THE WINSTON CHURCHILL MEMORIAL TRUST OF AUSTRALIA

2003 Churchill Fellowship

Report by - Kathy Daffurn

To study patient safety with particular reference to clinical governance and risk management

I understand that the Churchill Trust may publish this report, either in hard copy or on the intranet or both, and consent to such publication. I indemnify the Churchill Trust against any loss, costs or damages it may suffer arising out of any claim or proceedings made against the Trust in respect of or arising out of the publication of any report submitted to the Trust and which the Trust places on the website for access over the internet. I also warrant that my final report does not infringe the copyright of any person, or contain anything which is, or the incorporation of which into the final report is, actionable for defamation, a breach of any privacy law or obligation, breach of confidence, contempt of court, or passing-off or contravention of any other private right or any law. Signed Dated …………………………………………………………………………………………………………………

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INDEX Page number Acknowledgements 3 Abbreviations 5 Program Overview 6 Professional Program 7 Introduction 10 The Commission for Health Improvement 10 Clinical Governance 11 National Patient Safety Agency 15 Sheffield Teaching Hospitals 18 Scotland 18 Risk Management 21 Conclusions 24 Organisations visited 25 References 27 Useful Websites 27

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Acknowledgements My sincere thanks to the Churchill Trust for providing me the opportunity to travel overseas and study aspects of patient safety. The ongoing support and encouragement offered to me following the announcement of the 2003 Fellows has been just wonderful. It was an honor to be the recipient of a Churchill Scholarship and I encourage many other nurses to consider the rewards that being a Churchill Fellow can offer. Acknowledgments also to the staff of the institutions and organizations that I visited: To the staff of Commission for Health Improvement (CHI) in the United Kingdom, for making my 4-week experience within their organisation enjoyable and fruitful. I came to admire from the very outset their efficiency, a willingness to share their knowledge and their commitment to the ethos of CHI - all this under an uncertain future with the establishment of 'new CHAI' (The Commission for Health Audit and Inspection). In particular Amanda Squires (Quality Manager) and Anna Stokes (Learning and Development Administrator) who organised my program and ensured that I was comfortable and that my learning needs were met; also, Donna Boreham-Downey, Lorraine Foster, Jan Norman and Margaret McGlynn (Review Managers), Liz Fradd (Director of Nursing/Lead Director for CGRs), Andrea Groom (Assistant Director for CRGs), Richard Hamblin (Assistant Director Office for Information on Health Care Performance), Annika Hellner (Communications Officer), Joanne Hunter (Senior Manager, Operations and Quality), Emilie Roberts (Project Officer, CG Models), Amanda Squires (Quality Manager), Anna Sue Ward (Assistant Director for CGRs), Heather Wood (Investigations Manager), Karen Wright (Head of the Quality Improvement Team). From the National Patient Safety Agency: Jane Carthey (Assistant Director Patient Safety), Bruce Madge (Assistant Director Patient Experience and Public Involvement), Janice Miller and Miranda Nathan (Personal Assistants), Joanne Parker (Assistant Director Primary Care), Elaine Stevenson (Assistant Director of Modernisation, Older People). From Sheffield Teaching Hospitals: In particular my sincere thanks to Roy and Angela Brown (Senior Nurse Lecturers) for their kind hospitality and also for organizing my program in Sheffield; also Kate Bray (Critical Care Nurse Consultant, Sheffield Teaching Hospitals), Derek Bainbridge (Manager, ITU/HDU), Stella Langan (Manager/Matron, Critical Care Services, Northern General Hospital), Simon Richardson (Group Risk Management Advisor, Critical Care, Anaesthsia and Operating Theatres). From NHS Tayside Pat O’Connor (Risk Management Coordinator), Hilary Walker (Risk Management Coordinator), Philip Wilde (Project Manager). Ninewells Hospital Lynne Buttercase (Clinical Governance Facilitator), Jim Foulis (Clinical Skills Coordinator), Alison Moss (NHS Quality Improvement Scotland - Administrator), Fiona Paul (Specialist Liaison Nurse), Hazel Scofield (Patient Liaison Manager), Lesley

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Summerhill (Director of Nursing and Patient Services), Audrey Warden (Clinical Group Manager, Critical Care Clinical Group). From NHS Lothian Lothian Primary Care NHS Trust: John Donald (Referrals Advisor), Sue Gibbs (Clinical Effectiveness Manager), Dr Mike Winter (Medical Director). Royal Edinburgh Hospital Pat Murray (Chair, Clinical Risk Group), John Forrester (Risk Manager). Royal Hospital for Sick Children Annette Henderson (Clinical Effectiveness Manager, Women’s and Children’s Services), Dr Farida Hamza Mohammed (Trust Guideline Co-coordinator). The New Royal Infirmary of Edinburgh Alan Fisher (Trust ICP Facilitator).

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Abbreviations CG Clinical Governance CGR Clinical Governance Review CHI Commission for Health Improvement CHAI Commission for Health Audit and Inspection CRAG Clinical Resource and Audit Group CSBS Clinical Standards Board for Scotland NHS National Health Service NPSA National Patient Safety Agency NSF National Service Frameworks NICE National Institute for Clinical Excellence LPCT Lothian Primary Care Trust PCT Primary Care Trust QIS Quality Improvement Scotland QiT Quality Improvement Team SIGN Scottish Intercollegiate Guidelines Network SHA Special Health Authority SHB Special Health Board

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Program Overview Name: Associate Professor Kathy Daffurn Position: Co-Director (Nursing), Division of Critical Care, Liverpool Health Service.

Clinical Conjoint, University of Western Sydney.

