Distilling the lessons 1

ReseaRch & InnovatIonRIsK ManaGeMent FoR PatIent saFetY

distilling the lessonseURoPean WoRKshoP on RIsK ManaGeMent FoR PatIent saFetY

stephen Leyshon, eva turk, Morten Pytte, stephen Mcadam and charles vincent21st november 2012

EUROPEAN WORKSHOP ON RISK MANAGEMENT FOR PATIENT SAFETY2

about the authors:Stephen LeyShon MSc (Lond), MA (Lond), PG Dip (Lond), RN, DN, FHEA – Deputy Programme Director, Principle Researcher and Advisor in Patient Safety, Healthcare, DNV Research and Innovation

stephen Leyshon joined Dnv in 2011, where his responsibilities include managing applied research into person-centred care and risk management. Prior to this, he was the clinical Lead for Primary care and ambulance services at the UK’s nhs national Patient safety agency, working nationally and internationally to develop practice and policy to manage risk and improve the safety of care outside of hospital. a Registered nurse, stephen has over 20 years of experience in healthcare and his previous roles include Lecturer in health Policy and ethics at King’s college London, Research Fellow in Primary care at King’s college London (a shared appointment with University college London), Lecturer-Practitioner, and health services Manager. From 2008-2011, stephen was a member of the Department of health (england) nhs review of the safeguarding vulnerable adults national policy (‘no secrets’); from 2010-2011, a member of the Department of health (england) Independent safeguarding, vetting and Barring scheme Working Party; from 2008-2011, a co-opted member of the UK national ambulance Risk and safety Directors’ Group; and, from 2006-2008, chair of the London network for nursing and Midwifery in Primary care. stephen is also a former non-executive Director of a Primary care Group with co-lead responsibility for clinical governance.

eva turk MA, MBA – Senior Researcher, Healthcare, DNV Research and Innovation

eva turk joined the Dnv Research and Innovation, healthcare programme in oslo, norway in January 2012. Recently she joined the Joint action on Patient safety, where she is working on implementation of safe clinical practices in the eU. Prior to joining Dnv, eva was working at the national Institute of public health in slovenia, where she was responsible for implementation and development of health technology assessment (hta) in slovenia. she has been involved in many ec DG RtD Framework 6 and 7.

Morten pytte MD, PhD – Programme Director, Healthcare, DNV Research and Innovation

Morten Pytte joined Dnv Research & Innovation in 2011 where he is now the Programme Director for the healthcare programme. Morten is a physician by training specialised in anaesthesia and intensive care medicine with more than ten years of clinical experience. Besides anaesthesia and intensive care Morten’s clinical expertise is on sudden cardiac arrest and resuscitation. Between 2005 and 2009 Morten did clinical and experimental research on cardiopulmonary resuscitation and finished a one year fellowship at the Weil Institute of critical care Medicine in california in 2007-2008. Morten also participated in the development of evidence based international guidelines for cardiopulmonary resuscitation published jointly by the american heart association and the european Resuscitation counsel in 2008.

Stephen McadaM DPhil (Oxon) – Global Technical Director, Healthcare, DNV Business Assurance

an immunologist by training, stephen Mcadam spent a decade working in laboratories working with pathogens such as hIv and hcv in hospitals in the Us, africa and europe. Following a post-doctoral period at the national University hospital in oslo he spent 10 years in Dnv’s Department Research and Innovation exploring systems-based approaches to management and risk assessment in areas where the principal hazard is a biological agent (biorisk). stephen has collaborated with many of the world’s leading organisations in the area of laboratory biorisk management, including the W.h.o., ecDc, canadian science centre, and the UK health Protection agency. stephen spent two years establishing a research programme focused on patient safety before switching roles within Dnv to take on responsibility for developing Dnv’s standards in healthcare.

charLeS vincent MPhil, PhD – Professor of Clinical Safety Research, Department of Surgical Oncology and Technology, Imperial College London

charles vincent trained as a clinical Psychologist and worked in the British nhs for several years. since 1985 he has carried out research on the causes of harm to patients, the consequences for patients and staff and methods of prevention. he established the clinical Risk Unit at University college in 1995 where he was Professor of Psychology before moving to the Imperial college in 2002. he now directs the clinical safety Research Unit based in Department of Department of Biosurgery and technology, Imperial college London. he is the editor of clinical Risk Management (BMJ Publications, 2nd edition, 2001), author of Patient safety (2nd edition 2010) and author of many papers on risk, safety and medical error.

From 1999 to 2003 he was a commissioner on the UK commission for health Improvement and has advised on patient safety in many inquiries and committees. In 2007 he was appointed Director of the national Institute of health Research centre for Patient safety & service Quality at Imperial college healthcare trust. he is a Fellow of the academy of social sciences and was recently reappointed as a national Institute of health Research senior Investigator. Professor vincent is also an independent consultant and acted as rapporteur for the Workshop.

