carc

componcni of clinical governance therefore concentrates on the positive things that happen to patients

The first step to getting patient care right is, most often, knowing the right thing to do. The right thing to do for a patient may need to be determined according to the best available evidence of an intervention's effectiveness, the appropriateness of that intervention for that patient, the safety of the intervention, the overall health needs of the health service's target population, and the resource constraints under which the health service is functioning. Whether the intervention represents value for money and whether it provides the greatest benefit for the health service's population may also need to be determined. To ensure that the right thing is consistently and increasingly well undertaken in a health service, staff require appropriate training and adequate resources need to be provided. Ensuring that the right thing is done at the right time for a patient will also require attention when health care delivery systems are being developed.

Evaluation of the quality of care provided to patients requires that a standard of clinical performance be set. Best practice in a particular clinical area may be determined from sources external to the health service, such as scientific evidence from research studies published in medical journals, national and international clinical guidelines, or clinical practices at health services that are regarded as exemplars in providing care in that clinical area. The health service's actual performance in providing care for patients in this clinical area is then measured. If the actual performance deviates significantly from what is regarded as best practice, the deviation is analysed and appropriate corrective action is taken to close the gap between the actual performance and the desired standard. Importantly, ongoing monitoring of the health service's performance should continue to determine whether the action taken has successfully closed the gap.

The process of closing the gap between the clinical care that is being provided and best practice is referred to as quality improvement. In some instances, it may not be possible to achieve completely, and the cycle perpetuates indefinitely in a process of "continuous quality improvement", where performance continues to improve and gaps continue to narrow. It is also important to recognise that what constitutes best practice in a particular clinical area will change with lime, and therefore should be regularly redefined to incorporate advances in medical knowledge.

1.3.2 Patient safetyThe second major component of clinical governance in a health service is patient safety.13 The Agency for Healthcare Research and Quality in the US defines patient safety as "the absence of ihe poiential for, or the occurrence of, health care-associated injury to patients created by avoiding medical errors as well as taking action to prevent errors from causing injury".15 Patient safely can be simply defined as ensuring that the wrong things happen to patients less frequently.13 This component

of clinical governance concentrates on the negative things that happen to patients and taking action to ensure they occur less frequently.

The level of patient safety in a health service can be assessed reactively or proactively. Using the reactive approach, clinical activity is continuouslyX3nca/

gtnwnence ... is not a method for

managers to govern or control doctors, nor is it a method tor doctors to govern or control managers or other clinicians.'

Perkins R. et al N Z

Med J 2006;119: U2259


1 An overview ol clinical flcwemeno*

monitored, and if an adverse event is detected, it is analysed and appropriate action is taken to reduce the probability of recurrence. In the proactive approach to patient safety, systems of care are examined lo identify weak processes that represent an unacceptable level of risk of patients experiencing an advene event while they are receiving care. Once identified, changes are made to these processes and their systems are strengthened to reduce the probability of an adverse event occurring. As with quality improvement, ongoing monitoring of clinical activity should continue to determine whether the action taken or the process changes made have successfully reduced the chances of a patient experiencing an adverse event. Reducing the probability of an adverse event occurring is called risk management.

An important precondition in establishing risk management programs in health services is that qualified privilege has been obtained. Under the relevant legislation, information obtained from discussions in quality improvement committees about adverse events and errors oannot be disclosed or used in evidence in legal actions against hospitals and clinicians. Such privilege helps clinicians to openly discuss errors during quality improvement committee meetings.9

Importantly, there is considerable overlap between these two components of clinical governance (quality improvement and risk management). For example, an adverse event that is experienced by a patient may be detected by the risk management program, but could have occurred because of a gap in the quality of care provided. The essence of clinical governance is to ensure that the right things happen to patients more often (by making it easy to do the right thing) and that wrong things happen to patients less often (by making it difficult to do the wrong thing).16

1.4 The components of a clinical governance program

These major objectives of clinical governance are achieved using quality improvement and risk management. Clinical governance can be simplified into several basic components, comprising principles and activities that can be described and grouped in different ways. Despite the varying terminology, the main components of a clinical governance program in a health service include:■Evidence-based medicine — providing clinical care for patients in accordance with best practice

determined by scientific evidence.■Credentialling and privileging — determining that clinicians working in the health service have

the required qualifications, training and experience to safely undenake the clinical care they are providing, and that this care will continue to be provided to a high standard over time.

■Clinical audit — measuring the performance of individual clinicians and the health service's aggregate clinical performance in providing care to patients, and comparing these performances with best clinical practice and the performance of similar health services. Measurement should be across six dimensions of patient care — safety, effectiveness, patient-centeredness, timeliness, efficiency and equity.17

■Professional development — providing clinicians with appropriate continuing medical education and skills training necessary to provide high-quality, safe care.

■Consumer involvement — determining the needs of individual patients receiving care in the health service and the needs of the health service's patients as a group, and meeting these needs.

■Organisational factors — that appropriate resources, strong leadership and commitment, adequate education and support, and clear, timely and direct communication are provided by the health service within a culture that supports quality improvement and risk management. Ensuring these factors arc in place may require substantial culture change.Many of these activities are cornerstones of providing high-quality, safe carc. and have been

used for a long time in health services. Some of the activities overlap in their role in the overall clinical govcmancc

a health service. It is now timely and appropriate to include them in one comprehensive, integrated ctuucal governance model to continuously and effectively improve quality and safety in individual health services. We will examine each of these activities of clinical governance to demonstrate how they fit into the overall model and discuss how to operationalise each activity so they can be most effectively used by individual health services.

1.4.1 Evidence bawd medicineTo know the right thing to do for a patient requires that the clinical care provided is based on the best available scientific evidence about which interventions provide the best chance of obtaining the most favourable outcome for patients (eg, which investigations will provide the most useful information for medical staff, and which medications will provide the greatest probability of improving a patient's outcome). Such information is obtained from the results of clinical trials. The highest quality information is obtained from systematic reviews of multiple randomised controlled trials (RCTs); single RCTs may also provide high-quality evidence. Observational studies and expert consensus provide weaker evidence. The stronger the evidence, the more likely the intervention studied will improve the patient's outcome.18

Importantly, despite the increasing number of interventions demonstrated to be effective by RCTs,19 the answers to many questions that commonly arise when providing medical care have not been determined in such trials. In these situations, information from non-randomised trials or expert consensus opinion is viewed as representing best practice in those clinical areas, and this information is used to provide care.

Using information from the best available clinical trials or expert opinion in providing care to patients is known as practising evidence-based medicine. Evidence-based medicine has been defined as

the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external evidence from systematic research.20

1.4.1.1 Limitations of evidence-based medicineWherever possible, a health service's protocols and guidelines detailing how to manage patients with particular clinical conditions should be based on the best available scientific evidence. There are, however, limitations of attempting to practise evidence-based medicine:■ High-quality evidence from RCTs is not always available to answer the clinical questions that

may arise in everyday clinical practice. Expert clinical judgment will, to some degree, always be required to develop best-practice guidelines and in clinical practice.21 Many of these questions cannot be answered because the necessary trials would not gain the required ethics approval.

■ When high-quality evidence is available, the RCTs on which the recommendations are based have often excluded patients with comorbidities. Therefore, the findings may not be directly applicable to individual patients who have comorbidities and the condition studied in the trial.


■ Recommendations from RCTs are based on crude averages or summary results of all the patients who participated in the trial. These aggregated results do not accurately represent the typically substantial and highly skewed vanation in baseline risk of the patients in the trial, and therefore often cannot be meaningfully and easily applied to a typical patient. Most negative outcomes in trials occur in participants who are at high risk for such an outcome. However, most patients participating in these trials are at low risk for an adverse outcome. Further, the differences in benefit versus harm for different groups in RCTs are not routinely determined and reported. Importantly, if the therapy evaluated in the trial can benefit patients as well as harm them, patients with a low baseline risk may be more likely to be harmed by the therapy than benefit from it. Ideally, in everyday practice, when

1 An overview at dlncM Qavtmtnoa

clinicians are determining which patients should receive a recommended therapy, they should stratify their patients according to their risk of the experiencing the outcome the therapy has been demonstrated to prevent .22

■In the past, researchers have often not published the results of RCTs in which no benefit from the intervention was demonstrated, making any meta-analysis of trials in this clinical area less accurate. However, it is now becoming obligatory to register trials.

■Even when high-quality evidence is available to guide management in a particular clinical area, an evaluation of the cost and feasibility of consistently using this evidence in providing care to patients has often not been undertaken. In these circumstances, several important questions should then be considered. Are the resources available to apply the evidence? Do staff members have the appropriate skills and equipment to use the evidence? Will patients accept the treatment?23

With the large, ever-increasing amount of clinical research being undertaken, it is no longer possible for individual clinicians to read all published research papers relevant to their panicular area of clinical practice. Therefore, clinicians need ready access to summaries of relevant information from such research to practise evidence-based medicine. Such summaries arc available from databases of critical reviews of the scientific evidence or treatment protocols based on best


practice developed by national or international bodies. These summaries and guidelines should be readily available when and where clinicians need to make decisions about patient management in their health service.

Unlike the US, the UK and New Zealand, Australia does not have a national database of such information, so Australian health services need to use commercial sources. A further challenge for health services aiming to provide evidence-based care to their patients is that with the ever-increasing and changing evidence of what constitutes best practice in a particular clinical area, the health service's clinical policies require regular and systematic review and updating, which demands substantial time and resources. This updating process can be assisted by maintaining online policy and procedure manuals that are readily available to all staff, rather than hardcopy versions.

1.4.2 Clinical auditHealth services can monitor the degree of compliance with evidence-bascd medicine in clinical practice using clinical audit. Clinical audit systematically reviews the care provided to patients against explicit criteria of the structure, process and outcome of care. If gaps in care are detected, appropriate action is taken aimed at closing the gaps and thereby improving the quality of care. Ideally, the audit process will then continue to monitor the care to determine whether the actions taken have been successful in achieving the improve-ment. The data obtained must be reliable, and audits should therefore be undertaken using high standards of design, measurement, data collection and analysis. Clinical audits should have a multidisciplinary focus

' WV

"Doctor* need to accept to every cHric* daemon they metfB came*

aneconomc consequence that they am using up money tor one person that wt not be available tor others ^Managers need to value quahty as wet as financial risk management. They have to accept that doctors know more about what works for patients than they do. And they have to accept that the doctors make the decisions Mat cost money.'

Perkins R. et al

NZ Med J 2006 .119 U2259

rather than just focusing on medical aspects of carc. and Ik continuous rather than


intermittent or project-based. Ideally, clinical audit should be comprehensive and a routine part of clinical practice in a health service.10 Clinical audit will be discussed in greater detail in Chapter 2.

1.4.3 Credentialling and privilegingFor clinicians to do the right thing for their patients, they need to possess the required professional qualifications, have undenaken adequate training, and have an appropriate level of relevant experience. It is therefore essential for health services to ensure that the clinicians providing care in each clinical area in the service meet these basic requirements that are critical to providing high-quality, safe patient care.

Most health services have a credentialling and privileging process in which every doctor who wishes to work in the health service completes a detailed application form, outlining their professional qualifications and documenting where they have previously worked. They are also required to provide details of the areas of clinical medicine in which they wish to practise in the health service and the operations and procedures they wish to perform. Applicants may also be required to document the numbers of each type of operation or procedure they have performed during their careers to date and, most importantly, in the recent past.

References are sought by the health service about the clinician's suitability for the clinical appointment for which they have applied. Advice is then sought from the relevant specialty college or experts in the field about whether the clinician^ qualifications and experience are sufficient for practice within the health service, and which operations or procedures they should be allowed to undertake. The board of management, usually on the advice of its medical appointments subcommittee, then decide whether to formally appoint the clinician to the health service, and if so, approves their clinical areas of work, operations and procedures.

Before undertaking the credentialling and privileging process, health services should determine the range and depth of clinical services they can safely provide given the clinical expertise, facilities and resources available.24 Even though individual doctors may have appropriate qualifications and experience to undertake particular clinical procedures, the service may not have the facilities or support staff to ensure the procedures can be safely performed. The credentialling and privileging process is a critical pan of an effective clinical governance program. The process in Victoria is described in detail and the application forms used by Victorian health services are provided in a policy handbook.25

1.4.4 Professional developmentDoing the right thing for patients also requires that clinicians maintain their knowledge and skills in the clinical areas in which they are practising. Medical knowledge is an essential component of being able to provide high-quality care.26 Having given practitioners clinical privileges to practise in particular clinical areas and to perform specific operations and procedures, the service must then ensure that they maintain their knowledge in these clinical areas and their skills in performing the specific operations and procedures. By participating in appropriate continuing medical education, a clinician's knowledge can be maintained and expanded to incorporate new scientific evidence.

Ongoing education is now mandated by many professional bodies as part of their members' recenification process. Maintaining up-to-date knowledge in their clinical field is now regarded as clinicians' professional duty. As well as helping clinicians practise evidence-based medicine, health services can help them maintain and expand their knowledge by providing them with easy access to high-quality scientific databases of clinical trials and guidelines to support clinical decision making, and by encouraging clinicians to keep up-to-date in their clinical area of expertise. Opportunities should also be -made available to clinicians to receive education in how errors occur while providing care, and the ways quality and safety can be optimised for patients.24

1 An overview at cfcrnca) gowmgw

The form and content of continuing medical education need to be carefully chosen. Not all tonus of medical education are effective in changing clinical practice. Passive forms of education, such as didartir lectures, conferences and dissemination of educational materials, have been shown to be ineffective11 Education based on individuals' personal learning needs and with active participation, educational outreach and small group learning can be effective. As continuing medical education can be costly and occupy considerable clinician time, the potential impact on changing clinical practice of the methods used should be evaluated.23

Skills in performing specific operations and procedures can be maintained, firsdy by clinicians performing appropriate numbers of these procedures over time, and secondly by the health service auditing the clinician's performance in undertaking these operations and procedures and benchmarking their patients' outcomes and complication rates against the performance of their peers and rates published in the scientific literature. Information about individual clinicians' performance can be provided to the credentialling and privileging process at the time of the clinician's reappointment, or earlier if clinical audits show there may be serious quality or safety issues.

In our experience, such serious issues involving individual doctors arise infrequently, but they do occur. As with the general population, doctors may be impaired because of substance misuse or mental or physical illness; they may also have behavioural problems. Leape estimates that "30-40% of doctors at one time or another have a problem that poses a threat to safe patient care", and at any one time in a hospital with 100 doctors, one or two will need help.27 Leape advocates objectively and routinely monitoring all doctors' performance against accepted standards (similar to the routine assessment of airline pilots) to identify those with declining performance early. Constructive, prompt action can then be taken, including providing these doctors with feedback about their performance with a view to helping them return to competent and safe practice, thereby preventing patient harm.27

Health services that implement a clinical governance program should also develop a policy describing how they will monitor the performance of their doctors and deal with poor individual clinical performance. Episodes of poor clinical performance need to be carefully and sensitively managed. Some operation and procedural skills can be maintained with the use of skills training courses, including those provided in simulator laboratories. Continuing medical education and skills training are part of clinicians' professional development, which is an imponant pan of any clinical governance program.

1.4.5 Consumer involvementTo do the right thing for their patients, clinicians must know what their patients' wishes are regarding their care. Patients need to be involved in discussions about their treatment options and in making imponant decisions about their care. Patients as a group should also have aggregated input into how patients are cared for generally in their health service. Without knowing the requirements of patients — individually and as a group — it is less likely that the care provided will meet patients' needs. To date, patient involvement in health care processes has been low. Assessing their involvement can be difficult, as patients' understanding of involvement can vary widely, from feeling they are being made welcome, to be able to talk about their concerns, to being actively able to assess the advantages and disadvantages of their treatment options. In the UK, patients report good communication with doctors and continuity of care, but rate choice, involvement and information as poor.28

Importantly, expectations about the degree of their involvement in decision making about their care will vary considerably between patients. Further research is required to determine how and when patient involvement should occur, and the feasibility and cost of their involvement.21

Patients can also be part of the safely and quality improvement process by making complaints lo health scrviccs and by health services effectively dealing with the concerns raised, and actively by services through seeking their feedback. Other important areas of patient involvement arc open disclosure by clinicians and health services after adverse events have occurred and obtaining informed patient consent before procedures are undertaken.9

1.4.6 Organisational factionMany organisational factors are significant components of an effective clinical governance program. They include:5-9 29 30

■ Strong leadership provided by the governing body and executives to set the agenda.■ Quality of care and patient safety are made a high priority by the governing body and executive staff. Clinical governance ranks equally with corporate governance.■ High vigilance to ensure the health service is effectively providing high-quality, safe care.■ Systems are in place to recognise gaps or risks, and appropriate action is taken to coned these.■ Organisational structures and processes are created to undertake the program.■ Adequate resources are provided to conduct the program.■ The health service's clinicians show strong, effective leadership and commitment.■ Full engagement of clinicians and their acceptance of a central role in the program.■ Comprehensive education for all staff about the clinical governance process.■All staff have clearly defined roles and responsibilities in the program.■ Extensive use of multidisciplinary teams.■ Effective monitoring, data collection and reporting systems are in place to aid accurate, comprehensive assessment of clinical performance.■ Ready access to clinical evidence via specialist clinical databases and high-quality data to support effective clinical decision making.■ A culture that supports quality of care and patient safety by being open and participative, valuing education, and using blame rarely.■ A strong, healthy working relationship between senior management and health professionals in the organisation. This relationship should be built around "responsible autonomy" — the balance between clinicians' professional autonomy and accountability.■ Participation in accreditation processes wherever the organisation's performance is measured against predefined standards by external bodies.If these conditions are met, they should "empower highly motivated, highly skilled frontline staff to deliver a high quality service".31 Importantly, although the concept of clinical governance makes intuitive sense and much work has been done to create appropriate structures for it to be undertaken, it has not been critically evaluated, and there have been few reports of improved patient outcomes following its implementation.32

There is significant overlap and interdependence between the components of an effective clinical governance program. One component may use another to help solve a problem. For example, the risk management component may detect an adverse event that a patient has experienced. After analysis of the event, it may be decided that a clinical audit is required to help develop a strategy to reduce the probability of the adverse event recurring. An audit may also allow an estimate of the frequency of the adverse event. The standards used in the audit against which clinical performance will be measured should reflect best practice, as determined by the available scientific evidence. If the audit shows a significant gap between the care being provided and best practice, continuing medical education as part of the clinician professional development program may be used to try to close the gap Alternatively, if the clinical audit shows that the type of adverse event found by risk management has only occurred in patients under the care of one clinician and the event is thought to be preventable, it may be appropriate to report the results of the audit to the service's credentialling and privileging committee.

10


1 An overview ot rtimcaJ Qoverrwnoa

In this way, the various clinical

governance activities will be integrated, allowing the program to be maximally effective in improving the quality and safety of patient care. Previously, integration of clinical governance activities did not occur, and opportunities to improve the quality and safety of patient care were not fully utilised. Such integration requires good communication between the personnel involved in each of the program^ activities and appropriate reporting of the activities and results achieved to relevant staff and to the peak quality committee within the health service. Reporting clinical governance activities and the results achieved will be discussed funher in Chapter 8.

1.5 Reporting the results of the clinical governance program

The results of the quality improvement and risk management components of the program should be regularly reponed in two directions within the health service — up through the committee and management structure of the organisation to the board of management^ and down through the organisation to all clinical staff Clinical governance activities and the improvements they have achieved in the quality of patient care and level

of patient safety are also increasingly being reponed publicly as pan of health service annual reporting requirements.

1.6 Accountability for the clinical governance program in health services

Clinical governance in health services should be rigorous, organisation-wide and accountable.5 Responsibility and final accountability for the way in which the clinical governance framework is developed and implemented and its effectiveness, together with the quality and safety of the clinical services delivered within the health service, rests with the board of management and chief executive. In Victoria, the responsibilities of the board of management of each health service regarding quality and risk management are defined in legislation in the Health Services Act 1988 (Vic)."

It has been suggested that the accountability for and reporting of clinical governance activities within a health service should rank equally in importance with accountability for the organisation's finances.5 Although the board of management and executive stafT have significant responsibility for quality and safety in clinical areas, other stafT in the health service, particularly clinicians, also have professional "daily responsibility"5 for the effective implementation of and compliance with the components of the organisation's clinical governance program. Such responsibility requires clinicians lo accept transparent accountability, to work in teams in providing care, and to share

12


The reason for tweeting in cUnictt governance is lo improve quality of cere AM else is subservient to this. However this principle in itself causes a dash of ideologies between those who believe that * each patient deserves the best care (typically doctors with a sense of 'duty' towards their patients) and those who have to distribute funding and relate to a population (characteristically board directors and managers within an ethic of 'utHHariarrism' —the greatest good for the greatest number).'

Pertuns R. et

al A/Z Med J 2006:

119 U22S9

power in clinical areas.32 However, clinicians should also be given a high level of autonomy in areas of health service delivery in which they have a high level of expertise.9 Responsibility and accountability for quality and safety should be clearly defined at all levels of the health service from "board to bedside".30

1.7 A health service's role with the major components of a clinical governance program

Although all the activities of a clinical governance program discussed in the previous section are important, this book will deal predominantly with the main components of quality improvement and risk management. The other activities will be discussed as they apply to both these areas. However, even the above brief discussion of each of the activities of a clinical governance program highlights many of the critical processes that are required be in place for such a program to be fully effective.

Each health service must have a comprehensive, effective credentialling and privileging process in place for the appointment of its clinicians as one of the cornerstones of effective clinical governance. Each doctor wishing to work in the service must complete a detailed application form and proceed successfully through the appointment process before they commence work. Just as important as the initial assessment of the application and the candidate, the credentialling and privileging committee has an ongoing role with the clinicians it appoints to seek regular information, from clinical audits and the risk management program, regarding the performance of individual clinicians.

If these activities detect areas of concern regarding the care provided by individual clinicians, these must be fully investigated. Initially, the clinician involved should be given the opportunity to respond to the fmdings. However, in some instances, action may need to be taken, including curtailing or withdrawing the clinician's clinical privileges, requiring that specific operations or procedures are no longer be performed by that clinician, or that they only be performed under the direct supervision of a nominated clinician, or that the clinician be required to undertake specific medical education or skills training before providing further care to patients. Clearly, if such actions are determined to be required, they should be promptly taken. Although significant performance issues involving individual clinicians are relatively rare, they do occur, and the effectiveness of any clinical governance program will potentially be undermined if examples of individual poor clinical performance are not dealt with promptly and effectively. It is paramount that the health service deals with individual performance issues professionally, sensitively and in a timely manner.

Senior management and the health service can demonstrate their genuine commitment to clinical governance by fully supporting the professional development of their clinicians. Appropriate opportunities should be provided to clinicians to maintain their professional knowledge and skills. Such up-to- date knowledge and skills are important to practising evidence-based medicine and, as will be discussed later, can help effectively change clinical practice.

Ready access to the current knowledge base of evidence-based medicine is central to providing high- quality, safe care. As previously mentioned, to support the clinical governance program, health services need to provide clinicians with ready access to up-to-date clinical databases of critical reviews of the scientific evidence. Computers with links to such databases should be readily available in the health service's wards and various clinical departments.

As will be discussed further in the chapters on risk management, the conditions under which clinical work is undertaken in a health service have a significant impact on the level of patient safety. Work conditions should be made as safe as possible within the limitations of the resources available. Clinical

1 An overview of cfcmcaf jovemenoe

risk managemem continuously balances the level of patient safety that it is possible to achieve and com of achieving this level of safety. The level of safety may be increased by reducing workloads and shift lengths, providing adequate supervision and appropriate equipment, and by continuously monitoring patient safety using a comprehensive risk management program.

Clinical audit is a core part of quality improvement and, as discussed earlier, is essential for the effective ongoing credentialling and privileging of medical staff. Senior management in health services should therefore actively support clinical audit. This support includes: the availability of appropriate data collection systems; using information technology where possible; and adequate protected time for clinicians to design, undertake and analyse clinical audits-, and, most importantly, take appropriate action in response to the results of the audits. The methodology and place of clinical audit in quality improvement and patient safety will be discussed further in the chapters on detecting gaps in patient care and implementing change.

In the past, consumers' views about the quality of the care they have received in health services have been inconsistently sought. In an effective clinical governance program, the health care provided is patient-centred, so consumers' views are regularly and appropriately sought. Consumers' views can be obtained from surveys, focus groups and consumer advisory panels. Health services should aeate systems to ensure consumers' views about the care they have received are obtained and acted upon.

The culture of the health service is an important factor in achieving effective clinical governance. Support of staff, communication throughout the organisation and how negative events are handled in the service are all important issues and will be discussed in detail in Chapter 9.

* »

■flnMipMnl

■ Regulation is a core role of management that ensures an organisation's activities will achieve its goals.

■ Governance is about regulation and the framework used to achieve it.

■ Previously, governance in health services has concentrated on corporate governance (ie, financial and business outcomes).

■ Clinical governance is the regulation of quality and safety in clinical care.

■ Clinical governance has two main components — quality improvement (doing the right thing to patients more frequently) and risk management (doing the wrong thing to patients less frequently).

■ The core principles and activities of clinical governance are:>■ Evidence-based medicine — providing clinical care for patients in accordance with best

practice determined by the available scientific evidence.

> Credentialling and privileging — determining that clinicians working in the health service have the required qualifications, training and experience to provide care in a designated clinical area and they are providing this care to a high standard.

> Clinical audit — measuring individual clinicians' performance and the health service's aggregate performance, and comparing them with best practice.

> Professional development — providing clinicians with appropriate continuing medical education and skills training.

> Consumer involvement — determining the needs of individual patients and patients as a group, and meeting these needs.


> Organisational factors — that appropriate resources, strong leadership, adequate support and education and clear, timely and direct communication are provided by the health service to support the above activities.

■ Final accountability for clinical governance rests with the health service's board of management and chief executive, but clinicians have daily responsibility for complying with clinical governance requirements.

■ A key factor in establishing and maintaining an effective clinical governance program is the support of the health service and senior management for the program. Such support can be provided by:

> Allocating protected time for medical staff to participate in activities that support effective clinical governance (eg, clinical audits, continuing medical education and skills updates).

> Ensuring the conditions of work under which clinical care is provided are conducive to high-quality, safe care.

> Supporting the clinical audit process (eg, by providing appropriate stalling, information technology and data collection).

> Dealing with poor clinical performance by individual clinicians sensitively, lairly and in a timely manner

> Providing ready access to current clinical databases of high-quality clinical research and guidelines in all clinical areas to support clinical decision making.

1 An overview of clinical go*emanoe

References1 Lapides PO, Hermanson DR, Beasley JV, et al. Corporate Governance Center. Kennesaw State

Unweraity, 2002

2 ASX Corporate Governance Council. Corporate governance principles and

recommendations. 2nd ed. 9f&ey Australian Securities Exchange. 2007.

www.asx.com.au/about/governance/index.htm (accessed Oct 2006)

3 Encycogov.com. What is corporate governance? 2006.

www.encycogov.com/WhatlsCorpGov.asp (accessed Oct 2008).

4 Deighan M, Bullivant J. Re-energising clinical governance through integrated governance.

Clin Chem Lab Med 2006; 44: 692-693.5 Scally G, Donaldson LJ. The NHS's 50 anniversary. Clinical governance and the drive for quality mprcvomor* in the new NHS in England. BMJ1998: 317: 61-65.6 Australian Council on Healthcare Standards. ACHS News, Issue 12. Sydney. ACHS, 20M.7 World Health Organization. The principles of quality assurance. Copenhagen: WHO. 1983 (Report on a WHO meeting).8 Gray C. What is clinical governance? BMJ Career Focus 2005; 330: 254-261.9 Braithwaite J, Travaglia JF. An overview of clinical governance policies, practices and initiatives. Aust Health Rev 2008; 32: 10-22.

10 Spark Jl, RoweS. Clinical governance: its effect on surgery and the surgeon. ANZ J Surg 2004;

74: 167-170.

11 Halligan A, Donaldson L. Implementing clinical governance: turning vision into reality.

8M/2001; 322:1413-1417.

12 Degeling P. Realising the developmental potential of clinical governance. Clin Chem Lab Med

2006; 44:688-G91.

http://www.encycogov.com/WhatlsCorpGov.asp

http://www.asx.com.au/about/governance/index.htm

13 Niselle P. Managing medical indemnity: must we choose between quality assurance and risk management [letter]? MedJAust2DOA. 181: 520.14 Lohr KN, Schroeder SA. A strategy for quality assurance in Medicare. N Engl J Med 1990; 322: 707-712.15 Agency for Health Care Research and Quality. AHRQ's Patient Safety Initiative: building foundations, reducing risk. Interim report to the Senate Committee on Appropriations. Rockville. Md: AHRQ Publications. 2003.16 Kohn LT. Corrigan JM. Donaldson MS. To error is human: building a safer health system. Washington. DC: National Academy Press. 1999.17 Institute of Medicine. Crossing the quality chasm: a new health system for the twenty-first century. Washington. DC: National Academies Press. 2001.18 Berenholz SM. Pronovost PJ. Monitoring patient safety. Crit Care Clin 2007:23:659-673.19 Cook DJ. Montori VM. McMullin JP. et al. Improving patients' safety locally: changing clinician behaviour. Lancet 2004; 363: 1224-1230.20 Sackett DL. William MC. Rosenberg WMC. et al. Evidence based medicine: what it is and what it isnl. BMJ 1996: 312: 71-72.21 Chassin MR. Quality of health care. Part 3: improving the quality of care. N Engl J Med 1996:335:1060-1063.22 Kent DM. Hayward RA. Limitations of applying summary results of clinical trials to individual patients: the need tor risk stratilication. JAMA 2007, 298: 1209-1212.23 Grol R. Improving the quality of medical care. Building bridges among professional pride, payer profit, and patient satisfaction. JAMA 2001: 284: 2578-2585.24 Scott IA, Poole PJ. Jayathissa S. Improving quality and safety of hospital care: a reappraisal and an agenda for clinically relevant relorm. Intern Med J 2007; 38: 44-55.25 Victorian Government Department ol Human Services. Credentialling and defining the scope of clinical practice for medical practitioners in Victorian health services - a policy handbook. Melbourne: Victorian Government Department of Human Services, 2007.26 Holmboe ES. Lipner R. Greiner A. Assessing quality of care: knowledge matters. JAMA 2008; 299: 338-34027 Leape LL. When good doctors go bad. Ann Surg 2006; 244: 649-652.28 Elwyn G. Buetlow S. Hibbard J, Wensing M. Respecting the subjective: quality measurement from the patients perspective. BMJ 2007; 335: 1021-1022.29 Degeling PJ, Maxwell S, ledema R. Hunter DJ. Making clinical governance work. 6MJ2004. 329: 679-68130 Balding C. Clinical governance: another name for quality - or improving on improvement? HIM J 2004. 33 137- 139.

31 HaKgan A. Right here, right now. NHS Magazine 2001; Jul 6.32 Peftons R. Pefcowitz A, Seddon M. Quality improvement in New Zealand healthcare. Part 7. clinical governance — an attempt to bring quality into reality. N Z Med J 2006; 119: U2259.33 Victorian Health Services Act 1988. Division 9 B - Public Health Services, Section 65 S - Board of Directors, (iv) - (vii). □


2 Quality improvement — measuring clinical performance and closing gaps in clinical care

This chapter will:■ Define quality improvement■ Discuss what best practice is and how to locate it■ Discuss how to determine the clinical areas in which quality improvement should be

undertaken■ Outline how to conduct a clinical audit — how to define criteria that represent best

practice: data entry, collection and analysis: benchmarking; how to report and discuss results: how to take action: the audit cycle: and the resources required

■ Review whole-of-practice audits■ Define clinical indicators, and discuss their role and the many different indicators available■ Present a comprehensive audit checklist.

2.1 Defining quality improvement

Quality improvement is one of the two major components of clinical governance. The second component, risk management, is discussed in Chapter 3. There are two main approaches to quality improvement used in health care. One approach, clinical audit, begins by defining a

desired standard of performance or care to be provided to patients. The care provided is then measured, and if it meets the desired

standard, no action is usually required. However, if there is a significant difference between the desired and actual standards of care, the difference is analysed and action taken, aimed at closing

the gap. The care provided continues to be monitored to determine if the action has been successful in closing the gap (Figure 2.1). In

practice, several cycles of measurement and action are often required to close the gap.

An alternative approach to quality improvement is system redesign. A system of health care delivery that clearly needs improvement is chosen, and the processes that comprise the system are identified. Each process is then examined to see whether it can be modified to improve the overall performance of the system and reduce waste. The two approaches overlap, as system redesign is commonly used to close gaps detected in performance.Unfortunately, there are many significant gaps in the care provided to patients compared with best practice. Only 50% of patients receive recommended preventive care, and 70% receive recommended acute care.1 These gaps are so extreme that "the greatest opportunities to improve patient outcomes will probably nol come from discovering new treatments bui from effective deliver)' of existing therapies".2 A systematic strategy is required to routinely monitor and report the quality of carc being provided.1

Figure 2.1 Bask quality improvement cyd*

2.2 Deciding the clinical areas in which quality improvement activities should be undertakenDespite extensive summarisation of research findings and best-practice recommendations into formats of manageable size for clinicians to use, the number of opportunities available to develop standards of care in different clinical areas is far greater than can be fully utilised by individual health services. Each service will therefore need to determine the clinical areas in which they wish to develop standards of care and measure their performance.

Several approaches are available. Often, a useful place to begin is with the health serviced most frequently coded principal diagnosis-related groups by admission. Best practice could be defined for several of these high-volume diagnoses, and clinical performance could then be measured. Alternatively, some organisations, such as the National Institute of Clinical Studies, have published lists of major gaps in provision of clinical care across the full continuum of health.3,4 Some gaps are in primary care (eg, inappropriately prescribing antibiotics for the common cold and acute bronchitis; advising on smoking cessation) and others in acute hospital care (eg, preventing venous thromboembolism, managing acute and cancer pain). The best available evidence is presented for each gap, together with current clinical practice.

Further, medical journals such as Evidence-Based Medicine (www.ebm.bmj.com) and Evidence-Based Nursing (www.ebn.bmj.com) alert clinicians about important advances by summarising and reviewing the best evidence-based research from the large number of articles published in medical journals; these summaries are published every 2 months. The contents page of each issue of these journals could be scanned by individual health services to identify areas where there may be gaps in the care they provide, thereby providing direction for quality improvement activities. Based on research about medical errors, lists of clinical interventions whose effectiveness is supported by high levels of scientific evidence have also been published,5-6 and could also provide direction for local quality improvement programs.

There are many clinical areas in which quality improvement initiatives can be chosen for implementation, making selection of initiatives potentially difficult. One selection criterion could be that the improvement initiative should have the maximum potential positive impact on patient mortality and morbidity. The Pareto principle, where the 20% of initiatives that could potentially achieve 80% of the total possible positive impact on patient care, could be chosen for implementation.

Alternatively, interventions could be chosen according to the resources that their introduction would save the health service. Such

' there isms systematic evidence about qualify of care... More information is available on the quality of airlines, restaurants, cars and VCRs than on the quality of health

Schuster MA. et al MilbankO

2005; 83:843-895

http://www.ebn.bmj.com/

http://www.ebm.bmj.com/

interventions could be implemented on the understanding that the savings made from their introduction would be used to make further improvements in the quality of care provided, perhaps by implementing interventions that

2 Quality mpfowemen

significantly reduce patient mortality and morbidity,'but either require additional mouiw to implement, or where implementation will not result in savings being made.

Another important selection criterion is that the clinicians in the health service feel the intervention chosen is clinically tmpottara

This criterion has significant implications for successfully achieving change in clinical practice, and wil be discussed further in Chapter 6.In essence, the clinical areas chosen to undertake

quality improvement initiatives depend on two major factors:■ The importance of the clinical problem in which intervention is being considered. Is the clinical area one of high volume, significant mortality and morbidity, substantial cost, unexplained variation in care, or suboptimal care being provided to patients?■ The opportunity the clinical area provides for effective clinical intervention Gaps in care provided should have been identified, and evidence-based guidelines that would improve patient outcomes if implemented should be available.2,7,8

2.3 Components of a quality improvement program

2.3.1 Finding best practiceThe first task in quality improvement in health care is to define the desired standard of care to be provided. Quality is a multidimensional-construct, meaning it has multiple attributes, each of which may have a different measure.9 No single measure can comprehensively reflect all the attributes. The dimensions of care include clinical factors, cost, patient satisfaction and functional health status. A "balanced scorecard" or "clinical value compass" can be developed that includes measures of each dimension.10 Health care should also be safe, effective, patient-centred, timely, efficient and equitable." Patients may place greater weight on some dimensions of quality (such as waiting times) than clinicians.12 Measures of best practice for each of these dimensions should be sought. Such measures will still not provide a complete assessment of quality, but an increasingly more accurate one can be drawn from multiple perspectives.9

The desired standard may be determined by the scientific evidence that is available, benchmarking against similar organisations, or using standards set by external organisations,

2 Quality mpfowemen

such as accreditation or funding bodies. The desired standard of clinical care is usually best practice according to the highest- quality scientific evidence available at the time. The major sources of information about what constitutes best practice in clinical care are systematic reviews or meta-analyses of clinical research publications in medical journals. There are many medical journals, and the number of individual articles reporting the results of clinical research is huge, with over 30 000 new publications added to the MEDLINE database each month. The volume of clinical research that is continuously published is far greater than could be regularly reviewed by clinicians in an individual health service.

To provide high-quality, safe care, clinicians will be increasingly reliant on "clinical pathways, clinical practice guidelines and decision support tools".13 Fortunately, a number of organisations systematically review the scientific literature and produce critical reviews and summaries of the research published over a wide range of clinical areas. Clinical practice guidelines, or "systematically developed statement(s) to assist decisions for practitioner and patient about appropriate health care for specific clinical circumstances", are also developed.14 These guidelines are developed by many national and international groups, and describe best practice for treating patients with many clinical conditions. Sources of information about best practice include:

2 Quality mpfowemen

■Systematic reviews undenaken by the Cochrane Collaboration (www.cochrane.org) and in Clinical Evidence, which is published by the BMJ biannually in prim and updated monthly online (clinicalevidence.bmj.com/ceweb/index.jsp).

■Individual clinical reviews, meta-analyses or the results of randomised controlled trials published in medical journals.

Clinical guidelines and the level of scientific evidence supporting each component are available for a wide range of clinical conditions, from sources including:■The National Guideline Clearinghouse (with almost 2000 guidelines currently listed), which is an

initiative of the Agency for Healthcare Research and Quality (AHRQ) and the Department of Health and Human Services in the United States (www.guideline.gov).

■The National Health Service's National Institute for Health and Clinical Excellence in the United Kingdom (www.nice.org.uk).

■The Scottish Intercollegiate Guidelines Network (SIGN) (www.sign.ac.uk).If high-quality scientific evidence for best practice in managing patients with a particular medical condition is not available, expert consensus may be used.15 SIGN has formalised expert consensus using a three-stage process of considered judgment. The level of evidence and the impact of that evidence (including potential harm and practicality of implementation) are judged, and key recommendations are identified.

One problem with systematic reviews and guidelines is that best practice in a particular clinical area will change over time because of the large amount of clinical research being continuously undertaken. An analysis of 100 systematic reviews found that in 23%, signals for updating occurred within 2 years.16 Therefore, reviews and guidelines should be regularly updated. Finally, guidelines are documents that indicate what should be done in patient care in ideal circumstances. In individual health services, these guidelines should be used to develop protocols that reflect local needs and conditions and detail what should be done, by whom, when and how.

2.3.2 Defining criteria that represent best practiceAs discussed previously, there are several quite different dimensions of patient care, and the quality of each is often assessed using different methods. For example, the level of patient satisfaction may be assessed using patient surveys, interviews or focus groups. By contrast, the compliance of an individual health service with the standards set by accreditation bodies is usually assessed by health services completing a presurvey questionnaire before surveyors observe how the health service functions during a site visit conducted over several days. Traditionally, quality of care has been divided into three components:■structure (how care is organised)■process (what is done to patients)■ outcome (the results of what is done to patients).17

It has been suggested that culture, or the "collective attitudes and beliefs of caregivers", should

be added as a fourth element of quality.18 New structural measures have also been suggested,

including: institutional variables (eg, credentialling of clinical staff and the degree of senior

management involvement in safety and quality programs); task variables (eg, the presence of

protocols); or team variables (eg, the degree to which frontline staff feel comfortable alerting

management about areas of concerns).19

Several structural components of health services (such as staffing levels, equipment, human resources processes, and methods of reimbursement) have been shown to be associated with

20


http://www.sign.ac.uk/

http://www.nice.org.uk/

http://www.guideline.gov/

http://www.cochrane.org/

clinical outcome, although caution should be used in making inferences about cause and effect. Often, structural changes require substantial investment, beyond the resources available to individual health services.20 Therefore,

21


2 Quality improvwnani

we will confine our discussion to the structural elements that are within the control of local senior management, and particularly the assessment of the clinical component of patient care and how clinical audit is undertaken.

Once best practice in the management of patients with ? particular clinical condition has been determined, clinical audit can be used to measure and compare the performance of the health service. Firsdy, the criteria that reflect best practice according to the scientific evidence need to be determined. A criterion can be defined as "a discrete, clearly definable and measurable phenomenon ... Relevant to definition of quality ... [and] so clearly defined that we can say whether it is present or not".21 The choice of criteria is important, as the frequency with which criteria are attained determines the level of performance by clinicians and the standard of care provided to patients.22

Criteria should be developed by a multidisciplinary group of medical, nursing and allied health clinicians, representing the health professionals who deliver care to patients in the clinical area under review. Such membership should increase the probability that the criteria chosen accurately reflect the quality of care being provided, and facilitate local ownership of the measures and acceptance of the process. The criteria should reflect best practice in medicine, nursing and allied health, and the important aspects of effectiveness, safety and efficiency as well as professional, organisational (such as wailing times and coordination and continuity of care) and patient- oriented dimensions. With all these considerations, a large number of criteria may be developed, and it may be necessary to rank them according to their importance and measurability, and reduce them to a workable number.8

Information about best practice can be obtained from a review of the scientific literature, clinical practice guidelines or expert consensus.23

Best-practice criteria can then be developed from these sources that reflect the highest level of scientific evidence available, and that level can be stated for each criterion.7

Although guidelines are usually comprehensive and of high quality, some are lengthy and require transformation into criteria against which performance can be measured. For example, a literature review of mechanical ventilation produced a 100-page evidence-based summary, from which five actions were identified that could be taken daily and measured for patients receiving ventilation9

Alternatively, criteria that have already been developed in particular clinical areas can be obtained from the literature, databases and sources of international indicators, such as the RAND Corporation (www.rand.org), the AHRQ (www.ahrq.gov/) and the National Primary Care Research and Development Centre (www.npcrdc.ac.uk). Indicators chosen from these resources require adjustment for local needs and conditions.8

http://www.npcrdc.ac.uk/

http://www.ahrq.gov/

http://www.rand.org/


Whether criteria are developed locally or taken directly from external sources, they should be clinically important, clearly definable, objective, specific, measurable and theoretically sound.23 Precise definitions of the numerator and denominator of each criterion should be available from external sources and modified appropriately, or developed locally.8

Without such definitions, the validity and reliability of the data that are collected will be compromised.9

•QuaWyl is... apmrnaMngtHQ,.time-consvning business that depends for its success st leest as much on our s&tty to modify the behavior of patients, purchasers, and providers of care as it does on the Collection of good data about performance '

Blimenthal 0 N Engl J Med

1996.335 1328-1331


If appropriate, patient inclusion and exclusion criteria should also be determined.7 Ideally, few patients will need to be excluded from the audit, allowing a comprehensive assessment of care to be made. The criteria should be valid (ie, measure what it is intended to measure) and reliable (ie, repeated measures obtain similar results).7 The criteria should also be clinically important and have been demonstrated to improve patient outcome when provided in their care.7

As well defining the criteria to be used in assessing performance, standards for acceptable levels of compliance with each criterion should also be developed. For example, a criterion could be that all patients with acute coronary syndrome should receive aspirin. It is unlikely that a health service with a large number of such patients will achieve 100% compliance with this criterion, and some patients may not be able to safely take aspirin. In acknowledging this reality, an appropriate standard could be that 85% of patients with acute coronary syndrome receive aspirin.

2.3.2.1 The advantages and disadvantages of process and outcome measuresCriteria represent standards of care, and can be process or outcome measures. 715 Process measures examine what is being done to provide care (eg, if patients have undergone investigations, been referred to specialists or received medication), and outcome measures examine the health status of the patient after treatment (eg, functional health status, quality of life, morbidity or mortality).715 Both measures require specific definitions if the results are to be meaningful, especially for comparison. Importantly, process measures vary with the behaviour of the health care provider.22

Process measures are generally easier to interpret, and are more sensitive in detecting changes in clinical practice in small samples of patients over short periods of lime, than outcome measures. Outcomes often require considerable time to become evident, and much larger numbers of patients are needed to detect significant differences between samples. Outcomes measures vary not only because of changes in the quality of care that has been provided, but also because of definitions, data quality, casemix, and chance.20-24 Outcome measures may require adjustment for casemix, including patient characteristics (eg, age, sex, functional status, comorbidities and illness severity), and such adjustment may still be incomplete because of unknown prognostic factors.20

Importantly, apart from a few surgical procedures, "outcome is neither a sensitive nor a specific marker for quality of care".20 However, some outcome measures can be used as criteria, especially if the outcomes occur in a short period of time or if a high volume of patients are being audited.15-

25 Although process measures are more frequently used to assess quality of care, outcome measures may demonstrate differences in the quality of care (such as a surgeon's operating skills) that are not assessable by using a limited number of process measures.26

If process criteria are used, they should be scientifically demonstrated (preferably by randomised controlled trials) to be clearly linked to patient outcomes. In other words, the process measures chosen should clearly affect outcomes, so that they will be a measure of ihe quality of care that has been provided.7 15 In practice, a combination of process and outcomes measures are commonly used to measure quality, costs and patient satisfaction.10

Clinicians prefer process measures, to which they can influence adherence, over outcome measures, which can be influenced by factors beyond their control. Process measures can be easily incorporated in routine data collection, and can act as a reminder to clinicians about processes of care they should be providing. However, these measures require updating as research influences best practice. Patients and funders often prefer outcome measures, which do noi usually require revision. However, patient outcomes may be infrequent and delayed, thereby hindering timely feedback lo clinicians and requiring more resources for long-term follow-up of patients and risk adjustment of data. If possible, a balanced set of process and outcome measures


should be used.2 Alternatively, one or two major outcome measures (eg, mortality and morbidity) and several related process measures could be chosen "

2 QuaMy improvement

Using process measures has a significant advantage — if the measurement is below the target levd and timely feedback is provided, management and clinicians can quickly identify the problem and determine appropriate action to address it. If an outcome measure (such as mortality) is poor, clinicians may not know where to direct their attention to improve it. Was the result due to poor quality of care or other factors, such as poor data quality, inadequate adjustmenL for casemix, structural factors, chance, or unknown factors? If outcome measures are used to penalise or stigmatise individuals or health services, then dysfunctional behaviour, such as gaming of data, patients or care, may occur to diston the measure.

The criteria chosen may depend on their clinical importance to patient outcome, the strength of evidence supporting the effects of the criteria on patient outcome, their validity and reliability, and how easy it is to collect data on the criteria.7,8 The criteria should also be diverse, and should comprehensively cover the treatment of the clinical condition. As a final check of the criteria 's validity, the clinicians who will be receiving data on their clinical performance need to be asked whethlt they feel the criteria are measurable, accurately evaluate imponant aspects of quality of care, are meaningful to them in trying to improve the care they provide, and are measures they have the control to alter.2-918

One potential problem with conducting clinical audits is choosing too many criteria against which to measure clinical performance. A balance is required, as large number of criteria can make data extraction and collection more difficult, whereas a small number of criteria may limit the components of patient care that can be assessed. A good balance can be achieved using about 12 criteria to measure a care process.8

At Wimmera Base Hospital, a medium-sized hospital, we prefer to measure a small number of key criteria, which makes data collection simpler and allows the results of the audit to be concisely reported. For example, interventions that have been shown to decrease mortality in patients with acute myocardial infarction include administration of aspirin, thrombolytic therapy, ^-biockers and ACE (angiotensin converting enzyme) inhibitors. Therefore, appropriate criteria would be administration of aspirin in the emergency department, administration of ^-blockers in the first 24 hours of the patient!; admission, the lime between the patient arriving at the emergency department and commencement of thrombolytic therapy and administration of ACE inhibitors on discharge. Outcomes measures, such as 30-day mortality, may not be useful in a hospital of this size because significant trends may take some time to become apparent.

Whichever criteria are chosen, they will require updating over time as the results of further research in the clinical area becomes available.26

2.3.3 Data entryThe time clinicians must spend entering clinical audit data is a significant factor in gaining their suppon for the activity. Participating in clinical audit should not be a significant time burden for senior clinicians, and data entry should be made as efficient as possible. Designing the audit to allow data to be entered by non-clinical personnel or junior medical staff can save considerable time for senior clinicians. Data entered by clinicians can also be significantly reduced if patient identification data from the hospital patient information technology system can be automatically entered into the database created for the audit, rather than being re-entered by clinical staff. Data entry can be assisted by clinical data being rapidly entered by clinicians using personal digital assistants when they are close to the patient (eg, in the operating theatre or at the bedside). The data from personal digital assistants can then be uploaded to the database when it is convenient.27

23


Where possible, prospective audit is preferred to retrospective audit, as the data collected is more likely to be complete.28 The accuracy of the data is critical. A sample of the data should be checked for completeness and accuracy.29 The method chosen for data entry and the data collection spreadsheets or forms to be used, whether paper-based or electronic, should be reviewed for any ambiguities by clinicians not associated with the audit before it commencing.28

They should also be tested on a small scale to determine whether the criteria chosen are clear and the data can be readily collected,30 and to identify and reduce problems when the audit is commenced on a large scale. Whichever method is used to enter or collect data, the audit should be embedded as firmly as possible as pan of routine, everyday practice of the health service, and, wherever possible, included in existing clinical and administrative patient care documentation. Such actions should reduce costs and missing data, and support the sustainability of the audit.7

2.3.4 Data collectionThe audit should be as simple as possible. Wherever possible, electronic data collection is preferred, but if paper-based audits are used, data should be easy to collect. Developing and using data abstraction tools that are simple, shon and easy to use will assist data collection. Wherever possible, data that are already being routinely collected in the health service should be used,25 and obtained using automated processes and existing data files.818 The data should be readily available and inexpensive to collect.7

Sometimes, it may be necessary to balance the scientific soundness of measures that are chosen against the feasibility of their collection.18 The "who, what, when, where and how" of the data collection should be defined, as should the burden of data collection on staff.2 Ideally, a database should be created that optimises the quality of data to be analysed, aids identification of missing data, and assists with the creation of reports.31 Data that identify individual patients must be kept confidential, and all data must be securely stored.

2.3.5 Measure baseline performance — small-scale testingThe measurability of processes of care can be difficult to predict. It is therefore important to test the audit tools, data entry and collection systems on a small scale before conducting a comprehensive audit 8 Testing may show that criteria definitions require more detail, the data sought are not available, or the resources required to collect them are too great. 2 A final decision should be made regarding the feasibility of each component of the audit: criteria measurement, data entry, data collection, analysis, and timely, actionable feedback before proceeding to a large-scale audit. The best test of the feasibility of the data collection tools and process is to measure the baseline performance against which the effectiveness of the intervention will be assessed.31

2.3.6 Analysis and review of audit resultsFollowing data collection, the proportion of patients whose care meets each criterion representing best practice is determined. The rate of compliance with best practice can be compared with rates in the scientific literature. National or international rates may be available for some criteria. For example, national and state averages and individual hospital data are available for a number of process measures of the management of acute myocardial infarction, cardiac failure, pneumonia and surgical infection prevention in the US from the Department of Health and Human Services (www.hospitalcom- pare.hhs.gov).

Local comparisons can be made with similar-sized health services in the same region. Individual health services can also review their rates over time to identify trends. When comparing data external to the health service, it is essential that the definitions of the criteria being measured are rigorously specified, and that the populations measured and the data collection methods are standardised. Without standardisation, results may vary substantially because of differences in

2 OuflMy improvement

the methods used, and differences' in the measures obtained may not represent differences in quality of care, making comparisons meaningless.9

If a significant difference is found between best practice and the care provided, an analysts of the difference should be undertaken and appropriate action taken to try to close the gap. The process of analysing the gap in care and taking action to close it is discussed funher in Chapter 6.

The audit results should be analysed for statistical and clinical significance. As these audits are not randomised controlled trials, there is risk of bias from confounding variables. In particular, organisational factors may greatly influence treatment effects, and it may therefore be difficult to irplicate the results achieved in one setting in others. Also, organisational factors change in individual organisations over time, altering the effects of interventions.2

Many quality improvement programs continually measure performance using small samples of data collected over time. Such measurement can be incorporated into the daily clinical routine. The results can then be graphed (rather than using tables) on run or process control charts^o look for variation in performance. Such charts plot the criterion measurement on the y axis and time on the x axis. If the variation in performance exceeds three standard deviations (the control limit) above or below the trend line, this is referred to as special-cause variation, and the reason for it should be quickly sought. Variation within the control limits is regarded as common-cause variation, and is a property of the system delivering care. Using graphs to depict the data allows variation in performance to be easily seen and interpreted without requiring statistical expertise. Such time-series data and the resultant process control charts provide continuous feedback to clinicians.2

Often, measurements of criteria will be made using samples of patients, rather than all patients, to reduce costs. However, in some clinical areas, activity may be low and the sample size will therefore be small, even if all patients are included in the audit. Whatever the circumstances, when presenting d2ta to clinicians, estimates of the precision of measurements (confidence intervals) should be included.18

2.3.7 Taking actionIt is essential that areas of concern raised by an audit are thoroughly analysed, and that recommendations for changes in how clinical care is provided are made and acted upon. Unfortunately, recommendations are often not made and action not taken following an audit,28

making the process ineffective in improving quality of care, and probably demotivating staff to continue with the method. Without appropriate action, an audit becomes an observational study about clinical practice at one point in time, and is of limited value. Some actions may require additional resources, which may test the senior management's support for clinical audit.

Importantly, once action is taken, the audit should continue to ensure that the gap detected has been closed; this may take several audit cycles. A common error in clinical audit is to assume that once action is taken, the gap will be closed. Such effective action is uncommon, and repeated audit cycles are usually needed to successfully close a gap. Also, changes made in response to an audit may have unexpected positive or negative consequences, which may also need to be managed.23

The overall effect of audit and feedback in changing clinical behaviour was assessed in five randomised controlled trials. A median absolute improvement of 7.0% (95% CI, 1.3%-16%) in the process measures used was found.32 These results will be discussed further in Chapter 6.


2.3.8 Reporting audit resultsThe results of an audit, and the resultant recommendations for changes in how patient care is provided, should be reported to the relevant clinicians and their respective groups and throughout the health service using its management and committee structure. Reporting clinical governance activities, including clinical audit, will be discussed further in Chapter 7. Although such reports need to be detailed, ii is imperative ihey maintain patients' privacy and confidentiality The reports should contain appropriate statistical information (eg. means and confidencc intervals) together with a simple

2 OuflMy improvement

interpretation of the results for staff members without training in statistics.8 Colourful tables and graphs that clearly demonstrate trends and significant results should also be used.2-3.9 ResourcesHealth services' senior management must provide adequate resources to support clinical audit so that it can be undertaken to a high standard. Resources may include appropriate dedicated staff, such as project officers and secretarial assistance, and computers and information technology support. Some of staff involved in audit may need additional training in measurement and analysis of data.18 Most importantly, clinicians cite a lack of protected time to participate in audits as the most frequent deficiency in such programs,25 and this critical issue should be addressed with the relevant clinicians when designing the audit program.

2.3.10 Education, communication and leadershipAll clinical staff should be provided with edu-cation about clinical audit, which should help engage them in the program. When an audit is being considered, potential participants should be informed of the proposal. Their involvement and feedback should be actively sought for the selection of the clinical area to be audited, the audit criteria, design of data collection tools, data analysis and review the results. A senior clinician working in the clinical area under review should also have overall responsibility for each of the major components of the audit

30process.

The quality improvement arm of the Wimmei

Figure 2.2 Wlmmera model of quality improvement

model is represented diagramatically in Figure 2.2.


2.4 Quality improvement collaboratives33

Another approach to quality improvement is for a number of three- to four-person teams from different health services (typically between 20 and 40) to collaborate and focus on quality improvement in one specific are» of clinical care over 1 to 2 years. Strategies for improvement are designed and implemented, and learning and insights are shared in multiple meetings between teams over several months, with the aim of achieving dramatic improvements in short periods. New knowledge is applied

locally by teams using multiple plan-do-study-act cycles. A set of core indicators are determined tor the collaborative, and reported progressively by each team.

Competition is promoted between teams, and the results of innovations are shared with a view to rapidly developing effective strategies. An initial collaborative involving a particular area in a health service may then be expanded to involve the whole* service and other health services. The collaborative approach has been developed by the US Institute for Healthcare Improvement, and has been used on a large scale in the US and the UK. There are similarities between the collaborative approach and the usual audit cycle. Although collaboratives are conducted over multiple sites, the many teams involved are thought to enhance learning *about, and development of, effective strategies.

Collaboratives require substantial time and money. Unfortunately, acceptance qf the methodology is largely the result of subjective impressions, such as shared beliefs and anecdotal evidence, rather than rigorous, objective evaluation of its effectiveness and appropriate use. The studies are uncontrolled and have design limitations. Publications of collaboratives consist largely of subjective evaluations or self- assessments of the effects and lessons leamt during the project, without objective evaluations of outcome changes.

Therefore, "the overall effectiveness [of the quality improvement collaborative method] remains highly uncertain but is probably modest".33 The improvements achieved by individual health services range from remarkable to only modest, and success may be due to other factors within the organisation. More research is required into the determinants of successful use of collaboratives to achieve quality improvement.

2.5 Whole-of-practice audits

As well as conducting clinical audits for specific conditions, whole-of-practice clinical audits, in which all clinical performance in a clinical unit or area is continuously assessed, should also be undertaken in individual health services. Whole-of-practice audits are most developed in surgery. An outstanding example is the Lothian Surgical Audit in Scotland, which commenced in 1946. This audit has demonstrated a reduction in patient complications and mortality, has been instrumental in changing surgical practice in that region, and has provided a valuable source of education and research opportunities for surgeons.34

The model has been extended into all surgical specialties across 51 hospitals in Scotland as the Scottish Audit of Surgical Mortality, and has been replicated in Western Australia as the Wfestem Australian Audit of Surgical Mortality. Participation in the program by surgeons is voluntary and involves "systematic, independent and external peer review" of "all patients who have died while under the care of a surgeon".35 The Royal Australasian College of Surgeons intends to extend the WA program throughout Australia and New Zealand.36

For ongoing professional re-certification, the Royal Australasian College of Surgeons requires that surgeons participate in peer-reviewed surgical audit, undergo credentialling at an approved hospital, and maintain knowledge and skills.37 A survey of Australian surgical units in public hospitals in 1998 found that, although most units conducted audits, the audits did not met the then requirements of the College in over two-thirds of cases, because of insufficient resources.38

2.5.I Data to be collectedCurrently, the College suggests that surgical audits collcct data comprising a minimum and expanded dataset; additional data can be added for each specialty group as required, or to meet an individual surgeon^ requirements. Patient complications can be graded according to their

2 Quality tmprovtnrmn

27

severity and recorded as pan of the audit. Using generic databases, individual health services can create databases to meet their clinicians' needs. Importantly, the creation and maintenance of these databases will require information technology suppon from the health service.27

The data collected in whole-of-practice audits can provide useful information about clinical workload and patient access (eg, patient throughput, waiting times, and operation postponements), utilisation and efficiency (eg, use of investigations and adequacy of pain relief), and safety and efficacy (eg, mortality, complications of surgery, re-operation and re-admission rates).27

Whole-of-practice audits of medical services are more difficult to undertake than in surgery, as medical patients often have several comorbidities, making meaningful comparisons more difficult. However, despite this limitation, medical units should still be able to undertake meaningful whole-of- practice audits in a similar manner to their surgical colleagues. For example, the National Sentinel Audit of Stroke, conducted biannually by the Royal College of Physicians' Clinical Effectiveness and Evaluation Unit since 1998, reviews all patients admitted with stroke across all hospitals in England, Wales and Northern Ireland.39 In 2006, detailed data were compared with evidence-based standards for the investigation and management of 13 625 patients admitted with stroke over 3 months, demonstrating improvement in clinical practice, highlighting areas requiring attention, and allowing health services to compare their performance with best practice and national data.39

2.5.2 Review of audit resultsIn larger health services, whole-of-practice audit data should be formally reviewed on a regular basis by each clinical or specially unit. The frequency of these reviews will depend on the size of the hospital and its clinical throughput. A regular clinical or specialty unit review meeting attended by panicipating clinicians may discuss the audit results, "near misses", incident reports and patient complaints that have been made for the period under review, and may present specific cases.27 The discussion in these meetings should be "open, non-confrontational, non-judgmental, friendly and confidential".30 In smaller hospitals, the health service's peak quality committee can review the whole-of-practice audit results with its clinicians. The results should be reviewed over time to identify trends within the health service and be benchmarked with similar clinical units in like health services.

2.5.3 Implementing audit recommendationsImplementing some of the recommendations made by the audit review will require the assistance of various groups (eg, safety committee, pharmacy committee) and individuals (eg, clinical risk manager, infection control manager, supervisor of intern training) within the health service. For some major recommendations, especially those involving several departments or clinical areas, specific working parties may need to be established to analyse the problems and determine and implement appropriate solutions. The process of implementing major change in how patient care is provided will be discussed in detail in Chapter 6.

The health service's peak quality committee, hospital management and the clinical teams who participated in the audits should monitor progress made towards implementing major audit recommendations. It is important that audit recommendations are implemented in a timely manner. Such action sends an important message to clinicians that the health service values clinical audit and their participation in it, and is also genuinely committed to providing high-quality, safe care. Without appropriate, timely action to close the gaps in care and reduce the risks to patients detected by audits, the process will most likely wither.


28

2.5.4 Reporting audit results to the aedentlalllng and privileging committee Whole-of-practice audit data detailing the performance of individual clinicians should also be regularly forwarded to the health service's credentialling and privileging committee. These data allow the conmnnrr to ensure that the clinical privileges granted to individual clinicians remain appropriate. The comraioee should use the data to determine whether individual clinicians are undertaking sufficient numbers of each operation or procedure they have been granted privileges to perform to maintain their technical skills, and whether these operations and procedures are being performed safely. If the committee is concerned with the performance of an individual clinician, it is essential that data from the whole-of-practice audit (especially outcome measures) are reviewed to ensure that they do not refleci casemix variation, aspects of the structure of the organisation, or the processes of care used in managing such patients before the clinical performance of the individual clinician is deemed primarily responsibleJor the outcomes.20

2.5.5 Feedback to cliniciansWhole-of-practice data should also be provided to individual clinicians who can then compare their data over time, with clinicians undertaking similar work in the health service or in like health services, and against standards set by professional organisations, best practice and national and international data.8 Such feedback can lead to improvement in performance of 10% to 15%.*°

2.6 Clinical indicators

2.6.1 DefinitionThe Australian Council on Healthcare Standards defines a clinical indicator as:a measure of the clinical management and outcome of patient care. They are not exact standards against which hospitals must measure their clinical performance, but rather are designed as flags that "indicate" possible problems or opportunities to improve patient care. They are a tool to assist in assessing whether or not a standard in patient care is being met.41 A clinical indicator has also been defined as "a measurable aspect of care provided for which there is evidence that it represents quality on the grounds of scientific research or consensus among experts".22 42 More recently, indicators have been used less as flags for potential improvement, and more as measures of performance or quality.

2.6.2 Types of indicatorsClinical indicators are measures related to a clinical condition. They may be:43

■ Structural indicators (what is needed). These provide qualitative information about the health services environment (eg, physical resources, policies and procedures) and are usually present or absent■ Process indicators (what is done in providing care). These provide quantitative data on the effectiveness of policies and procedures.■ Outcome measures (what is achieved). These provide quantitative data on the outcomes of systems. Process measures are favoured because they are often more sensitive to changes in how clinical care isbeing provided. Desirable characteristics of indicators include being:■ measurable■ clcarly definable■ meaningful as a measure of care


29

■ valid and reliable■ objective■ able to be benchmarkcd over time or with like organisations, or national or international standards

The quality of many clinical activities can be measured using clinical indicators and benchmarking the results obtained. However, determining the clinical area in which to measure clinical performance can present problems because of the many different options that are available. These options include measuring clinical performance in the management of patients who present with diagnoses in the most frequent diagnostic-related groups in the health service, where measures are available for benchmarking, what is measurable (although care must be taken, as what is measurable may not be clinically important), and where the absence of a panicular component of care has a negative effect on mortality and morbidity.

Importantly, what matters clinically may be difficult to accurately measure, and indicators may be of limited use in some clinical areas. Also, different indicators may be important in different levels of the health system. What is regarded as imponant and useful to measure by individual clinicians, clinical teams, senior management, patients and health departments may be quite different.

2.6-3 Indicator programsThe major Australian program for acute health care quality indicators is the collaborative development of clinical indicators by the Australian Council on Healthcare Standards and the relevant speciality colleges. These indicators reflect the provider's perspective and emphasise technical proficiency. They are available to all organisations, and are included in the Council's accreditation requirements.

Reporting indicators to the Council is not mandatory for accreditation, but health services are required to use data to demonstrate improvement in performance. Health services participating in the clinical indicator program report their results to the Council for each indicator they have chosen to measure. Aggregated data is provided by the Council twice yearly to allow similar-sized hospitals to compare their results for particular indicators.43 There are many indicator programs, including:■ The Australian Council on Healthcare Standards Clinical Indicator Program — 23 clinical

indicator sets, covering general and specialist surgery, obstetrics, pathology, radiology, internal medicine, intensive care, anaesthetics, mental health, adverse drug reactions, dermatology, emergency medicine, and infection control (www.achs.org.au/ClinicalIndicators). Many of these indicator sets have been updated multiple times.

■ The US Joint Commission on Accreditation of Healthcare Organizations National Hospital Quality Measures — indicator sets for acute myocardial infarction, heart failure, community acquired pneumonia, surgical care, pregnancy and related conditions, and paediatric asthma (www.jointcommission.org/PerformanceMeasurement/PerformanceMeasurement)

■ The UK National Health Service (NHS) Better Care, Better Value Indicators — 15 indicators ol efficiency including length of stay, day-case rate, preoperative bed-days (www.productivity.nhs.uk/ default.aspx).

■ The NHS Scotland Clinical Indicators — survival following hip fracture, stroke, acute myocardial infarction; medical and surgical re-admissions; and mortality after surgery (www.indicators.scot.nhs.uk).

■ AHRQ Quality Indicators are grouped in four areas: prevention (hospital admissions and disease complications that could have been avoided with good outpatient care); inpatient (32


30

http://www.productivity.nhs.uk/

http://www.achs.org.au/ClinicalIndicators

indicators covering volume, utilisation and mortality); patient safety (indicators screen for adverse events); and paediatrics (www.qualityindicators.ahrq.gov).

■ Quality Use of Medicines in Australian Hospitals — 30 indicators grouped into six sets: antithrombotic therapy; antibiotic therapy; medication ordering; pain management; continuity of care; and hospital-wide medication management policies (www.ciap.health.nsw.gov.au/nswiag/indicalors.html).

■ Victorian Maternity Services Performance Indicators — 10 key maternity services "evidence- informed" indicators (www .health.vic.gov.au/maiernitycare ).


31

http://www.health.vic.gov.au/maiernitycare

http://www.ciap.health.nsw.gov.au/nswiag/indicalors.html

http://www.qualityindicators.ahrq.gov/

Clinical indicators that are valid, reliable measures of the quality of care being provided in panirular clinical situations should be chosen and collected. An extensive review of the literature has found very few indicators that meet these requirements.44

At Wimmera Health Care Group, clinical indicators have been used as (lags of potential deficiencies in service delivery systems. Clinical indicators are not used extensively, but on some occasions, they have alened the hospital's clinical quality committee that there may be a problem in a particular clinical area. In response to the level of a particular indicator, the committee has requested that a focus audit and analysis be undertaken to determine the strengths and weaknesses of the health care delivery systems that are involved.

The nature and content of individual audits will vary. Although the points listed in Checklist 2.1 are not relevant to every audit, the various issues they raise should be actively consideiyd when designing and conducting an audit, rather than passively overlooked.