Address: Locked Bag 7103 Liverpool BC NSW 1871 Australia

Contact Details: Phone 61 2 9828 3414

Fax 61 2 9828 3577 Email: Kathy.Daffurn@swsahs.nsw.gov.au

Fellowship Objective: The aim of my fellowship was to spend 4 weeks with the Commission for Health Improvement (CHI) in London, and also visit National Health Service (NHS) Hospital and Primary Care Trusts in England and Scotland. I was also able to visit the NHS National Patient Safety Agency. I was primarily interested in finding out about patient safety in the NHS with a particular emphasis on clinical governance and risk management structures and strategies. Fellowship Highlights: I had many highlights during my 6-week visit to the United Kingdom. My knowledge and understanding of clinical governance and risk management has increased immeasurably. I hope to be able to transfer the information that I have gained to establish improved patient safety strategies within my own Area Health Service. I met some amazing and motivated people and hope to keep in touch and to share ideas over the next few years through what will be an enormously challenging era for health. As many ‘fellows’ before me, I was also able to take the opportunity to combine study with some very enjoyable social activities. One amusing highlight of my visit was during my trip to Gateshead with two CGR managers from CHI. On checking into the hotel and because I was a visitor from Australia the hotel manager gave me a complimentary upgrade to a ‘theme’ room. The upgrade offered the choice of an Arabian, Hollywood or Wild West Room. I choose the Arabian room and what a room it was, the décor was truly amazing – I expected Lawrence of Arabia to appear at any minute. Who knows what surprises would have been in store if I had chosen the Wild West Room?

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Professional Program: Date Activity/visit Personnel Involved Relevance to project 31/11 Travel to London 1&2/12 Free time in London

Locate CHI

3/11 Induction to CHI Interviews with key personnel

Learning & Development Administrator Pre Review Team Manager Head, Quality Improvement Team (QIT)

Trust reviews, methodology Work of QiT and project introduction

4-6h/11 Travel to Newcastle and involvement in stakeholder interviews as part of the review Gateshead PCT

Fourteen interviews at three sites in Gateshead Observed review process to gain an understanding of issues affecting the various stakeholders and also the recording and coding of interview responses

7/11 National Patient Safety Agency Interviews with key personnel

Assistant Director, Older People Assistant Director, Patient Experience and Public Involvement Assistant Director, Patient Safety Assistant Director, Primary Care

Overview of the role of the NPSA Patient experience and public involvement Safety Solution development

8/11 Free time Organise travel to Beverley

9-14/11 Travel to Beverley (Sunday) Observed review process of Yorkshire Wolds and Coast PCT

(i) Evening meeting with review team (ii) Interviews conducted over three days at Withernsea Community Hospital, Hornsea Cottage Hospital, Hedon GP Practice, Executive Offices of the PCT at Beaver Lodge, Westwood Community Hospital (Beverley), Community Pharmacy and Private Optometry Practice. Around 120 interviews were conducted; I was involved in 23. (iii) Feedback of the interviews occurred every evening from around 6pm to 8pm (iv) Presentation by individual reviewers to rest of review team on their impressions and findings from the interviews evidence tables occurred on day four (iv) Scoring of PCT with sign off by whole review team occurred on the morning of day five

To gain an understanding of the review process, important aspects of clinical governance, documentation and coding of interview responses, the role of the ‘analysts’

15-16/11 Free time Research and commence preparation of presentation to QiT and project report

Own study Research various methods of hospital accreditation

17/11 Interviews with key personnel Return to CHI Reading time CHI documents Continue preparation for presentation to QiT

Senior Manager, (Operations and Quality), Chair, Quality Manual Group Assistant Director for CGRs Review Manager

Quality manager role, discussion on review week, presentation to QiT Strategies to improve clinical governance of trusts which receive poor rating Risk management models

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Date Activity/visit Personnel Involved Relevance to project 18/11 At CHI for study time and interviews with key

personnel Attend staff presentation

Investigations Manager Chair, CHAI

The process for initiating and managing service failures Role of CHAI, a new role and vision, shape structure and scope of new organisation, current progress including barriers

19/11 Free time Organise travel to Scotland

20/11 Study time Prepare presentation to QiT members

Own study Comparison of 'standards' vs. CHI approach to health system review

21/11 Reading/putting together report Interviews with key personnel CHI

Communications officer Project Officer CG models

CHI communication process and how ensuing reports are disseminated CG models

22-23/11 Free time

25/11 Report writing, review information collected throughout CHI experience Interview key personnel

Assistant Director, Office for Information on Health Care Performance

Information management models

26/11 CRG training Meeting with Head of QiT

Review Managers and QiT

CHI Review process Overview of CHI program and whether expectations met

27/11 Travel to Sheffield Lecturer in Critical Care, University of Sheffield,

Opportunities for training for nurses Risk management models Organisational models for critical care

28/11 Visits to ITU/HDU Rotherham District General Hospital and Northern General Hospital Interviews with Discussions with key personnel

Manager ,ITU Anaesthesia Consultant, ITU (unavailable for interview) Outreach Sisters Senior Nurse Lecturer Group Risk Management Advisor, Critical Care, Anaesthesia Operating Services Manager/Matron Critical Care Services, NGH

Discussion re: clinical governance and risk management training for clinical staff and also risk management models

29-30/11 Free time and travel to Scotland

1/12 Travel to Dundee Visit to Ninewells, ICU Interviews with key personnel

Clinical Group Manager, Critical Care Clinical Group Specialist Liaison Nurse

Overview of organisational structure NHS Tayside Role of Specialist Liaison Nurse and discussion regarding medical emergency team

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Date Activity/visit Personnel Involved Relevance to project 2/12 Ninewells Hospital

Meeting with clinical governance team Presentation and discussion of clinical governance structure

Clinical Governance Facilitator Administrator, Quality Improvement Scotland Patient Liaison Manager

Role of team members Overview of clinical governance structure, achievements and future directions

3/12 Attend clinical governance awards Director of Nursing and Patient Services Key Note Speech by the Very Reverend Graham Forbes, Provost St Mary’s Cathedral, Edinburgh

Examples of Clinical Governance achievements, 6 verbal and 10 poster presentations

4/12 Kings Cross Hospital Meeting with key personnel

Head of Risk Management Project Manager Risk Management Co-coordinator Director of Nursing and Patient Services

Risk management model, SMART IT System, future visions, achievements and risk management register Current and proposed structures NHS Dayside and Nursing Strategy