Distilling the lessons 3

critical messages

Patient safety incidents are a major cause of harm in all countries

significant progress in patient safety has been made in the last 20 years but this is inconsistent across clinical settings, organisations and

countries

one obstacle to further progress is how to move

from small-scale innovation to spread and sustainability:

breaking the cycle of ‘projectness’ to create lasting

change at system levels

Risk management offers a potential way to create patient safety at a system level by providing a

framework to address human, technological and organisational

factors, i.e. the nexus where preventable harm most often arises

For healthcare to mature and capitalise on the value of risk management, action is needed on:

a. tackling risk at a system level – mapping processes to identify and act on system vulnerability and variability

b. augmenting the technical side of quality development to focus more on the informal, political ‘art’ of improvement so that organisational attitudes, behaviours and cultures are adequately addressed. Risk management can provide a structure to achieve this balance as it ad-dresses the intersection of human, technical and organisational factors

c. Promoting education for change so that every member of the health-care workforce is engaged in and has ownership of, as well as the competence to contribute to, the assessment and management of risk

d. Developing person-centred care – moving away from thinking of risk in terms of isolated service silos to reflect the realities of patient expe-rience (and therefore the potential for harm) as they transition within and between primary, secondary and tertiary health and social care

1 3 4

2

6

Despite its potential, evidence suggests that the use of risk management to

deal with system vulnerability and variability in healthcare is at uneven levels of maturity

5

EUROPEAN WORKSHOP ON RISK MANAGEMENT FOR PATIENT SAFETY4

This is DNVDnv is a global provider of services for managing risk. established in 1864, Dnv’s mission is the safeguarding of life, property and the environment. Dnv comprises 300 offices in 100 countries with 10000 employees. our vision is to create a global impact towards ensuring a safe and sustainable future.

ReseaRch aND iNNoVaTioN iN DNVthe objective of our strategic research is to enable long term innovation through new knowledge and services. such research is carried out in programme areas believed to be of particular significance to Dnv and society.

european workshop on risk management for patient safety: distilling the lessons

Photo: istockphoto

Distilling the lessons 5

Introduction ................................................................................................................................................................................................6the workshop and its aim .....................................................................................................................................................7context .............................................................................................................................................................................................................7Why risk management for patient safety? .....................................................................................................8summary of the day .......................................................................................................................................................................9

european policy initiatives – successes, priorities and challenges ...................10european research on quality improvement, patient safety and risk management – current practice and areas for development....................13

Reflections on the workshop – distilling the lessons ....................................................................16Where next? ..........................................................................................................................................................................................18conclusions ............................................................................................................................................................................................18appendix one: Workshop participation .........................................................................................................20appendix two: Workshop programme ...........................................................................................................21References ................................................................................................................................................................................................22

contents

Design, layout and print production: erik tanche nilssen as, 03/2013. Printed on environmentally friendly paper. Photo, front page: istockphoto.

EUROPEAN WORKSHOP ON RISK MANAGEMENT FOR PATIENT SAFETY6

this report summarises the discussion points from Dnv’s european Workshop on Risk Management for Patient safety. In drawing together the presentations and dialogue from the day, it focuses on highlighting the key learning and recom-mendations.

introduction

Photo: Damir cvetojevic

Distilling the lessons 7

an invitation only event, the workshop was held on the 21st of november 2012 in Brussels. Its aim was to provide an opportunity to bring together national and international leaders in research, policy and practice in order to identify the current state of risk management for patient safety and to articulate future actions for reducing harm to patients.

the workshop and its aim

every day around the world many millions of people receive effective and compassionate healthcare. It is also well established1 that a significant proportion are harmed by the very same health services: glob-ally, estimates suggest that about 10% of patients admitted to hospital will experience some degree of adverse event. systematic action on patient safety is only a little more than a decade old and there has been substantial progress on a number of fronts. however there is general agreement that the ambitious targets of earlier years have not been met and there has been much speculation about why this might be2 3 4.

In contrast, other safety critical sectors that involve high risk processes have been more successful at addressing risk and reducing harm5. Responding to major disasters such as Flixborough6 and Piper alpha7, other sectors have made greater improve-ments to their safety by using risk based approaches: working to ensure that they have an appropriate number and strength of prevention and mitigation controls in place relative to their hazards.

It is unclear why healthcare struggles to manage risk in comparison to other safety critical sectors8. certainly patient safety remains a tough problem to solve not just because of its massive scale but also because of the complex interaction of cultural, technical, clinical and psychological factors. the workshop was an opportunity to explore these rea-sons in more depth, review progress to date and to make suggestions for improvement.

context

EUROPEAN WORKSHOP ON RISK MANAGEMENT FOR PATIENT SAFETY8

why risk management for patient safety?healthcare is a safety critical sector9 that needs to get better at managing risk proactively10. Good quality healthcare depends on the safe and efficient functioning of multiple interlinked systems and services11. these systems encompass micro, meso and macro levels (e.g. the clinical, organisation-al and regional/national/international). they are dynamic, can be complex, and include the flow of information, physical resources, time and people. In healthcare, individu-al people (in the form of the service user) are, or should be, at the centre of systems: the systems and how they work should be designed to achieve quality care (figure one).