Owckfest 2.1 Conducting a dinkal audit715 "'27

________________________________________________Yas No WIPN/AlAldMoristtRhamiaoaivad comprehensive education about the audit process. 12 Relevant staff have received training in how to undertake an audit.3 Ihe aucft process has management support demonstrated by:■ Adequate resources are available to conduct the audit (eg, a project officer if required, secretarial assistance, protected clinician time to participate in the audit activities).■ A senior executive staff member is closely involved with the audit process.■ This staff member is respected by medical and nursing staff in the hospital.4 The audit topic is selected after the consideration of the:■ size of the gap in care being provided;■ frequency, harm and preventability of a particular adverse event; or■ benefits, costs and feasibility of an intervention.5 The audt topic is regarded as important by clinicians.6 There is a clinical leader of the audit.7 Al potential participants in the audit are informed well in advance of the proposal to undertake the audt They are invited to be involved with and give feedback regarding the development of the area to be audited, the selection of audit criteria, the design of data collection tools, data analysis, and the review of the audits findings.8 The criteria against which performance will be assessed are developed by a multidisciplinary team of relevant health professionals, reflect best practice and are:■ balanced across the dimensions of care■ evidence-based

■ measurable■ collectable■ key measures that affect patient outcome (about 12)■ process measures, or outcome measures with short timeframes■ able to be readily benchmarked9 The suitability of the criteria are checked in a small-scale trial.10 The care provided to all patients, or an appropriate sample of patients is audited.11 Data entry is electronic where possible, and designed to minimise clinicians' time commitment.12 Data collection is prospective where possible.13 AB data collected are securely stored.14 A sample of the data is routinely checked for accuracy and completeness.15 If a paper-based audit is conducted, data extraction tools have been developed and successfully tested on a small scale before being fully implemented.16 Where possible, some data that are already being routinely collected are used in the audit.17 Data that identify individual patients are kept confidential.18 The results of the audit are reviewed constructively in meetings of relevant clinicians, and appropriate recommendations to improve the quality and safety of patient care are made.19 The results of audits and the recommendations made are forwarded to all participating dinidans. relevant staff and senior management at the health service.20 Benchmarking over time, between clinical units and against like health services and national and international data are undertaken.21 Recommendations for action are analysed and acted upon in a timely manner.22 The audit cycle continues until the identified gap in the care being provided is closed.23 The criteria against which performance is assessed are regularly reviewed to consider changes in best practice over time.24 Comprehensive whole-of-practice audits are continuously conducted in all major clinical areas of the healtfi service.25 The results of whole-of-practice audits are regularly forwarded to relevant clinicians, senior

2 Quality improvement

management and the credentialling and privileging committee of the health service.__________________________________________________j viflP = *xv m progress N/A = not applicable

m Quality improvement is a major component of clinical governance.■ The quality improvement process identifies gaps between the actual

performance in providing care and (he desired standard of care, then takes action to close the gaps.

■ The usual desired standard of care is best practice according to the highest-quality scientific evidenoe available at the time.

■ Multiple sources of information about what constitutes best practice in many clinical areas are available in written and electronic form.

■ Choosing clinical areas and interventions for improvement may be difficult because of the large number of opportunities available. ♦

■ Clinical audit is the method used to detect gaps in care.

■ The clinical area to be audited should be regarded as important by clinicians

working in that area.

■ Adequate resources are required to undertake clinical audit.

■ Participating clinicians need to be kept informed and involved with each stage

of the audit process.■ The criteria used to measure performance require careful selection. Where

possible, a small number of key evidence-based process measures or outcome measures with short time frames should be used.

■ The amount of time required by clinicians to fully participate in clinical audit is critical to its success. Data entry should be designed to require minimal clinician time, and clinicians should be given protected time to fully participate in the audit process. '

■ The results of audits should be reviewed constructively in meetings of relevant clinicians, and appropriate recommendations about patient care should be made.

■ The results of audits and the recommendations made should be forwarded to all the clinicians involved in providing care in the clinical area, relevant staff and senior management.

■ Recommendations for action arising from the analyses of the results of audits should be acted upon in a timely manner.

■ Multiple audit cycles in which performance is measured and action is taken are almost invariably required to close a gap in care.

■ The results of audits should be benchmarked within the health service and externally with like organisations.

■ As well as specific audits, comprehensive whole-of-practice audits should be conducted in all major clinical areas of a health service, and the results should be used in the credentialling and privileging process.

■ Clinical indicators are flags of possible problems or opportunities to improve care for particular clinical conditions. A variety of indicators in many clinical areas are available from programs developed in several countries.

References

t Schuster MA. McGtynn EA, Brook RH. How good is the quality of health care in the United States? Milbank Q 2005;

83:843-896.2 Pronomst pj. Nolan T, Zeger S, et al. How can clinicians measure safety and quality in acute care? Lancet 2004; 363:1061-1067.3 National Institute of Clinical Studies. Evidence-practice gaps report. Vol 1. Melbourne: NICS. 2003. www.nhmrc.gov .au/nics/asp /irKlex .asp (accessed Oct 2008).4 National Institute of Clinical Studies. Evidence-practice gaps report. Vol 2. Melbourne: NICS. 2005. www .nhmrc.gov.au/nics/asp/index.asp (accessed Oct 2008).5 Shojania KG. Duncan BW. McDonald KM, Wachter RM. editors/Making health care safer: a critical analysis of patient safety practices. Rockville, Md: Agency for Healthcare Research and Quality, 2001. (Evidence Reporl/ Technology Assessment No. 43; AHRQ publication 01-E058.)6 Shojania KG. Duncan BW, McDonald KM, Wachter RM. Safe but sound. Patient safety meets evidence-based medicine. JAMA 2002; 288: 508-513.7 Mainz J. Developing evidence-based clinical indicators: a state of the art methods primer. Int J Qua! Health Care 2003; 15:i5-i11.8 Wollersheifn H. Hermens R. Hulscher M, et al. Clinical indicators: development and applications. Neth J Med 2007; 65: 15-22.9 Pionovost PJ. Thompson DA. Holzrnueller CG. et al. Defining and measuring patient safety. Crit Care Clin 2005; 21: 1-19.10 Nelson EC, Mohr JJ, Batalden PB, Plume SK. Improving health care, part 1: the clinical value compass. Jt Comm J dual Improv 1996; 22: 243-258.11 Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington. DC: National Academy Press. 2001.


http://www.nhmrc.gov.au/nics/asp/index.asp

http://www.nhmrc.gov.au/nics/asp/irKlex.asp

12 Blumenthal D, Epstein A. The role of physicians in the future of quality management. N Eng J Med 1996; 335: 1328-1331.13 Bion JF. Heffner JE. Challenges in the care of the acutely ill. Lancet 2004; 363:970-77.14 Institute of Medicine; Field MJ. Lohr KN. editors. Guidelines for clinical practice: from development to use. Washington. DC: National Academy Press. 1992.15 Mainz J. Defining and classifying clinical indicators for quality improvement. Int J Oual Health Care 2003; 15:523- 530.16 Shoiania KG. Sampson M. Ansari MT, et al. How quickly do systematic reviews go out of dale? A survival analysis. Ann Intern Med 2007; 147: 224-233.17 Donabedian A. Evaluating the quality of medical care. Milbank Mem Fund O 1966; 44: 166-206.18 Berenhotlz SM, Pronovost PJ. Monitoring patient safety. Crit Care Clin 2007; 23: 659-673.19 Pronovost PJ. Angus DC, Dorman T. et al. Physician staffing patterns and clinical outcomes in critically ill patients: a systematic review. JAMA 2002; 288: 2151-2162.20 Litford R. Mohammed MA, Spiegelhalter D. Thomson R. Use and misuse ol process and outcome data in managing performance of acute medical care: avoiding institutional stigma. Lancet 2004; 363: 1147-1154.21 Donabedian A. Explorations in quality assessment and monitoring. Vol II. The criteria and standards of quality. Ann Arbor. Mich: Health Administration Press, 1982.22 Lawrence M. Olesen F. Indicators of quality in health care. Eur J Gen Pract 1997; 3: 103-108.23 Seddon M. Buchanan J. Quality improvement in New Zealand healthcare. Part 3: achieving care through clinical audit. NZMedJ2006; 119: U2108.24 Mant J, Hicks N. Detecting differences in quality of care: the sensitivity of measures of process and outcome in treating acute myocardial infarction. BMJ1995:311: 793-796.25. National Institute for Health and Clinical Excellence. Principles for best practice in clinical audit. Oxford: Radcliffe Medical Press. 2002. www.nice.org.uk/media/796/23/BestPracticeClinicalAudit.pdf (accessed Oct 2008).28 Brook RH. McGlynn EA. Cleary PD. Measuring quality of care. N Eng J Med 1996; 335: 966-970.


http://www.nice.org.uk/media/796/23/BestPracticeClinicalAudit.pdf

http://www.nice.org.uk/media/796/23/BestPracticeClinicalAudit.pdf

27 Watters DA, Green AJ, van Rij A. Guidelines for surgical audit in Australia and New Zealand. ANZ J Surg 2006; 76 78-83.28 Brown PM. The audit cycle: a guide to success. Br J Hosp Med

2006; 67:116-117.29 Collopy BT. Ensuring accuracy of clinical data is only part of the audit process. J QuaI Clin Pract 2001; 21: 74-75.30 Gibbons AJ, Dhariwal DK. Audit for doctors: how to do it. BMJ2Q03, 327: S1-S2.31 Pronovost PJ, Berenholtz SM, Goeschel CA, et al. Creating high reliability in health care organizations. Health Sarv Res 2006; 41: 1599-1617.32 Grimshaw JM, Thomas RE. MacLennan G, et al. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess 2004; 8:1-84.33 Mittman BS. Creating the evidence base for quality improvement collaboratives. Ann Intern Med 2004; 140:897- 901.34 Aitken RJ, Nixon SJ, Ruckley CV. Lothian Surgical Audit: a 15-year experience of improvemeat in surgical practice through regional computerised audit. Lancet 1997; 350: 800-804.35 Semmens JB, Aitken J, Sanfilippo FM, et al. The Western Australian Audit of Surgical Mortality: advancing surgical accountability. Med J Aust 2005; 183: 504-508.36 Semmens JB, Mountain JA, Sanfilippo FM, et al. Providers and consumers support the Western Australian Audit of Surgical Mortality. ANZ J Surg 2006, 76: 442-447.37 Royal Australasian College of Surgeons. Continuing professional development program information manual 2007- 2009. Melbourne: Royal Australasian College of Surgeons, 2006. www.surgeons .org/Content/NavigationMenu/ FellowshipandStandards/CPDRecertification/default.htm (accesssed Oct 2008).38 Eno LM, Spigelman AD. A survey of surgical audit in Australia: whither clinical governance? J Qua! CUn Pract 2000; 20: 2-4.39 Royal College of Physicians. National Sentinel Audit 2006. Prepared on behalf of the Intercollegiate Stroke Working Party. London: RCP, 2007.40 Van der Weijden T, Grol R. Feedback and reminders. In: Grol R, Wensing M. Eccles M, editors. Improving patient care: the implementation of change in clinical practice. Edinburgh: Elsevier, 2005:158-172.41 Australian Council on Healthcare Standards. Clinical indicators — user manuals. Sydney: ACHS. 1998.


http://www.surgeons.org/Content/NavigationMenu/

42 Australian Council on Healthcare Standards. ACHS Clinical Indicator Program Information 2008. Sydney: ACHS. 2007.43 Campbell SM, Braspenning J. Hutchison A, Marshall M. Research methods used in developing and applying quality indicators in primary care. Oual Sal Health Care 2002; 11: 358-364.44 McNeil JJ Report on patient safety monitoring systems. Melbourne: Victorian Department of Health and AgedCare. 1999. □Enhancing patient care3 Risk management — why do adverse eventshappen to patients?

This chapter will:

■ Discuss health care delivery systems and their properties■ Examine the frequency of adverse events in health care and their preventatiblity■ Examine reasons why errors occur and the role of latent factors, active errors and barriers■ Compare the punitive and systems responses to errors■ Characterise an ideal quality improvement and risk management system in health care *■ Provide a flow chart of the Wimmera Model of Clinical Quality Improvement and Risk Management.

3.1 Health care delivery as a system

The second major component of clinical governance is risk management. Unless adequate barriers are in place, accidents will occur.' In health care, an accident that causes harm to a patient is called an adverse patient event. When looking at why adverse patient events happen, it is useful to view health care delivery as a system. This systems approach helps develop models to explain how adverse events occur. The factors contributing to the event are determined, and this information helps develop strategies to make the system safer by reducing the probability of adverse events recurring.

3.1.1 Defining o systemIndustries deliver their products and services using systems. Health care is no exception, although it is somewhat behind other industries in embracing a systems approach to improving the quality of theservices it provides.

A system comprises many inter-related processes designed to achieve an objective. For example, a patient attending an emergency department with chest pain will be entering a system designed to deal with that clinical problem. The processes in this system may include: triage of the patient by nursing staff; medical assessment of the patient by hospital medical officers; an intravenous line being inserted: an electrocardiogram being performed and interpreted; a blood sample being taken, sent to the pathology laboratory, analysed and the results reported; and oral and intravenous medication being administered.Importantly, health care delivery systems differ from other complex industries, such as aviation, where service delivery systems comprise a greater proportion of mechanical, rather than human, components Unfortunately, the greater human component in health care, and the sometimes high level of uncertainty in the diagnosis and treatment of patients, may result in error and gaps in patient care occurring more frequently than in other, more mechanical, industries.

3.1.2 Properties of systemsThe outcome produced by a system is a property of that system. Improving the outcome requires a change in the processes that make up the system, not merely a requirement that health professionals work harder within the existing system.Often, the relationships between individual processes in health care delivery arc not simple causc and effect, bui are complex networks of relationships that can change with time 2 In the above clinical



scenario, a patient may be unable to give a clear history of their chest pain, which may result in inappropriate triage and delayed medical assessment. The process of patient assessment outside of normal working hours may require a doctor to be paged to the emergency department, thereby introducing an additional process into the system. After-hours laboratory staff may need to be called into the hospital to perform blood tests, which may delay analysis and reporting of results.

Health care is provided using simple and complex delivery systems. Complexity can arise from the number of processes in the system and the number of options available to clinicians at each decision point in the system. Simple systems can have predictable outcomes. Complex systems, however, are usually not linear, and can have multiple interactions between its components and with components external to the system.3 Outcomes produced by complex systems can rarely be predicted with certainty. Unexpected and unintended negative outcomes occur frequently, and are more likely to occur as systems build in complexity.4

When a change is made to a system, factors not directly related to the change may affect the outcome. Many components of complex systems are inter-related, and a change in one component may unexpectedly affect another. In particular, social interactions in systems are rarely linear and are often unpredictable.3 System participants may view the system's function and purpose differently.5 Unfortunately, it is not possible to keep all the other components of the system constant while a change to one component is made.3

These general properties of complex systems are important to consider when determining how health care delivery systems should be redesigned to reduce adverse events. Because of the complexity of many health care delivery systems, a systematic, detailed analysis — of the characteristics ol any proposed change, the people who will be required to change their behaviour, and the setting in which the change is proposed — will need to be made, and a change implementation strategy tailored to these characteristics should be developed. Relevant staff members should help identify interventions with the greatest probability of success and important barriers and facilitators of the proposed change or intervention.3 The process of implementing change will be discussed in detail in Chapter 6.

3.2 The extent of adverse events

Previously, iatrogenic patient injury in health care was thought to be rare, unpreventable and related to the performance of individual clinicians. However, the Harvard Medical Practice Study, which reviewed a random sample of 30 000 patients in acute hospitals in New York state in 1984, showed that iatrogenic injury occurred in 3.7% of hospitalised patients.6 The study concluded that iatrogenic

"Acute care hosptals are complex, dynamic environments (hat kjnctcn (ormaftjx dun) as a result Of tie interplay of

tfwQTiO departments; loams and individuate.'

Cook OJ. et al Lancet 2004; 363: 1224-1230

complications affect over 1.3 million hospitalised patients annually in the United States, and that almost 70% ol these events are preventable.6

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The Quality in Australian Health Care Study showed that 16.6% of patient admissions in Australia were associated with an adverse event.7 Over half of the adverse events were considered to be preventable. Extrapolating these findings to all Australian hospitals indicated that about 470 000 patient admissions and 3.3 million bed-days annually were attributable to adverse events.

There has been much debate about why the rate of adverse events in Australia was so much higher than in the US. Further studies were undertaken, comparing the adverse event rate in Utah and Colorado with the results of the Quality in Australian Health Care Study. After taking into account the differences in how the studies were conducted and the how the data were treated, the adverse event rale in Australia was adjusted to 10.6%, compared with 3.2% in "the US. This threefold difference was thought to be due to dilTerent thresholds for admission and discharge in Australian hospitals, and underreporting of some adverse events by reviewers in the US.8 A further comparison was undertaken, and no differences in quality of care were identified between the countries.9

The Harvard Medical Practice Study methodology was replicated in New Zealand, the United Kingdom, Denmark, France, the Netherlands and Canada. Although these studies found different rates of adverse events, it is thought that about 10% of hospital patients experience an adverse event, and at least 50% of these are preventable.10

3.3 The reasons why errors occur

Organisational accidents in other complex industries, such as aviation and nuclear power, have been analysed extensively.11 The model developed by Professor James Reason helps explain why accidents occur (Figure 3.1).12

3.3.1 Latent factorsEvery organisation has a number of latent factors that provide the background against which an error can occur. The number and magnitude of these latent factors are frequently determined by decisions made a long way from the coalface. Usually, senior management makes decisions about how resources are allocated to each area in an organisation. Inevitably, because of the finite resources that are available, there is a trade-ofT between the quantity of resources allocated for running the organisation and clinical care and the resources directed toward safety. These resource allocation decisions affect many aspects of the organisation's work environment, including:

Figure 3.1 Organisational accident model12

Contributory factors influencing clinical

practice

Organisational and

corporate

culture

Defence barriers

Accident/ incident

TaskError-producing conditions

ErrorsManagement decisions and organisational processes

Violation- producing conditions

Violations

T T T

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■ the number, seniority, knowledge and skill level of the staff employed to work in each area

■ the workload each individual is expected to complete■ the length and frequency of work shifts■ the degree of supervision of staff members■ the quantity and quality of equipment provided to undenake the

required tasks■ the frequency of equipment maintenance.

How senior management allocate the resources available to the organisation will affect the probability of particular types of adverse events occuring. For example, a decision may be made by senior management to reduce the frequency of equipment maintenance. This reduction may increase the probability of a serious equipment failure occurring. Although reducing maintenance will save costs in the short term, the resultant equipment failure could contribute to an accident or downtime occurring and reduced production in the long term.

However, attempting to address individual latent factors is not always straightforward. For example, efforts have been made in many countries to reduce clinician shift lengths to reduce fatigue in an attempt to reduce the frequency with which clinicians make errors. However, reducing shift lengths increases patient handovers between shifts, which may result in increases in communication failure and discontinuity of care, leading to adverse events.13 Latent factors are "accidents waiting to happen".14 Often, latent factors are not addressed proactively because they contribute to a background level of risk that is often not recognised until a serious event occurs. Funher, a decision by management that increases the magnitude of a latent factor may not have an immediate effect. The adverse events resulting from this management decision may take months or years to occur. Therefore, one of the most productive things an organisation can do is proactively examine all its potential latent factors, and take steps to reduce their number and size, thereby strengthening the systems of care before a serious event occurs. "Latent failures represent a tremendous opponunity to improve patient safety."13

3.3.2 Active errorsOn the other hand, active errors occur closer to the interface where health professionals provide clinical care to patients. The Agency for Healthcare Research and Quality in the US defines medical errors as "mistakes made in the process of care that result in, or have the potential to result in, harm to patients".15 Active errors can be classified according to the appropriateness (or otherwise) of the management plan formulated for the patient's care. The management plan may be appropriate for the clinical situation, but not be correctly executed because errors such as slips (eg, due to inattention) or lapses (eg, due to failure of memory) occur. Alternatively, the action may be performed correctly, but the plan may be inappropriate because of mistakes such

^Heaflhoate systems are compter adaptive systems—the parts have toe freedom and ab&ty to respond to Stimuli in many different arid fundamentally unpredictable ways.'

Ptsek PE. Green halgh T 8MJ2001;323 625-628

as not applying an appropriate rule or a lack of knowledge about how to deal with a particular clinical situation. Unlike latent errors, active errors are more likely to have an immediate effect.

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Errors can be further classified as errors of omission (failure to provide a component of appropriate care) and errors of commission (where a component of care is provided but it is inappropriate). Errors of omission are more common, more difficult to identify, and are thought to have a greater effect on patientsafety.16,17

Latent factors and active errors frequently act together, often through a unique combination of circumstances. Fortunately, barriers are often in place to prevent adverse events, even when an active error has occurred and latent factors are present. The strongest barrier against adverse events may be patients' resistance to potentially harmful events.

For example, a patient may be given incorrect medication or the wrong dose of a medication but suffer no ill effects; or an active error may delay the diagnosis of a serious condition being made, but often the patient will make a full recovery, perhaps delayed, despite the error having occurred. Further, there are often double and triple checks built into health care delivery systems that art as barriers to adverse events occurring. For example, a nurse or ward pharmacist may detect an incorrect dose of a drug written by a doctor on a medication chart. Similarly, a mechanical barrier such as an oximeter alarm may be in place to warn an anaesthetist that a patient's oxygen saturation is falling.

3.4 Errors and adverse events

Although some errors can be fatal or cause'significant and permanent harm to patients, it is important to realise that not all errors result in harm, and that errors are far more common than adverse events.18 Most errors occur with medications, and the vast majority of these are minor and do not harm patients. Such errors may include patients being administered medication at the wrong time or being given medication that was prescribed for another patient. Some of these errors are detected, and intervention occurs before they reach the patient. Others do reach the patient, but have little or no effect. Adverse events can occur as the result of error or despite appropriate care having been given. For example, a procedure that is correctly indicated for a patient may be performed correctly, but still result in a complication (eg, infection or haemorrhage).

There may be a bias in the errors that are detected. It is more likely that errors related to treatment will be detected than errors related to diagnosis or prevention. Often, treatment errors are highly visible or recognised more quickly because the patient has experienced obvious harm. Failure to diagnose or adequately prevent a medical condition may not be realised for months or years.19

3.5 The response to errors

Previously, when adverse events have occurred in the delivery of medical care, there was a tendency to blame individual health care professionals, punish them, demand perfection in their performance and insist that they try harder. Importantly, such punitive responses, rather than positively changing clinical behaviour, have frequently led to adverse events and near misses not being reported for fear of punitive action being taken.20 Punitive responses result in under-reporting, the continued presence of hazards to patient safety, and valuable opportunities being

missed to examine and strengthen the systems that allow adverse events to occur. Viewing health care deliver)' as comprising a number of systems focuscs the analysis of adverse events on the components of the systems involved, and away from apportioning blame to individuals.

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Why is the natural tendency to blame individuals when an error occurs? At the individual level, it is a human tendency to blame others when bad outcomes occur. When people perform a task poorly, it is often attributed to their personality or ability, but invariably, on more detailed examination, the circumstances in which the error occurred are also found to have affected the individual's actions. Further, many people erroneously believe that only incompetent clinicians make errors, whereas in reality, highly competent doctors can also make mistakes. Individuals are also blamed for making errors with the bias of hindsight — others examining the incident often believe that errors were more foreseeable than they were in real time, because their knowledge of the outcome alters their perceptions of the incident.21

At the organisational level, it is easy to find errors made by individuals at the staff-patient interface or "sharp end" after an incident has occurred. Therefore, investigation of the incident may stop at the interface, without an examination of the conditions of work or latent factors that were present at the lime the incident occurred, which conveniently limits any attribution of blame at the higher management levels in the organisation.21

The modem industrial approach to error reduction is to avoid blaming individuals unless they have committed an intentionally unsafe act, and instead analyse the components of the systems that contributed to the error occurring. Then, the latent factors that created the environment that allowed the error to occur can be dealt with, improving the system as a whole. Delivery systems can be redesigned to reduce the probability of errors occurring by taking appropriate action, including:■ simplifying the systems involved■ standardising procedures■ introducing constraints■ using reminders and checklists.These actions will be discussed in detail in Chapter 6.

It is important to acknowledge that, although some authors believe that health care can learn from other industries, they have also questioned the complete applicability of such industrial approaches to health care, citing the highly complex nature of health care delivery, the very individual needs of each patient (as opposed to producing a relatively small number of different types of items on a production line), the uncertainty associated with many o( the decisions that are made in providing care to a patient (eg, when the diagnosis is uncertain or a patient has several associated comorbidities), the incomplete evidence base in the scientific literature upon which to base rational decision making, and the unpredictable, sometimes extreme workloads. It has

PRMisioniNotosihe defray of mKons of sendees by thousands ct heath professionals to hunteds of thousands of inpatients using complicated equipment, procedures and processes. A major difficulty is that a zero error rate... is not seriously possible to get close to. let alone achieve, in health care. People are living longer, with more serious illnesses and multiple comorbidities, and treatment is complex, sometimes risky, even dangerous.' Braithwaite J, Travaglia JF Aust

Health Rev 2008: 32: 10-22

been suggested that a military model may be more applicable in managing acutely ill patients "with the uncertainties of warfare, friendly fire and 'collateral damage'".13

3 Riek management

3 RM< managemtra

3.6 The basic risk management process

A basic risk management program should detect adverse events that have occurred in an organisa-tion; analyse them and ascertain their level of risk; determine and take appropriate action to reduce the probability of the adverse event recurring; and continue to monitor activity to assess whether the actions taken have been successful (Figure 3.2).

Also, risks present in an organisation can be detected by analysing adverse events that occurred in similar organisations, and the associated risk reduced in a similar manner as if the event had occurred within the organisation.

3.7 The basic risk management process in health care

The basic risk management process requires expansion for use in health care. Clinical activity should be screened for potential adverse events and clinical incidents should be reported. Clinical

review is then required to assess if an adverse event has occurred. If so, its risk is determined according to its probability and consequence.

Risks to the health service can also be detected by analysing events that have

occurred in other health services and can be reduced in a similar manner than if the event

had occurred in the organisation.

Figure 3.3 The Wimmera clinical risk management model

Once identified, risks require prioritisation for action. Such action many involve minor changes, but more often major changes to health care delivery systems are required. Most importantly, after action has been taken, clinical activity should continue to be monitored and evaluated to determine whether the action has been successful in reducing the nsk and preventing the panicular adverse event from recurring (Figure 3.3)

3 Riek management


3.8 Characteristics of an ideal quality improvement and risk management system

What characteristics of best-practice quality improvement systems should we strive to incorporate when developing a quality improvement and clinical risk management program? Although all the following criteria are unlikely to be met by one quality improvement approach or system, they provide valuable signposts to the direction that quality improvement and risk management projects should take in individual organisations. The criteria are:■ positive impact on the standard of patient care■ continuous■ misses few (if any) major negative outcomes■ provides, direct, timely feedback and action■ automatic, continuous monitoring of risk and the effects of action■ uses multiple sources of information■ relatively inexpensive■ confidential■ objective (uses external performance standards where possible)■ provides a comprehensive, continuous flow of information to hospital staff members, senior executives and the board of management■ logical and scientific■ involves all clinical staff members and functions across the continuum of care in the hospital■ provides valid, useful information■ simple to understand and apply■ takes a minimum of time.

3.9 The Wimmera quality improvement and risk management model

The Wimmera quality improvement and clinical risk management model attempts to address most of the above criteria, and provides a systematic approach to quality improvement and clinical risk management that comprises five basic, sequential and coordinated components:■ detecting gaps in patient care, adverse events or risk to patients using multiple methods■ analysing these gaps, adverse events and risks■ determining the importance of each gap and the risk each event poses to patients and the hospital, and prioritising them■ determining and taking appropriate actions to close the gaps or reduce the risks■ monitoring the effects of these actions.The components of the model are outlined in Figure 3.4.Over the next four chapters, we will examine each of these components in detail, and describe the steps that can be followed to implement such a program in a hospital.

■ Health care is delivered using complex systems consisting of many inter-related processes and a large human component.

■ The outcomes produced by complex systems are uncertain.

Figure 3.4 The Wlmmere quality tmprovement end risk management model

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■ Gaps in care, and unexpected and. unintended negative outcomes, occur frequently. Further, a large proportion are preventable.

■ Adverse events occur when active errors (eg, slips, lapses, rule violations or inadequate knowledge) interact with latent factors (eg, inadequate supervision, lack of skills, high workloads and inadequate equipment) and barriers are ineffective in preventing the adverse event from occurring.■ The usual response to errors in heath care is punitive — to blame individuals, expect perfection and demand that individuals try harder.■ Punitive responses do not change clinical practice, and may result in under-reporting of adverse events to avoid punishment.■ A systems approach to gap and adverse event analysis can identify weaknesses in health care delivery systems. These systems can then be redesigned to close gaps and reduce the probability of adverse events recurring.

■ The characteristics of an ideal quality improvement and risk management program can be defined.■ The Wimmera quality improvement and clinical risk management program:> detects gaps in care, adverse events and risks using multiple methods;> analyses them;> assesses the importance of each gap and the risks associated with each adverse event and prioritises them;> determines and takes appropriate actions to close the gaps or reduce the risks; and> monitors the effects of these actions.

References1 Reason J. Human error. Cambridge. Mass: Cambridge University Press. 1992.2 Senge P. The fifth discipline: the art and practice of the learning organization. London: Doubleday/Cenlury Business, 1990.3 Litaker D. Tomolo A. Liberatore V, et al. Using complexity theory to build interventions that improve

health care delivery in primary care. J Gen Intern Med 2006:21: S30-S34.4 Nolan TW. Understanding medical systems. Ann Intern Med 1996; 128:293-298.5 lies V. Sutherland K. Organisational change: a review for health care managers, professionals and researchers London: National Co-ordinating Centre for NHS Service Delivery and Organisation R & 0.2001.6 Brennan TA. Leape LL. Laird NM. et al. Incidence of adverse events and negligence in hospitalised patients: results of the Harvard Medical Practice Study 1. N Engl J Med 1991; 324:370-376.7 Wilson RM. Runciman WB. Gibberd RW, et al. The Quality in Australian Health Care Stufly. MedJAust 1995:163: 458-71.8 Thomas EJ. Studdert OM. Runciman WB. et al. A comparison of iatrogenic injury studies in Australia and the USA I: context, methods, casemix. population, patient and hospital characteristics. Int J Oual Health Care 2000; 12: 371-378.9 Runciman WB. Webb RK, Helps SC. et al. A comparison of iatrogenic injury studies in Australia and the USA II: reviewer behaviour and quality of care. Int J Qual Health Care 2000:12:379-388.10 Leape LL. Scope of problem and history of patient safety. Obstet Gynecol Clin N Am 2008; 35:1-10.11 Leape LL. Error in medicine. JAMA 1994; 272:1351-1857.12 Reason J. Understanding adverse events: the human factor. In: Vincent C. editor. Clinical risk management enhancing patient safety. London: BMJ Book's. 2001.13 Bion JF, Heffner JE. Challenges in the care of the acutely ill. Lancet 2004; 363: 970-977.14 Shojania KG, Wald H, Gross R. Understanding medical error and improving patient safety in the inpatient setting. Med Clin N Am 2002: 86: 847-867.15 Agency for Health Care Research and Quality. AHRQ's Patient Safety Initiative: building foundations, reducing risk. Interim report to the Senate Committee on Appropriations. Rockville. Md: AHRQ. (AHRQ Publication No. 04- RG005, 2003.)16 Angus DC, Black N. Improving care of the critically ill: institutional and health-care system approaches. Lancet 2004; 363: 1314-1320.17 Cook DJ, Montori VM, McMullin JP, et al. Improving patients' safety locally: changing clinician behaviour Lancet 2004; 363: 1224-1230.18 Resar RK, Rozich JD, Classen D. Methodology and rationale for the measurement of harm with trigger tools. Oual Sal Health Care 2003:12 (Suppl II): ii39-ii45.19 La Pietra L. Calligaris L. Molendini L. et al. Medical errors and clinical risk management: state of the art. ACTA

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Otorhinolaryngol Ital 2005; 25: 339-346.20 Leape LL. Why should we report adverse events? J Eval Clin Pract 1999; 5:1-4.21 Reason JT. Carthey J. de Leval MR. Diagnosing "vulnerable system syndrome": an essential prerequisite to effective risk management. Oual Saf Health Care 2001; 10: ii2l-ii25. □

Enhancing patient care4 Detecting adverse events and risk

This chapter will:

■ Discuss the methods available to detect adverse events and risk in health services■ Describe the major reactive methods of detecting adverse events and proactive methods of JMucMng rirtc. and their

advantages and disadvantages.

4.1 Methods of detecting adverse events and risko

As has been discussed previously, clinical risk management is about ensuring that adverse patient events occur less frequently. The first step in reducing the frequency of adverse events is to identify when such events have occurred. Such information is available to health services from two imponant sources:■Adverse events that have occurred to patients within the health service. This method is referred to as reactive risk management. No single method has been developed to detect all adverse events that occur, so multiple, diverse methods are used.■Adverse events that have occuned in other health services should be obtained from many sources and used to examine the health service's relevant delivery systems to identify areas of risk within the service. This method is referred to as proactive risk management.The benefits of this second approach are numerous. Lessons can be leamt and applied from a much larger pool of adverse events than those that might occur in an individual health service. Information about adverse events that occur rarely in individual health services can also be utilised. Using information about adverse events that have occurred elsewhere, weaknesses in health care delivery systems can be proactively identified without patients being harmed or staff in the health service having to experience the psychological trauma of a serious adverse event.There are four basic methods that can be used to detect the adverse events that have occuned to patients in a health service:■directly observing an adverse event■receiving a legal claim made by a patient concerning an adverse event■reading the details of an adverse event in the patient medical record■being told the details of an adverse event by a clinician or patient. Information about adverse events at other health services is available from:■legislative requirements to report specific clinical events (eg, consultative committees in specific clinical areas, coroners' inquests)■voluntary and mandator)' reporting of clinical incidents and specific events (eg, national databases of clinical incidents and sentinel events)■commercial requirements to report adverse events or risks to the health care field (eg. drug and equipment alerts from pharmaceutical companies and medical equipment manufacturers)■media reports of adverse events■clinical journal articles in which adverse events are described■the findings of inquiries into individual health services or specific clinical areas in those health

services.As well as health services learning from adverse events that occurred elsewhere, different t\pcs of proactive risk management methods are available to reduce risk and prevent adverse events, including■examining the work conditions in the health service when designing health care delivery svstcms. and taking action to strengthen any weaknesses that arc dctcctcd

3 Riek management

Despite these limitations, claims can still provide useful information about rare events that occur in health services, and often provide a very detailed (albeit legally based) analysis of an individual adverse event. Claims can detect latent factors that were present when the adverse event occurred and deficiencies in processes of care that were delivered. With the analysis of large samples of claims usually conducted by medical defence organisations rather than individual health services, important clinical themes in specific clinical specialities become apparent. Key lessons from this information can be used to direct quality and safety programs in health services and prevent recurrence of similar events. At the individual health service level, all claims made against the service should be analysed as part of the service's quality improvement and patient safety program, but in most services, such analysis will only be a very small pan of their overall program.5

Because of the limitations of direct observation and legal claims, most adverse event detection programs in health services use medical record review or clinical incident reporting, or both, to detect adverse events.Box 4.1 Harvard Medical Practice Study screening criteria for advene events'

1 Hospitalisation within previous year for patients younger than 65 years old, and previous 6 months for older patients

2 Admission to any hospital after current discharge3 Previous failure of medical management or unfavourable results

4 Trauma incurred in hospital

5 Unfavourable drug reaction4n hospital

6 Transfer from general care to a special care unit

7 Transfer to another acute care hospital

8 Return to operating theatre during current period of hospitalisation

9 Treatment for organ damage after an invasive procedure

10 Acute myocardial infarction, cerebrovascular accident, or pulmonary embolus during or after an invasive procedure

11 Neurological deficit at discharge12 Death13 Temperature higher than 38.3°C on day before or day of discharge

14 Cardiac or respiratory arrest15 Five-minute Apgar score < 6. or complication of abortion or labour and delivery

16 Other undesirable outcome17 Indication of litigation in the medical record18 Length of hospital stay above 90th percentile for diagnosis-related group in patients aged under 70 years, and 95th percentile in those aged 70 years or older.

4.2.3.1 Inpatient screening criteriaFonunately, several studies have developed screening criteria to help identify these "high-risk" records The largest study, the Harvard Medical Practice Study,7 developed and used 18 screening criteria (Box 4.1) Using these criteria to screen medical records in a sample group of hospitals, the Harvard Medical Practice Study found most adverse events that occurred during the period under review Most importantly, it is not necessary to find all adverse events documented in a hospitals medical records for the clinical risk management program in an individual health service to be effective Finding all

4 Detecting advert* events and rta*

4.2.3 Medical record reviewIt is not practical to continuously review the medical records of all the patients admitted to hospital. The volume of records requiring review would be high, and most records would not contain any evidence of adverse events. Therefore, a more efficient approach is required. How can most significant adverse events recorded in patient medical records be found without having to review all or a large number of medicalrecords? Medical records with a higher-than-average probability of containing an adverse event need to be identified.

■assessing the risk of individual patients experiencing common adverse events and taking appropriate preventive action

■ encouraging patients to take an active role in the care they are receiving at the health service■using preventive health strategies to reduce the prevalence of common and preventable

medical conditions, thereby reducing the need for hospital admissions.Wc will first discuss each of the methods available to individual health services to detect adverse events that have occurred in their facilities. We will then outline how individual health services can detect areas of risk in their organisation using information about adverse events that have occurred outside the service, and discuss other proactive methods of risk reduction.

4.2 Reactive risk management — detecting adverse events

4.2.1 Direct observationDirectly observing an adverse event has the advantage of the event being detected prospectively, and studies suggest that most adverse events, especially medication errors, are detected using this method.1 Direct observation has been used for relatively short periods of time in operating theatres, and has detected process variations that had the potential to result in adverse events. However, most of these variations were recognised by theatre staff and did not progress to adverse events. Direct observation in operating theatres identified communication breakdown, information loss, multiple competing tasks and high workload as areas for patient safety initiatives.2 Observing clinicians discussing adverse events during regularly scheduled daytime education and patient care meetings found these discussions to be a useful source of information about adverse events.1 Directly observing nurses found two types of failures in the care delivery process: problems (a disruption to being able to execute a task because something that was needed, such as supplies, medication or information, was unavailable), and errors. Of the failures, 86% were problems.3

Although short observation periods in clinical areas may yield useful information to improve patient safety, complete 24-hour direct observation of patients and staff would be very costly. The routine use of direct observation to detect adverse events is not financially or logistically feasible, nor would it be desirable to have all hospital staff members and patients observed constantly.

4.2.2 Legal claimsLegal claims related to adverse patient events occur infrequently compared with the number of admissions and outpatient attendances in an individual health service, and are a small proportion of the adverse events that occur in acute hospitals. In the Harvard Medical Practice Study, more than two- thirds of adverse events detected were judged to be preventable, and half of these were due to negligence. However, less than 2% of patients with injuries due to negligence took legal action.4 Therefore, legal claims are not a large source of information about adverse events, and when such claims are made, they often concern an adverse event already detected by the health service using other methods

Claims are a small, unrepresentative sample of the adverse events thai occur in an individual health service. The claims made can be biased to adverse events that led to severe injuries, and there are often long delays between the event occurring and the claim being made. Sometimes the claims relate to injuries that were not caused by medical management.5 Claims are more likely to be made if patients feel they have been treated with disrespect or if clinicians have not been open and forthcoming about what has happened, whether or not negligence has occurred. Overall, medical errors are common, but legal claims are rare.6


50

Despite these limitations, claims can still provide useful information about rare events that occur in health services, and often provide a very detailed (albeit legally based) analysis of an individual adverse event. Claims can detect latent factors that were present when the adverse event occurred and deficiencies in processes of care that were delivered. With the analysis of large samples of claims usually conducted by medical defence organisations rather than individual health services, important clinical themes in specific clinical specialities become apparent. Key lessons from this information can be used to direct quality and safety programs in health services and prevent recurrence of similar events. At the individual health service level, all claims made against the service should be analysed as part of the service's quality improvement and patient safety program, but in most services, such analysis will only be a very small part of their overall program.5

Because of the limitations of direct observation and legal claims, most adverse event detection programs in health services use medical record review or clinical incident reporting, or both, to delect adverse events.Box 4.1 Harvard Medical Practice Study screening criteria for advene event*7

1 Hospitalisation within previous year for patients younger than 65 years old, and previous 6 months tor older patients

2 Admission to any hospital after current discharge3 Previous failure of medical management or unfavourable results

4 Trauma incurred in hospital

5 Unfavourable drug reaction in hospital

6 Transfer from general care to a special care unit

7 Transfer to another acute^are hospital

8 Return to operating theatre during current period of hospitalisation

9 Treatment for organ damage after an invasive procedure

10 Acute myocardial infarction, cerebrovascular accident, or pulmonary embolus during or after an invasive procedure

11 Neurological deficit at discharge12 Death13 Temperature higher than 38.3°C on day before or day of discharge

14 Cardiac or respiratory arrest15 Five-minute Apgar score < 6, or complication of abortion or labour and delivery

16 Other undesirable outcome17 Indication of litigation in the medical record18 Length of hospital stay above 90th percentile for diagnosis-related group in patients aged under 70 years, and 95th percentile in those aged 70 years or older.

4.2.3.1 Inpatient screening criteriaFortunately, several studies have developed screening criteria to help identify these "high-risk" records. The largest study, the Harvard Medical Practice Study,7 developed and used 18 screening criteria (Box 4.1).Using these criteria to screen medical records in a sample group of hospitals, the Harvard Medical Practice Study found most adverse events that occurred during the period under review Most importantly, it is not necessary to find aII adverse events documented in a hospitals medical records for the clinical risk management program in an individual health service to be effective Finding all

4.2.3 Medical record reviewIt is not practical to continuously review the medical records of all the patients admitted to hospital. The volume of records requiring review would be high, and most records would not contain any evidence of adverse events. Therefore, a more efficient approach is required. How can most significant adverse events recorded in patient medical records be found without having 10 review all or a large number of medicalrecords? Medical records with a higher-than-average probability of containing an adverse event need to be identified.

4 Detecting adverse event* ana rm

Si

documented adverse events is important for epidemiological studies to determine overall adverse event rates in health services in a region or country. However, at the individual health service level, continuously detecting all adverse events, and analysing and responding to them all, would be an overwhelming, demotivating task. At Wimmera Health Care Group, our aim was to find most major adverse events that occurred, and to provide a continuous flow of information about these events to give direction and a realistic, practical workload to our clinical quality improvement and risk management activities.

Intuitively, if a serious adverse event occurs to a patient in a hospital they may:■ die■ have an increased length of stay in hospital■ be transferred to the hospitals intensive care unit■ be re-admitted to the hospital after a recent discharge■ be taken back to the operating theatre after surgery■ be transferred to a larger hospital for management of complications arising from the

adverse event. Other patient outcomes may result from the adverse event having occurred, but these general patient

outcomes are an effective place to begin looking for adverse events.The nine general patient outcome

criteria used at Wimmera Health Care Group (Box 4.2) were developed from a more comprehensive list of screening criteria initially used in the Californian Insurance Feasibility Study8 and modified by Medical Management Analysis9 (Box 4.3).

The criteria chosen are broad, and some hospitals, especially those providing predominantly specialised services such as obstetrics or specialised surgery, will benefit from modifying these screening criteria and developing and using additional screening criteria specific to their clinical areas. For example, the rate of adverse events in obstetrics is lower than in other clinical areas in hospitals, although important quality issues are still present. Medical record review using general patient outcome screening criteria will be ineffective in monitoring and guiding quality and safety programs in obstetrics. However, a large number of specific obstetric screening criteria have been developed to overcome this.10

In addition to adverse events detected using these nine general patient outcome criteria, there are clerical diagnostic codes that can be used to detect adverse events. All admissions to Australian hospitals have the patient's diagnoses coded using the International classification of diseases, 10th revision, Australian Modification (1CD-10-AM) after the patient is discharged from the health service. Adverse events, such as injuries and complications that have arisen from care provided to patients, can be coded using this classification.

Unfortunately, these codes do not differentiate between adverse events that occurred outside the hospital and required the patient's admission to hospital for treatment and adverse events that occurred during the patient's admission. Therefore, an additional "C" (complication) prefix is added as an incidence flag to the code in Victoria and Queensland to indicate that the complication occurred and was treated during the admission. However, this prefix does not capture complications that are detected after the'patient has been discharged from hospital.


Box 4.2 Inpatient screening criteria used at Wimmera Health Care Group

1 Death

2 Return to operating theatre within 7 days

3 Transfer from general ward to intensive care unit

4 Unplanned re-admission within 28 days of discharge

5 Cardiac arrest

6 Transfer to another acute care facility

7 Length of stay greater than 21 days 0 Booked for

theatre and cancelled

9 Any medical record recommended for review.

Box 4.3 Medical Management Analysis general outcome screening criteria*

1 Admission for complications or adverse results of outpatient management2 Admission for complications or incomplete management of problems on previous hospitalisation

3 Operative consent: a Incomplete

b Missing before procedure c Different procedure

d Different surgeon e Not signed I Risks not

explained g Other4 Unplanned removal, injury, or repair of organ or structure during surgery, invasive procedure or vaginal delivery5 Unplanned return to operating theatre on this admission6 Invasive procedure or pathology:a Pathology report does not match pre-operative

diagnosis b Non-

diagnostic tissue c No

tissue removed d Other

7 Transfusion:

a Iatrogenic bleeding or anaemia b Not clinically

indicated c Transfusion reaction

8 Nosocomial infection

9 Antibiotic or drug utilisation

10 Cardiac or respiratory arrest: low Apgar score

11 Transfer from general care to special care unit: a

Complication

J> Utilisation problem

12 Other patient complication(s)

13 Hospital-incurred patient incident a Fall

b Intravenous problem c Medication error d Skin problem

e Other «14 Abnormal laboratory, x-ray, or other test results not addressed by physician15 Neurological deficit present at discharge that was not present on admission16 Transfer to another acute care facility17 Death18 Subsequent visit to emergency department or outpatient department for complication or adverse results related to this hospitalisation19 Length of stay greater than_____percentile or allotteddays:

a Complication

b Diagnostic or treatment problem c Placement problem

20 Medical records review — physician

21 Medical records review — nursing22 Departmental or other problem(s) (eg. admitting, emergency department, laboratory, x-ray)23 Patient or family dissatisfaction.

Despite this limitation, these "external cause codes" can be used as a clerical screen to

detect adverse events in addition to the nine general patient outcome criteria listed above. Importantly, the successful use of ICD-10-AM codes to detect adverse events is dependent on the codes being correctly assigned, and the pre-existing diagnoses and the diagnoses made during the admission being correctly identified by medical record department coding staff."

The ninth screening criterion, "any medical record recommended for review", although not a clerical screening criterion, provides a useful and important method to detect additional adverse events. Using this criterion, any member of the clinical staff (medical, nursing or allied health) can refer the medical record of any patient about whom they have concerns about their care to the risk management program for review in the same manner as medical records screened positive for any of the other eight criteria. Using this criterion allows medical records to undergo medical review even if they do not meet any of the first eight general patient outcome criteria. Not all adverse events will be detected using only these eight general criteria. Therefore, having a broad additional criterion that facilitates medical review of patient records not meeting any of the limited general patient outcome screening criteria allows additional adverse events to be detected.

4212 The screening processImportantly, clerical rather than clinical staff can use these criteria to screen medical records. This reduces screening costs, so that clinical staff can concentrate on reviewing medical records that have been screened positive, rather than reviewing the medical records of all patients admitted to the hospital or a randomly selected sample of these records. Screening and review of medical records can occur retrospectively or concurrently with the patient^ admission. However, in practice it is easier to undertake medical record screening after the patient has been discharged.

At Wimmera Health Care Group, health information services staff screen all inpatient medical records after patient discharge as part of their normal duties. Medical records are screened at three points in the health information services department:■ at assembly of the record after patient discharge■ when the discharge summary is typed■ during coding of the admission.

This triple check results in few records being screened incorrectly, either as falsely positive or falsely negative. In our experience, about 10% of the inpatient medical records screened in a medium-sized general hospital will be positive for one or more of the nine general patient outcome screening criteria.12

At Wimmera Health Care Group from 2000 to 2007, 9.4% of admissions screened positive for one or more criterion. Of these, 40% were unplanned re-admission within 28 days and 40% were transfer to another acute care facility.

However, the proportion of medical records that screen positive will depend on the size and nature of hospital using the methodology and the number of screening criteria used. For example, the Royal Children's Hospital (a quaternary paediatric hospital in Melbourne, Victoria) used three screening criteria (death, unexpected admission to the intensive care unit and clinician referral for record review), and found that 1.6% of all admissions to the hospital over a 6-year period screened positive for one or more of these criteria.13

4.2.3.3 Which screening criteria to useHealth services considering introducing a medical record review program often ask us which of the nine screening criteria we recommend. We have used the same screening criteria since the commencement of our program in 1989 to observe trends over time. We strongly believe that the medical records of all patient deaths that occur in a hospital should be reviewed. Some hospitals using our program have changed the "patient death" screening criterion to "unexpected patient death" to reduce the number of records screened positive but are found on medical review not to contain an adverse event. In our experience, many patients who die in hospital are receiving palliative care. Therefore, changing the criterion to unexpected deaths may be useful to reduce the number of patient deaths requiring medical review, but the records of all patient deaths would still need to be screened by a clinician to eliminate deaths that were expected. Voluntary, confidential review of 90% of deaths of surgical patients over 9 years in Scotland, followed by feedback to the surgeons and anaesthetists involved and collective annual reporting has been associated with a reduction in surgical mortality and associated adverse events.14

The criterion of admission to the intensive care unit from a general ward is the most effective and efficient screening criterion, and we recommend its use in any medical record review program. In a review of 100 consecutive adult emergency admissions to two intensive care units in England, 54 were assessed as having received suboptimal care before their admission to the unit, and two-thirds of these were transferred late.15 It is often the case that seriously ill patients who would benefit from intensive treatment are in general wards16 and although early warning programs have been developed to detect ward patients who are deteriorating,1718 the criterion of transfer to the


intensive care unit from the general ward still yields useful information about the quality and safety of the care provided on general wards.


We also recommend using the criterion of clinical staff being able to refer any records for review about which they have concerns. In our experience, this criterion is used sparingly but raises important usue* The criterion of cardiac arrest has not been very useful. Inpatients who have a cardiac arrest either die and are reviewed under patient deaths, or survive and are transferred from the general ward to intensive care (unless they are already in intensive care), so their medical record is reviewed under this criterion.

Patients booked for theatre and cancelled was a very useful screening criterion when we commenced our program. However, since the establishment of a preadmission clinic, most patient records that screened positive under this criterion have been found on medical review not to contain an adverse event. Most of these cancelled theatre cases are patients booked for elective surgery who develop respiratory tract infections or whose clinical condition resolves.

We have reduced the length-of-stay criterion from 28 days to 21 days, in line with the general reduction in hospital length of stay in Victoria and elsewhere. Transfer to another acute care facility is a useful criterion for small and medium-sized hospitals that often transfer patients with complex clinical problems to larger centres. However, this screening criterion is not useful for tertiary centres that infrequently transfer patients to other health services because of the complexity of their management.

4.2.3.4 Who should screen medical records?Instead of using medical records department stafT, nursing stall can screen medical records. Nurse screening has two advantages. Firstly, additional screening criteria, such as those used in the Harvard Medical Practice Study, can be used — including those that require some clinical judgement. Using more screening criteria increases the number of adverse events detected. Secondly, nursing staff can screen medical records while the patient is in hospital, rather than after discharge. This prospective screening can result in adverse events being detected and acted upon more quickly and, in some cases, can thereby limit the harm that occurs to patients from adverse events. A major disadvantage of having nurses screen medical records is the increased cost. Nurses working on a ward are unlikely to be able to screen the medical records of all patients on the ward in addition to their normal duties. Employment of additional nurses would be necessary to screen medical records, and would therefore increase screening costs.

4.2.3.5 Emergency department screening criteriaAdverse events do not only occur to patients admitted to hospital, and the two-step screening and medical review process to detect adverse events can be used in other clinical areas of a health service, such as the emergency department. At Wimmera Health Care Group, emergency department medical records are screened using slightly different criteria to those used for inpatient screening (Box 4.4). A specific report within our administrative database details those records that meet these criteria.

At Wimmera Health Care Group, 3.3% of emergency department attendances screened positive for one or more of these criteria between 2000 and 2006. Of these, 36% were attendances within 28 days of discharge and 21% were unplanned representation within 48 hours.

4.2.3.6 Medical review

Regardless of the method used to screen medical records, when a record is screened positive, it requires medical review to determine whether an adverse event occurred Designated senior medical staff usually

Box 4.4 Emergency department meaning criteria used at Wimmera Health Cara Group1 Re-presentation within 48 hours with same or similar symptoms2 Unplanned presentation within 28 days of hospital discharge

3 Transfer to another acute care facility

4 Length of stay greater than 6 hours

5 Death.


perform this review. In a general hospital, a cross-section of medical staff, including at least surgeons, physicians and general practitioners, are required to review medical records. These medical reviewers should preferably be nominated by the hospital's medical staff and have a strong commitment to quality improvement and risk management. Medical records that screen positive can be allocated randomly to these nominated doctors for review, or each doctor can be allocated all the records that screen positive for one or two of the screening criteria. Obviously, doctors should not review a patient's record if they admitted the patient into hospital, or if they were significantly involved with the patient^ treatment.

At medical review, the doctor reviews an allocated medical record and completes an adverse event analysis form. The Wimmera Health Care Group adverse event analysis form is shown in Appendix 1. This form contains patient details and scales to help determine whether an adverse event has occurred, and if so, to assess its severity, preventability, and the factors that have contributed to it occurring. Hospitals should design an adverse event analysis form to meet their own needs.1. Defining adverse events. First, a definition of what constitutes an adverse patient event should be chosen. Examples of definitions used in two large studies are:■ An untoward patient event, which under optimal conditions is not a natural consequence of the

patient's disease or treatment (from Medical Management Analysis).9

■ An unintended injury that results in temporary or permanent disability, including increased length of stay and/or financial loss, which is caused by health care management rather than the disease process (from the Quality in Australian Health Care Study).19

We found the Medical Management Analysis definition more useful as it allows a broad range of patient events to be classified as adverse.

2. Determining whether an adverse event has occurred. Next, a scale to help medical reviewers determine using implicit judgement whether an adverse event has occurred should be developed or chosen. The six-point scale (Box 4.5) was used in the Harvard Medical Practice Study4 and the Quality in Australian Health Care Study19 to help the medical reviewers determine whether medi-cal management, rather than the disease process, caused an adverse event.

When assessing the quality of care provided to a patient, implicit or explicit

judgement can be used. When using implicit judgement, prior standards of care that reflect good quality care are not set. Medical reviewers using implicit judgement attempt to answer the questions: was the process of care provided to the patient adequate?; could better care have improved the patient's outcome?; and, was the overall quality of care acceptable? Alternatively, when using explicit judgement, process measures thai represent good-quality care are determined before the judgement being made by the medical reviewer.20 As discussed previously, explicit judgement is used in clinical audits of care received by patients with particular clinical conditions. When medical record review is used to detect adverse events, records of patients with a wide range of medical conditions are reviewed. It is therefore not feasible to determine explicit criteria for good-quality care for all clinical conditions. To overcome this problem, medical reviewers use implicit judgement to determine whether an adverse event was present in the medical record.

In the Harvard Medical Practice Study and the Quality in Australian Health Care Study, a score of four or more on the management causation scale was considered to be an adverse patient

Box 4.5 Management causation scale

1 = Little or no evidence

2 = Slight evidence

3 = Not likely (less than 50: 50 odds but a close call)

4 = More likely than not (greater than 50: 50 odds but a close call)5 = Strong evidence

6 = Virtually certain.


event.419 This scale is easy to'use and was shown in the Harvard Medical Practice Study to have a moderate level of reliability between reviewers 4


Recent assessments of the use of implicit judgements to determine whether a medical record contains an adverse event have shown moderate to poor inter-rater reliability (ie, the degree u> which independent medical reviewers agree that a medical record contains an adverse event). However, medical reviewers disagreed about errors and preventability more than about recognising an advene event.21 Medical reviewers' judgements may also be affected by hindsight bias,22 and by their attempts to reconstruct what had occurred during a patient's admission while having access, on occasion, to incomplete information.2

Increasing the number of doctors who review each medical record can increase the reliability between medical reviewers, but if more doctors were routinely involved in their health serviced risk management programs, this would add considerably to the cost of the program.23 Inter-rater reliability is imponant in research to determine the rates of adverse events. However, it is less important for risk management programs in individual health services. *

In our experience, most major adverse events are easily recognised by medical stafT. In the program at Wimmera Base Hospital, there has been occasional disagreement between medical reviewers about whether some minor events were adverse, but in practice, these differences in opinion were usually not significant. The main aim of the screening and review process is not to find every adverse event, but to detect most major events and, where appropriate, to take action to prevent their recurrence.

Significantly, when using a limited number of general patient outcome screening criteria to detect adverse events in medical records, there is a high false-positive rate (ie, records-screening positive for one or more of the criteria but not containing an adverse event). In our program in a medium-sized general hospital, about 10% of medical records screen positive for one or more of the nine screening criteria, but only one in 10 of these records has been found to contain an adverse event on medical review. 3. Rating the severity and preventability of an adverse event. The adverse event analysis form used at Wimmera Health Care Group also contains scales for the medical reviewers to rate the severity and preveniability of the adverse events they delect, and checklists to help document the factors they consider contributed to the event. This information aids the analysis of each event, and collecting these data over time allows trends to be observed. At Wimmera Health Care Group we used the severity scale developed by Medical Management Analysis9 (Box 4.6).Another useful severity scale that categorises patient harm is adapted from the National Coordi-nating Council for Medication Error Reporting and Prevention taxonomy of adverse medication events (www.nccmerp.org/aboutMedErrors.html), which has been applied to adverse events (Box 4.7).24

Box 4.6 Medical Management Analysts severity scale9

0 = Minor severity (no disability; no significant resultant discomfort; no cosmetic or functional impairment; and no increased length of stay as a result of adveree event).1 = Minor temporary (minimal to moderate clinical effect requiring no or minimal clinical intervention: or no increased length of stay or rehospitalisation for same or related problem).2 = Minor permanent (minimal to moderate clinical effect with permanent residual effect, without significant functional or cosmetic impairment).3 = Major temporary (moderate to severe clinical effect with no significant functional or cosmetic residual effect. This usually results in increased length of stay or rehospitalisation and requires moderate to maior clinical intervention).4 = Major permanent (moderate to severe clinical effect with significant functional or cosmetic residual)5 = Potential major or major contributing (when doubt exists as to the outcome but the probability is that a major impairment or repeated hospitalisation will be necessary. The outcome may result in major impairment).$ = Death.

Minor adverse event > Mapr adverse event ■

severity score 0-2

severity score 3-6


http://www.nccmerp.org/aboutMedErrors.html

The Agency for Healthcare Research and Quality in the United States defines a preventable adverse event as "harm that could be avoided through reasonable planning or proper execution of an action".25 The preventability of adverse events can be assessed using a scale used in the Harvard Medical Practice Study4 (Box 4.8).

When the medical review and adverse event analysis form is completed, the medical reviewer returns the medical record and form to health information services. Data from the analysis form are entered into a database, and if an adverse event has been detected, the form is sent to the clinical risk manager. The medical reviewer keeps the details of the adverse event for discussion at the next surveillance committee meeting. This committee reviews each significant adverse event and determines what actions are necessary to reduce the probability of a particular event recur-ring. The operations of the surveillance committee will be discussed in detail in Chapter 5.

The two-step screening and medical review process should be undertaken in a timely manner in relation to the patient's discharge, as an urgent response to an adverse event is sometimes required. If detailed analysis of an adverse event is required, it is preferable that this analysis be undertaken promptly, while rotating junior medical staff are still working at the hospital and staff involved in providing care to the patient can clearly remember the patient and the circumstances surrounding the event. Ideally, the screening of a patient's medical record should be completed 1-2 days after discharge and medical review completed 2-4 weeks after screening the record.

4.2.3.7 Medical record review form modifications

Although the medical record review form used in the Harvard study was the model used for

developing the Wimmera medical record review, and has been used in epidemiological studies of

adverse events in hospitals in several countries, it has limitations. Modifications have therefore

been made to make the medical review process and the form easier to complete:26

■ The form has been divided into five modules — patient information and background, the

disability caused by the adverse event, when during the hospital admission the event occurred,

the principal problem (ie, the most important problem in the delivery of care) and the

contributory factors and preventability of the event.

■ The definitions of significant terms have been included to save reviewers referring to other

documents.■ A shdn accompanying instruction document has been developed.

Box 4.7 National Coordinating Coundl for Mediation Error Reporting and Prevention severity scaleCMagory E: contributed to temporary harm to the patient and required interventionCrtayuiy F: contributed to temporary harm to the patient and required initial or prolonged hospitalisation

Category G: contributed to permanent patient harm

Category H: required intervention to sustain life

Category I: contributed to the patient's death.

Box 4.8 Preventability scale1 = Little or no evidence for preventability2 = Slight or modest evidence for preventability3 s Preventability not quite likely — less than 50: 50 but a close call

4 = Preventability not quite likely — more than 50: 50 but a close call

5 = Strong evidence for preventability

6 = Virtually certain evidence for preventability.

The score can be grouped into three categories: No

preventability (score = 1)

Low preventability (score = 2-3) High preventability

(score = 4-6).


a A systematic approach to determining the contributory factors of the adverse event has been included. These contributory factors will be discussed in Chapter 5. Often, the

contributory factors are best determined by interviewing the clinicians who provided care for the patient, although it was fek that if the reviewer was familiar with the work environment in

which the adverse event occurred, he or she would be able to determine the major contributory factors without conducting interviews. The authors note that training reviewers

including the review of trial cases was essential. They also commented that medical record review had not been used to its full potential, and it could have an important role in routine

review at the local level. The modified form comprises 29 pages, although tick boxes are used extensively and not all pages need to be completed for each case review. The form is an

excellent resource that allows individual health services to determine which modules they wish to use and modify to suit their local needs and conditions and in particular the resources they have available.26 The Modular Review Form 2 is available at the Quality and Safety in Health

Care website (www.qshc.com/cgi/data/12/6/411/DC2/1).

4.2.3.8 The limitations of medical record review Medical record review has three main limitations.

1. It is dependent on the quality of the contents of the patient's medical record27

In many hospitals,

most documentation in the medical record is handwritten, and some parts of the record may be difficult to read. Entries may be of poor quality with incomplete, inaccurate, confusing and conflicting data.28 Sometimes the details of the nature and effect of an adverse event may not be recorded in the medical record.26

Importantly, the effective screening of discharge summaries requires that a summary is available. In one study, a third of patients discharged from hospital had not had a discharge summary generated. Also, the summary's contents need to be of high quality.29

Each patient admission to Wimmera Health Care Group has a discharge summary dictated and typed shortly after discharge. These typed summaries greatly assist the medical staff when they review medical records that screen positive. A prompt, accurate and typed discharge summary also improves communication between hospitals and referring doctors.

To help junior medical staff prepare high-quality patient discharge summaries, we developed an electronic discharge summary template. The template comprises headings of the clinical information required in the summary and unlimited space for free text under each heading. The template can be accessed when the patient is admitted to the hospital and added to as required during the admission by junior medical stalf using computers located in most clinical areas. Alternatively, junior staff may dictate or handwrite discharge summaries if they prefer; these summaries are then promptly typed by health information service staff. To assist the medical record review process, some hospitals request that their junior doctors indicate on the discharge summary documentation whether an adverse event has occurred during the patient's admission.

A comprehensive, typed discharge summary is an essential clinical risk management strategy and it also helps the medical review process detect adverse events. We encourage hospitals that do not already have a typed discharge summary in place to consider its benefits for clinical communication and detection of adverse events.2. It requires additional resources to implement a continuous and ongoing program. Medical record review has been described as "a cumbersome and costly method of identifying adverse events" 22

However, in the program used at Wimmera Health Care Group, using a limited number of general patient outcome screening criteria that can be identified by clcrical rather than clinical staff, and having typed discharge summaries, the overall cost of the program was modest.12 Using


http://www.qshc.com/cgi/data/12/6/411/DC2/1

fewer screening critcna can reduce the cost of implementing and maintaining a medical record review program With fewer


criteria, fewer medical records will screen positive and require medical review, which is the most expensive part in the program. Individual health services need to determine whether they wish to introduce such a program, and if so, the scale of the program.3. It has a higK false-positive rate. In other words, many medical records are screened positive for one or more of the screening criteria but on medical review are found to not contain an adverse event.

Attempts have been made to address this limitation using a combination of electronic and manual review processes. Some health services have undertaken electronic screening of multiple databases, including administrative data, ICD codes, keyword searches of discharge summaries and medical records searching for patient complications, laboratory results and medication prescribing. These databases have been screened independently or in combination using searching algorithms and natural language processors to extract information to help detect adverse events, and have met with varying success.

However, the main problem with electronic screening, as with manual medical record review, is the high false-positive rate. The rate has been reduced by requiring multiple screening criteria to be met before a medical record review is required.30 Such electronic screening will be most effective if a health service is already using an electronic medical record.

Although medical record review results in review of many medical records that do not contain an adverse event, some of these records do contain evidence of errors that either caused no harm, or were intercepted before they caused harm. It has been our experience that when the review of patient records has not delected adverse events, other valuable information has frequently been found, highlighting system weaknesses in the hospital. Information about errors and near misses, as opposed 10 information solely about adverse events, provides valuable additional information to help make health care systems safer.

4.2.3.9 Trigger toolsIn further attempts to reduce the high false-positive rate of medical record review, some health services use triggers to detect adverse events. A trigger is an "occurrence, prompt or flag found on review of the medical record that 'triggers' further investigation to determine the presence or absence of an adverse event".28 Rather than focusing on errors, triggers target events that could be linked to patient harm.28

Medical record review has been enhanced by using "active surveillance"31 in which 21 electronic triggers of specified abnormal laboratory results (above and below predetermined thresholds) or

changes of predetermined magnitude, prescription of high-risk medications (eg, warfarin) and medications abruptly stopped or used as antidotes known to be associated with adverse events (eg, naloxone) are used as screening criteria to prompt a rapid, focused and real-time medical record review to detect possible adverse events28 (Box 4.9).Using electronic triggers, patient medical records triggered as positive can be reviewed while the patient is still in hospital. Such review allows more information about the patient's care that may not be recorded in the patient's medical record to be obtained, and for rapid intervention to potentially occur while the patient is in hospital to prevent or reduce harm from the adverse event. Using triggers, electronic lists of patients

Bex 4.9 Examples of trigger tools■ Positive blood culture

■ Blood transfusion

■ Intubation

■ New-onset dialysis

■ Vitamin K use

■ Platelet count < 50 x 10®/L

■ INR > 6

■ PTT> 100 s■ Doubling of serum creatinine

■ Anti-emetic use

■ Abrupt fall in haemoglobin > 4 g/dL

INR = international normalised ratio PTT «

partial thromboplastin time


who meet one or more triggers are generated each day and an appropriately trained nurse and pharmacist review each medical record.

In one study, the triggers of elevated international normalised ratio (INR) and positive blood cultures had the highest yield for detecting adverse events. Importantly, reviewing the medical records prompted by a trigger also detects adverse events beyond those related to the trigger. Of the 327 medical records prompted by a trigger for review, 74% contained air adverse event.51

To reduce costs, trigger tools can also be used regularly with small samples of medical records audited at set time intervals, rather than continuously screening all patient admissions.20

Although much of the work done with trigger tools has used electronic screening, the costs can be reduced by using a manual screening process and reviewing a small sample of medical records.28

An advantage of trigger tools is that they can be customised to specific clinical environments.28

For example, trigger tools have been developed that are patient age- and medical department-specific, which is logical, given that the numbers and types of adverse events that occur in hospitals vary with patient age and the area in the hospital in which they are receiving care.