5/12 Write up notes and free time

6-7/121 Report preparation and free time

9-10/12 Overview of visit to NHS Lothian Meeting with key personnel

Lothian Primary Care NHS Trust Clinical Effectiveness Facilitator Referrals Advisor, Lothian PCT Medical Director, Lothian PCT Lothian University Hospitals NHS Trust Clinical Effectiveness Manager, Women’s and Children’s Services Trust Guideline Coordinator

Informal session with the Clinical Governance Support Team Developing and implementation of Clinical Guidelines in Lothian A medical director’s view of the world Overview of clinical governance and risk management Implementing Guidelines

11/12 Visit to Stevenson House LPCT Meetings with key personnel New Royal Infirmary of Edinburgh, Little France Meeting with key personnel

Clinical Governance Manager Chair, Clinical Risk Group Risk Manager Trust Integrated Care Pathways Facilitator

Overview of structures, strategies and implementation of clinical governance within LPCT Role of NHS Quality Improvement Scotland Links to NHS Lothian Developing and Implementing Integrated Care pathways

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Introduction: Patient safety, clinical governance and risk management are particular challenges facing the Australian health system. Research reports conducted in 1995 have estimated up to 14,000 preventable deaths occur in Australian hospitals each year. Reports from other countries are similar with estimations that 850,000 incidents harm or nearly harm inpatients in the United Kingdom (UK). This includes 22,000 preventable deaths1. In response to these problems the UK introduced a series of reforms to improve the quality of care in the National Health Service ( NHS). The establishment of the Commission for Health Improvement and a number of Special Health Authorities (SHA), the NHS National Patient Safety Agency and the NHS Modernisation Agency supported the reforms. My fellowship allowed me to spend 4 weeks with CHI and also allowed me to visit a number of health facilities in England and Scotland to explore the reforms that had been introduced. I was particularly interested in the ‘clinical governance movement’, risk management models and the role that CHI played in the clinical governance review of all Health Trusts. The Commission for Health Improvement: The Commission for Health Improvement (CHI) was established under the Health Act (UK) in 1999, independent2 of the NHS. Its major aim was to address unacceptable variations in patient care with specific directives to look at standards and quality. It used a developmental approach to support the NHS to continuously improve. CHI’s four statutory functions were:

o A rolling program of clinical governance reviews of every Health Trust in England and Wales3.

o Monitoring and review of how the NHS met the recommendations of National Service Frameworks4 (NSF) and National Institute for Clinical Excellence (NICE) clinical guidelines.

o Investigations into serious service failures in the NHS and to advise and support NHS investigations and inquiries.

o Leadership by collecting and sharing notable practice in the NHS and guidance on running NHS investigations.

The Commission for Health Audit and Inspection: A new organisation, The Commission for Health Audit and Inspection (CHAI) has been established and is expected to begin operating on April 1st 2004. A number of organisations or sections of organisations including CHI are “being abolished or tinkered with to make up the new CHAI”. These are the Audit Commission’s Value for Money Section and the National Care Standards Commission’s Private and Voluntary Care Section. The Mental Health Act Commission will be incorporated as part of the new organisation in 2005. 1 NHS, Seven Steps to Patient Safety: A Guide for NHS Staff, National Patient Safety Agency, 2003. 2 CHI works closely with the Department of Health, but operates independently from it. 3 Scotland has its own regulatory body, Quality Improvement Scotland. 4 A rolling program of National Service Frameworks (NSF) was launched in 1998 with the Calman Framework for cancer services.

The frameworks set standards for a defined service or care group. Other frameworks, which have been developed, are those for coronary heart disease, older people, and also for mental health. CHI reviews of these frameworks are planned for 2004/2005.

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“the new organisation seeks to ensure improvement in the delivery of health care…………………….. patients think it is a good idea”

The new organisation is being established to support radical changes to the regulation of health care, which CHI cannot do, as it is hampered by its legislative mandate or as some referred it to, its “statutory corset”. CHAI will be the single inspectorate for the NHS and Private Sectors (Private Sector Licensing). Its brief extends to complaints and clinical standards. CHAI will have strong Analytical Centre with “enthusiasm for intelligent information, secured by a firewall and data that we will all trust”. At the time of my visit, a vision document for the new organisation had been released and comments were being sought. One of CHAI’s major aims is to be known and recognized for its reliability, trustworthiness and knowledge about the state of the nation’s health care. Clinical Governance: Clinical governance is described in the UK Governments White Paper ‘A First Class Service5, as

“a framework through which NHS organisations are accountable for continuously improving the quality of their services and safe guarding high standards of care by creating an environment in which excellence in clinical care will flourish”.

It is considered that sound clinical governance6, will effectively ensure: o Continuous improvement of patient services and care, o A patient centered approach that includes treating patients courteously,

involving them in decisions about their care and keeping them informed, o A commitment to quality, which ensures that health professionals are up to

date in their practices and properly supervised where necessary, o The minimisation of clinical errors and the commitment to learning from

mistakes when they do occur.

Clinical Governance Reviews: Clinical governance encompasses an organisation’s systems and processes for monitoring services. A clinical governance review7 (CGR) aims to test whether clinical governance arrangements are effective. The review also identifies best practice and areas for improvement, it looks at the systems and processes for monitoring and improving services and whether they are working and making a difference to patient care. The report provided by CHI, gives the Trust an independent assessment of how well they are doing.

“they must have turned over ideas on how to improve the service” The seven components or ‘pillars’ assessed in a clinical governance review are, consultation and patient involvement, clinical risk management, clinical audit, research and clinical effectiveness, staffing and staff management, education, training and 5 Department of Health, A First Class Service: Quality in the New NHS, NHS Executive, 1988, UK. 6 Scaly G, & Donaldson J, The NHS's 50th Anniversary, looking forward, clinical governance and the drive for quality improvement

in the new NHS in England, British Medical Journal, 317:61-65, 1998. 7 CHI employs around 55 review managers who normally conduct up to 3 reviews per annum.