When things go wrong in healthcare, it is often a failure of the design of the system to achieve the desired result12. a framework to engage critically with systems and the risks they may pose to the people at their centre is, therefore, valuable.

Risk management is a cyclical, continuous and dynamic process of assessing hazards (i.e. the ‘business as usual’ that could lead to harm, including preparing for emergencies) and selecting, implementing and evaluating controls to reduce the potential of those hazards from becoming

adverse events13 (figure two). It offers a potential frame-work to create patient safety at a system level by providing a means to address human, technological and organisation-al issues, i.e. the constellation of factors and circumstances where preventable harm most often arises14.

Prioritize and establish risk treatment goals to minimize or eliminate the risk

1Estimate

risk

2Evaluate

risk

3Identify options

5Act

6Evaluate

outcomes

4Make

decisions

Identify risksfrom pasts events

Consider likely impact of uncontrolled risk

Develop specific, realistic action plans

to meet goals

Work collaborativelyto overcome risk

Collect data tomeasure changes

- revise risk assessment

Continous risk communication

Review current practices to highlight areas of weakness and possible risk

Safe

Person centered

SustainableCost efficient

Effective

Figure two: Risk management cycle15

Figure one: Quality care

Distilling the lessons 9

summary of the dayover 50 participants drawn from regional, national and international organisations representing patients, profes-sionals, healthcare providers, research institutions and policy makers took part in the workshop (appendix one). the programme (appendix two) was divided into two broad themes: patient safety policy and patient safety practice.

In the morning, presentations were given on european-wide policy developments and research into the practice of quality improvement, risk management and patient safety. the afternoon focused on a series of group and plenary discussions addressing how risk management for patient safety can be developed further. this section gives a brief summary of the day.

Photo: Damir cvetojevic

Photo: Damir cvetojevic

eURoPean WoRKshoP on RIsK ManaGeMent FoR PatIent saFetY10

european poLicy initiativeS – SucceSSeS, prioritieS and

chaLLengeS

Opening remarks: The European Commission’s work for patient safety – Directorate General Health and Consumers – Katja Neubauer

Patient safety is a key priority for the commission and risk management is reflected in a number of initiatives aimed at protecting both patients and the health and safety of healthcare workers. these include regulation on the safety of blood, tissues and organs; regulation on the safety of clinical devices; and research on the working environment and patient outcomes. In addition, the commission Patient safety and Quality of care Working Group brings together representa-tives from all 27 european Union (eU) Member states, european Free trade association (eFta) countries, international organisations and eU bodies to foster the exchange of best practice and to develop the patient safety and quality agenda.

In 2009, the european council made recommendations on patient safety16. a review of the implementation was published by the european commission in november 201217. although much progress has been made since the 2009 council Recommendation, significant disparities remain in the implementation of patient safety strategies and programmes across Member states. Box one highlights some of the key challenges that remain.

Box one: Key challenges remaining in the implementation of patient safety strategies and programmes across Member States

Further details on the work of the Directorate General are available at: www.ec.europa.eu/dgs/health_consumer.

·· Developing the role of the patient and citizen in patient safety

·· the education and training of health workers in patient safety

·· safety initiatives need to address non-hospital care

·· assessing the costs of unsafe care in order to help political prioritisation

DIstILLInG the Lessons 11

european poLicy initiativeS – SucceSSeS, prioritieS and

chaLLengeS

Keynote: W.H.O. Patient Safety – World Health Organization – Dr Agnes Leotsakos presented by Dr Valentina Hafner

the mission of the W.h.o. Patient safety programme is to coordinate, facilitate and accelerate patient safety improvements around the world by being a leader and advocating for change; generating and sharing knowledge and expertise; and supporting countries in the implemen-tation of patient safety actions. examples of success include clean care is safe care, the safe surgery checklist, the safe childbirth checklist and Injection safety.

existing research and field experience show that patient safety does not rely on sophisticated clinical technologies and procedures only but requires a proper consideration of complex and high pressure environments, in which both equipment and the human factor play a key role. W.h.o. patient safety program is constantly adjusting its strategic interventions to enhance safer care at global and regional level by raising awareness, developing tools and supporting capacity building of the patient/consumer and the professional/service provider communities. In line with this work, a number of critical elements for building patient safety at a country level are presented in box two.