A trigger tool with 23 triggers has been developed to detect adverse events in intensive care units. Of 1294 medical records from 13 intensive care units in the US that were triggered and subsequently medically reviewed, 55% were found to contain one or more adverse events. The most frequent triggers that screened positive were procedure-associated events, haemoglobin level drop, intubation or reintubation, pulmonary embolism tests, pneumonia not present on admission, and positive blood culture.24

A trigger tool with 17 triggers has also been developed for use in neonatal intensive care units. Of 749 medical records from 15 neonatal intensive care units, 554 adverse events were detected, of which 56% were preventable. The most frequent adverse events detected in neonatal intensive care units were nosocomial infection, catheter infiltration, abnormal cranial imaging, and unplanned extubation requiring re-intubation.32 Trigger tools can also be customised for use in ambulatory care settings using triggers such as emergency department attendance, admission to hospital, and prescription of more than five medications.28 Trigger tools have been used with the standardisation of protocols for the use of high- risk drugs and a medication reconciliation program, to reduce adverse drug events by 60% over 4 years in a community hospital in the US.33

The Institute for Healthcare Improvement in the US developed a comprehensive trigger tool in which 53 triggers are used across six modules — cares, medication, surgical, intensive care, perinatal and the emergency department. The Institute recommends fonnightly review of a sample of 10 medical records, randomly chosen from all patients discharged from the health service over the previous 2 weeks, to determine whether a trigger is present. All records are reviewed for triggers in the care and medication modules, and in the other modules if applicable. A 20-minute limit is set for the review of each record. Data are collected on the number of adverse events delected per 1000 bed-days, per 100 admissions or as a percentage of admissions. 34 Using this methodology, 40-50 incidents of harm have been found per 100 admissions.35

Importantly, trigger tools do not measure the true incidence of adverse events in health services, but they do improve the detection of such events, thereby providing valuable information to health services about how to improve the quality and safety of the patient care they provide.32

A significant limitation of trigger tools is that they may miss adverse events that are not apparent or that have not occurred by the day of the review. Such events may be detected by retrospective medical record review. Therefore, using trigger tools and retrospective medical record review together may be more effective than using one method alone. Further limitations of the trigger tool methodology are the cost of the staff undertaking the surveillance of medical


records, and that the triggers currently bring used are likely to overestimate adverse drug events and underestimate adverse events not related in


medications. Balancing these limitations, however, is the significant advantage that interventions to prevent patient harm were made in 14% of patients whose medical records were triggered and required review. These interventions mostly related to incorrect prescription of medications and incorrect documentation of clinical information.

4.2-1/0 Medkol record review — the bottom lineMedical record review detects adverse events not found by other methods, and provides a unique perspective of the adverse events that occur in hospitals. It ensures that clinical activity in an individual health service is automatically and continuously reviewed, without the need for prompts or reminders from management to clinicians to undenake quality improvement and risk management activities.

In our opinion, health services should use medical record review as an important component of their clinical quality and safety programs. However, it is important that each health service tailors the process to their needs and conditions. Such programs should be commenced on a small scale, perhaps in one unit or clinical area in the service using a limited number of screening criteria, before being implemented organisation-wide. It is less costly to use medical records staff to screen records using clerical screening criteria than it is to use nursing staff, even if clerical screening is conducted after the patient's discharge and limits the criteria that can be used.

Wimmera Health Care Group has run medical review programs for inpatients for 19 years and in the emergency department for 11 years. Not all the adverse events that have occurred in the hospital over these periods have been delected by the programs, as only a limited number of screening criteria have been used. However, the number and types of screening criteria and three of the four reviewers have remained constant, allowing the rate of adverse events to be meaningfully compared over a long period, and the effects of the actions assessed. A reduction in the rate of adverse events has achieved by both programs (Figure 4.1 and Figure 4.2).

We believe that the medical records of all patients who die in hospital should be reviewed, although most will probably not contain an adverse event. The criterion of admission to the

intensiv

Figure 4.1 Wimmera Health Care Group Inpatient medical record review adverse event rate (percentage of separations)

16%14% ■

cfO- ^ jfi ^ J? ^ # ^ ^ &

y y y y y y y y y y y y y y y y


e care unit from a general ward is the most effective and efficient screening criterion that we use, and we


recommend its use in any medical record review program. We also recommend using the criterion of clinical staff being able to refer the records of any patient about whom they have concerns about their care for review.

Once established, the medical record review program can be supplemented with a few relevant triggers that can be easily screened manually (eg, screening 20 medical records each month, which may detect eight to 10 adverse events) or complication codes that are created when coding records. The doctors performing the medical reviews should use a simple analysis form consisting of several simple scales. Ensuring that the health service's discharge summaries are high-quality also supports the review process.

4.2.4 Clinical incident reportingThe details of many adverse events and most (if not all) near misses that occur in a hospital are not recorded in patients' medical records, and therefore require other methods of detection. Another important source of information about adverse events is for clinical incidents to be voluntarily reponed by health service stafT.

4.2.4.1 Definition of a clinical incident and near missThe Australian Incident Monitoring System (AIMS) defines a clinical incident as "any event that has caused harm or has the potential to harm a patient, visitor or stafT member, or any event which involves malfunction, damage or loss of equipment or property and any event which might lead to a complaint".1'1 A near miss is "an occurrence of an error that did not result in harm".17

The definition of a clinical incident is much wider than the definitions of adverse events discussed in the section on medical record review, which require patient harm to have occurred as the result of medical management. Clinical incidents include events where there is potential of harm occumng, such as near misses — where an error occurs, but is delected before the patient is afTectcd. Many hospitals already have an incident reporting system in place to capture information about incidents

Figure 4.2 Wimmera Health Care Group emergency medical record review adverse event rate (percentage of attendances)

1.6* -|

0% -I----------1----------1----------1----------1-----------1----------1----------r-----------1-----------1 J* &

# r & ^ #Year

1.4% -

1.2* - §

i o % - 1

0.8% -

j 0.6% -o <

0.4% -

0.2% -


(clinical and non-clinical) and report the details to their insurers as a requirement of their insurance policies


Relationship of dMcof incidents to adverse eventsChnkat incidents in which a patient is harmed while receiving care are regarded as adverse events. Chnical incident reporting is the best method of detecting potential adverse events and near misses,30 and provides valuable information about the risks experienced by patients while they are receiving care. A study of industrial accidents in the 1940s estimated that for every major adverse event, there were 29 minor events and 300 near misses.38 Therefore, waiting for adverse events to occur, rather than reporting and acting upon near misses, overlooks many opportunities to improve patient safety and prevent adverse events that could have been avoided if action had been taken in response to a related near miss.

In our experience, adverse events detected by clinical incident reporting have little overlap with adverse events detected by screening and reviewing medical records;39 this finding has been supported by other studies.40 Further, the proportion of adverse events occurring in a health service that are detected using clinical incident reporting alone is low.30,41

4.2.4.3 What incidents are reported and who reports themThe incidents reported in hospital-based reporting systems fall into three broad categories: unexpected adverse outcomes, procedural breakdowns and catastrophic events.21 The most common clinical incidents reported by stafT are patient falls, medication errors and equipment failure. Unfortunately, there is limited reporting by stafT of issues arising from clinical treatment such as misdiagnosis or delayed therapy.13 ''0

In our experience, most incident reports in hospitals are written by nursing staff; medical staff complete few forms. The low reporting of incidents by medical staff has been found in other studies,42 although in the United Kingdom, doctors provide about 10% of reports of clinical incidents.40 The AIMS found that only 2% of clinical incidents reported to it by health services between 1998 and 2002 were submitted by doctors.43 However, the incidents reported by doctors tended to have more serious patient outcomes.44

A survey of 12 AIMS users found that clinical incident reporting had resulted in significant changes being made in several areas, including how equipment was used, medication was prescribed and administered and patients' risk of falling while they were hospital was assessed, although changes in patient outcomes as a result of such changes were difficult to measure.44 But some authors feel that "the potential of incident reporting has not been realised in health care, primarily because incident reporting tends to be punitive and focused on people rather than systems"45

4.2.4.4 The characteristics of an ideal incident reporting system

Ideally, an incident reporting system should clearly detail the types of incidents to be reported, and

staff should be educated about which incidents they should report and how to report them. The

system should facilitate easy, prompt reporting by staff, whether harm has occurred to a patient or

staff member, and the incident should be investigated immediately. Information from the

investigation should be used to provide prompt feedback to the staff member who reported the

incident, and appropriate action (eg, system changes rather than punitive action) should be

promptly taken to reduce the chances of the incident recurring.41 "Systems that result in no

feedback or improvements will soon produce only a trickle of reports."21

The rationale and operational procedures (ie, what types of incidents should be reported and how they should be reported) of the incident reporting program should be a major part of staff orientation and education programs.41 Information from individual and aggregate clinical incidents, and especially the actions that have been taken to improve safety in response to reports, should be continuously incorporated into staff education programs and regularly reported to clinicians and hospital management. Clinical incidents should also be reported to a national database to identify


trends in rlimcal incidents and low-frequency incidents and their associated risks that may only be able to be identified on a larger scale than within an individual health service.

4.2.4.5 Limitations of clinical incident reporting

The major limitation of clinical incident reporting is under-reporting, especially by medical staff.

Other limitations include potential bias in the events that ate reported, incomplete details being

provided in reports, and an ambiguous, or not readily available, denominator to determine valid

incident or adverse event rates.46

Under-reporting of clinical incidents. Although clinical incident reporting is the most common method used by health services to detect adverse events, not alPclinical incidents that occur are reported.47,46 Extremely large differences have been found between the number of medication errors that were directly observed in studies and the number of these incidents reported. "Major events may be more reliably reported, but near misses are likely to be ignored, deferred or forgotten in the pressured environment of clinical work."49

Under-reporting is thought to occur because of work demands creating time pressures on staff, beliefs by staff that the reporting of incidents may result in punitive repercussions (such as legal action, or negative effects on careers), failure to recognise that a clinical incident has occurred, not understanding what types of incidents should be reported,41 cumbersome reporting formats, difficulty identifying errors of omission, a long lead time between the errors and the negative outcome, and health services not providing feedback or taking appropriate remedial action.49

The very low rate of reporting by doctors is related to "fear of blame, retribution, disciplinary and legal action" in response to mistakes that they or their colleagues have made.30 Doctors need to be fully engaged in reporting incidents for the program to be most effective. Therefore, any legitimate concerns that doctors have about the incident reporting process should be adequately addressed.51

Other issues raised by doctors regarding incident reporting include not knowing when or how to report an incident, reporting being viewed by doctors as a nursing duty, time constraints and lack of feedback after incidents are reported.

In a study in six hospitals in South Australia, in which an incident reporting system had been in place for at least 5 years in each hospital, over half the doctors responding to a survey did not know how to locale an incident reporting form in their hospital or what to do with a completed incident form. In addition, 40% of consultants or registrars working in these hospitals had never completed an incident form.30 This study also found that the most frequent barrier to the reporting of clinical incidents by both doctors and nurses was lack of feedback after incidents were reported.

In another study of 65 surgical trainees working in a National Health Service (NHS) Trust in the UK, 52% were unclear about which incidents should be reported, only 12% of those who had reported an incident received feedback, and none were informed of changes that were made as a result of the repon they had made. When asked to give reasons for not reporting incidents, 55% of trainees stated that it was not part of the doctors' culture.52 Some organisations believe that not reporting and acting on safety problems is "an unacceptable breach of duty'' and in the long term, addressing safety problems in a health service honestly and transparently significantly outweighs any potential risk of legal action or negative media reports.55

Part of the large difference in the frequency of clinical incidents reported by doctors and nurses is related to the different cultures between these two groups.

Much of the emphasis in nursing education is on learning practices and following rules. Physicians arc taught analytic thinking and individual responsibility, rules are much less important and sometimes regarded as subject to individual veto.54

In not reporting clinical incidents, doctors were concerned about the consequences from forces external to the health service such as the coroner and litigation.


The medical profession has a culture that values privacy, professional autonomy, collegiality, self- regulation, organisationally opaque systems of accountability and relatively few directives. However, nurses reponing clinical incidents were more concerned about internal forces within the health service and how these forces would respond to the error having been made. Nursing practice is heavily protocol-driven, with strong role models reporting incidents and concern by nurses about covering themselves by reporting an incident.43

Reporting of clinical incidents by doctors has been enhanced in anaesthesia using handheld computers. Anaesthetists electronically record routine data on the cases they undertake, their successes and failures in undertaking specific procedures and clinical incidents that occur. Incidents, including near misses, are recorded where and when they occur. All data are transmitted to a secure database, and data analysis is automatically sent back to the clinician in the form of process control charts. Information about major adverse events is automatically emailed to the hospital quality manager.55 An incident was reported for 3.5% of 4441 anaesthetic procedures reported to the database. In a comparison with medical records review, only one incident was noted in the medical records of a sample of 208 of these patients.56 The authors believe similar programs can be developed and implemented in all medical specialties.Incomplete and biased reporting. A further limitation of incident reporting is that in those clinical incidents that are reported the information provided is frequently incomplete, especially regarding details of the factors that contributed to the incident occurring.57 Also, the incidents chosen to be reported may be subject to bias, and are most likely to be reported shortly after they occur — before the patient's outcome is completely known.58 With this bias in identifying and reporting incidents, only a small, non-random proportion of incidents being reported, and the lack of a denominator, meaningful error rates cannot be determined from incident reporting.45,46,59 Importantly, unlike medical record review, incident reporting does not have a readily available denominator and is therefore not useful in determining the rates of incidents it detects.Difficulties interpreting data. Interpreting the reasons for trends in the incident reporting rate is also difficult. Does an increase in the number of incidents reported during a period mean that incidents are occurring more frequently, or that staff are reporting events more frequently? Does a decrease in the number of incidents reported mean that fewer incidents are occurring and the health service is therefore safer, or that staff are reporting less frequently because they are too busy, or the reporting of incidents rarely results in appropriate change occurring, or punitive action has been taken against a staff member following the reporting of an incident?46,59 Unfortunately, "trending of incident reports is a biased measure of whether safety is improving".46

4.2.4.6 Addressing the limitations of clinical incident reportingThe limitations of incident reporting are significant, and many steps have been taken to address them. Previously, reports of clinical incidents were entirely paper-based, but online reporting systems are now used in many health services. To facilitate incident reporting, the forms or electronic formats used should be readily accessible and provide a balance between being easy to complete and providing sufficient information for the clinical risk manager to begin investigating the incident. The more specific the questions on the incident report form are, the easier it is to complete, but the more limited the information provided will be. The more general the questions are, the more detail is provided, but the more time is required to analyse the report.60

A trial-and-error process may be necessary in individual health services to develop the most useful form for staff who submit and analyse reports. Some incident reporting programs use several reporting options, including a one-page incident tepoit form, online reporting and 24 hours a day, 7 days a week telephone reporting facility to reduce the burden of reporting.42 Interestingly, despite these repotting options being available, staff still preferred a paper-based reporting method over


online reporting; one-fifth of reports were made by telephone 42 The voluntary reporting of clinical incidents, especially near misses, have also been increased by continuously prompting doctors, nurses and pharmacists to report incidents.10

Successful implementation and maintenance of an effective incident reporting program require substantial education of all staff about the incident reporting program (what types of incidents should be reported and how they can be reported). They also require appropriate changes in the culture of the health service in how it deals with the information provided in these reports and the staff who have made reports. Some incident reporting programs have developed manuals explaining its rationale and the program operation. These manuals have been distributed to clinical staff to increase their knowledge and address their concerns about incident reporting^ These programs have also organised education sessions as part of existing departmental meetings and strategically placed posters about the program in clinical and staff areas to promote reporting.42 In one program, feedback was enhanced by providing individual feedback to staff who reported major incidents, aggregate data were presented at regular department meetings, and a regular newsletter containing statistics, summaries of investigations and recommendations arising from the analysis of incidents was distributed to all clinical staff.42

The clinical incidents reported by staff should be investigated and appropriate action taken in a timely manner. In one program in the US, all the clinical incidents that were reported were immediately assessed for the frequency of their occurrence and the severity of their consequences. On the basis of this assessment, each incident was given one of three ratings. According to this rating, the health service's patient safety alert policy decreed that investigation of the incident and its resolution was required to occur within 24 hours, 72 hours or 1 week of the incident being reported. Significantly, as the staff in the health service in the study realised that the issues contributing to the incidents they were reporting were being properly addressed, the number of incidents reported increased substantially.33

Reporting of clinical incidents should be confidential, but should health services allow anonymous reporting of incidents? The availability of anonymous reporting should, in theory, increase the number of incidents reported by staff, as there is little chance of blame or retribution occurring after the report is made, unless the clinician involved in the incident can be identified from the details in the repon. A disadvantage of anonymous reporting is that the staff who receive the incident repon and are trying to analyse the event cannot contact the person who submitted the report to obtain more details about the circumstances surrounding the incident. Further, the information in the repon may be unreliable. Anonymous reporting also limits the degree to which the important issues of accountability and transparency can be addressed when dealing with incidents.61 A further danger of anonymous reporting is that managers may assume that such reports are being made by disaffected staff, and may therefore not lake ihe details of such reports seriously.

The small size of some health services and the very small number of staff in highly specialised clinical areas may make it impossible to anonymously report some incidents.60 However, given that the details of a significant incident may not be reported unless it can be done anonymously, without the repon being made, the health service may remain unaware of a serious system weakness. If the option to repon an incident anonymously — with the reporter not having to identify themselves and not allowed to identify others involved in the incident — is available, medical staff may be more motivated to report a problem.51 On balance, having anonymous incident reporting available is preferable to significant clinical incidents not being reported.424,7 The Wimmera Health Can Group approach to clinical incident reporting We have used the AIMS incident reporting system developed by the Australian Patient Safety Foundation. The incident reponing forms and computer software program have recently undeigone considerable improvement. In addition, a web-based system will be available in the near future.

The AIMS program has developed incident reponing forms that are individualised for users, and a reponing system suitable for use by all clinical and non-clinical areas in a health service. The form


provides prompts for the collection of information about the incident. A free narrative section provides the most useful information to assist with the analysis of the incident and significant space is allocated for this information.62

Ginical incidents are reported locally, either with identifying details or anonymously. Data are entered locally by staff who have undertaken accredited coder training with the Australian Patient Safety Foundation. All information entered into the local database is de-identified. Public hospitals in most Australian states enter clinical incident data into statewide databases. These databases can identify trends in low-frequency adverse events that may not be obvious to individual hospitals.

The AIMS allows individual health services to generate their own reports of the numbers and types of incidents reported throughout the health service or in individual clinical areas, and to compare their data with other like, but de-identified, health services.62 Although the AIMS is the most frequently used incident reporting system used by public hospitals in Australia, other reporting systems are available.

To determine the severity of each clinical incident, the Victorian Department of Human Service's incident severity rating classification is used at Wimmera Health Care Group. This method of classification is used instead of risk rating for a number of reasons: the person reporting the incident is able to determine the level of severity, initiating the appropriate response by management at the time of the incident; incidents are not necessarily risks — risks are detected as a result of the incident investigation; and to be able to rate risks, knowledge is required about consequence and probability and this is generally not known at the time of the incident.63 The Victorian Department of Human Service's Incident Severity Rating Classifications are:■ Incident Severity Rating 1. Relatively infrequent, clear-cut events that occur independently of a

patient's condition; commonly reflect hospital system and process deficiencies; and results in or have the realistic potential to result in, an unexpected death or a permanent disabling injury or psychological harm to a person and includes reportable sentinel events.

■ Incident Severity Rating 2. Events that result in a temporary loss of function (sensory, motor, physiological or intellectual) that are unrelated to the natural course of the patient's illness and differ from the expected outcome of person's management.

■ Incident Severity Rating 3. Events that result in a person requiring increased treatment, but not hospitalisation or an increased length of stay.

■ Incident Severity Rating 4. Events that result in minor injury requiring only first aid treatment or no injury.For clinical incident reporting to be effective, clinical staff require education about:

■ the types of incidents that should be reported■ the availability of incident reporting forms or electronic formats and how they should be completed■ how the information that is reponed is used to improve the quality and safety of patient care

provided in the hospital.Most importantly, stafT members require prompt feedback that the incidents they have reported

have been fully investigated and appropriate changes made to the systems that allowed the events to occur. If it can be demonstrated to staff members who report incidents that this information is being used to improve patient care in their hospital, this provides positive reinforcement of the reporting behaviour and will act as a powerful motivator for staff members to continue to report incidents.

At Wimmera Health Care Group, the low reporting of incidents by doctors is compounded by the many junior doctors who rotate from Melbourne to Horsham for 10-week periods. In this short time frame, it is challenging to educate these doctors about which incidents they should report and how


they can be reported. It is especially difficult to reassure them that the culture of the health service is such that incidents reported will be positively received, and the information used constructively to improve the quality and safety of patient care. Many of these doctors feel that they will be blamed for errors if they report incidents. These junior doctors are educated about the incident reporting program shortly after they arrive at the hospital. However, this education on its own is usually not enough to encourage them to report incidents.

Additional strategies are required to motivate junior doctors to report the incidents they have observed or have been involved in. The director of medical services meets with these doctors each week, and among the administrative matters that are discussed, the director asks them whether there have been any instances where the care provided to patients has not gone well, or whether they have experienced or observed any problems in providing care to their patients in the previous week. The incidents raised are discussed and recorded, promptly investigated and appropriate action taken to reduce the probability of the incidents recurring. The director then provides feedback to the junior doctors about the investigations and the actions taken in response at the next meeting with them. Once an initial reticence with discussing incidents with the medical director (who has line responsibility for these doctors in the hospital) is overcome and the doctors see they can influence how clinical care is provided in the hospital, a steady stream of incidents usually flows over the remaining weeks of their rotation.

Using such an intensive approach to obtaining information about clinical incidents from junior medical staff is supported by a study that surveyed staff in two tertiary hospitals in the US about their experiences with adverse events. The study found that junior medical staff commonly encountered and were associated with errors. Many of these adverse events were not recorded in medical records, perhaps because of fear of punitive action and litigation. Therefore, obtaining information about clinical incidents from junior medical staff may provide information that other methods will not find, and which is complementary to information obtained from other sources. Junior medical staff should, therefore, be closely involved in quality improvement and safety programs in health services. Such involvement may also assist in educating these stalf about errors.64

Engaging senior medical staff to report clinical incidents can be even more challenging. The hospital has made it clear to senior doctors that it would be pleased to receive information about incidents in any form they wish to use: by letter, telephone call or stopping the director of medical services in the corridor to discuss an incident. Medical staff are an important source of information about clinical incidents that occur in a hospital, and we have tried to make reporting clinical incidents as easy as possible for them.

Clinical incident reporting is a major component of Wimmera Health Care Group!; clinical risk management program. We consistently provide staff education about the importance of incident reporting, feedback to them about the findings of investigations of incidents they have reported, and timely action to correct weaknesses that are identified. Although we cannot be certain that these actions have contributed to the increase in the number of incidents reported, we are pleased that staff have substantially increased the number of reports they are making (Figure 4.3).

All adverse events delected by clinical incident reporting are discussed at surveillance committee meetings. These adverse events are dealt with in the same manner as events detected using medical record review. The events are analysed and appropriate action is determined and taken to reduce the chances of the events recurring. Some adverse events detected by clinical incident reporting may require immediate action by the clinical risk manager and, if appropriate, analysis and action are expedited and


the details discussed at the next surveillance committee meeting. The methods used in analysing adverse events will be discussed in more detail in Chapter 5.

4.2.4.8 Clinical incident reporting — the bottom lineEach health service should have a clinical incident reporting system as one of the cornerstones of its quality improvement and risk management program. However, used in isolation, incident reporting does not provide a comprehensive view of the risks present in a health service. Clinical incident reporting detects different types of adverse events from those recorded in the patient medical record. It an important source of information about near misses, which are rarely recorded in the medical record. Without such reporting, many risks present in the health service will most likely remain undetected, perhaps until a major adverse event occurs. Incident reported should therefore be used in conjunction with other more systematic and powerful methods of adverse event detection such as structured medical record review.40

The core components of an effective clinical incident reporting program are:■ Provide extensive initial and ongoing education about the program for all staff.■ Ensure all staff are clearly aware of what constitutes an incident (especially the importance of near misses), which incidents should be to reported, and the process to be followed in reporting incidents.■ Make it easy for staff to repon incidents by providing multiple, simple, readily available reporting methods.■ Ensure that reporting is confidential, and allow anonymous incident reporting.■ Rapidly acknowledge to staff who have reported an incident that it has been received by the program and is being investigated.■ Investigate all incidents in a timely manner.■ Provide timely feedback of the results of the investigation to the staff who reported the incident and those who were involved in the incident.■ Take timely and system-based actions to reduce the risks that have been identified by the investigation of clinical incidents.■ Do not take punitive actions in response to reported clinical incidents unless an "intentionally unsafe act* has occurred.

Rgure 4.3 Annual number of Incidents reported at Wimmera Health Care Group

Year


a Ensure that some of the actions taken in response to reported incidents are highly visible to all staff a Demonstrate to stafT that incident reponing can change their work environment, and increase the

quality of care they provide and the level of patient safety, a Regularly report the results of the clinical incident reporting program both up and down organisation a Use national incident reporting databases to detect areas of risk in the health service and to provide resources and tools to improve patient safety.

4.2.5 Sentinel event reportingReporting of major adverse events, and their subsequent investigations externally to the health service in which they occurred, allows the lessons learnt by an 'individual health service to be used by other organisations to avoid similar events from occurring in their facilities. The external organisation can aggregate the results of multiple reports, identify trends and risks and djpseminate this information widely. Important characteristics of successful external reporting systems are that those reporting the events are safe Trom disciplinary action and that the process of reporting is not onerous. Also, reponing of such events must be perceived as worthwhile, with expert analysis of these reports being undertaken, timely feedback being provided to reporting health services and appropriate dissemination of useful findings to the health care field. The process should also be confidential, independent, systems-oriented and responsive to recommendations.65

4.2.5.1 Sentinel event reporting in the United StatesIn the US, the Joint Commission on Accreditation of Healthcare Organizations reviews the response of individual health services to major or sentinel events that have occurred at their facilities as pan of its accreditation process. These events are referred to as sentinel because they require an immediate investigation and response. An appropriate response includes "a timely, thorough and credible root- cause analysis; developing an action plan designed to implement improvements to reduce risk; implementing the improvements and monitoring the effectiveness of those improvements".66

Root-cause analysis is a process of identifying the causal factors of the sentinel event and making improvements to reduce the probability of the event recurring. An action plan is developed, outlining the strategies to be implemented by the health service, who is responsible within the health service for their implementation, and how strategies' effectiveness will be measured. Each health service's sentinel event policy and examples of root-cause analyses the service has conducted during the previous year are examined during the service's accreditation survey to determine if they comply with the Commission^ standards.

In the US's health service accreditation system, sentinel events include surgery on the wrong patient or body part, inpatient suicide, and incompatible blood transfusions. Each health service is encouraged to report any sentinel event that occurs in the service to the Commission. Although most sentinel event reports to the Commission are made by health services, they may also be informed by complaints made to them by patients and their relatives, media reports and events identified by surveyors during health service accreditation surveys.

Once the event is reported to the Commission, the root-cause analysis performed by the health service is reviewed to ensure that it is "thorough and credible" and that the action plan is acceptable. If these documents meet the required standards, the Commission will assign a follow-up activity to the health service. This activity is usually an audit comprising measures to ensure that the actions taken in response to the sentinel event were effective and sustained. The report of this audit is required to be submitted to the Commission within 4 months. Failure by the health service to meet any of these standards may result in a change in their accreditation status.


Since January 1995, over 4000 sentinel events have been reported to the Commission, most commonly for wrong-site surgery, inpatient suicide and complications associated with operations. Health services in the US have reported about 350 sentinel events each year for the past 3 years. Comparing reporting to the Commission with mandatory reporting to some state authorities in the US, sentinel events may be under-reported to the Commission by a factor of 20.21

The Commission enters the details of each sentinel event, root-cause analysis and action plan into a database for analysis. If panicular sentinel events are found to have occurred with significant frequency, Sentinel Event Alerts are written and made available on the Commission's website. The Alerts provide de-identified descriptions of the sentinel events, the number reported to them, the causes found in root- cause analyses, the risk reduction strategies that were implemented by the reporting health services, the Commission's recommendations regarding the sentinel event, and links to further resources. Since February 1998, 37 Sentinel Event Alerts have been issued by the Commission on a many topics, including wrong-site surgery, restraint deaths, blood-transfusion errors, needlestick injuries and anaesthetic awareness.

Unfortunately, the Commission sentinel event program is viewed as cumbersome and time- consuming, and may result in health services losing their accreditation status. Health services are also worried about the public disclosure of details of individual sentinel events leading to possible litigation and the potential loss of reputation. These factors may inhibit the reporting of sentinel events to the Commission.

Sentinel event reporting and analysis requires a balance between the requirements for public evidence of accountability with the possibility of sanctions for serious violations, and the potential problems for health services if full disclosure of all sentinel events occurs. Some legislative protection for health services may be necessary for some documents created during analysis and response to sentinel events, and such legislation may increase reporting of significant adverse events.65 Although the hurdles surrounding the reporting of sentinel events are substantial, the benefits of aggregated information about adverse events provided by the Sentinel Event Alerts for the development of safer systems across the health care field are substantial.

4.2 J.2 Sentinel event reporting in AustraliaIn April 2004, Australian Health Ministers decided that "all public hospitals [are | to report sentinel events, either to the state department or to an agreed third party ... [and] that all states and territories will contribute to a national report on sentinel events . . ."67

In addition to hospitals reporting clinical incidents to their insurers, some health care bureaucracies in Australia request that hospitals report to them the details of specific major adverse or sentinel events when they occur in the hospital.68

The Victorian Government Department of Human Services has developed a sentinel event program as part of its Clinical Risk Management Strategy. Its reporting criteria are similar to those of the US Joint Commission. The Department has defined sentinel events as relatively infrequent, clear-cut events that occur independently of a patient's condition; commonly reflect hospital system and process deficiencies; and result in negative outcomes for patients.68 The Department wishes to gather as much information as possible by accumulating reports of similar events from different health services, and examining them for common underlying contributing causes. This information is used to aid collective preventive efforts to improve patient safety. The current list of sentinel events required to be reported to the Department is:■ procedures involving the wrong patient or body part■ suicide in an inpatient■ retained instruments or other material after surgery requiring re-operation or further tuigcai

procedure


■intravascular gas embolism resulting in serious neurological damage or death■haemolytic blood transfusion reaction resulting from blood-group incompatibility■medication error leading to the death of a patient reasonably believed to be due to incorrect

administration of drugs■maternal death or serious morbidity associated with labour or delivery■infant discharge to wrong family■other catastrophic event.

In addition to reporting the details of these events <o the Department when they occur, Victorian public hospitals are required to conduct a root-cause analysis and report the results of these investigations and a risk reduction plan of the actions they have taken, orjjlan to take, to prevent the event recurring. The risk reduction plan describes the actions that have will be taken to reduce the probability of the event recurring, who within the health service is responsible for taking each action, when the action is to be completed, which senior executive is accountable for minimising the future risk of the event and how change will be measured and outcomes evaluated after action has been taken.

In 2005-2006, 91 sentinel events that occurred in Victorian public hospitals were reported to the Department; 49 were classified as "other catastrophic events". Annual reports detailing the number and type of sentinel events, and factors contributing to the events, are reported to state departments of health and published annually in Victoria, New South Wales, South Australia, Western Australia and Queensland.

In Victoria, a Department-appointed reference group reviews all sentinel events reponed by Victorian health services and the detailed analysis of the event conducted by the health service and actions they have taken in response to the event. Feedback is provided to the health service on the root-cause analysis they have conducted and, if necessary, recommendations are made regarding funher action to be taken by the organisation. Information from these reviews thought to be of value to all health services in the state is provided to them via a newsletter, issuing alens for significant events and publishing an annual report including several case studies and risk reduction strategies. In addition, the reference group makes a number of recommendations to the Department regarding areas of clinical risk detected in the sentinel event reports and thought to be applicable to other health services in Victoria.

In July 2007, the Australian Institute of Health and Welfare and the Australian Commission on Safety and Quality in Health Care published a report on sentinel events that occurred in Australian public hospitals in 2004-05.69 The report documented the number of sentinel events reponed by health services to their state bureaucracies across Australia under each type of event together with contributory factors and several case histories.

4.2.5.3 Sentinel event reporting — the bottom lineSentinel events are serious adverse events and usually only occur infrequently in individual hospitals. It is likely that medical record review or clinical incident reponing will detect most sentinel events Individual health services will probably gain more from reviewing the case histories in the annual reports of sentinel event programs produced by each state health department and the national sentinel event report for potential areas of high clinical risk than from only reviewing the probably infrequent sentinel events that will occur within the health service itself each year.

Making use of the alerts issued by organisations such as the Joint Commission can assist health services by indicating areas of potential risk that may not be evident at the local level, and providing resources to reduce risk developed from reviewing the scientific literature and

4 Detecting adveree even* and flefc

consulting clinical experts. These resources can be appropriately modified by individual health services to meet local


needs and conditions. Such resources can save individual health services much time in not having to sun the nsk reduction process in a clinical area with a blank sheet of paper, undertake their own detailed literature review and "reinvent the wheel" when developing appropriate policies and tools for staff to use.

Health services should regularly scan the alerts prepared by organisations such as the Joint Commission to see whether any of the alerts issued are relevant to their own organisation. Also, if risks art detected in particular clinical areas using the health serviced medical record review or clinical incident reporting programs, the alerts can be scanned again to see if resources have already been developed elsewhere to effectively deal with these risks.

4.2.6 General practitioner feedbackPatients are spending less lime in hospital. Therefore, the effects of adverse events that have occurred dunng hospital admissions may not become evident until after patients have been discharged. Some of these adverse events may be serious enough to require the patientls re-admission to the hospital. If so, the adverse event will probably be detected by the medical record review process, as the admission will screen positive for the criterion "unplanned re-admission within 21 days of discharge". More commonly, the adverse event will not require re-admission to hospital. To capture details of such adverse events not requiring re-admission at Wimmera Health Care Group, each patient's general practitioner is sent a feedback form attached to the patient!; inpatient discharge summary (Figure 4.4). The form is open- ended and simple to complete.

The patient's general practitioner is requested to keep the feedback form in their patient's clinic medical record for 28 days, and to send the form to the hospital if an adverse event related to medical care received at the hospital is evident when the general practitioner reviews the patient. The form is returned to the director of medical services, who forwards the information to the clinical risk manager.

Support for this component of the clinical risk management model was obtained from the local Division of General Practice (whose membership comprises most general practitioners in the region), who assisted the hospital in its attempts to encourage doctors in the region to complete the feedback form when adverse events were found.

When the hospital receives a completed feedback form from a general practitioner, the patient's medical record is promptly reviewed and the details of the event are discussed with the relevant staff members. If an adverse event is thought to have occurred, an adverse event analysis form is completed and the event discussed at the next surveillance committee meeting. Only a small number of feedback forms are returned to the hospital, but adverse events detected by using general practitioner feedback have been different from those detected using medical record review and clinical incident reporting. As wuh other adverse event detection methods, general practitioner feedback appears to detect events from a different perspective to other detection strategies.

After the clinical risk manager has conducted a thorough investigation of the event, the general practitioner who provided the feedback is sent a letter thanking them for taking the time to inform the hospital of the event. The letter also provides a summary of the findings of the investigation into the event and details of the actions taken to reduce the probability of the event recurring. It is hoped that by providing this feedback, it will demonstrate to general practitioners that their action in providing this information about their patients' care can improve the system of health care delivery, thereby encouraging them to report further events.

The nsk of an adverse event increases when there arc weaknesses in health care delivery systems. Weaknesses can become apparent with a change in provider and location of care, which occurs after a patient is discharged from hospital In a Canadian siudy, more than one in five


74

patients discharged from a teaching hospital medical unit experienced a post-discharge adverse event related lo the medical care


75

Figure 4.4 Wimmera Health Care Group general practMener feedback form

Wimmera Health Care Group General Practitioner Feedback Form

Feedbedt IflfMiiiilkinThis card it to be completed for thw patiem following transfer or diKhaige torn the Wimmera

Health Care Group if an advene event hat occurred. If no atone event please retain in patient's record for 28 days

Local CP

Advene event definitionAn untoward patient event that, under optimal conditions, it not a natural consequence of the patient's disease or treatment.

Date adverse event recognised

Summary of adverse event

received in hospital. The most common adverse events were adverse drug events (72%). therapeutic errors (16%), and nosocomial infections (11%). Half of these adverse events were preventable or ameliorable.70 Obtaining feedback from general practitioners after patients are discharged from hospital is an important source of information about adverse events related to hospital care, and provides useful information to improve the quality and safety of care. The authors of the study suggested that patients required closer follow-up after discharge from hospital, and that communication with primary care providers and home care services should be enhanced.70

Adverse events detected by general practitioners after the patientls discharge from hospital can result in action being taken by the hospital to improve the transfer of care between the hospital and primary care, allowing patients to move more safely between these two providers of their care.


3 Jc «•C

IV

4L2.7 OWcol pathways and variance analysisClinical pathways provide an evidence-based framework for high-quality, coordinated care. They aim to optimise outcomes for patients by adapting best practice in a particular clinical area to local conditions with prudent use of resources. Ideally, clinical pathways should be developed by a multidisciplinary team using evidence from relevant high-quality clinical trials or, where this is not possible, from consensus of expert opinion. Clinical practice guidelines issued by national medical bodies are useful resources, but they may require modification to suit local conditions.

Ginical pathways enable standardisation of care where appropriate, which improves quality by preventing omissions of essential elements in care and reducing practice variation. When used within a multidisciplinary team approach, a clinical pathway can be incorporated into a medical record and provide details of the care to be provided by all members of the health care team within a time frame. It reduces documentation time for standard care, as only the initials of the health care professionals involved are required to indicate the components and details of the care that has been provided.

When using clinical pathways, staff should consider whether the recommended management is appropriate for their patient. If a particular treatment or investigation is not required, or a different approach is necessary, a variance should be recorded. This recognises that an individual approach to care is essential to allow for comorbidities, patient variation and process difficulties. Similarly, if expected outcomes are not met, complications arise or patient recovery time exceeds expectations then documentation of these outcomes as variances is required.

Variation in care is treated as an exception, and written documentation is required, detailing the reason for the variation if known, the action taken and outcome achieved. This detail ei\ables analysis of variances and allows system and clinical improvements to be made as trends are identified. Variances may be analysed for each diagnosis-related pathway using a specific software program, or an audit of relevant clinical indicators may be conducted. A combination of variance analysis and audit of clinical indicators provides an opportunity to measure targeted improvements and detect adverse events. Regular review (by the multidisciplinary team that designed and uses the pathway) of the results

Figure 4.5 Proportion of patients with ST elevation acute myocardial infarction who received key interventions before and after the introduction of the clinical pathway

irrw. a-----------------------------------—-----------■ - - -■-----------------------------------m-----------^

80% -i

c .3

// □ ■ - - - a A Patients who received aspirin in the emergency department

o o 0-Blocker prescribed to eligible patients on discharge

| 40%-

0 £

q/ 0 Lipid therapy commenced (or eligible patients

L P-Blocker received by eligible patients within 24 hours of admission

20% -

X Fasting lipid levels measured


I I Pre-pathway Post-pathway Jarv-Oec Oct 2000- 1999

Dec 2001 (n-42) (n — 31)

2002 (n-43) I 2003 ' 2004 2005 2006 2007 (n-25) (n-

22) (n-24) (n-17) (n-21)


achieved using individual pathways enables process and clinical improvements to be made using the clinical pathway as a guideline for care and as a measurement tool.

The stroke pathway and ST elevation myocardial infarction pathway, examples of clinical pathways developed at Wimmera Health Care Group and incorporated into patient medical records, are available on the Wimmera Health Care Group website (www.whcg.org.au/Quality/index.aspx). Figures 4.5 and 4.6 show the improvements in process resulting from the introduction of these pathways. The development and use of clinical pathways will be discussed further in Chapter 7.

4.2.8 Patient satisfactionResearch has shown that patients are unable to accurately judge the quality of the technical aspects of the clinical care that they receive.71 They are, however, able to accurately assess the quality of their nonclinical care, which is a significant component of the quality of care and service provided by hospitals.

Despite the limitations of comments received from patients about the care they have received, such information still provides valuable feedback to hospitals about how to improve aspects of their health care delivery. This information can be obtained using patient satisfaction surveys, focus groups and patient complaints.

We have used information from these three sources to provide information from yet another perspective about where to direct our efforts to improve our health care delivery systems. Previously, most information obtained from these sources has been about the non-clinical aspects of patient care (eg, noise, privacy, temperature and the quality of food). More recently, treatment and inadequate communication between clinical staff and patients are issues raised most commonly as an area of patient dissatisfaction. Although patients may not be able to appreciate whether an error has occurred while they are receiving medical care, they are usually well aware if they have been harmed during the process.24

We have found focus groups extremely valuable for obtaining feedback from patients. At Wimmera Health Care Group, focus group meetings, comprising patients who have received treatment in a particular clinical area of the hospital, are conducted. These patients are invited to attend a group meeting with a facilitator. A consistent format for these group meetings has been developed. Information

Figure 4.6 Proportion of patients with stroke who received key interventions before and after the introduction of the clinical pathway

100% -,

80% -

60% -

£ 40% -

Dysphagia screen performed within 24 hours of admissionAspirin or clopidogrel administered within 24 hours of admission of patients with ischaemic strokeComputed tomography brain scan within 24 hours of admissionRegular neurological observations performed for the first 48 hours following the stroke

4 Detecting adverse events and

20% -

http://www.whcg.org.au/Quality/index.aspx

Pre-pathway Post-pathway Jul 1999- Jun- Apr 2000 Dec 2000 (n-27) (n - 37)

2006 2007 (n-35) (n-31!


2001 (n-8)

2002 (n-21)

2003 (n-36)

2004 (n-44)

2005 (n-49)

obtained from focus group sessions is then discussed with the staff members who cared for the patients in the hospital. This information can be positive and negative. Hospital stafT members in the area under review are requested to review this information and develop and implement plans to address the issues before a follow-up focus group session.

One limitation of focus groups is that, given the small number of patients involved in each group session, an individual patient^ views may dominate discussion in the group and therefore may bias the results obtained. To overcome this limitation, some issues raised by participants in focus group sessions are investigated further by drafting appropriate questions and including them in a patient satisfaction survey mailed to a larger sample of patients who have received treatment from the same clinical area of the hospital.

4.3 Proactive risk management — detecting risks

4.3.1 Consultative councils and committeesThe Victorian Government has established a number of consultative councils, comprising health professionals working in specialised clinical areas. These councils are given the task of reviewing clinical care in their area of expertise, and making recommendations about how this care should be provided. They are also advisory bodies to the Victorian Minister for Health. The Consultative Council on Obstetric and Paediatric Mortality and Morbidity (established in 1962 under the Health Act 1958 [VicD, the Victorian Consultative Council on Anaesthetics Mortality and Morbidity, and the Victorian Surgical Consultative Council all analyse information sent to them voluntarily by clinicians and hospitals on patient deaths and adverse events. Under legislation, the information provided to Councils cannot be accessed by third parties.

After undertaking this analysis, the Councils make recommendations about how care can be provided with increased safety. This information is included in their annual reports, which are circulated to relevant clinicians, hospitals, the Department of Health and the Minister for Health. These recommendations can then be adapted by individual hospitals for local conditions and incorporated into their service delivery systems.72

4.3.2 Coronial reportsCoronial reports about patient deaths in hospitals often provide very detailed analysis of the failures of some health care delivery systems. In 1 year, individual hospitals may be involved with a small number of coronial inquests into deaths associated with an adverse event. Fortunately, few adverse events that occur in hospitals result in patient death. In our experience, by studying coronial reports about adverse events that have occurred in other hospitals, it has been possible to strengthen the related health care delivery systems within our own hospital.

A coronial report into the unexpected death of a patient at another hospital is analysed by the surveillance committee in the same way as an adverse event that has occurred at Wimmera Health Care Group. Staff members ask: could the adverse event described in the coronial report occur in this hospital? Invariably, the answer is yes. Action can then be taken to strengthen the relevant systems to reduce the probability of a similar event occurring at Wimmera Health Care Group. As a consequence, the resilience of the delivery systems in question and the subsequent quality of care are improved without staff members having to experience the negative emotions attached to dealing with the consequences of a serious adverse event that has occurred in their own hospital.


On" occasion, the Victorian Department of Human Services has sent each health service in the state a summary of a coronial inquest into a patient's death in a hospital, copies of the actions taken by the health service in response to the death and the coroner's findings. The Department has also provided health services with copies of any forms or policies that the health service has developed in response w the death, and contact details to obtain further information about the actions the health servioe has taken. Such information has been well received by health services and has saved them considenMe work in not having to "reinvent the wheel" to strengthen system weaknesses related to the advene tw* that has been the subject of the coronial inquest.

The Coronial Liaison Service in Victoria (an initiative of the State Coroner's Office of Victoria and the Victorian Institute of Forensic Medicine) electronically distributes two quarterly newsleuen: the Coronal Communiqut (www. vifm. org/communique html) and the Residential Aged Care Coronial CommunufU (www.vifm.org/n963.html). These newsletters discuss cases reported to the State Coroner and thought to be of interest to health care professionals and the aged care community, with an emphasis on system failures. In our experience, Coronial recommendations can be an effectivejnethod of changing clinical behaviour.

4.3.3 Information from InsurersFortunately, only a very small proportion of the adverse events that occur in hospitals result in litigation. Through their imponant role in providing indemnity cover, hospital insurers and medical defence organisations have an overview of the types of events that may result in litigation, and they regularly provide advice about how hospitals and clinical staff members can prevent such events. For example, some medical defence organisations give advice about many issues, including documentation in medical records, communication with patients and preventive measures that should be taken in high-risk clinical situations to prevent adverse events occurring. Using this information as a guide, the relevant hospital systems can be checked to ensure that these recommended practices are in place.

Similarly, some hospital insurers recommend processes that hospitals should have in place, such as procedures for obtaining informed consent and for undertaking medical research. Again, it is relatively easy to check the relevant hospital systems to see whether these measures are in place.

Insurers and medical defence organisations send their members regular reports and bulletins, highlighting significant adverse events that have occurred in hospitals and private medical practices, and which recommend appropriate preventive actions that should be taken to reduce the probability of such events occurring. This information can be dealt with in a similar manner to coronial reports.

Some medical defence organisations encourage their members to develop clinical risk management programs in their practices and offer reduced medical indemnity insurance premiums to doctors who develop such programs to an appropriate standard. These organisations also offer their members education programs about clinical risk management, which should help health services educate their medical staff about risk management and in developing hospital wide programs.

Each hospital has information available about adverse events that have occurred at the hospital and have resulted in litigation. The surveillance committee can review these adverse events, but most will already have been detected by medical record review or clinical incident reporting. In our experience, very few adverse events in individual hospitals result in litigation. Reviewing aggregate data and the details of events and claims that have occurred at other hospitals is a more useful way to improve delivery systems in one's own hospital with claims information.


http://www.vifm.org/n963.html

In the US, the 10 most common causes of medical malpractice lawsuits are: medication errors, incorrect diagnosis, resulting in incorrect or delayed treatment; inadequate supervision of junior medical and nursing staff; delayed treatment; failure to provide adequate information about the rtsks of treatment for the patient to be able to give informed consent; doctors performing procedures for which they have inadequate skill or experience; unexpected patient death due to inadequate clinical history being taken, iatrogenic injury, such as wound infections and fractures obtained while in hospital; pain, suffering and emotional distress following procedures where patients have unrealistic expectations of the outcomes; and lack of teamwork and communication by hospital staff members about the patient's clinical condition. Numerous strategies are available to reduce the probability of many of these adverse events occurring.71 In our experience, a consistent theme in adverse events that are referred to insurers is poor communication between doctors and with their patients.

4*3.4 StotewMt and national databases of clinical IncidentsAs discussed previously, clinical incident reporting can be expanded beyond incident reporting at the individual health service level to reporting on a state or national basis. Such reporting creates a large, unique and valuable database of incidents that can occur in a health service. These national databases, where data from incidents in many health services have been aggregated, can identify risks associated with low-frequency events and higher-level system factors whose significance may not be realised at the local level.6''74 National databases can also focus analysis on clinical incidents reponed in specialised clinical areas, such as intensive care units.45-65

The Australian Patient Safety Foundation in Australia has developed statewide databases. In the UK, the NHS has created the National Patient Safety Agency to develop a national database of clinical incidents. The National Center for Patient Safety of the Veterans Health Administration, a 173-facility system in the US, has also developed a database of investigations into major incidents.

4.3.4.1 The Australian Patient Safety FoundationThe Australian Patient Safety Foundation is a non-profit, independent organisation originating from an incident monitoring study in anaesthesia in 1989. The Foundation provides a patient incident reporting and monitoring system (the AIMS software) through a commercial subsidiary for all public hospitals in New South Wales, Western Australia and South Australia, and some health services in the Northern Territory, Victoria, Queensland and New Zealand. The Foundation aggregates and analyses deidentified data to determine "contributing, minimising and preventive factors which can then be used in devising corrective strategies and action plans for incidents affecting patient safety."75

For example, incidents involving patients and physical violence or violent verbal exchange that were reported over a 2-year period were analysed and preventive strategies proposed and published,75 as have data about bums patients have received in hospitals.76 Although hospitals from many pans of Australia send incident data to the Foundation, this information is entered into statewide databases, not an overall national database.

4.3.4.2 The National Reporting and Learning System in the United KingdomThe National Patient Safety Agency, which reports annually to the British parliament, has responsibility for the National Reporting and Learning System, through which clinical incidents are voluntarily reported by staff in all NHS organisations in England and Wales. In 2005, the Agency received almost half a million reports of patient safety incidents. These incidents are analysed "to


inform patient safety learning, action and priority setting across the NHS".58 Individual health services are also able to compare their incident reporting data with like services.

After analysis of clinical incidents at a national level and examination of other sources of relevant information such as published literature, national audits, litigation claims and product regulatory agencies and consultation with relevant expert clinicians and patient groups, information may be sent to all NHS organisations. This information may be provided in one of three forms: patient safety alerts that require prompt action by health services to address high-risk areas; patient safety notices that strongly advise health services to take action in particular areas; or patient safety information, which suggests actions that organisations should consider taking. Lay versions of this information are also developed.


4 Detecting adverse everts and «#

Patient safety alerts. These alerts detail the number of clinical incidents that have been reported in the area of concern and relevant litigation data. Details of actions to be taken by health services to reduce risks in these areas and deadlines for their completion are also given. Appropriate templates and exemplar documents (including patient education) to address the risk are created and sent to health services to help them take action. These documents are also available on the Agency's website (www.npsa.nhs.uk/alerts-and-directives), with the .reminder that the documents will require local adaptation and should be ratified for use by local clinicians. Where possible, attempts are made to redesign systems to eliminate risks rather than issue further guidelines.74 Over 30 alerts and notices have been issued by the Agency over the past 3 years. They cover a wide range of topics, including standardisation of patient wristbands, administration of intravenous infusions to children, and early identification of failure to act on radiology imaging reports.

With the issuing of alerts and patient safety notices and information, much valuable and useful information has been sent to health services arising from the analysis of clihical incidents at a national level. However, there have been concerns expressed about some of the alerts issued. Some clinicians fed some alerts detailing mandatory requirements for changes in clinical practice are being issued before strong scientific evidence supporting such changes is available. Such alerts are viewed by some clinicians as "knee-jerk" reactions to a small number of adverse events, and that issuing alerts in such a manner may increase doctors' resistance to changing their practice in a particular clinical area. One such alert concerned the positioning of nasogastric tubes and the type of paper and supplementary tests used to test for the position of the tube. The changes suggested in the alert had not been tested in clinical practice. A survey of neonatal units in the UK showed over half the units had not made the changes in the alert 9 months after it had been issued.

These events highlight the importance of good evidence in the scientific literature supporting the proposed changes in clinical practice described in alerts, of recommending changes that are practical to implement, and of a perceived need by clinicians for change, and of strong support for the recommendation by relevant professional bodies. Changing practice without strong evidence of the change being safe may result in replacing one risk with another.77 The difficulty arises when the Agency receives a series of incident reports in a clinical area that clearly indicates a problem, but there is no high-quality evidence in the scientific literature to support recommendations to change clinical practice. It has been argued, however, that although the guidelines regarding testing of the position of nasogastric tubes were not ideal, they were still a step in the correct direction, as issuing an alen should increase awareness of the problem and the associated uncenainties and confusion, and also, hopefully, encourage reporting of further incidents in this area.78

Detailed reports are also published by the Agency. One such repon reviewed incidents involving 107 patients whose deaths in hospital in 2005 were reponed because of concerns about the safety7 of their care.79 The report also reviewed relevant claims data and the scientific literature. Recommendations were made about clinical deterioration in patients not being recognised or not being acted upon, and problems associated with resuscitation. The report not only highlighted the problems, but also provided examples of good practice regarding these issues already being undenaken in some health services in the NHS with a view to individual health services reviewing their systems and performance in these important areas.

There has been criticism of the Agency, as there is still significant under-reporting of serious incidents and medication errors, and the potential learning from over one million reponed incidents into improvements at the coalface across the NHS has not been maximised, with serious delays in developing and sharing of effective solutions to incidents.80 Pan of problem may be lack of a minimum dataset to classify patient safety incidents 81 43.43 The feterans Health Administration incident reporting system

http://www.npsa.nhs.uk/alerts-and-directives

The Veterans Health Administration incident reponing system in the US is run under the direction of its National Center for Patient Safety, which provides tools, training and expert consultants for all the Administration^ facilities. The system was developed to meet several criteria essential in creating an effective incident reponing program:■ The program was to be seen as non-punitive by Administration staff reporting incidents.■ Analyses of the incidents were to be undertaken by multidisciplinary teams drawn from the

patient- staff coalface of the health service, to generate the most innovative and effective solutions to the system weaknesses that were detected.

■ Timely feedback was to be provided to all staff who reported incidents to indicate that their report had been appropriately dealt with by the facility and not lost in the system.

■ Near misses or close calls, as well as adverse events, were identified and reported. In the Administration^ experience, near misses occurred more frequently than adverse events, with high- priority close calls making up 90% of reported incidents. Importantly, these near misses identified the same weaknesses in systems as adverse events, and were therefore equally valuable in improving patient safety. The major difference between a near miss and an adverse event is that with the near miss, a barrier in the organisation stopped the error affecting the patient and causing an adverse event. Focusing only on events that cause harm to patients and not capturing data from near misses would significantly detract from the potential benefits of a health service's quality improvement and patient safety program.61 Also, the analysis of near misses is less likely to be affected by the reviewers displaying hindsight bias (where the assessment of an event is affected by the reviewer knowing the patient's outcome).21

Importantly, the Administration felt it may be easier for staff to report near misses than adverse events because there was no attached fear of punitive action, liability or embarrassment.

■ Reporting clinical incidents did not require significant additional work to be done by staff.■ The major objective of the program of improving the level of patient safety was clear to staff.

The Veterans Health Administration also recognised that implementation of such an extensive patient safety program needed to be incremental and would require significant staff training. The Administration placed the program highly in its organisational structure, centrally and in each facility. At the local level, such positioning of the program clearly indicated to staff that patient safety was a high priority in the organisation and facilitated communication between the program safety manager and the chief executive at each facility. Centrally, the Director of the National Center for Patient Safety, which oversees the incident reporting system, reports directly to the Under Secretary of Health. This process may assist if the program is not being fully supported by the management at a local facility.82

The Administration made it clear to its staff that the program was not an incident-counting exercise, and that it would not measure the success of the program by the number of incidents that were reported. Rather, if more incidents were reported, it could indicate that an appropriate culture, in which stafT felt able to freely report incidents without personal repercussions, had been developed at a facility. The Administration regarded incident reporting as very important, because "you can't fix what you don't know about".83

The Administration's program created a prioritising scoring method related to the severity and frequency of each incident to allow a Safety Assessment Code score to be calculated and action to be taken in response to the priority of the incident. This scoring method resulted in consistent handling of clinical incidents throughout the many Administration facilities. This assessment and scoring of incidents will be discussed in more detail in Chapter 5.An intentionally unsafe act. Importantly, although the Veterans Health Administration incident reporting system aimed to be non-punitive, it did not provide those reporting incidents with total

4 Detecting advert* event* «nd tm

immunity from disciplinary action. The Administration gave an undertaking to its staff that as long as the incident reported did not involve an "intentionally unsafe act", punitive action would not be taken because of findings of an investigation into an incident. The Administration defined an "intentionally unsafe act" as "a criminal act, a purposefully unsafe act, an act related to alcohol or substance abuse of an impaired provider or staff member, or events involving alleged or suspected patient abuse of any kind".83 Incident reporting in the Administration's program involving such acts could result in disciplinary action being taken by the facility.83 In other industries such as aviation, immunity for reponing non-criminal offences has been an incentive to reponing incidents.61

Alerts and advisories. As a result of the reponing and analysis of clinical incidents, over 70 alerts and advisories have been sent to Veterans Health Administration facilities and posted on the Administration's website (www.va.gov/ncps/alerts.html) since 2000. Many of these relate to equipment warnings and provide details of incidents, actions that facilities should take to reduce or eliminate the associated risk, information from the manufacturers of the equipment and contact detail? for further information. A bimonthly newsletter with details of findings and ideas from the analyses of reponed incidents is also published (www.va.gov/ncps/TIPS/tips.html).

In 2000, the Administration extended their mandatory internal reporting system to include a voluntary external reporting system developed in partnership with the National Aeronautic and Space Administration (NASA), which manages an aviation safety reporting system. NASA was seen as an impartial third party with the skills and track record to run the program. The program is called the VA- NASA Patient Safety Reporting System, and its primary aim was learning from incidents, rather than accountability. Administration staff mail incident reports send directly to NASA. Importantly, these reports are not made anonymously. Identification of the reporter allows contact to be made by the person analysing the report to obtain additional information to enhance understanding of the incident. After this contact, the report is de-identified, ensuring that no punitive consequences result from the incident being reported. Reports are made in narrative form to provide more information about the context of the incident.84

Other smaller-scale incident reporting databases have been established in the US, including a web- based incident reporting system in Pennsylvania. The Patient Safety Authority, an independent state agency, was established under legislation aimed at reducing medical error and all Pennsylvania-licenced hospitals are required to report serious events and incidents. The Authority publishes quarterly patient safety advisories (www.psa.state.pa.us), in which it reviews trends in reported events and advises agencies "of immediate changes that can be instituted to reduce Serious Events and Incidents".

4.3.5 Media reportsReports appear frequently in the media about adverse events that have occurred to patients in hospitals These reports are often useful in identifying weaknesses in health care delivery systems. Unfortunately, unlike coronial reports, media reports are often sensationalised and do not contain all the details of how and why particular adverse events occurred; they also often contain inaccuracies. Despite these shortcomings, we have still found it worthwhile to analyse media reports. We use them as prompts to examine the strength of relevant delivery systems in our own hospital that relate to the system deficiencies discussed in individual media reports of adverse events.

Some adverse events may occur only rarely in an individual hospital, but even those occurring as infrequently as once every 10 years may have significant negative consequences. It is worthwhile, therefore, to take action to prevent such an event occurring in one's own hospital by learning about the system weaknesses that have contributed to such an event occurring


http://www.psa.state.pa.us/

http://www.va.gov/ncps/TIPS/tips.html

http://www.va.gov/ncps/alerts.html

elsewhere. This proactive method of preventing adverse events requires a degree of discipline in following up such media reports, and a systematic approach to analysing and acting on the adverse events described in them. As with coronial


reports, although this proactive approach requires additional work, it requires considerably less emotional energy than having to deal with the same system issues in an emotionally charged environment after a major adverse event has occurred in one's own hospital.

4.3.6 Clinical JournalsThe volume of clinical information available to health professionals is expanding rapidly. It is not possible to read about and implement all advances in clinical knowledge and quality activities described in medical journals. We often find useful information in relevant journals, which we regularly scan for details of innovative quality improvement programs and clinical improvement initiatives in specific areas.

Useful articles fall into two board categories; they describe:■ innovations which can enhance the components of our quality

improvement and clinical risk management system■ clinical advances that can guide future modifications for how we provide

clinical care.Invariably, we find far more ideas in these articles than we can

effectively and efficiently implement. Copies of relevant articles are sent to the surveillance committee for discussion or to multidisciplinary groups in the hospital who are developing clinical pathways.

In the Wimmera program, information from multiple external sources about adverse events and system improvements is used to reduce the probability of adverse events occurring in our hospital. We have gained valuable insights and benefited from the observations made of other hospitals' experience with adverse events and their system improvements.

4.3.7 Pharmaceutical and equipment alertsHealth services periodically receive product alerts from pharmaceutical companies and equipment manufacturers about the safety of their products. These alens may require withdrawal of medication from the hospital pharmacy, or urgent withdrawal and review of equipment used in delivering care. These products may represent an unacceptable risk to patient safety until they are appropriately dealt with. In our experience, companies send such alerts to several people within each health service in the hope that by widely distributing this information, it is more likely that appropriate action will be taken to eliminate the risk. Unfortunately, this wide distribution may result in an uncoordinated approach in dealing with the risk, or worse, that appropriate action is not taken as staff sent the alert believe someone else in the health service will take the required action.

As with other areas of risk management, a systematic and integrated approach is required to reduce or eliminate the risk associated with each product alert. The products that represent a risk to patients and the alert should be recorded on the health service's risk register when

Tenant safety inquiries acnsstoeworid consistently identity toe same recurring problems as the cause of iatrogenia: health care below promulgated standards: lack of quality-monitoring processes, patients, family members and concerned staff being ignored and excluded; wtiisttebtowers being vilified, and persistent deficiencies in teamwork, systems and communication.'

Travaglia JF. et al

Med J Aust 2008: 188: 437-

438


they are received by the service, and remain on the register until the risk has been eliminated or reduced to an acceptable level. In the NHS, numerous alerts from the Medicine and Healthcare Products Regulatory Agency are sent to all


health services via the Central Alening System (previously known as the Safety Alert Broadcast). These alerts provide details of the problem with panicular items of equipment and designate those NHS personnel and organisations that need to take action. In Australia, alerts and advisories regarding medicines and medical devices are displayed on the Therapeutic Goods Administration website (www.tga.gov.au) and sent to individual doctors and health services.

4.3.8 Inquiries into individual health services or specific clinical areas In health service*After high-profile adverse events or a series of serious adverse events in one health service, governments may establish inquiries to determine the extent of the adverse events and the reasons why they have occurred, and to make recommendations to correct deficiencies in clinical governance and systems in the health service. Such inquiries have been held in the UK into complex paediatric cardiac surgery undertaken the Bristol Royal Infirmary83 and in Australia into patient deaths at Bundabeig Base Hospital in Queensland,86 Campbelltown and Camden Hospital in Sydney,87 obstetrics and gynaecological services at King Edward Memorial Hospital in Penh88 and neurosurgical services at the Canberra Hospital.89 These inquiries were established after stafT, often at great personal cost, became whisdeblow- ers after repeated attempts to have concerns addressed internally did not result in appropriate action being taken by senior management and clinicians in these services.

The reports are salutary, useTul reminders to management and clinicians in any health service about what can go wrong in the delivery oT health services without adequate and effective clinical governance procedures. The recommendations often describe what should be included in a health service's clinical governance framework to ensure that effective quality improvement and patient safety activities are undertaken. Faunce and Bolsin provide a brief summary of the major deficiencies found by the inquiries in the Australian health services listed above (except Bundaberg) in a discussion on whistleblowers.90 A review of hospital inquiries in Australia looked at the impact on staff and safety and found that:91 a Concerns about clinical standards were raised by staff with management, but these concerns were

mishandled, resulting in whistleblowing in four hospitals, a After each whistleblowing episode, an official inquiry was undertaken and made recommendations

about how to improve patient safety in the hospital concerned, a Following these inquiries, there was generally a loss of trust in management and among clinicians.

Patients and the community also lost trust in the hospitals, a Such trust needed to be rebuilt before stafT will report mistakes or other concerns about safety, a To successfully implement patient safety procedures requires the development of policies detailing the professional duty of staff to report concerns about colleagues if they believe these concerns pose a risk to patients.

A review of numerous inquiries conducted in the NHS over many years found although the reports were published (and therefore accessible), they were lengthy and hard to read, and that probably only the executive summaries and press reports would be widely read. Most inquiries into failures in quality of care found similar causes: organisational and geographic isolation (lack of transfer of innovation and limited peer review); inadequate leadership (unwilling to address known problems); system and process failure; poor communication (problems not detected); and disempowerment of staff and patients (staff discouraged from raising concerns). The authors fell that the consistency of the causes of these failures could reflect that the recommendations of these inquiries were not properly implemented across the health care field, and that lessons from these failures were not always leamt. They believed that appropriate communication and dissemination of the reports of such inquiries was very important 01


http://www.tga.gov.au/

A more recent review of 13 major investigations undertaken in the NHS since 2004 found that "the themes that emerge are depressingly familiar":93 services with weak leadership; lacking effective direction; tolerating quality failures; trying to meet conflicting targets; inadequately using data, and lacking teamwork. The review also warned of the negative effect of continuous organisational restructuring, which diverts management^ attention from the quality of patient care. Continuity of leadership is an important factor in providing high-quality care. One health service that was investigated had seven chief executives in 10 years.93,94

4.4 Additional proactive risk management methods

As well as health services learning from adverse events that occurred elsewhere, different types of proactive risk management methods are available to reduce risk and prevent adverse events. These methods include examining the conditions of work in the health service when designing health care delivery systems and taking action to strengthen any weaknesses that are detected; assessing the risk of individual patients experiencing common adverse events and taking appropriate preventive action; encouraging patients to take an active role in their care; and using preventive health strategies to reduce the prevalence of common and preventable medical conditions, thereby reducing the need for hospital admissions.

4.4.1 Examining latent factors or conditions of workIt is important to examine the latent factors or conditions of work present in the health service when designing new systems or assessing existing ones. When examining how they provide care, health services should ask: do staff have the appropriate skills and training for the clinical seryices they are providing; are stafT members' workloads and shift lengths appropriate, and is the appropriate equipment readily available them to safely provide the required care? Proactively examining such latent factors or conditions of work present in delivery systems and addressing the deficiencies can reduce the probability of errors and adverse events.

Such a proactive approach to risk management has been formalised by the Veterans Health Administration in its Health Care Failure Mode and Effect Analysis. The program is consistent with the Joint Commission's accreditation standard that health services in the US have a proactive program to identify risks to patient safety. The standard requires that the program identify failure modes and determine the causes of the failure and how critical the effect of such failure is to the safety of that system of care. Processes should then be redesigned to address these failures and tested to ensure that the changes made have resulted in the desired outcomes being achieved. Health services accredited by the Commission are required to undertake at least one Health Care Failure Mode and Effect Analysis annually.

The Veterans Health Administration program begins with the health service deciding which area should be studied. The area chosen is usually high-risk because of the considerable resources required to undertake the analysis. For example, an area identified by the Joint Commission as being frequently reported as sentinel events may be chosen for study. A multidisciplinary team including subject experts is then assembled. The processes and subprocesses of the selected area are then assembled into a flow diagram.

Processes in health care can be very complex, and often a small, manageable pan of the process will be selected and studied in detail. All failure modes (how the system may fail) in the processes in the selected area and their causes are identified. A hazard score is calculated using the same definitions for severity and probability as the Safety Assessment Code (see Section 4.2.4). A

4 Detecting adveree everts and

decision tree algorithm is then used to determine which failure modes require action to be taken. The action aims to reduce the probability of the failure occurring, or to reduce its severity.

Some failure modes will not require action because there is an effective control measure in place to decrease the probability of the failure occurring, or the area identified is not assessed as critical. Where action is required, the support of management is obtained and outcome measures are determined. After action is taken, the functioning of the system is tested to ensure that the changes have not created new vulnerabilities in the system.95

As mentioned previously, such analysis is resource-intensive and time-consuming, and its effectiveness in improving safety has not been determined.96 Health Care Failure Mode and Effect Analysis should be used selectively and in carefully chosen areas to be cost-effective. For organisations with limited resources, a simple examination of the latent factors present in a particular system of health care delivery could be used more frequently and should also bs effective in reducing risk.

4.4.2 Assessing individual patients' risks of experiencing common advene eventsIt is imponant to assess each inpatient's risk of experiencing adverse events 1hat are known to occur commonly in hospitals. For example, when patients are admitted to hospital, they can be assessed for their risk of falling or developing a pressure ulcer or venous thromboembolus. If the risk of experiencing such adverse events is found to be high, appropriate preventive measures can be taken to reduce the probability that these events will occur during the admission. In our experience, such assessments are often completed, but when a patient is determined to have a medium or high risk of a panicular adverse event, appropriate preventive action is not consistently taken.

Criteria have also been developed to alen staff of patients on the ward who may be deteriorating clinically and at risk of cardiac arrest. When one or more of these criteria or clinical markers (such as the patient's pulse rate, respiratory rate, blot>d pressure, oxygen saturation and urine output) are outside predetermined limits, a medical emergency team is called and immediately assesses the patient to prevent their clinical condition deteriorating further. This proactive approach has resulted in earlier intervention for patients who are deteriorating clinically97 These early warning systems49 empower staff to obtain assistance for seriously ill patients to prevent an adverse event or limit the harm it causes.

4.4.3 Patients taking an active role in their careEncouraging patients (or parents, if the patient is a child) to lake an active role in monitoring their safety while receiving care can make it more difficult for adverse events to occur. Patients can be the ultimate barriers in preventing errors by clinicians from causing harm. Suitable roles for patients that will increase their level of safely include helping clinicians reach the correct diagnosis, ensuring they are well informed about the advantages and disadvantages of their treatment options, and playing an active role with their clinicians in deciding which treatment option is the most appropriate to meet their needs.

Patients should choose an appropriately trained clinician who is experienced in treating patients with their medical condition, or performing procedures the patient requires, and who practises medicine safely. Patients should also ensure that the treatment they receive is the treatment that is regarded as best practice for their condition and is consistent with the treatment that has been ordered for them to have. Patients can check that the treatment is being correctly administered, identify side effects and adverse events related to their treatment, and rapidly notify nursing and medical staff about these effects.