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continuing development and also the use of information about the patient’s experience, outcomes and processes. Each ‘pillar’ is assessed using six key themes; accountability and structures, strategies and plans, application of policies, quality improvement and learning, resources and training for staff and performance indicators.

Each ‘pillar’ is scored on a four-point scale. Two additional areas, strategic capacity and patient experience8 are assessed but not scored, as there is currently no rigorous evaluation method for scoring these components. A review takes 24 weeks to complete, which includes report publication 9. Reviews of all Acute, Ambulance and Learning Disability Trusts are now complete. Reviews of Primary Care Trusts are currently under way10.

The review process comprises 4 key phases. A team of senior health executives and consumers form the review team. A number of information ‘analysts’ and administrative personnel support them. Phase one (15 weeks): Pre visit preparation This phase involves the Trust collecting and providing relevant information, which includes strategy documents and a staff survey implemented as part of the review. This initial information is distilled and fed back to the Trust Executive by the CGR team. During this feedback session, the Trust is given the opportunity to present corporate plans, indicate its strengths and weaknesses and discuss future strategies. Phase two: Stakeholder interviews The CGR manager conducts stakeholder interviews over three days at sites within the Trust boundaries. The interviews aim to document evidence of patient and stakeholders dealings with the Trust, which is used to support recommendations in the final CGR report. In essence the interviews are designed “to determine whether the Trust is doing what it says it is”. Stakeholders interviewed include health economy partners, social services and district auditors, local voluntary agencies, staff from local acute, mental health and ambulance Trusts, patients11 and other service users and carers. It is usual for up to 20 stakeholder interviews to be conducted. Phase three: review week Review week occurs over four and a half days. More than 100 interviews and observational visits are conducted. Information provided is confidential and ‘non-attributable’. However if a serious issue is raised, the interviewee is advised that this information will be fed back to the Trust Executive.

8 The approach to assessing clinical governance in relation to patient experience involves clinical effectiveness, access to services,

organisation of care, humanity of care and environment. 9 A review looks at patients and carers, clinical teams and corporate strategy; it does not assess individuals or examine every service

area. 10 By September 2003, 317 clinical governance reviews had been conducted. 11 General practitioners are provided with a standardised letter to send to nominated patients to contact CHI with a view to discussing

their interest in being involved in the interviews.

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Using evidence collected from all phases of the review, the Trust is assigned the four point score on each of the seven ‘pillars’ as follows:

(i) Little or no progress at strategic and planning or at operational level (ii) a)Worthwhile progress and development at operational level but not at

strategic level and planning level OR b)Worthwhile progress and development at operational level but not at strategic planning level OR c)Worthwhile progress and development at strategic and planning and at operational level, but not across the organisation

(iii) Good strategic grasp and substantial implementation. Alignment of activity and development across the strategic planning levels and operational leave of the Trust

(iv) Excellence – coordinated activity and development across the organisation and with partnership organisations in the local health community that is demonstrably leading to improvement. Clarity about the next stage of clinical governance

I was provided with an opportunity to be involved in stakeholder interviews as part of the Gateshead Primary Care Trust CGR, and also in the review week of the Yorkshire Wolds and Coast Primary Care Trust CGR. Primary Care Trusts (PCTs) were introduced under the Health Act (UK) 1999 and were established in successive annual waves commencing in April 2002. They provide primary and community health care and commission services for populations ranging from 120,000 to 160,000 people. Primary Care Trusts include, GP and dispensing practices, GP branch surgeries, community pharmacies, registered opticians, registered dental and optometry practices, other dental access centres and mobile dental units and a range of community health clinics. They have a number of responsibilities which include improving the health of the their population, integrating and further developing primary care services, providing community services and commissioning secondary care services. It was an interesting experience. I was impressed by the rigor and consistency of the process. All recommendations have to be supported by evidence statements, which are obtained from the information provided by the Trusts, and also stakeholder and staff interviews. Information analysts external to CHI are contracted to manage the large amounts of facts and information provided. CRG reviews, emerging themes: In 2001 CHI contracted an external research team to examine completed CGR reports to identify emerging themes. Six major themes emerged:

o Policies and strategies not being implemented or partly implemented or ineffectively, “there is no rung from the top to the bottom nor across the organisation”. This can include national policies and legislative requirements.

o Organisations work reactively rather than proactively, i.e. responding to problems, incidents and events when they occur rather than doing risk assessments to identify and minimize the risk.

o A lack of organisational wide approaches to clinical audit with results seldom shared.

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o Lack of organisational wide systems to capture incidents. o In 80% of cases there is poor communication from strategic to operational level.

Some units will not report up and staff doesn’t always know who to report to. o There are “barriers of discipline and clinical area” i.e. between doctors and

nurses and nurses and allied health groups.

“put barriers around the care of patients and then they will fall through the gaps”

Additional themes, which are emerging from subsequent reviews, include the importance of strong leadership, issues of resourcing low priority services, poor organisational culture, and weak risk management systems. What have the CGRs achieved? There is mixed response to the CGRs. Some clinicians who work at the ‘bedside’ feel that nothing has changed. Others feel that the ‘clinical governance movement’ has created a strong response from management who appear to have shifted their focus from finances to patient safety and appear to have a greater understanding of their responsibilities. Some feel that reviews have been “the most single mover and shaker” of the health system. Impact stories include a nurse who was running 4 HDU beds and a number of other monitored beds by herself – after a CHI review the unit got more staff. One Acute Care Trust received a bad report – CHI went back 6 months later to find staff involved in building solutions and an organisational response to issues in the Emergency Department. Overall, from my observation, it would appear that the reviews have assisted NHS managers and organisations develop clearer lines of accountability, to improve and strengthen their risk management systems and also to improve methods of assessing clinical care. CHI Investigations: The Commission for Health Improvement also conducts investigations into service failures. An investigation can stem from a request by the Secretary of State or the First Secretary of the Welsh Assembly Government, from an individual or organisation or as result of concerns during a CGR. CHI receives from 100 to 200 requests for an investigation each month. Requests are initially assessed by the CHI General Inquiries and Screening Unit, followed by second stage screening where they undergo a standardized checklist. The assessment process takes into account whether an incident is of high severity, whether there is evidence of high-risk activity, if there are patterns of service failure, if a repeated service failure is not addressed or there is evidence of management or organisational failure beyond a single area or team12. The aim of the investigation is to establish the cause of the adverse events and systems failures, to help the organisation and the NHS learn lessons to improve patient care and to 12 A request may not under go a CHI investigation but may go forward as a ‘fast track CGR’. The CGR team would be requested to

look closely at a particular service or team.