Box two: Critical elements for building patient safety at a country level

Further details on the work of W.H.O. on patient safety are available at: www.who.int/patientsafety

·· Leadership and commitment to tackle patient safety locally and nationally

·· advocacy and awareness raising of patient safety, the costs of unsafe care and solu-tions for improving systems

·· Building networks and partnerships (nationally and internationally) and engaging and empowering patients to create momentum

·· Implementing local and national campaigns to ensure known solutions are used to address particular safety needs

·· Building capacity systematically and sustainably through education and local adaption to support the adoption of patient safety practices – including the use of guidelines, standards and mechanisms to report and analyse adverse events

·· Learning from others experience through benchmarking and networking with exem-plar hospitals at a national and international level – adapting solutions to the local context

·· Building an informed culture with an emphasis on learning and accountability

EUROPEAN WORKSHOP ON RISK MANAGEMENT FOR PATIENT SAFETY12

New perspectives for patient safety in the EU – The European Network for Patient Safety and Quality of Care (PaSQ Joint Action) – Dr Jean Bacou

PasQ works to exchange knowledge and facilitate capacity building across europe on issues related to healthcare quality. the network provides an eU level platform for collaboration between the 27 Member states, international organisations and stakeholders. through its 61 partners, its objective is to support the implementation of the council Recommendation on Patient safety18 and to address changing perspectives on patient safety – in particular, growing awareness of the need to standardise practice and to harmonise quality improvement mecha-nisms. current areas of work include:

· the selection of safe clinical Practices for Patient safety to be implemented in 15 participat-ing Member states. these safe practices will be selected according to the following criteria: their transferability, efficiency, and the level of resources needed to implement them. the implementation of the safe practices will start in June 2013.

· Increasing understanding of different quality improvement systems in use across the eU.

Box three summarises future priorities for PasQ.

Box three: Future priorities for PaSQ

Further details on the work of PaSQ are available at: www.pasq.eu

·· creating a european exchange programme for quality initiatives

·· Work within the context of the eU Directive (2011/24/eU) on Patients’ Rights in cross-Border healthcare to support the implementation of the council Recommenda-tion on Patient safety

european poLicy initiativeS – SucceSSeS, prioritieS and

chaLLengeS

Distilling the lessons 13

Risk management in 6 EU countries: findings from the DUQuE project – Prof Rosa Sunol

the Deepening Understanding of Quality Improvement in europe project (DUQue) addresses the effectiveness of quality improvement systems in european hospitals. a european Frame-work Programme seven (FP7) funded project running from 2007 to 2013, its objective is to test whether organisational quality improvement and culture, professionals’ involvement, and patient empowerment are associated with the quality of care in european hospitals. It builds on an earlier european Framework Programme six project, MaRQuIs (Methods of assessing Re-sponse to Quality Improvement strategies), which investigated quality improvement strategies across the european Union19. DUQue uses a cross-sectional, observational design drawing on surveys and audits in nearly 200 randomly selected hospitals.

through nine partners in eight countries, DUQue has developed an innovative method for assessing quality management systems – the quality management systems index (QMsI) – and related themes such as governance, leadership, processes and improvements. the QMsI will fa-cilitate decision making through hospital and purchaser appraisal tools – providing an overview and synthesis on the effectiveness of quality and safety strategies in hospitals and departments.

Key findings related to risk management are shown in box four.

Box four: Key findings with an implication for risk management

Further details on DUQuE are available at: www.duque.eu.

·· the need to tackle variability remains a pressing issue within and between services

·· For example, in the care of patients suffering a cerebrovascular accident, data shows significant variation in the likelihood of a patient receiving a diagnostic ct or MRI scan within 24 hours and treatment with a platelet inhibitor within 48 hours

·· the care of patients with hip fracture also shows significant variation on such indices as the administration of prophylactic antibiotics within one hour prior to surgical incision and the extent to which patients are mobilised with 24 hours of surgery

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Managing quality and safety improvement in European hospitals: lessons from the QUASER project – Prof Naomi Fulop

QUaseR is also an FP7 funded project running from 2010 to 2013. Its aim is to explore relationships between organisational and cultural characteristics of hospitals and how these impact on clinical effectiveness, patient safety and patient experience in european countries. QUaseR brings together seven research partners over five countries supported by a stakeholder group from across the eU.

although many healthcare organisations in europe have a good understanding of basic quality strategies (such as Lean, six sigma and PDsa), there is less understanding of how to implement and sustain such interventions. Lead-ership, organisational culture, teamwork and organisational structures and processes are all critical in creating lasting change5. QUaseR explores these factors through an analysis of the national context in each country coupled with an in-depth study of 10 general hospitals (two in each participating country): drawing on data from 387 semi-structured interviews and 780 hours of observations over a one year period.

Initial findings are shown in box five.

Box five: Initial findings

Further details on QUASER are available at: www.ucl.ac.uk/dahr/quaser.