To date, the contribution patients can make to increase their own safety while receiving care has been under-utilised. Often, patients are passive recipients of medical care, but their potential to play a positive, active role is considerable. There will be considerable variation between patients and different clinical circumstances with the same patient as to where on the passive-active spectrum they wish he when receiving carc.qH Variation in patient involvement in their safety may be related to demographics, the severity of their illness, the selling in which health carc is being provided and whether the safctv behaviour challenges the clinicians' professionalism. However, whatever safety role patients choosc to lake, they can only be a safety "buffer" in addition to those in place in the hearth service — the responsibility for providing safe care still resides with the clinician.99

4.4.4 Preventive medicinePatients can also prevent adverse events from occurring to them by taking good care of their health. One latent factor that contributes to errors occurring in providing health care to patients is the workload of the clinicians providing the care. Many clinical conditions, such as ischaemic heart disease and diabetes, are significantly related to patients' lifestyles, and are therefore highly preventable. If these conditions can be prevented by lifestyle modification, the demand on health services and individual clinician workloads will be lowered and the probability of adverse events occurring in hospitals will be reduced.

4.5 Systematic review of external information about risk

There are many sources of information about adverse events that have occurred in other health services and several other proactive methods of risk management. Individual health services require a coordinated approach to systematically and regularly review each of these sources and methods, and to direct appropriate information to the service's quality improvement and risk management program. A comprehensive list of sources of information relevant to the health service should be created, and a staff member assigned to regularly review each source and present relevant information to appropriate staff members and to the quality and safety program. Alternatively, specific clinical areas (eg, pharmacy) could review the external sources appropriate to that area and direct this information to the program. Responses to this information throughout the health service could then be tracked.100 In our experience, much information will be available from these sources, and will require extensive filtering so that information relevant to the needs and conditions of the individual health service is located, distributed and appropriate action taken. The major challenge will be to deal effectively with the volume of information available, and to harness it to achieve the maximum positive effect on quality and safety.

Reactive risk nwnnflwnwtf—delecting adweiae evwilsIn the Wimmera model, adverse events are detected

using diverse methods:■ Medical record review — health information services

staff screen all inpatient medical records after discharge using nine general patient outcome criteria; and records screening positive undergo medical review. Record review provides an automatic, continuous flow of information about adverse events. The method detects adverse events not found by other methods and important issues not related to adverse events. Medical record review has a high false-positive


rate and can be costly and time-consuming. Three screening criteria are recommended for initial use: patient death, transfer from the general ward to the intensive care unit, and any patient record referred for review by a clinician. The screening criteria used should be tailored to local needs and conditions and using trigger tools can enhance record review

■ Clinical incident reporting — staff members report adverse events and near misses locally and the health service reports the details to a national database. Incident reporting detects adverse events not detected by other methods. The effectiveness of incident reporting is limited by under-reporting, especially by doctors. Staff should be educated about what incidents to report and how to report them. It should be easy for staff to report incidents, and timely feedback should be provided to them about the results of the investigation and the actions taken in response to reports they have made. Where possible, actions taken in response to reports should be made visible to staff. It should be demonstrated to staff that they can improve the care they provide and their work environment by reporting incidents.

■ Sentinel event reporting — details of a prescribed list of serious adverse events are reported by health services to the Victorian Department of Human Services shortly after they occur, with subsequent reporting of the results obtained from their detailed analysis of the event and action taken by the hospital in response to this analysis.

■ General practitioner feedback — feedback forms are sent to all referring general practitioners after their patients are discharged from hospital, requesting details of any adverse events they have detected that may be related to their patient's hospital care.

■ Clinical pathway variance analysis — variation from guidelines and/or outcomes within a clinical pathway are reviewed to detect adverse events and process difficulties.

■ Patient satisfaction — details of adverse events are collected from patient satisfaction surveys, focus groups and patient complaints.

Proactive risk management — detecting risksRisks are proactively detected in the Wimmera Clinical

Risk Management program:


■ Using external sources — adverse events that have occurred at other hospitals are reviewed to determine if they could occur at Wimmera Health Care Group. Details of adverse events occurring at other health services obtained from media reports, coronial investigations, clinical journals, consultative committees, state and national databases and health service inquiries, are systematically reviewed to detect system weaknesses and risk locally.

■ Reviewing latent factors when developing new delivery systems or reviewing existing systems.

■ Assessing individual patients' risks of common adverse events (eg, falls, thromboembolisms) and taking action to prevent them occurring.References1 Arx*ews LB, Stocking C, Krizek T. et al. An alternative strategy (or studying adverse events in medical care. Lancet 1997; 349:309-313.2 Christian CK, Gustafson ML. Roth EM, et al. A prospective study of patient safety in the operating room. Surgery 2006; 139.159-173.3 Tucker AL. Edmondson AC. Why hospitals don't learn from failures; organisational and psychological dynamics that inhibit system change. Calif Manage Review2003; 45: 55-72.4 Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalised patients: results of the Harvard Medical Practice Study 1. N Engl J Med 1991; 324:370-376.5 Vincent CA. Davy C, Esmail A, et al. Learning from litigation. The role of claims analysis in patient safety. J Eval Clin Pract 2005; 12: 665-674.6 Wu AW. Handling hospital errors: is disclosure the best defence? Ann Intern Med 1999; 131: 970-972.7 Hiatt HH. Barnes BA, Brennan TA, et al. A study of medical injury and medical malpractice: an overview. N Engl J Med 1989; 321: 480-484.8 California Medical Association and California Hospital Association. Report on the Medical Insurance Feasibility Study. San Francisco: Sutter Publications, 1977.9 Craddick JW, Bader B. Medical management analysis: a systematic approach to quality assurance and risk management. Auburn, Calif: Joyce W Craddick, 1983.10 Forster AJ, Fung I, Caughey S. et al. Adverse events detected by clinical surveillance on an obstetric service. Otostef Gynecol 2006; 108: 1073-1083.


11 Jackson T. Duckett S. Shepheard J, Baxter K. Measurement of adverse events using incidence flagged' diagnosis codes. J Health ServRes Policy 2006; 11: 21-26.12 Wolff AM. Limited adverse occurrence screening: using medical record review to reduce adverse patient events. MedJAust 1996; 164: 458-46113 Dunn KL. Reddy P, Moulden A, Bowes G. Medical record review of deaths, unexpected intensive care unit admissions, and clinician referrals: detection of adverse events and insight into the system. Arch Dis Child 2006; 91: 169-172.14 Thompson AM, Ashraf Z, Burton H, Stonebridge PA. Mapping changes in surgical mortality over 9 years by peer review audit. Br J Surg 2005.92: 1449-1452.15 McQuillan P, Pilkington S. Allan A, et al. Confidential inquiry into quality of care before admission to intensive care. BMJ 1998; 316: 1853-1858.16 Goldhill DR. Worthington L. Mulcahy A. et al. The patient-at-risk team: identifying and managing seriously ill ward patients. Anaesthesia 1999; 54: 853-860.17 Stenhouse C. Coates S. Tivey M, Allsop P. Prospective evaluation of a modified Early Warning Score to aid earlier detection of patients developing critical illness on a surgical ward. Br J Anaesth 2000: 84: 663.18 Buist MD. Moore GE. Bernard SA. et al. Effects of a medical emergency team on the reduction of incidence of and mortality form unexpected cardiac arrests in hospital: preliminary study. BMJ 2002: 324: 387-390.19 Wilson RM. Runciman WB. Gibberd RW. et al. The Quality in Australian Health Care Study MedJAust 1995:163: 458-471.20 Brook RH, McGlynn EA. Cleary PD. Measuring quality of care. N Engl J Med 1996; 335: 966-970.21 Shojania KG. Wald H. Gross R. Understanding medical error and improving patient safety in the inpatient setting. Med Clin N Am 2002; 86: 847-867.22 Neale G. Woloshynowych M. Retrospective case record review: a blunt instrument that needs sharpening Qual Saf Health Care 2003; 12: 2-3.23 Thomas EJ. Studdert DM. Brennan TA. The reliability of medical record review for estimating adverse event rates Ann Intern Med 2002; 136: 812-816.


24 Resar RK. Rozich JD. Simmonds T. Haraden CR A trigger tool to indentify adverse events in the intensive care Lr»t Jt Comm J Qua! Saf2006; 32: 585-590.

25 Agency for Health Care Research and Quality. AHRQ's Patient Safety Initiative: building foundation*, (educing risk. Interim report to the Senate Committee on Appropriations. Rockville. Md: AHRQ. (AHRQ Publication No 04- RG005, 2003.)26 Woloshynowych M, Neale G, Vincent C. Case record review of adverse events: a new approach. Qual SafHetfh Care 2003; 12:411-415.27 Michel P, Quenon JL. de Sarasqueta AM, Scemama O. Comparison of three methods tor estimating rata of adverse events and rates of preventable adverse events in acute care hospitals. BMJ2004,328:19®-20228 Resar RK, Rozich JD, Classen D. Methodology and rationale for the measurement of harm with trigger tools. Qua/ Saf Health Care 2003; 12 Suppl II: ii39-ii45.29 Forster AJ, Anrade J. van Walraven C. Validation of a discharge summary term search method to detect adverse events. J Am Med Inform Assoc 2005; 12: 200-206.30 Murff HJ, Patel VL. Hripcsak G. Bates DW. Detecting adverse events for patient safety research: a review of current methodologies. J Biomed Inform 2003; 36:131-14331 Szekendi MK, Sullivan C, Bobb A, et al. Active surveillance using electronic triggers to detect adverse events in hospitalised patients Qual Saf Health Care 2006; 15:184-190.32 Sharek PJ, Horbar JD, Mason W. et al. Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to indentify harm in North American NICUs. Pediatrics 2006: 118 1332-1340.33 Rozich JD, Resar RK. Medication safety: one organisation's approach to the challenge. JCOM2001; 8:27-34.34 Institute for Healthcare Improvement. Global Trigger Tool 2007. www.ihi.org/IHI/Topics/PatientSafety/SafetyGen- eral/Tools/lntrotoTriggerToolsforldentifyingAEs.htm (accessed Oct 2008).35 McCannon CJ, Hackbarth AD. Griffin FA. Miles to go: an introduction to the 5 Million Lives Campaign. Jt Comm J Qual Patient Sat 2007; 33: 477-484.36 Australian Patient Safety Foundation. What is incident reporting? The Australian Incident Monitoring Study.


http://www.ihi.org/IHI/Topics/PatientSafety/SafetyGen-

Adelaide: APSF, 1997.37 Kohn LT. Corrigan JM. Donaldson MS. To error is human: building a safer health system. Washington, DC: NationalAcademy Press, 1999.38 Heinrich HW. Industrial accident prevention: a scientific approach. New York: McGraw-Hill. 1941.39 Wolff AM, Bourke J. Campbell IA. Leembruggen DW. Detecting and reducing hospital adverse events: outcomes of the Wimmera clinical risk management program. MedJAust200'\: 174:621-625.40 Olsen S. Neale G, Schwab K. et al. Hospital staff should use more than one method to detect adverse events and potential adverse events: incident reporting, pharmacist surveillance and local real time record review may all have a place. Qual Saf Health Care 2007; 16:40-44.41 Cullen DJ, Bates DW, Small SD. et al. The incident reponing system does not detect adverse events: a problem for quality improvement. Jt Comm J Qual Improv 1995; 21:541-548.42 Evans SM, Smith BJ, Esterman A. Runciman WB. Evaluation of an intervention aimed at improving voluntary incident reporting in hospitals. Qual Saf Health Care 2007; 16: 169-175.43 Kingston MJ, Evans SM. Smith BJ. Berry JG. Altitudes of doctors and nurses towards incident reporting: a qualitative analysis. Med J Aust 2004; 181:36-39.44 Spigelman AD. Swan J. Review of the Australian Incident Monitoring System. ANZJSurg 2005; 75:657-661.45 Pronovost PJ, Thompson DA. Holzmueller CG, et al. Defining and measuring patient safety. Crit Cere Chn 2006: 21: 1-19.46 Berenholtz SM, Pronovost PJ. Monitoring patient safety. Crit Care Clin 2007; 23: 659-673.47 Stanhope N, Crowley-Murphy M. Vincent C, et al. An evaluation of adverse incident reporting. J Eval Chn Pract 1999; 5: 5-12.48 O'Dowd A. Adverse incidents in NHS are still under-reported. BMJ2006; 333: 59.49 Bion JF, Heffner JE. Challenges in the care of the acutely ill. Lancet 2004; 363: 970-97750 Evans SM, Berry JG. Smith BJ. et al. Attitudes and barriers to incident reporting: a collaborative hospital study Qual Saf Health Care 2006; 15: 39-43.51 Runciman W, Merry A, McCall Smith A Improving patients' safety by gathering information. BMJ 2001; 323 298


52 Sharma A. Jain P. Ray B, et al. Incident reporting in surgical trainees. Ann R Coll Surg Engl 2004; 86 Suppl: 158- 159.

53 Furman C. Captan R. Applying the Toyota production system: using a patient safety alert system to reduce error. Jt Comm J Oual Irr^xov 2007; 33:376-386.

54 Leape L. Interview Is hospital patient care becoming safer? A conversation with Lucian Leape. Health Aff (km*ood) 2007; 26: w687-w696

55 Bolsin SN. Faunce T. Colson M. Using portable digital technology for clinical care and critical incidents: a new model. Aust Health Rev 2005; 29: 297-305.

56 Freestone L. Bolsin SN, Colson M. et al. Voluntary incident reporting by anaesthetic trainees in an Australian hospital. Int J Oual Health Care 2006; 18: 452-457.

57 Tighe CM, Woloshynowych M, Brown R, et al. Incident reporting in one UK accident and emergency department. Ac&d Emerg Nurs 2006; 14: 27-37.

58 National Patient Safety Agency. Annual report 2006107. London: NPSA, 2007.

59 Pronovost PJ. Miller MR. Wachter RM. Tracking progress in patient safety: an elusive target. JAMA 2006:296:696- 699.

60 01.eary M, Chappell SL. Confidential incident reporting systems create vital awareness of safety problems. ICAOJ 1996; 51: 11-13.

61-Barach P, Small SO. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. BMJ 2000; 320: 759-763.

62 Runciman WB. Lessons from the Australian Patient Safety Foundation: setting up a national patient safety surveillance system — is this the right model? Oual Saf Health Care 2002:11:246-251.

63 Victorian Department of Human Services. Root Cause Analysts Education Module 1 and 2 What's in it for you? www.health.vic.gov.au/clinrisk/downloads/rca_education_mod12.ppt (accessed Oct 2008).

64 Jagsi R, Kitch BT, Weinstein DF, et al. Residents report on adverse events and their causes. Ar.ch Intern Med2005; 165: 2607-2613.

65 Leape L. Reporting of adverse events. N Engl J Med 2002; 347:1633-1638.

66 Joint Commission on Accreditation of Healthcare Organizations. Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, III: Joint Commission Resources. 2005.

67 Australian Health Ministers' Conference. Health Ministers agree to reform agenda. Joint communique 2004; 23 Apr. Canberra: Australian Government Department of Health and Ageing. 2004. www.health.gov.au/internetymain/ publishing.nsf/Content/health-mediarel-yr2004-jointcom-jc001.htm (accessed Jan 2009).

68 Victorian Department of Human Services. Acute Health Division Clinical Risk Management Strategy 2001. Melbourne: Victorian Department of Human Services, 2001.

69 Australian Institute of Health and Welfare and the Australian Commission on Safety and Quality in Health Care. Sentinel events in Australian public hospitals 2004-05. Canberra: AIHW, July 2007.

70 Forster AJ, Clark HD, Menard A, et al. Adverse events among medical patients after discharge from hospital. CMAJ200A. 170: 345-349.

71 Fitzpatrick R. Surveys of patient satisfaction: 1 — important general considerations. BMJ 1991; 302: 887-889.

72 Dunn KL. Moulden A. McDougall P, Bowes G. Patient safety: a view from down under. Pediatr Clin N Am 2006.56: 1217-1230.

73 Glabman M. The top ten malpractice claims. Hosp Health Netw2004; 78: 60-66.

74 Williams SK. Osborn SS. The development of the National Reporting and Learning System in England and Wales. Med J Aust200B: 184 (10 Suppl): S65-S68.


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http://www.health.gov.au/internetymain/

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http://www.health.vic.gov.au/clinrisk/downloads/rca_education_mod12.ppt

75 Benveniste KA. Hibbert PD. Runciman WB. Violence in health care: the contribution of the Australian Patient Safety Foundation to incident monitoring and analysis. Med J Aust 2005: 183: 348-351.

76 Hibbert P. Benveniste K. Burns received in hospitals. Insights from the Australian Incident Monitoring System Adelaide: Australian Patient Safety Foundation. 2003.

77 Freer Y. Lyon A. Risk management, or just a different risk? Arch Dis Child Fetal Neonatal Ed 2006: 91: F327-F329.

78 Vincent CA, Lee ACH. Hanna GB. Patient safety alerts: a balance between evidence and action Arch Dis Child Fetal Neonatal Ed 2006:91: F314-F315.

79 Thomson R. Luettel D. Healey F, Scobie S. Safer care for acutely ill patient: learning from terioue nodinK London: National Patient Safety Agency. 2007. www.npsanhs.uk/nrls/alerls-and^ective6/dtrect^^ acutely-ill-patient/ (accessed Jan 2009).80 Committee of Public Accounts. Fifty-first report: a safer place for patients: learning to improve patient aMy London: United Kingdom Parliament, 2006: 6 Jul. wvw.parliament.uk/pariiamenlafy_committoos/oorrwTwBaejtif_ public_accounts/pac060706_pn5l elm (accessed Oct 2008).61 Emslie S. 2001-2006: a patient safety odyssey where the vision remains unfulfilled. Health Care Risk Bap 2006: Sep: 14-15.82 Bagian JP. Gosbee J. Lee CZ. et al. The Veterans Affairs root cause analysis system in action. Jt Comm J Que!Improv 2002; 28:531-545.83 Bagian JP. Lee C. Gosbee J. et al. Developing and deploying a patient safety program in a large health care delivery system: you cant fix what you don't know about. Jt Comm J QuaI Improv 2001:27:522-532.84 Bagian JP. Gosbee JW. Lee CZ. The VA-NASA Patient Safety Reporting System. Fed Pract 2001; Mar: 10-1585 The Inquiry into the management ot care of children receiving complex heart surgery at the Bristol Royal Infirmary Bristol: Bristol Royal Infirmary Inquiry. 2001. www.Bristol-inquiry.org.uk/ (accessed Oct 2008).86 Final report of the Queensland Public Hospitals Commission of Inquiry. (The Davies report). Brisbane: Queensland Government, Nov 2005. www.qphci.qld.gov.au (accessed Oct 2006).87 Special Commission of Inquiry into Campbelltown and Cambden hospitals. Final report. Sydney: NSW Department of Health, 2004.88 Douglas N, Robinson J, Fahey K. Inquiry into obstetric and gynaecological services at King Edward Memorial Hospital 1990-2000. Final report. Perth: Government of Western Australia. 2001.89 Community and Health Services Complaints Commissioner of the ACT. A final report of the investigation into adverse patient outcomes of neurosurgical services provided by the Canberra Hospital. Canberra: ACT Government. 2003.90 Faunce TA, Bolsin SNC. Three Australian whistleblowing sagas: lessons for internal and external regulation. MedJAust2004, 181: 44-47.91 Dunbar JA. Reddy P, Beresford B, et al; In the wake of hospital inquiries: impact on staff and safety. MedJAust

2007; 187: 476-477.92 Walshe K. Higgins J. The use and impact of inquiries in the NHS.

BMJ2002.325:895-900.93 Ham C. Quality failures in the NHS. SH/2008; 336: 340-341.94 Healthcare Commission. Learning from investigations. London: HC. 2008.95 DeRosier J, Stalhandske E. Bagian J. Nudell T. Using Health Care Failure Mode and Effect Analysis™: the VA National Center lor Patient Safety 's prospective risk analysis system. Jt Comm J Qual Improv2002: 28: 248-267.96 Wollersheim H. Clinical incidents and risk prevention. Neth J Med 2007; 65: 49-54.

http://www.qphci.qld.gov.au/

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97 Green AL, Williams A. An evaluation of an early warning clinical marker referral tool. Intensive Crit Cam Nurs 2006; 22: 274-282.98 Vincent CA. Coulter A. Patient safety: what about the patient? Qual Saf Health Care 2002:11: 76-80.99 Davis RE, Jacklin R. Sevdalis N. Vincent CA. Patient involvement in patient safety: what factors influence patient participation and engagement? Health Expect 2007:10: 259-267.100 Stevens P. Mallow A. Laxer RM. Blueprint for patient safety. Pediatr Clin North Am 2006: 53:1253-1267. □Enhancing patient care5 Analysing adverse events and prioritising action

This chapter will:

■ Discuss management of patients who have experienced an adverse event and staff who have bean involved in an adverse event

■ Examine the analysis of adverse events using systems and root-cause analysis

■ Discuss the determination of the level of risk of an adverse event

■ Describe the development of a risk register

■ List the criteria against which adverse events can be prioritised for action

■ Examine the composition and activities of a surveillance committee that reviews adverse events.

After an adverse event is detected, the usual next stage in the risk management process is to analyse the event. This helps the staff involved in the incident, and the health service, leam from the event and take appropriate action to reduce the probability of it recurring. Before analysis is commenced, two critical checks are required:■Have the patient and their relatives been appropriately managed following the incident?■Have the clinical staff involved in the incident been appropriately managed?Many adverse events have considerable negative effects on the patient, their relatives, and the staff who provided the care. It is imponant to ensure all three groups have been appropriately managed. If so, the event can be analysed in detail and action to prevent a recurrence prioritised.

It is now believed that "open, honest and timely disclosure should be the only approach to medical error". 1 However, the issue is "multidimensional, emergent and complex".2 Previously, it was thought that open disclosure (including admitting mistakes to peers and talking openly and apologising to patients) was too difficult and would increase the nsk of litigation and tarnish the reputation and financial viability of individual clinicians and health services. 2 The decision whether to disclose information about errors to patients was individual and did not occur frequently. When it did occur, it was not done systematically or with organisational suppon, and was often not handled satisfactorily.

Much of the anger expressed by patients and their relatives about errors related to how they were treated after the event, rather than the event itself. They understood that mistakes happen, but expected an honest, human response from their clinicians after they occurred. The fear experienced by clinicians and health services after an error in patient care was often worse than what followed in reality.

Although open disclosure has been practised in very few health services, there are limited high-quality data and some anecdotal evidence that open, honest and timely disclosure may decrease the risk of litigation and result in better outcomes for patients, clinicians and health services. Open disclosure is now a standard of Australian Council on Healthcare Standards and the Joint Commission on the Accreditation of Healthcare Organizations in the United States.1

The Australian Council for the Safety and Quality in Health Care developed the National Standard on Open Disclosure, which was endorsed by the Australian Health Ministers Conference in July 2003. The Standard includes an apology, a factual explanation of what occurred, the consequences of the event, how it was managed and the action taken to prevent a recurrence. Currently, 42 Australian health services are participating in a national evaluation of open disclosure. An evaluation by the 12 participating Victorian health services found, among other things:■there was no standardised approach to open disclosure within the sites■if there was a strong culture of quality and safety in an individual health service, open disclosure was more readily

adopted

94

■ open disclosure complements existing risk management strategies■ overall the documentation of open disclosure discussions was poor■ the term "open disclosure" was felt to be negative.The recommendations of the evaluation included that a standardised education program and toolkit be developed, open disclosure be integrated into each health service's clinical risk management policy, and a more meaningful name for the process be developed. The Victorian Depanment of Human Services plans to roll out the open disclosure program to all health services in the state.3

5.1 Managing a patient who has experienced an adverse event

Patients who are unwell or are in hospital to undergo procedures may feel vulnerable and traumatised even after successfully undergoing straightforward procedures. If harm occurs to a patient receiving medical care, it may cause a severe reaction because of the event or how clinical staff managed it. If the event is handled insensitively, the patient may experience more trauma than if the staff acknowledged the event occurred, were open about what had happened and why, and explained the action that was taken or planned to be taken to prevent other patients experiencing a similar event. It is particularly difficult for patients if they must continue to be treated by the staff responsible for the event.4 Patients and their relatives may fear further harm or retribution from those caring for them, and clinicians may turn away from them.5

After patients experience an adverse event, they may feel guilty, fearful, distrusting and isolated.4,5 Their experience is similar to patients with posttraumatic stress disorder. They may experience flashbacks of the event, anxiety, and depression, all of which may affect their relationships and work. Their relatives may also have difficulties coping, especially if the patient dies as a result of the event, and the death is thought to be avoidable.4 Relatives often experience similar, or even stronger feelings of guilt (about not watching closely enough), than the clinicians treating the patient. They also fear that confronting clinicians may result in further injury.5

If patients believe, correctly or incorrectly, that they have experienced an adverse event as a result of medical management, the clinician providing the care should take their concerns seriously. It may add to the patient's distress if these concerns are ignored.4 Relatives of patients who have been harmed by a medical error have said "what we needed was for someone to reach out and connect with us in human terms ".5 When responding to such concerns, clinicians should be sympathetic, open and honest. They should provide a full explanation to the patient of what has occurred, apologise if appropriate, and inform

T opte bate*) that you let a patient about am* and they make tao phone cats. One is to fie press, the other totoeir lawyer. It does not work that way. *

Conway J. et al Qual Sal Health Care 2004;

13: 3-5


them of the steps being taken to prevent similar events occurring to others. If clinicians ignore these actions, they may add to the patient's distress, and the patient or relatives may make a formal complaint to the

5 Analysing adverse events and prioritising action

health service or the relevant professional registration body, or commence litigation,4 as "silence and evasion breed distrust".5

Although clinicians may understandably feel uncomfortable about their relationship with these patients and wish to distance themselves, such patients require more, not less, suppon. Clinicians should ask their patients how the adverse event has affected them, physically and psychologically. If the patient is severely affected, formal psychological treatment may be needed, and the patient should be offered the option of referral to another service.4

If medical mismanagement has clearly occurred, the health service should inform their insurers and discuss with them the possibility of providing immediate financial suppon for the patient and their dependants. Such suppon may initially pay the patient's medical and hospital costs for any additional treatment and hospital stay required as a result of the fiarm experienced. These responses to adverse events should be strongly and explicitly supported by written policies and by detailing procedures that should be followed when a patient has been harmed while receiving care in the health service.

5.2 Managing a staff member who has been involved in an adverse eventThe staff involved in providing the care that resulted in an adverse event and significant harm also need support. Many physicians experience significant distress and job-related stress following a serious error or near miss.4

Clinicians ... often suffer alone after making mistakes, agonising over the harm they have caused, the loss of their patients' trust, the loss of rheir colleagues' respect, their diminished self-confidence, andthe potential effects of the error on their careers.5

Such feelings often remain unaddressed, and these physicians feel inadequately supported by their health service.6

As well as fearing sanctions, complaints and litigation affecting their reputation, these staff may be feeling guilt, shame, anxiety, depression and isolation. Some may feel like giving up their clinical practice or leaving the profession. These effects can be so severe that this group has been described as the "second victim" of an error.7 Clinicians are often self-critical and set high personal standards in providing care. Consequently, when they make a mistake, they can be extremely hard on themselves. Some may respond dysfunctionally with anger and projection of blame onto other staff or patients; this may become more extreme with litigation.7

The culture in clinical practice expects perfection in providing care. Mistakes are unacceptable' and. if made, reflect a weakness in the clinician's character. These views are unrealistic and weigh heavily on some clinicians. After a significant adverse event has occurred, the clinicians involved often require support from their colleagues, and psychological intervention if their reaction to the event is severe. Such support and intervention are rarely forthcoming7 and, even if provided, may be difficult for some doctors to accept.4 Colleagues should encourage the clinician to talk with them about what has occurred and inquire about the psychological effect of the error and how they are coping.'

Given the significant impact major errors can have on clinicians, health services should consider providing formal and informal methods of supporting clinicians after their involvement in serious adverse events or near misses.6 Given the increasing complexity and demands of modem medicine, clinicians will continue to make errors. How the health service and its clinicians deals


with patients, relatives and professional staff after an error has occurred can be decisive in its outcome."


5.3 Analysis of adverse events

Analysis of adverse events is well established in other complex industries, such as aviation and nuclear power. In health care, the analysis of adverse events can take several forms. In the US, the Joint Commission uses root- cause analysis (described later in this chapter) to analyse sentinel events; the Veterans Health Administration has a similar process using triage questions to analyse frequent and catastrophic events in its facilities. These methods are detailed, resource intensive and time-consuming.

In the case of adverse events detected by medical record review, sufficient information can be often obtained from the review form (discussed in Chapter 4). If required, this information can be supplemented by interviews to clarify aspects of care.8

5.3. I Systems analysisIf a detailed analysis is required, systems analysis — a less intensive method of analysing adverse events than root-cause analysis — has been developed.4 This approach combines Reason's model of organisational accidents (described in Chapter 3), which was developed for use in complex industrial systems, with the factors affecting how clinical care is provided. In the systems analysis model, accidents result from an often complex series of events and departures from safe practice, and are associated with a wide range of contributory factors. System analysis aims to find system weaknesses to explain why an event occurred.

When adverse events occur, the media often concentrate on the actions taken by the doctors and nurses involved in the event. However, research has shown that the probability of an error occurring in the workplace increases if the conditions of work are adverse or suboptimal. Reason's model of organisational accidents aims to identify and focus on pre-existing organisational factors that have contributed to the adverse event or near miss. Reason believes that adverse events and near misses are preceded by an "unsafe act", where a staff member at the coalface makes an error or mistake.

Importantly, these errors are preceded by error-producing conditions and latent factors, which are together referred to as contributory factors. These factors are the conditions under which staff were working when the adverse event occurred. Many contributory factors are the result of decisions made by management that have negatively affected the conditions of work in the organisation and increased the likelihood that errors will be made. In systems analysis, error-producing and organisational factors have been combined into a comprehensive framework of contributory factors that affect how care is provided. By determining and understanding these contributory factors, appropriate action can be planned and taken to improve the conditions under which


care is provided, thereby improving the quality of care and level of patient safety.

The systems analysis of an adverse event commences with a summary of the event being made in chronological order. Three steps are then undertaken:


YMierlhansarrpV ass&nring biame, patients and tamiies want both to understand their s^jeHon fully and to know what the event has taught caregivers and their institutions."

Delbanco T. Bell SK N Engl J Med 2007;

357: 1682-1683

1. The patient's care management problems are identified. These problems are actions or omissions made by staff such as mistakes, lapses of judgement or deliberate departures from the policies, procedure* and standards set by health services, which led to the adverse event. Example include: (ailing to monitor a patient, not obtaining assistance when needed, delay in making a diagnosis, failing to adequately supervise junior staff, and providing the wrong treatment to a patient. There may be more than one care management problem associated with an adverse event; each is identified and individually analysed.

2. Relevant clinical events and the patient's condition are recorded to provide the clinical context of the event. Examples include; the patient was extremely short of breath, bleeding profusely, his or her conscious state was deteriorating, or blood pressure was falling.

3. The factors that resulted in the care management problem are identified. These contributory factors are grouped under seven headings — institutional (eg, the medicolegal environment prevents open disclosure of errors to patients and their relatives); organisational and management (eg, financial constraints delay replacement of ageing equipment); work environment (eg, staff have excessive patient workloads, there are insufficient staff); team (eg, inadequate supervision of junior doctors); individual staff member (eg, a doctor lacks certain procedural skills); task (eg, lack of a protocol to treat patients with a particular condition, investigation results not available in a timely manner); and patient (eg, multiple and complex clinical problems, communication problems). A combination of contributory factors will frequently be identified when analysing a single adverse event. The boors identified may be specific for that adverse event or recurrent and longstanding, reflecting a systemic problem that affects patient safety in a clinical area or the whole service.

Depending on the complexity and seriousness of the adverse event or near miss, the analysis can be undertaken by the relevant clinicians, the clinical risk manager or a multidisciplinary team. A two-page summary (available from Department of Psychology at University College London at wwwpatient- safety.ucl.ac.uk/Caseanalysisl.pdf and www.patientsafety.ucl.ac.uk/Caseanalysis2.pdO and a forma) protocol (second edition available from the Clinical Safety Research Unit of Imperial College London at www.csru.org.uk/downloads/SACI.pdO have been developed so the investigation can be systematically and comprehensively undertaken, and to reduce the chance that simplistic explanations are developed that blame individuals for the event. Staff require training and practice to effectively use the protocol.

The information required by the protocol can be obtained by reviewing the patient^ medical record and discussing the event with key staff caring for the patient. A structured interview using a checklist of psychological and organisational factors is used, and staff are asked their opinions about the reasons for each care management problem. This information helps establish the often complex sequence of events resulting in the adverse event, and helps identify the main care management problem and contributing factors. Staff are also asked about the impact of the adverse event on them, the patient and their relatives, and other staff. The analysis aims to identify the most important contributory factor and to use this information to improve the safety of the relevant delivery system. Four questions should be answered by the analysis:■What happened?■How did it happen?■Why did it happen?■What can we learn from this and what changes should we make, if any?

It has also been suggested that adverse events should be discussed with the patients involved and. if appropriate, their relatives. Both are potentially important sources of useful


http://www.csru.org.uk/downloads/SACI.pdO

http://www.patientsafety.ucl.ac.uk/Caseanalysis2.pdO

information that have not previously been routinely used. Frequently, open discussion with patients who have expenenced an adverse event and their relatives may not occur because the clinician and health service fear that punitive action and litigation may result. The patient should be informed of the results of the analysis of the adverse event, particularly what action will be taken to prevent similar adverse events from occurring


Analysis of adverse events and near misses may repeatedly find the same contributory factors, indicating that certain delivery systems require strengthening. If analysis shows that substantial system changes may be required to prevent an adverse event recurring, it may be necessary to obtain additional information about the system under review from analyses of previous similar adverse events and audits. Some analyses may reveal problems requiring immediate action to reduce risks to patients.

After the analysis is completed, a formal repon should be written, detailing the care management problems and contributory factors identified, the actions required to prevent the event recurring, who is responsible for the implementation of these actions, and how the outcomes of these actions will be monitored. A brief version of systems analysis can be used for the immediate investigation of an adverse event.9 In our experience, this may often be sufficient to adequately deal with many of the adverse events that occur in a medium-sized general hospital. If, after immediate investigation, it is found that the event is serious or has important educational benefit, a full systems analysis should be undertaken.

5.3.2 Root-cause analysisIn the Veterans Health Administration, incident reporting system staff voluntarily report clinical incidents to their facility's Patient Safety Manager. The Manager assesses the real and potential frequency and consequence of the incident. Often, perhaps because of good fortune, the actual consequence of an incident is minor, but it could have been catastrophic. For clinical incidents scored as 3 or higher (ie, catastrophic, or major and frequent) using the Safety Assessment Code, whether real or potential, the Administration requires a detailed root-cause analysis to be undertaken. The analysis provides a structure to investigate the incident and answer three questions:■ What happened?■ Why did it happen?■ What can we do to prevent it happening again?

A multidisciplinary team of frontline staff undertakes the analysis. The team uses 78 triage questions, available in card format on the Administration's website, and follow five rules of causation to ensure that a sufficiently deep analysis of the causative factors is undertaken. The questions cover: human factors, communication, training and fatigue or scheduling; environment and equipment; rules, policies and procedures; and barriers or safeguards.10

After the multidisciplinary team has completed the root-cause analysis, it is electronically submitted to the Administration's National Center for Patient Safety. The expert staff at the Center review the analysis and provide rapid, detailed feedback to the reporting facility. This feedback includes comments on whether the elements of each criterion have been met for the Safety Assessment Code scores

and whether they accurately reflect the description of the event, and the adequacy of the flowchart, contributing factors, action

statements and outcome measures. Reporting all root-cause analyses to the Center allows it to monitor the quality and completeness of all analyses

ipnMQVSOiOR •Hr awn wtfurea patients and ther kniK it may bebecause of their own taatngsolgum. fear, ant isolation, compounded by legal or institutional advice. Paralyzed by shame or lacking their own iMtderstanding of why the error occurred, physicians may find a bedside conversation too awkward.'

■ Detbanco T. Bell SK N Engl J Med

2007;357: 1682-1683


undertaken in the Administration's facilities. Further, the Center can rapidly alert other facilities of hazards that have been identified if they require prompt action. The Centert staff can also provide a wide range of technical expertise to reponing facilities regarding incident analysis, and provide reference materials or solutions for similar incidents that have been developed at other Administration sites.10

The findings of the root-cause analysis are communicated to the staff member who reported the incident to demonstrate that the incident has been appropriately investigated. This staff member is able to comment on the findings of the investigation and the proposed corrective actions. To ensure that appropriate action is taken in response to the incident, the chief executive of the facility must approve the actions proposed by the analysis team. If the chief executive wishes to modify the actions, he or she needs to provide the team with reasons for the changes. This process may go through several cycles until there is final agreement between the chief executive and the team. The chief executive then endorses the action plan, arranges funding for its implementation and accepts responsibility that it will be implemented within 45 days. The team then determines how the effectiveness of these actions and any unintended consequences can be measured. Team members may be rewarded for their participation in the program with continuing education credits."

The details of root-cause analyses are entered into a database that can be accessed by other Administration facilities. In response to the incidents reported centrally, system-wide alerts and advisories are sent by the Center to all Administration facilities in the form of shon safety summaries and are posted on the their website. Sometimes, several months after an alert has been sent to all facilities, a follow-up is conducted by email to determine whether the alert has successfully reached appropriate staff at the frontline of each facility and whether operational changes have been made as a result of the facility receiving the alert.

5.3.2.1 Limitations of root<ause analysisRoot-cause analysis is an important tool in the assessment of major accidents in complex industries such as aviation and nuclear power. Major accidents occur infrequently in these industries; however, epidemiological studies of adverse events in health services in several countries show that major adverse events occur more frequently in health care.1213 However, the effectiveness of root-cause analysis is limited,14 because:a Analyses are often incompletely or incorrectly undertaken, and their quality varies widely between

health services.a Undertaking a comprehensive analysis to determine the root causes of an adverse event is time-

consuming, requiring 20-90 hours of staff time, a The commonest actions taken in response to analyses are re-education and writing a policy; these are unlikely to reduce the risk and have little effect outside

the individual health service. The causes of incidents are often common across health services and high-probability actions often require system or equipment redesign at a higher level than individual health

services, a After action is taken in response to the risks identified by analyses, follow-up on the outcomes of

actions taken is rare, so it is not known whether the risk has been reduced, a It is difficult lo establish a root cause, as adverse events occur because of "varied, diffuse and overlapping failures".15

a As with other methods of analysis of adverse events, hindsight bias may influence their assessment .11,

Berwick believes that "the very idea of a 'root cause' is misleading, because most system failures result from complex interactions between latent failures ... and specific actions; conclusions about root causes are often illusions created by hindsight bias".1'

Comprehensive root-cause analysis programs have been established in most Australian states and territories. These programs are supported by detailed education and documentation packages Information is available online about programs in Victoria (www .hcallhAic .gov.au/clinrisk/sminclAca.himV South


http://www.hcallhAic.gov.au/clinrisk/sminclAca.himV

Australia (.www.safctyandquaHty.sa.gov.au/safetyandquality), and Queensland (www.health.qld.gov.au/

patientsafetyAm/webpages/whatisrca.asp).

SJ.3 The Learning from Defects toolReferred to as a "lighter" version of root-cause analysis, the Learning From Defects tool uses the

contributing factors identified by systems analysis.18 An important addition in the Tool is documentation

of factors that prevented or reduced harm from the error. The Tool is divided into three sections:1. An explanation of what happened.2. A review and check of all the factors that caused or increased patient harm and reduced or

eliminated harm.3. Specific actions to reduce the probability of

the defect recurring, the designation of a ___________ _________person to lead the actions being taken, specification of dates for the assessment of the progress of the actions, their completion date, and details of how an evaluation will be undertaken to determine if the risk has been reduced.All stafT involved in providing care related to the defect are present when the defect is analysed and a case summary learning tool is prepared for distribution to relevant staff. A one-page user guide for the tool has been developed.18

Whichever method is chosen to investigate adverse events, health services should develop appropriate policies and procedures that include first and foremost how the needs of the patient, their relatives and the staff involved in the incident will be addressed. The policy should also detail how the incident will be investigated, recommendations will be made, appropriate action will be taken, and ongoing monitoring of clinical activity will be undertaken. A policy on disclosure of details of adverse events, to help clinicians talk with patients and their relatives, should also be developed.19

5.3.4 Analysis of adverse events detected by medical record review at Wimmera Health Care GroupAt Wimmera Health Care Group, we use a rela-tively brief technique to analyse adverse events detected by medical review. After a medical reviewer detects an adverse event, the details are recorded on an adverse event analysis form (Appendix 1) The medical reviewer determines the sevepty and preventability of the adverse

Box 5.1 Quality in Australian Health Care Study error cause scale20

TreatmentT1 = Complication/failure in technical performanceT2 = Failure to follow policy, protocol or guideline when indicated

T3 = Acting on insufficient information

T4 = Slip/lapse in activities in which operator is skilled

T5 = Inadequate knowledge/experience

T6 = Inappropriate or not indicated care

T7 = No/wrong/delayed treatmentDiagnosis D1 = Failure synthesise/decide/act on available informationD2 = Failure request/arrange procedure or consultation

D3 = Missed diagnosis System51 = Lack of care or attention/failure to attend when called

52 = Failure in communication

53 = Equipment failure/unavailability

54 = Inadequate staff

55 = Staff latigue/distress/sickness

56 = Poor discharge planningPrevention P1 = Inadequate (ollow-up ol treatment/monitoringP2 = Failure to provide indicated prophylactic

treatment.


http://www.health.qld.gov.au/

http://www.safctyandquaHty.sa.gov.au/safetyandquality

Box 5.3 Use deAnMom

Underuse: Failure to provide a health care servioe when it would have produced a favourable outcome for a patient. Overuse: A health care service is provided under circumstances in which its potential for harm exceeds the possible benefit Misuse: An appropriate health service is selected, but a preventable complication occurs and the patient does not receive the full potential benefits of the service.

event using the scales outlined in Chapter 4. The reviewer then documents the latent factors and active errors that were present and that may have contributed to the adverse event occurring. It can be difficult to classify precisely all the latent factors and active errors associated with every adverse event that is detected. We found the framework used by the Quality in Australian Health Care Study for analysing errors enabled us to classify the factors associated with most events (Box 5.1).20 Another classification of errors was used in the Harvard Medical Practice Study21 (Box 5.2).

A funher classification of adverse events into those associated with underuse, overuse and misuse is then made. These terms are defined in Box 5.3.

This classification is useful because actions taken to reduce adverse events associated with overuse and misuse if successful, will result in cost savings. A reduction in adverse events associated with underuse will, however, increase costs. For example, the use of low molecular weight heparin perioperatively will reduce the incidence of deep vein thrombosis and pulmonary embolus. These adverse events may occur more frequently if low molecular weight heparin is not used consistently (ie, it is being underused), but its appropriate use will increase pharmaceutical costs.

5.4 Prioritising adverse events for action

Analysis of adverse events is an important part of the clinical risk management process. In our experience, analysis of adverse events and the systems in which they occur, together with the planning of appropriate action to prevent recurrences, has the potential to take some lime, delaying prompt action to prevent the recurrence of particular events. A practical balance is required between these two factors

5.4.I Why adverse events should be prioritisedThe number of adverse events detected by clinical

risk management programs will depend on the

number of detection methods used. In our

experience, using all detection methods outlined in

the

Box 5.2 Harvard Medical Practice Study types of errors21

Diagnostic

Error or delay in diagnosis

Failure to employ indicated tests

Use of outmoded tests or therapy

Failure to act on results of monitoring or testingTreatment

Error in performance of an operation, procedure, or test

Error in administering treatment

Error in the dose or method of using a drug

Avoidable delay in treatment or in responding toan abnormal test

Inappropriate (not indicated) care

Preventive

Failure to provide prophylactic treatment Inadequate

monitoring or follow-up of treatment Other

Failure of communication Equipment failure Other

system failure.


lhbleS.1 Measures of probability Uml Daecriplor Description

5 Almost certain Is already occurring or is very likely to occur several times in the next 12 months

4 Likely Will probably occur several times in the next 1 to 2 years

3 Possible Might occur once during the next 1 to 2 years

2 Unlikely Could occur at some time over the next 5 years

1 Rare May occur in exception circumstances, sometime in 5 to 30 years

Itt lie 5.2 Measures of consequence

U mel Descriptor Description

5 Catastrophic Death, huge financial loss or threat to goodwill

4 Major Major permanent injury, increased length of stay or re-admission, major financial loss

3 Moderate Major temporary injury, increased length of stay or re-admission, medium financial loss

2 Minor Minor treatment required, no increased length of stay or re-admission, minor financial loss

1 Insignificant No injuries, low financial loss

Tabic 5.3 Wimmera Health Care Group risk assessment matrix

Probability

8c •

Almost certain (5) Ukely (4) Possible (3) Unlikely (2) Rare(1)

Catastrophic (5)

Extreme Extreme Extreme Extreme High

5 | Major (4) Extreme Extreme Extreme High Moderate

c oModerate (3)

Extreme High Moderate Moderate Low

o Minor (2) High Moderate Moderate Low Low

Insignificant (1)

Moderate

Moderate Low Low Low

Wimmera model will detect more adverse events than can be effectively dealt with at any one lime.

Even with sufficient resources, it may not be possible to simultaneously make all the system changes

required to address the subsequent issues for change and improvement raised by the analysis of an

adverse event. Therefore, the adverse events detected must be prioritised systematically. Different

methods of prioritisation are discussed later in this chapter.

5.4.2 Assessing the level of risk


The level of risk associated with each adverse event that is detected is assessed. The probability or

likelihood of the adverse event occurring and the consequence of the adverse event are estimated using

quantitative and qualitative measurement scales. At Wimmera Health Care Group, we use measures

modified, from AS/NZS 4360: 200422 (Tables 5 1, 5.2 and 5.3).



A level of risk for each adverse event is then determined by multiplying the likelihood of the event by its consequence. This calculation provides a score for the level of risk associated with each event, and allows adverse events to be categorised as low, medium, high, or extreme risk, and then to be ranked.

5.4.3 The risk registerRanking adverse events allows a risk register to be created. The register enables adverse events with the greatest level of risk to patients or the health service to be seen easily, and allows the systems in a hospital with the greatest potential for improvement to be identified. The register also provides a useful method of reporting the risks facing the organisation to senior executives, clinical stafT, the hospital's quality committee and board of management.

Examples of the types of adverse events that may appear on a risk register report are shown in Table 5.4. As more adverse events and risks are detected, the register will become longer. Maintaining the register in an electronic format helps keep track of the increasing number of A'ents and their associated recommendations.

5.5 The surveillance committee

At Wimmera Health Care Group, a surveillance committee reviews the information contained in the risk register. When the project began in 1989, this committee consisted entirely of medical reviewers, and the committee's recommendations regarding patient care were sent to the medical staff for discussion and ratification. Coordination of the medical record review process and the implementation of the committee's recommendations were undertaken by the director of medical services.

At this time, it was felt that if a full and frank discussion of adverse events was to occur, only medical staff could be present at the surveillance committee meetings. Medical stafT believed that the presence of other clinical staff at these meetings would inhibit an open discussion of errors. Occasionally, senior resident medical staff were invited to the surveillance committee's meetings to provide them with some experience in clinical quality improvement and risk management. From time to time, other specialists and general practitioners were invited to assist with particular clinical issues facing the committee, and to demonstrate how the medical record review process and committee's activities were conducted.

It is difficult to change clinical practice across professional boundaries without the participation of key- clinical staff from a cross section of different professions. By restricting the membership of the surveillance committee to medical staff, other members of stafT, especially nurses, were not pan of the discussions that analysed and determined the appropriate actions to take in response to individual adverse events that were detected. This membership restriction occurred despite nurses being an essential part of the hospital's health care delivery systems. Consequently, the restriction limited the effectiveness of surveillance committee by reducing the range and types of issues that could be thoroughly and comprehensively discussed at meetings and the possible changes that could be successfully made to improve delivery systems.

In 1997, the Department of Human Services in Victoria chose Wimmera Health Care Group to be one of four hospital clinical risk management program pilot sites in Victoria. This decision and the associated additional funding enabled the hospital to appoint a full-time clinical risk manager. A senior nurse with intensive care and nurse unit manager experience was appointed to the position. The clinical risk manager became a member of the surveillance committee and a nurse unit manager of an acute ward was also invited to attend committee meetings.

After these membership changes, the range of issues discussed by the committee increased Recommendations for changes to clinical care made by the surveillance committee were then taken

106

Ifcbfe 5.4 Rkk register

9smple risk register/action plan

Rlsk/hazardfexposure to Risk ranking

loss; opportunity lor -----------------------Improvement P C S R

Poor communication of abnormal

radiology results by external service provider

Lack of security for N20

Current falls risk

assessment scoring system does not score patients presenting post- fall as

"high risk" for falls

Inadequate assessment of pain

Abdominal

pain incorrectly diagnosed

Inadequate clinical handover between covering medical

units and home medical units

Inadequate analgesia for

DM risk Wmttfted Source

ED medical record review

External report

Sep 2007

5 3 15 E

Feb

2008

5 3 15 E

Clinical incident reporting

5 2 10 HMay

2008

Sentinel event

Oct 2007

2 3 10 H

Dec 2007

ED medical record review

inpatient medical record review

GP feedback

3 3 9 M

3 3 9 M

Jan 2007

Mar2008

4 2 8 M


patients discharged from day procedure

108

Risk reduction strategy; continuous Improvement

pereotV department

Expected end date Measurable outcome

Dele: May 2000


Contract negotiations to include process for notification of

abnormal results

Purpose-built cupboard placed in obstetrics unit. Mobile N20 cylinders kept in locked drug room. Security increased in

medical gas store area

Modify the falls risk assessment form so that patients admitted

following a fall are automatically assessed as "high risk" for falls

Implementation of Victorian Quality Council's Acute Pain Management Measurement

Toolkit

Clinical pathway developed for the diagnosis and management

of abdominal pain

Develop and implement a process for clinical handover between medical staff after

hours

Patient information brochure developed on 'How to manage

pain at home"Executive

Engineering; Nurse Unit Manager O&G; Nurse Unit Manager ED

Falls Risk Committee

Clinical Risk Manager

Clinical Risk Manager

Director of Medical Services

Pharmacy/Day Procedure Unit

Service provider contractincludes

process for notification of

abnormal radiology results

NO storages are secure

The number of patients admitted post-fall who are assessed as "high risk" for falls (medical record audit)

Number of patients whose pain is assessed according to pain measurement policy and protocol (medical record

audit)

Compliance with pathway process measures (clinical

pathway audit)

Staff compliance and satisfaction with handover

process (staff survey)

Patient satisfaction with analgesia information

(nalipnl

Jun 2008

Dec 2008

Dec 2008

Jun 2008

Sep 2008

Aug 2008

Jun 2008

directly to the hospital's senior medical staff group and nursing practice committee. Recommendations resulting from high and extreme organisational risks were taken to the organisation's peak quality committee and board of management. Surveillance committee members gave the reasons for each of the recommendations made in person to medical and nursing staff. In addition, the clinical risk manager attended regular allied health staff meetings to provide details about adverse events relevant to their clinical areas, and explaining the background behind recent recommendations made by the surveillance committee. The clinical risk manager also obtained details from allied health staff about adverse events that may have occurred recently in their departments and any areas where they thought patients or the hospital may have been at risk. After these changes to the membership of the surveillance com miner were made, the recommendations for change made in response to adverse events covered the aspects of the hospital's health care delivery systems more broadly.

More recently, with the increasing use of clinical pathways to implement changes to clinical caie in the hospital, the hospital's clinical pathway coordinator was invited to be ^member of the surveillance committee. This has helped the coordinator to design clinical pathways that reduce the probability of these adverse events occurring.

5.5.1 Composition of the committeeThe current membership of the surveillance committee is: a visiting surgeon (chairperson) a director of medical services a visiting physician (also director of intensive care)a visiting general practitioner (also director of postgraduate medical education) a nurse unit manager (acute medical/surgical ward) a clinical risk manager a clinical pathway coordinator.

Because of the large number of adverse events related to medication errors, some health services have added a pharmacist to their surveillance committees,8 and suggestions have been made that consumers should also be part of the committee.

If a surveillance committee is established in a health service, it is important to select an appropriate name for the committee that appears neither punitive nor exclusive. Our surveillance committee is called the "Patient Care Committee", as this focuses on what we are trying to achieve — high-quality, safe patient care. A more specific name such as the "Medical Audit Committee" may project an image of a medical committee that judges medical practice and has no input from other disciplines, such as nursing.

5.5.2 Statutory ImmunityFor the surveillance committee to be effective, clinicians need to participate in full, frank discussions of quality issues. Such discussion is promoted if participating clinicians are confident that the content of such discussion will not be made available outside the committee. In individual Victorian health services, statutory immunity is available from the Minister for Health to services under Section 139 of the Health Services Act 1988 (Vic). Such immunity aims to ensure that confidential information generated by approved quality assurance bodies is not disclosed to people other than committee members or admitted in court proceedings. To provide the surveillance committee with statutory immunity, the committee at Wimmera Health Care Group is constituted as a subcommittee of the board of management's quality committee.



The surveillance committee meets cver>' 2 months. At these meetings, cach medical reviewer presents a report summarising details of the medical records they have reviewed and the adverse events they have delected. The clinical risk manager presents a summary report of the risk register, identifying issues lor

discussion by the committee and recommendations for clinical practice changes in the hospital. The committee also reviews information about adverse events that have occurred outside the hospital and that have been included in coronial, media and consultative council and committee reports, and the relevant recommendations that have been made.

15J Committee reports

Box 5.4 contains examples of recommendations made by the Wimmera Health Care Group Patient Care Committee. These recommendations are presented to the medical staff group — the peak medical group in the hospital. Care is taken that the recommendations are positively framed and clearly define actions to be considered, rather than detailing errors that have been made and allowing the responsible clinicians to possibly be identified.

Box 5.4 Wimmera Health Care Group medical staff group report1. Management of snake bite

The committee recommends that antivenom stocks in Wimmera hospitals be documented and that this

information, together with guidelines regarding the management of snake bite, be disseminated to all

doctors and hospitals in the region.

2. Intravenous lines

The committee recommends that intravenous lines be dated on a sticker on the entry site dressing.

3. Caidtopulmonary resuscitation

The committee recommends that the physician on call be contacted in the event of cardiopulmonary

resuscitation continuing for more than 30 minutes or if the patient requiring cardiopulmonary resuscitation is

transferred to the intensive care unit.

4. Emergency temporary pacing

The committee recommends that emergency temporary pacing wires be inserted in the operating theatre.

5. Invasive procedures

The committee recommends that before any invasive procedure is undertaken by the resident

medical staff (including central line and chest tube insertion), the proposed procedure be discussed

with the appropriate consultant.

o. renem repons

The committee recommends that when a hospital medical officer is called to the ward in response to an

incident, they should make an entry in the medical record in addition to completing the incident report.

7. Patient admission procedure

■ All non-elective patients being admitted to the hospital (except obstetric patients) must come through the accident and emergency department. Patients in a stable condition may only require a rapid medical and nursing assessment. These patients can then be quickly transferred to the ward, where a lull admission can be done at a later time.■ The appropriate registrar (during business hours) or the second on-call hospital medical officer (after hours) shall review all patients who are admitted via the accident and emergency department. The appropriate registrar or the second on-call hospital medical officer shall be informed of the admission by the intern on duty inthe accident and emergency department. On some occasions, the review can take place by telephone.■ The intern in the accident and emergency department must inform the appropriate visiting medical officer

and obtain their agreement to admit the patient under that visiting medical officer s bed card. The one

exception is wtien patients are admitted for short-term observation (eg. patients having a 4-hour neurological

observation after a minor head injury)



5.6 Principles for prioritising action to prevent adverse

events recurringThe risk register ranks risks according to the multiple of their probability of occuning and their consequence when they occur. The relatively large number of events detected creates a problem, as the resources available for quality improvement and ris*k management programs in individual health services are limited.

Which risks should be addressed by the health service, and how can they be prioritised so appropriate action is taken in a timely manner? Ideally, the highest risks should be eliminated or minimised first. However, usually because of resource limitations, other approaches are used for prioritisation. These methods include addressing adverse events that occur frequendy, cause serious harm, use substantial resources after they occur, and where there is strong evidence that available in^rventions are effective in preventing adverse events, feasible, safe, generaliseable and sustainable. The advantages and limitations of these alternative approaches to prioritisation for action will now be discussed.

5.6.1 Using frequency and harm to prioritise actionAfter the publication of the large epidemiological studies of adverse events such as the Harvard Medical Practice Study and the Quality in Australian Health Care Study, many clinical risk management programs have emphasised taking action to prevent adverse events that cause the most harm to patients. Although the consequences of some of these adverse events are extremely serious, many events, occur infrequently. Therefore, prioritising actiQn to prevent adverse events according to the harm they cause will reduce significant harm to a small number of patients.

Another approach in determining which adverse events to address is to concentrate on events that occur frequently. However, many frequently occurring adverse events do not cause major harm to patients. Therefore, prioritising action according to the frequency of adverse events will prevent many events, but only reduce the overall harm caused to patients by a small amount. As demonstrated in the risk register, multiplying the probability of the adverse event occurring by the consequence or harm that results when it does occur provides a measure of the risk of the event and helps prioritise action.

5.6.2 Using the cost of adverse events to prioritise action

Another approach is to focus on adverse events that use the most resources. Using data from the Quality in Australian Health Care Study and diagnosis-related group cost weights "crude... back of the envelope" estimates of the annual direct cost to hospitals of adverse events in 1999 was made. This assessment was based on the additional bed-days required to treat patients who had experienced an adverse event.21 The most costly adverse events are listed in Box 5.5.

Box 5.5 Annual cost of adverse events*3

Wound infection: $140 millionWarfarin: $100 millionFalls: $45 millionPulmonary embolus: $40 millionDeep vein thrombosis: $35 millionNon-steroidal anti-inflammatory gastrointestinal bleeds: $30 millionUnnecessary operations: $30 millionPressure injury/skin tear $25 million


In a further study, a sample of adverse events that would typically occur annually in a notional 250-bed hospital was examined. The resource utilisation of each adverse event was determined according to the additional patient length of hospital stay required. The adverse events that would have occurred were determined to require 11 500 additional bed-days, or 10% of the hospi tal's total annual bed-days. Also, 60% of the additional resources were used after "mundane"

110


adverse events occurred that led to minor disabilities and only 40% were used after "serious" adverse events that led to major disability or death. Mundane adverse events included postoperative pain, nausea and vomiting, pressure sores and catheter related infections. Reducing the number of mundane adverse events would benefit a greater number of patients than addressing serious events. Clearly, mundane and serious adverse events need to be addressed by individual health services in a balanced way."

Although mundane adverse events have less dramatic consequences than serious events, it may be appropriate to take action to reduce the rate of mundane events because of the considerable additional resources they consume. Addressing resource-intensive adverse events could result in considerable savings to a health service. These savings could then be used to reduce the number of less resource- intensive adverse events.

5.4.3 Using the evidence of the effectiveness of Interventions to prioritise actionAnother approach is to focus on those patient safety practices for which there is strong evidence of effectiveness in preventing adverse events. A patient safety practice is "a type of process or structure whose application reduces the probability of adverse events resulting from exposure to the health care system across a range of diseases and procedures".25

In an ambitious, challenging project, potential practices for patient safety improvement were comprehensively evaluated and a list of 83 practices were rated using general scores (low, medium, high) according to: their potential impact (based on the prevalence and severity of the patient safety target and the current utilisation of the practice); strength of evidence supporting the practice (only practices supported by randomised controlled trials reporting clinical outcomes were evaluated); effect size (unclear, negligible, modest, robust); the need for vigilance to reduce potential negative collateral effects of the practice; cost; and complexity (logistic barriers). In an attempt to answer thefollowing question for the leader of a health service "if I wanted to improve patient safety at my institution over the next 3 years and resources were not a significant consideration, how would 1

grade this practice?", a rating from zero to 10 was given as a combined assessment of the impact of the patient safety practice and the strength of supporting evidence. A table of ratings for each practice is available at www.ahrq.gov/clinic/ptsafety/chap59a.htm.

The categories of patient safety practices include adverse drug events, infectious complications of hospitalisation, complications of anaesthesia, surgery and other invasive procedures, complications in hospitalised older patients, system issues and human factors engineering, approaches to education and training and informed consent. The greatest strength of evidence ratings (impact and strength) were found for the practices listed in Box 5.6.2526

If the three criteria of importance, frequency and strength of evidence are used the three highest priorities were:

111

Box 5.6 Interventions with the greatestsbength of evidence■ Appropriate venous thromboembolism prophylaxis.■ Use of perioperative ^-blockers.■ Use of maximum sterile barriers during catheter insertion■ Appropriate use of antibiotic prophylaxis to prevent surgical site infection.■ Asking that patients recall and restate what they have been told during the process of obtaining informed consent.■ Continuous aspiration of subglottic secretions to prevent ventilator-associated pneumonia.■ Use of pressure-relieving bedding materials.■ Use of real-time ultrasound guidance during central line insertion.■ Patient self-management using home monitoring devices to prevent adverse events related to warfarin therapy■ Various nutritional strategies to reduce mortality and morbidity in postsurgical and critically ill patients.■ Antibiotic-impregnated catheters to prevent central venous catheter-related bloodstream infections.

http://www.ahrq.gov/clinic/ptsafety/chap59a.htm


a anticoagulation therapy to prevent deep vein thrombosis a antibiotic prophylaxis to prevent surgical infections a use of pressure relieving materials to prevent pressure ulcers.

Importantly, "the evidence base in patient safety remains young and has not yet stabilized",27

and subsequent studies can reveal contradictory evidence about benefits and previously unrecognised problems. Meta-analysis including subsequently published randomised controlled trials of the use of perioperative p-blockers has shown "questionable benefit and definite harm".27

Therefore, more than just evidence should be considered in deciding which interventions should be implemented.27

5.6.3.1 Limitations of using effectiveness to prioritise actionPrioritisation of safety practices according to their supporting evidence and effectiveness has been keenly debated. Leape and colleagues regarded the list of 83 patient safety practices as neither complete nor appropriate, with most being quality improvement initiatives rather than safety practices.20 They also felt many of the practices reflected technical advances in science that prevent complications, rather than reduce errors.28

The evaluation of the effectiveness of each safety practice placed emphasis on the existence of randomised controlled trials. However, many key, simple, intuitively attractive, commonly used and well accepted safety practices lack evidence about their effectiveness and only a few of these practices were on the list. Some of the trials required to demonstrate the effectiveness of many of these practices may not be able to be done, and those that could be done may show that some of these practices are ineffective, wasteful or even harmful.26

Because of the requirement for high-quality evidence of the effectiveness of a safety practice for it to be included on the list, the listed practices are biased toward areas where considerable research has been undertaken such as drugs, devices and procedures. However, there has been little research in health care on error prevention; this is why few error prevention practices are listed. Further, even if there is strong evidence that an intervention is effective, it should not necessarily be a high priority for implementation.28

Leape and colleagues state that to provide safe care to patients requires three steps: a identifying that the care worksa ensuring patients who would benefit from the care receive it a delivering the care without error.28

The list of safety practices only addresses the first step. Successful implementation of the second and third steps requires the development of safe systems of health care delivery that are based on human- factor principles and that attempt to reduce errors due to human cognition by using practices such as simplifying and standardising systems and using checklists. This approach results in many small changes being made to areas such as equipment, organisation, supervision and training that haw a significant aggregate effect.

Making many small changes based on sound principles and experience has been used successfully for many years in aviation,28 although not with the level of evidence of effectiveness required in clinical medicine.26 The equivalent scenario to aviation in medicine is anaesthesia, where the approach of incremental and multiple small changes, rather than the use of controlled trials, has been associated with a reduction in anaesthesia-related mortality.28 The counter-argument is that appropriate standards need to be used to evaluate even "obviously beneficial" practices. Some practices that appear to make obvious sense may be later shown to cause more harm than benefit. Also, small changes to one aspect of a complex system can increase the complexity of the system and result in unexpected and sometimes negative effects elsewhere in the system. Therefore, ongoing vigilance is required once change? have been made.26


A further difficulty in conducting controlled trials in patient safety research is that although the number of adverse events occurring in hospitals is large, the frequency of individual adverse events is low. Therefore, trials aimed at demonstrating reductions in already small numbers of specific adverse events will be difficult to conduct.28 Surrogate markers of adverse events may sometimes need to be used, so a reduction in actual adverse events will not be demonstrable. As with drug trials, there may be difficulties in implementing patient safety interventions that are effective in clinical studies into routine clinical practice, with potentially significant changes in skill levels, patients and settings.26

When deciding which patient safety practices to implement in a health service, reasonable judgement based on the best available evidence, experience and cost needs to be exercised. Decisions need to be made about which practices will most likely result in the greatest reduction in adverse events. Unfonunately, the availability and quantity of high-quality evidence about the effectiveness of individual practices will probably not reflect the frequency with which particular types of adverse events occur. Waiting for trials to be undertaken because the relevant evidence about the effectiveness of a particular patient safety practice is not available would result in inaction, and may not always be an option. Ideally, the practices implemented should be those that will reduce the most adverse events.

"An unquestioning embrace of dozens of promising practices from other fields is likely to be wasteful, distracting and potentially dangerous."25 Overall, "the general insistence on evidence does not prevent implementation of practical, low risk but understudied interventions that seem likely to work." Even with a balanced and considered approach errors in the selection of practices for implementation will be made. However, on balance, such an approach will increase the level of patient safety.26

5.6.4 Using comprehensive programs developed by external organisations to ' prioritise actionClearly, the direction of quality improvement and patient safety programs in individual health services should be tailored to the local needs and conditions of each organisation and the community it serves. Where possible, gaps in health care delivery and risks that are detected should be addressed. However, there is probably much commonality in the gaps and risks in different hospitals that provide acute care. Another approach to prioritising action is to look at the initiatives being taken by large quality improvement and safety programs elsewhere and see if they are applicable locally. These programs are called quality improvement collaboratives, and were described in Chapter 2.

An example is the 100000 Lives Campaign in the US, which was expanded to the 5 Million Lives Campaign in 2006. This campaign aimed to reduce five million incidents of harm during a 2-year period across many hospitals in the US. The initial program recommended hospitals in the campaign utilise six well known interventions to reduce mortality:■ deploy rapid-response teams to patients at risk of cardiac or respiratory arrest■ deliver reliable, evidence-based care for acute myocardial infarction■ prevent adverse drug events through drug reconciliation■ prevent central line infections■ prevent surgical site infections■ prevent ventilator-associated pneumonia.

Each participating health service developed systems of care to ensure that each eligible patient received each evidence-based element of care for the above clinical situations. An additional six interventions were added for the 5 Million Lives Campaign:■ prevent pressure ulcers■ reduce methicillin-resistant Staphylococcus aureus infection■ prevent harm from high-alert medications (initially anticoagulants, sedatives, narcotics and insulin)

112


■ reduce surgical complications (eg, venous thromboembolus prophylaxis)

113


■deliver reliable, evidence-based care for congestive hean failure to reduce readmission■involve boards of directors to make hospitals safer.

Participating hospitals were encouraged to add their own harm-reduction innovations and interventions to the list. The campaigns provided resources to participating hospitals. These resources, which include how-to guides and tools for managing and measuring change are available on the Institute lor Healthcare Improvement's website (www.ihi.org/ihi/programs/campaign/). These interventions will be assessed using trigger tools to determine the rate of harm in a random sample of patient medical records The initial 100000 Lives Campaign is currently being evaluated,29 and preliminary results are positive with significant reductions in infection rates.30

The Joint Commission in the US requires hospitals to implement 13 high impact, evidence-based and measurable safe practices, referred to as National Patient Safety Goals. Goals include improving patient identification, communication and medication safety, reducing health care associated infections, reducing harm from falls, minimising risks of influenza, encouraging patient involvement and preventing pressure ulcers. For example, to improve the accuracy of patient identification, the two requirements are: use at least two patient identifiers when providing care, and conduct a final verification process, such as "time out", before starting any procedure. The details and requirements for each goal are available from the Joint Commission website (www.jointcommission.oi^PatientSafety/ NationalPatientSafetyGoals).Some authors believe that safety risks and problems in individual health services are hetero-geneous and local. Therefore, safety problems identified in large programs may not be problems in a local setting. It has been suggested that individual health services adopt a "local epidemiological approach" — assess their environment and identify local problem patterns and allocate their limited resources to local priorities to use local solutions rather than "a one-size-fits-all strategy" from a national program.31 Such an approach is similar to the risk register developed from adverse events and risks that are detected locally that was discussed earlier and has been used in delecting adverse events in neonatal medicine.32

When prioritising gaps and risks for action, the criteria in Box 5.7 should be considered.19-27,33

Recently, two further approaches to prioritising interventions have been proposed.