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restore public confidence in the service. The investigative team is specialist based with similar membership to a CGR team. The information analyst is a permanent CHI employee and not contracted from outside contractors, as is the case for a CGR. The investigation differs from a CGR as the team is often probing into the unknown; they have a wider remit and can focus their investigations but also have the scope to look at broader areas of impact. The investigation often attracts increased publicity and invariably there is a greater chance of a legal challenge due to the serious nature of the investigation. All information is treated as confidential and is ‘non-attributable’ unless required by court order or by the police in connection with a serious offence. Eleven investigations and 12 fast track CGRs had been conducted at the time of my visit to CHI. The reports and are published on the CHI website. CHI’s Quality Improvement Team (QiT): CHI’s internal QiT comprises six quality managers. Each have a separate portfolio with the aim of improving both internal processes and also the process of the CHI reviews. The importance of consistency in the review process had been recognized and as a result, the QiT team with the assistance of a senior CGR review manager have developed a ‘Manual of Clinical Governance Review /Inspection’. The development of the manual has followed an embedded learning process. Concurrent with the manual development a series of ‘knowledge network signposts’, have also been written. The signposts guide CGR managers ‘what to look for’ when they are examining specific aspects of the Trust’s business. The sign posts cover areas such as the Caldicott Guidance, private finance initiatives in the NHS, The National Service Framework for Mental Health, the national survey for patients and staff, library services in the NHS, investors in people, integrated care pathways, independent sector diagnostic and treatment centers and community nursing Each ‘signpost’, provides a description of the topic, implications for CHI and also key sources and web links through which the CRG review managers and other reviewers may seek out further information. Communication Strategies: CHI has a very ‘slick’13 communication strategy for providing information on all aspects of a review. This includes information for the public, the Trust staff, the media and other relevant parties on the review process, inviting stakeholders to be involved, and also review outcomes. Review reports are distributed locally and are also accessible on the CHI website. National Patient Safety Agency: The National Patient Safety Agency (NPSA) is a Special Health Authority of the NHS, established in July 200114. It followed the publication of two patient safety reports

13 The dissemination of information follows a well-defined timetable articulated in a clear task log. 14 National Patient Safety Agency, Annual Report 2001-2002, The areas of policy that determine how the NPSA works are

Department of Health, Plan for England (July), ‘Priorities and Planning Framework 2003-2006, October 2002, Department of Health ‘Learning From Bristol, The Department of Health’s Response to the Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984-1995, (Command Paper 5207), June 2001., Department of Health, Building a Safer

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published by the Department of Health: An Organisation with a Memory (2000) and Building a Safer NHS for patients (2001). The NPSA has a number of statutory functions and aims to make patient care safer for all NHS patients, wherever they are treated by:

o Establishing and managing a national reporting system for adverse events and near misses

o Assimilating safety related information from other organisations o Designing solutions that prevent patient harm o Setting targets and monitoring progress o Promoting research into patient safety o Advising ministers and relevant others on patient safety issues o Promoting an open and fair culture in the NHS o Developing memoranda of understanding (MOU) with other key health care

organisations that have an interest or involvement in patient safety National Reporting and Learning System: The UK has set up a National Reporting and Learning System (NRLS). In an initial six-month pilot of the NRLS, twenty seven thousand incidents were reported from England and Wales. An electronic reporting form is currently under refinement. The NPSA expects that a robust system will be set up by 2005. Voluntary reporting by patients and staff will be encouraged. Reporting by staff is not meant to circumvent current risk management systems.

“ reporting trends of doctors and nurse are different, the challenge is to engage the disengaged”

The NPSA will also be working to actively collect and collate information on patient safety from all available sources15. Importantly the whole of the NHS will be able to use the information to learn from current mistakes and share information on a range of safety solutions. CHAI will look at trends from NPSA with the aim of understanding the risk to patient safety and to develop national priorities for the NHS including safety solutions. Safety Solutions: The NPSA works with many organisations towards designing and testing solutions where it is identified the patient is at risk. The safety solutions involve improving medication safety, reducing hospital acquired infection, improving safety for women and children, those with mental ill health or a learning disability and also doing the right thing to the right patient. The overall aim of this collaborative approach is to avoid duplication of effort and to share lessons learnt across the wider NHS. One notable project was the Potassium Chloride Patient Safety Alert. The risk to patient safety from incidents related to potassium chloride had been identified in research conducted in the UK and elsewhere. Forty incidents reported in the pilot of the NPLS had

NHS for Patients, London 2001., The Prevention of Intrathecal Medication Errors, A report to the Chief medical Officer’, April 2002, Improving Health in Wales, January 2001.

15 NHS, National Patient Safety Agency, Corporate Plan, 2002 - 2003.

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involved potassium chloride. In Australia following this alert, many hospitals changed their policies on the storage of intravenous potassium solutions and other management and practice issues. The NPSA have twenty-six major safety projects completed or underway, they include:

o Further reducing the risk of accidental spinal injection of vinca alkaloids such as Vincristine

o Identifying safe practices for the use of Methotrexate o The safe labeling and packaging for medicines in hospitals o Training and development in medication safety16 o Hand hygiene improvement o The safe use of infusion devices17 o The use of hip padding in the elderly18