·· Quality improvement is largely at the margins of hospital priorities and routines

·· hospital approaches to quality improvement are dominated by a ‘project to project’ mentality rather than a systems-wide approach

·· the technical side of quality improvement (with its focus on tools and data) predominates over the infor-mal, political art (with its focus on changing attitudes, behaviours and cultures)

·· Governance, compliance and accountability are key drivers rather than learning and cultural change

·· Quality improvement is largely enacted through professional groups with limited patient and public involvement

·· there is wide variation in the nature of managerial and clinical relations in the five countries

·· Multi-level and hospital wide leadership systems for quality improvement are rare but vital

european reSearch on quaLity iMproveMent, patient Safety and riSk ManageMent – current practice and

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Distilling the lessons 15

Healthcare Risk Management: early results from a DNV scoping project – Eva Turk, Dr Anna Hayman Robertson, Stephen Leyshon

the objective of the healthcare Risk Management research is to understand how hospitals are engaging in risk man-agement at a system-wide level to improve patient safety. Running over the period 2012-13, the research combines a systematic literature review with three hospital case studies using semi-structured, in-depth interviews in two coun-tries (norway and the UK). the study focuses on risk assessment as an example of one element within risk manage-ment. In case one, staff were selected from a specific patient pathway. In cases two and three, staff were selected from two clinical units in each hospital. In all three case studies, all respondents were selected to represent different roles and depth of experience (including staff with clinical contact, managers, and ancillary and administration staff). the main findings are summarised in box six.

Box six: Main findings and conclusions

Further details on DNV’s patient safety research can be found at: www.dnv.com/patientsafety

·· although the publication rate on risk assessment methods in healthcare has increased in the last 20 years, the literature remains at a largely descriptive level

·· Where there is empirical work on systems-wide risk assessments within the literature, clinical staff voiced concern about validity, reliability, impact and user-friendliness

·· there is evidence of variable maturity in system-wide risk management processes within and across the hospitals that formed the case studies

·· In comparison, individual patient specific risk assessments are common (e.g. asa scores)

·· Frontline staff frequently discussed patient safety issues (including identifying problems in reducing harm) but were less clear on their role in, or potential impact of, system-wide risk management in improving quality and the patient experience

·· this was compounded by a disconnection between senior management and frontline staff in some of the hospitals in the case studies

·· there is also evidence that healthcare is a hypercomplex system and that this may be a factor in why healthcare struggles to achieve the same level of safety improvement that other sectors have achieved

·· hypercomplexity should not be seen as an excuse for not attempting to improve quality and safety but, rather, highlights the importance of mapping processes and addressing human and organisational factors in any quality improvement approach (including risk management)

european reSearch on quaLity iMproveMent, patient Safety and riSk ManageMent – current practice and

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the workshop was an opportunity for interaction and reflection between policy makers, patient representatives, researchers and professional groups. the presentations and discussion throughout the day highlighted that interven-tions at the local, national and international level are having an impact on patient safety and that there is a vibrant patient safety community working across nations.

In addition to highlighting areas of impact, the workshop also identified examples of where patient safety faces a number of critical challenges in the coming years. these challenges can be divided into two broad areas: those specific to risk management for patient safety, and those of a broader quality improvement nature (table one). Keeping with the aim of the workshop, this section concentrates on the former.

tackLing riSk at a SySteM LeveLhealthcare is delivered through a series of interacting clinical (micro), organisational (meso), and regional/nation-al/international (macro) systems. as the DUQue research demonstrates, variability and vulnerability continue to be problems as patients move within and between these. Improving reliability within and across systems is a core ambition of healthcare quality improvement as a means to reducing patient harm20.

experience from other safety critical sectors suggests that improvements can be achieved through mapping processes (including how processes connect) 21, identifying and assess-ing risks, establishing controls and continuously monitor-ing to evaluate their efficacy22. healthcare has begun to develop a similar evidence base. For example, data from the MaRQuIs project suggest that hospitals “… that have either ISO certification or accreditation [i.e. processes that build in the identification, assessment and management of risk within systems] are safer and better than those which have neither …”23.

coMpetence in the poLiticaL arta finding of the QUaseR research is that the technical side of quality development needs to be augmented by inclusion of the informal, political ‘art’ of improvement to ensure

that organisational attitudes, behaviours and cultures are adequately addressed. the introduction of patient safety initiatives without attending to these factors is a recipe for failure24. Risk management is a means to create this balance as it provides a formal structure to consider the human, technical and organisational factors that intersect to affect the likelihood and consequences of harm.

education for changeclinicians and managers have a critical role to play in advancing risk management and patient safety. Reflection on the W.h.o.’s experience of developing international pa-tient safety campaigns identifies that it is essential to build workforces that have the competence to initiate, enact and embed change in order to achieve an informed culture of practice (table two).