5.6.5 A simple, straightforward approach to deciding which adverse events to address and how to address them

http://www.ihi.org/ihi/programs/campaign/

Given the preceding discussion about the many criteria that can be used to determine which adverse events to address, it is important to acknowledge that simpler methods of setting intervention priorities can be used. One such method is described below.

Box 5.7 Criteria to help prioritise gaps andrisks for action■ The frequency of the adverse event, size of the gap between the care provided and best practice, and the prevalence of the clinical condition■ The harm patients are experiencing from suboptimal care and the adverse event■ Preventability — the strength of the evidence o( the effectiveness of the intervention in improving patient outcome: the size of the impact the intervention has on patient outcome■ Does the intervention have any unintended or undesirable consequences that require monitoring?■ The complexity of the intervention — is it a major change in how care is delivered?■ Cost of implementing the intervention and change in practice — are adequate resources available?■ Benefits to the health service — the resources saved (by preventing adverse events) by implementing the intervention■ Feasibility — what barriers and facilitators are there to implementing the intervention?■ Does implementation of the intervention have the potential to create momentum for additional quality and safety initiatives?■ External imperatives (eg. mandatory accreditation standards)■ How many initiatives can be realistically undertaken at any one time given the resources and expertise availability and the magnitude of initiative7

■ If higher-risk adverse events occur before implementation of the intervention, priorities may change with some initiatives suspended or delayed


Important points

5 Analysing adverse events and pnoribeng actoor

Each clinical area in the health service selects five topics based on errors made in that area described in the literature. Topics are chosen according to the frequency with which the errors are made, the harm that patients experience following the error, and the degree of preventability of the error. Two process indicators and one outcome indicator are selected or developed for each topic. The indicators are measured and the results are peer reviewed and benchmarked against the best performance locally, nationally and internationally. Comparative feedback is also provided to the clinicians in the clinical area. If the results are more than two standard deviations below the average, a plan for improvement with indicator targets and a timeframe is developed with the input of clinicians and implemented. The indicators continue to be measured and feedback provided until the indicator targets are reached.34

5.6.6 A "balanced diet" approachAnother approach is to choose a "balanced diet" of interventions in the following categories:27

■ "Low hanging fruit" — interventions that address common patient problems, have strong supporting evidence, high impact and are easy to implement and have low potential for harm (eg, ultrasound- guided central venous catheter insertion, prevention of catheter-related bloodstream infection, removal of urinary catheters after 48-72 hours to reduce catheter-associated urinary tract infections). Interventions with lower-quality supporting evidence and high impact (eg, structured discharge summaries including changes in medication since admission and pending investigations, postdis- charge follow-up phone calls).

■ Momentum-generating projects — interventions with modest or little supporting evidence, but that promote interprofessional collaboration which has the potential to generate further quality and safely initiatives (eg, rapid response teams, executive "walk rounds" and teamwork training).

■ System-wide interventions that affect day-to-day practice (eg, computerised provider order entry and electronic medical records).The authors did not recommend some commonly used interventions thai provided less benefit

lo patients compared with the effort required lo implement ihem (eg, medication reconciliation, incident reporting and root-cause analysis).27 These interventions may be of benefit to some patients, but other inventions may be more beneficial and resources available are limited.

m Analysis of adverse events comprises three stages: ensuring that the patient, their relatives and the clinicians who provided the care have been appropriately managed: analysis of the event: and prioritisalion of action to prevent a recurrence.

■ Adverse events can be analysed using systems analysis, root-cause analysis or a simplified versions of these methods. A balance is required between taking adequate time for appropriate analysis of adverse events and taking action in a timely manner to prevent the recurrence of events.

a Analysis determines the probability, consequence, preventability. and latent factors and active errors

that contributed to the adverse event occurring.

a The level of risk associated with an adverse event is equal to the probability of the event multiplied by theconsequences of the event.a A hospital clinical risk management program will detect more adverse events than can be effectively dealt with. Therefore, adverse events need to be prioritised for action. 4

a Criteria to consider when prioritising events include: the frequency of the event, the harm it causes, its preventability and the cost, feasibility, complexity and unintended consequences of the required intervention. Comprehensive external risk reduction programs may also be used to prioritise actions.

a Maintaining a risk register of adverse events ranked by their level of risk helps focus attention to where action is most required to reduce risk.

a The composition of the surveillance committee that reviews adverse events should alkm meaningful discussion of a wide variety of events.

a Statutory immunity should be obtained for the surveillance committee's activities.

References1 Lamb R. Open disclosure: the only approach to medical error. Qual Saf Health Care 2004; 13:3-5.2 Australian Commission on Safety and Quality in Health Care. Open disclosure: a review of the literature. Canberra- ACSQHC. 2008.3 Victorian Government Department of Human Services. Open disclosure statewide pilot project evaluation report. Metoourne: DHS. 2007.4 Vincent C. Understanding and responding to adverse events. N Engl J Med 2003; 348:1051-1056.5 Deibanco T. Bell SK. Guilty, afraid, and alone — struggling with medical error. N Engl J Med 2007; 357: 1682- 1683.6 Waterman AD. Garbutt J, Hazel E, et al. The emotional impact of medical errors on practicing physicians in the United States and Canada. Jt Comm J Qual Improv 2007; 33: 467-476.7 WU A. Medical error: the second victim. BMJ 2000; 320: 726-727.8 Dunn KL. Moulden A, McDougall P. Bowes G. Patient safety: a view Irom down under. Pediatr Clin N Am 2006; 53: 1217-1230.9 Vincent C. Taylor-Adams S. Stanhope N. Framework for analysing risk and safety in clinical medicine. BMJ 1998: 316: 1154-1157.10 Bagian JP. Gosbee J. Lee CZ. et al. The Veterans Affairs root cause analysis system in action. Jt Comm J Qual Improv 2002: 28: 531-545.11 Bagian JP, Lee C, Gosbee J, et al. Developing and deploying a patient safety program in a large health

care delivery system: you cant fix what you don't know about. Jt Comm J Qual Improv 2001; 27: 522-532.

12 Brennan TA. Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalised

patients: results of the Harvard Medical Practice Study 1. N Engl J Med 1991; 324:370-376.13 Wilson RM, Runciman WB, Gibberd RW, et al. The Quality in Australian Health Care Study. MedJAust 1995; 163: 458-471.

14 Wu AW. Lipshutz AKM, Pronovost PJ. Effectiveness and efficiency of root cause analysis in medicine. JAMA 2008: 299:685-687.15 8km JF. Heffner JE. Challenges in the care of the acutely ill. Lancet 2004:363:970-977.16 Shojania KG. Wald H. Gross R. Understanding medical error and improving patient safety in the inpatient

setting. Med Clin N Am 2002: 86: 847-867.17 Berwick DM. Errors today and errors tomorrow. N Engl J Med 2003; 348: 2570-2572.18 Pronovost PJ. Holzmueller CG. Martinez E. et al. A practical tool to learn from defects in patient care. Jt Comm J Qual Patient Saf2006:32: 102-108.19 Stevens P. Matlow A. Laxer RM. Blueprint for patient safety. Pediatr Clin North Am 2006; 53: 1253-1267.20 Wilson RM. Harrison BT, Gibberd RW. et al. An analysis of the causes of adverse events from the Quality

in Australian Health Care Study. MedJAust 1999: 170: 411-415.21 Leape L. Lawthers AG. Brennan TA. et al. Preventing medical injury. Qual Rev Bull 1993; 19: 144-149.

22 Standards Australia/Standards New Zealand. Risk management guidelines companion to AS/NZS 4360:

2004. Sydney/Wellington: SA/SNZ. 2004.

23 Rigby K. Clark RB. Runciman WB. Adverse events in health care: setting priorities based on economic

evaluation. J Qual Clin Practice 1999; 19: 7-12.

24 Runciman WB. Edmonds MJ. Pradhan M. Setting priorities for patient safety. Qual Saf Health Care 2002;

11: 224- 229

25 Shojania KG. Duncan BW. McDonald KM. Wachter RM. eds. Making health care safer: a critical analysis

of patient safety practices. Rockville. Md: Agency for Healthcare Research and Quality. 2001. (Evidence

Report/Technology Assessment 43. AHRQ Publication No. 01-E058.)


Important points

5 Analysing adverse events and pnoribeng actoor

28 Shojania KG. Duncan BW. McDonald KM. Wachter RM. Safe but sound. Patient safety meets evidence-

based medicine JAMA 2002; 288: 508-513

27 Ranji SR. Shojania KG. Implementing patient safety interventions in your hospital: what lo try and what to

avoid. Med Clin N Am 2008; 92: 275-293.

flfl

28 Leape LL. Berwick DM. Bates DW. What practices will most improve safety? Evidence-baaed medicine meets patient safety. JAMA 2002: 288: 501: 507.

29 McCannon CJ, Hackbarth AD. Griffin FA. Miles to go: an introduction to the 5 Million Lives Campaign Jt Comm J Oual Patient Sat2007; 33:477-484.30 Berwick DM. Will is the way to win the patient safety war. Health ServJ2007; 117. 18-19.31 Larsen G. Parker H. Patients' safety: think and act locally. Lancet 2008; 371:364-365.32 Ligi I. Arnaud F. Jouve E. et al. Iatrogenic events in admitted neonates: a prospective cohort study. Lancet 2000: 371:404-410.

33 Grimshaw J. Eccles M. Thomas R. MacLennan G. Toward evidence-based quality improvement: evidence (and its limitations) of

the effectiveness of guideline dissemination and implementation strategies 1966-1996. J Gen InternMed 2006,21: s14-s20.34 Wollersheim H. Clinical incidents and risk prevention. Neth J Med2007; 65: 49-54. □


6 Taking action to close gaps in care and prevent adverse events recurring — evidence and theory

This chapter will:m Examine the factors that facilitate and impede the adoption,

implementation and maintenance oI change and innovation in health services

■ Discuss theories from many disciplines relevant to implementing change and their practical implications lor achieving change in health care

■ Describe different approaches to change based on how people behave individually and in groups and organisations

■ Outline how to develop change strategies *■ Discuss the evidence supporting various change strategies■ Describe a change model using the strategies of quality

improvement and system redesign.

Determining the gaps in care provided to patients and the risks to which they are exposed is demanding, but it is easier than determining and taking effective action to close the gaps and reduce the risks. Health care delivery systems are complex and the components can interact unpredictably effecting interventions.1 Also, closing gaps and reducing risks requires changing clinical behaviour, which is often difficult.

Most health care research is about understanding disease processes and finding effective treatments, rather than determining the best ways of delivering safe care.2 Clinicians seek high-quality scientific evidence that treatments are beneficial and safe, but such evidence is often not sought before implementing quality improvement and risk reduction initiatives. Health services often implement quality improvement initiatives without first evaluating their effectiveness and whether they have unintended negative consequences (which is well recognised when making changes in complex systems) or cause harm to patients, or whether they are the best use of the limited resources available.3

Evidence for the effectiveness of implementation strategies is often not available or is limited. 3 The effects of implementation strategies are modest, and they may be effective in one setting and not another. Although there are "still no magic bullets",4 some strategies, such as computerised ordering and prescribing involving "information technology |are) often oversold as a definitive quality and safety solution". 5 Future improvements are likely to be incremental.4 Strategies currently used are based on intuition, anecdotes of strategies used in other health services, and high-profile, poorly evaluated quality improvement techniques from other industries, rather than on high-quality scientific evidence.4

Quality improvement implementation strategies in health care began with passive diffusion. It was generally thought that clinicians would automatically change their behaviour when research providing strong evidence of significant treatment effects was published or presented at conferences. Clinicians found it difficult to accurately evaluate the evidence, and reading journals or attending lectures had little effect on clinical practice.4 6 It was then thought that creating guidelines and reviews summarising research and presenting "bottom-line" recommendations would change clinician behaviour But the effect was not as great as initially thought.4 6

Next, health services tried to implement industrial-style quality improvement strategies, such as total quality management and continuous quality improvement, whose effectiveness was only superficially evaluated in the other industries4 They were used with audit and feedback, reminders and educational research, consumed considerable resources and only produced modest benefits in patient care Doctors

felt that these measures reduced their autonomy, leading to clinician resistance.6

Systems engineering, involving system redesign and often requiring major information technology input, was then used. Decision suppoYt tools, together with automated prompts and reminders, were made available at the bedside, but the results were often disappointing.4,6

Clearly, further study of the barriers to effective implementation of change is required.4 Currently, theories from other disciplines in which changing behaviour is also important have been used to implement change in health care6 and will be presented later in this chapter.

Systems of health care delivery are often complex, unstable and non-linear, and many proposed changes are complex forms of social change with multiple components. The effectiveness of such change is sensitive to a broad range of contextual factors.7 To be successful, programs should "introduce the appropriate ideas and opportunities ('mechanisms') to groups in the appropriate social and cultural conditions ('contexts')".8 Attention to the mechanism of change and the context in which it is being made, which does not usually occur in experimental designs (such as randomised controlled trials), may help generalise the change to other contexts.7

Important contextual factors in determining the effectiveness of quality improvement implementation strategies are: the nature of the intervention; the target group of health service staff; the patients who are .to receive the intervention; features of the organisation (eg, its size, structure, leadership, governance, culture, communication and resources); and sociopolitical and other factors (eg, regulations and legislation) that affect the health service. The paucity of high-quality research adds to the uncertainty of each factor's role. Often, factors such as culture and leadership within organisations are not robustly studied and the interventions used are only broadly described.

There is a pressing need to determine the "active ingredients" of each intervention. This information would help us understand why interventions work and what aids or interferes with their effectiveness in particular settings. An adjustment in the expectations of senior management in health services, government and other funding bodies of what the implementation strategies can realistically achieve is also required. As with advances in clinical medicine, the gains achieved in quality improvement are likely to be incremental and modest4

Effective implementation of quality improvement and patient safely strategies is difficult. How, then, can health services implement initiatives that will close the gaps and reduce the risks they have identified? The success of an intervention depends on the interaction of many factors at multiple levels of ihe health service.

With the shortage of good scientific evidence to suppon strategies, it is appropriate to look at theories about how individuals leam, behave and change. A theory can be defined as "a system of ideas or statements held as an explanation or account of a group of facts or

Thedsfictetolhe performance of the heath care system an enormous and the rate el change appears

McGlynn EA Med Care 2007; 45: Ml


phenomena" 9 Theories are made up of many theoretical constructs or component parts 9 Theories aid our understanding of phenomena, and can be used to predict behaviour in varying circumstances. By understanding theories of how these factors are influenced and interact, appro-


6 Taking action to close gaps in care and prevent adverse everts recurring

priately tailored strategies can be developed. This approach should also encourage the

systematic analyse at factors influencing the success of an intervention.10 The following actions are

required:

1. Systematically determine the factors that will influence (facilitate or impede) the

implementation at the proposed change. Section 6.1 provides a comprehensive checklist of

factors developed from the literature.

2. Review the relevant theories about individual, group and organisational behaviour. Section 6.2

gives a brief description of theories from a wide range of disciplines thought to be relevant to

quality improvement and implementing change in health care.10

3. Develop practical approaches and strategies from these theories to address the identified (actors The main aim of this book is to provide a practical guide to quality improvement and patient safety for those at the coalface. Therefore, assumptions about human behaviour will be distilled from the theories presented and listed in a practical format (Chapter 7). *

6.1 Determinants of implementing a change within a health service

A review of implementation of innovations in health care organisations identified 50 determinants or influencing factors, and categorised them into five groups: characteristics of the sociopolitical context; characteristics of the organisation; characteristics of the user; characteristics of the innovation; and characteristics of the patients (Figure 6.1)." The authors recommended that determinants relevant to the successful implementation of a proposed change be systematically sought; this was rarely done in the studies reviewed."

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Figure 6.1 Determinants of innovation within health care organisations11


The target group of the strategy and relevant others should be asked, using interviews or questionnaires, to identify the determinants they perceive as influencing the success of the implementation of the change. They should classify them as facilitating, impeding or neutral to the implementation and grade their importance. In a review, determinants were reported as impeding 2.5 times more frequently than facilitating, and were infrequently reported as neutral. 11 When the determinants are identified, an appropriate theory can be selected as a starting point to influence the determinant and a strategy developed to organise ■ or operationalise the theory. A change strategy tailored to the determinants can then be developed.

Undertaking a systematic determinant analysis ensures that the strategy developed focuses on the determinants that the target group believes are relevant. The importance of each of the 50 determinants identified in the review will vary with the change or innovation being proposed. However, the authors suggest that this list of potential determinants provides a checklist to help develop effective change strategies.11

A review of the diffusion of innovations in service industries, including health care, reviewed literature in sociology, psychology, anthropology, epidemiology, marketing, organisation and management and information and communications technology.1 The authors developed a conceptual model for considering the determinants of diffusion, dissemination and implementation in health service delivery and organisation.1 The review enabled a useful, but not totally exhaustive, lists of attributes and determinants to be developed, which should be used by health services considering adopting an innovation. However, these factors should be examined with the understanding that — given the complexity of health care delivery systems, the multiple and often unpredictable interactions of the interdependent components of the system, and the great variety of contexts and settings in which health care is provided — the presence of these factors will not guarantee the successful adoption of the innovation.

Another study reviewed change in clinical practice from a slightly different perspective to determine why doctors do not follow guidelines.12 The authors found a number of determinants that impeded the uptake of guidelines. They identified potential barriers to a proposed change and categorised them as follows:■knowledge — lack of awareness or familiarity■attitudes — lack of agreement, self-efficacy, outcome expectancy, inertia of previous practice■external barriers — patient, guideline and environmental factors.12

Although concentrating on barriers, this study found many determinants also elicited by the other reviews. We have integrated and modified the results of these three reviews to produce a list of the determinants of the success of an innovation (Box 6.1). These determinants are supported by variable levels of evidence and expert opinion. The presence of a determinant may facilitate the adoption, implementation and maintenance of an innovation, whereas its absence may impede the innovation. Clearly, not all determinants are relevant to each innovation nor are all determinants required to be present before an innovation is introduced.

Systematic determinant analysis to identify key determinants and design and implement strategies to address them is critical to successfully changing how health care is delivered. In a study that examined use of ^-blockers in patients with myocardial infarction, cardiologists, emergency physicians, nurses, quality managers and senior administrators in eight hospitals in the United States were interviewed and asked to describe the major initiatives their hospital had undertaken to improve the care of patients with acute myocardial infarction and the difficulties and successes with each initiative. Six broad factors described the improvement efforts of hospitals:■setting goals (goal content, goal specificity, goal challenge, the degree to which goals were shared)

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■administrative support (organisational philosophy regarding quality improvement and resources made available — care coordinators, chart abstractors, computer and analytical support, quality improvement training)

Box 6.1 Determinants of adoption, Implementation and maintenance of Imovetlon1'"'"

Characteristics ot Innovation

a Clearly effective

a Low complexity

a Compatible with values, norms and needs of users

a Can be trialled on a small scale

a Benefits clearly visible to users

a Can be modified to meet individual needs

a Relevant to users' work; improves task performance

■ Knowledge required to use the innovation can be transferred across settings

a Supported — training, help desk

e High relative advantage in effectiveness or cost-effectiveness

a Supported by high-quality scientific evidence *

a Observable benefits

a Appealing to use

a Low associated risks

a Frequent use

a Clear procedures

a Low cost

a Little time required

e Implications and effects of the innovation fully assessed and anticipated

a Innovation adapted to local needs and conditions

Characteristics ol users — target groups/subgroups and their members

a Sufficient knowledge level to implement innovation

a Sufficient skill level to implement innovation

a Sufficient experience to implement innovation

a Motivated to use innovation

a Meets an identified need for users

a Aware of innovation, what it does, how to use it, and how it will affect them personally

a Individuals considering adoption have similar backgrounds

a Champions in social network support innovation

a Colleagues are implementing (modelling) required behaviour

a Opinion leaders (respected, trusted professionals who influence [positively or negatively] the beliefs and

actions of their colleagues) are available

a High support of colleagues to implement

a High support of other professionals to implement

123


B High support ol supervisors to implement

a High self-eflicacy

a Perceived ownership of innovation

a Belief that patients will cooperate

a Belief that patients will be satisfied

B No ethical problems with innovation

a Users' goals match aims of innovation

a Low level of work-related stress

a Few potential users j

flov 6 1 (continued or> •"><=»,' as j*"

124

So* 6.1 (contfciued)

■ Patients willing to cooperate■ Patients are aware of benefits■ Adds value for patient■ Lo* risks for patient

■ Low cost to patient

■ Low level of patient discomfort

■ Patient preferences match innovation

■ High level of patient compliance

Characteristics of the organisationSize

■ Size — may be easier to implement an innovation in a medium-sized organisation with fewer staff to engage than in a large organisation. However, it may also be difficult to introduce change in a small health service if there are only one or two doctors who may not support the innovation.

■ Manageable number of users to be reached — it may be easier to engage 5-10 clinicians than 50-100

Structure■ Divided into semi-autonomous departments or units

■ Departments or units contain foci of specialised professional knowledge

■ Semi-autonomous multidisciplinary project teams established

■ Flexible structure for decision making

Leadership■ Strong leadership

■ Clear vision

■ Senior management actively involved and frequently consulted

■ Decentralised decision-making process and procedures

■ Operational decision making devolved to teams "on the ground"

■ Senior management supports implementation

■ Innovation designed to appeal to key opinion leaders

Culture■ Current situation viewed as intolerable — clear evidence change is required

■ Learning organisation culture — support for shared knowledge

■ Opportunities for interprofessional teamwork, and involvement of clinicians in management networks and vice versa

■ Accurate and timely feedback provided to users

■ Climate conducive to experimentation and risk taking

■ Good collaboration between involved departments

■ Users involved in development

■ Supporters of the innovation outnumber, and are more strategically placed in the organisation than, opponents of the

innovation

Governance■ Close and effective monitoring and evaluation process

Communication■ Effective communication across departmental boundaries

Box 6 1 (continued on next page)Box 6.1 {continued)Resources■ Adequate financial resources available

Enhwdng patient care

124

a Dedicated and ongoing funding available■ Reimbursement or replacement staff available for involved staff■ Administrative support available■ Effective data collection systems available■ Adequate time available■ Coordinator available■ Low staff turnover■ Full staffing■ Much relevant expertise available Education■ On-the-job training provided with high-quality materials on how to use innovation■ Support provided to integrate in individual's daily work

Administrative■ Well arranged relevant logistical procedures■ Organisational climate — secure financial situation, low level of threats, role and viability of service secureCharacteristics ot sociopolitical context and external factorsa Critical mass of comparable organisations adopting innovationa Opportunity for lormal networking initiatives (eg. collaborations) of comparable organisations workingtogether to implement the innovation a Complies with relevant regulations and legislationa People who have significant ties inside and outside the organisation and link the organisation externally can

capture and assimilate ideas for innovations a Adequate funding for health services, appropriate health legislation and policies.

a clinician support (presence of leaders, degree of engagement in improvement effort, ability to lead change, supportive, single leader — a clinical champion who is highly respected as an expert clinician, committed to using the intervention, and has consensus-building skills to resolve conflicting views)a design (improving adherence to an existing system or redesigning an existing system) andimplementation styles of improvement strategies a use of data (availability and acceptance of current evidence-based research on benefits of intervention; using valid and credible data benchmarked against a reasonable comparison group, to provide timely feedback to clinicians' on their use of the intervention) a contextual factors (hospital size, affiliation and organisational turbulence — turnover of seniormanagement and clinicians, financial stress).13 Four characteristics were present in hospitals in which more than 65% of patients with acute myocardial infarction received (i-blockers on discharge:a widespread sharing of and agreement with the goal of improvement (including substantial buy-in by clinical staff)

Enhwdng patient care

125

■substantial administrative suppon (board of management and senior management requesting performance data, senior management participating in quality improvement project teams, and adequate resources being provided to undertake the intervention)

■strong clinician leadership (clinicians committed to using the intervention) rather than just clinician participation

■high-quality data feedback (that is credible to clinicians). Information

given to clinicians about their individual performance inprescribing ^-blockers (described by one clinician as "objective enlightenment") powerfully influenced their behaviour. Surprisingly, given the considerable efforts being made to use and evaluate different strategies to improve quality of care, the high- and low-use hospitals did not differ in the type or style of initiatives they used to try to increase p-blocker usage. This suggests that factors such as those discussed above are equally — if not more — important in determining the success of implementing interventions, and emphasises the importance of analysing the proposed intervention, target groups and settings when designing implementation strategies.

Importantly, staff in both hospital groups described change occurring slowly, and difficulty in sustaining improvement A commonly described scenario was "a cycle of change, characterised by inertia in the beginning, a learning curve, accelerated improvement, a plateau, and either decline or maintenance".13 A subsequent quantitative study found that "hospitals without strong administrative support and physician leadership for quality improvement efforts are unlikely to effect desired performance improvement".14

A list of determinants has been presented for individual health services to identify the major determinants influencing the success of the implementation of change. We will now describe theories of human behaviour from a variety of disciplines from which practical approaches and strategies can be developed to implement change.

6.2 Theories relevant to the implementation of change

and their practical implications for change in health

careAttention should be given to theories that may be relevant in health care and attempt to describe and explain human behaviour and how changes take place in individuals and organisations. Theories should address the questions: "Why do people or organizational entities behave as they do? Given the way they behave, what would motivate them to change behaviour?The theories presented here are from many fields, often outside health care. No single theory addresses all the factors that influence change, and the factors that they consider overlap considerably.9


6 Taking action to close gape in care and prevent adverse events recurring

These theories allow hypotheses to be extracted about factors that may influence the success of implementing change.10 Using these hypotheses,nhetacfco/

sciantffic work underpinning even some of the most popular models for change in health care is striking'

Groi FtP. et al Milbank Q

2007;85 93-138

appropriate interventions can be designed to overcome barriers and use facilitators ("why do people behave as observed in this setting, and what intervention could effect desirable change?") as part of an overall strategy to implement the required change." Importantly, few theories have been thoroughly tested, and there is only limited evidence that using theoretical approaches in health care is effective in achieving change.10

Interventions in clinical medicine have often been evaluated in ran-domised controlled trials, meta-analyses and systematic reviews. However, the evaluation of implementation strategies is mostly descriptive and observational, rather than experimental. This lower level of evidence only allows "educated guesses" or "speculative rules" to be made about how to best support the implementation of interventions.16

Many theories could be relevant to implementing change in health care. As this book aims to provide a practical guide to change, the theories are briefly described and the practical implications of these theories summarised after the description. The theory descriptions have been summarised from two detailed sources.1017 Theories used extensively, or thought to have significant potential in implementing change, are described in more detail using additional sources. The aim is to use theories as a source of practical suggestions about potential strategies for achieving change. Many of these suggestions are incorporated into a practical step-by-step framework for change, described in Chapter 7.These theories can be grouped in two'ways. Firstly, they can be categorised according to different approaches to change, including educational, epidemiological, marketing, external influence, social interaction, managerial and control and compulsion,18 which will be discussed later in this chapter. Some theories have contributed to more than one of the approaches. Relevant theories can also be classified as theories:10

■of change in health care■ focused on individuals■ related to social interaction■ related organisational context■ related to political and economic context■ related to patients.The theories will be discussed using this classification.

6.2.I Theories of change in health care6.2.1.1 Process theoriesProcess theories relate to implementation of change, including planning the change and influencing the target group. Practical elements common to these theories and relevant to health care include:10

■ Use a systematic, well planned approach that considers all relevant factors.■ Involve the target group in developing and implementing the plan.



■Carefully examine the characteristics of the innovation (eg, the evidence base supporting the innovation, its complexity, compatibility with norms and values, cost-bencfit analysis, associated risks, the involvement

'ttatao became dmr that environmental factor* which rrtbOed cOnidan access to knowledge or its application to overlay practice were mote important than clinician ignorance or pigheadedness in retardmg4xogress to best practice'

Scon i ACP J Club

2007 146 A6-A11

required of the target group) looking for factors thai will facilitate or impede its implementation.

■Use a sequential approach to implementation, which solves different problems at each stage.

■Use diagnostic or problem analysis to determine factors that will assist or hinder implementation.

■ Develop and use strategies that are closely linked to the results of the diagnostic or problem analysis.

■ Monitor progress to determine whether the intended changes are being achieved, and adjust the plan accordingly.

■Use a cyclical approach of continuous learning and improving.

6.2.1.2 Stages of Change TheoryThe stages of change or "readiness to change" model describes a sequence of six stages of change within a cycle through which individuals progress to successfully achieve change.19-20 The model was developed to successfully change behaviour in individuals with addictions to nicotine, alcohol and other drugs, and is now being used in changing other types of behaviour. Each stage in the sequence requires specific strategies to be used to facilitate progression to the next stage. The same model is used whether the impetus for change is an external influence, an internal commitment by the individual, or both. Most importantly, different subgroups within the target group in a health care organisation will be at different stages of the change cycle, and will require different strategies to help them move to the next stage.

Individuals move through each of the stages of change at least once, and frequently several times, while trying to change their behaviour. The stages of change are as follows:20-21

1. Precontemplation — the individual has not yet thought about making changes to his or her behaviour in this area, perhaps because of a lack of basic knowledge, and may even avoid reading, talking or thinking about such a change. The individual has no intention of changing in the foreseeable future.

2. Contemplation — the individual is aware of the problem and has started to seriously think about making a change, but their level of ambivalence is high. On one hand, the individual wants to change this behaviour; on the other hand, the individual wants things to stay the same. The individual is weighing up the positive and negative aspects of making the change and the personal effort needed to make the change. The individual has not made any commitment to change and has not done anything to make the change. Individuals may stay in this stage for long periods of time.

3. Preparation — the individual has made a decision to change his or her behaviour in the near future. The individual is unsure whether this is the right decision, and is concerned about how to deal with potential problems that could arise from making the change. The individual has not yet taken effective action.

*.., knowtadgemustbe emctedandmade sooM entering into the stock ot knowledge constructed and stand by other individuals. Knowledge depends for its circulation on interpersonal networks and will spread only if these social features are taken into account and barriers overcome.'

"Greenhalgh T,

etal MilbankQ 2004;

82: 581-629



4. Action — the individual takes active steps to make a real change to his or her behaviour The actions are visible, and may require considerable commitment and effort.

5. Maintenance — the individual continues successfully with this change in behaviour, which has become consolidated and fully integrated.

6. Relapse — the individual had started to make changes in behaviour, but has slipped back into original behaviour and an earlier stage in the change cycle.At any one lime, individuals in groups will be* at different stages of the cycle of change. Most

individuals will be in the precontemplation and contemplation stages of the cycle. Few individuals will be in the action stage. Each stage requires specific action to be taken by an individual to successfully move to the next stage. The strategy used to facilitate change should be matched to the stage of the change cycle individuals are in. Those in the:■ Precontemplation stage may benefit from having their consciousness raised by creating

awareness and thinking about the consequences of not changing. ^■Contemplation stage may benefit from more information about the issue (especially evidence

about the benefits of the change) as they continue to weigh up the positives and negatives of making the change.

■ Preparation stage may benefit from a discussion reinforcing their ability to make the change and to consider undertaking a trial of the change.

■Action stage may benefit from reinforcement of their changed behaviour using incentives, support and resources to facilitate the change.

■ Maintenance stage made need support to fully stabilise and maintain the change to avoid relapsing. Regular positive feedback may also assist in maintaining the change.

a Relapse stage may feel demoralised and need support to leam from their experience and use different strategies for change the future.If individuals are in the early stages ofthe cycle, forcing change on them (eg, by senior

management) is unlikely to be successful, and it may be detrimental. Individuals in the precontemplation stage ofthe cycle who are coerced into changing by others may change their behaviour while pressure is being applied, but their behaviour will most likely revert back when the pressure is not longer being applied.

Individuals will probably experience some ambivalence throughout the change cycle, and the degree of ambivalence will vary according to which stage in the cycle they are in. Ambivalence usually reduces as an individual moves successfully through the cycle. Individuals are most likely to give up making the change in the relapse stage. Relapse is a normal part of the change process, and not a problem unless individuals despair about not being able to change and give up.

The stages of change model has been extended to behaviour in organisations, and in particular to target groups within a health service, with the following strategies for the organisation attempting to have the target group move to the next stage in the cycle 19,22 (Table 6.1).

The main implication of the stages of change model for health services is that different members of the target group or subgroups will almost certainly be at different stages of the model regarding any- proposed intervention. They will require the different strategies to help them move to the next stage The model has been expanded and synthesised with other change models into a 10-siep model invoking the stages of orientation, insight, acceptance, change and maintenance.23

a Determine which stage each subgroup and key individuals in the target group is at, and use appropriate change strategies to help them progress to the next stage.

6.2.2 Theories related to individualsThese theories discuss determinants of change in individuals — how they make decisions, how thev learn and what influences their motivation to make changes.



IMUe 6.1 Stages of Change modelStage Target group

actionOrganisation's strategy

Piecortempiation

Not aware improvement possible

Raise awareness (eg, opinion leaders, academic detailing, workshops, conferences small group discussions)

Contemplation

Weighs up advantages and disadvantages of change

Increase understanding of change (eg, opinion leaders, academic detailing, workshops, conferences small group discussions)

Preparation

Makes plans made for change

Reduce barriers and increase facilitators to change (eg, modify practice environment, participatory skills development, patient education, involvement in development and adaption of guideline)

Action Changes behaviour

Change behaviour (eg. modify practice environment, participatory skills development, patient education, involvement in development and adaption of guideline)

Maintenance

Decides to continue change, or relapses to previous behaviour

Maintain behaviour (eg, audit and feedback, reminder systems)

6.22. / Cognitive theoriesCognitive theories examine how individuals think and make decisions. They assume that

professionals balance the advantages and disadvantages of the available treatment alternatives

with the patient to provide the best and most appropriate care. For this process to be accurately

undertaken, high-quality, convincing information should be available to professionals detailing the

advantages and disadvantages of the available treatment alternatives. Professionals sometimes use

their previous experience with patients with similar clinical problems to make decisions — in some

cases, this information may be inadequate or out of date.■ Provide current, timely, relevant, convincing and high-quality (scientific) information to

professionals to help them make clinical decisions (eg, guidelines, decision aids and evidence-based clinical pathways and protocols).

6.2.2.3 Education theoriesFor learning to occur, new knowledge should be actively used and linked to previous knowledge. Motivation to change is increased if professionals are working on problems they have experienced

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in practice. Motivation to leam is driven more by internal motivation (especially to improve personal competence) than external pressure. Individual motives to learn and personal learning styles can vary greatly. For example, some professionals need new experiences and accept the need for change quickly. Others prefer to carefully examine all the options before making a change. Some professionals require rigorous, logical arguments for change; others decide to change because of personal experience.24

■ Seek to achieve change in clinical areas where professionals have experienced problems

and had to deal with their effects and involve them in finding solutions.

m Determine the learning needs and styles of individual professionals and tailor strategies

for change accordingly.

6.2.2.3 Attitude theories — Theory of Planned BehaviourThe Theory of Planned Behaviour states that individuals' behaviour is influenced by their intention to

perform that behaviour. Intention is influenced by their attitudes towards the behaviour (determined

by the expected outcome of the behaviour and whether these outcomes are positive or negative),

by the perceived subjective norm (Do important others behave this way?), and by perceived

behavioural control (Can 1 perform the behaviour in this setting?; Can I resist the social pressure?).25

■In the education program for the proposed change, opinion leaders should closely link the change in behaviour to the desired clinical outcome and view the outcome positively.

■Opinion leaders should model the behaviour to demonstrate that it can be done and that

they believe it is important.

6.2.2.4 Motivation theoriesChanging behaviour within organisations requires motivation by individual to change. Unfortunately, the commonest feeling towards change is ambivalence. The current situation is most familiar and within individuals' comfort zone, whereas the required change will often take them outside this zone. Therefore, changing individual behaviour can be difficult, particularly in organisations where many individuals work.

An individual's drives and desires that make up motivation are complex. The large number of theories developed to explain motivation probably reflects the complexity and limited understanding of the subject, as well as the difficulty of incorporating all aspects of motivation into one cohesive theory. Despite these difficulties, motivation remains a key determinant of whether a change can be successfully implemented in an organisation. Therefore, we describe several motivation theories relevant to individuals working in health care, and provide practical strategies arising from these theories. Herzberg's Motivation-Hygiene Theory.26 This theory proposes that intrinsic factors (eg, achievement, recognition and responsibility) are associated with job satisfaction and motivation, whereas extrinsic factors (eg, salary, supervision, working conditions and relationships with work colleagues) are associated with job dissatisfaction Hygiene factors are factors that reduce job dissatisfaction. According to Herzberg, reducing job dissatisfaction does not increase motivation.a Concentrate on achievement, recognition and responsibility to increase motivation.Three Needs Theory.26 In this theory of motivation, individuals have three acquired needs: achieve-ment, power and affiliation. The need for achievement refers to personal (rather than organisational) achievement, and is the desire to do something better than it has been done before. Individuals with a high need for achievement like to be stretched. They are willing to accept personal responsibility for finding solutions to problems, want rapid feedback about their performance and like to be set challenging (but not extreme) goals. Easy goals do not motivate them.a Provide responsibility for solving problems, challenging goals and rapid feedback.Goal-setting Theory.26 This theory states that developing specific goals increases individuals' performance, and that difficult goals — when individuals accept them as appropriate — will increase

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their performance. Individuals' participation in setting their goals increases their acceptance of these goals and their commitment to achieving them.a Allow individuals to set their own goals, and ensure they arc specific.Reinforcement Theory.26 This theory states that behaviour is the result of conscqucnces The consequences of a particular behaviour reinforce that behaviour, thereby increasing the likelihood that the behaviour will continue or recur. Therefore, employees should be rewarded if they arc behaving in a

132

manner thai is in accordance with the organisation's wishes and the organisation desires that this behaviour continue. The sooner a reward is provided for desired behaviour, the more effectively it will reinforce it. Importantly, punishment in response to an undesired behaviour is only temporarily effective in changing behaviour, and may also result in dysfunctional behaviour. If undesirable behaviour is exhibited, it is often best dealt with by non-reinforcement, such as ignoring the behaviour or not rewarding it.■ If possible, reward appropriate behaviour shortly after it occurs.Jobs Characteristics Model.26 Designing motivating jobs can increase motivation. The Jobs Characteristics Model seeks to increase work's meaningfulness by increasing the number and variety of skills that an employee is required to possess to complete the task; increasing task identity by allowing the employee to complete whole pieces of work, rather than small pieces of a larger work, and increasing the significance of the tasks to complete; providing increased responsibility to complete the task through increased autonomy; and providing information to the employee on the their performance through feedback. Using this model allows employees to leam about their performance on a task they care about.

This approach is most suitable for employees with a high growth need, bui is not suitable for low growth need individuals. This difference in the suitability of the jobs characteristics model between individuals emphasises that, despite the large number of models of motivation thai have been developed, on some occasions an individual approach will be required to motivate employees.

■Allow individuals to work on whole tasks rather than parts.

a Provide appropriate training where required to increase

skills, m Increase autonomy and responsibility, m Provide

feedback on performance.

Expectancy Theory.26 This is the most comprehensive theory about motivation. According to this theory, an individual has an expectation lhat if they exert themselves at a particular level the effort will be followed by an outcome, and the outcome will have a degree of attractiveness. The theory attempts to link motivation or individual effort to individual performance, the rewards offered by the organisation and the level of satisfaction provided towards achieving the individual's goals. The theory strongly relies on the individual's perceptions of performance, rewards and goals. This perception will vary according to individuals' personalities and needs, and in some instances, the individual's perceptions will noi be based in reality.

Expectancy theory considers individuals' perceptions of the rewards ihe activity will provide, how attractive the rewards are 10 individuals, the effort individuals must make to achieve ihe rewards, and individuals' perceptions of their abilities and skills to successfully undertake ihe activity. To maintain individuals' motivation, there needs to be a strong

organisational change found in the literature gma the impression that change is (orcan be) a rational, controlled and orderly process. In practice, however, organisational change is chaotic, often involving shifting goals, discontinuous activities, surprising events and unexpected combinations of changes and outcomes'

lies V. Sutherland K Organisational

change: a review tor health care managers,

professionals and researchers



link between the amount of effort lhat they make and the performance they achieve. The reward provided by the organisation should be attractive to

them and consistent with their goals. Using the expectancy model, motivation will decrease if individuals perceive that, despite much effort, they cannot achieve a high level of performance, that the reward provided by the organisation is not appropriate; and the reward is not consistent with their goals.a Provide adequate support so that effort by an individual will result

in performance. a Tailor rewards to the individual's

personality and needs.6.2.2.5 Motivating professionalsThe factors that motivate employees vary across different groups within organisations. As well as reflecting individual personality and skill differences, these differing motivating factors may also reflect different needs and goals between individuals of different groups in an organisation. Improving quality and safety in health services involves working predominantly with the professienals who deliver clinical care. Research has found that some motivating factors are specific to professionals in the workforce.26'27 Professionals are strongly committed to their profession, which they may view as a lifefc work. They are prepared to work variable hours and have a strong need to keep up-to-date in their fields. They like to work on important areas in their field, be challenged by problems and find solutions. They also like to be supponed by the organisation they work for. Professionals are motivated by challenging problems, and like autonomy to work on what interests them and flexibility in solving problems and implementing solutions.

Appropriate rewards for health care professionals include: providing opportunities, supponed financially and with locum cover, to attend education programs to maintain knowledge in their area of expertise; public and private recognition of their efforts in solving important problems in the organisation; acknowledgement of their value to the organisation and real interest from management in the areas and problems they are working on. A major difference between other groups and professionals in an organisation is that professionals are well paid, and therefore may not rank financial reward highly as a motivating factor.Ensure:a The proposed change is in an area clinicians consider

important. a The problem to be solved is challenging. a Adequate

support (eg, resources) is provided.

a Autonomy and flexibility are given to solve the problem and implement the solution,

m Rewards are provided to increase the knowledge of clinicians, a Recognition is given

of the efforts of clinicians to solve important problems. a Senior management has a

genuine interest in the problems clinicians are trying to solve.How hard and long individuals will persist in trying to carry out a task to achieve a goal depends

on their beliefs about their ability to successfully complete the task. If individuals have previously successfully completed a task, or if they believe they can successfully complete the task, they will be motivated to try Therefore, it is important that organisations realistically assess their employees' abilities. Appropriate training should be provided to aid motivation if organisations believe their employees abilities are below that required to successfully undertake a specific task.a Assess whether clinicians have the knowledge and skills to solve the problem, and if

not, provide the required training.6JL2.6 kmombon Diffusion TheoryDiffusion of innovations in health care is often slow, and provides a major challenge to clinicians and health services. There are three "clusters of influence" that correlate with the rate of spread of an innovation:16-20 the willingness of different groups to adopt the innovation, characteristics of the innovation, and the degree to which changes can be made to the innovation locally.



Innovation Diffusion Theory recognises different groups with regard to their willingness to adopt innovations.28 The population to whom the innovation may spread are divided into five statistically defined, but somewhat artificial, categories relative to the average time for adoption of the innovation:16'28

■ Innovators (venturesome; 2.5% of those to whom the innovation may spread) are the fastest adopters. Innovators are adventurous, cross boundaries and are able to tolerate risk. Clinical innovators are focused on new ideas and are personally heavily invested in a specialised topic. The search for innovations is best undertaken by the innovators in the service. Importantly, innovators influence early adopters.

■ Early adopters (respectable; 13.5%) have high status in the organisation and are regarded as opinion leaders. They speak with innovators and are influenced by them. Early adopters speak with each other and select what they would like to try with the aim of reducing uncertainty. The early majority adopters watch the behaviour of the early adopters.

■ Early majority adopters (deliberate; 34%) watch the early adopters and are influenced by ihem. The early majority will try what meets their immediate needs rather than just interesting ideas.

■ Late majority adopters (sceptical; 34%) are sceptical about change, but the opinions of their colleagues are important to them. They watch the early majority for local proof (rather than proof from external sources) that it is safe to adopt an innovation. They adopt an innovation when it becomes standard practice.

■ Laggards (traditional; 16%) resist change. They are traditionalists who use what is tried and true. When 15% to 20% of the potential adopters have adopted the innovation, sufficient momentum has

been generated and it is difficult to stop further dissemination.28

Opinion leaders are respected, trusted professionals who represent the social norms in the selling and are role models for other professionals in the network. Although not innovators, they are potentially key "facilitators, supporters and problem solvers"10 in any significant change. Others in the network trust them to compare the proposed innovations with the current norms and provide a valued opinion. The opinion leaders in the health service should be identified to use "the social and communication networks that are naturally developed by ... practitioners".29 Randomised controlled trials have shown that using opinion leaders to promote evidence-based practice enhances clinicians' adherence to such practice by an average of 10% in absolute terms.30

Initially, clinicians may be sceptical about the relevance and transferability of research findings to iheir patients. Therefore, they look to clinicians they trusi and regard as leaders to use ihe research findings or innovations, evaluate them and then provide information about their effectiveness and relevance to local needs and conditions. Opinion leaders remove the risk of using the findings or innovations for other clinicians.29 Most contact between opinion leaders and other clinicians occurs informally in hospital wards, telephone consultations and during hospital sponsored events. Formal communication channels, such as ground rounds and pharmaceutical sponsored events, are far less commonly used.29

However, it may be difficult to define and identify opinion leaders. There is little knowledge about what opinion leaders do or how they do it, and whether they have particular traits that affect their success. The attributes of an effective opinion leader cannot be confidently defined.'0 Opinion leaders can be identified by asking clinicians who are the opinion leaders, or asking them to judge others from a preselected list of possible opinion leaders.30 The former method may result in incomplete identification of opinion leaders if survey response rales are low.

Different opinion leaders may need to be identified to promote changes in different or complex clinical conditions and to different target groups.30 The mean number of "technical advice" opinion

leaders in each health care organisation was five (range, 3-9).30 In a survey of all clinicians in 17 health organisations in the US, some clinicians identified as opinions leaders were not recognised as such by directors of medical service.29 Many opinion leaders were proud of being viewed as such by their peers.29 Opinion leaders are important messengers, and should be chosen to actively participate in projects to implement change.■ Health services should identify innovators in the organisation and provide support for them to

systematically search for suitable innovations supported by scientific evidence by formally

searching the scientific literature, attending scientific conferences and visiting exemplar health

services or services with innovative programs.16

m Once innovators have identified potential innovations, health services should facilitate and support

meetings between innovators and early adopters, so that innovators can report on their findings,

m Health services should then provide the time and resources required for early adopters who wish

to test the changes on a small scale. These early adopters should be asked to make the changes

highly- visible so that the early majority (especially those in the target group) can observe the

process.'6 m Following successful small scale-testing of the change, the health service should

encourage social interaction between early adopters and the early majority. Early adopters could

speak to the early majority as a whole or individually. Face-to-face communication is most effective

in providing information about the effects of innovations. Importantly, the early majority should

receive information about the change from someone in their local network who they believe is

credible.'6 m Throughout these processes, it is critical that health services ensure there are frequent

opportunities, both formal and informal, for extensive communication between these various groups.Perceptions about an innovation have a significant influence on the rate it spreads, and five

perceptions are most influential:16,11

a Benefit of the change ("is it a better idea or practice than that which exists now?") — if knowledge about the innovation can be provided to individuals and reduces their uncertainty, they will be more likely to adopt it. The more unusual or unfamiliar the innovation, the greater the uncertainty, increasing the need for information about the innovation for adopters to accept it. a Compatibility with values, beliefs, past history, structures, procedures and current needs ("does it fit in with the existing circumstances?") — if current practices are acceptable to clinicians, it will be difficult for them to adopt changes, a Complexity of the innovation ("is it too complicated for our needs?") — degree of difficulty in implementing innovation. Simpler innovations spread faster, so sometimes innovations are simplified or re-invented to aid diffusion. If possible, adopt the high leverage (responsible for most of the result of the change) components of the change (eg, guideline), a Trialability ("can it be piloted and modified to fit our purposes?") — belief that the change can be

tested on a small scale without requiring extensive lime and resources, a Observability ("can we see it working well in our environment?") — can first waich others implement change.

Changes to interventions or "reinvention" at the local level are a normal part of ihc successful dissemination of innovations.■ W/h tc possible, the innovation should be perceived to be benrficial, com/Hit iblc. simple,

Itialahlc antl obsc noble.a Health services should cncoura^c intcncntions to be adapted to local needs and conditions.



Finally, motivation for behavioural change has a number of properties that should be kept in mind when trying to implement change in an organisation:21'32

■ An individual's level of motivation to change is not constant over time.■ Motivation is task-specific.■ Taking action creates motivation.■ Although goals are important to achieve behavioural change because they provide a direction for actions to take place, goals alone do not create motivation.■ Mixed feelings or ambivalence commonly accompany change. Total commitment to change is not required to commence change. If an individual feels more positive than negative about change, it can commence.■ Change is not the result of a simple decision.■ Change is an ongoing, complex process, not a destination.■ Change can move individuals out of their comfort zones and the natural response is to resist the change. Change may be an opportunity for an individual to leam and develop, to use creativity and initiative and offers challenges and stimulation, but it may often be perceived as threatening. However, the discomfort individuals feel during the change process may indicate they are moving forward.■ Individuals have different needs, personalities, skills and attitudes, and therefore different motivators. A uniform approach to motivating a group may not be successful — some individuals will need a personal approach to increase their motivation.

6.2.3 Theories related to social interaction6.2.3.1 Communication theoriesTheories about communication aim to change individual attitudes and behaviours using effective communication. The characteristics of the source of the communication (eg, credibility), the recipient (eg, prior knowledge) and the communication itself (eg, repetition, perceived validity, personal relevance and functionality) are all important.

■Adapt the message to the target group's knowledge, skills and motivation.

■ Use convincing messages presented by credible individuals, and use them repeatedly.

■Allow time for the target group to absorb, understand and accept the message.

6.23.2 Social Learning TheorySocial Learning Theory assumes a continuous interaction between the professional, his or her performance and the social environment, reinforcing each other in changing behaviour. Factors that explain changing behaviour include the individual's ability to learn by doing, observing others modelling the behaviour (demonstrating that it can be done and leads to expected results), and reinforcement by positive feedback from important others in the setting.

■ Professionals need to observe each others' behaviour.

m Professionals need to observe the behaviour of respected peers and opinion leaders as role

models, m Respected peers need to provide positive reinforcement of desired behaviour to

professionals.

6.23.3 Social network and influence theories

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The Social Network Theory descnbes how change is influenced by the structure of the social

network. Individuals do not behave in isolation, and uptake of change may depend on the strength

of lies between individuals in the network, the proportion of people who have already taken up the

change and the individuals threshold for taking up change.

■ Enhance interaction between professionals who have and have not taken up the change.The Social Influence Theory describes how an individual's behaviour is influenced by the behaviour they observe in others, the social norms in the network and the formal or informal exchange of opinions with peers and important others in a network. Change may occur after a local consensus is reached. Interactions in the social network, views of opinion leaders, expectations of significant peers and availability of education are important factors in facilitating or preventing change.Opinion leaders play a key role in these theories. Surprisingly, clinicians rarely direcdy access research or clinical guidelines, but rely on "mindlines", or internalised, tacit guidelines that are developed by brief reading, but mainly by experience and through formal and informal interactions within professional networks with opinion leaders, and interactions with patients and pharmaceutical representatives (who are often regarded with considerable scepticism).33 Opinion leaders play a key role in influencing the clinical decisions made by other doctors who respect them. Importantly, opinion leaders' knowledge should be based on the best available evidence.

a Study interactions in the network and identify the opinion leaders.m Seek the support of opinion leaders for the proposed change.m Emphasise to opinion leaders that they have a key role in modelling the behaviour required for the proposed change, changing the social norm in the target group and disseminating information.

a Ensure that opinion leaders have ready access to high-quality evidence about best practice.a Ensure that adequate opportunities are available for networking formally and informally betweenclinicians and those they regard as opinion leaders.

6.2.3.4 Theories related to team effectivenessTeams' success relies on many factors, including: having clear, common goals; the presence of a

team champion; the sharing of information; trust; participative decision making; encouragement for

new- ideas; few conflicts; a commitment by team members to perform to the best of their ability;

support for the proposed change; and the size and mix of the membership of the team.

a Develop common goals and targets.m Encourage participative decision making.

6.2.3.5Theories on professional developmentHealth professionals have considerable autonomy in making decisions about clinical care. They have a strong loyalty to their profession, which is probably greater than their loyalty to their hospital Professional standards set by professional bodies influence the behaviour of individual professionals. Therefore, where possible, it is useful to propose changes that are consistent with professional standards, as such changes should be easier to implement.

a Where possible, seek a standard for the area of change being proposed developed by the relevant professional body and use it to develop a local standard.

a Use professional pride, professional standards and loyalties to help implement change.AJ.3.6 Theories on leadershipLeaders can be influential in facilitating or obstructing change. The leadership required by an organisation may vary with the type of change being proposed. Leaders may have formal authority or be informal leaders by possessing valued expertise or skills or belonging to a key group in the

hospital. Leaders can support change by achieving goals or changing the organisation's culture. The involvement and commitment of senior hospital management is a critical to the success of any proposed major changes to patient care — it can increase productivity and staff satisfaction. 34,35

Management staff can demonstrate their commitment to major change projects by making them pan of the hospital's strategic plan.Strategies that consistently improve quality include: engaging physicians, training personnel, building systems, effective delegation and accountability, personal involvement and modelling of values, a flexible strategy with resources, and creating a vision.36

■ Identify the formal and informal leaders in the relevant area.m Inform leaders about how they can use their power and influence to continuously support the proposed change (eg, initiating activities, modelling the desired behaviour).

■ Ensure the support of senior management for the proposed change.

6.2.4 Theories related to organisational context

6.2.4.1 Theories of innovative organisationsThe characteristics of organisations that adopt change more quickly and easily include: highly specialised individual roles, a high level professionalism, decentralised decision making, available technical knowledge, good internal and external communication and a positive attitude to change among leaders and managers.37

■In health care organisations, specific individuals, more than the organisation as a whole, have been shown to be responsible for and influential in achieving change

m Engage the support of the professional who is most influential regarding the proposed change.

m Promote participation in the change process.

m Delegate decision making about the change to multidisciplinary teams.

■Increase the level of responsibilities at the clinician-patient interface.

6.2.4.2 Theory of Quality ManagementTotal quality management or continuous quality improvement "refers to a management process directed at establishing organised continuous improvement activities, involving everyone in an organisation in a totally integrated effon toward improving performance at every level".39 Quality management continuously examines the processes in a system in an iterative approach using a plan-do-study-act cycle. According to this theory, change can only be successfully achieved by changing the system. The process is organisation-wide, uses multidisciplinary teams and is patient-centred.Clinical activity is continuously monitored, data collected and variation in care is analysed statistically and if appropriate reduced. Uncontrolled variation in processes is regarded as the cause of quality problems and requires control by those working at the front line to improve quality.40

There is a continuous cycle of monitoring, analysing, making appropriate changes and then continuing to monitor their effects.Total quality management requires strong leadership to create an appropriate culture in which staff are a key element. Physician involvement in the process and concentration on patient care, rather than cost saving, is crucial 41 However, quality management has not had a dramatic impact in health care, as it has in other industries. Importantly, the evidence of its effectiveness elsewhere was anecdotal and usually comprises case descriptions of its implementation in individual companies written by their staff 40

Senior management staff in administrative areas of hospitals have used quality management, but there has been little evidence in the scientific literature of its effectiveness in improving clinical outcomes. Many clinicians are sceptical of the process and view it as a passing fad. The


6 Taking action to close gaps in care and prevent adverse events <*cumng

decentralised control lhat is a major feature of quality management can be threatening to senior management. Successful innovation in organisations requires a customer focus (particularly understanding their needs), suppon from leaders, the organisation keeping to its mission, and obtaining information about best practices from other organisations.42

Newer methods of quality management have met some of the requirements discussed here, but their effectiveness in terms of cost, time demands and applicability to clinical practice has not been studied.43

■ Examine processes of care in the system for which change is proposed and change them if necessary.a Use an ongoing cycle of continuously monitoring activity, analysing the results, planning and

mahing changes and monitoring their effects.

6.2.4.3Process Redesign Theory and theories of integrated careThese theories aim to improve the organisation and management of care processes so that optimal patient-centred care is provided. They involve analysing and redesigning multidisciplinary care processes and using clinical pathways. The redesign may be radical or gradual, and can involve task reallocation, information transfer and greater coordination of care between health professionals. A case manager may be appointed for areas where clinical care is complex. The redesign may involve the delegation by medical staff of some duties to nursing, allied health and non-clinical staff. Reminders to healih professionals and feedback about their performance are imponant elements of the process.

a Analyse, reconsider and redesign related processes of care that make up a system so that they cm be optimally delivered and integrated into normal routine patient care.

6.2.4.4 Complexity TheoryHealth care is a complex system with many interconnected components that interact continuously and can behave unpredictably. These interactions are more imponant than actions on the components of system. Small influences in one part of system can have large effects on other pans of system, so targets for parts of systems may not be met. The system should be viewed as a whole, rather than concentrating on its parts, and simple goals should be set for the whole system.

The conditions under which strategies are developed to implement a change in practice will change over time. Therefore, the strategies initially developed may require change as implementation progresses. Dealing with changed conditions may be assisted by an external facilitator, who maintains regular contact with opinion leaders and other relevant clinicians participating in the change project to help with problem solving and deal with unanticipated challenges as they arise.15

6.2.4.5 Theory of Organisational LearningA learning organisation can change its behaviour when new knowledge is acquired by individuals in the organisation. Barriers to organisational learning include problem solving in pans without considering interactions, changing by reacting rather than continuously trying to improve and focusing on competition rather than cooperation leading to an emphasis on short term results rather than long-term solutions

A learning organisation:44""1 a uses the collective learning experience of all employees a knows what is happening outside the organisation

1»


■ allows its employees to learn through open communication, making all information (positive and negative) readily accessible and allowing debate and experimentation while tolerating failure and supponing ongoing education at all levels■ uses measurement as a source of learning■ has leadership that is involved, interactive and suppons staff and change■ has a common picture of the gap between actual and desired performance■supports new ideas at all levels■ demonstrates its learning by changing routines and embedding the change.The components of a learning Organisation will be discussed further in Chapter 9.

■ Ensure the collective knowledge in the organisation is used to change behaviour.

m Encourage continuous information sharing and experimentation in problem solving.

■ Find out how other organisations are dealing with this problem.

m Ensure leaders support the change project and are actively involved,

m Offer opportunities for continuous learning.

6.2.4.6 Theories on organisational culture

Organisational culture is difficult to define. Is culture "something an organisation possesses" or does culture itself define "the whole character and experience of organisational life"?47 Is the culture of an organisation linked to its performance? If so, can a change in an organisation's culture change its performance?47 It is postulated that there are four types of cultures depending on the position of the organisation along two continuums: flexibility-control and internal-external orientation. Changes in teamwork, flexibility and external orientation can stimulate changes in performance. However, cultures emphasising formal structures and regulations are detrimental to quality improvement activities.■Aim to create teamwork, flexibility and an external orientation.

6.2.5 Theories related to the political and economic context

6.2.5.1 Economic (reimbursement) theoriesReimbursement may influence individual and organisational performance. The nature and liming of reimbursements and incentives for clinical services influence how care is provided. Fee-for-service payments result in additional actions being undertaking by clinicians, which can be targeted toward implementation of quality improvement activities.■ Use material and non-material rewards and incentives (eg, increased budget or staff, support for educational activities) to encourage and reward appropriate behaviour and good results.

6.2.5.2 Theory of Contracting

Quality standards and targets could be incorporated into clinicians' contracts. The contractual specifications could include the use of specific clinical practice guidelines and targets for process criteria for recommendations in these guidelines.

6.2.6 Theories related to patients6.2.6.1 Theories on factors related to patientsPatient expectations and behaviour and their care providers' perceptions about these expectations can influence care. Patients could be informed about major programs to change clinical care. They could be informed of large change programs via news media, and local quality improvement initiatives when they

140


are admitted to hospital. Caution would be needed to ensure they correctly understood the aims

of the program and how it affects their care during their admission. Patients could remind

professionals about this part of their care during their stay in hospital.a Consider whether patients could act as facilitators of change in any change program.

6.3 Approaches to change

Numerous theories of change in human behaviour have been described and practical strategies distilled from each. Many of these theories and strategies have been grouped together to develop several general approaches to change. These approaches will be briefly described and various strategies described in detail.

Different disciplines have developed different approaches to implementing change. These approaches are based on assumptions about how people behave individually, in groups and in organisations. These assumptions are, in turn, based on many theories of behavioural change and have been used in different approaches to assist in understanding and implementing change in health services. These approaches can be divided in two groups of influence on behaviour — internal and external to the individual.18

Internal influences include a desire by some individuals to achieve competence in a particular area (small group interactive education sessions are used); others have a desire to make rational decisions based on evidence (evidence-based guidelines are used) and marketing influences (products are designed to meet an individual's needs and influence their behaviour). In these approaches, change comes from within the individual and satisfies an inner need, and the individual takes personal responsibility for making the change. The emphasis is on processes internal to the individual and is found in the educational, epidemiological and marketing approaches.18

External influences include the conditioning of particular behaviour (using feedback, reminders and incentives); social influences (the opinion of experts are important); a managerial approach (the system is redesigned to influence behaviour); and the use of external power (using legislation, regulation and discipline). The change comes from external influences and is found in the social interaction, managerial and control and compulsion approaches.18

These approaches are listed below together with associated interventions and strategies (adapted from Grol18) (Table 6.2). There is no evidence that any one of these approaches is more effective than another.

6.4 Developing change strategies

Multiple theories describing individual and organisational behavioural change have been developed However, there is no single coherent and unified theory to explain the factors that facilitate and impede change. The lack of a theory and the absence of robust, generalisable evidence for implementation makes it difficult for health professionals and senior managers to make rational decisions about which change strategies to use.48 "We generally have very limited understanding of the factors that determine the success of a quality improvement intervention."4

A theoretical framework for interventions is needed to explain and predict the behaviour of individual health professionals, clinical teams, health organisations and health systems. Implementation strategies should be evaluated through the stages of theory, modelling,

exploratory tnal, definitive randomised controlled trials and long-term implementation — similar to the process of evaluating new medications

Ifcble U Approaches to Implementing changeOwaoach

Focus Intervention; strategies

Education*

Internal motivation to achieve Interactive small group

learningprofessional competence Problem-based learning using

problems faced each dayEpidemiological Rational

decision making

Provide convincing and credible evidence (eg. guidelines)

based on evidence

Moftoting Attractive proposal for change

Conduct a needs analysis — adapt change to meet needs

based on target group needs

Adjust change to local conditions

Disseminate change widely — personally and throughmedia

External Behaviour directed by

Feedback about performance — compared with others

influence

external influences before

Reminders

or after a specific action —

Rewards

conditioning SanctionsSocial Influenced by

other peopleUsing opinion leaders to influence others



interaction considered important

Outreach visits from experts — academic detailingPeer reviewPatient pressure to use an innovation

Managerial

Creating conditions for

Changing system

change Redesigning care processesPoor quality is equated withsystem failure

Control and Use external power to change

Legislation

compulsion behaviour—will want to avoid

Regulation (eg. accreditation)

negative consequences

Contracts

Disciplinary measuresBudgeting

Without such evaluation, current implementation research is similar to introducing an antihypertensive drug without understanding its pharmacology, the physiology of blood pressure, the pathophysiology of blood pressure control, and conducting trials in animals.49

Where possible, strategies for implementing change should be considered that match the determinants (barriers and facilitators) for the change, the systematic determinant analysis of the proposed change, and the target group, patients, organisation, and sociopolitical context.22 Each part of the change may need its own implementation strategy. Further, more barriers and facilitators will probably be identified than can be appropriately addressed, so barriers and facilitators should be ranked according to their imponance and changeability.22

Often, interventions for overcoming barriers will be developed using "evidence of effectiveness when available, as well as experience, commonsense and creativity",50 theory, personal preference, intuition, familiarity22 51 and personal and potentially biased beliefs about human behaviour and change,10 rather than formal and objective methods.

When people are planning changes they often adopt a naive and opportunistic attitude. A strategy is usually chosen quickly and often does nor produce the expected result ... Until we have gained a better understanding, the most practical advice to individuals responsible for changing and improving practice is to be aware of their own assumptions about human behaviour and change.10

Importantly, the barriers to effective implementation may be due more to organisational problems than to individual doctors who, after superficial analysis, are often cited as the barrier.

The rationale for choosing particular implementation interventions for research is usually not given. Analysis of barriers often influences the content of the implementation intervention, rather than the selection of the type of intervention. Design of implementation interventions is still in its infancy and "the translation of identified barriers to tailor made implementation interventions is still a black box".51 A review of the use of guideline dissemination and implementation strategies found few studies that explicitly stated the rationale or theory behind why particular interventions were selected, and selection could have been based on an assessment of causal mechanisms or a "kitchen sink" approach.48 "It is plausible that multifaceted interventions built upon a careful assessment of barriers and coherent theoretical base may be more effective than single interventions."48

Strategies to promote professional behavioural change that could be used to implement research findings are: (adapted from Grimshaw and colleagues52):

a educational materials — distribution (by mail or personal delivery) of

recommendations for clinical care, including clinical practice

guidelines a participation by health care providers in conferences,

lectures and workshops

a local consensus process to develop an appropriate agreed guideline

and

intervention process a

educational outreach visits

a local opinion leaders

a patient-mediated interventions — specific information sought from or

given to patients a audit and feedback

a reminders

a marketing — personal interviewing, focus groups, surveys of targeted

providers to identify barriers and the design of interventions to

address these barriers

a multifaceted interventions — any intervention lhat includes two or

more of ihe above.Some barriers, such as lack of knowledge, have a logical strategy to

overcome ihe barrier, but may require additional resources. However, for some barriers, such as changing the organisational culture, there is no logical, directly applicable strategy. Other barriers, such as clinician workload and lime availability, require senior management input to address, which should be a key role of ihe executive champion on the change project team.50 As with best practice in clinical medicine, where


(Many concept* described here] can ba implemented in many different ways, not at of them observing the core principles although they may sport the label.

lies V. Sutherland K Organisational

cnange a review lor health care managers,

protessio-ials and

researchers


possible, ihe strategies chosen to implemeni change should be supported by high-quality scientific evidence of their effectiveness. Although such evidence is often limited, a literature search should still be conducted as part of the planning process to determine


6J IwptoxarwnU achieved with Implementation interventions*4

No. of

Msdlsn absolute improvement randomlaad (range)

controlled trials Dissemination of educational materials

Audit and feedback

Reminders

Mufti faceted interventions

incorporating education outreach Opinion leaders30

+8.1% (+3.6% to+17%) 4

+7.0% (+1.3% to+16%) 5

+14.1% (-1.0% 10+34%) 14

+6.0% (-4.0% to+17.4%) 11

+10% (-6.0% to +25%) 12

which strategies, if any, have been previously used to successfully implement similar changes in similar settings.

Adding further complexity to the selection of strategies is that dilferent strategies may be needed to implement change in each of the subgroups of the target group. The effectiveness of individual implementation strategies varies with many of the determinants discussed earlier, and a strategy effective in one setting may be ineffective in another. Using a combination of strategies may increase or decrease the overall effectiveness of the plan, be more difficult and require more effort to implement, and may increase costs. Also, with multiple strategies, there will be a limit to the amount of energy within the organisation available to implement change at one time.

6.5 The evidence about change strategies

The first systematic review of trials of interventions to improve professional practice (aptly entitled No magic bullets) examined 102 studies published between 1970 and 1993, and classified strategies according to their effectiveness as:■ Generally ineffective — lectures, publication of research and mailing of information.

144


■ Variably effective — audit and feedback, local opinion leaders, local consensus and patient mediated intervention.

145

Enhancing P*twnt care

■ Generally effective — reminders to perform actions (manual or computerised), small group interactive problem based educational meetings, academic detailing and multiple strategies chosen after an analysis of potential barriers to change.33

A review of 41 systematic reviews of interventions 5 years later found modest improvements with active (eg, reminders and educational outreach) and multifaceted interventions, but passive interventions (eg, mailing guidelines to targeted clinicians) when used alone were largely ineffective in changing behaviour. Audit and feedback and the use of local opinion leaders were variably effective approaches. Reminders and educational outreach aimed at changing prescribing behaviour were found to be generally effective. No strategies were effective under all circumstances. Multifaceted interventions aimed at addressing potential barriers to change were more effective than single interventions,52 although it was difficult to separate the effective components. A further review in 2004 showed modest but consistent median absolute improvements of approximately 10% in process measures, with wide variations in effect size54 (Table 6.3).