In 2003 the NPSA published a guide for NHS staff titled Seven Steps to Patient Safety. Safety Officers: The NPSA has also employed 32 Patient Safety officers who are allocated to regions across England and Wales. The overall aim of this initiative is to add to the repository of information on projects, and initiatives to improve patient safety. The patient safety officers will be the “face of the NPSA” and are expected to work closely with Health Trusts and in particular local Patient Advice and Liaison Services (PALS). Patient Advice and Liaison Services have recently replaced Community Health Councils. The PALS service pre-empts patient complaints and then directs them to the Independent Complaints Advisory Service (ICAS) for investigation. Four project officers will target patient safety issues involving age, ethnicity, sensory deprivation and gender. Root Cause Analysis Training: In parallel to the roll out of the NRLS, the NPSA will also provide training and a tool kit in Root Cause Analysis (RCA) for NHS staff. Three levels of training are provided; a one day training (“borrowed from Australia”); a three day ‘train the trainer’ program; and a longer Master Class. The NPSA is working closely with the NHS Modernisation Agency’s Clinical Governance Support Unit (Leicester) on this initiative. An incident decision tree for managers was being piloted at the time of my visit. Public Involvement: The NPSA also responds to inquiries and patient concerns; on average ten patient complaints are received each month. At the time of my visit, the NPSA did not have the authority to investigate complaints. It was not clear whether this would change with the establishment of CHAI. An open disclosure framework is currently under development. One staff member interviewed commended the work on open disclosure being conducted in Australia. 16 NHS, National Patient Safety Agency, Business Plan, 2003 - 2004. 17 Sixty per cent of incidents involving infusion pumps were attributed to human error, the aim is to reduce the range and numbers of

pumps in use. Six pilot sites are involved, the project involves setting up an equipment library so that standardization and maintenance issue are more easily managed.

18 This project involves the use of hip protectors for elderly persons to reduce hip injuries to falls slips and trips. The project involves design issues and how female patients in particular can be encouraged to wear the protectors which are not that attractive.

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Sheffield Teaching Hospitals: The major focus of my visit to the Northern General Hospital (NGH) and Rotherham District General Hospital (RDGH) was to explore various risk management strategies in place in the clinical setting. One notable difference from my own institution, which is in place in the 2000 bed NGH, is an ICU nurse outreach service. Two experienced clinical nurses run the service, which aims to better manage the transition of patients from ICU to the general wards. Patients enter the outreach program following an assessment using the Patient at Risk (PAR) Score. The outreach nurses provide advice on patient management and also training for ward staff. The ward staff is also able to contact the ICU outreach nurse for any other patients they feel are at risk. In addition an ICU follow up clinic service is conducted. The outreach nurses showed a strong interest in the medical emergency team in place within Australian hospitals. From discussions it seems that the ICU outreach service and the MET each meet differing needs of the ward patient. Further research comparing the MET concept with that of an ICU outreach service would be interesting. Clinical staff (medical and nursing) have the opportunity of receiving training in early recognition of critical illness through the Alert Program developed by the Portsmouth Health Trust.

Acute Life threatening Events Recognition Treatment

Scotland: The Scottish NHS is managed separately from the NHS in England and Wales. It is managed through the ‘Scottish Executive’ Health Department. In February 2003 the Scottish Executive published the White Paper Partnership for Care, which set out plans to improve health, modernise health services and also to deliver high quality care. A key theme of the health improvement plan was to dissolve NHS Trusts and to devolve Trust duties and responsibilities to new operating divisions. This devolution and the new structure were to remove barriers between primary and hospital care. Services are now slowly being amalgamated as one single NHS organisations. The statutory responsibilities of Trusts have also been amended so that the Trust Chief Executive Officer (CEO) is now accountable for the quality of care. The CEO is expected to ensure that local arrangements are in place to give him/her and the Trust board assurance that this duty is being met.

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“the task is to make sure that the machinery is working effectively, that the right information flow is flowing appropriately throughout the organisation and that action is being taken when required”19

NHS Quality Improvement Scotland: All Health Trusts in Scotland are required to comply with a number of reporting requirements set out by a number of regulating bodies. In 2003 these major organisations were amalgamated to form NHS Quality Improvement Scotland (QIS). The aim of QIS is to improve the quality of health care by setting clinical standards and monitoring performance. The organisations amalgamated were the Clinical Resource and Audit Group (CRAG) responsible for goals for clinical effectiveness; the Clinical Standards Board for Scotland (CSBS) responsible for the generic clinical governance standards; the Scottish Hospitals Advisory Service (SHAS) who were responsible for Performance Standards for vulnerable groups, the Health Technology Board for Scotland (HTBS), and the Nursing and Midwifery Practice Development Unit (NMPDU). The work of the Scottish Intercollegiate Guideline Network (SIGN) has also been incorporated Clinical Governance Reviews: Clinical governance reviews of Scottish Health Trusts had previously been conducted by the CSBS with local reports published in 2002. A second round of reviews had been conducted in 2002/2003. The Trusts had been reviewed against generic clinical governance standards developed by the CSBS. Trusts are currently being reviewed for specific aspects of their services rather than the organisation as a whole. This form of review commenced in 2003 with reviews of adult renal services and systems for infection control. Published reports provide a National overview supported by local reports. Clinical standards for the various aspects of Trust business, such as cleaning services, specialist palliative care, care of the aged in acute settings, diabetes and so on are currently being developed. They are also reviewed to determine implementation of Scottish Intercollegiate Guidelines Network (SIGN), which amusingly was described by one person interviewed as “the tartan version” of the NICE guidelines. I had the opportunity to visit NHS Tayside in the North of Scotland and also NHS Lothian (Edinburgh). My visit to NHS Tayside was mainly within the Acute Services of the Trust and in NHS Lothian within Primary Care Services. Shared Governance Model: NHS Tayside comprises Ninewells Hospital, Perth Hospital and associated Primary Care Services. It has a matrix organisational structure operating a shared governance model. Executives are assigned responsibility for across Trust services and work closely with the Directors of seven clinical groups: medicine and cardiovascular, critical care, musculoskeletal and accident and emergency, clinical support services, surgery and oncology, specialist services, and also women’s and child health.