the QUaseR research found that multi-level and hospital wide leadership systems for quality improvement are rare but vital. Patient safety and risk management are now embedded in some aspects of the nursing and medical cur-riculum in some countries, but progress in building capacity and understanding of risk management and patient safety remains slow. there is a need both for more specialists in the area and more understanding of risk management amongst health professionals of all disciplines if the value of risk management in healthcare is to be realised.

perSon-centred carethe commission’s review26 of the 2009 council recommen-dations on patient safety27 identified the need to develop initiatives that particularly address care outside of hospital. this reflects the realities of the patient experience as they move across boundaries and as health economies around the world aim to integrate primary, secondary and tertiary services in the pursuit of person-centred care28 29 30 31. the use of process mapping (an element of risk management that establishes the context of the patient’s experience) has the potential to increase safety by detailing and tracking risks along patient pathways and across primary, secondary and tertiary health and social care boundaries – thus en-abling the design of appropriate controls to minimise harm.

reflections on the workshop – distilling the lessons

Distilling the lessons 17

chaLLengeS Specific to riSk ManageMent for patient Safety

chaLLengeS of a broader quaLity iMproveMent nature

·· tackling risk at a system level – mapping processes to identify and act on system vulnerability and variability

·· the technical side of quality improvement needs to be augmented by more focus on the informal, political ‘art’ of improvement to ensure that organisational attitudes, behaviours and cultures are adequately addressed

·· Promoting education for change so that every mem-ber of the healthcare workforce is engaged in and has ownership of, as well as the competence to con-tribute to, the assessment and management of risk

·· Person-centred care – moving away from thinking of risk in terms of isolated service silos to reflect the realities of patient experience (and therefore the potential for harm) as they transition within and between primary, secondary and tertiary health and social care

·· the role of patients and citizens in advocating for patient safety improvements – empowering patients and the public to push for improvement in health services safety

·· Measurement of safety – moving from the current focus on harm as a proxy indicator towards measur-ing safety through controls

·· Documenting the economic cost of harm to support political prioritisation

·· Rationalisation, standardisation and harmonisation of procedures and accreditation – both across or-ganisations to ensure integration of care and across countries as patients exercise their right to cross-bor-der healthcare within the eU

table one: challenges for (a) risk management for patient safety and (b) broader quality improvement distilled from the workshop presentations and discussion

a reporting cuLture

creating an organizational culture in which people are prepared to report their errors and ‘near misses’. as part of this process data needs to be analysed and fed back to staff to ensure action is taken to reduce risk

a fLexibLe cuLture

one which respects the competencies of ‘front-line’ staff and which allows control (combined with support) to pass to experts closest to the patients

a juSt cuLture

an organization where people are clear on acceptable and unacceptable levels of behaviour. a culture where there is an atmosphere of trust and accountability, rather than an absence of blame, in which procedures are in place to identify and remedy poor performance

a Learning cuLture

a culture where there is a willingness and competence to draw appropriate conclusions from risk management and safety-related information systems, together with a will to implement reform

table two: the essential elements for an informed culture of practice24

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where next?all over the world health care workers are proving that patient safety can be greatly improved and many complications or harm events that were previously considered unavoidable can be prevented: they are redefining what is acceptable in terms of patient safety32. Despite this patients are still harmed and improvement is still needed. the presentations and discussion during the workshop reinforced the need to continue de-veloping safety management in healthcare, i.e. the creation and refinement of systems to prevent accidents, injuries, and other adverse occurrences33.

Risk management is a core part of that process. It cannot solve all problems or prevent all future harm but it can help organisations to understand and improve their systems and processes. Dnv will continue to work with others to support this and is committed to hosting future forums to move the evidence and dialogue forward.

conclusionsPatient safety has much to be proud of but needs to transform if it is going to achieve the improvement in care that is still needed. the focus at present is largely on develop-ing interventions to increase reliability at individual points in a care process. this has been entirely reasonable as an initial approach. however, the field needs to mature from an emphasis on piece-meal evolution and intervention to trying to improve systems through purposeful design and specification of standards along care pathways. Patient safety and quality improvement will have to move to a deeper understanding of underly-ing safety issues and on building reliability and resilience into the fabric of the healthcare system. Risk management offers one potential way to achieve this and to create patient safety at a system level by providing a structure to map, assess and address human, technological and organisational factors.