There were two very different conclusions in this review from earlier ones — there was no significant difference in the effect sizes of multiple and single interventions, and passive

146


interventions showed modest but consistent improvements.54 For exam-ple, the use of printed educational material resulted in improvement and has the advantages of low cost and feasibility in individual health services.48 Further, the effects of multiple interventions did not increase with the number of interventions used.48 In conclusion, "uncertainty remains as to the likely effectiveness of different quality improvement strategies",48 and "general conclusions about what works are still tenta-tive."4

Funher complicating the issue are the results of a review by Shojania and colleagues of the effects of 11 quality improvement strategies on glycaemic control in patients with type 2 diabetes.55 They reviewed 66 trials (including 50 randomised controlled trials). As with previous reviews of quality improvement strategies, most strategies produced small to modest improvements in glycaemic control. However, two strategies, team changes and case management, were associated with the largest pooled reductions in glycated haemoglobin.

Case management was defined as "any system for coordinating diagnosis, treatment or ongoing patient management ... by a person or multidisciplinary team in collaboration with or supplementary to the primary care clinician". Team changes were defined as "changes to the primary care team including adding a team member (eg, nurse specialist in diabetes care, pharmacists, nutritionists, podiatrists) or using multidisciplinary teams ... in ongoing management, or expansion ... of professional roles (nurse ... adjusting medication)".55 An evaluation of the resources required to use each strategy was not made, but it is likely that case management and team changes are resource-intensive when compared with other less effective strategies.

6.6 Change strategies commonly used at the

Wimmera Health Care Group

The effectiveness of most change strategies is disappointing. Health services have therefore looked to other industries for guidance. Quality management and analysis and redesign of service delivery processes and systems (described earlier in this chapter) have been used extensively to reduce errors in other complex industries. Briefly, quality management (also called continuous quality improvement or total quality management) involves a continuous cycle of analysing quality problems, determining solutions, taking appropriate action, monitoring the effects of these actions and then determining whether further action is required. In process redesign (also called re- engineering), the processes that make up a health care delivery system arc analysed and redesigned with the aim of optimising patient care.

We have found these strategies effective in improving the quality and safety of health care delivery at the Wimmera Health Care Group,

147

•.wh*n(ta*9,wmf

management] hm been tried in hoapt^t eo far doctor* are not effective on quality

improvement teams. They arrive lata or not at all to the meeting*, they dominate when they are present; and they sometimes leap to solutions before the team has done its « proper diagnostic work on the process *

Berwick D etal BMJ1992: 304 304

306

Enhancing P*twnt care

although the results we have obtained may be specific to the contcxt in which we work

148


Some authors have criticised the use of these strategies because they have not been evaluated to the standard of clinical research, and their

effectiveness is only supported by observational and anecdotal evidence rather than high- quality experimental studies.4 However, the lack of strong evidence may reflect the lack of high-quality studies, rather than the ineffectiveness of the strategies.56

At the Wimmera Health Care Group, quality management is used and processes are redesigned to improve systems using three main strategies, as described below.

6.6.I Simplifying systems and tasks (to reduce complexity)By reducing the number of processes in a system,

the probability of unintended and unpredictable outcomes is reduced. For example, if a system has eight processes and the probability of any single process failing is 10%, the probability of a system failure due to one or more process failures is l-0.98 = 0.57. If the complexity of the system is decreased to five processes of care, the probability of the system failing due to one or more process failures drops to 1 -0.95 = 0.41.

6.6.2 Standardising procedures (to reduce unwarranted variation)If procedures are consistently performed in the same way, the probability of unintended negative events occurring will be reduced. In hospitals, variations in the way medications are prescribed or different types of equipment are used for similar purposes are common. These variations usually add little to the quality of care provided, but increase the probability of adverse events occurring. For example, there are several equally effective protocols that can be used for commencing patients on anticoagulation therapy. If more than one protocol is used commonly in a hospital, it is possible that two protocols will be confused and an error may result. If junior doctors and nursing staff are trained to use only one anticoagulation protocol, this will reduce variation in care delivery and thereby reduce the probability of associated adverse events.

Standardisation is important for achieving quality improvement, but there is a lack of standardisation in providing evidence-based or guideline adherent health care. Some doctors are resistant to standardisation and label the approach "cookbook medicine". However, "they fail to acknowledge that if you have a good cookbook and follow the instructions, you can expect to achieve the intended outcome".57

149

'At the organisational iM( fwnuw from consktamgan innovation to successful routinamg H is generally a nonlinear process characterized by multiple shocks, setbacks and unanticipated events.'

Greenhaigh. et al 2004. citing Van de Ven AH. et al.

The innovation journey


In a study of vulnerable patients aged over 65 years old and living in the community, those provided with higher-quality care in accordance with 21 quality indicators (eg, pneumococcal vaccine, falls assessment, weight measurement, cognitive screen) lived longer — 28% of patients who received 44% of the recommended care died in the following 3 years, compared with 18% of patients who received 62% of the recommended care. The authors concluded "better performance on process quality measures is strongly associated with better survival among community-dwelling vulnerable older

adults".38 Sometimes there can be a significant delay between the provision of some processes of clinical care and the resultant positive patient outcome. Such delay can limit the motivation of doctors to comply with these processes of care. Although achieving standardisation in the delivery of care requires substantial work, it should be a key component of quality improvement programs.57

6.6.3 Using reminders end checklists (to decrease dependence on memory)Clinical trials provide information about an increasing number of interventions that, if used, benefit the health of patients with panicular clinical conditions. As a result, medical care is becoming increasingly complicated. Frequently, the most beneficial medical care comprises a number of investigations, medications and other treatments. Often, medical staff are required tc^ recall detailed treatment plans for medical conditions from memory, without other information sources being readily available. Health professionals are often expected to function at an unrealistically high cognitive state, requiring heavy reliance on accurate recall from memory.59

If there are 10 important steps to be followed in the management of a patient with a particular medical condition, is it reasonable to expect clinicians to be able to recall perfectly all 10 steps from memory for each of the next 100 patients that they treat with that condition? A simple way to reduce this heavy reliance on human memory, with its inherent unreliability, is to use comprehensive checklists and reminders. In their most complex form, these checklists and reminders form a detailed patient pathway that maps a complete treatment plan for patients with particular medical conditions for each day that they are in hospital. Often, a simple checklist requiring each treatment step to be initialled is sufficient to ensure clinical staff are reminded of all the steps they need to take when treating a patient in a particular clinical situation.

Checklists have been a key instrument in reducing errors in aviation, aeronautics and product manufacturing. A checklist is "a list of action items or criteria arranged in a systematic manner, allowing the user to record the presence/absence of the individual items listed to ensure that all are considered or completed" 60 "Typically, each item is checked off as it is completed, verified, identified or answered, by placing a mark in a designated space" 61 Checklists aim to reduce error and increase adherence to best practice. They improve the recall of items and standardise processes. Checklists may be paper-based or electronic. In health care, it can be difficult to standardise all care processes because of patient variation. Resistance to checklists can arise because they could be perceived as an admission of weakness in not being able to recall of the treatment processes required, or limiting clinical judgement and the autonomy of decision making 60

Expert panels can design effective checklists in a particular clinical area using prepublished guidelines of best practice in that area and

"... one ct ihe moat important issues in dosing the loop on safety initiatives * taking a scientific approach to assessment of t behavioural change strategies are indeed being applied, and whether they are achieving the desired patient outcome This feedback is only possible with rigorous surveillance, audits, and other observational studies, followed by reinforcing strategies when needed.'

Cook DJ. et al Lancet 2004: 363 1224-1230



conducting small-scale tests of draft checklists until appropriate checklists arc developed

Checklists should not be developed for all decisions required to be made by clinicians, as there is a risk of 'checklist fatigue* developing.61

Ultimately, checklists can only act as guides and prompts for clinicians to remind them of all the steps required to treat patients with particular conditions. Checklists cannot provide advice that is totally appropriate for every patient with a specific clinical condition. The variation in care given to patients while clinicians are using guidelines can be as high as 25%, due to important differences between individual patients. For example, patients with the same primary condition, which would benefit from treatment given in accordance with the guidelines, may have different comorbidities that could affect which treatment would provide them with the most benefit.

When using clinical guidelines, it is appropriate to provide treatment that deviates from sections of the pathway guidelines when recommendations are not appropriate for an individual patient. Deviations from guidelines, and the reasons why the deviations were necessary, should be documented in the medical record. Analysis of these deviations can be used measure compliance with processes and to detect adverse events, which further improve the guidelines.

The effectiveness of using reminders and checklists is demonstrated in a study of 100 intensive care units in Michigan in the US. The study aimed, among other things, to reduce the number of patients with catheter-related bloodstream infections following insertion of central lines. Five evidence-based behaviour-specific interventions were introduced: wash your hands, use full barrier precautions, prepare the insenion site with chlorhexidine antiseptic, avoid the femoral site for insertion, and remove unnecessary lines. A checklist of these actions was created for doctors. The nurses assisting them were empowered to perform an independent check and ensure that the doctor followed each for the actions under non-emergency conditions. The proportion of intensive care units observed with no catheter- related bloodstream infections increased from 59% at baseline to 80% 7-9 months after implementation of the strategy.62

6.6.4 Introducing constraints (to make performing en error more difficult)Constraints are incorporated into systems to make it more difficult to take an action that will increase the probability of an adverse event. For example, the design of an item of equipment can be a constraint. Two items of equipment, if inadvertently joined, may result in an adverse patient event. If the two pieces of equipment cannot be physically joined because of the way they are designed, the adverse event cannot occur. A junior resident being unable to directly discharge a patient from an emergency department without the patient being reviewed by a senior doctor is another example of a constraint.

6.6.5 Providing timely delivery of adequate and accurate information (so that decisions can be made with appropriate data)Designing a system appropriately should result in the right clinical information being available in the right place, to the right person, and at the right lime. Examples include a patient's biochemistry and haematology results being available in the emergency departmeni immediately after their blood samples have been analysed in the laboratory; a copy of the patient's discharge summary for their previous admission to the hospital being available to the resident medical staff when the patient re-presents to the hospital's emergency department; and a typed list of the patient's discharge medication following a recent hospital admission being available lo the patient's general practitioner when the patient presents to them for follow-up.

Other system changes include:



■ building buffers into systems so that if errors occur, their effects are absorbed before causing harm to

patients■designing processes so that taking the correct action is ihe easiest action to take■designing processes that are consistent with human abilities to manage stress, time pressures

and workloads (given the limits of human memory and the limitations on human performance due to circadian rhythm)

■carefully automating systems so that staff know in which situations to over-ride the automation.

6.7 Actions commonly taken to prevent adverse events that are

generally ineffectiveIt is important to comment on those strategies aimed at changing clinical behaviour that are ineffective, because in our experience they are still commonly used in health care. Firstly, medicine has traditionally used a punitive model to attempt to change clinical behaviour. Individuals are blamed for adverse events that occur while care is being provided. There is an expectation that health fare professionals should deliver care perfectly. If an adverse event occurs, it is regarded as the fault of the health care professionals providing care to the patient. The clinicians involved are frequently punished, told to try harder and to be more careful.

Although punishment has not been shown to prevent adverse events and may be counterproductive, it is still commonly used. Some weaknesses in complex systems may not be evident until a serious adverse event occurs, several minor events or near misses may have previously occurred. Staff are less likely to report these events if they fear punitive action being taken. The system may therefore remain weak until a serious adverse event occurs.

Secondly, attempts are frequently made to change clinical behaviour by creating or changing clinical policies and issuing memoranda. After an adverse event, a clinical policy may be issued as a memorandum to prevent the event recurring. However, with constantly changing clinical staff in many hospitals it is difficult to ensure that a policy detailed as a memorandum is followed. In our experience, prompts, reminders and extensive training are also required.

■ Implementing and sustaining change is the most difficult part of quality improvement and risk management■ There are many determinants (both facilitating and impeding) of the success of implementing change. They in>«tve the change itself, the target group, the organisation, patients and the sociopolitical context. The effectiveness of implementation strategies can be sensitive to differences in the characteristics of each of these groups.■ A single unifying theory of changing human behaviour has not been developed. There are many theories (often overlapping) from a variety of disciplines that can be used to understand various aspects of human behaviour. They provide a range of potential strategies for implementing change. There is, however, little scientific evidence to support many of these theories.■ Due to the complexity of health care delivery systems and the large number of determinants of implementing a change, a comprehensive and systematic approach is required to identify major

determinants, their effect on the change and their changeability. Strategies developed from theories of behavioural change often need to be selected and implemented to address the major determinants.■ Many strategies used by health services to implement quality improvements and reduce risk are not evidence-based. There is limited evidence about what is effective in implementing change to improve quality. Most quality improvement strategies have a modest effect (10% in absolute terms), with a wide• effect range. Single quality improvement implementation strategies may be as effective as multiple strategies.■ Although not supported by high-quality evidence, our experience (which may be specific to the Wimmera Health Care Group) of using a combination of quality management and system redesign to: simplify systems and tasks: standardise procedures: use reminders and checklists: and introduce constraints and provide timely delivery of adequate, accurate information has been effective in implementing and sustaining change to improve quality and safety.

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dissemination and implementation of clinical practice guidelines. Oual Sal Health Care 1999; 8: 177-18320 Prochaska JO. DiClemente CC. Norcross JC. In search of how people change: applications to addictive behaviours. Am Psychol 1992; 47: 1102-1114.21 Grant A. Greene J. It's your life. What are you going to do with it? 2nd ed. Harlow: Pearson Education. 200422 van Bokhoven MA. Kok G. van der Weijden T. Designing a quality improvement intervention: a systematic

approach. Qual Sat Health Care 2003; 12: 215-220.

23 Grol R. Implementing guidelines in general practice care Qual Health Care 1992: 1: 184-191.

24 Lewis AP. Bolden KJ. General practitioners and their learning styles. J R Coll Gen Pract 1989: 39: 187-189

25 Ajzen I. The theory of planned behaviour. Organ Behav Hum 1991: 50: 179-211

26 Robbins S. Bergman R. Stagg I. Coulter M Management. 4th ed Sydney: Pearson Education. 2006

27 Alpert M. The care and feeding of engineers Fortune 1992; Sep 21: 86-95

28 Rogers EM. Diffusion of innovations. 4th ed New York: Free Press. 1995

29 Collins BA. Hawks JW. Davis R. From theory to practice: identifying authentic opinion leaders to improve

care Managed Care 2000: 56-62.

1S1

30 Ooumt G, Gatteilari M, Grimshaw J, O'Brien MA. Local opinion leaders: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2007; (1): 1-28.

31 Brafthwafte J. Travaglia JF. An overview of clinical governance policies, practices and initiatives. Aust Health Rev 2008:32: 10-22.32 Grant A. Greene J. Coach yourself O work. Get yourself a (working) life. Sydney: ABC Books, 2005.33 Gabbay J, Ie May A. Evidence based guidelines or collectively constructed "mindlines?" Ethnographic study of knowledge

management in primary care. BMJ 2004; 329:1013-1016.

34 Weiner B, Shortell S, Alexander J. Promoting clinical involvement in hospital quality improvement efforts: the effects of top

management, board and physician leadership. Health Serv Rev 1997; 32:491-510.

35 Rodgers R, Hunter JE, Rogers DL. Influence of top management commitment on management program success. J Appl Psychol 1993; 78: 151-155.

36 Ovretveit J. The leader's role in quality and safety improvement; a review of research and guidance; the 'Improving Action

Evaluation Project." Fourth report. Stockholm: Association of County Councils (Lanstingsfor- bundet), 2004.

37 Damanpour F. Organizational innovation: a meta-analysis of effects of determinants and moderators. Acad Manage J1991; 34:

555-590.38 Scott WR. Innovation in medical care organizations. Med Care Rev 1990; 47: 165-192.39 AJmaraz J. Quality management and the process of change. J Organ Change Manag 1994; 7: 6-15.40 lies V, Sutherland K. Organisational change: a review for health care managers, professionals and researchers. London: National

Co-ordinating Centre for NHS Service Delivery and Organisation R & D , 2001.41 Blumenthal D, Kilo CM. A report card on continuous quality improvement. Milbank Q 1998; 76: 625-648.42 Gustafson DH, Hundt AS. Findings of innovation research applied to quality management principles for health care. Health Care

Manage Rev 1995; 20:16-33.

43 Grol R. Improving the quality of medical care: building bridges among professional pride, payer profit, and patient satisfaction. JAMA 2001: 20: 2578-2585.

44 DiBella AJ. Nevis EC, Gould JM. Understanding organizational learning capability. J Manage Stud 1996; 33:361- 379.

45 Nevis EC, DiBella AJ, Gould JM. Understanding organizations as learning systems. Sloan Manage Rev 1995:36: 73-85.

46 Lahteenmaki S, Toivonen J, Mattila M. Critical aspects of organizational learning research and proposals for its measurement. Br J Manage 2001; 12: 113-129.

47 Scott T, Mannion R, Marshall M, Davies H. Does organisational culture influence health care performance? A review of the

evidence. J Health Serv Res Policy 2003; 8:105-117.

48 Grimshaw J, Eccles M. Thomas R, MacLennan G. Toward evidence-based quality improvement: evidence (and its limitations) of

the effectiveness of guideline dissemination and implementation strategies 1966-1998. J Gen Intern Med 2006; 21: S14-

S20.

49 Eccles M, Grimshaw J, Walker A, Johnston M. Changing the behaviour of healthcare professionals: the use of theory in promoting

the uptake of research findings. J Clin Epidemiol 2005: 58: 107-112.

50 Schouten JA, Hulscher ME, Natsch S, et al. Barriers to optimal antibiotic use for community-acquired pneumonia at hospitals: a

qualitative study. Oual Saf Health Care 2007; 16:143-149.

51 Bosch M, van der Weijden T, Wensing M. Grol R. Tailoring quality improvement interventions to identified barriers: a multiple case

analysis. J Eval Clin Prac 2007; 13: 161-168.

52 Grimshaw JM. Shirran L, Thomas R, et al. Changing provider behaviour: an overview of systematic reviews ol interventions. Med Care 2001; 39: ii2-ii45.

53 Oxman AD, Thomson MA, Davis DA, Hayes RB. No magic bullets: a systematic review of 102 trials of interventions to improve

professional practice. CMAJ1995; 153: 1423-1431.

54 Grimshaw JM, Thomas RE. MacLennan G, et al. Effectiveness and efficiency of guideline dissemination and implementation

strategies. Health Technol Assess 2004; 8: 1-84.

55 Shojania KG. Ranji SR, McDonald KM, et al. Effects of quality improvement strategies lor type 2 diabetes on glycemic control JAMA 2006: 296: 427-440.

56 Ovretveit J. What are the best strategies for bensuring quality in hospitals? Copenhagen: World Health Organization Regional

Office for Europe's Health Evidence Network, 2003.

57 McGlynn EA. Intended and unintended consequences. What should we really worry about? Med Care 2007, 45 3-5.

58 Higashi T, Shekelle PG, Adams J, et al. Vulnerable older patients receiving higher quality care survive longer Ann Intern Med

2005; 148: 274-281.59 Leape LL. Error in medicine. JAMA 1994; 272: 1351-1857.60 Hales BM, Pronovost PJ. The checklist — a tool for error management and performance improvement. J Crit Can2006; 21:231-235.61 Hales B, Terblanche M, Fowler R, Sibbald W. Development of medical checklists for improved quality of patient care. Int J Qual Health Care 2007; 1-9.

62 Pronovost PJ. Berenholtz SM, Goeschel CA, et al. Creating high reliability in health care organizations. Health Serv fles2006; 41:

1599-1617. □Enhancing patient care



7 A practical framework to close gaps in patient care and reduce risks to patients

This chapter will:m Present a practical, step-by-step framework to close gaps and

reduce risks■ Discuss why it can be difficult to motivate doctors to participate in

quality and safety programs■ Present strategies to help engage doctors in quality and safety

programs■ Describe how the framework was used to develop clinical

pathways and improve the management of patents with stroke■ Present a checklist to close gaps and reduce risks.

«

It is easy to understand why improving the quality and safely of health care delivery is so difficult — health care delivery systems are complex and comprise many parts that often interact unpredictably. A single unifying theory of change in human behaviour on which to base change strategies is not available. Instead, many theories of human behaviour, often with substantial overlap, have been developed in an attempt to explain and predict behaviour (described in detail in Chapter 6). These theories have resulted in the development and use of many strategies (often of modest or unknown effectiveness) to address the multiple determinants of implementing change, which are sensitive to characteristics of the intervention, target group, patients and organisation.How, then, should individual health services try to close gaps and reduce risks? Several broad principles are useful:■A comprehensive, systematic approach is required to identify the major facilitating and impeding determinants of

success of the intervention, the target group and the organisation.■ Strategies should be developed to address the imponant and modifiable determinants.■Once action has been taken to implement these strategies, very close monitoring of its effects is required. Timely

feedback of results should be given to the target group and changes in strategies and objectives made as required.

7.1 A practical framework

We have developed a detailed framework for successfully implementing change in health services by combining the available evidence1"' with our experience in quality improvement and patient safety over 19 years. The framework is a series of practical steps to help health serv ices achieve change to closc gaps and reduce risks. A series of questions and actions function as signposts for designing and implementing a comprehensive, well planned change program, and motivating clinicians to change their behaviour and practice.

Not all the steps in the framework need to be addressed for even- change in practicc that is contemplated. Many changes required to close gaps and reducc risks arc simple, and appropnate action can be quickly taken. Some changes arc small and will not require teams to design, implement and evaluate them in practice. But, however small the proposed change, each step in the framework should be considered by the health service's clinical risk manager, who should make an active decision about whether an action needs to be taken, rather than being passively omittedIn essence, change involves identifying gaps or risks (usually as deviations from a standard or best practice"*, systematically analysing the situation, determining and taking appropriate corrective action to close the gap or reduce the risk (by providing service that meets the predetermined standard), and closely monitoring the results of the actions taken. These steps can be expanded as follows:■ Identify a gap in care or risk to patients and determine its causes.■ Identify an appropriate intervention, and ensure it is supported by scientific evidence.■ Identify the target group.■ Establish whether key clinical groups regard the intervention as important — ask opinion leaders.■ Undertake a risk-benefit analysis of implementing the intervention.■ Determine whether the target group supports the intervention.■ Determine whether the intervention has management support. Is there an executive champion? Will adequate resources be made available?■ Undertake a systematic determinant analysis at all levels — identify the major facilitators and impediments.■ Design a detailed implementation and maintenance strategy and plan.■ Test the intervention on a small scale.■ Implement the intervention systematically on a larger scale.■ Closely monitor the results of the intervention and modify the plan accordingly.■ Communicate the results widely.

■ Evaluate the program.The practical aspects of each step will be discussed below.

7.1.1 Step I: identify a gap in the quality of patient care or detect an adverse event with significant risk to patientsClinical governance comprises two parts, quality and safety. The quality improvement program will detect gaps in the care being provided and best practice as supported by scientific evidence. The risk management program will delect adverse events and risks. To close a gap or reduce a risk, a change may be required in how care is delivered. More gaps and risk will be detected than can be dealt with at one time and they should be prioritised for action, as discussed in Chapter 5.

7.1.2 Step 2: analyse the gap or risk to determine its causes and whether any change is required in how health care is delivered in the area concernedThe gap or risk should be analysed to determine its causes and whether any change is required in how care is delivered. The analysis need not be exhaustive, but must determine whether change is required and if so, identify the main changes. A comprehensive analysis will be undertaken later.

7.1.3 Step 3: determine the quality of the evidence supporting the benefits of the required changeClinicians require convincing evidence of the effectiveness of a proposed change for them to modify the way they care for their patients.4 High-quality evidence of the benefits to patients should come from reputable sources, including Cochrane reviews, professional colleges, or guidelines from national expert bodies Detailed evaluations of many quality and safety initiatives have been done by these groups and are readily available.

7.1.4 Step 4: identify the target group, major stakeholders, opinion leaders and clinical championsThe target group (staff members who need to change their behaviour to successfully implement the required change) and its subgroups should be identified so that change strategies can be tailored to meet

their needs. The main clinical groups in acute hospitals are medical, nursing and allied health staff. However, there are important subgroups within each group. For example, the medical group may comprise junior medical staff, registrars, specialists and general practitioners. The needs of each subgroup will be different, and strategies to change their clinical practice should be developed to account for these differences.

Three other key groups should be identified:■Stakeholders — individuals or groups affected by the change, and whose

cooperation is needed to implement it.■Opinion leaders — respected and influential clinicians whose opinion

target group members will seek about the proposed change.a Clinical champions — early adopters of the change, passionate about making the change, will encourage other clinicians to make the change , and support the change at clinical meetings. Some authors suggest patients and their relatives should also be involved in considering changes in how their care will be provided.5 Clearly, patients should be active participants in decisions about their care. Many health services now have consumer representatives on their quality improvement committees, but not many involve them in designing new systems of health care delivery or changing existing systems.

7.1.5 Step 5: determine whether the gap or risk Is important for the target group members and whether they acknowledge ownership of the issueTo improve care, health services need to motivate health professionals to change their behaviour. Professionals are likely to be motivated to work on problems they consider important. The impact of the proposed change should be identified "in ways that resonate with decision makers and frontline providers".6 Health care professionals are likely to support changes that directly and positively affect their patients' outcomes. By contrast, clinicians may consider compliance with paperwork unimportant. Therefore, they are more likely to be motivated to change their prescribing of aspirin, P-blockers and ACE (angiotensin-converting enzyme) inhibitors for patients with acute myocardial infarction, which will increase their survival rates. They are less likely to be motivated to ensure patients' medical records are complete so that the coding, which determines the level of funding the health service receives to provide clinical care, is accurately completed.

In a postal survey in the United Slates, a third of physicians reported thai although they had experienced errors when their family members had received care, they believed errors occurred infrequently.7 These doctors did not see medical errors as one of the important problems in health carc, and did not share the urgency of some national organisations about the issue. They also believed that a substantial number of deaths associated with medical errors were not preventable, and only two actions would be effective in reducing errors — requiring hospitals to develop systems to reduce errors and increasing the number of nurses.' Therefore, in individual health services, some doctors will not see error prevention as important The

7 A practical framework to close gaps in patient care and reduoe risks to ps*ients

Success is likely to depend as much on the quality of implementation, on the sensitivity to different points of view and the degree & support from influential organisation members as the soundness of the change approach adopted... Much of the evidence demonstrates that top management involvement is critical to success but we must [also] remember the importance 6f opinion-formers within the professions.'

lies V. Sutherland K Organisational change: a review for heath cam

managers, prdassunala and

researchers


authors conclude, "perhaps the most critical issue will be to provide sceptical physicians with scientific pnxrf that proposed strategies will, in fact, reduce preventable medical errors and the harm they cause".7

At any one time in health services, there are many more behaviours that can be changed with a positive effect on patient outcomes than there are resources and organisational energy to successfully make these changes. As behavioural change is more likely to be successful if clinicians feel the proposed behaviours are important, health services may best concentrate on these issues.

A determination should be made about who "owns" the problems associated with the gaps and risks being reviewed. It can be difficult unsuccessfully analyse and solve system problems that are viewed by clinicians as belonging to the health service's administration. Often, clinicians do not accept ownership of any ponion of the problems associated with particular risks, even though they are major stakeholders in the delivery system under review.

It will be difficult for health services to change clinician behaviour if the relevant clinicians believe that the proposed change is clinically unimportant, and that their behaviour is not responsible for any part of the gjip or risk. These clinicians are in the precontemplation and contemplation stage of the change cycle. Rather than forcing change on them, health services should continue to raise awareness and understanding about the issue.

7.1.6 Step 6: describe the present state of health cere delivery regarding the gap or risk to the target groupThe target group should be provided with an accurate, well documented assessment of the present state of care delivery in the area under review. Although major studies have shown large gaps in care provided to patients and significant rates of adverse events, individual clinicians at the coalface are often unaware of these problems. From their personal experience, they believe harm occurs infrequently to their patients.8 The assessment should make the gaps and risks visible, and raise clinicians' awareness. The data presented may include details of admissions with poor patient outcomes, clinical audits showing high complication rates, variation in the care provided, or unfavourable benchmarking against similar health services. Presentation of the absolute numbers of adverse events or poor patient outcomes in the health service or the community may have more impact than percentages or rates, as may comparative data from similar health services.9

The data presented should be concise, clear, and of a high standard. Diagrams and graphs in which trends can be easily seen are useful. Clinicians often have limited time for reading proposals, and do not appreciate reading inaccurate information and poorly presented documents. It is difficult to motivate clinicians to change their behaviour if the data outlining the problem is inaccurate or flawed. A supportive clinician should review the validity and accuracy of the data to be presented to the target group.

7.1.7 Step 7: determine whether a number of clinicians are dissatisfied with the present situationDissatisfaction with the present situation is an excellent starting point to create motivation for

change.12 Therefore, it is useful to assess whether clinicians are dissatisfied with how carc is

currently provided in the area under review.

7.1.8 Step 8: present a clear, realistic vision for the future to

the target group

158


After the present situation has been presented, a clear, realistic vision of what can be achieved by

making appropriate changes should be presented to the target group. The vision should be a sharp

contrast to the present situation. The greater the difference between the present situation with

which clinicians are unhappy and the vision, the greater the motivation to change.12 Clinicians also

need to feel the vision provides something worthwhile for their patients.

159

The vision should be accurate, aiid presented concisely and clearly. With the volume of research published each year, it is impossible for doctors to read all research relevant to their clinical practice and develop their own evidence-based guides for delivering care.4 If there are significant gaps in patient cane in their area of practice in the hospital, many doctors may appreciate being informed of potentially significant improvements that can be made to the care they provide.

The way this information is presented is important. Many doctors will complain about increasing demands being placed on them and their time. They'will, therefore, appreciate concise, easy-to- understand and high-quality presentations in areas of significant potential benefit to their patients. As well as concise summaries of the evidence and slide presentations of the literature, the complete literature review and the publications from which the review was derived should be available for clinicians who wish to read them.10

The vision presented to the target group must be realistic. Otherwise, it will be difficult to gain the support of relevant clinicians. The vision should be based on valid information from reliable, well regarded sources. If the change has been achieved at a comparable health service, details about their program should be presented. A respected clinician from that health service could be invited to speak to the target group about the health service's experiences. A respected expert in the clinical area, from outside the hospital if necessary, could be asked to present an up-to-date review of research in the area of concern.

7.1.9 Step 9: weigh up the costs and benefits of the change being consideredAfter a presentation has been made, many clinicians will assess its validity and how realistic the proposed changes are for the health service. They will also evaluate how the proposed change fits into their existing practice. Medical staff may be influenced by their personal clinical experience when assessing proposed changes to clinical practice. For example, individual doctors may not have had a patient under their care who did not receive appropriate thromboembolism prophylaxis and went on to develop a pulmonary embolus. However, they may have had several patients who were given appropriate prophylaxis and developed wound haematomas or more serious bleeding. If clinicians have recently had patients develop severe negative outcomes when using the proposed change in their practice, these experiences may weigh heavily in their assessment of the change.

If the benefits of making the change are greater than the personal cost of making the change and clinicians see the change as feasible, it will be attractive to them and they will be more likely to change their practice. It is therefore imponant to make the costs of the change to the target group as small as possible. Wherever possible, the proposed change should not impose an additional workload on clinicians and especially not increase demands on their lime. Removing or reducing barriers to the change, creating a more efficient delivery system and making it as easy as possible for clinicians to undertake the proposed change, can reduce the costs of changing behaviour. A clear, concise written list of the benefits and costs of making the proposed changes may help clinicians determine whether they wish to be part of the project.

In obtaining clinician support, the proposed changes should be a genuine attempt by the health service to improve the quality of care being provided, and not primarily a cost-cutting exercise by management (although some quality improvement activities can reduce the use of inappropriate care and thereby simultaneously improve the quality of care and reduce costs for the health service) 4 Cost containment or reduction and quality improvement can be compatible with health care,11 but it can be difficult to convince clinicians of this relationship, as "previous efforts to


improve quality often were perceived as cost-cutting efforts that were disguised as quality",' with the main aim or reducing costs and increasing profits.12

"In addition to deciding whether and when evidence is sufficient in quality and quantity to be used in practice, issues such as minimal harm, feasibility, and low cost might shift clinicians over the trratmcnt threshold.*11 Importantly, the cost-benefit ratio will change with time. Clinicians will continually assess the benefits and costs to them as they change their practice to determine whether the benefits continue to outweigh the costs, continuing to make the change worthwhile. Ideally, once the changes are in place, the benefits will increase without an increase in costs, and clinicians will continue to suppon the change.

7.1.10 Step 10: determine whether the hospital's senior management will support the propon d changeConsistent suppon for the proposed change from senior management stafT is critical. They should allocate an appropriate budget, appoint a project officer to coordinate the change if the project is large enough to require such a role, provide secretarial suppon, and, if warranted, approve the provision of extra stall to cover the normal duties oT key people in the target group while they are participating in the project. The proposed changes may also require structural changes, including job redesign, new equipment and additional training. These changes require additional resources in the shon term beTore any medium- to long-term savings may be made, funher stressing already-stretched health service budgets. In shon, "improving safety costs money in the short term",8 and for some changes, the financial costs may always exceed the benefits.

Senior management should also nominate an executive champion or sponsor to directly support the change project. The executive sponsor should be an active, hands-on member of the change project team, and should guide the project through the hospital's bureaucracy such as obtaining approval for new or changed hospital policies. The executive champion can also obtain resources for the project and remove some barriers.10 The chief executive and other senior management staff often have limited knowledge about key clinical issues. Having an executive champion on the project team will keep them informed about important issues that arise and the progress the team is making.14

An ideal executive sponsor for a significant clinical change project is the director of medical services. Directors of medical services are medically trained, can appreciate the clinical aspects of the proposed change, and have detailed knowledge of the hospital's bureaucratic and administrative structures and processes. Directors of medical services also have an appropriate level of authority to rapidly and effectively solve problems, especially those involving several clinical areas or departments. They can also ensure funding and support for the project from senior management. Frequently, quality improvement projects are given funding for a limited time. After a change in clinical behaviour has been achieved, the funding ceases and the health service is expected to continue to maintain the improvements made, which often requires ongoing funding. The director of medical services, having been an active participant in the project, is well positioned in the health service to help secure ongoing funding for the project.

If the change project is large, the chief executive should formally approve the support that senior management and the health service will provide. Such support signals to the target group and other hospital staff that senior management has a genuine interest in quality and safety in the hospital, regards the project as important, and will provide the necessary resources and expertise for the change in order to be successfully implemented.

7.1.11 Step 11: assess the stage of change of individual clinicians in the target group


A critical issue is the stage in the change cycle that individual clinicians in the target group are at

when trying to initiate change. After the presentations of the current state and future vision, some

clinicians will be ready to change, while others will be contemplating the change and not ready to

take action. Clinicians at different stages of the change cycle require different approaches to help

them move to the next stage Importantly, clinicians who are not ready to take action should not

be forced or coerced to change, as this is unlikely to achieve sustained change. Not all clinicians

need to be ready for change in order for the change process to commence


7 A practical framework to close gaps in patient care and reduce riak* to ptfiantt

The health service should begin working with clinicians in the target group who are early adopters of change and are in the preparation and action stages of the change cycle. An assessment should be made as to whether there is a commitment to change from a cross-section of the target group and whether there are enough clinicians to form a project team to design and implement the change.

Working with clinicians in the preparation and action stages of the cycle may result in the change initially being implemented in one clinical area, rather than throughout the service. However, making the change in one area allows it to be trialled on a small scale and improvements to be made and used later on a larger scale.

Clinicians in the precontemplation and contemplation stages of the change cycle may need individual approaches to help them progress to the preparation and action stages. They may benefit from receiving more information to increase their understanding of the proposed change. Even though they are not ready to make the change, they are now aware of the issue and have high-quality information with which to make their assessment. Also, after they see the changes made and the success achieved by the "early adopters", they may progress to the preparation and action stages. Eventually, a critical point will be reached at which many of the clinicians in the target group have made the required changes to their practice, acceptance of the change has substantial momentum, and hopefully most of the remaining clinicians will follow their colleagues and make the change.

7.1.12 Step 12: form a project teamWhen extensive gaps in care are identified or adverse events associated with a significant level of risk are detected and complex delivery systems are involved, a multidisciplinary team should be formed to close the gap and reduce the risk. The team should not be regarded as another hospital committee, but as a problem-solving group with a specific task and a short-to-medium-term time horizon. The selection of appropriate team members is critical as "the effort, skill and even personalities of key personnel can substantially affect the success or failure of a given quality improvement intervention".15

TAMA Project team compositionThe team should comprise:■clinicians from the target group who are innovators or early adopters of the proposed change■ if the change project is large, a project officer to coordinate and organise the project (including

undertaking literature searches and sourcing information about what occurs at other hospitals regarding the proposed change)

■an executive sponsor and staff with technical expertise in areas relevant to the change (eg, clinical specialists, pharmacists, health information managers and information technology staff)

■secretarial assistance to keep minutes, prepare agendas and policy documents, and design implementation tools.Membership should also include major stakeholders from areas of the hospital affected by the

delivery systems to be reviewed. It is essential that the team includes clinicians with a strong motivation to solve the problems at hand and clinicians who are regarded as clinical leaders by their peers. "The selection ... of clinical champions is a fundamental step for the success of the strategy."4

As previously discussed, senior management should be represented with sufficient authority to provide the resources to analyse the gaps and adverse events, review the systems involved and guide the team's proposed system changes through the hospital's bureaucracy. A group facilitator with problem- solving and risk-management skills should be considered to assist the team. A

161


health information manager should be pan of the team, as such managers have skills in clinical data extraction and measurement, which are important for analysing adverse events and monitoring the cffects of actions

162

Hospitals should also consider patient or consumer representation on the team, and should be able to co-opt other staff as required.

When deciding if the composition of the team is appropriate, an assessment should be made whether the team has the technical expertise required to solve the problems before it and a sufficiently diverse membership to promote ownership of the changes in the relevant areas of the organisation and assist the implementation and maintenance of the changes.

Where possible, members of the team who are not employees of the hospital should be paid for the time they spend at team meetings and preparing information for the team. Additional resources to provide payment and cover for the usual duties of project team members should be made available for hospital employees if, as is frequently the case, significant lime is required to close the gaps and reduce the risks that have been identified. To burden hospital staff who already have heavy workloads with considerable extra duties will reduce the effectiveness of the team.

7.1.12.2 Role of the project teomThe team's role is to analyse the gaps identified or the risks detected and determine and take appropriate action to close the gaps or reduce the probability of the risk. This role requires the development of goals and a detailed implementation plan. The team should also have responsibility for implementing the plan. The team requires terms of reference detailing its objectives, membership, responsibilities and reporting requirements. The team should appoint a leader, usually a clinical champion who is passionate about quality and safety generally or the proposed change, or an opinion leader who is an influential, respected clinician in the hospital.

Appropriate responsibility and autonomy should be given 10 ihe team to allow it to undertake an analysis of ihe referred gap in care or risk and to take appropriate action. The team members will have diverse needs and will want to adapt the change to their work setting, which should be encouraged. Team members should be brought together early in the change process 10 support each other, to allow local ownership of the project and the tools 10 developed, and to share the project's goals. This involvement also ensures that the representatives of stakeholder clinicians have an interest in the project's goal and are therefore more likely to accept it.

Involvement in planning and implementing the change gives clinicians increased control over their work environment. Control can be a powerful motivator for clinicians to take appropriate action to achieve the goals of the group. Importantly, goals imposed by senior management onto clinicians without their input are likely to decrease motivation, even if the goals are appropriate. A collective decision that the change is worthwhile is required, and the team seeking to make the changes should share this vision.


7.1.12.3 Advantages of teamsUsing teams to achieve goals in organisations has several advantages.16

The creation of teams to plan and implement change allows staff from a

diverse range of clinical and other backgrounds in the hospital to come

together.


V. organ'salio*iu< change is a process that can be fac&tated by perceptive and insightful planning and analysis and well crafted, sensitive implementation phases, while acknowledging that it can be never fully isolated from the elfects of serendipidity, uncertainty and chance.'

lies V. Sutherland K Organisational change: a review for health care

managers, professionals and

researchers

Diversity of membership brings staff with a wide range of skills and experience to the discussion,

allowing different perspectives to be presented on how goals can be achieved, and stimulating the

development of innovative ideas.A significant proponion of the team should comprise clinicians who directly provide patient care in the area where change is proposed. These clinicians are part of the target group and will know the setting for the change well. They will bring imponant knowledge to the discussion about what occurs at the coalface when providing care. Such informed discussion'will often allow anticipation of problems that may occur in implementing the change. One or more of these clinicians should be the clinical champions of the project, and should speak in support of it at clinical meetings. The team approach also promotes cooperation between clinicians and other staff from the various disciplines involved in the change process and allows better decisions to be made.

7.1.13 Step 13: analyse the gap or risk and Identify barriers and facilitators of the proposed change or interventionThe initial task of the project team is to:

■ Analyse the gap identified or risk detected.■ Identify the determinants (or factors) of the proposed change or intervention, target group, patients, organisation and sociopolitical context and their facilitators and barriers.■ Determine the resources available in the health service.

7.1.13.1 Analysis of the gap in care or riskThe project team reviews the referred gap or risk, determines the service delivery systems involved, and identifies the latent factors (eg, equipment maintenance, work design, workload, skills, supervision, lengths of shifts and allocation of resources) and active errors (eg, lapses, mistakes and rule violations) lhat contributed to the gap or risk occurring.The team should draw a (low diagram of the existing delivery system and identify key processes in the system. The team should determine where ihe gaps and latent factors or errors leading to adverse events occur in the system.10 The team should then determine if any further information is required. On some occasions, insufficient information will be available from analysing a gap or single adverse event for the team to accurately identify the main issues. They may then request that a focused audit be undertaken lo assess the frequency and severity of the gap or adverse event and to identify the contributory factors. The analysis may also involve reviewing relevant case notes and scientific literature, and conducting interviews, surveys or focus groups with staff and patients. Analysis of adverse events is discussed in detail in Chapter 5.

7.1.13.2 Analysis of the determinants of the proposed change or intervention, target group, patients, organisation, sociopolitical context and their facilitators and barriersThe determinants of the proposed change or intervention should be identified — this is similar to a diagnostic process or needs assessment in clinical medicine. The influence of the context (with its barriers and facilitators) in which a change is being proposed is being recognised as increasingly important to the successful implementation of change.1' Factors to consider include■ Is the proposed change simple or complex?■ Does it comprise a single component or multiple components?■ How do these components interact?■ Is the change dependent on the skill or effort of key people?


■ Is the change supported by high-quality scientific evidence?18



The complexity of the change is also affected by the number of processes or subprqcesses in the relevant delivery system, and the breadth of the process or the number of choices presented at decision points in the system.17

The components of the change or intervention may be quite different. For example, the proposed change may be that a clinical practice guideline be used in the health service. Such guidelines usually comprise a number of quite different recommendations. Individual recommendations may relate to different aspects of patient care, such as monitoring, investigations or medication. Each recommendation may be quite different in nature, require adoption by different clinical groups, and present different barriers to implementation, therefore requiring different implementation strategies.The determinants of the target group and each of its subgroups should be identified. This analysis requires:■ Examination of individual factors of target group members, such as their knowledge, experience and skills in the relevant clinical area, attitudes to change generally and the proposed change specifically, working arrangements (eg, full-time or pan-time, salaried or fee-for-service) and personality and their needs regarding the proposed change.■ Identification of innovators in the target group who could influence the practice of early adopters regarding the proposed change.■ Examination of the social context in which the gap in care or adverse event has occurred, including the culture of the hospital, the social network and the behaviour of other clinical colleagues.■ Consideration of patient factors, such as their knowledge, attitude, needs, socioeconomic status, and severity of illness.■ Identification of economic, administrative and organisational factors, including whether there are adequate budgets, numbers of suitably qualified personnel, and equipment; relevant hospital policies; the organisational structure; and how change is usually achieved in the organisation.■ Identification of major stakeholders in the change.The checklist of potential determinants that influence adoption and implementation of an innovation presented in Chapter 6 should be used to establish the determinants in each major category (innovation, target group, patients, organisation and sociopolitical context) for the change being proposed. The determinants should be assessed for their effect (facilitating, impeding or neutral), importance and changeability and ranked according to their perceived importance.With small innovations or changes, it may be sufficient to ask project teams members to identify the determinants and their effect, importance and changeability. However, it is often necessary to go outside the project team and seek information about the determinants from a larger sample of the target group, such as all junior doctors in the hospital. This information may be sought using in-depth interviews, small group sessions, such as focus groups, or surveys.19

To determine the perspectives of intensive care unit staff about the potential determinants and consequences of semirecumbent position in patients receiving mechanical ventilation, interviews were undertaking using the following structure and prompts:13

■ Current practice> How do you usually manage patients with this condition?■ Current knowledge

> What is the optimal management of patients with this condition?

> What are the risks of not managing the patient optimally?

■ Considering research in this area

164


> How should care be provided for patients with this condition?■ Barriers to using the intervention> How do you decide whether to use this intervention?

165

7 A practical framework to close gaps in patient care and reduce risks to paeans

> What makes it easy to use?

> What makes it difficult to use?

> Why would you or other clinicians not use this intervention?

> What are the most important factors in determining whether to use the

intervention? a Implementing the intervention

> What strategies should be used to implement the intervention?

> What can be done to make it easier for the intervention to be used?

> What can other health professionals do to make it easier to use the intervention?

> What can the hospital administration do to make it easier to use the intervention?

> Do you have any other suggestions?As the interviews progressed, emerging themes were identified and modified in an iterative

process after presentation for validation or refutation to different professionals, focus groups and groups representative of intensive care staff. The study found that knowledge of the intervention among staff was variable. After being presented with the scientific evidence, staff endorsed acceptance of the intervention. Barriers to implementation of the intervention were raised under the general headings of: alternatives to the intervention, contraindications to the intervention, potential risk of harm, safety, and lack of resources. Staff suggested multiple implementation strategies.13

The authors believed the wide range of stafT interviewed and participating in the process led to a broader view being obtained of the determinants of the intervention's implementation. They also felt more trials supporting the intervention would have led to staff citing fewer barriers. Although not undertaken in their study, the authors suggested that the perspective of patients and family members regarding interventions should also be obtained and considered.13 The study found that under- utilisation of the intervention was due to "insufficient awareness of its potential benefits, teal and perceived deterrents, lack of agreement about who is responsible for its implementation and lack of enabling and reinforcing strategies".13 These reasons are probably common to why many interventions are not fully utilised.

All major determinants should be identified. Clinicians might not identify some high-level organisational determinants; this information may need to be objectively, widely and actively sought from other stakeholders.20 In a study of barriers to the use of key recommendations for management of community- acquired pneumonia, a large variety of barriers were reported. Different barriers were identified for each recommendation by different clinical groups and subgroups. Doctors did not perceive the same barriers perceived by nurses, and junior doctors did not perceive the same barriers perceived by senior doctors.19 Eliciting opinions from only one group is likely to result in missing significant barriers that could be identified by other groups. Each recommendation has its own pattern of barriers that must be determined and addressed. Barriers may also vary widely between health services, and each service should identify its barriers and develop implementation strategies to address these, rather than simply implementing a strategy that was successful elsewhere.19

7.1.13.3 Analysis of resources and skillsTwo determinants of successful adoption and implementation of change require further discussion. It is unlikely that individual hospitals will have sufficient resources to make appropriate changes to their delivery systems in response to every gap or adverse event. If the level of risk associated with an adverse event is sufficient to require action to be taken, an assessment should be made as to whether the systems review and changes required are feasible. A complete review of a large delivery system may require more resources than an individual hospital has available. If resources

1«S

are insufficient to undertake a complete review, senior management, together with the project team, should decide whether to initially undertake a partial review of the relevant systems and make some of the changes required (especially those with the greatest leverage), or, if the system is large, to provide sufficient additional resources to complete a comprehensive review and make all the required changes. Some changes required to close gaps or reduce risks are costly, especially if additional staff or new equipment are required; however, some simple strategies can also be effective.9

The project team should also assess whether the members of the target group have the knowledge, skills and experience to make the proposed changes, or whether they need further education and training. The team should review previous successful change programs in the health service that achieved similar goals, and identify strengths in the organisation that can be used for the current project.

The project team should look to other health services that have successfully achieved the changes being proposed. Have these health services published the methods they used, the results they obtained, and the problems they encountered and solved when achieving this change? A literature search will often locate such publications. It can be useful for project team members to speak with people involved in these projects. Health services are often proud of what they have achieved in improving patient quality and safety, and are pleased to talk about their experiences, receive visits from other health services and share any relevant resources they have developed during their own change projects. Seeing and learning about such projects not only provides valuable information for the project team, but also increases motivation.

7.1.13.4 Determining best practiceThe evidence of best practice in the delivery system under review should be sought. It is important noi to spend excessive time undertaking an exhaustive literature review, as this is likely to delay making ihe proposed changes. The most recent evidence-based review of the relevant clinical area is a useful place to begin. However, high-quality information of best practice based on the results of randomised clinical trials is frequently not available to answer many common questions in clinical practice. Therefore, treatment recommendations are often based on less rigorous trials or on ihe consensus of experts in the field. It is likely that other health services, professional bodies and national health care organisations have developed treatment guidelines and clinical pathways for the management of patients with the clinical conditions being reviewed. Copies of such documents are readily available and will expedite the change process. They should be developed into local protocols by the project team to meet local needs and conditions.

7.1.14 Step 14: the project team set shared goalsAlthough the health service has already outlined a vision for ihe proposed change, this should be developed into a goal or goals. Goals provide a focus and direction for subsequent action. Having goals makes it more likely thai they will be achieved. Working towards goals can be enjoyable, and achieving them can be a significant source of job satisfaction. The goals should be set by ihe project team and shared by its members and senior management.

A useful acronym in developing goals is thai they should be SMART (specific, measurable, attractive, realistic and time-framed):1,2

■ Specific — goals should clearly specify the actions required to achieve them. The specificity of

the goal helps determine whether the actions taken are achieving the goal.

■ Measurable — meaningful, valid measures allow objective evaluation of progress being made

towards the goal.


■ Attractive — goals should reflect what clinicians in ihe target group believe is important and

want to achieve


■ Realistic — the goals set must be realistically, within the health service's and the team's capabilities. The goals should reflect the resources available to achieve them, the abilities of the participants to undertake the actions required to achieve them, and, if available, the health service's past experience in achieving similar goals. The members of the team should feel confident that they can perform at the level require^ to achieve the goals. If the goals are set unrealistically high, success will be unlikely and motivation for the project and similar future projects may decrease. Commitment to the goal will be high if clinicians in the target group feel the goal is both important and attainable.

■Time-framed — a date for achieving each goal should be set. Major goals often take time to achieve, and it may be difficult to consistently maintain motivation for the change over a long period. Therefore, the goals set • should be achievable in a reasonably shon time frame. If the date for achieving the goal is not clearly visible on the short-term horizon, intermediate goals with closer completion dates should be set. This action will allow smaller goals to be regularly achieved aiding motivation for the long-term major goal.3

An example of a goal that meets these criteria is:

to decrease our current 2% incidence of catheter related bacteraemia to 1% within 1 year by implementing the following: insenion under full barrier sterile techniques, ultrasound' guidance for difficult insertion, avoidance of the femoral insertion site, use of antibiotic coated catheters for high risk patients or long term use, ho scheduled catheter changes, new site replacement and avoidance of guidewire exchange, and dry gauze rather than transparent dressing 9

7.1.15 Step 15: construct a list of strategies available to close the gap or reduce the riskAfter a systematic analysis of the determinants and their efTects, importance and changeability have been made, a list of the major and changeable determinants can be compiled. Some members of the target group will already have been asked which strategies they believe would be effective in implementing the proposed change. The list of determinants and strategies should be verified with other members of the target group.

If the project team is reviewing an adverse event and one or more errors have been identified there are four broad actions that can be considered. Ranked from strongest to weakest, they are:1. reducing or eliminating the errors from occurring2. making the errors visible3. reducing harm to the patient after the error has occurred

4. creating a policy regarding behaviour in the clinical area and re-educating staff.21

Unfortunately, often the weakest interventions arc used and only superficial attempts arc

made to improve patient safely. If the weakest intervention.

'I eanl metre ite effort that* needed to bring about ethcthm change if I'm not truly convinced it is necessary'

lies V. Sutherland K Organisational change: a review for heath can

managers, profession's ana researchers


creating a policy, was chosen, the effectiveness of this intervention can be measured in the following ways:■ the presence of the policy

■ the staffs knowledge of the policy

■ the use of the policy.

Previously, the presence of a policy was used extensively in health service accreditation programs

as a measure of effectiveness. Measuring the appropriate use of a policy is the most reliable method

of assessing the effectiveness of the intervention, and is the preferred method of measurement.21

7.1.16 Step 16: choose the best strategy or strategiesAfter constructing a list of strategies available to close the gap or reduce the risk, the team should decide which strategy or strategies are the most appropriate. After this decision has been made, the team should determine whether there are sufficient resources available to make the proposed changes and to educate staiT about them. If resources are not adequate, the team should assess whether there is sufficient lime lo obtain the required resources and to act on the problem in a timely manner.

Once the issue of resources has been addressed, the project team should anticipate the potential barriers to implementing the change. Strategies should then be developed to overcome these barriers. Unintended negative consequences resulting from the strategy should also be anticipated, and action planned to prevent them. Where possible, these implementation strategies should address the latent factors identified in the analysis and improve defences.

Before finishing the development of the strategy, the team should assess whether the overall strategy is too complex. A highly complex strategy is less likely to be successful.

7.1.17 Step 17: plan the Implementation of the change strategy carefully but efficientlyCareful planning is an essential pan of any change. The extent of the plan will vary with the size of the project and the setting. As discussed previously, it is paramount to the success of a change project that the project team have autonomy and responsibility for analysing and solving the problem and implementing the solution.

7.1.17.1 Creating a planA plan is a series of concrete steps or actions designed to achieve a goal. Setting goals stimulates planning. However, effective change requires a balance between planning and commencing action. Time is required to analyse the problem, evaluate possible solutions, and carefully plan the necessary actions to design and implement the change. Careful planning increases the likelihood that the project's goal will be achieved. However, over-analysis of the situation may lead to procrastination.

Although detailed planning will reduce the chances of things going wrong, such planning is unlikely to totally eliminate negative events. Some events will not be foreseeable, however painstaking the planning. Also, if planning takes an excessively long time, this may delay action being taken; in turn, inaction may reduce the target groups motivation for change. A balance between the lime spent planning and commencing action is needed. Planning should be comprehensive but not exhaustive. Attempts should be made to anticipate potential problems. Action can then be taken to prevent these problems occurring, or, if they cannot be eliminated, preparations to deal with them can be made.

7. I. 17.2 Components of a plan


tea

A written plan for the implementation of the change should be developed. The plan should include a

sequence of concrete, actionable steps that need to be taken to successfully achieve the proposed

change The plan should also include details of the individuals or groups responsible for each action

andthe target date for completion of the action. The resources required to achieve the change, including people, materials and budget, should be determined and documented.The timetable to complete the plan needs to be both realistic and feasible. In our experience, hospitals make two common errors in planning:■ Significantly underestimating the time to complete each of the actions requited to successfully implement the change.■Trying to achieve too much change too quickly, which can lead to the failure of the project.In our experience, it is best to begin with small steps towards achieving the overall goal and to plan for some early successes. By testing the effectiveness of the various implementation strategies on a small scale first, the effects of the strategies can be observed and if required, the strategies and sometimes the goals can be adjusted. Using this small-scale iterative process, the change program can be gradually expanded throughout the hospital and serious large-scale implementation problems can be avoided.The plan should include details of how the implementation will be organi^d, performance will be measured, how tools for change and data collection will be developed and the project will be evaluated.

7.1.17.3 Developing took to implement change strategiesOften, the strategies for implementing a proposed change require the development of a tool to facilitate the change. Some of these tools can form pan of a clinical decision suppon system *in which characteristics of individual patients are used to generate patient specific assessments or recommendations that are then presented to clinicians for consideration''.22 For example, to improve the use of thromboembolism prophylaxis among inpatients, one strategy would be to develop a tool to assess the risk of each patient developing a thromboembolus. Tools can be computer-based or non-electronic.The development of effective tools is critical to the success of a change project. Kawamoto and colleagues reviewed 11 randomised controlled trials, and found four features of clinical suppon systems that were associated with improved clinical practice: suppon was provided automatically as part of the clinician workflow, delivered at the time and place of decision making, provided actionable recommendations, and was computer-generated. Importantly, these features reduce the amount of work and time required by clinicians to receive and act on the recommendations generated by support systems.22 Tools should also be:■based on good-quality evidence■adapted to meet the needs of the target group, its subgroups and the characteristics of the setting■easy to understand■attractively designed■of high quality■difficult to miss in the medical record■ readily available when required at the clinician-patient interface■incorporated into the daily routine of patient care■updated as new evidence becomes available.Often, there is no need for health services to "reinvent the wheel" when developing tools. Sharing information and tools for quality improvement and patient safety between health services can save many hours of valuable staff time. Health services can also save considerable resources by not going down the same "blind alleys" as other health services.However, whenever tools have been developed in one health service, they arc unlikely to fit perfectly into the delivery systems of another. Therefore, it is important to modify such tools to


the target group's needs and the health service's local conditions. Target group members will need input into modifying


tea


these tools, as local ownership is imponant. Finally, before changing health care delivery systems radically, it is important to determine whether some systems and resources already in place may assist in the change process.

7J.I 7.4 Develop a balanced set of outcome and process measuresThe plan should include how performance will be measured during the project, including what measurements will be made, when they will be made and how data will be collected. Where possible, existing hospital data collection .systems and databases should be used. Valid, reliable measures of performance toward the overall goal of the project should be developed.The project team should devise a balanced set of system performance measures, preferably including process and outcome measures. To be balanced, measures should be chosen from each of four categories:23

■ clinical (eg, patient outcomes, compliance with treatment processes)■ cost (eg, patient length of stay)■ patient satisfaction■ functional health status — in this category, a patient's health is measured in several areas using standardised assessment tools before and after they receive medical care.Of the four categories, functional health status requires the most resources and is used the least. Where possible, measures should address the six dimensions of patient care identified by the US Institute of Medicine: safety, effectiveness, patient-centeredness, timeliness, efficiency and equity.2''Where possible, we prefer to use process measures, as they are more sensitive than outcome measures in assessing changes in system performance. For example, administering aspirin to patients with an acute myocardial infarction is a treatment process that has been shown in high-quality clinical trials to significantly reduce patient mortality, a clinical outcome measure. The proportion of patients with an acute myocardial infarction who are given aspirin is a sensitive process measure, and significant changes in the rate of compliance with this treatment can be rapidly demonstrated. However, demonstrating a significant improvement in the related outcome measure of subsequent patient monality requires a larger sample of patients, a longer time period and risk adjustment of the outcomes.A funher example is preventing venous thromboembolus in hospital inpatients. Using a process measure, the proportion of inpatients who have venous thromboembolism risk assessment completed and appropriate prophylaxis given, provides a meaningful measure of the success of the intervention within a few days. However, using the outcome measure of the proportion of inpatients who develop a deep vein thrombosis may take some time to show a statistically significant result. The performance measures chosen should be:■ Limited in number — too many measures increases the complexity of data collection.■ Of high leverage — measures highly correlated with patient outcomes are most important.■ Able to be clearly and unambiguously defined — measures that are poorly defined make analysis less meaningful.■ Easily identified and collected — if measures can be collected as part of the daily routine of existing hospital staff, data will be easier to collect and more likely to be collected.■ Low cost to collect — resources for quality improvement and risk management activities in health care are limited. If these resources are not spent unnecessarily on complicated data collection, they can be directed to other quality and safely activities.These criteria are the same as those used for measuremeni of performance in conducting clinical audit as outlined in Chapter 2.

The continuous monitoring and measuremeni of progress towards achieving ihe proposed change

should be part of the plan.

7.1.17.5 Create data collection tools

Data collection tools that reflect the key performance measures chosen by the team should be

created. An assessment should also be made about whether the required data can be simply

collected. Project teams aim to improve the safety and quality of health care delivery systems in a

timely manner, no* conduct formal clinical research. Although the data collected should be valid and

reliable, they should be able to be collected efficiently as part of hospital staff's daily activities, and

should not be a separate task that requires substantial additional resources.

170

7 A practical framework to close gaps in patient care and reduoe risks lo patterns

7.1.17.6 Education and trainingThe implementation plan should contain a program to educate staff about the proposed change and

training them in making the proposed changes. Effective education and training programs involve

small groups, are personal (with outreach visits), provide the opportunity for social interaction and

use opinion leaders. Education and training programs should develop and use high-quality materials

7.1.17.7 SustainabilityThe changes should be fully integrated into the existing structures and processes in place in the

hospital and made part of the daily routine of providing patient care. Such integration will sustain

the changes.

7.1.17.8 Project nameDeveloping an appealing name and symbol for the project can help remind and motivate staff about the change. A recent project to increase the use of thromboembolism prophylaxis in hospital inpatients was entitled "stop the clot" and eye-catching stickers were used on medication charts to remind staff to assess their patients' risk of thromboembolism.

As discussed earlier, if effective action can' be safely taken, it should be allowed to commence as soon as possible with close monitoring of its effectiveness. Prolonged delays in commencing action may lessen the target group's motivation.

7.1.18 Step IS: disseminate draft versions of the plan widely for comment and InputA major mistake in developing implementation plans with potentially far-reaching effects is lo develop ihe plan in isolation from those whose work will be affected by it. At a minimum, key stakeholders in the change project should be provided with drafts of the implementation plan and their input actively sought. Drafts of the plan should be placed on the agenda of the regular meetings of the peak medical, nursing and quality committees or groups of the hospital, again seeking input and feedback.

As the drafts are revised, the details should be discussed regularly at key clinical and education meetings at the hospital. Ideally, drafts of the plan should be widely disseminated throughout the hospital. Comments on the plan should be discussed by the project team and changes and improvements made accordingly. Such wide review before the implementation of the plan may flag significant problems that were not originally foreseen by the project team.

The final version of the plan should be available to all staff, especially members of the target group, stakeholders and opinion leaders. Copies should be sent to all major clinical groups in the hospital and a copy placed on the hospital intranet. The plan should contain the waiver that it may be modified in response to the results obtained after implementation.

Implementation of the plan should provide no surprises to the various stakeholders and other hospital staff. It is clearly detrimental to the success of changc projects if major stakeholders and senior members of the target group first learn of the change being implemented from their junior mcdical staff or bv a memorandum from senior management to all staff.

171


7.1.19 Step I9: toke baseline measurementsA baseline measurement of the key performance measures selected should be taken before any change strategies are implemented to avoid the Hawthorne effect (where observation of staff influences their performance), and so thai improvement can be demonstrated after the changes have been made. Taking buseline measurements also tests the suitability of the data collection tools and systems.

7.1.20 Step 20: implement the chosen strategies using small-scale rapid testsBecause health care delivery systems are complex and their outcomes are often unpredictable, the strategy chosen should initially be implemented as a small-scale, low-cost and easily reversible test. This allows knowledge to be gained about the properties of the redesigned system. It is then possible to determine whether the new system and the strategies chosen for its implementation can achieve the intended outcome and what unintended consequences may occur.

Small-scale tests also allow ihe suitability of materials and interventions lo be tested with the target group, and the coherence and effectiveness of the change process and the accuracy of the planned lime frames to be assessed.25 If the outcome of the system changes is suboptimal, ihe effects of any negative outcomes will be limited because of its small scale, and of little risk to the health service. It may also be easier to convince staff who have doubts about the proposed change lo participate in a small-scale trial.

Despite a lack of high-quality scientific evidence of its effectiveness, the plan-do-study-aci cycle is a well established quality improvement process. The cycle includes identifying system design or redesignopportunities, setting priorities for improvement and implementing an improvement strategy. The model is based on a trial-and-learning approach that requires setting aims, determining measures,

making changes, assessing results and taking further action (Figure 7.1).26

7.1.21 Step 21: analyse the results of the testA rapid assessment should be made after the firsi small-scale test. The results should be analysed and a decision made about whether the system changes and implementation strategies should be adopted, modified or abandoned. The most likely outcome is that the changes and strategies will

require modification, and further small- scale and rapid tests will need to be performed. The changes will be usually ready for larger-scale implementation after several cycles of modifications and small-

scale tests.

7.1.22 Step 22: take deliberate and continuous action to implement the plan

An obvious key to successfully achieving goals is taking action. However, emergencies and distractions abound in busy modern health services, and it can

be easy to remain inactive about quality and safety

issues, which often appear less urgent than

172

Figure 7.1 The plan-do-study-act approach to performance improvement

What are we trying to accomplish?

How will we know that a change is an

improvement7

What changes can we make that will result in improvement?

tPlan

Design or redesign

DoTest change

Artao^ed frryn Leape et al'

7 A practical framework to close gaps in patient care and reduoe risks to patterns

other problems. Procrastination can also seem a comfortable solution to many problems,

especially in the shon term. However, there is usually a cost associated with procrastination. In the

medium and long term, inaction through procrastination will leave the problem unresolved. With

time, the problem may become larger, more complex, and more difficult to solve.Purposeful action needs to be taken to increase motivation and achieve goals. The first steps are

often the most difficult — ambivalence will be high and the comfort of the status quo will appear attractive However, by taking appropriate action toward achieving the goal, motivation is increased, ambivalence reduced and further action results. A positive spiral of action, motivation and further action is created.1 *

7.1.23 Step 23: monitor the progress being made to/ward the goal and provide feedback about progress to the participantsThe implementation should be closely monitored to ensure that the actions in the plan are completed as scheduled. Stetler and colleagues suggested asking the following questions: A^e there discrepancies between the plan and how it is being operationalised? Are there any barriers or facilitators that were not foreseen in the planning stage? Is the plan being implemented to schedule? Do any pans of the implementation strategy require revision?27 The effects on patient care of the changes should be continuously monitored using the performance measures detailed in the plan.

Continuous monitoring of progress towards the project's goal helps provide timely, accurate, tailored and meaningful feedback to the target group and other staff. Continuous monitoring is more resource- intensive than monitoring at set intervals; however, it reduces the chance that problems and poor performance that occur during a non-monitoring period will be missed. Existing communication avenues (eg, committees, education meetings and staff newsletters) can be used to provide regular updates on the progress of the project, aggregate feedback on performance in providing clinical care and the opportunity to discuss the results.

The effect of feedback on behaviour is variable, which may be explained by how it is given. In one study, health services lhat provided care thai was highly adherent to clinical practice guidelines, provided feedback to individual clinicians that was: timely enough to be useful and actionable (monthly or more frequently was regarded as timely); about their individual clinical performance; given in a non- punitive manner (assessed by the tone in which feedback was given), making it less likely to be resisted; and, if possible, feedback could be customised by individuals according to their needs (allowing them to put data into a form that was meaningful to them). Providing such feedback is consistent with the feedback intervention theory and is giving "actionable feedback".28

In interviews about data feedback conducted with 45 clinical and administrative staff in eight US hospitals, major themes elicited were:29

a the data must be perceived as valid and credible by doctors (this may take time lo develop and ispartly dependent on the source and timelines of the data) a benchmarking (against other like

health services and over time within an individual health service)improves the meaningfulness of the data a feedback is enhanced by having respected doctors

(clinical champions) review the data and present them to other doctorsa feedback to doctors about their individual performance may be effective, but may also be perceived as punitivea data feedback must be ongoing to maintain improved performance.The perceived validity and meaningfulness of the data were central to the effectiveness of data

feedback and the process should be embedded in the delivery of care to patients.20

Feedback about performance should be given as soon as possible after care has been provided Such feedback can be a strong motivator for staff to continue their participation in a change project Fccdhack to clinicians about their individual performance and their performance compared with* other clinicians can be a powerful motivator, and may appeal to some clinicians' competitive nature. In a randomised controlled trial of physician performance in the management of patients with

diabetes in an ambulatory setting, physicians given feedback about their own performance together with achievable benchmark feedback (the average performance of the top 10% of the physicians being assessed) performed significantly belter than physicians only given feedback about their own performance. Achievable benchmark feedback "represents a realistic standard of excellence attained by the top performers in that group* and providing this information enhanced the effect of individual feedback.30

Individual clinician feedback should be given privately and not made available to the project team — feedback to the team should be given in aggregate form. Data comparing clinicians' performance should not identify the performance of individual clinicians. As with other pans of the change process, feedback can be commenced with the small-scale change trials, and its form and frequency can be modified over time.

In addition to monitoring progress toward the shared goal or goals, the benefits and costs of making the change need to be continually assessed. If the costs to individual clinicians begin to rise compared with the benefits, their motivation may be reduced. If this reduction in motivation occurs, the plan and goal may require adjustment.

7.1.23.1 Monitoring to deal with relapseIf the implementation of the project is positive, the clinicians involved will see that they are moving closer to their goal. They will experience the benefits of making the change and this will help maintain their motivation. However, relapse to the original behaviour and unexpected setbacks are often an inevitable pan of change. Relapse needs to be expected, prepared for, and when it occuVs, corrective action taken. Relapses may be temporary and due to external factors beyond the project team's control.

When a relapse occurs, the project team should relleci on what has happened, determine what went wrong and take corrective action. The team and hospital can learn from relapses about what does and does not work in the change process, especially at the local level. When a relapse occurs, team members should be reminded that despite this outcome, they have done their best.