19 NHS Lothian, Lothian University Hospitals Trust, Clinical Governance Strategy”, 2002/2003.

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The clinical governance strategies include the sharing of information across the Trust, “staff being up on the job”, a coordinated approach to clinical audit, a register of clinical effectiveness activities across the Trust and reports from clinical groups on their clinical governance activities. Staff is provided with incentives for being involved in clinical governance projects with the reward of an annual prize of ₤750. There is an emphasis on “working together as a team”. Staff from the ICU at Perth Hospital for example, are expected to transfer to the ICU in Ninewells Hospital (40 klms away) if their unit is not busy. This initiative involved “working closely with the unions” and staff from both units and now operates successfully with staff in both units requesting opportunities for an ICU rotation. There is also an emphasis on patient and public involvement with a focus on the patient. Through the work of the Patient Advice Liaison Service (PALS) there is a move away form the negative connotations of complaints. Each complaint is viewed as an opportunity to improve the service. The Director of Nursing is the Clinical Governance Lead for the organisation and also has the responsibility for the professional development and learning needs of all nurses. A training needs analysis has been conducted. This has resulted in the establishment of a sound nurse education and training strategy comprising a clinical skills program, clinical leadership training and also mandatory training. Strong university links support the development of additional ongoing training needs. Clinical Effectiveness: The Lothian Primary Care Trusts Clinical Governance Strategy was developed in 2001.

The Trust had been able to demonstrate an excellent track record in clinical effectiveness activity “dating back to and building on work of its

component predecessor organisations”20. In 2003 an explicit framework for clinical effectiveness was developed for implementation at all levels of the new NHS Lothian. It had been agreed that adopting a system wide approach to clinical quality programs would ensure the delivery of maximum health gain through quality assured clinical services. The framework would also facilitate a proactive approach to supporting and resourcing the clinical effectiveness programs, establish clinical effectiveness priorities, reduce duplication of effort, enable transparent monitoring of activity and outcomes and also encourage the sharing of good practices. A committee structure, clinical effectiveness groups and teams as well as a generic tool to assist in the planning, prioritisation and monitoring of programs support the strategy The framework integrates a number of accountabilities and reporting requirements as set out by the Scottish Executive Performance Assessment Framework, Generic Clinical Standards (CSBS), Goals for Clinical Effectiveness (CRAG), Performance Indicators for Vulnerable Groups (SHAS) and the Clinical Negligence and Other Risk Identity Scheme (CNORIS).

20 NHS Lothian, Lothian Primary Care Trust, “A Framework for Delivering Clinically Effective Services”, 2003, p. 3.

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The CRAG goals for clinical effectiveness are as follows: o Development of an explicit clinical effectiveness strategy o Appropriate infrastructure to support clinical audit and clinical effectiveness o A culture in which clinical effectiveness is integral to all clinical care o Clinical effectiveness programs which support priority setting are established

in all clinical areas and which demonstrate collaboration between professional groups and across organisations

o Increased public/patient participation o The ability to demonstrate that cost effectiveness issues are being addressed

along side clinical effectiveness. o Clinical effectiveness as a prominent feature of the health improvement

process o The ability to demonstrate that clinical effectiveness programs are informing

changes to practice, improvements in standards of care and providing best value

Clinical Guidelines: In Scotland more than 50 clinical guidelines have been developed by the Scottish Intercollegiate Guideline Network (SIGN). The guidelines have been developed using a collaborative approach involving a number of clinical experts. Both NHS Tayside and NHS Lothian have developed a SIGN guideline implementation and review process. The process involves the relevant clinical team, identifying implications for the Trust, changes required to current practice and time required for implementation. Risk Management: My visit to Sheffield University Hospitals, NHS Lothian and NHS Tayside21 consolidated my understanding of risk management and in particular the advantages of fully integrated incident monitoring and risk management systems. Each organisation had risk management strategies in place. There was recognition that “clinical risk needs to be a major part of the agenda”. Risk management teams supported the strategies. Risk registers were an important feature in all organizations. Teaching in risk management strategies and techniques was also very evident. The incentive for improved risk management systems in NHS Tayside and NHS Lothian was the introduction of CNORIS, a risk management scheme for the NHS in Scotland. It has two main aims. The first is to provide cost-effective claims management and financial risk pooling arrangements for all Scotland’s NHS Trusts and Health Boards22. The second is to encourage a rigorous and logical approach to risk management in both clinical and non-clinical sectors in the NHS. All Trusts and Boards are assessed against the CNORIS standards23 through an initial self-assessment followed by an official audit on site.

21 Both Trust also had well documented clinical governance frameworks. The Risk Management Standards (Scotland) are based on the

Australian and New Zealand Standards for Health Care. Many people that I met were impressed by the work that Australia had been doing.

22 A risk-pooling scheme also exists in the NHS for England & Wales. 23 This includes standards on learning from and responding to ‘adverse incident’ and ‘significant adverse event’.

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Risk Management Reporting Systems: NHS Tayside had the advantage of a strong Information Management and Technology (IM&T) Strategy due to a decision two years previously to combine resources and form a regional service24. The IM&T team comprised fourteen software developers and as a result NHS Tayside was able to build in-house systems to suit a range of needs. They had used their strength to build an electronic web based System for Managing Assessing Risk (SMART). The system has “everything in it”; all incidents, minutes of meetings, information on risks, reportable incident briefs, ‘flags’ to indicate when reviews and reports are due and also a training element. It also produced the organisation’s ‘risk register’, which more recently had been renamed to the ‘risk control plan’. They did this as they felt that the ‘risk register’ “conjured up a once only event”. The risk register identifies corporate risk and is linked to the business planning process. The planned second development phase of SMART is an electronic form25. The risk management team will form links through QIS with the NPSA who as previously mentioned were also working towards the development of an electronic form. NHS Lothian utilized a commercially produced Adverse Event and Reporting System with similar features to the SMART program. Incident reviews: In NHS Tayside, an Adverse Incident Management Group reviews all reported incidents. The incidents are assessed using a similar methodology to the Severity Assessment Code (SAC) implemented by the NSW Health Department. Reportable incident briefs and root cause analysis (RCAs) are required on all red category incidents. Complaints are also managed using a similar methodology. There is a large focus in the organisation of learning from mistakes. A simple and catchy method the ‘risk radar’ has been introduced to encourage staff to identify and manage risk.