Distilling the lessons 19

Photo: nina eirin Rangoy

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appendix one: workshop participation

individuaLS froM the foLLowing organiSationS took part in the workShop:ec Directorate General health and consumers; W.h.o. europe; Joint action for Patient safety and Quality of care (PasQ); european hospital and healthcare Federation (hoPe); european Patients’ Forum (eFP); standing committee of european Doc-tors (cPMe); european Union of Medical specialists (UeMs); european health Management association (ehMa); european Union of Private hospitals (UehP); national school of Public health, Management and Professional Development, Romania; semmelweis University; czech Ministry of health; QUaseR/University of stavanger, norway; Danish health and Medicines agency; Federal Public service (health, Food chain and environment), Belgium; Berlin chamber of Physicians; Mission of nor-way to the eU; Ministère des affaires sociales et de la santé (DGos), France; norwegian Knowledge centre for the health services; austrian Ministry of health; QUaseR/University college London, UK; DUQue/avedis Donabedian Research Institute, Universitat autonoma Barcelona, spain; Imperial college London, UK.

Please note: the views expressed in this report are those of the authors and do not necessarily reflect the position or policy of any individual participant or organisation.

Distilling the lessons 21

appendix two: workshop programme

10:00-10:05 Introduction (stephen Leyshon, Deputy Programme Director, Dnv healthcare Research and Innovation and Workshop chair)

10:05-10:10 Welcoming remarks (Dr Rune torhaug, Managing Director Dnv Research and Innovation)

10:10-10:30 opening remarks: an overview of the european commission’s work and priorities in relation to risk management for patient safety (Katja neubauer, Deputy head of Unit, healthcare systems, Director-ate General health and consumers, european commission)

10:30-11:10 Keynote: W.h.o. Patient safety (Dr valentina hafner, Programme Manager, health care Quality, W.h.o. Regional office for europe)

11:10-11:30 healthcare risk management: early results from a Dnv scoping project (eva turk, Dr anna hayman Robertson and stephen Leyshon, Dnv healthcare R&I)

11:30-11:40 coffee and networking

11:40-12:00 setting the context of current eU patient safety/quality improvement activity: the Joint action on Patient safety and Quality (Dr Jean Bacou, Joint action for Patient safety and Quality of care and advisor for International affairs and Patient safety, French national authority for health – has)

12:00-12:20 Risk management in 6 eU countries: findings from the DUQue project (Prof Rosa sunol, Director, ave-dis Donabedian Research Institute, Universitat autonoma Barcelona)

12:20-12:40 Managing quality and safety improvement in european hospitals: lessons from the QUaseR project (Prof naomi Fulop, Professor of healthcare organisation and Management, Department of applied health Research, University college London)

12:40-12:50 Morning conclusion – drawing together key points and setting scene for the afternoon (Dr Morten Pytte, Programme Director, Dnv healthcare Research and Innovation)

12:50-13:50 Lunch

13:50-15:05 Parallel group-work:• Moving from prescriptive to performance based risk management in healthcare • the role of patients in system risk management • the implications of the implementation review report of the eU council

recommendations on patient safety • Risk management for quality improvement and high reliability in healthcare

15:05-15:15 coffee and networking

15:15-16:25 Feedback from group-work and plenary discussion (facilitated by Prof. charles vincent, Professor of clinical safety Research, Imperial college London and event rapporteur)

16:25-16:35 coffee and networking

16:35-17:00 summation address (Prof charles vincent, Professor of clinical safety Research, Imperial college Lon-don and event rapporteur)

17:00-17:15 closing address (Ketil Djønne, vice President, external affairs, Dnv)

EUROPEAN WORKSHOP ON RISK MANAGEMENT FOR PATIENT SAFETY22

references1 vincent c (2006) Patient safety London: elsevier2 amalberti R, Benhamou D, auroy Y and Degos L. (2011)

adverse events in medicine: easy to count, complicated to understand, and complex to prevent Journal of Biomedical Informatics 44 (3) 390-394

3 Leape LL and Berwick DM (2005) Five years after to err is human: what have we learned? JaMa 293 2384-2390

4 Dixon Wood M, Mcnicol s and Martin G (2012) evidence: overcoming challenges to Improving Quality – Lessons from the health Foundation’s Improvement Programme evaluations and Relevant Literature London: the health Foundation

5 the health Foundation (2012) Using safety cases in industry and health care London: the health Foundation

6 health and safety executive (1975) the Flixborough Disaster: Report of the court of Inquiry London: hMso

7 the hon Lord cullen (1990) the Public Inquiry into the Piper alpha Disaster – volumes I & II London: Department of energy

8 Provonost PJ, Berenholtz sM and Morlock LL (2011) Is quality of care improving in the UK? Yes, but we do not know why BMJ 342 (12 February) 341-342

9 Design council (2003) Design for patient safety: a sys-tem-wide design-led approach to tackling patient safety in the nhs London: Department of health

10 hollnagel e (2012) Proactive approaches to safety manage-ment London: the health Foundation

11 shortell sM and singer sJ (2008) Improving patient safety by taking systems seriously JaMa 299 (4) 445-7

12 the Mid-staffordshire nhs Foundation trust Public Inquiry (chaired by Robert Francis Qc) (2013) Report of the Mid-staf-fordshire nhs Foundation trust Public Inquiry volumes 1-3 London: the stationery office – available at: www.midstaffs-publicinquiry.com/report