Perseverance, in spite of slow progress towards the goal or relapses in behaviour, is important in ultimately achieving the goal. However, perseverance should only be sought from the team if the goal remains reasonable. Therefore, after a relapse the team should consider whether the goal is still realistic and whether the strategies being used remain appropriate. If not, it may be appropriate for the team to revise their goal and the plan and strategies they are using. In retrospect, it may be fell that the initial goal was set unrealistically high.

7.1.24 Step 24: communicate proposed changes and results to staffHospital staff should regularly receive updates about a project's progress. A balance in the quantity of information provided is required between overload, where staff may ignore important information, and insufficient information, which may make implementation at the coalface difficult. The project team should determine the appropriate mode and frequency of communication to staff. Options include: posters, emails answering frequently asked questions, messages in communication books, newsletters, staff meetings and in-service training. It is important to engage key medical and nursing staff in the project. This can be assisted by sending drafts of new policies or changes to existing policies, processes and forms for their information and comment before implementation of any changes.

Once the changes have been implemented, the results obtained should be reported regularly to all clinical staff members, senior management through the committee structure of the hospital and ultimately to the board of management. Hospitals in Victoria are now required to publicly report the



improvements in health care delivery that they have achieved in annual

"quality of care" reports.

7.1.25 Step 25: assess whether the changes made are sustainableAfter implementing the changes and having them in place for some time, the team should assess whether the changes are sustainable and have become routine practice. If sustainability has not been achieved, further work is required. The change process is not about achieving short-term results, but aims for sustainable, long-term improvements. Such improvements require discipline lo remain focused on the changes being implemented, and vigilance to ensure the project is achieving its goals.

In the Wimmera Health Care Group, we have been able to achieve significant, measurable improvements in the quality of care provided in a particular clinical area on several occasions. We have then concentrated on another clinical area requiring improvement, only to find that the improvement achieved in the first area has been significantly eroded some time later. Unfonunately, a reduction in clinical improvement often only comes to our attention when an adverse event occurs.

Frequently, an adverse event recurs because the initial changes made to the relevant delivery system were not maintained. The recurrence may also be due to factors that were not detected in the initial analysis, or not present when the initial adverse event occurred. Once an improvement has been achieved in an area, sample measurements of key processes related to the redesigned system should continue to be made and reported. The project team could then meet once or twice a year to review the ongoing results of the change. Sustainability is hard to achieve, and, in our experience, constant vigilance is required to maintain the positive changes that have been made.

7.1.26 Step 26: when the project's goal Is achieved, celebrate the success and reward the participantsWhen the project's goal has been achieved, the accomplishment should be celebrated within the health service and publicly recognised. The important role played by each of the project team members should be acknowledged. Consideration should also be given to appropriately rewarding the team members. Appropriate rewards for clinicians include formal, public recognition of their contribution to the project and the significance of their work in improving the quality and safely of patient care, and supporting them to participate in activities to maintain their knowledge and skills in their area of clinical expertise. Rewards may also need lo be tailored to reflect the personality differences of some project team members.

The efforts of the project team members could also be recognised by helping them publish a paper in a professional journal describing the methods used and the results achieved in the project. Publishing a paper serves two purposes. Firstly, it allows the staff who participated in the project to be publicly acknowledged to their peers. Secondly, others in the health care field can learn about how behaviour was successfully changed in a clinical area in a health scrvicc and can

The quality at erne cannot improve i we harness the Knowledge and creative energy at physicians and other health professionals tor the purpose of redesigning the intricate, interlocking processes that constitute modern * healthcare.... physicians do have a number of skills and attributes that no other participants in the healthcare marketplace have in quite the same combination scientific training and understanding of medical diagnostics, and therapeutics, an understanding of patients'individual circumstances, an ongoing personal relationship with patients, and perhaps most

important, an ethical and professional commitment to placing patients 'welfare first'

Blumenthai D.Epstein A N Engl J

Med 1996.

335 1328-1331

consider the appropriateness of applying these lessons in their own scrvicc.



7.1*27 Step 27: evaluate the projectThe project should be evaluated and the project team should reflect on the process in which they have participated. Were the goals of the project achieved? Were the steps of the implementation plan undertaken as proposed? What did and did not work at each stage of the project? Did the overall benefits of the change in practice outweigh the costs? What were the positives and negatives associated with the change process? How could some of the lessons leamt about health care delivery systems, problem solving and quality improvement be transferred to other groups in the hospital who are planning projects to change clinical practice, and to the health care field generally?

Stakeholders can also be asked about the value of each intervention, their level of satisfaction with the intervention and change process, additional barriers or facilitators they became aware of as the change was implemented, and any refinements that would make in undertaking future change projects.27

7.1.28 Step 28: continue to monitor performance and resource availabilityWhen the change in clinical practice has been successfully implemented, the health service may consider the project complete and stop monitoring results in that clinical area. The health service may also reduce or withdraw funding for the activity. If the clinical changes are now embedded in routine patient care, these actions may be appropriate. However, in our experience, such action may result in clinical practice relapsing to levels before the project commencing. Some change processes require ongoing support and vigilance for the changes to be sustained.

Clinical practice should continue to be monitored even though the change project has formally concluded, and feedback about clinical performance in this area should continue to be provided to relevant groups as occurred during the project. If the measures monitored fall over time, action will be required to deal with these relapses.

If ongoing resources are required for the changes and clinical improvements to be maintained, steps should be taken to ensure they continue to be provided. The project's executive champion is in an ideal position in the hospital to ensure lhat, if required, such resources continue to be made available to maintain the improvements achieved. The executive champion has extensive knowledge of the change project having been an active member of the team and possessing the detailed knowledge of the processes required by the hospital to be followed to obtain ongoing resources.

7.1.29 Step 29: regularly update and review the scientific evidence for best practice in the clinical anaWith the large amount of research being undertaken, what constitutes best practice in a clinical area may change rapidly. It is unlikely that clinical practice guidelines will remain current for long. Therefore, when the project is completed, a date should be set to review the evidence regarding clinical practice and what constitutes best practice in the area of the change. This review should occur earlier if research substantially altering best practice is published.

It is difficult to specify a time period in which a review of best practice should occur. However, as a guide, in an analysis of 100 quantitative systemic reviews, the median time before substantive new evidence signalled that updating the review was required was 5.5 years. However, in 23% of reviews, a signal for updating occurred within 2 years of the publication of the review.31

7.2 Motivating doctors to participate in quality

and safety programs

With their key role in delivery of patient care, doctors should be an integral part of the quality and safety programs in the health services in which they work. For a variety of reasons, such involvement does not always occur. Therefore, it is important to review doctors' attitudes towards quality and safety programs and to discuss factors that may increase their engagement.

Most doctors care greatly about the care they provide to their patients. However, some believe that it is only their skills that protect their patients from harm from the system. Further, most doctors believe that they provide good-quality care that does not need to improve. Therefore, many doctors are not motivated to change. They would be motivated to change if they fell more discomfort with the current level of quality being provided. For this reason, quality of care needs to be consistently measured, although some doctors resist being measured.32

Although many doctors are passionate about the quality of care they provide to their patients, doctors as a group are often viewed as obstacles to quality improvement and patient safety. Some doctors view such programs as interfering with the delivery of care to their patients and a waste of lime, although others are clearly leaders in this area.32

Difficulty in fully engaging doctors in quality and safety programs has been a longstanding problem in health care, and is a significant issue. Doctors regard clinical governance as primarily financially and patient-throughput driven. They view audits as time-consuming and resulting in little change in practice. They report few clinical incidents. Why do doctors behave this way toward quality and safety programs? Are doctors just too busy, or do they need to remain in control to participate in these programs and feel this control is threatened?33

Doctors and other clinical groups need education about safety and quality, and this should start at university (even though the curriculum is already crowded). However, medical, nursing and pharmacy students receive little education about patient safety in their undergraduate courses.34 Therefore, their education in health services about quality and safety after they graduate is important. In addition, ongoing teaching about errors and adverse events as occurs for clinical advances may be required.

This education should begin at orientation, with staff told of the programs in the service and also what incidents to report and how to report them. Regular education sessions could cover many of the topics discussed in this book, including how errors occur, the importance of latent factors, how adverse events are detected and acted upon, and lessons learnt from external sources. Individual and group feedback

"TnapHtofevmyHntthat hat occurred. IHe majority of doctors today are Stat not very Involved in the promotion of patient safety. There is leas resistance... but there is not the active participation that is needed. Safety is not a daily concern of most doctors, and it should be. Nursing is way ahead of us on this, but even there things can be improved. Physician apathy continues to be area/drag.'

Leape L

Health Alt (HMwood)2007: 26.

w687-w696



about incidents that have been reported and adverse events detected can be given, and quality and safety initiatives currently being undertaken discussed. Disclosure of information to patients and relatives about adverse events that have occurred should also be discussed. Using lectures and monthly conferences has resulted in no

overall change to junior doctors' attitudes and behaviour to quality and safety issues, with major barriers cited being lack of time, extra paperwork and career and reputation concerns.35

Given the increasing complexity of medicine, with patients having more comorbidities and the availability of more diagnostic and treatment options, doctors need to work as pan of a team to solve difficult, complex problems. However, doctors are given almost complete autonomy to provide health care. Therefore, influencing their behaviour can be difficult. Their training instils fierce professional pride, individualism and resistance to attempts to reduce their independence. Some doctors find it difficult to work in teams.36 Doctors are sceptical of and resistant to quality improvement programs because of a reluctance to change, misunderstanding the aims of the pro-grams, and a dislike of how programs are promoted. It takes time to influence doctors. Their initial support of programs may be fragile, and they will need to see tangible and ongoing evidence of the benefit of the program.37 They have seen many local and national initiatives in the past, and are sceptical that new programs will make any difference to the quality of care or their work environment. Some reasons why doctors do not follow clinical practice guidelines are given in Box 7.1.38 Engaging doctors in quality and safety is complex, and there will not be one simple solution. As discussed in Chapter 6, change strategies should be tailored to the characteristics of the target group (often substantially comprising doctors) as well as the characteristics of the intervention, the setting, the patients and the context. In each situation, the important barriers and facilitators will need to be identified and strategies developed to overcome them to change clinical behaviour.

Sometimes, the link between appropriate action and its effect is delayed, influencing clinical behaviour. Doctors may not use some evidence-based preventive interventions because they do not receive direct, immediate feedback — and by consequence, positive reinforcement — about the intervention's effectiveness in preventing a negative outcome in an individual patient. The benefit to the patient is real and often significant, but it is delayed. This is in direct contrast to some evidenced-based therapeutic interventions, where the benefit to the patient is obvious and the doctor receives direct, immediate feedback that the intervention has had a positive effect on the patient's outcome.9 For example, ensuring that patients who have had an acute myocardial infraction are taking P-blockers will reduce the probability of them having further infarcts, but the effect is not immediately obvious to the medical staff providing the medication. In contrast,

administering intramuscular adrenalin to a patient with acute anaphylaxis will have immediate effect, reinforcing its benefit to medical staff.

Many of theses factors have been discussed in earlier chapters. In any situation, the important factors impeding clinicians taking appropriate action should be identified. Many of these barriers can be modified or eliminated, and implementation strategies can be tailored to overcome them and improve care (Checklist 7.1).

Bo* 7.1 Reason* why doctors do not follow dMcal

practice guidelines3* ■ Unaware of guideline■ Difficult to access guideline■ Lack of time to become familiar with guideline■ Do not agree with content of guideline■ Guideline not applicable to the patient■ Guideline not cost-beneficial■ Source of guideline not credible■ Guideline too general■ Guideline too rigid■ Guideline challenges autonomy■ Guideline not practical■ Believe cannot perform guideline recommendation (self-efficacy)■ Believe following guideline will not lead to desired patient outcome■ Habit and routine of previous practices■ Guideline inconsistent with patient preferences■ Presence of contradictory guidelines■ Lack of time or resources to use guideline■ Organisational restraints■ Lack of reimbursement for using guideline■ Perceived increase in malpractice liability if use guideline.



Checklist 7.1 Engaging doctors in quality Improvement and patient safety programs Actions_____tts NetWF *A1 The effectiveness of the proposed change is supported by High-qualHyaueiiUlK.evKleiiusfoni va credible source.

2 The proposed change is in an area of clinical importance to physicians and improves their patients' outcomes.

3 The change is not primarily a cost-cutting exercise.

4 The change does not impose significant work and time commitments on already-busy doctors.

5 Doctors are consulted in the early stages when the change proposal is being developed andasked for their input. Any legitimate concerns they express are adequately addressed. I l l

6 The effectiveness of the implementation strategy for the change process of change is scientifically based and is not just the latest management fad.

«

7 Adequate resources are provided to implement the change.

8 Doctors are given protected time to participate in the program.

9 It is easy for doctors to participate in the change process.

10 Management is consistent in its approach to quality improvement and safety initiatives.

11 There is little turnover in management staffing.34

12 Doctors are provided with confidential, timely and meaningful feedback about their performance in implementing the change.

13 The participation of doctors in the program and the results achieved are publidy acknowledged.N/A = not applicable. WIP = work in progress.

7.3 The framework in action — clinical pathways39

Many of the strategies to close gaps and reduce risks discussed in this book have been incorporated in the development of clinical pathways at Wimmera Health Care Group.Wherever possible, the care provided to patients should be consistent with best practice according to the highest-quality scientific evidence. To help health professionals, evidence-based clinical practice guidelines have been developed to manage many clinical conditions. These guidelines can be complex and lengthy, and multiple guidelines can exist for the management of the same condition. Further, these guidelines may not be readily available or easy to use in acute care situations. Their effectiveness may be limited by resource constraints such as staff skills and equipment availability. Clinical guidelines need to be simplified and incorporated into everyday hospital practice.Many gaps identified by quality improvement programs, and adverse events detected by risk management programs were clustered around the care provided to patients with panicular clinical conditions. There was high variability in the care provided. With the shon rotations and high turnover of junior medical stalT, high compliance with evidence-based clinical guidelines would be unlikely to beachieved.Using system redesign, it was decided to:■ determine best practice in the management of high-frequency clinical conditions:■ modify best practice for local needs and conditions;■ break down best practice into a series of actions; and■ incorporate these actions into a daily checklist of reminders that would form the patient's mcdical recordSuch clinical pathways were developed for 30 clinical conditions, and the following steps werefollowed:1 A senior nurse was appointed as the clinical pathway coordinator.2. There was an established clinical risk management culture in the hospital. Clinical and executive champions were identified and invited to participate in the pathway program.

3. Clinical conditions were chosen for pathway development because

> Gaps and adverse events were consistently delected in management of patients with the

conditions.

Suboptimal treatment of the conditions resulted in considerable patient

harm. >• Some clinical conditions were treated frequently in the health

service.4. A multidisciplinary team was established to develop the pathway. If individual members were required to undertake considerable additional work in developing the pathway, they were paid for their time or they were replaced in their normal duties.5. Information was collated on what constituted best practice for the condition under review.

Sources of information included a literature search, clinical guidelines developed by other organisations and information about how the condition was managed at other health services.

6. The pathway was developed. It contained information for clinical decision making, evidence-based guidelines, and checklists and reminders for patient care in the emergency department and each day in hospital.

7. Draft pathways were circulated for comments to all medical staff and other relevant staff.

8. Small-scale trials of the pathway were conducted and appropriate modifications made.

9. Education sessions about how pathways were to be used were conducted for staff.10.Audits measuring compliance with process measures known to have considerable positive

impact on patient outcome were undertaken. If a gap was detected, corrective action was taken and monitoring continued. Several cycles of action, monitoring, analysis and modification were required to close thegap

11.Medical staff members were provided with feedback about their individual performance.12.The results of the program were reported using a top-down and bottom-up approach — up

organisation to board of management and down the organisation to all staff.The limitations of clinical pathways include:■ It is not feasible to develop clinical pathways for the management of every clinical condition. In our experience, using 30 clinical pathways in several specialties, about 46% of the patients on the wards at any one time are on a clinical pathway.■ Each clinical step in a pathway is not necessarily appropriate in the management of every patient on that pathway. Clinical judgment must still be used to determine an individual patient's care.■ Management of patients with some medical conditions, such as stroke, is complex, but such pathways can still be developed, despite being difficult to write. Often, management of patients for elective surgery can be much simpler, and pathways for these clinical situations can be developed more quickly.■A patient is placed on a clinical pathway for management of their major clinical condition. However, some patients have more than one significant clinical condition. In our experience, care is required to ensure that their other significant comorbidities continue to be actively managed and not neglected.■ Pathways are not suitable for the management of patients with two significant conditions for which clinical pathways are available. It is confusing and may be detrimental to place a patient on two pathways simultaneously.■ Effective use of clinical pathways is resource-intensive. Each new clinician requires orientation and ongoing education about the method With many junior medical staff rotating to Wimmera Base



Hospital every 10 weeks, such education takes significant time. Also, the pathways used at Wimmera Base Hospital are paper-based, and audits of their use are also resource-intensive. In addition, pathways should be kept current for changes in best practice, and this requires ongoing scanning of the scientific literature.

7.3.1 Case study — the stroke clinical pathway •Using medical record review, adverse events were detected in the management of patients admitted with stroke. These events included aspiration and prolonged length of stay.

A multidisciplinary team was formed, with the aim -of reducing the frequency of these events and establish a plan of care for acute stroke management. The team had the support of senior executive and clinical stafT to help implement change strategies. The team aimed to produce a clinical pathway for management of patients with acute stroke, and was given adequate resources and infrastructure support to undertake the task. Membership of the team included clinical stafT strongly committed to providing high-quality care and comprised: a specialist physician, a resident medical officer, a pharmacist, a physiotherapist, a speech therapist, a social worker, an occupational therapist, nursing staff from the medical ward, emergency department and rehabilitation area, and a clinical pathway coordinator.

A literature search was undertaken to identify evidence-based best practice for each stage in the management of patients with stroke. The pathway was designed to be the medical record of the patient's admission. The pathway contained: a summary of evidence-based clinical guidelines for easy reference; a flow diagram of major diagnostic and management decision points; detailed pro-forma medical admission and allied health assessment forms; a nursing risk assessment form; a checklist for medical, nursing and allied health staff regarding management, investigation and referrals for each day of the admission; and sections for medical and allied health clinical notes.

All clinical areas involved in the care of these patients were sent draft copies of the pathway requesting feedback. This feedback resulted in significant modifications. A final pathway was then produced, and extensive education sessions were held with nursing, resident medical officers and visiting medical staff regarding its implementation.

An evaluation of the pathway implementation was undertaken, which included stroke patients admitted between 31 July 1999 and 30 April 2000 (prepathway) and between 1 June 2000 and 31 December 2002 (postpathway). This evaluation measured the degree of compliance with four key process measures before and after the introduction of the pathway. The four measures were chosen to be followed were the proportion of patients with stroke who:a had a computed tomography brain scan done within 24 hours of

admission (100% prepathway v 99.0% postpathway); a had a dysphagia screen performed within 24 hours of admission (51.8% v 92.5%);

-HyouwoMBmm start tomorrow to change practice and implement evidence, prepare well: involve the relevant people; develop a proposal for change that is evidence-based, feasible, and attractive: Study the mam difficulties in achieving the change, and select a set of strategies and measures at different levels linked to that problem; of course, within your budget and possibilities. Define indicators for measurement of success and monitor progress continuously or a regular intervals. And. finally, enjoy working on making patients' care more effective, efficient, safe, and friendly.'

Grol R. Grimshaw J Lancet 2003: 362 122S-1230


■ if the stroke was ischaemic stroke, were given aspirin or clopidogrel within 24 hours of admission (36.8% v 92.2%). and■ had regular neurological observations performed during first 48 hours after stroke (25.9% v 78.3%).These improvements have now been sustained for a period of 8 years (see Figure 4.4). The pre- and postpathway results were reviewed by the team and reported in graphical form to all clinical groups in the hospital. The progress of the team in developing and implementing the pathway was reported each month to the hospital's peak quality committee, which is a subcommittee of the board of management.Following the discussion in this chapter, a checklist of the practical steps to be considered when planning to implement change is given in Checklist 7.2.

182


Checklist 7.2 [continued)

Actions Mo

183

Checklist 7.2 Implementing change

Actions Yes No WIP N/A

11dentify a gap in the quality of patient care, or detect a significant risk to patients.

2 Analyse the gap or risk to determine its causes and whether any change is required in the way health care is

delivered in the clinical area.

3 Determine the quality of the evidence supporting the benefits of the change.

4 Identify the target group, major stakeholders, opinion leaders and clinical champions.

■ Target group — staff members who need to change their behaviour to successfully implement the change.

■ Stakeholders — individuals or groups who will be affected by the change, and whose cooperation is needed to

implement the change.

■ Opinion leaders — respected and influential clinicians whose opinion members of the target group will seek

about the change.

■ Clinical champions — clinicians with a strong motivation to change behaviour in the area of the change.

5 Determine whether the gap or adverse event in which the health service would like change to occur is an

important issue for the target group, and whether they acknowledge any ownership of the issue.

6 Describe the present state of health care delivery regarding the gap or adverse event to the target group.

■ Ensure data are accurate, clear and concise.

7 Determine whether clinicians are dissatisfied with the quality of the care presently provided.8 Present a clear, realistic vision for the future to the target group.

9 Weigh up the benefits and the costs of making the change.

10 Determine whether the management of the hospital is prepared to support the proposed change.

■ Adequate resources need to be provided.■ A senior manager should be actively involved on the change project team.

11 toaem the stage in the change cycle that individual clinicians in the target group are in.

Checklist 72 (continued on next page)


12Form a project team:

■ that is short-term

■ that is multidisciplinary ^

■ whose membership comprises representatives of target group (and its subgroups), clinical champions, major stakeholders, individuals with required expertise, project coordinator, secretarial support

■ that has terms of reference.

13 Undertake a comprehensive, systematic analysis of the gap or adverse event Identify the determinants of the proposed change or intervention, target group, patients, organisation and sociopolitical context, and their barriers and facilitators.

■ identify latent factors and active errors

■ widely seek and validate information from target group and relevant others to identify important determinants

■ identify the major determinants that can be changed

■ ensure resources are adequate to make the change

■ determine best practice in the clinical area under review.14The project team should set shared goals.

■ Goals should be are specific, measurable, attractive, realistic and time-framed.

15Construct a list of strategies available to close the gap or reduce the risk.

■ Where possible, appropriate strategies are matched against major determinants.

■ Evidence-based strategies are considered if appropriate — dissemination of educational materials, audit and feedback, reminders, multifaceted interventions incorporating education outreach, and opinion leaders.

■ System redesign is considered — simplifying systems, standardising procedures, using reminders and checklists, introducing constraints, providing timely and accurate communication.

16Choose the best strategy or strategies.

■ Is the strategy simple?

17Plan the implementation of the chosen change strategy carefully but efficiently.

■ Put plans in writing and detail the actions to be taken to achieve the proposed change, the individuals responsible for completing each action and the date when the action will be completed.

■ Identify barriers to implementation and design strategies to overcome them.

■ Develop data collection tools that are easy and efficient to use.

■A balanced set of outcome and process measures are developed:> At least one measure from each category: clinical, cost, patient satisfaction and functional health status.

Measures are limited in number, highly correlated with patient outcomes, of high leverage, clearly defined, easily identified and collected and low cost to collect.

18Widely disseminate draft versions of the plan for comment and input.

19Take baseline measurements.

■Could the required data be obtained and were adequate data collection systems in place?

«

184


('Wis! ~ (continued ,->- nape1

Checkfict 7.2 (continued)

OIMIJIO Yas No WIP N/A

20 Implement the chosen strategies using small-scale rapid tests.

21 Analyse the results of the fkst test.

■ Do the chosen strategies require change? Abandon or modify the strategy if required.

■ Do the project goals require change?

■ It is most likely that several cycles of testing will be required.

■ When test is successful, implement changes more widely in the organisation.

22 Take deliberate and continuous action to implement the plan.

23 Monitor the progress being made towards the goals, and provide feedback about progress to the participants.

24 Communicate the proposed changes and results to staff.

25 Make assessments about whether the changes made are sustainable.

■ Are the changes embedded into the daily routine of patient care?

26 When the goal is achieved, celebrate success and reward the participants.

27 Evaluate the project.■ Reflect on the lessons leamt during this change process.

28 Continue to monitor performance and resource availability.

29 Regularly review the scientific evidence for best practice in the clinical area and update practice in the

hospital.

W1P = work in progress. N/A = not applicable.

Important points■ Strategies to successfully change behaviour must involve the target group (those in the health sanrioe

required to change their behaviour in order to successfully implement the change).

■ Given the complexity and unpredictability of health care systems, results of change strategies must be closely monitored. Timely feedback of results should occur, and modification of strategies or goate made if required.

Key characteristics ot successful change projects

■ High-quality scientific evidence supports the benefits of the proposed change.

■ The proposed change is important to the members of the target group.■ Senior management support Ihe change by providing adequate resources and a senior manager to actively

participate in the project team responsible for implementing the change.

■ There is a large gap between the present and desired states of health care deliver in the clinical area in which the change is proposed.

■ The benefits to the target group of the proposed change outweigh the costs.■ A project team comprising target group representatives, those with required expertise and support staff is

created.

■ The project team and senior management develop shared goals to achieve the proposed change.■ The project team is responsible for analysing the gap or risk, creating a detailed plan to close the gap or

reduce the risk, and implementing the plan.

185


■ Comprehensive, systematic analysis of the determinants influencing the success of the change (the innovation, target group, organisation and sociopolitical context) is undertaken.

■ The plan addresses each of the major determinants (facilitating and impeding) to achieving the change and comprises a sequence of actions with timelines designed to achieve the change.

■ Deliberate, continuous action is taken to implement the plan, commencing with small-scale rapid tests.

■ Individual, timely feedback is given to target group members about their performance.

■ Project team members are recognised for their contribution when the change is achieved.

■ The results of the change are monitored and reported after the change project is completed.

Engaging doctors In quality and safety programs

■ Doctors should be an integral part of a health service's quality and safety program.

■ Most doctors are committed to providing high-quality, safe care to their patients.■ Doctors are more likely to be engaged in quality and safety programs if making changes does not require a

significant amount of their time, the proposed change is supported by high-quality scientific evidence and will improve their patients' outcomes, they are consulted early and consistently about the proposed changes and are provided with adequate resources and timely, meaningful feedback about their performance.

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27 Stetler CB. Legro MW. Wallace CM, et al. The role ol formative evaluation in implementation research and the OUERI experience. J Gen Intern Med 2006; 21: S1-S828 Hysong SJ. Best RG, Pugh JA. Audit and feedback and clinical practice guideline adherence: making leedback actionable Implement Sci 2006; 19

29 Bradley EH, Holmbee ES, Matters JA. et al. Data feedback efforts in quality improvement losaont teamed from US hospitals. Qual Saf Health Care 2004:13:26-31.30 Kiefe CI. Allison JJ. Williams OD. Person SD. Improving quality improvement using achievable benchmarks for physician feedback: a randomised controlled trial. JAMA 2001; 285:2871-2879.31 Shojania KG. Sampson M, Ansari MT. et al. How quickly do systemic reviews go out of dale? A survival analyse Ann Intern Med 2007; 147: 224-233.32 Goode LD. Clancy CM. Kimball HR. et al. When is "good epough"? The role and responsibility of physicians to improve patient safety. Acad Med2002; 77. 947-952.33 Neale G. Vincent C. Darzi A. The problem of engaging hospital doctors in promoting safety and quality in clinical care. JRSoc Health 2007; 127: 87-94.34 Leape L. Is hospital patient care becoming safer? A conversation with Lucian Leape. Interview by Peter I Buerhaus. Health Alt (Millwood) 2007; 26: w687-w696.35 Coyle YM, Mercer SQ, Murphy-Cullen CL, et al. Effectiveness of a graduate medical education program for improving medical event reporting attitude and behaviour. Qual Saf Health Care 2005; 14:383-388.36 Blumenthal D, Kilo CM. A report card on continuous quality improvement. Milbank Q 1998; 76: 625-647.37 Gollop R, Whitby E, Buchanan D. Ketley D. Influencing skeptical staff to become supporters of service improvement: a qualitative study of doctors' and managers' views. Qual Saf Health Care 2004; 13. 108-114.38 Cabana MD, Rand CS, Powe NR, et al. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA 1999: 282: 1458-1465.39 Wolff AM, Taylor SA, McCabe JF. Using checklists and reminders in clinical pathways to improve hospital inpatient care Med J Aust 2004; 181: 428-431. □


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in

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8 Reporting the activities and results of the clinical

governance program

This chapter will:

a Outline the activities of the quality improvement and risk management programs that should be reported■ Discuss what form they should be reported in■ Describe how and to whom they should be reported.

The activities of the clinical governance program and the results achieved should be reported both up the organisation through the committee structure and to the main clinical groups and senior management to the board of management, and down the organisation to all clinical staff in the health service.The board of management should be confident that the program's activities are being undertaken as planned, that clinical care is provided in accordance with best practice, and that the risk for patients receiving care is appropriate.Some health services have developed scorecards to evaluate and report their performance in quality and safety. These scorecards are usually brief, and provide a rapid way for board members, senior executives, staff members and the public to obtain an overview of the service's performance. Much thought and effort is required to determine the measures to be used in the scorecard. The measures should be valid (including the evidence supporting the measure and that improving performance will improve patient outcomes), reliable, useful, feasible, clinically significant, and important to those required to improve quality and safely at the frontline of the service. Measures will often require prioritisation because of the many available.1

Adequate resources should be allocated by the health service to collect, analyse and report the data. Using multiple measures to assess performance often requires the development of standardised data collection tools, training staff to use them, regular review of the quality of data collection, and reporting and minimisation of missing data.1

Many aspects of best practice and data collection and analysis (discussed in Chapter 2) are also relevant to measures used in quality and safety scorecards.The quality improvement program should repon the number of medical staff who have been appointed over the period of the report, the clinical areas in which they have been granted privileges to practice, and any changes in clinical privileges made for existing medical staff. The results of clinical audits, both routine and focused, that have been undertaken should also be reported. Any gaps between the clinical care provided and best practice should be highlighted, together with the actions taken, or planned to be taken, to close the gaps. Routine clinical audits may be undertaken in high- volume clinical areas, and a balanced set of measures should be used to concisely report on the health service's performance.

"One of the dHfictAieein addressing quality management issues with the same interest and rigour as financial management is the lack of robust universal systems for collecting and reporting on key areas of quality and risk . . . All health services should agree upon a minimum dataset of high-risk issues to be regularly reported throughout the organization.'

Balding C Health Inf Manag 2004: 33 137-139

6 Reporting the activities and results of the clinical governance popem

The risk management program should report the number of medical records that screened positive for each screening criterion and required medical review, and the number of adverse events detected. The number of clinical incident reports made by clinical stafT and the number containing adverse events should also be included. A risk register detailing the extreme and high clinical risks currently present in the service should be pan of the report. The report should also include the actions proposed to reduce or eliminate these risks, the staff responsible Tor these actions being taken, and their completion dates.

According to the "rule of rescue", humans respond to stories more than they respond to statistics. Therefore, the statistics presented should also be supported by carefully chosen case histories, which help focus the health service and keep patient safety "front and center".2

Equally imponant to reporting up the organisation is reporting the activities and results of the clinical governance program to all the clinical staff in the health service. In our experience, producing an attractive one-page newsletter each month can best disseminate this information. The contents of the newsletter cover the major activities of the program and the actions taken that to improve quality and safety. The layout is colourful and graphs are used to display results and trends. To ensure all clinical staff receive the newsletter, it is attached to their pay slips and is displayed on all hospital noticeboards.

Important points

m Quality improvement and risk management activities should be reported up the organisation to the governing body and down the

organisation to those at the clinician-patient interface.

■ A balanced set of measures should be reported, and could include: the results of focus and whole of practice audits and the gaps identified and

actions taken; clinical indicators that have been measured and benchmarked; the risk register detailing significant adverse events and risks detected

by the risk management program and the actions taken; medical staff appointments and changes in clinical privileges.■ Education about the program can be undertaken at staff orientation and by distributing regular newsletters.

References1 Pronovost PJ. Berenholtz SM. Needham DM. A Iramework for health care organizations to develop and evaluate a safety scorecard. JAMA 2007; 298:

2063-2065.

2 James B. Brent James on reducing harm to patients and improving quality. Interview by Susan V White. J Healthc Qua! 2007; 29: 35-44. °

9 A quality improvement and patient safety culture

This chapter will:

m Discuss the components of an informed culture■ Outline the types of safety cultures■ Describe the spectrum of safety cultures, from vulnerable Jo resilient■ Present a checklist of the characteristics of a high-reliability health service■ Discuss how an organisation's patient safety culture can be measured, including the instruments available.

Hospital services are facing ever-increasing demands, and financial pressure limits the services provided. Each day, many pressing "bushfires" occupy senior management. Quality and safety issues may be pushed into the background while "more pressing" issues are dealt with. Safety issues may therefore not receive appropriate attention. Eventually, action is taken, often only

9 A quality improvement and patent safety a«ure

1»1

after a "disaster" occurs and an external agency, such as the coroner, obtains the attention of relevant individuals in the organisation.1 The development of a "safety culture" may detect and reduce risks in a timely manner and prevent adverse events occurring before action needs to be taken.

Culture is "the way we do things around here".2 An organisation's culture influences patient safety.3 For example, can concerns about safely be raised with senior management by frontline stafT? Are these concerns adequately investigated, and is appropriate action taken in a timely manner? Safety culture is one component of the wider construct of organisational culture. Culture is something an organisation is (the beliefs, altitudes and values of its members) and has (the structures, practices, controls and policies).4 5 Culture evolves over time according to local conditions, past events and leadership. It is easier for management to change structures and policies than beliefs and attitudes.The concept of a safety culture, although often poorly understood, is strongly desired by many organisations. There is increasing recognition that differences in safety cultures is a significant factor in the variation in accident rates between organisations, and that changing organisational culture is important in improving patient safety.6 From 2008, the Joint Commission on Accreditation of Healthcare Organizations in the United States will require health services to undertake an annual assessment of their organisational culture as part of the leadership standard for accreditation of services. A safely culture can be "socially engineered" by gradually and persistently bringing together and applying the essential components a safety culture, which are ways of doing, thinking and managing.1

A safely culture reflects the "ability of individuals or organizations to deal with risks and hazards so as to avoid damage or losses and yet still achieve their goals".7 The Insiiiuie of Medicine in ihe US stated that "the biggest challenge to moving toward a safer health system is changing the culture from one of blaming individuals for errors to one in which errors are treated not as personal failures but as opportunities to improve the system and prevent harm".8

In a strong culture, goals and values are shared across ihe entire organisation guiding people in how they should act in particular situations. The safely culture drives the organisation to the maximal level of safety

9.1 Types of organisational cultureWestrum proposed three organisational cultures according lo how an organisation processed information, including how much information (lows, its relevance, timeliness and appropriateness ° He



Boa 9.1 lypes of organisational culture*

■Preoccupation with personal power and needs.■Information is a personal resource to be withheld or provided to advance particular groups within the organisation.■Failure is covered up and individuals blamed.■New ideas are actively crushed.■Sharing and learning with others is discouraged.■Most immature state of cultural maturity.

■Preoccupation with rules, positions and departmental turf.■Communication may stop at departmental boundaries.■Systems have been developed for communication.■Information is collected but may be ignored.■New ideas are seen as creating problems.■Learning and sharing are tolerated but not encouraged.Generative■Preoccupation with the organisation's mission.■Information is actively sought.■Good information flow assists creativity, problem solving and innovation, and builds bridges and cooperation between departments.■New ideas are encouraged and often implemented.■Failure prompts inquiry.■Most advanced state of cultural maturity.

described three responses (thoughts, emotions and actions) to opportunities for innovation, problems and danger signals. These responses were shaped by management's preoccupations, which are absorbed by the workforce and shape the organisation's culture (Box 9.1).9

Although organisational culture is much wider than safety case studies and anecdotal evidence suggest, good information flow in organisations is strongly related to safety.9 In generative cultures, safety problems are more likely to be raised with inquiry into the problem and repair of latent sources of error. What has been leamt about the problem and its causes and solutions are then communicated to other parts of the organisation.

9.2 Components of an informed culture

The most important component of a safety culture is that it is an informed culture (ie, there is an "effective safety information system").1 The system collects data about incidents and near misses, analyses the data, and regularly communicates appropriate information throughout the organisation. Management is therefore aware of the hazards in the organisation and the level of safety.Four subcomponents interact to create an informed culture: reporting culture, just culture, flexible culture and learning culture. Importantly, the presence of these four elements in an individual organisation does not ensure a safety culture exists. Putting them into place is only the first step. These practices need to function effectively to move to the next stage of a safety culture — being something an

192


organisation is, such as its beliefs and values. Developing a safety

culture is a continuous struggle and joumey, rather than a destination

and endpoint.1

9.2.1 Reporting cultureThose in contact with the hazards facing the organisation at the coalface repon incidents and near misses. Such reponing requires staff trust, which is developed by taking non-punitive action rather than blaming individuals for incidents (unless "unsafe acts" have occurred), and maintaining confidentiality. Reponing is easy, rapid feedback from investigations and actions taken are given to the reporter, and aggregate information about trends and actions are reponed to all staff.1 There is a record of appropriate action being taken in response to reports.

9.2.2 Just cultureMost adverse events are the result of system deficiencies. However, at ti actions taken by staff are clearly unsafe and unacceptable, and appropriate sanctions need to be applied. A framework could be developed to help determine culpability, and could consider:

were the actions and consequences intended, was there unauthorized substance abuse, did the individual knowingly violate safe operating procedures and were the details of these procedures available, workable, intelligible and correct, in light of how events unfolded and were perceived by those in real time, is it likely that another individual with comparable qualifications and experience, would have behaved any differently, does the individual involved have a history of unsafe acts?1

Staff usually know which individuals continually break rules. If management and staff are aware of such behaviour and appropriate action is not taken, morale may be affected and the effectiveness of the organisations disciplinary system put in doubt. If appropriate disciplinary action is taken, it demonstrates to staff that the system works, and reinforces the boundary between acceptable and unacceptable behaviour. Such action makes the organisation safer and increases the belief by stafl that they are working in a just culture.1

9.2.3 Flexible cultureA flexible culture adapts effectively when demands change. If a dangerous situation occurs, the organisation has the flexibility lo give control to experts al ihe coalface (thereby respecting their skills and experience) and revert to the normal line of reporting after the emergency has passed.

Such flexibility requires a disciplined approach to working and frontline leaders who have been carefully selected, extensively trained, and who are able lo work safely and effectively in infrequent and dangerous situations for which standard operating procedures cannot or may not be developed. Such staff require detailed knowledge of the activities undertaken ai the frontline and the conditions thai may be

organisations mm I thatleedtoreHstMyle foe suppression and containment, in short, 0te management of fatures... those organizations committed to safety at foe highest level — high reliability organizations — adopt « a special approach to its pursuit.'

ScHuknan PR Qual Sal Health Cm* 2004; 13: *3»*44e


encountered there, have a high degree of professionalism, training and experience, and the respect of management and frontline staff.1


•J.4 Learning cuftureA Warning culture analyses safety information appropriately and takes action to make* the required changes. Learning organisations maintain flexibility in an environment of rapid change and uncertainty, and innovate to be able to compete.1 Key cultural features of a learning organisation are:6,1011

■ Open systems thinking — to see the interconnection of activities through knowledge sharing, feedback and communication.■ Improving individual capabilities — for an organisation to achieve excellence, individuals constantly improve their proficiencies by recognising their knowledge, experience and results. Members of the organisation are encouraged, and personal and professional development are valued.■ Team teaming — develop team, rather than professional or individual, learning.■ Updating mental models — finding new ways of doing things.■ A cohesive vision — a shared understanding of a coherent vision.■ Tolerance of mistakes — to encourage innovation and taking measured risks.■ Trust between managers, leaders and staff.Key structural features of learning organisations are:6

■ "Flauer"organisational management structures (fewer levels of management).■ Teamwork structures.■ Incentives and rewards for learning.■ Belter information and communication networks.■ Research and development programs and budgets. There are three levels of learning:11

■ Single loop — detection and correction of error (eg, clinical audit).■ Double loop — redefining the organisation's goals, norms, policies and procedures (eg, system redesign).■ Meta-leaming — building on experiences of learning to develop new learning strategies. "Implicitly, a practice that leams is also going to be safer and be able to improve continuously."6

However, most publications about organisational learning in health care discuss this theory and its application and barriers. Little has been published about its full implementation in a health service or evidence of its effectiveness.6

9.3 Types of safety cultures

Additional frameworks have been developed to assess the maturity of the safety culture within an

organisation. Parker and Hudson extended Westrum's model of organisational cultures to five

levels and applied it to safety culture (Box 9.2).12

Bex 9.2 Levels of organisational safety culture12

Level 1: pathological — why do we need to waste our time on risk management and salety issues?

Level 2: reactive — we take risk seriously and do something every lime we have an incident.

Level 3: caiculative — we have systems in place to manage all likely risks.

Level 4: proactive — we are always on the alert, thinking about risks that might emerge.

Level 5: generative — risk management is an integral part of everything we do.

194

9 A quality improvement and patient safety cufc*e

These levels can be applied across organisational dimensions, such as commitment to patient safety, perceptions of causes of incidents and their reponing, investigating incidents, learning following an incident, communication within the workplace, staff management, staff education and training about risk management, and teamwork. Organisations can develop criteria for each dimension that are appropriate for their local needs and conditions. The service can then compare safety behaviour in the workplace with the criteria for the five levels of safety across each dimension. This comparison should highlight deficiencies, stimulate discussion, identify areas for improvement, allow interventions to be evaluated and provide appropriate benchmarks to assess safety performance in the health service. Safety culture assessment can be a springboard for directing action to raise the safety culture to the next level.13

9.4 The safety spectrum in health services — from resilience to

vulnerability *There is a spectrum of safety in health services — some are resilient to adverse events, whereas others are quite vulnerable.14 Most lie in the middle of the spectrum; however, they can move in either direction over lime. Organisations can use "navigational aids" to determine their position on the spectrum. These aids are reactive (information about adverse events and near misses) and proactive (safety indicators to identify latent conditions that increase the probability of an adverse event or near miss occurring), and provide information about the level of a health service's resilience to error.14

9.4. I Why some health services are more vulnerable to operational hazards than othenPreviously, in most health services, clinical activity was reviewed in mortality and morbidity meetings and grand rounds, which focused on the medical care patients received, and the performance of individual doctors and the errors they made. Such review was made with the benefit of hindsight, and there was a marked lack of systems, multidisciplinary or human factors analysis.15 Systems with weaknesses resulting in adverse events remained weak.

In vulnerable health services, where the systems created and used are more likely to result in an adverse event or near miss, "a recurrent cluster" of three "organisational pathologies" are present: blaming those at the frontline of the organisation (blame), denying that the errors occurring are the result of weaknesses in workplace systems (denial) and pursuit of financial and production goals without attention to safety issues (pursuit of the wrong kind of excellence). No organisation in a complex industry is completely free of these characteristics, and they need to be recognised and remedial action taken.16

Until recently, there was little impetus for the culture in vulnerable health services to change. Unlike aviation and nuclear power, where a single error can have catastrophic effects, errors in health care, although they can cause the death of a patient, usually only afTect one patient at a time. However, in contrast with other complex industries, errors are frequent in health care.

9.4.2 The important characteristics of resilient or high-reliability health servicesMore conditions occur than can be anticipated or planned for when designing health care delivery systems, creating a large variety of novel problems. The components of systems can interact unpredictably, resulting in unexpected events that place a high premium on the experience and skill of clinicians to provide a wide range of services. Demand for acute health care is often unpredictable and uncontrollable, further challenging clinicians to be able to respond appropriately in real time The need for improvisation may be high at times, cutting across departments and hierarchies and requiring "bending* of procedures to provide appropriate care in a timely manner. There is also a high potential for serious adverse events to occur. Professionals have a critical role in making decisions in high-reliability organisations, which focus on real-time challenges using formal principles, experiential knowledge, pattern recognition, intuition and improvisation.17

1«S

A safety culture can provide a defence against inherent weaknesses in the organisation's systems. A poor safety culture may mean that workers do not understand or fear the operational hazards. Such ignorance may encourage non-compliance with safe operating procedures and the perpetuation of longstanding, recognised gaps in defences, which may be worked around rather than closed, as concern about them is not great enough for corrective action to be taken. Recurrent patterns of error may then occur, although major adverse events may only occur infrequently, resulting in complacency and making a change in culture difficult. As the resources available for quality improvement are limited, a balance between safety and cost is necessary to keep risks as low as practical while ensuring that the organisation remains in business. The practical components of an informed culture are known and can be engineered and a safe culture created (Checklist 9.1).18

Checklist 9.1 (continued)

ACTIONS YM NO IMP MM


Oieddbt 9.1 Characteristics of a high-raliabllity haalth service

Actions Yes No W1P N/A

1 Mian safety is placed above other short-term (usually financial) priorities.19

2 High-reliability professionals, who can combine principles and experience, are recruited and trained.'7

3 Staff education about quality and safety is important, commences during their orientation, and is ongoing. They

are taught that quality and safety are the responsfcility of all staff, not just management. Because of the high

turnover of junior medcal staff between hospitals and clinical areas within hospitals, education about quality and

patient safety is a standing component of their education program. Each staff member regularly receives easily

understandable information, including results of the quality improvement and patient safety activities undertaken in

the health service.

4 Adequate resources are provided by senior management for effective quality improvement and risk management

activities. These resources may include the employment of a clinical risk manager and other staff, secretarial

assistance, computers, audit tools, electronic incident reporting systems and trigger tools.

5 The dinical risk manager and quality manager report directly to the chief executive or a clinical ( visional head, are appropriately trained in risk management, and are given appropriate status and remuneration.

6 Staff are genuinely encouraged to raise quality and safety issues in real time. They can raise issues directly with

the chief executive, executive staff, the clinical risk manager, the quality manager, the occupational health and safety

officer, or the appropriate department head.

7 Quality or safety issues raised by staff are responded to quickly.

8 Board of management and senior management meetings routinely discuss quality and safety issues together with

financial and business issues. Safety is put above finance on board meeting agendas.30 Board of management

members and senior executives are aware of all major adverse events or near misses that occur and the major risks

faced by the health service. They are regularly updated about the progress being made to reduce these risks. Some

board members are allocated specific responsibility for quality and safety.1

Checklist 9 1 (continued on next page)


9 Quality improvement and pstiant safety are standng agenda Heme of meetings of lay professional groups within the health service. The dinical risk manager, the quality manager or the executive responsible for risk management attend these meetings and report on theactivities of these programs. *10 Responsibility for safety cannot be delegated from the chief executive.20

11 Patients have an integral role in safety efforts, and patient representatives are involved in quality improvement and risk management project team

meetings.20

12 Multidisciplinary teams are empowered to analyse gaps, adverse events and risks, and plan and implement changes to close gaps and reduce risks.20

13 Quality improvement and patient safety are key components of the health serviced « strategic plan, together with finance, the range of dinical services

provided and the organisation's major staffing, building and equipment requirements. The health service displays its strategic plan throughout its facilities

and features it prominently in its annual report. The quality improvement and safety objectives and activities of each department and division are a key

component of annual business plans and reports. The indusion of quality and safety in the health service's strategic plan sends a strong message to staff

and the community of the strong commitment to these areas at senior levels in the organisation. Regular reports of the health service's progress towards

the strategic plan objectives are made to the board of management, key professional groups and staff.

14 Adverse events and near misses are openly discussed in regular multidisciplinary meetings to learn from them and prevent their recurrence.

15 In analysing adverse events and near misses, major stakeholders and frontline staff are actively involved in analysing the event and determining

appropriate action to reduce the probability of recurrence. Senior management is actively involved, and assists if the event crosses departmental

boundaries. Senior management approves proposed actions to reduce risks, the timetable for implementation, delegation of tasks, and any other substantial

requirements, such as additional staff, building alterations or new equipment. Where safe to do so, senior management allows frontline staff to determine

and make changes they feel are appropriate to adequately address the event

16 The health service uses proactive and reactive methods to increase resilience to error. The organisation proactively

looks for weaknesses in the systems it uses to provide care. Latent factors or conditions of work, such as staff workloads,

shift length, skill levels and the degree of supervision of junior staff members, are assessed when designing new health

care delivery systems or assessing existing systems. The health service uses multiple methods to detect adverse events

and near misses (eg, medical record review, clinical incident reporting) to obtain different perspectives of events

occurring in the organisation.

17 There is a positive incident reporting culture in the organisation. Staff dearly understand which incidents they should report and appreciate that reporting

can increase quality and safety Reporting rates are high for doctors and nurses. Staff receive timely feedback of investigation results of incidents they have

reported. Recommendations for action are made in response to incident reports, and the timelines for completing these actions are consistently met

18 Clinical audits are undertaken These include continuous whole-of-practice audits and, where appropriate, focused audits following adverse events and near misses19 Actions taken in the health service to improve quality and safety are system improvements, and are not punitive against individual staff members unless

there is evidence that an "unsafe act" has occurred. Assessments are made of unsafe acts, and management and appropriate peers determine the

disciplinary action to be taken. I A process is available for individuals if they

wish to appeal against the judgment.1 IN/A = not applicable WIP = work in piogress

9.5 Measuring the patient safety cultureIt is important to understand the patient safety culture in an individual organisation. This can be achieved using individual interviews or focus groups, but they are time-consuming and resource- intensive. Self-administered surveys using standardised questions designed to measure the components of a safety culture that can be completed anonymously by health service staff are more efficient.21 An assessment of nine surveys showed considerable variation.22 The surveys can measure the patient safety climate throughout the health service or in specific areas. Seven of the surveys are completed by individuals and two by teams. All the surveys use a 5-point Likert scale and the number of items to be completed varies from 19 to 194. Two surveys measure the degree to which actions have taken place in response to safety concerns that have been raised. Five common dimensions in these surveys are: leadership, policies and procedures, staffing, communication and reporting. The quantity and quality of psychometric testing varies considerably between survey tools. The survey results are used to make comparisons within and between health services, and to compare health services with other complex industries.22

Each survey has different domains, limited validity and reliability, and variable response rates.22 The measurement of culture is evolving, with disagreement about measurement (which domains are important), scoring and how to improve culture. Also, the causes of variation in culture are not understood.2 Two examples of surveys are given below.

9.5.I Safety Attitudes Questionnaire"The most commonly used and rigorously validated is the Safety Attitudes Questionnaire."23 The questionnaire uses a double-sided single page, has 60 items and "measures six domains: safety climate, teamwork climate, perceptions of management, stress recognition, job satisfaction, and working conditions". The survey takes about 10 to 15 minutes to complete. There is also an open-ended question: "What are your top three recommendations for improving patient care in this clinical area?" Versions of the questionnaire, together with a user's manual and benchmarking data, can be downloaded at the University of Texas Center of Excellence for Patient Safety Research and Practice website (

www.uth.tmc.edu/schools/med/imed/patient_safety/survey6ztools.htm). 24

The Safety Attitude Questionnaire is the only survey that has been used to explore the relationship between the safety climate score and patient safety outcomes.22 Interventions have been shown to improve the safety and teamwork climate, although this may be associated with deterioration in another domain.2 Such tools can measure teamwork and communication, and there is evidence that these measures relate to safety outcomes.23 Valid comparisons can be undertaken in individual clinical areas over time, between clinical areas in an individual health service, between health services, and with other complex industries.24

Some authors have recommended that health services use the Safety Attitudes Questionnaire annually to measure the safety culture across all work units throughout their organisation.2 The Questionnaire has received a greater than 80% response rate, which aids interpretation. After the survey, the results should be presented to senior management and all staff. Specific interventions, focusing on individual work units, should be undertaken to improve culture, although there is currently limited evidence to support the effectiveness of such interventions. Most importantly, the variability of culture is greater within than between health services.2 Although caution is being recommended in the interpretation of safety climate surveys, the greatest challenge will be changing the organisational climate after it has been measured 22


http://www.uth.tmc.edu/schools/med/imed/patient_safety/survey6ztools.htm).24

http://www.uth.tmc.edu/schools/med/imed/patient_safety/survey6ztools.htm).24


More recently, Pronovost and colleagues developed a safety framework that incorporates the

Solely Attitudes Questionnaire and is used in over 100 intensive care units in Michigan in the

US. It compiurt four domains:3

1. How often do we harm patients? — measurements of specific adverse event rates (eg, catheter- related bacteraemia).

2. How often do we provide the interventions that patients should receive? — measurement of the proportion of patients who receive a specific evidence-based intervention (eg, proportion of ventilated patients receiving elevation of the head of bed and prophylaxis for peptic ulcers and deep vein thrombosis).

3. How do we know we leamt from defects? — proportion of months each patient care area leamt from mistakes (eg, proportion of months in which at least one sentinel event was reviewed and a policy was created/revised and/or staff awareness or use of that policy was measured).

4. How well have we created a culture of safety? — annual assessment of safety culture in each unit using the Safety Attitudes Questionnnaire (eg, percentage of areas in health service where 80% of staff report a positive safety and teamwork culture).The first two domains can be measured as valid rates; however, the second two, although

essential for safety, cannot.3,25

9.5.2 Manchester Patient Safety Framework26

The Manchester Patient Safety Framework has also been recently developed using the earlier work of Westrum and Reason. Acknowledging the complexity of and difficulty in understanding the concept of a safety culture, a framework was developed that aimed to deconstruct safety culture and make it meaningful to managers and frontline staff by increasing their understanding and stimulating discussion for improvement. The Framework uses nine dimensions to express safety culture (Box 9.3), which are described in a straightforward manner at each of the five levels of organisational maturity.

The instrument is completed individually by staff, and the level of maturity at which the health service is functioning is determined. Teams within the health service can then use the results in self- reflection and education activities to help determine the appropriate action to take to improve the safely culture. The instrument can then be used lo measure progress. Frameworks have been developed for primary care, acute care, ambulance and mental health. A facilitator's guide and the frameworks and evaluation sheets are available at

www.npsa.nhs.uk/nrls/improvingpatientsafety/ humanfactors/mapsaf/.

Box 9.3 Dimensions of the Manchester Patient Safety Framework — acuta■ Commitment to overall continuous improvement■ Priority given to safety■ System errors and individual responsibility a Recording incidents and best practicea Evaluating incidents and best practice a Learning and effecting change■ Communication about safety issuesa Personal management and safety issues a Staff education and training.

http://www.npsa.nhs.uk/nrls/improvingpatientsafety/

■ Cuftixe is something an organisation is (eg, beliefs, attitudes) and has (eg, structures, practices). Management has greater control to change structures and practices than culture.

■ The most important component of a safety culture is that it is informed, which has four subcomponents — reporting, just, flexible and learning culture.

■ The presence of these components does not ensure a safety culture — they must also function effectively.

■ There is a spectrum of safety in health services — from resilient to vulnerable. Health services can determine their position on the spectrum using reactive aids (information about adverse events and near misses) and proactive aids (indicators to identify latent factors).

■ The characteristics of high-reliability health services have been described, and a checklist is available.


■ The patient safety culture can be measured. The most commonly used and best evaluated tool is the Safety Attitudes Questionnaire. New frameworks such as the Manchester Patient Safety Framework have been developed, but they have not extensively evaluated.

References1 Reason J. Managing the risks of organizational accidents. Aidershcrt. UK: Ashgate. 1997.2 Pronovost P. Sexton B. Assessing safety culture: guidelines and recommendations. QuaI Saf Health Care 2006. 14: 231-233.3 Pronovost PJ, Berenholtz SM. Goeschel CA, et al. Creating high reliability in health care organizations Health Sen Res 2006; 41: 1599-1617.

4 Bate P. The impact of organisational culture on approadhes to organizational problem-solving In: Salaman G. editor. Human resource strategies. London: Sage, 1992.5 Thompson N. Stradling S, Murphy M. O'Neill P. Stress and organisational structure. BrJSoc Work 1996; 28:647-665.6 Dunbar J, Reddy P. McAvoy B, et al. The contribution of approaches to organisational change in optimising tfw primary care workforce. Canberra: Australian Primary Health Care Research Institute, 2007.7 Reason J. Safety paradoxes and safety culture. Injury Control Saf Prevent 2000; 7: 3-14.8 Institute of Medicine. Crossing the quality chasm: a new health system for the 2fst century. Washington. DC: National Academy Press, 2001.9 Westrum R. A typology of organizational cultures. Oual Saf Health Care 2004; 13 (Suppl II): 022-027.


10 Senge PM. The fifth discipline: the art and practice of the learning organisation. New Yortc Currency Doubleday. 1994.11 Davies HTO, Nutley SM. Developing learning organisations in the new NHS. BMJ 2000: 320: 998-1001.12 Parker D, Hudson PT. HSE: understanding your culture. Shell International Exploration and Production. EP 2001-5124,2001.13 Nieva VF, Sorra J. Safety culture assessment: a tool for improving patient safety in healthcare organizations. Oual Saf Health Care 2003; 12: ii17-ii23.14 Carthey J. de Leval MR. Reason JT. Institutional resilience in healthcare systems. Oual Health Care 2001:10:29-32.15 Barach P. Small SD. Reporting and preventing medical mishaps: lessons from non-medical near miss leporting systems. BMJ 2000; 320: 759-763.16 Reason JT, Carthey J, de Leval MR. Diagnosing "vulnerable system syndrome*: an essential prerequisite to effective risk

management. Oual Saf Health Care 2001; 10: ii21-ii25.17 Schulman PR. General attributes of safe organisations. Oual Saf

Health Care 2004; 13: ii39-ii44.18 Reason J. Achieving a safe culture: theory and practice. Work Stress 1998; 12:293-306.19 Stevens P, Matlow A. Laxer RM. Blueprint for patient safety.

Pediatr Clin N Am 2006:53:1253-1267.20 Hastings G. Eight steps to better patient safety. Health Serv J 2006; 116:28-2921 Kho ME. Carbone JM, Lucas J. Cook DJ. Safety Climate Survey: reliability of results from a multicenter ICU survey Qual Sat Health Care 2005; 14:273-278.22 Colla JB, Bracken AC, Kinney LM. Weeks WB. Measuring patient safety climate: a review of surveys Oual Saf Health Care 2005; 14. 364-366.


23 Berenholtz SM, Pronovost PJ. Monitoring patient safety. Crit Care Clin 2007; 23: 659-673.24 Sexton JB, Helmreich RL, Neilands TB, et al. The Safety Attitudes Questionnaire: pyschometric properties, benchmarking data and emerging research. BMC Health Serv Res 2006; 6: 44.25 Pronovost P. Holzmueller CG, Needham DM, et al. How will we know patients are safer? An organization-wide approach to measuring and improving safety. Crit Care Med 2006; 34: 1988-1995.26 Kirk S. Parker D. Claridge T. et al. Patient safety culture in primary care: developing a theoretical framework tor practical use. Oual Saf Health Care 2007; 16: 313-320. □


10 Eighteen practical steps to implementing a clinical risk management program in a health service

This chapter will:

m Present a comprehensive and practical step-by-step approach and a checklist for imptemendng a clinical risk management program in a health service.

10.1 Where to start

The most difficult task in commencing a clinical risk management program is to determine precisely how and where to begin. In our experience, with many quality improvement activities, there is the potential for much activity to take place. Undertaking such activity may make us feel good, as if we are achieving something


worthwhile. However, when we examine the effects of this activity on the quality of patient care provided, it is often difficult to demonstrate measurable improvement.

The primary aim of implementing and maintaining a clinical risk management program in a health service is to reduce the risk to the patients who are receiving care. It is important, therefore, not to fall into the "activity trap" of undertaking quality improvement and risk management activities to comply superficially with external accreditatiori and funding requirements. All risk management initiatives undertaken must aim to demonstrate measurable improvement in the safety of clinical care provided to patients.

Modifying this step-by-step guide to meet local needs and conditions will significantly increase the likelihood of successfully implementing a clinical risk management program. Although this guide may- look daunting, it is a series of signposts. It is not necessary for individual health services to undertake all the steps outlined in this chapter in their entirety or at the same time. As with the implementation cycle discussed previously, implementation of a clinical risk management program in an individual health service should be undertaken in small, manageable steps using signposts that are appropriate for the local needs and conditions unique to each organisation.

10.1.1 Step I: develop an Information sheet to explain the purpose and methods used ki a clinical risk management program

Explaining the concepts of a clinical risk management program to health service staff and board of management members with little knowledge in this area can be difficult. We have prepared a summary (Appendix 2), which can be modified to suit local conditions. The summary can be used to help clinicians and management understand what clinical risk management is, and provide an overview of how such a program is developed, implemented, run and maintained.

10.1.2 Step 2: find clinical championsMedical staff support is critical to the success of any clinical risk management program Some doctors may be apprehensive about an activity that closely examines the mcdical care they provide Despite an initial negative response from some doctors, mcdical staff should be closely involved with the development ofthe program, and all doctors working in the health service should be kept fully informed of the program's progress.

A cnttcal early step in the development of any clinical risk management is to find a clinical champion. In our experience, every health service will have some medical stafT who are passionate about providing high-quality, safe medical care to their patients. Clinician champions should preferably have some of the following characteristics:■ a high profile in the health service■ a track record of introducing innovations in their clinical areas■ have helped write clinical policies and protocols■ have the respect of medical and nursing staff.

Some potential clinical champions may be finding it difficult to introduce changes to clinical practices in their areas of clinical expenise. A clinical risk management program that is effective in introducing changes in clinical behaviour may help such clinical champions in their quality improvement and risk management endeavours in their own clinical area. Instead of working in isolation to achieve change, these clinical champions could use the resources of a more effective clinical risk management program to achieve quality and safety improvements in clinical care.

10.1.3 Step 3: find an executive championFor clinical champions to effectively change clinical behaviour, they will frequently require the assistance of an executive champion with the authority to make decisions about how resources are allocated and how changes in service delivery systems are to be made in the health service. An executive champion will know how major decisions are made in the health service and will be able to guide system changes through the health service bureaucracy. The more "hands on" the executive champion is, the more effective the project will be in successfully reducing clinical risk. Ideally, the executive champion should be an active member of the surveillance committee that reviews adverse events, and of some of the multidisciplinary teams attempting to close gaps in care and prevent adverse events recurring. Such committee participation will allow the executive champion to facilitate rapid changes in delivery systems when they are required.

At Wimmera Health Care Group, the executive champion is the director of medical services. In most health services, directors of medical services deal daily with quality and risk management issues, and frequendy with coronial and claims management matters. They are appropriately placed to be significant drivers of clinical risk management programs. Also, medical record screening and review (and the important role of the health information service in these processes) are cornerstones of the clinical risk management process, and directors of medical services are usually responsible for the health information service in most health services' organisational structures. Obviously, it assists the implementation process of a clinical risk management program if the director of medical services and the director of nursing services are both strongly committed to the health service providing high-quality clinical care.

10.1.4 Step 4: obtain chief executive officer support and find champions in the board of managementStrong support for the clinical risk management program will also be required from the health service's chief executive officer and board of management members. Most chief executive officers are extremely busy and. in the current environment, predominantly occupied with ensuring the financial survival of their health services. Increasingly demanding clinical governance requirements indicate that chief executive officers are also responsible for the standard of clinical care that is provided (together with clinical staff and board of management members).

In most health services, the peak quality committee is usually a subcommittee of the board of management Some board members will be members of the quality committee and are logical choices as clinical risk management champions at board of management level. Having such champions should facilitate discussion about issues raised by the clinical risk management program at the highest levels d the organisation, and aid appropriate and effective action being taken by the health service to address these issues.

The dedication of senior staff and the board of management to the development and maintenance of a clinical risk management program can be strengthened by the health service committing itself to the attainment of effective clinical risk management as one of its major objectives. This objective can be incorporated into the health service's strategic plan and be included in its quality plan and annual quality of care report. Also, individual departments can appropriately modify and incorporate this objective into their annual department business plans and daily work practices.

10.1.5 Step 5: allocate adequate resourcesWhen clinical and executive champions have been identified, sufficient resources should be allocated to effectively design, implement and run the clinical risk management prograi®. Although staff in all clinical areas of a health service should participate in quality improvement and risk management programs as pan of their usual activities, already busy clinical staff should not be expected to develop and maintain extensive clinical risk management programs as pan of their existing duties. Additional resources are required for clinical risk management activities to be effectively undertaken. The extent of the additional resources required will depend on the size of the clinical risk management program. Even small programs will require additional resources to detect and review adverse events and coordinate the actions designed to prevent the recurrence of particular adverse events. Redesigning complex health care systems and successfully implementing and maintaining such system changes is labour-intensive. To burden existing staff with yet another significant duty without providing adequate resources will limit the effectiveness of the program and may threaten its viability.


10.1.6 Step 6: appoint a clinical risk managerMedium and large health services should consider appointing a full-time clinical risk manager to be responsible for coordinating the development, introduction and maintenance of the clinical risk management program. At Wimmera Health Care Group, we appointed an experienced senior nursing staff member to the position of clinical risk manager. Ideally, the clinical risk manager should have considerable clinical experience and the respect of medical and nursing staff. The clinical risk manager will require a high degree of self-motivation, have good written and verbal communication skills and be able to work effectively as pan of a multidisciplinary team. Some administrative experience may also be an advantage.

At the Wimmera Health Care Group, the clinical risk manager collects information about adverse events delected using the various detection methods described in Chapter 4. Serious events are reported immediately lo the director of medical services and/or the director of nursing services for analysis and action. All events, whether serious or less serious, are analysed and investigated, and the clinical risk manager coordinates implementation of appropriate clinical risk reduction strategies. The clinical risk manager compiles data from all events delected and writes monthly aggregate reports for the director of medical services, director of nursing services, the surveillance committee and the quality committee The clinical risk manager should be an active member of both these imponant committees. The clinical risk manager works closely with:

■ the health service's quality manager — to ensure that the clinical risk management program is fully integrated into the health service's quality improvement and risk management activities: and■ the complaints liaison officer — to allow information about adverse events described in patient complaints to be analysed and acted upon in the same manner as adverse events detected using other methods.Al Wimmera Health Care Group, the clinical risk manager reports directly to the director of

medical services. The clinical risk manager liaises with medical, nursing, paramedical and administrative staff to promote organisation-wide awareness and ownership of clinical risk management activities and programs.

Although the board of management and senior executives are responsible for providing overall direction to the clinical risk management program and promoting cultural change, the clinical risk manager is responsible for the daily operation of the program.

19.1.7 Step 7: ensure the health service has adequate clinical Information systemsAdequate resources are also required to ensure that appropriate clinical information systems are in place and operating effectively. A high level of commitment to the clinical risk management program is required from the organisation's health information services and information technology department, whose role is to establish and maintain information systems that can consistently provide high-quality clinical information.

Health information services staff screen inpatient medical records lo determine which ones require medical review, locate records to enable clinical audits lo be undertaken, and enter data from adverse event analysis forms. Using software specifically written by the information technology department, health information services staff compile reports of ihe medical record screening process and adverse event detection rates.

Health information managers are also responsible for extracting data from administrative dataseis to assist the performance and analysis of specific clinical reviews. Furthermore, these managers help all clinicians maintain high-quality documentation in the medical record. Medical records are usually a valuable source of clinical information. If the medical record documentation of clinical care is poor, opportunities to review and improve this care will be diminished.

10.1.8 Step 8: obtain statutory immunity for the activity of the clinical risk management programBefore implementing a clinical risk management program, health services should obtain statutory immunity for their board of management quality committee and its subcommittees, including the clinical risk management program surveillance committee. Every health service should ensure that all quality improvement and risk management activities involving confidential discussions about patient medical records and documentation identifying the health service and its staff are covered by statutory immunity. All participants in these activities need to be aware that the program is covered by statutory immunity, and the implications of this cover.

Granting statutory immunity prevents program participants from being compelled to divulge any information derived from any confidential discussions that were part of approved quality activities, and that identifies any individual, in a legal court or tribunal against a medical practitioner or health service.

In Victoria, statutory immunity is granted under Section 139 of the Health Services Act 1988 (Vic). The Australian Government grants statutory immunity under Part VC of the Health Insurance Act 1973 (Cwlth). There are some differences between the two acts, so health care organisations should contact the relevant government service to decide which is the most appropriate act for their needs.

10 Eighteen practical steps to implementing a clinical risk management program

10.1.9 Step 9: educate staff about the principles of clinical risk management and the activities of the health service's clinical risk management programIt is essential to educate health service staff about the principles of clinical risk management and

the details of the program operating in their health service. All staff members should participate in

the program. It should not be viewed as yet another quality activity that the organisation has to

undertake to meet external quality improvement requirements, and that is someone else's

responsibility in the health service to undenake and complete.

As well as education about the program, there must also be active participation by clinical

staff and management in the activities of the program. Actions speak louder than words, and

staff need to see that their participation in the program results in improved patient care and an

enhanced work environment, and that senior management actively support the program.

Detection of adverse events without appropriate action and improvement will limit the

effectiveness of any clinical risk management program.

10.1.10 Step 10: arrange a program launch to signify the organisation's commitment to the processWhen the essential components of the clinical risk management program are in place, the health service should officially launch the program. This could be a specific event involving a wide cross-section of staff and board of management members. Such an event could be used to publicly announce the health service's commitment to the program from the highest levels within the organisltion.