Recognise the risk Analyse the risks Determine the current controls Action plan for improvement Review

Book tokens are also awarded to encourage staff as an incentive to report incidents. The organisation is also active in “disseminating lessons to be learnt” and risk alerts through safety newsletters. NHS Lothian has Critical Incident Review Group comprising senior management, clinicians and also members from the organisations clinical governance and risk management teams. This group had a remit to develop organisational policies and

24 Interestingly all staff had access to email. Managers who required access to other software applications within their realm of

responsibility can sign on to the system using a single password. The system was protected by “secure firewalls and an organisational email policy that was rigidly monitored”.

25 Phase three will include complaints management and phase four claims management.

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procedures for the reporting of incidents and to recommend Trust wide systems to ensure appropriate reporting and review.

“Patients are protected and we learn form our mistakes”

Conclusions: I feel fortunate to have been able to observe first hand the work being done in the NHS to improve patient safety. England and Wales have adopted slightly different approaches to those used in Scottish NHS; however, in essence national strategies to review and oversee the quality of health services had been successfully adopted. National strategies include changes to the role of senior health managers to incorporate responsibility for the quality of care, mandatory inspection of the effectiveness of clinical governance structures and activities of all Health Trusts, the establishment of Special Health Authorities and Boards to develop and monitor standards of care, the development National Service Frameworks and also Clinical Guidelines (NICE and SIGN) to guide the delivery of care which also includes a mandatory review to assess levels of implementation, development of risk pooling systems which encourage the implementation of robust risk management models, (also the subject of mandatory review), and clinical governance education and support programs for managers, through the NHS Modernisation Agency. My thoughts on benefits to the Australian Health System are in line with recommendations proposed in a report prepared by a team of health professionals from NSW Health, The Institute of Clinical Excellence and The University of NSW who recently visited the United Kingdom26. In particular the design and institution of “an inspection system to review clinical and organisational performance ………..and recommend remedial action”. Key areas in which I hope to be able to make important changes in my own Area Health Service include the strengthening of current clinical governance and risk management frameworks (already underway), the strengthening of organisational wide reporting and review of incidents and near misses, the implementation of an organizational wide clinical effectiveness strategy, the introduction of a corporate risk register and also clinical governance and risk management training for all managers. Areas I intend to keep in touch with are the reports of three projects currently being conducted by CHI. These are the development of an information management model, the development of a risk relationship model and development of a new audit and assessment tool to ensure consistency and scoring of Trusts under review. I will follow with interest the development of the NPSA National Reporting and Learning System and also the safety projects that they are currently conducting. I feel that my own health service would stand to gain from a number of the NPSA initiatives in particular standardisation of equipment devices and involvement of the patient in hand hygiene improvement initiatives.

26 Report . Study Tour of Clinical Governance in the NHS, M. Robinson, Dr I O’Rourke, & A/Proffessor J. Braithwaite.

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Important messages which were evident to me through all discussions and observations is the need to support patient safety and risk management strategies with funding and expertise, the importance of collaboration and the sharing of information, and the need to develop the whole of the organisation clinical governance, clinical effectiveness and risk management strategies in that are understood and respected by the clinical staff.

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Organisations Visited: Commission for Health Improvement Finsbury Towers 103-105 Bunhill Row London National Patient Safety Agency 4-8 Maple Street London WC1 02079279530 Ninewells Hospital Dundee DD1 9SY 01382632678 NHS Tayside Kings Cross Hospital Clepington Road Dundee 01382424171 NHS Lothian Stevenson House 555Gorgie Road Edinburgh EH11 3LG Rotherham District General Hospital Moorgate Road Rotherham South Yorkshire S60 2UD Northern General Hospital Herries Road Sheffield S5 7AU Royal Hospital for Sick Children 9 Sciennes Road Edinburgh EH9 1LF

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Royal Edinburgh Hospital Morningside Terrace Edinburgh EH10 5HF New Royal Infirmary of Edinburgh Little France Old Dalkeith Road Edinburgh EH16 4SA

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References: 1. NHS, Seven Steps to Patient Safety: A Guide for NHS Staff, National Patient Safety

Agency, 2003. 2. Department of Health, A First Class Service: Quality in the New NHS, NHS

Executive, 1988, UK. 3. Scaly G, and Donaldson J, The NHS’s 50th Anniversary, looking forward, clinical

governance and the drive for quality improvement in the new NHS in England, British Medical Journal, 317: 61-65, 1998.

4. Department of Health, Plan for England (July), ‘Priorities and Planning Framework 2003-2006, October 2002.

5. Department of Health, Learning from Bristol, The Department of Health’s Response to the Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984 – 1995, available at www.doh.gov.uk/bristoninquiryresponse, 2002.

6. National Patient Safety Agency Annual Report 2001-2002. 7. Department of Health, An organisation with a Memory, The Stationary Office, June

2000, available at www.doh.gov.uk/org.memreport.index.htm. 8. Department of Health, Building a Safer NHS for Patients, London, May 2001,

available at www.doh.gov.uk/buildsafenhs. 9. The prevention of intrathecal medication errors, a report to the Chief Medical

Officer, April 2002. 10. Improving Health in Wales, January 2001. 11. NHS, National Patient Safety Agency, Corporate Plan, 2002-2003. 12. NHS, National Patient Safety Agency, Business Plan, 2003-2004. 13. NHS Lothian, Lothian University Hospitals Trust, Clinical Governance Strategy,

2002/2003. 14. NHS Lothian, Lothian Primary Care Trust, “A Framework for Delivering Clinically

Effective Services”, 2003. Useful websites: Commission for Audit and Health Inspection, www.chai.org.uk Commission for Health Improvement, www.chi.nhs.uk NHS Modernisation Agency, www.modern.nhs.uk NHS Clinical Governance Support Team, (Leicester), www.cgsupport.nhs.uk NHS National Patient safety Agency, www.npsa.nhs.au NHS Quality Improvement Scotland, www.nhs.healthquality.org