13 Iso (2009) Iso 31000:2009 Risk Management – Principles and Guidelines Geneva: Iso – available at: www.iso.org/iso/home/standards/iso31000.htm

14 Who (2008) Global Priorities for Research in Patient safety Geneva: World health organisation

15 Leyshon s (2005) Principles of risk management in community nursing BJcn 10 (7) 330-333

16 eU council (2009) council Recommendation (2009/c 151/01) on Patient safety Brussels: eU council – available at: www.ec.europa.eu/health/patient_safety/docs/council_2009_en.pdf

17 eU commission (2012) Report from the commission to the council on the Basis of Member states’ reports on the Imple-mentation of the council Recommendation (2009/c 151/01) on Patient safety Brussels: eU commission – available at: www.ec.europa.eu/health/patient_safety/docs/council_2009_report_en.pdf

18 eU council (2009) op. cit.19 sunol R, vallejo P, thomson a, Lombarts MJMh, shaw cD

and Klazinga n (2009) Impact of quality strategies on hospital outputs Quality and safety in healthcare 18 (suppl I) i62-i68

20 the health Foundation (2011) evidence scan: high reliability organisations London: the health Foundation

21 Bowen De and Youngdahl W (1998) ‘Lean’ service: In defense of a production line approach International Journal of service Industry Management 9 (3) 207-225

22 Berstein PL (1996) against the Gods: the Remarkable story of Risk new York: Wiley and sons

23 shaw c, Groene o, Mora n and sunol R (2010) accreditation and Iso certification: do they explain differences in quality management in european hospitals? International Journal for Quality in health care 22 (6) 445-451 p: 449

24 Dixon-Woods M, Bosk cL, aveling eL, Goeschel ca, Pron-ovost PJ (2011) explaining Michigan: developing an ex post theory of a quality improvement program Milbank Quarterly 89 (2) 167-205

25 adapted from: clinical Governance support team (2003) Risk management: the strategic leadership of clinical governance in Pcts – a learning resource for the members of Pct Boards and Pecs 2nd edition Leicester: nhs Modernisation agency

26 eU council (2009) op. cit.27 eU commission (2012) op. cit. 28 UnFPa and helpage International (2012) ageing in the

twenty-first century: a celebration and a challenge new York: UnFPa

29 clements B et al (2012) the economics of Public health care Reform in advanced and emerging economies Washington, Dc: International Monetary Fund

30 ham c, Dixon a & Brooke B (2012) transforming the Delivery of health and social care – the case for Fundamental change London: King’s Fund

31 ham c and curry n (2011) Integrated care – What is it? Does it Work? What does it mean for the nhs? London: King’s Fund

32 nPsa (2008) the ‘how to Guide’ for Leadership for Patient safety London: nPsa – available at: www.patientsafetyfirst.nhs.uk/ashx/asset.ashx?path=/how-to-guides-2008-09-19/Leadership%201.1_17sept08.pdf

33 national Library of Medicine (2013) Mesh Descriptor Data: safety Management – available at: www.nlm.nih.gov/cgi/mesh/2013/MB_cgi

Distilling the lessons 23

risk management in healthcare In collaboration with independent patient safety experts and healthcare provider organisations, we are adapting, refining and testing methods for system level risk management already used by Dnv in other sectors so that they are suitable for healthcare settings. the priority for 2013 will be on the development of safety cases in healthcare and methods for assess-ing and influencing organisations’ safety culture – addressing the ‘softer’ issues underpinning quality improvement.

system knowledge of healthcare from a risk perspectiveWorking with independent experts in the field of analytics, we are ex-ploring how automated data capture and analysis can be better used to inform healthcare providers of their risks, thus enabling the creation of more valid, reliable and cost efficient controls.

person-centred careconcerns over the sustainability of healthcare coupled with its well-rec-ognised poor safety record are leading patients, policy makers and providers to look for new models of care delivery. In collaboration with independent experts in the fields of patient safety and health policy, we are examining how risk management solutions can support the adoption of person-centred care models.

Dnv’s healthcare Research and Innovation Programme addresses the important issue of reducing harm in healthcare: an example of how Dnv contributes to safeguarding life. In achieving this, the emphasis is on how healthcare and other safety critical industries can share learning for their and society’s mutual benefit.

in 2013 the programme will focus on three key areas where dnv’s 150 year experience can be used to reduce harm:

More information on Dnv’s healthcare Research and Innovation Programme is available here: www.dnv.com/patientsafety

EUROPEAN WORKSHOP ON RISK MANAGEMENT FOR PATIENT SAFETY24

Det noRsKe veRItas asReseaRch & InnovatIonno-1322 høvik, norway I tel: +47 67 57 99 00 I Fax: +47 67 57 99 11www.dnv.com