10.1.11 Step 11: determine the extent of the clinical risk management programWhat form should the clinical risk management program take in your health service? Fortunately, the components of the Wimmera clinical risk management model can be implemented gradually. Each adverse event detection method can be added individually and sequentially as the clinical risk management program expands.

In our experience, commencing clinical risk management with a form of medical record review is the most rational approach. By starting the medical record review component of the program on a small scale, perhaps using only one or two medical record screening criteria, the detection, analysis and action components of the program can be correctly and firmly established. We recommend commencing screening with three criteria: patient death,- transfer from general ward to intensive care unit and any record recommended for review. Once these processes are in place, the number of screening criteria being used can be increased.

We use nine criteria lhat can be screened by clerical stafT. We chose these criteria from a larger list used in the Medical Management Analysis' and the Harvard Medical Practice Study.2 Some oT the other criteria require some form of clinical assessment of the medical record to determine whether it screens positive.

Either health information services or nursing staff can undertake the screening process. We decided to use health information services staff, as they could screen the medical records as part of their usual activities. This screening could be done at three points in the department:■when the medical record was compiled in the department after discharge■when the discharge summary was being typed■during coding of the admission.

This triple check resulted in few records being screened incorrectly.When the clinical risk management program began and medical records were sent for medical

review, the first major finding was the poor quality of documentation in some pans of the medical record. Medical reviewers commented that on some occasions they were unable to determine whether an admission contained an adverse event because significant parts of the medical record had not been completed. The poor quality of some sections of the medical record has been a consistent initial finding among other health services that have implemented the medical record review component of the clinical risk management program.

At Wimmera Health Care Group, one of the first major system changes made as a result of regularlv rcviewing medical records was to replace the usual blank medical record admission sheets with a structured admission history and examination sheet. The use of this sheet quickly improved the quality of information recorded in patients' medical record. More recently, multidisciplinary clinical pathways, including detailed reminders and checklists, have been introduced as the medical record sheets for patients admitted for one of a list of specific conditions. The use of clinical pathway medical records has further improved the standard of documentation in the medical records.

Once a medical record screening and medical review program is established, the surveillance committee will receive a constant stream of information about adverse events and suboptimal processes in the health service. In our experience, these events raise more issues requiring review


than can be dealt with at one time. A clinical risk management program can attempt to deal simultaneously with all the issues raised by the adverse events it detects. If this approach is taken, however, clinical staff are more likely to become confused and overwhelmed by the number of changes occurring simultaneously to the already complex systems they are expected to use when caring for patients. This highlights the need for a risk register to be developed and adverse events to be prioritised for action.

We wanted to establish a clinical risk management program that was viewed by staff as being an effective way to improve patient care. As the medical reviewers begin to detect adverse events that have occurred in a health service, we recommend that the surveillance committee concentrates on several smaller and somewhat easier health care delivery system weaknesses that these events identify. Hopefully, by attempting to deal with a few easier and more manageable issues first, a small number of improvements in the quality of patient care can be achieved rapidly. These improvements can then be used to demonstrate the effectiveness of the clinical risk management process to staff. Building on these early successful interventions, more complex problems can be tackled. We have consistently found that a useful approach to successfully changing complex systems is to "think big but start small".3

10.1.12 Step 12: promptly address areas and Individuals providing consistently poor-quality careAfter the clinical risk management program has been established and the surveillance committee has reviewed the details of a number of adverse events, evidence of consistently poor-quality care provided in some clinical areas of the health service and by some individual clinicians may become evident. Poor- quality care concentrated in one clinical area of a health service or involving one or a small number of clinicians can be one of the most difficult issues that a clinical risk management program and health service have to address.

In our experience, once such issues are detected, if a detailed analysis and appropriate action are not taken, the adverse events are likely to continue to occur and be detected, and therefore require discussion at subsequent surveillance committee meetings. One of the strengths of the Wimmera model is that if appropriate action is not taken and these types of adverse events recur, they will continue to be found by the detection processes that are in place.

If these problems are ignored and left to recur because the surveillance committee feels they are too difficult and unpleasant to deal with, the integrity of the whole clinical risk management program may be called into question by health service staff. If the surveillance committee does not take appropriate action, eventually the magnitude of the problems will expand and the issues will become confronting. The first step in examining the issues may be for the surveillance committee to request a focused audit of clinical activity involving the area or clinician in question. In our experience, as difficult as these types of situations may be, the earlier the issues are faced directly, the quicker appropriate corrective action can be taken. Ultimately, clinical risk management programs are about reducing risk and improving the safety and quality of care provided to patients, not about avoiding difficult problems because they are unpleasant to tackle.Fortunately, evidence of repeated poor-quality work by individual clinicians is seen rarely,

but when it does occur, the risk management program usually detects it. On becoming aware

of the problem through the program, the clinical risk manager will refer the matter to the

director of medical services If the problem cannot be resolved appropriately at that level in the

organisation, the matter will need to be referred to the health service's appointments

committee.

10.1.13 Step 13: prepare for hard work — the road to quality Improvement b not an earn/ and steady

pathChanging clinical behaviour in a health service can be hard work. The health care delivery systems within which we provide care to our patients are complex, and positive changes are often difficult to achieve. Unintended negative events will occur even with the best intentions, and with the most meticulous planning and implementation of change processes. Clinicians and senior health service management should acknowledge the limitations the current environment in health services places on their performance in providing high-quality patient care. ■*

Successfully improving health care delivery systems frequently requires taking two steps forward and one step back. Some health care professionals will be resistant to the change process. For some clinicians, the prospect of a significant change in their work environment may engender fear about losing territory in the health service and control over their workplace. Individual stafT members' responses to change will vary greatly. If possible, when initiating change to the processes within systems, concentrate efforts on staff members who are naturally early acceptors of change. Change may take some lime to be accepted by all the staff who are involved in the system under review — allow adequate time for it to occur. Persistence is a key factor in successfully changing behaviour.

10.1.14 Step 14: do not expect clinical risk management activities to routinely generaterevenue or reduce costsAs discussed earlier, adverse events can be associated with the underuse, overuse or misuse of resources. Quality improvement activities that aim to reduce underuse in a health service can increase costs in the short term. Activities that aim to reduce overuse and misuse can reduce costs. Although many quality improvement activities in health services will reduce health-related


costs to the community, these savings will not necessarily be translated to improvements in health services' balance sheets. Further, the money saved by some quality improvement activities can be directed lo other improvement activities that are needed lo deliver besi-praciice clinical care, but require additional resources and do not save money.

10.1.15 Step 15: acknowledge and reward high-quality careSome health care financing systems reward health services financially for providing medical care that complies with evidence-based processes that have been shown in clinical trials to improve patient outcomes. Appropriate compliance by health service staff with treatment guidelines based on the best evidence, and the resultant improvement in the quality of care provided to patients, should be acknowledged and rewarded, both internally by the health service and externally by the health service's funding body.

10.1.16 Step 16: stay focused on taking and completing actions that will really make a difference to the quality of patient careAs discussed earlier, the surveillance committee will receive information about more adverse events and system weaknesses than it can immediately address. Members of the surveillance committor and the clinical risk manager may wish to deal with all the issues raised and not prioritise the adverse events ihev haw cktected for more detailed analysis and action. Health services can be very busy places, with patient demand for services exceeding those available, resulting in intense financial pressure. It can be easy for the attention of senior executives and clinicians to be directed daily to the urgent major service or financial issues facing their health service. They can be sidetracked putting out "bushfires" and be unable to concentrate fully on ensuring that the health service's clinical risk management program is effectively reducing the frequency of adverse patient events. Although latent factors will be present and will contribute to weaknesses in the health service's delivery systems, there is often a considerable time delay before these factors cause an adverse event. It is easy for senior staff to defer correcting these latent factors, as it is unlikely that inattention to such factors will result in a serious adverse event occurring in the short term.

Senior executives in the health service and the clinical risk manager should regularly take time to reflect on where the health service's resources are best directed to have the most positive impact on the standard of patient care. To maintain an appropriate focus, they should regularly review the risk register to ensure that appropriate action is being consistently taken to reduce the frequency of adverse events with the highest associated level of risk. In addition, the executive champion and clinical risk manager should regularly review the comprehensive clinical risk management program checklist provided at the end of this chapter (Checklist 10.1). The checklist details the main signposts to improving the chances of successfully developing, implementing and maintaining a clinical risk management program in a health service.

It is not envisaged that individual health services would fulfil all the criteria on the checklist; however, the more criteria that are modified by health services and programs to meet local needs and conditions, the greater the probability that individual clinical risk management programs will be successful. By taking time to refer regularly to the checklist, health services will be able to see where their existing clinical risk management program may be strengthened.

10.1.17 Step I7: continue to look for Ideos to enhance your health service's clinical risk management programIdeas for clinical quality improvement abound, and can be easily found by regularly looking inside and outside of your own health service. Many quality improvement initiatives and programs are reported in medical journals. Two excellent websites are the United Slates Agency for Healthcare Research and Quality's Morbidity and Mortality Rounds on the Web

(www.webmm.ahrq.gov), which presents cases in many clinical specialties with commentary, take-home points and references; and their Patient Safety Network

(www.psnet.ahrq.gov), which provides a comprehensive list of journal, newspaper and magazine articles. In our experience, more innovative ideas about clinical risk management and quality improvement are available than can be efficiently and effectively implemented into an individual health service's clinical risk management program.

Developing and maintaining a clinical risk management program is a continual process of planning, action and evaluation. Small changes are frequently made as the result of practical experience gained in implementing and running a clinical risk management program and ideas described in journals, at conference presentations, and in discussions wiih colleagues.

Informal and formal links for the exchange of ideas can be established with other health services with clinical risk management programs, university departments with research interests in quality improvement, and leaders in the quality improvement field. Many health service and medical conferences now have quality streams, and conferences with quality themes are regularly held around the world. These conferences give organisations the opportunity to present their work to the field and discuss ideas with colleagues grappling with the same problems of how to reduce risk and improve the quality of clinical care they provide.


http://www.psnet.ahrq.gov/

http://www.webmm.ahrq.gov/


I0.1.I8 Step 18: take a constructive, long-term view to changing cultureThe Wimmera model presents a solid framework upon which an effective clinical risk management program can be built in individual health services. The modules that make up the model can be selected, modified and implemented at a rate appropriate to the resources and quality improvement requirements of individual health services.

Whatever quality improvement model a health service chooses to use, it will need to function within the culture of the organisation. It is difficult to define a health service's culture and positively influence the culture to increase the probability of successfully implementing a clinical risk management program. What practical advice can be given to health services about how to create a culture that encourages improvement in the quality of care it provides?

The following core practices (and those discussed in the previous chapter) can help create a culture in a health service that supports quality improvement.

10.1.18.1 Communicate openly and honestlyCommunication between staff in the health service should be open and honest. Staff at all levels in the organisation should feel comfortable to express their true feelings about the factors that may have contributed to adverse events that were detected by the health service's clinical risk management program, and about any proposed changes to delivery systems in the health service following analysis of these events. If staff feel that their concerns will not be entirely heard and considered when decisions about changes to delivery systems are made, or that they will be singled out for saying what they honestly feel, open and honest communication will be stifled and consequently, some system weaknesses in the health service's delivery systems will remain unaddressed.

10.1.18.2 Respect decisions made at the coalfaceStaff at the coalface often know accurately the changes required to heath care delivery systems in their work area to produce high-quality patient care. Although health service senior executives and boards of management have overall responsibility for the quality of care provided by the organisation, they should be prepared to delegate an appropriate level of responsibility and autonomy for changing delivery systems to staff at the coalface. The opinions of staff should be routinely sought, valued, and taken into account to allow decisions about delivery systems to be made regularly from the bottom up in the health service, rather than the more frequent top-down approach.

Using the Wimmera model, staff at the coalface can undertake appropriate analysis of an adverse event and the factors in the system's design that have contributed to the event. They can design and implement subsequent system changes to prevent recurrences. These system changes should not be overturned by senior management without detailed discussion with the staff involved, and without careful consideration of the message such action sends to workers about their true level of autonomy and responsibility in the organisation. Such negative messages from senior management severely affect the success of a clinical risk management program.

10.1.18.3 Use a just culture approach in dealing with errorsA just culture approach to dealing with errors is a cornerstone in the successful establishment of a clinical risk management program — staff must feel safe to report errors. A just culture approach, however, requires a major shift from the current practices in many health services.

If a punitive rather than just culture approach to adverse events is in place, health service staff are unlikely to inform senior staff that they have made an error. If such communication does not occur, senior management may not be aware of serious weaknesses in their health serviced service delivery systems until a serious adverse event occurs that cannot go unreported Without staff feeling comfortable

to communicate the details of adverse events that occur, weaknesses in delivery systems.will remain in place and more adverse events will occur.

10.1.18.4 Senior management should encourage the reporting of adverse eventsHow can this situation be addressed so that adverse events are consistently reported? Again, actions speak louder than words. Senior management should encourage reporting of adverse events by all staff, and state clearly that punitive action will not be taken against staff members who report adverse events lhat occur as a result of delivery system failures. Undoubtedly, after such statements staff members will be watching carefully to see what actions senior management take when an adverse event is reported, to determine whether management is genuine about what they are saying.Clearly, in some extreme situations (eg, if a staff member comes to work intoxicated or under the influence of drugs and an adverse event occurs as a result), strong action is appropriate and should be taken. However, if a system failure contributes to an adverse event occurring (the far more common situation) and this adverse event is reported, the stafT member should be thanked for reporting the event. The importance of reporting such events in the subsequent improvement of delivery systems should be emphasised again to the staff member, and no punitive action should taken.

211

Checklist 10.1 The implementation and maintenance of a clinical risk management programin a health service

Actions Yes No W1P N/A

1 Has an information sheet been developed to help explain the objectives of adinical risk management program, and the methods such a program uses?

2 Have clinical champions been found for the program?

■ Do they have high profiles in the health service?

■ Do they have a record of introducing innovative practices in their areas of activity in the health

service?■ Have they had experience writing clinical policies and protocols?

■ Are they respected by medical and nursing staff in the health service?

3 Has an executive champion been found for the program?

■ Does the executive champion have authority to allocate some resources in the health service?■ Does the executive champion have knowledge of how major decisions are made in the health service?

■ Is the executive champion prepared to be an active member of the surveillance committee and some of

the multidisciplinary problem-solving teams?

■ Is the executive champion strongly committed to the health service providing high-quality clinical care?4 Do the chief executive officer and board of management support the program?Have board of management clinical risk management champions been found?

■ Is attainment of an effective clinical risk management program a major objective m the health service's

strategic plan?

| 5 Have adequate resources been allocated to effectively run the clinical risk ; management

program?

Checklist tO 1 (continued on next page)

212



6 Has a clinical risk manager been appointed?

■ Does the clinical risk manager have:

> Extensive, varied clinical experience?

> Some administrative experience?

> Good written and verbal communication skills?

> The respect of medical and nursing staff members in the health service?

> The ability to work well in a multidisciplinary team?

■ Is the clinical risk manager a member of the health service's main quality committee; the occupational health and safety committee; and other clinical review committees in the medical, nursing and allied health areas of the health service?7 Does the health service have adequate clinical information systems?■ Do the heads of health information services and the information technology department support the clinical risk management program?■ Are health information services staff able to screen medical records?8 Has statutory immunity been obtained for all activities of the program?9 Have staff members been educated about the principles of clinical risk management and the activities of the health service's clinical risk management program?■ Is education about the principles of clinical risk management and the health service's program part of the health service's staff orientation program?■ Are sessions about the principles of clinical risk management and issues raised by the health service's program held as a regular part of medical, nursing and allied health postgraduate education programs?■ Are some changes made in systems of health care delivery as a result of the clinical risk management program highly visible to health service staff?10 Has a program launch that will signify the organisation's commitment to the process been arranged?

11 Has the extent of the clinical risk management program that the health service wishes to establish been determined?

■ How will adverse events be detected?

■ Medical record review:

> Which general patient outcome screening criteria will be used?> Should any unique screening criteria be developed (eg, in obstetrics or paediatrics)?> Will clerical or nursing staff members undertake the screening?> Will screening be undertaken while patients are in health service or after they have been

discharged?> Will screening be undertaken on inpatient or emergency department medical records, or

both?> If inpatient records are to be screened, is there a typed discharge summary available for

each inpatient admission?■ Clinical incident reporting:>• Has a clinical incident reporting system been chosen?> Have staff members received education about which incidents to report and how to report

them?> Are incident report forms readily accessible?

rtinklit 10.1 (continued)

________________________________________________________________ Yea No WIP N/A

I Sentinel MWA reporting:

Am staff aware of the current list of sentinel events that are to be reported?

■ General practitioner feedback:> Are general practitioners consistently reminded about reporting adverse events experienced by recent inpatients?> bit easy for general practitioners to report adverse events?>• Is reporting of adverse events by general practitioners supported by the local division of general practice?

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> Are general practitioners rapidly acknowledged and given feedback regarding adverse events they have reported?■ Clinical pathways:> Have clinical areas been chosen in which clinical pathways will be developed?> Have key process measures been developed to monitor compliance with pathways?

> Has a method for analysing variance from pathways been developed?

■ Clinical indicators:

> Have clinical indicators for measurement been chosen?

> Are the indicators chosen valid and reliable?

■ Patient satisfaction:

>■ Which methods will be used to measure the level of patient satisfaction (eg, patient satisfaction surveys, focus groups and/or patient complaints)?■ External sources of risk (eg, coronial reports, media reports, information from insurers, statewide and national databases, consultative councils and committees and clinical journals):> Which newspapers, medical journals and websites will be regularly screened and by whom?

■ Has a definition of an adverse event been chosen?

■ Has an adverse event analysis form been devised?

■ How will adverse events be analysed?

■ Has a surveillance committee been established?

■ Is the membership of the surveillance committee appropriately balanced?

■ How will appropriate action be determined in response to an adverse event being detected?■ Are adverse events prioritised for detailed analysis and action according to their level of risk?■ Have adverse events that may provide relatively easy and early "wins" been targeted for early action to provide the program with an early positive image of being responsive and effective?

■ Are health service staff members who report incidents and adverse events acknowledged? Are they thanked for reporting adverse events? Are they informed in a timely manner of the results of the investigations of the events they have reported and the actions that have been taken to prevent the events recurring?

■ How will the effectiveness of actions taken to prevent the

recurrence of particular adverse events be determined?

Checklist 10 1 (continued on next page)


Actions Vss No wr MM

232


■ How are surveillance committee recommendations followed up to ensure they have been implemented?

■ Is the overall response time from an adverse event being detected to action being taken appropriate? .

12Are areas and individuals who are providing consistently poor-quality care promptly addressed?■ Have adverse events been detected but not addressed because the issues

raised are too difficult or unpleasant to deal with?13 Where possible, have clinicians who are early acceptors of change been involved with attempts to implement changes to delivery systems in the health service?14 Have senior management and clinicians been educated that clinical risk management activities do not routinely deliver cost savings in the short term?15Has high-quality patient care been acknowledged and rewarded?

■ Are staff informed regularly about the quality of care they provide? If so, which of the following methods are being used?

> posters

> emails answering frequently asked questions

> messages in communication books >■ newsletters

> staff meetings

> education sessions.■ Have staff members been rewarded for providing high-quality care?

16Are staff and senior management focused on taking and completing actions that will make a significant difference to the quality of patient care the health service provides?■ Is the risk register, and the actions decided upon to reduce the probability of

specific adverse events recurring, reviewed regularly to ensure progress is being made to address the issues associated with the highest level of risk?

17 Is the health service's clinical risk management program being enhanced continually using ideas gained from sources external to the health service?■ Are clinical journals, websites and other sources scanned continuously for

innovative ideas to improve components of the program?■ Does the health service have links with other health services operating dinical

risk management programs, so that information can be shared?18Are constructive actions being taken to positively change the culture in the health service in the long term?■ Do senior management and clinicians encourage open, honest communication?

■ Are staff members delegated an appropriate level of responsibility and autonomy to be able to effectively change service delivery systems?

■ Are the system changes in response to adverse events developed from the bottom up in the health service?

■ Have senior management stated clearly that a non-punitive approach will be taken throughout the health service when dealing with errors that are reported?

■ Is there clear evidence that a non-punitive approach is being taken with staff who report adverse events?

4

N/A = not applicable WIP = work in progress

Thanwiarslapsnirnplemertrqadini&riskmanageme

■ Dovotap an information sheet to explain the purpose and methods used in the program.■ find clinical champions.

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■ find an executive champion.■ Obtain chief executive officer support and find board of management champions.■ Allocate adequate resources.■ Appoint a clinical risk manager.■ Ensure the health service has adequate clinical information systems.■ Obtain statutory immunity for the activity of the program.

■ Educate staff about the principles of clinical risk management and the activities of the health service's program.

■ Arrange a launch of the program to signify the organisation's commitment.■ Determine the extent of the program the health service wishes to establish.■ Promptly address areas and individuals providing consistently poor-quality care.■ Prepare for hard work.■ Do not expect clinical risk management activities to routinely generate revenue or reduce costs.■ Acknowledge and reward high-quality care.■ Stay focused on taking and completing actions that will make a difference to the quality of patient care.■ Continue to look for ideas to enhance your health service's program.■ Take a constructive, long-term view to changing culture.

References1 Craddick JW. Bader B. Medical management analysis: a systematic approach to quality assurance and risk management. Auburn. Calif: Joyce W Craddick. 1983.2 Hiatt HH. Barnes BA. Brennan TA. et al. A study of medical injury and medical malpractice: an overview. N Engl J Med 1989: 321: 480-484.3 Nelson EC. Splaine ME. Batalden PB. et al. Building measurement and data collection into medical practice. Ann Intern Med 1998: 128: 460-466. □

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11 Implementing a clinical risk management program in a small hospital

Thh chapter will:■ Discuss practical steps for implementing a clinical risk management program in a smal hospital. wMch nay have only one or

two doctors on staff.

11.1 Problems unique to small hospitals that want^o undertake a clinical risk management program

Clinical risk management programs can be implemented in hospitals of any size. The nature and size of the programs will vary, however, not only because of different local needs and conditions, but also with the complexity and size of the hospitals involved. Many components of the clinical risk management program described so far are designed to be implemented in medium-sized and large hospitals. However, some features of clinical risk management programs in hospitals of this size cannot be translated easily into small hospitals, which may have only one or two doctors on staff.

One significant problem for doctors who work together closely is that it is difficult to objectively review the medical records of patients treated by their colleagues. Similarly, it is difficult for doctors working alone in small hospitals to objectively review their own work. A different approach to clinical risk management is clearly required in these situations.

11.2 Modifications required for programs in small hospitals

To attempt to overcome these difficulties, the medical records that meet screening criteria could be sent to a larger centre for review. Such an approach would need to be handled sensitively, as it would be easy for doctors in small hospitals to feel that medical reviewers in the larger centres were sitting in judgment of the medical care they provide.

Alternatively, several small hospitals could combine resources to run a clinical risk management program for all the small hospitals in a region. Doctors in small hospitals could review the medical records of patients who were admitted to other small hospitals in the region. This approach has the advantage that the doctors reviewing medical records are working in a similar environment to the doctors whose work is being reviewed, and would therefore be sensitive to some of the issues faced by doctors working in isolation in small hospitals.

Such an approach has been developed in the Wimmera region of Victoria. Building on the expenence of the clinical risk management program developed at Wimmera Health Care Group, the Monash University Centre for Rural Health engaged the West Vic Division of General Practice to develop a clinical risk management program for small rural hospitals. Initially, the Division set about gaining general practitioner support for the program. With general practitioner support, small rural hospitals in the area were then approached to join together to conduct a region-wide clinical risk management program that was coordinated by the West Vic Division of General Practice.

11.3 Screening and medical review

In essence, the small hospital clinical risk management program operates in a similar manner to the medical record review component of the program at Wimmera Health Care Group (described in Chapter 4 and other earlier chapters). Medical records of patients discharged at each participating hospital are screened by health information managers at that hospital, using seven general outcome criteria:

■ patient death

■ return to theatre within 7 days

■ unplanned re-admission within 28 days

■ transfer to another acute care facility

■ patient length of stay greater than 21 days

■ unexpected re-admission following discharge from another hospital

■ any record that has been recommended by a doctor for peer review.

235


If a record screens positive for at least one of these criteria, it is photocopied and sent to the program's project officer, who sends it to a doctor from an adjacent geographical area for medical review. At medical review, the doctor determines whether an adverse event has occurred, and if so, assesses the severity and preventability of the event. The adverse event is discussed at a regular meeting of the medical reviewers. This group of reviewers makes recommendations about clinical care, and details of these recommendations are sent to all participating doctors and hospitals.

11.4 Obtaining the support of small hospitals

By participating in this program, small hospitals gain the benefit of:

■ an independent review being undertaken of some of their medical records

■ access to the details of recommendations for dealing with adverse events that have occurred within their hospital and at others of a similar size

■ general practitioner involvement with hospital quality improvement and risk management programs. As some of the participating hospitals are independent organisations and can be separated by significant distances, the program is conducted with some important differences from programs conducted in larger hospitals. Considerable effort is required to provide information to general practitioners and hospitals about how a region-wide clinical risk management program would be conducted and the benefits of participating. It is necessary to gain the approval of these general practitioners and hospitals. In the Wimmera small hospitals project, the West Vic Division of General Practice and the Monash University Centre for Rural Health undertook this task. To help gain acceptance among general practitioners and small rural hospitals, the program was coordinated by an independent body, even though expertise in clinical risk management was available at the main referral hospital in the region.

11.5 The logistics of screening and medical review

After approval has been obtained, an extensive education program about the clinical risk management program should be provided to key hospital staff. The Division seeks doctors to act as medical reviewers, and conducts training sessions on how to review records and complete the adverse event analysis form.The hospital's health information manager screens the medical records of all patients at each participating hospital on discharge. Because of the distances between hospitals, any record that screens positive is photocopied. The original medical record remains at the participating hospital and the copy is sent to the program project officer. The project officer then forwards the photocopied medical record and an adverse event analysis form to a medical reviewer from an adjacent geographical area. Because of the confidential nature of the medical record, a system is developed that maintains the security of the copied medical record; this includes posting all copied medical records by registered mail and coding data entry.

General practitioners working in difTerent geographical areas within the same region are grouped together for the purposes of the program, to allow anonymous "arms-length" medical review. General practitioners do not review their own medical records. The medical reviewer reviews the medical record and determines whether an adverse event has occurred. If an event is detected, the medical reviewer summarises the clinical details and assesses the severity'and preventability of the event. Once the medical review has been completed, the photocopy of the record and the completed adverse event analysis form are returned to the project officer. If no adverse event is identified, the copy of the record is shredded.

If, in the opinion of the medical reviewer, an adverse event has occurred, the reviewer's comments are sent to the treating general practitioner for comment. The treating general practitioner may be able to add further information about why panicular action was taken, and this information may assist further assessment of the admission. The treating general practitioner is also given the opportunity to comment on the assessment of the medical record made by the medical reviewer.

11.6 Reference panel recommendations

The general practitioners undertaking the medical reviews meet regularly as a reference panel. The panel discusses the clinical details of each of the adverse events detected. Issues are identified, and, if appropriate, recommendations are made to participating doctors and hospitals about clinical practice and administration changes they should consider. In addition, specialists' comments about management issues are sometimes sought. Following discussion of the adverse event at the reference panel, the copied medical record is shredded.

The summary of the clinical details of each case and the recommendations of the reference panel are sent to each member of the medical staff and the chief executive officers of the

236


participating hospitals. To complete the clinical risk management cycle at the local level, the doctors discuss the appropriateness of the reference panel recommendations in their hospital at the main quality forum in the hospital, and modify recommendations to be implemented locally. Following these discussions, a representative from each hospital provides feedback to the reference panel on action their hospital has taken in response to each case and the recommendations.

As with implementing clinical risk management programs in medium and large hospitals, we recommend that divisions of general practice, or equivalent organisations starting such a region-wide program, organise an extensive education program involving key hospital stafT — including hospital chief executive officers, general practitioners and health information managers. Incentives to general practitioners to participate include gaining credits towards maintaining vocational registration Clinical and executive champions need also be identified, and their support for the program should be gained A project officer should be appointed to conduct and coordinate the components of the program, and a steering committee formed to oversee the running of the program.

The Wimmera small hospitals clinical risk management program commenced in 1994 The program has promoted discussion of adverse events, provided meaningful peer review for general practitioners and small rural hospitals, and strengthened professional relationships in isolated communities There has been a cultural shift away from an attitude of individual blame to one that acknowledges systemic causes of adverse events.Knowledge and experience have been shared in a non-threatening way and recommendations have head k> quality improvement in small rural hospitals. As the coordinating body, the West Vic Division of General Practice is external to the hospitals in the program, and is not perceived as a threat to them. There has also been acceptance of the program by participating hospitals because it provides noncompetitive, anonymous peer review between neighbouring hospitals. The general practitioners have ownership of the program. The benefits of participating has become self-evident to them, and they therefore remain committed to the process.The small rural hospitals and the Division have been able to establish interventions aimed at improving the quality of patient care. The program has identified clinical and system issues, and implementing recommendations and providing general practitioner education has led to improved patient care in participating hospitals. The program has also identified trends that individual general practitioners and small rural hospitals would have been unable to recognise on their own. There has also been an improvement in the standard of medical records. Documentation improvement and the availability of discharge summaries, copies of antenatal results, and copies of death certificates have improved the continuity of patient care.

11.7 Small hospital clinical risk management manualThe West Vic Division of General Practice's clinical risk management program for small rural hospitals builds on the model developed at Wimmera Health Care Group. But, as already discussed, there are important differences in the two programs because of the diverse geographical location and independent functioning of participating general practitioners and hospitals. It is recognised that most small hospitals and some divisions will not have the infrastructure to establish a comprehensive, effective clinical risk management program without some guidance. Therefore, a detailed guide for each component of the program is provided in a manual for small hospitals wishing to establish such a program. This manual is available at the West Vic Division of General Practice website

(www.westvicdiv.asn.au/resources/ Resources%20Folder/CRM%20Manual.pdO and covers the following areas in detail:

■ preplanning

■ information meeting

■ governance

■ the roles of medical reviewers, chief executive officers, health information managers and project officers

■ statutory immunity

■ data collection tools

■ postal arrangements

■ flow of medical records

■ reference panel meetings

■ sample documents.

237

http://www.westvicdiv.asn.au/resources/


11.8 Introduction of the program across rural VictoriaIn 2001. the West Vic Division of General Practice began implementing the program through the six rural divisions of general practice into the 75 small hospitals in rural Victoria. The first annual report of the statewide program (for 2006-07) reported that 1681 medical records were reviewed across the state, and 163 recommendations to improve the care patients receive were made. Through the first annual report, some of the recommendations are now available to all doctors and health services throughout the state.1

11.9 Changes to the screening criteria

The screening criteria used by small hospitals have been reviewed and modified to reduce the

number of records that screen positive and are sent for medical review, but in which an adverse is

not found. The modified criteria are as follows:

■ unexpected patient death

■ unplanned return to theatre within 7 days

■ unplanned re-admission within 28 days of discharge

■ unexpected transfer to another health service

■ patient length of stay greater than 35 days

■ any record that has been recommended by a doctor or other health professional for

review.

Important points

■ The effectiveness of standalone clinical risk management programs in small hospitals is limited because it is difficult to independently and objectively review clinical care locally, as occurs in larger hospitals.

■ Grouping small hospitals together in a regional clinical risk management program allows inpatient care provided in a small hospital in one geographical area of the region to be reviewed by a doctor working in another area.

■ Having a neutral body, such as the regional division of general practice, rather than the major referral hospital in the region, coordinate the program helps engage doctors in small hospitals with the program.

■ The basic steps of a clinical risk management program of screening of medical records, medical review, analysis and recommendations are followed.> A photocopy of medical records screening positive lor one or more criteria is sent for medical review to a participating doctor in another hospital in the region.> If an adverse event is detected at medical review, the treating general practitioner is sent the reviewer's comments and invited to respond.>- A reference group of general practitioners in the region examines the medical review and the treatingdoctor's response and makes recommendations about patient care. >• These recommendations are considered by doctors in the region and the quality committee in each participating small hospital.

Reference

1 Victorian Government Department of Human Services Limited Adverse Occurrence Screening (LAOS) program annual report for 2006-07. Melbourne: Victorian Government Department of Human Services. 2007 www.health.vic.gov.au/clinrisk/publications/laos_report.htm (accessed Oct 2008) □

12 Important messages

This chapter wM:

■ Summarise the important messages of this book.

238

http://www.health.vic.gov.au/clinrisk/publications/laos_report.htm

http://www.health.vic.gov.au/clinrisk/publications/laos_report.htm


We have read many books and attended many workshops and conferences on clinical quality and safety Despite much being written, many people attending such programs, and much activity, improvements »n quality and safety have occurred slowly. There may be many reasons for this, including: the difficulty of changing health care delivery systems and clinical behaviour, information overload, insufficient resources being provided for such programs, lack of motivation to change, unsupponive health service cultures, or just too many other important issues diverting the attention of management and clinicians Given this depressing scenario, what important messages would we like clinicians and management to retain and apply after reading this book?

12.1 Health care as a systemHealth care is delivered using complex systems with many components that can interact unpredictably. Outcomes are often uncertain. Despite detailed planning, expect unintended negative outcomes and setbacks. Do not be disheartened and do not abandon quality and safety initiatives when such events occur. Every health service that is trying to improve will experience adversity — usually sooner rather than later. Try to leam from these experiences and apply the lessons leamt in the future.

12.2 Clinical governanceClinical governance is a difficult term to explain to clinicians, and doctors are likely to interpret governance as a form of control by management. Also, the principles and activities of clinical governance programs may be packaged in different ways and vary between programs, adding further complexity. The simplest explanation of clinical governance that we have found is that it is the regulation of the health care delivery systems to enhance patient care by ensuring:

■ quality improvement — doing the right thing for patients more often

■ risk management — doing the wrong thing for patients less often.Clinical governance is usually a much lower priority in health services than corporate

governance (or the regulation of financial or business outcomes). The financial performance of health services receives much more attention than their clinical performance. However, both components of performance are equally important. To raise the level of importance of clinical governance, it should be made a core component of the service's strategic plan, the first item on the agenda of the meetings of its board of management, and a standing agenda item at meetings of key clinical groups in the health servicc Adequate, ongoing resources (including staffing, protected time for clinician participation and ready- access to clinical databases) should be provided for the activities of the clinical governance program, or it will languish and be ineffective.

12.3 Quality improvementAudits have often been undertaken as a "compliance exercise" to meet the requirements of clinicians' continuing education or health service accreditation. Frequently, audit results have not resulted in action being taken to close gaps in clinical care. Audit should be a continuous, integral part of a serviced quality and safety program. Audits should be conducted with early and ongoing clinician involvement. Data collection and analysis should be of high quality. Above all, the recommendations for changes in health delivery systems arising from the analysis of audits should result in timely, appropriate and concrete action. After action has been taken, the audit cycle should continue until the gap in care has been closed.

12.4 Detection of adverse events and riskThere are two major ways to detect adverse events and risk — reactive methods, which detect adverse events, and proactive methods, which detect risk at a health service following the study of adverse events in other health services or the detection of weaknesses in health care delivery systems by actively looking for them. A clinical risk management program should use both methods, but we strongly recommend that health services use proactive methods extensively, because they avoid physical and psychological trauma to patients, their relatives, and staff, by addressing system weakness and preventing adverse event occurring.

12.4.I Reactive risk management — detecting adverse events and near missesWe recommend using a diverse range of methods to detect adverse events, as there is little overlap of events detected by different methods. Three methods are most useful:■ Medical record review

>■ A useful way to start is to use three screening criteria — patient deaths, transfers from the general ward to the intensive care unit, and any records referred for review by a clinician, then expanding the criteria as the program develops.> Ensuring there is comprehensive, typed discharge summary for each patient admission greatly assists with medical record review.

239


> Be aware that many records will screen positive for a criterion but will not contain an adverse event.

■ Clinical incident reporting. Many incident reporting programs languish because of poor

education of stafT about the process and non-existent feedback to those reporting incidents.

Important strategies for a successful program include

> Educate staff about what incidents should be reported and how to report them.

>• Provide timely feedback about the results of investigations and the actions taken in

response to reports

> Make many of the actions taken in response to reports visible to staff. Show staff thai they

can improve the care they provide and their work environment by reporting incidents.■ Feedback from general practitioners

> Systematically obtain feedback from general practitioners about adverse events they

detect after a patient's discharge from hospital.

> Many adverse events obvious to general practitioners will not require re-admission to

hospital, so without much feedback, health services would not be aware of ihem./ 2.4.2 Proactive risk management — detecting risksm Review latent factors or conditions of work when developing new delivery systems or reviewing existing systems. If delivery systems are created with inadequate staffing levels, supervision, training and equipment, then adverse events will occur.

■ Assess each patient's risk of common adverse events (eg, falls, thromboembolus) when they are admitted to the health service, and take action to reduce the probability of these events occurring.

■ Systematically review multiple sources of information about adverse events (national databases, consultative committees, coronial and media reports, pharmaceutical alerts and hospital inquiries) occurring at other health services to detect system weaknesses and local risks. Although this requires additional resources and work, it is well worth the elTort if it avoids the trauma of a serious and preventable adverse event within the health service.

12.5 Analysing adverse eventsThe first steps when analysing an adverse event are assessing whether:

■ ihe patient and their relatives have been a managed appropriately

■ the staff involved have been managed appropriately.In our experience, these steps are often not adequately taken. In panicular, the effects of an adverseevent on the staff involved are often overlooked. A full root-cause analysis of an adverse event is resource-intensive, and should be reserved for the mosiserious adverse events. Systems analysis, which determines the care management problems, the relevantclinical events and the contnbulory factors, is a more efficient analysis and should be most commonly used.

12.6 Prioritising gaps and risksIn health services with a strong safety culture, many more gaps, adverse events and risks will be detected than can be appropriately managed at any one time. Gaps, adverse events and risks can be prioritised foraction according to:

■ their frequency

■ the harm they cause

■ their preventability

■ their cost

■ their benefits

■ their feasibility lo change.Each health service will probably prioritise similar adverse events in a different order, depending on local needs and conditions.

12.7 Closing gaps and reducing risksMany opportunities will be available to health services to close clinical gaps or reduce risks. It is important valuable resources are not wasted on interventions that are going to be ineffective The

240


effectiveness of an intervention will be extremely sensitive to the context in which it is introduced, and an intervention effective in one health service may not be effective in another.

241


12.7.1 Three Important questions when considering an InterventionWhen considering an intervention to close a gap or reduce a risk, the following conditions should be met before developing and implementing the change:■ Is the change scientifically based? There are many interventions available that have been demonstrated to improve quality and safety, so it is important not to waste valuable resources on unproven interventions.■ Do medical stafT believe the gap or risk is important? The support of medical staff is crucial to the successful implementation of many changes in health care. Without their support, many interventions will not be successful. There are so many interventions available — why waste resources on interventions not supported by them?■ Will management provide adequate resources and hands-on involvement? Many interventions require substantial resources for implementation and maintenance. Under-resourced interventions are likely to fail. Senior management involvement in project committees assists implementation, especially across departments, and creates ownership of the intervention at executive level in the health service. Executives are less likely to stop a successful quality and safety program if they have been closely involved in each stage of the program^ development.

12.7.2 The importance of contextThe context in which the intervention is planned is critical to its successful implementation. It is important to systematically determine (by interview or other forms of feedback from the target group and others) the characteristics of the■ change or innovation■ the users or target group■ patients

■ organisation (size, role, structure, administration, governance, communication, culture, leadership and resources)■ sociopolitical context and external factorsthat facilitate or impede the adoption and implementation of the change. In our experience, the characteristics of the users or target group are the most critical elements in determining the success of the intervention.After the determinants have been identified, they should be ranked according to their importance and changeability. Tailor the change strategy to address the major determinants using theories about behavioural change and the judgement of target group members. Remember, some determinants (eg, strong clinical leadership, adequate resources, and senior management participating involvement in project teams) may be more important than the number and type of implementation strategies used. Although this approach is subjective, it is valuable, given the complex nature of the health care environment and the limited scientific evidence about successful change strategies.

12.7.3 Implementation strategies

242

12 Important kimnqh

Implementation strategies (eg, dissemination of educational materials, audit and feedback, reminders, multifaceted interventions incorporating education outreach, and using opinion leaders) only have a moderate effect, which is sensitive to many determinants. However, in some contexts they can be very effective.Although not supported by scientific evidence, we have found it most effective to use a combination of quality improvement and system redesign strategies to implement and sustain change to improve quality and safety. Individual strategies that we have used include: simplifying systems, standardising procedures, using checklists and reminders, introducing constraints, and timely delivery of adequate and accurate information. We acknowledge that our success in using these strategies may be speafu. to the context in which we work, but we feel they may be also be effective in other health services

12.7.4 Use resources developed elsewhereAvoid reinventing the wheel — use resources (eg, literature and systematic reviews, policies, procedures, key process and outcome measures, educational material, and strategies) developed externally to the health service and tailor them to local needs and conditions. The resources available for quality and safety programs are usually very limited. Why waste them by re-creating a tool that has already been developed by another health service?

12.7.5 Small-scale testing of strategiesTest the change strategy on a small scale first, and make modifications before implementing it through the health service. As mentioned previously, as well as the change strategy itself, the success of quality and safety interventions are highly sensitive to the context in which they are introduced. Negative surprises can and do occur in complex health care delivery systems. Small-scale tests allow the effects of strategies in complex systems to be observed and changes made accordingly made without major disasters occurring.

12.7.6 Be vigilantIt is imponant to be vigilant. Monitor the effects of any change closely and modify the change strategy if required. We have frequently observed a change being successfully made, but attenuating over time. Surveillance of the performance of systems should be ongoing.

12.7.7 Provide feedback to clinicians about their performanceProvide confidential, timely, credible and non-punitive feedback about individual performance and achievable benchmarks to clinicians. People like feedback about their performance, and clinicians are no exception. If they are performing poorly compared with their peers, they usually do not want others to see their results. However, many will wish to improve their results. Do not provide clinicians with poor- quality data, as this could undermine the credibility of the quality and safety program.

12.8 Conclusion

Finally, quality improvement and risk management in health care is a joumey rather than a destination The terrain may be difficult, the process slow and improvements difficult to maintain. Much evidence and opinion about how to proceed has been presented here. Perhaps the biggest obstacle to change in complex organisations is inertia. Taking effective action is up to the individuals within organisations As with any strategy in life: keep it simple, do your best, do not give up and success is likely to follow.1

References

1 Buchanan J. Learning Irom legends: Australian cricket Sydney: Fairfax Media Publications. 2008 □

2S7Enhancing patient eve

Appendix 1: Wimmera Health Care Group Adverse Event -

Analysis Form

Episode No URNo: Admission Date | Discharge Date

ED Inpatient

Criteria (Circle all criteria met during admission)

1. Death «

2. Transfer to Intensive Care Unit

3. Cardiac arrest

4. Length of stay greater than 21 days

5. Returning to theatre within 7 days

6. Unplanned re-admission within 28 days

7. Transfer to another acute care facility

8. Booked theatre cases cancelled

9. External cause code (Y40-Y84)

10. Accident &r Emergency length of stay greater than 6 hours

11. Unplanned A& E re-presentation within 48 hours

12.Unplanned A & E attendance within 28 days of hospital discharge

Clinical ReviewAn adverse event is an untoward patient event which under optimal conditions is not a natural consequence of the patient's disease or treatment.

12 Important kimnqh

Please evaluate the clinical care given by rating the evidence that an adverse patient occurrence was causcd bv medical management (circle the appropriate number)

1. Little or no evidence of an adverse event caused by management

2. Slight evidence

3. Not quite likely (less than 50:50 odds but a close call)

4. More likely than not (greater than 50:50 odds, but a close call)

5. Strong evidence

6. Virtually certain evidence

If an adverse event has occurred where did it occur:

1. Within this hospital

2. Another hospital

3. Outside hospital including general practitioner care

If yes, please give relevant clinical details: _______________________________________________

No disability no significant resultant discomfort of functional impairment; and no increased length of stay as a result of the adverse event.

Minimal to moderate clinical effect requiring no or minimal clinical intervention, or no increased

length of stay or re-presentation for the same or related problem. Minimal to moderate dinical effect with

permanent residual and without significant functional or cosmetic impairment.

Moderate to severe clinical effect with no significant functional or

cosmetic residual effect. This usually results in increased length of

stay or re-hospitalisation and requires moderate to major clinical

intervention.

Moderate to severe clinical effect with significant functional or cosmetic

residual. When doubts exist as to the outcome but the probability is

that a major impairment or repeated presentations or hospitalisation will

be necessary. The outcome may result in major impairment.

Error cause scale

Tl Complications/failure in technical performance

T2 Failure to follow policy, protocol or guideline when indicated

T3 Acting on insufficient information

T4 Slip/lapse in activities in which operator is skilled

T5 Inadequate knowledge/experience

T6 Inappropriate or not indicated care

T7 No/wrong/delayed treatment

D1 Failure synthesise/decide/act on available information

D2 Failure request/arrange procedure or consultation

D3 Missed diagnosis

SI Lade of care or attention/failure to attend when called

S2 Failure in communication

S3 Equipment failure/not available

S4 Inadequate staff

S5 Staff fatigue/distress/sickness

56 Poor discharge planning

PI Inadequate follow up of treatment/monitoring

P2 Failure to provide indicated prophylactic treatment

0 a MinorsMi^f

1 Minor temporary

2 Mtoor permanent

3 Major temporary

4

5

Major permanentPotential major or

major continuing

Death

code the severity of the adverse event


Use Scales1 Mhinr Appropriate health service selected but poorly provided

2 Underuse Failure to provide health service when benefits exceed the risk

3 Overuse Provision of a health service when risks exceed the benefits

Preventability

1 Little or no evidence for preventability

2 Slight or modest evidence for preventability

3 Preventability not quite likely: less than 50: 50 but dose call

4 Preventability not quite likely: more than 50: 50 but close call

5 Strong evidence for preventability

6 Virtually certain evidence for preventability

What further action would you recommend1 None

2 Change in relevant hospital policy

3 Presentation of case at a postgraduate meeting

4 A detailed quality assurance program to investigate these type of occurrences in detail

5 Discussion with the doctor involved

6 Informing the hospital insurers of the case

7 Other, please specify:

Reviewer's signature.


Date _______/ _______/

Appendix 2: Clinical risk management executive summary

This summary explains the concepts of a clinical risk management program to health service staff and board of management members with little knowledge in this area. It can be modified to suit local conditions and is available at www.whcg.org.au/Quality/index.aspxHealth care delivery is associated with a high error rate compared with other complex industries. Traditional medical quality assurance has resulted in much activity, often lacking integration and resulting in disappointingly small, inconsistent improvements in the quality of patient care (with a few exceptions in specific areas). This summary describes a comprehensive clinical risk management program designed to integrate detection and reduction of adverse patient events into the everyday activity of an acute general hospital.

Clinical risk management is about reducing the probability of negative patient events. This involves detecting adverse events, analysing their risk severity, and taking appropriate action to prevent their recurrence. The Wimmera Clinical Risk Management Project began this process by developing several methods for detecting adverse events. The initial detection method was medical record review using a two-step process of screening all inpatient medical records using general medical outcome criteria (eg, return to the operating theatre, re-admission within 21 days of discharge) and medically reviewing records that screened positive. This method detects many adverse events in an effective, efficient manner. Analysis of these adverse events and the taking of appropriate action has resulted in a significant reduction in the rate of inpatient adverse events that has been sustained over 16 years.

The two-step process has been modified for use in reviewing emergency department medical records. These modified screening criteria have been in use for over 11 years, and have allowed efficient detection of adverse events in the emergency department. Appropriate action has then been taken, which has reduced the rate of adverse events.

To improve the detection of adverse events, a coordinated method of clinical incidents being reported by staff members was introduced. Clinical incidents and near misses are reported by staff both to the hospitals involved in this program and to a national database of the Australian Patient Safety Foundation. The most common incident reported has been patient falls (47.7% of all incidents reported). A significant finding was the low overlap of adverse events detected by both the medical record review process and clinical incident reporting. Each detection method appears to find adverse events from a different pool.

Despite using these comprehensive methods to detect adverse events, some events are still not found. An adverse event may occur after a patient is discharged from hospital, but the event may be due to their treatment while they were in hospital. For example, a wound infection after surgery may develop several days after discharge. To capture this important information, each hospital inpatient discharge summary that is sent to the patients general practitioner also contains an adverse patient event reporting form. If the patient's general practitioner detects an adverse event after discharge, it can easily be reported to the clinical risk management program. This process detects adverse events that are often not recorded in the hospital medical records and have not been reported by hospital staff.

Preventability

http://www.whcg.org.au/Quality/index.aspx

Some adverse events occur infrequently, and may only be detected once every few years in individual hospital clinical risk management programs. To maximise the benefit of this pool of valuable information about serious but infrequent events, information about adverse events that have occurred at other hospitals has been used as if the event has actually occurred at Wimmera Health Care Group. Information about such adverse events is available from coronial reports, consultative committee annual reports (eg, the Consultative Council on Obstetric and Paediatric Mortality and Morbidity, the Victorian Consultative Council on Anaesthetic Mortality and Morbidity, and the Victorian Surgical Consultative Council), hospital insurers, medical indemnity organisations and clinical journals. After an adverse event is repotted by one of these sources, the question is asked: Could this adverse event occur here? If the answer is yes, analysis and action are taken to reduce the probability of such an event occurring It is not necessary for a hospital to wait to actually experience a particular low-frequency advene event to benefit from it having occurred elsewhere.

In a similar preventive vein, undertaking a risk assessment for each patient admitted to the hospital can prevent common adverse events. Fot* example, each patient aged over 65 years who is admitted lo the hospital undergoes a falls risk assessment. Patients assessed as high risk for having a fall while in hospital are managed on adjustable-height beds and in rooms close to the nurses' stations so that assistance is close at hand if required.

There is sometimes a delay in adverse events being detected by reviewing medical records or by staff members reporting clinical incidents. To capture the details of more adverse events shortly after they occur, the use of evidence-based clinical pathways for particular filinical situations will be expanded for both inpatients and emergency department patients. Variances from pathways can be reported at the time they are recorded in the medical record and analysis of the variance will tie undertaken prompdy.

Although research has shown patients to be poor judges of the quality of the clinical care they receive, they are able to accurately assess the quality of non-clinical care, which is a significant component of the quality of care and service provided by hospitals. Information from patients provides valuable data for improvement of systems in hospitals. Adverse events that have occurred from the patient's perspective are also delected. This is achieved using information from patient satisfaction surveys, focus groups and patient complaints.

In this clinical risk management program, it has become apparent that it is not possible to manage the risk associated with all the adverse events detected. Therefore, as each adverse event is detected, the risk associated with the event is determined. The probability and consequences of the risk are assessed, and a risk severity rating is given to the adverse event in accordance with the Standards Australia/Standards New Zealand Risk Management Standard. The adverse events are then ranked according to their risk severity rating. Those with the most severe rating are given priority for analysis and action aimed at eliminating or reducing their risk. In the case of adverse events with low risk severity, a decision is made as to whether to take action or to accept the risk and continue monitoring the particular adverse event.

The actions taken to manage clinical risk have been a large component of this program to date. After an adverse event has been detected, the risk is analysed, and if the risk severity is high, a multidisciplinary team is assembled. An aim for quality improvement is established by the team, together with a balanced set of process and outcome measures. Options to improve systems involved in the adverse event are derived empirically or from research (evidence-based, if possible) or observation, and are examined in detail. Small-scale tests are undertaken to implement chosen improvement strategies after baseline measurements are taken. Measured results of the tests are analysed and improvement strategies are adopted, modified or abandoned. Further small tests are then undertaken if required, following the same sequence. This strategy has underpinned the significant improvements that have been achieved in the adverse event rates in this clinical risk management program.

A major component of the system improvements program has been the implementation of the results of research into error prevention. Adverse events are analysed to identify latent factors (eg, workload, level of supervision, communication and equipment) and active factors (eg, memory lapses and slips) that contributed to the error occurring. Actions taken have concentrated on improving the work environment and removing total reliance on the weakest components of human cognitive function, especially shon-term memory and the ability to be distracted from the task at hand. Strategies used to address these issues include simplification of systems,


standardisation of procedures, use of reminders and checklists, and the timely delivery of information.

Information from the program is regularly reported to participating doctors, clinical staff and hospital quality committees and boards of management.

Reducing the probability of adverse events occurring in hospitals requires a comprehensive, integrated approach to detecting adverse events, analysing the events and taking appropriate action to successfully reduce the chances of the events recurring. The process requires support from senior clinicians and executive staff, board of management members and all health care professionals working at a hospital. The work is labour-intensive and requires additional resources. However, the rewards of improving the level of patient safety are attainable and significant. The establishment and maintenance of an effective clinical risk management program is a worthy objective for all hospitals. □

234

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success, 120-121,135.144.225.226

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hospital, 171

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journals junior ambcal suff.

23.28,59,69.146. 157.164.178

KKing Edward Memorial Hospital. Penh. 85

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learning theories. 120.139-140

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legal action

M____________________

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board. 11.14,203.204-205,206.211

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98

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review. 51. 55-58, 73, 74.89.98.99.

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medication errors. 41,64,65 MEDLINE.

19 mental illness, doctors. 9 meta-

analysis, 7,19.20 methodology, 27

military model. 42

Monash University Centre for Rural

Health, 217.218 monitoring clinical

activity. 5 clinician performance.

9.12,227 compliance. 7

health service performance. 1

morbidity. 19,22.30.195 mortality.

19.22-23.30, 111. 195

30-day. 23 motivating, clinicians. 157-

158.177-179 motivation theories. 131-

133 motivation to change and learn,

130. 133.157

multidisciplinary team. 7.21.

76.100.139, 145.208

mundane adverse events see adverse

events, mundane

N-National Coordinating Council lor

Medication Error Reporting and

Prevention, 57,58b

National Institute of Clinical Studies,

18 National Primary Care Research

and Development Centre, UK, 21

"near misses",

28,63,64,65,82,192,195 negative

consequences of change, 38,119,

168,209,223 negligence, 50 neonatal

units. 61,81 Netherlands, 39 New

South Wales, 80 Quality Use of

Medicines in Australian Hospitals, 30

New Zealand, 39.80,233 non-clinical

personnel. 23 non-compliance, 196

non-randomised trials, 6 non-reponing

of incidents, 41,65 Nonhem Territory,

80 nursing staff. 55.146.205 director,

204 education, 65 failure in care

delivery. 50

O

obstetric screening criteria, 52

online policy and procedure manuals.

7,67

online reponing. 66-67

open disclosure. 9.10,50.95-96

documentation. 96 operational

hazards, 195 opinion leaders.

134.137,144.156-157. 171

technical. 135 organisational

accident model. 39/ organisational

factors. 5.86.138-140 and change.

124b. 130(. 138.163-165 clinical

governance, 10-11,14 culture. 191-

192.192b, 194-195.194b

Organisational Learning Theory.

139-140 outcomes. 9.10. 20. 52

health care system. 37-38 outcome

measures. 22-23,29,170 screening

criteria. 53b. 218 ownership of the

issue. 157-158

PPareto Principle. 18 patient

and adverse events, 39.87,95-

97.99,225 and change. 140-

141.163-165 characteristics, 124b

and clinicians, 137 complaints.

28.71.77-78 identification data, 23

passive recipients, 87-88 privacy.

25-26 resistance, 41 sampling, 25

patient caie, 52,76,99,179

dimensions, 5,170 gaps in quality.

155 improving, 3.140-141 meetings,

50 patient-centred, 13

standardisation, 76 patient deaths,

54.72.207 patient management

plan, 40 patient outcomes see

outcomes patient representation,

162 patient safely. 4-5.50,87 alerts.

80.81,83 culture. 191-201

levels. 194b information, 80-81

monitoring. 13,87-88 notices. 80-81

practice. 110-111 spectrum. 195-197

surveys. 198-199 patient safety

manager. 100 patient safety

programs. 177-179.179c patient

satisfaction, 20, 22, 77-78.89 patient

surveys, 20,78 peer review,

27,85.135,220 performance, 1,132

clinical, 21,27, 29,30 monitoring, 5,9

standards, 4 clinicians, 21,27,29,

30.174 dealing with poor

performance. 14 improvement. 172/

measures. 170 monitoring. 1. 5.9.

12.176 variation graphing, 25

23*

personal digital assistants, 23

pharmaceutical alerts, 49.84-85

pharmaceutical companies. 137

pharmacy committcc. 28 plan-do-

study-act cyclc. 27.138.172.172/

Planned Behaviour, Theory of. 131

political and economic theones. 140

preadmission clinic. 55 preventability

scalc. 58b preventive health

strategies. 50.88 prioritising action

adverse events. 103-105. 109-114.

113b. 225

external programs application, 112-

113

risk management, 43 privacy,

patient. 25-26 privileges, withdrawing.

12 privileging see credentialling and

privileging probability, adverse events.

98,104 procedures, standardising. 146-

147 process control charts, 25 process,

indicators. 29 process measures, 22-

23,29,170 Process Redesign Theory,

139 process theories, 127-128

professional development, 5,8-9,12,

14,137 -

professional experience, 8 professional

organisations. 29 professional

qualifications. 8 *

professional responsibility. 11

professionals motivating, 133,157-158

rewarding, 133 project name, 171

project officer. 160

project team. 161-163,166-

168.174,175

evaluate the project, 176 protocols.

20.146 publications, 18.20,21,84,159

punitive response. 41.46.69,83,99,149.

211-212

Qqualifications, 8

Quality in Australian Health Care

Study, 39, 56.109

error cause scale, 102b quality of

care. 3-4,10.85-86 components, 20

gaps. 156,163.208-209 measuring, 22

quality improvement, 11,13-14,17-35.

111.138.145, 209-210 clinical area

selection, 18-19 collaboratives. 26-27

committees. 5.28,206 cycle. 17/

definition, 17,20-22

evidence and theory for improving, 119

hospitals, 122,125

important points, 33, 223, 224

siraicgics. 145

Wimmera model, 26f, 43-44, 45/

quality improvement programs.

191*201

components. 19-20, 179 imponant

points. 200 motivating doctors, 157-

158,177-179. 179f

quality management. 119. 138-139.

145-149qittkty manager. 205Quality and S^eiy m Health Gas. 59Quality Um of Medum to AmalmmHocp*ak. 30Queensland. 52,80.102questionnaire, safety tftiudr. IM-M

Rrandomised controlled wtk, 6.22.

111-112.127,134,174rapid response teams. 112re-ceitifiadon, 8.27

Reason. James. 39.98

recovery times. 76

reference panel. 219-220references, dmictms, 8regulating. 1.14Reinforcement Theoty 131relapse. 174.175.176relatives and adverse events. 95.96-97.99.225

reminders. 147-148.208 reponing

advene events. 177 audit results, 25-

26.29 behaviour. 68

clinical governance program. 11. 189-

190

clinical incident. 63-71.193

incomplete nd bistil, 66 limitations,

65-66 online, 66-67under-repoiting, 41.65,69 commercial requirements, 49 culture. 193 mandatory, 49time, 71

voluntary; 49.67 research.

79.120.159 Residential Aged Cm

Cervrid Communique 79

resources. 7.13,20-21.25.26.110-111.

125b. 210 allocation, 39-40.59-

60.205.223.226 analysis. 165-166

developed elsewhere. 227

monitoring. 176 saving. 18

responsibility, defining. 12

responsible autonomy; 10 results. 7

clinkal audit. 13.24-25 replicating. 25

revenue. 209 nsk

assessment. 104-105.104t. 233

detecting. 40-93.225

rienafywg ra of risk. 49.78.88. 156-17*mtaong, 167-168 nsk —f iiW!W. 5. 10.11.12.14.28 advent events. 37-47 important points, 46,223,223 proactive, 49-50.78-88.179 important points, 89,225 ■ process, 43.43f, 44 ■active, 49.50-78 important points. 89,224 Wimmera model. 43(. 44,45/. 89 see abs clinical risk management program risk register. 105.1061.210 role models. 134root-cause analysis. 71.73.98,100-102bmitanans. 101-102 Royal Australasian College of Surgeons. 27 Royal Children* Hospital, Melbourne, 54 Royal College of Physicians. 28

ssafety alerts and notices, 80,81,83 safety assessment code. 100 safety at work, 12see ciso patient safety safety committee, 28 safety framework, 199.199b safety programs see patient safety programs scientific evidence. 6.19.81.172.176, 179.226scientific literature see literature search Scottish IntercoUegule Guidelines Network. 20sentinel event, 71-74.89.98Sentinel Event Alerts. 72.73.74%vemy scale. 57k. 207daft lengths. 13,40.86SIGN, see Scottish Intercollegiate Guidelinesit . Inenpontgmubux laboratories. 9sue visas. 20small group learning. 9small-scale tests. 23.24-25.161.172.227SMART goals. 166-167sodal influence theories. 136-137social mesxaoas. 38.136-138Social Learning Theory, 136Social Network and Influence Theory,136-137suuupotocal content, 125b. 163-165 South Australia. 80. 102 Off. 23. 157 ad advene events. 97.99. 211.225 and change implementation, 160 and clinical risk management, 206-207, 209,226medical staff group report, Wimmera, 108 supervision, 40see also clinicians; doctors; junior medical staff; nursing stafT staff-patient interface, 42 stakeholder 156-157,161,164,171,176 standards, 1,95,104 of care, 19.21 clinical performance, 4 data collection, 24-25 procedural, 146-147 professional, 29 Standards Australia/New Zealand, 104,233 storage of data, 24 strategic plans, 1 stroke, 28,77/, 181-182 structural change, 160 structural indicators, 29 substance abuse, doctors, 9 suicide, inpatient, 72 supervision of clinicians, 12,13 intern training, 28 surgery, 27-28 deaths, 54 wrong-site, 72 surveillance committee. 58.69,74,105, 208,209statutory immunity, 107-108 surveys, 13,20,71.164.198 presurvey questionnaire. 20 system failure, 85 identifying gaps, 156 simplifying system, 146 system performance. 170 system redesign, 17,179 systematic determinant analysis, 122

systems analysis. 98-100 systems engineering. 120

Ttables of results and trends, 26 uigei group. 122.130(. 171 analysis. 164characteristics, 123b. 134,135.160 education, 166 identifying. 156-166 informing, 158-159 vision for change, 158-159,163-165 teams, 11-12, 162-163 changes, 145quality improvemenl, 26, 137

see.also project team telephone reporting, 67 tests, small-scale, 23,24-25,172,227 TGA see Therapeutic Goods Administration theories of change in health care and individuals, 129-136 attitude theories — Theory of Planned Behaviour, 131 cognitive theories, 130 education theories, 130 motivation theories, 131 expectancy theory, 132-133 Goal-setting Theory, 131 Herzbergt Motivation-Hygiene Theory, 131

Innovation Diffusion Theory, 134 Jobs Characteristics Model, 132 motivating professionals, 133 Reinforcement Theory, 131 Three Needs Theory, 131 organisational context, 138-140 complexity theory, 139 innovative organisations, 138 integrated care, 139 organisational culture, 140 organisational learning, 139-140 Process Redesign Theory, 139 quality management. 138-139 and patients. 140-141 political and economic context, 140 contracting theory. 140 economic (reimbursement) theory, 140 process theories, 127-128 and social interaction, 136-138 communication theories, 136 leadership, 138 professional development, 137 Social Learning Theory, 136 social network and inlluence theories, 136-137team effectiveness. 137 Stages of

Change Theory. 128-129.130t Therapeutic Goods Administration, 85 Three Needs Theory, 131 lime. 14. 76 timetables, 169total quality management, 119,138-139, 145training, 68, 166,178,218 clinicians, 8 data analysis, 26 treatment errors, 41 trends. 24,26 mailing change, 144,161 trigger tools, 60-62,60b


uunder-reporting, 41,65 unintended injury, 36 United Kingdom. 21,27.39.54 databases, 80-81 Imperial College London, 99 Inquiries into health services, 85-86 Lothian Surgical Audit in Scotland, 27 National Health Service, 3 Belter Care. Better Value Indicators, 30 Central Alerting System, 85 Medicine and Healthcare Products Regulatory Agency. 84-85 National Institute for Health and Clinical Excellence. 20

Scotland Clinical Indicators. 30 National Health Service Trust, 65 National Patient Safety Agency, 80 National Primary Care Research and Development Centre, 21 National Reporting and Learning System, 80-81National Sentinel Audit of Stroke, 28 Royal College of Physicians' Clinical Effectiveness and Evaluation Unit.*28 Scottish Audit of Surgical Mortality, 27 Scottish Intercollegiate Guidelines Network. 20 United States. 52.135.157.173 5 Million Lives Campaign. 112-113 Agency for Healthcare Research and Quality, 4,20.21.40,58.210

Quality Indicators, 30 California Insurance Feasibility Study, 52 California Medical Management Analysis, 52Department of Health and Human Sen-ices, 20Harvard Medical Practice Study, 38-39,50. 51, 51b, 55. 56. 58, 103, 103b, 109, 207 Institute for Healthcare Improvement. 27, 61. 113Institute of Medicine. 191 Joint Commission on Accreditation of Hcalthcarc

Organizations, 30, 71-73,86, 95,98,113,191NASA see United Sutes. National Aeronautical Space Administration National Aeronautical Space Administration. 83 National Center for Palienl Safety, 80 National Guidelines Clearinghouse. US. 20 National Hospital Quality Measures, 30, 71-73.86.95.98.113.191 Patient Safety Network. 210 Pennsylvania, Patient Safety Authority, 83 Safety Assessment Code score, 82,86 sentinel reporting, 71-72,73VA-NASA Patient Safety Reporting System. 83

Veterans Health Administration Health Care Failure Mode and Effect Analysis. 86-87incident reporting system. 82-83,86,

98.100 University College London, 99 unsafe acts, 82-83.193

Vvariance analysis, 76-77,89 Victoria, 11.52,54.79.80.101 102. 174-175

Consultative Council on Obstetricand Paediatric Mortality and

Morbidity, 23,78Department of Health. 78 Department of Human Services. 78.95, 96-97.105 Clinical Risk Management Strategy,72-73Incident Severity Rating Classification, 68small hospitals program,

220-221 State Coroneri Office, 79 Victorian Consultative Council on Anaesthetics Mortality and Morbidity, 78,232Victorian Maternity Services Performance Indicators, 30

Victorian Minister for Health, 78, 107 Victorian Surgical Consultative Council. 78. 232voluntary reporting, 27,67, 100

wwirnng timet. 19websaes. 59.77.99.100.102,210 VMaUfnJtufuab.80Audfe of Suipcal Monday. 27 Western Victoria Divaton of Gcneoi Practice. 217,218.220 whisdeblowtis. 85 whok-of-pnoice

mhOu. 27-29 Wunmera Hokh Care Gtoup. vu. 23.52. 78,84,175.204-207 advene event analysis. 57.89.102-103. 211.229-231

form, 56 changc strategies, 145-149 clinical incident reporting. 66-70.70f dinial indicators, 31 clinical pathways. 76f. Tlj. 179-194 discharge summary, 59.74 general practitioner tmfhark fonn, 74.75f Patient Care Commute*. 105.107-100. 108bquality improvement and risk management modd. 26f. 43(. 44.45f. 46.89risk assessment matrix, 104c screening criteria emergency department. 55k. 63f inpatients. 52b

medical record. 54.58-59.62f. 217-220 small hospitals program, 217-221 website. 77Wimmera Clinical Ride Matagemem Project. 232 work environment. 39.49.195 working conditions. 12.14.96latent (actors. 86-87 workloads. 13.40.86.88.159 Warld Health Organization. 3


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242


ENHANCINGPATIENT CAREWe all want the best possible standard of care for our patients.But high-quality, safe health care can be difficult to achieve. Above all, it requires cultural change, which in turn can only occur through the dedicated, consistent efforts of clinical safety champions.Alan Wolff and Sally Taylor are two such champions. Based on their well recognised work in the Wimmera Health Care Group in Victoria, Australia, they have created a commonsense guide to quality improvement and risk management. Their experience at a regional hospital has led to a pragmatic framework that guides other health services through the relevant evidence and theory, down to the finest details.Enhancing Patient Care will be of use to anyone who wants to set up or improve a quality improvement and risk management program, regardless of size and budget.

A b o u t t h e a u t h o r s

Alan Wolff is the Director of Medical Services at Wimmera Base Hospital. He has 27 years' experience

in medical administration, and has a research interest in quality improvement and risk management

methods and their use in hospitals. He was involved in the development of Wimmera Base Hospital's

adverse event screening program, which began in June 1989 and was , Av' one of the first

commenced in an Australian hospital.

Sally Taylor has worked in clinical risk management

for 10 years and is currently the Clinical Risk Manager of the Wimmera Health Care Group. She has

experience ' with quality and risk programs in both regional and small rural hospitals. She has a clinical

background and qualifications in midwifery and inter care nursing.

Mjtm